Federal Register Vol. 81, No.70,

Federal Register Volume 81, Issue 70 (April 12, 2016)

Page Range21449-21697
FR Document

81_FR_70
Current View
Page and SubjectPDF
81 FR 21540 - Sunshine Act NoticePDF
81 FR 21533 - Sunshine Act MeetingPDF
81 FR 21592 - Sunshine Act MeetingPDF
81 FR 21608 - Sunshine Act Meeting NoticePDF
81 FR 21611 - In the Matter of Royale Globe Holding Inc., File No. 500-1; Order of Suspension of TradingPDF
81 FR 21534 - Sunshine Act Meeting NoticePDF
81 FR 21614 - Sunshine Act MeetingPDF
81 FR 21635 - Sunshine Act MeetingPDF
81 FR 21482 - Fisheries of the Exclusive Economic Zone off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management AreaPDF
81 FR 21548 - Sunshine Act MeetingsPDF
81 FR 21583 - Submission for OMB Review; 30-day Comment Request; The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Diseases Among Men and Women in Agriculture (NIEHS)PDF
81 FR 21541 - Applications for New Awards; Advanced Placement Test Fee ProgramPDF
81 FR 21643 - Notice of Information Collection Under OMB Emergency Review: Adoptive Family Relief Act Refund ApplicationPDF
81 FR 21538 - Export Trade Certificate of ReviewPDF
81 FR 21539 - Quarterly Update to Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of DutyPDF
81 FR 21449 - Aviation Training Device Credit for Pilot CertificationPDF
81 FR 21537 - Citric Acid and Certain Citrate Salts From the People's Republic of China: Notice of Court Decision Not in Harmony With Final Results of Countervailing Duty Administrative Review and Notice of Amended Final Results Pursuant to Court Decision; 2011PDF
81 FR 21481 - Atlantic Highly Migratory Species; Atlantic Bluefin Tuna FisheriesPDF
81 FR 21536 - Polyethylene Retail Carrier Bags From Thailand: Preliminary Results of Antidumping Duty Administrative Review; 2014-2015PDF
81 FR 21607 - Sequoyah State-of-the-Art Reactor Consequence AnalysesPDF
81 FR 21465 - Servicemembers' Group Life Insurance and Veterans' Group Life Insurance-Slayer's Rule ExclusionPDF
81 FR 21462 - Special Local Regulation; Chesapeake Bay, Between Sandy Point and Kent Island, MDPDF
81 FR 21535 - Transportation and Related Equipment Technical Advisory Committee; Notice of Partially Closed MeetingPDF
81 FR 21540 - US Air Force Exclusive Patent LicensePDF
81 FR 21547 - Information Collections Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
81 FR 21511 - Connect America Fund, ETC Annual Reports and Certification; Developing a Unified Intercarrier Compensation RegimePDF
81 FR 21546 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
81 FR 21534 - Information Systems, Technical Advisory Committee; Notice of Partially Closed MeetingPDF
81 FR 21535 - Sensors and Instrumentation Technical Advisory Committee; Notice of Partially Closed MeetingPDF
81 FR 21534 - Materials Technical Advisory Committee; Notice of Partially Closed MeetingPDF
81 FR 21593 - Submission for OMB Review, Comment Request, Proposed Collection; Guidelines for Grants to States Program Five-Year EvaluationsPDF
81 FR 21549 - Agency Information Collection Activities; Submission for OMB Review; Comment RequestPDF
81 FR 21479 - Medicaid Program; Deadline for Access Monitoring Review Plan SubmissionsPDF
81 FR 21553 - Proposed Information Collection Activity; Comment RequestPDF
81 FR 21662 - Continental Tire the Americas, LLC, Grant of Petition for Decision of Inconsequential NoncompliancePDF
81 FR 21660 - Mercedes-Benz USA LLC, Denial of Petition for Decision of Inconsequential NoncompliancePDF
81 FR 21663 - Morgan 3 Wheeler Limited, Denial of Petition for Decision of Inconsequential NoncompliancePDF
81 FR 21647 - Qualification of Drivers; Exemption Applications; VisionPDF
81 FR 21548 - Notice of Termination; 10468 Westside Community Bank, University Place, WashingtonPDF
81 FR 21589 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
81 FR 21649 - Qualification of Drivers; Exemption Applications; Diabetes MellitusPDF
81 FR 21655 - Qualification of Drivers; Exemption Applications; VisionPDF
81 FR 21659 - Stop Signal OverrunsPDF
81 FR 21497 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 21667 - Proposed Information Collection (Civilian Health And Medical Program of the Department of Veterans Affairs (CHAMPVA) Benefits-Application, Claim, Other Health Insurance & Potential Liability); Activity: Comment RequestPDF
81 FR 21545 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Indian Education Professional Development Grants Program: GPRA and Service Payback Data CollectionPDF
81 FR 21585 - Endangered and Threatened Wildlife and Plants; Application To Amend Incidental Take Permit; Revised Diversified Pacific Low-Effect Habitat Conservation Plan and Associated Documents, City of Redlands, San Bernardino County, CaliforniaPDF
81 FR 21587 - Application for an Enhancement of Survival Permit for the Proposed Springs Preserve Safe Harbor Agreement, Las Vegas, Clark County, NevadaPDF
81 FR 21548 - Notice of Termination; 10494 Syringa Bank, Boise, IdahoPDF
81 FR 21548 - Notice of Termination; 10169 St. Stephen State Bank, St. Stephen, MinnesotaPDF
81 FR 21549 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
81 FR 21549 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
81 FR 21533 - Submission for OMB Review; Comment RequestPDF
81 FR 21579 - Determination of Regulatory Review Period for Purposes of Patent Extension; GAZYVAPDF
81 FR 21555 - Determination of Regulatory Review Period for Purposes of Patent Extension; ADEMPASPDF
81 FR 21558 - EMD Serono; Withdrawal of Approval of a New Drug Application for LUVERISPDF
81 FR 21576 - Safety Considerations for Product Design To Minimize Medication Errors; Guidance for Industry; AvailabilityPDF
81 FR 21574 - Determination of Regulatory Review Period for Purposes of Patent Extension; APTIOMPDF
81 FR 21573 - Determination of Regulatory Review Period for Purposes of Patent Extension; APOQUELPDF
81 FR 21556 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Comparing Food Safety Knowledge, Attitude and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other ConsumersPDF
81 FR 21578 - Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Feed Regulatory Program StandardsPDF
81 FR 21577 - Donor Screening Recommendations To Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability; CorrectionPDF
81 FR 21558 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human SpecimensPDF
81 FR 21559 - Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for HearingPDF
81 FR 21480 - Migratory Bird Hunting; Final Frameworks for Migratory Bird Hunting RegulationsPDF
81 FR 21588 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
81 FR 21449 - Cyber Security at Fuel Cycle FacilitiesPDF
81 FR 21593 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards ConsiderationsPDF
81 FR 21506 - Mail Classification SchedulePDF
81 FR 21666 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Notice Regarding Unauthorized Access to Customer InformationPDF
81 FR 21645 - Petition for Exemption; Summary of Petition Received; Invictus Technical Solutions LLCPDF
81 FR 21478 - RESTORE Act Spill Impact Component AllocationPDF
81 FR 21550 - Emergency Funding for Puerto Rico Department of Health, Zika Virus OutbreakPDF
81 FR 21646 - Petition for Exemption; Summary of Petition Received; Cirrus Design CorporationPDF
81 FR 21642 - Reporting and Recordkeeping Requirements Under OMB ReviewPDF
81 FR 21644 - Petition for Exemption; Summary of Petition Received; Martin UAVPDF
81 FR 21644 - Petition for Exemption; Summary of Petition Received; The Dobbins CompanyPDF
81 FR 21645 - Petition for Exemption; Summary of Petition Received; AeroLogix Consulting Inc.PDF
81 FR 21646 - Petition for Exemption; Summary of Petition Received; Walt Disney Parks and Resorts U.S., Inc.PDF
81 FR 21642 - District of Columbia Disaster #DC-00007PDF
81 FR 21642 - Mississippi Disaster Number MS-00084PDF
81 FR 21641 - Texas Disaster Number TX-00465PDF
81 FR 21626 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order Granting Approval of Proposed Rule Change, as Modified by Amendment Nos. 1, 2, and 3 Thereto, Relating to the Listing and Trading of the Shares of the First Trust RiverFront Dynamic Europe ETF, First Trust RiverFront Dynamic Asia Pacific ETF, First Trust RiverFront Dynamic Emerging Markets ETF, and First Trust RiverFront Dynamic Developed International ETF of First Trust Exchange-Traded Fund IIIPDF
81 FR 21611 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Establish Fees for Options That Overlie a Reduced Value of the FTSE 100 Index and the FTSE China 50 IndexPDF
81 FR 21631 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule ChangeTo Amend Rule 1064PDF
81 FR 21623 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing of Proposed Rule Change To Amend Rule 952NY With Respect to Opening Trading in an Options SeriesPDF
81 FR 21639 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change to Rule 6.64 With Respect to Opening Trading in an Options SeriesPDF
81 FR 21632 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Order Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To Adopt an Early Trading Session and Three New Time-In-Force InstructionsPDF
81 FR 21620 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Order Approving Proposed Rule Change, as Modified by Amendment No. 1 Thereto, To Adopt an Early Trading Session and Three New Time-in-Force InstructionsPDF
81 FR 21636 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing of Proposed Rule Change Amending the Eighth Amended and Restated Operating Agreement of the ExchangePDF
81 FR 21615 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change, as Modified by Amendment No. 1 Thereto, Amending Section 4.01(a) of the NYSE Arca's Bylaws and NYSE Arca Rule 3.3 To Establish a Committee for Review as a Sub-Committee of the ROC and Making Conforming Changes to NYSE Arca RulesPDF
81 FR 21609 - Türkiye Sinai Kalkinma Bankasi A.Ş.; Notice of ApplicationPDF
81 FR 21551 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 21465 - Drawbridge Operation Regulation; Connecticut River, East Haddam, CTPDF
81 FR 21659 - FY16 Competitive Funding Opportunity: Grants for Buses and Bus Facilities and Low or No Emission Grant Programs; 5339(b) Grants for Buses and Bus Facilities Program and 5339(c) Low or No Emission Program-CorrectionPDF
81 FR 21582 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of MeetingPDF
81 FR 21584 - National Institute on Aging; Notice of Closed MeetingPDF
81 FR 21583 - Fogarty International Center; Notice of MeetingPDF
81 FR 21585 - Center for Scientific Review; Notice of Closed MeetingPDF
81 FR 21582 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 21582 - Temporary Reassignment of State, Tribal, and Local Personnel During a Public Health Emergency; CorrectionPDF
81 FR 21581 - Office of Global Affairs: Stakeholder Listening Session in Preparation for the 69th World Health AssemblyPDF
81 FR 21581 - Announcement of Establishment of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 and Solicitation of Nominations for Membership; CorrectionPDF
81 FR 21554 - National Child Care Hotline and Web site; Comment request; CorrectionPDF
81 FR 21472 - 1,2-Propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl] propoxy]-; Exemption From the Requirement of a TolerancePDF
81 FR 21468 - Approval and Promulgation of Air Quality Implementation Plans; Colorado; Revisions to Common Provisions and Regulation Number 3; CorrectionsPDF
81 FR 21470 - Approval and Promulgation of Implementation Plans; Spokane, Washington: Second 10-Year PM10PDF
81 FR 21491 - Airworthiness Directives; Bombardier, Inc. AirplanesPDF
81 FR 21591 - Aluminum: Competitive Conditions Affecting the U.S. Industry Institution of Investigation and Scheduling of HearingPDF
81 FR 21590 - Silicomanganese From AustraliaPDF
81 FR 21495 - Airworthiness Directives; Bombardier, Inc. AirplanesPDF
81 FR 21489 - Airworthiness Directives; Pacific Aerospace Limited AirplanesPDF
81 FR 21501 - Airworthiness Directives; Textron Aviation Inc. AirplanesPDF
81 FR 21484 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 21486 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 21503 - Airworthiness Directives; Bombardier, Inc. AirplanesPDF
81 FR 21493 - Airworthiness Directives; Airbus HelicoptersPDF
81 FR 21552 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
81 FR 21671 - Air Plan Approval; Minnesota and Michigan; Revision to 2013 Taconite Federal Implementation Plan Establishing BART for Taconite PlantsPDF

Issue

81 70 Tuesday, April 12, 2016 Contents Agriculture Agriculture Department See

Rural Utilities Service

AIRFORCE Air Force Department NOTICES Exclusive Patent Licenses, 21540-21541 2016-08378 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 21551-21552 2016-08297 Emergency Funding for Puerto Rico Department of Health, Zika virus Outbreak, 21550-21551 2016-08318 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicaid Program: Deadline for Access Monitoring Review Plan Submissions, 21479-21480 2016-08368 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 21552-21553 2016-08116 Chemical Chemical Safety and Hazard Investigation Board NOTICES Meetings; Sunshine Act, 21533-21534 2016-08526 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 21553 2016-08263 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Responding to Intimate Violence in Relationship Programs, 21553-21554 2016-08363 National Child Care Hotline and Web Site; Comment Request; Correction, 21554 2016-08283 Civil Rights Civil Rights Commission NOTICES Meetings; Sunshine Act, 21534 2016-08477 Coast Guard Coast Guard RULES Drawbridge Operations: Connecticut River, East Haddam, CT, 21465 2016-08296 Special Local Regulations: Chesapeake Bay, between Sandy Point and Kent Island, MD, 21462-21465 2016-08380 Commerce Commerce Department See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Unauthorized Access to Customer Information, 21666-21667 2016-08321 Corporation Corporation for National and Community Service NOTICES Meetings; Sunshine Act, 21540 2016-08548 Defense Department Defense Department See

Air Force Department

Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Indian Education Professional Development Grants Program: GPRA and Service Payback Data Collection, 21545-21546 2016-08347 Applications for New Awards: Advanced Placement Test Fee Program, 21541-21545 2016-08396 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Colorado; Revisions to Common Provisions and Regulation Number 3; Corrections, 21468-21470 2016-08274 Minnesota and Michigan; Revision to 2013 Taconite Federal Implementation Plan Establishing BART for Taconite Plants, 21672-21697 2016-07818 Spokane, WA; Second 10-Year PM10 Limited Maintenance Plan, 21470-21472 2016-08272 Exemptions from the Requirement of a Tolerance, 21472-21478 2016-08282 Federal Aviation Federal Aviation Administration RULES Aviation Training Device Credit for Pilot Certification, 21449-21462 2016-08388 PROPOSED RULES Airworthiness Directives: Airbus Airplanes, 21484-21488 2016-08253 2016-08255 Airbus Helicopters, 21493-21495 2016-08247 Boeing Company Airplanes, 21497-21501 2016-08349 Bombardier, Inc. Airplanes, 21491-21493, 21495-21497, 21503-21506 2016-08250 2016-08266 2016-08270 Pacific Aerospace Limited Airplanes, 21489-21491 2016-08261 Textron Aviation Inc. Airplanes, 21501-21503 2016-08259 NOTICES Petitions for Exemption; Summaries, 2016-08311 21644-21647 2016-08312 2016-08313 2016-08314 2016-08316 2016-08320 Federal Communications Federal Communications Commission PROPOSED RULES Connect America Fund, ETC Annual Reports and Certification; Developing a Unified Intercarrier Compensation Regime, 21511-21532 2016-08376 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2016-08374 21546-21548 2016-08377 Federal Deposit Federal Deposit Insurance Corporation NOTICES Terminations of Receiverships: St. Stephen State Bank; St. Stephen, MN, 21548 2016-08342 Syringa Bank; Boise, ID, 21548 2016-08343 Westside Community Bank; University Place, WA, 21548 2016-08357 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 21548-21549 2016-08417 Federal Motor Federal Motor Carrier Safety Administration NOTICES Qualification of Drivers; Exemption Applications: Diabetes Mellitus, 21649-21655 2016-08355 Vision, 21647-21649, 21655-21659 2016-08354 2016-08358 Federal Reserve Federal Reserve System NOTICES Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 21549 2016-08340 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 21549 2016-08341 Federal Trade Federal Trade Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 21549-21550 2016-08369 Federal Transit Federal Transit Administration NOTICES Funding Availabilities: Grants for Buses and Bus Facilities and Low or No Emission Grant Programs; Grants for Buses and Bus Facilities Program and Low or No Emission Program; Correction, 21659 2016-08295 Safety Advisories: Stop Signal Overruns, 21659-21660 2016-08353 Fish Fish and Wildlife Service RULES Migratory Bird Hunting: Final Frameworks for Migratory Bird Hunting Regulations; Corrections, 21480-21481 2016-08326 NOTICES Endangered and Threatened Species: Application to Amend Incidental Take Permit; Revised Diversified Pacific Low-Effect Habitat Conservation Plan and Associated Documents, City of Redlands, San Bernardino County, CA, 21585-21587 2016-08345 Permit Applications: Application for an Enhancement of Survival Permit for the Proposed Springs Preserve Safe Harbor Agreement, Las Vegas, Clark County, NV, 21587-21588 2016-08344 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Animal Feed Regulatory Program Standards, 21578-21579 2016-08331 Comparing Food Safety Knowledge, Attitude and Behavior Among English-dominant Hispanics, Spanish-dominant Hispanics, and Other Consumers, 21556-21558 2016-08332 Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens, 21558-21559 2016-08329 Determination of Regulatory Review Period for Purposes of Patent Extension: APTIOM, 21574-21576 2016-08334 Determination of Regulatory Review Periods: ADEMPAS, 21555-21556 2016-08337 APOQUEL, 21573-21574 2016-08333 GAZYVA, 21579-21581 2016-08338 Guidance: Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, etc.; Correction, 21577 2016-08330 Safety Considerations for Product Design to Minimize Medication Errors, 21576-21577 2016-08335 New Animal Drugs: Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing, 21559-21573 2016-08327 Withdrawals of Approvals of a New Drug Applications: EMD Serono LUVERIS, 21558 2016-08336 Gulf Coast Ecosystem Restoration Council Gulf Coast Ecosystem Restoration Council RULES RESTORE Act Spill Impact Component Allocation, 21478-21479 2016-08319 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

National Institutes of Health

NOTICES Committee Establishments and Requests for Nominations: Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030; Correction, 21581-21582 2016-08284 Meetings: Office of Global Affairs, 21581 2016-08287 Temporary Reassignment of State, Tribal, and Local Personnel During a Public Health Emergency; Correction, 21582 2016-08289
Homeland Homeland Security Department See

Coast Guard

Industry Industry and Security Bureau NOTICES Meetings: Information Systems Technical Advisory Committee, 21534 2016-08373 Materials Technical Advisory Committee, 21534-21535 2016-08371 Sensors and Instrumentation Technical Advisory Committee, 21535 2016-08372 Transportation and Related Equipment Technical Advisory Committee, 21535-21536 2016-08379 Institute of Museum and Library Services Institute of Museum and Library Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidelines for Grants to States Program Five-Year Evaluations, 21593 2016-08370 Interior Interior Department See

Fish and Wildlife Service

International Trade Adm International Trade Administration NOTICES Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of Duty; Quarterly Update, 21539-21540 2016-08389 Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Citric Acid and Certain Citrate Salts from the People's Republic of China, 21537-21538 2016-08387 Polyethylene Retail Carrier Bags from Thailand, 21536-21537 2016-08385 Export Trade Certificate of Review, 21538-21539 2016-08390 International Trade Com International Trade Commission NOTICES Complaints: Certain Digital Video Receivers and Hardware and Software Components Thereof, 21589-21590 2016-08356 Certain Portable Electronic Devices and Components Thereof, 21588-21589 2016-08325 Investigations; Determinations, Modifications, and Rulings, etc.: Aluminum: Competitive Conditions Affecting the U.S. Industry, 21591-21592 2016-08269 Silicomanganese from Australia, 21590-21591 2016-08268 Legal Legal Services Corporation NOTICES Meetings; Sunshine Act, 21592-21593 2016-08498 National Foundation National Foundation on the Arts and the Humanities See

Institute of Museum and Library Services

National Highway National Highway Traffic Safety Administration NOTICES Petitions for Decision of Inconsequential Noncompliance; Denials: Mercedes-Benz USA, LLC, 21660-21662 2016-08361 Petitions for Inconsequential Noncompliance: Continental Tire the Americas, LLC, 21662-21663 2016-08362 Morgan 3 Wheeler, Ltd., 21663-21666 2016-08360 National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Diseases among Men and Women in Agriculture, 21583-21584 2016-08397 Meetings: Center for Scientific Review, 2016-08290 21582, 21585 2016-08291 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 21582-21583 2016-08294 Fogarty International Center, 21583 2016-08292 National Institute on Aging, 21584-21585 2016-08293 National Oceanic National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species: Atlantic Bluefin Tuna Fisheries, 21481-21482 2016-08386 Fisheries of the Exclusive Economic Zone Off Alaska: Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area, 21482-21483 2016-08419 Nuclear Regulatory Nuclear Regulatory Commission RULES Cyber Security at Fuel Cycle Facilities, 21449 2016-08324 NOTICES Facility Operating Licenses: Applications and Amendments Involving Proposed No Significant Hazards Considerations, etc., 21593-21607 2016-08323 Meetings: Sequoyah State-of-the-Art Reactor Consequence Analyses, 21607-21608 2016-08383 Meetings; Sunshine Act, 21608 2016-08486 Postal Regulatory Postal Regulatory Commission PROPOSED RULES Mail Classification Schedule, 21506-21511 2016-08322 Rural Utilities Rural Utilities Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 21533 2016-08339 Securities Securities and Exchange Commission NOTICES Applications: Turkiye Sinai Kalkinma Bankasi A.S., 21609-21611 2016-08298 Meetings; Sunshine Act, 21614, 21635-21636 2016-08445 2016-08446 Self-Regulatory Organizations; Proposed Rule Changes: Chicago Board Options Exchange, Inc., 21611-21614 2016-08306 EDGA Exchange, Inc., 21620-21623 2016-08301 EDGX Exchange, Inc., 21632-21635 2016-08302 NASDAQ PHLX, LLC, 21631-21632 2016-08305 NASDAQ Stock Market, LLC, 21626-21631 2016-08307 NYSE Arca, Inc., 21615-21620, 21639-21641 2016-08299 2016-08303 NYSE MKT, LLC, 21623-21626, 21636-21639 2016-08300 2016-08304 Trading Suspension Orders: Royale Globe Holding Inc., 21611 2016-08484 Small Business Small Business Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 21642 2016-08315 Disaster Declarations: District of Columbia, 21642 2016-08310 Mississippi; Amendment 1, 21642-21643 2016-08309 Texas; Amendment 2, 21641-21642 2016-08308 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Adoptive Family Relief Act Refund Application, 21643-21644 2016-08391 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Motor Carrier Safety Administration

See

Federal Transit Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department See

Comptroller of the Currency

Veteran Affairs Veterans Affairs Department RULES Servicemembers' Group Life Insurance and Veterans' Group Life Insurance: Slayer's Rule Exclusion, 21465-21468 2016-08381 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Civilian Health and Medical Program of the Department of Veterans Affairs Benefits--Application, Claim, Other Health Insurance and Potential Liability, 21667-21669 2016-08348 Separate Parts In This Issue Part II Environmental Protection Agency, 21672-21697 2016-07818 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.

To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.

81 70 Tuesday, April 12, 2016 Rules and Regulations NUCLEAR REGULATORY COMMISSION 10 CFR Part 73 [NRC-2015-0179] RIN 3150-AJ64 Cyber Security at Fuel Cycle Facilities AGENCY:

Nuclear Regulatory Commission.

ACTION:

Final regulatory basis; availability.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) is making available a final regulatory basis document to support a rulemaking that would amend its regulations by adopting new cyber security requirements for certain nuclear fuel cycle facility (FCF) licensees in order to address safety, security, and safeguards consequences of concern. The NRC is not seeking public comments on this document. There will be an opportunity for formal public comment on the proposed rule when it is published in the Federal Register.

DATES:

The final regulatory basis is publicly available April 12, 2016.

ADDRESSES:

Please refer to Docket ID NRC-2015-0179 when contacting the NRC about the availability of information for this document. You may obtain publicly-available information related to this document by any of the following methods:

Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0179. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

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

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

FOR FURTHER INFORMATION CONTACT:

Matthew Bartlett, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7154; email [email protected]

SUPPLEMENTARY INFORMATION:

I. Background

In a September 4, 2015, Federal Register document (80 FR 53478), the NRC solicited comment from members of the public on a draft regulatory basis addressing the need for a rulemaking to implement cyber security for FCFs. The public comment period ended on October 5, 2015. The NRC received a total of 9 comment submissions from nongovernment organizations and industry. The NRC staff reviewed and considered the comments in finalizing the regulatory basis. The final regulatory basis is available in ADAMS under Accession No. ML15355A466 or on the Federal rulemaking Web site, www.regulations.gov, under Docket ID NRC-2015-0179.

II. Publicly-Available Documents

As the NRC continues its ongoing proposed rulemaking effort to implement cyber security requirements for FCFs in part 73 of title 10 of the Code of Federal Regulations, the NRC is making documents publicly available on the Federal rulemaking Web site, www.regulations.gov, under Docket ID NRC-2015-0179. By making these documents publicly available, the NRC seeks to inform stakeholders of the current status of the NRC's rulemaking development activities and to provide preparatory material for future public meetings.

The NRC may post additional materials relevant to this rulemaking at www.regulations.gov, under Docket ID NRC-2015-0179. Please take the following actions if you wish to receive alerts when changes or additions occur in a docket folder: (1) Navigate to the docket folder (NRC-2015-0179); (2) click the “Email Alert” link; and (3) enter your email address and select how frequently you would like to receive emails (daily, weekly, or monthly).

III. Plain Writing

The Plain Writing Act of 2010, (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, well-organized manner that also follows other best practices appropriate to the subject or field and the intended audience. Although regulations are exempt under the Act, the NRC is applying the same principles to its rulemaking documents. Therefore, the NRC has written this document to be consistent with the Plain Writing Act.

Dated at Rockville, Maryland, this 1st day of April, 2016.

For the Nuclear Regulatory Commission.

Shana R. Helton, Acting Deputy Director, Division of Fuel Cycle Safety, Safeguards, and Environmental Review, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2016-08324 Filed 4-11-16; 8:45 am] BILLING CODE 7590-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Parts 61 and 141 [Docket No.: FAA-2015-1846; Amdt. Nos. 61-136, 141-18] RIN 2120-AK71 Aviation Training Device Credit for Pilot Certification AGENCY:

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

ACTION:

Final rule.

SUMMARY:

This rulemaking relieves burdens on pilots seeking to obtain aeronautical experience, training, and certification by increasing the allowed use of aviation training devices. These actions are necessary to bring the regulations in line with the current capabilities of aviation training devices and the needs and activities of the general aviation training community and pilots.

DATES:

This rule is effective May 12, 2016.

ADDRESSES:

For information on where to obtain copies of rulemaking documents and other information related to this final rule, see “How To Obtain Additional Information” in the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

Marcel Bernard, Airmen Certification and Training Branch, Flight Standards Service, AFS-810, Federal Aviation Administration, 898 Airport Park Road, Suite 204, Glen Burnie, MD 21061; telephone: (410) 590-5364 x235 email [email protected]

SUPPLEMENTARY INFORMATION: I. Executive Summary

This rule finalizes the notice of proposed rulemaking (NPRM) regarding the use of aviation training devices for pilot certification. 80 FR 34338 (Jun. 16, 2015). The NPRM proposed to increase the maximum time that may be credited in an aviation training device (ATD) toward the aeronautical experience requirements for an instrument rating under § 61.65(i). The NPRM proposed to permit a person to credit a maximum of 20 hours of aeronautical experience acquired in an approved ATD toward the requirements for an instrument rating. By letter of authorization (LOA), devices that qualify as advanced aviation training devices (AATDs) were proposed to be authorized for up to 20 hours of experience to meet the instrument time requirements. Devices that qualify as basic aviation training devices (BATDs) were proposed to be authorized, by LOA, for a maximum of 10 hours of experience to meet the instrument time requirements.

Based on the comments received to the NPRM, the FAA is revising § 61.65 to include a specified allowance of 10 hours for BATDs and 20 hours for AATDs in part 61 (combined use not to exceed 20 hours) for the instrument rating.

The NPRM also addressed the use of ATDs in approved instrument rating courses. The NPRM proposed to amend appendix C to part 141 to increase the limit on the amount of training hours that may be accomplished in an ATD in an approved course for an instrument rating. The FAA proposed to allow ATDs to be used for no more than 40% of the total flight training hour requirements in an approved instrument rating course.

Based on the comments received to the NPRM, the FAA is revising appendix C to part 141 to include a specified allowance of 25% of creditable time in BATDs 1 and 40% of creditable time for AATDs under part 141 (not to exceed 40% total time) for the instrument rating.

1 If a course of training is approved under the minimum requirements as prescribed in part 141, appendix C, for the instrument rating (35 hours of training required), 25% in a BATD would equate to 8.75 hours and 40% in an AATD would equate to 14 hours.

Currently, § 61.65(i) requires a pilot who is logging instrument time in an ATD to wear a view-limiting device. The NPRM proposed to revise § 61.65(i)(4) to eliminate the requirement that pilots accomplishing instrument time in an ATD wear a view-limiting device. The FAA is finalizing this proposal without change.

II. Authority for This Rulemaking

The FAA's authority to issue rules on aviation safety is found in Title 49 of the United States Code (49 U.S.C.). 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 49 U.S.C. 106(f), which establishes the authority of the Administrator to promulgate regulations and rules; 49 U.S.C. 44701(a)(5), which requires the Administrator to promote safe flight of civil aircraft in air commerce by prescribing regulations and setting minimum standards for other practices, methods, and procedures necessary for safety in air commerce and national security; and 49 U.S.C. 44703(a), which requires the Administrator to prescribe regulations for the issuance of airman certificates when the Administrator finds, after investigation, that an individual is qualified for, and physically able to perform the duties related to, the position authorized by the certificate.

III. Background

Since the 1970s, the FAA has gradually expanded the permitted use of flight simulation for training—first permitting simulation to be used in air carrier training programs and eventually permitting pilots to credit time in devices toward the aeronautical experience requirements for airman certification and recency. Currently, title 14 of the Code of Federal Regulations (14 CFR) part 60 governs the qualification of flight simulation training devices (FSTDs), which include full flight simulators (FFSs) level A through D and flight training devices (FTDs) levels 4 through 7. The FAA has, however, approved other devices, including ATDs, for use in pilot certification training, under the authority provided in 14 CFR 61.4(c).2

2 Section 61.4(c) states that the “Administrator may approve a device other than a flight simulator or flight training device for specific purposes.”

For over 30 years, the FAA has issued LOAs to manufacturers of ground trainers, personal computer-based aviation training devices (PCATD), FTDs (levels 1 through 3), BATDs, and AATDs. These LOAs were based on guidance provided in advisory circulars (ACs) that set forth the qualifications and capabilities for the devices. Prior to 2008, most LOAs were issued under the guidance provided in AC 61-126, Qualification and Approval of Personal Computer-Based Aviation Training Devices, and AC 120-45, Airplane Flight Training Device Qualification. Starting in July 2008, the FAA approved devices in accordance with AC 61-136, FAA Approval of Basic Aviation Training Devices (BATD) and Advanced Aviation Training Devices (AATD). More recently, on December 3, 2014, the FAA published a revision to AC 61-136A, Approval of Aviation Training Devices and Their Use for Training and Experience.

In 2009, the FAA issued a final rule that for the first time introduced the term “aviation training device” into the regulations and placed express limits on the amount of instrument time in an ATD that could be credited toward the aeronautical experience requirements for an instrument rating.3

3 In a 2007 NPRM, the FAA proposed to limit the time in a personal computer-based aviation training device that could be credited toward the instrument rating. Pilot, Flight Instructor, and Pilot School Certification NPRM, 72 FR 5806 (Feb. 7, 2007). Three commenters recommended that the FAA use the terms “basic aviation training device” (BATD) and “advanced aviation training device” (AATD). Pilot, Flight Instructor, and Pilot School Certification Final Rule, 74 FR 42500 (Aug. 21, 2009) (“2009 Final Rule”). In response to the commenters, the FAA changed the regulatory text in the final rule to “aviation training device,” noting BATDs and AATDs “as being aviation training devices (ATD) are defined” in an advisory circular.

Since the 2009 final rule, § 61.65(i) has provided that no more than 10 hours of instrument time received in an ATD may be credited toward the instrument time requirements of that section. In addition, appendix C to part 141 permits an ATD to be used for no more than 10% of the total flight training hour requirements of an approved course for an instrument rating.

Prior to the 2009 final rule, the FAA had issued hundreds of LOAs to manufacturers of devices that permitted some ATDs (as well as ground trainers, and FTDs (levels 1 through 3)) to be used to a greater extent than was ultimately set forth in the regulations. The FAA continued to issue LOAs for AATDs in excess of the express limitations in the regulations after the publication of the 2009 final rule.

On January 2, 2014, the FAA published a notice of policy requiring manufacturers of ATDs to obtain new LOAs reflecting the appropriate regulatory allowances for ATD use. 79 FR 20.4 The notice of policy stated the FAA's conclusion that it could not use LOAs to exceed express limitations that had been placed in the regulations through notice and comment rulemaking. The FAA noted that, since August 2013, LOAs issued for new devices reflect current regulatory requirements. However, manufacturers and operators who held LOAs issued prior to August 2013 acted in reliance on FAA statements that were inconsistent with the regulations. Therefore, the FAA granted a limited exemption from the requirement in the regulations to provide manufacturers, operators, and pilots currently training for an instrument rating time to adjust to the reduction in creditable hours. This short-term exemption was intended to provide an interim period to transition the LOAs for all previously approved devices in accordance with the new policy. The FAA found the exemption to be in the public interest in order to prevent undue harm caused by reasonable reliance on the LOAs.

4 “Notice of Policy Change for the Use of FAA Approved Training Devices,” January 2, 2014.

As stated in the notice of policy, this short term exemption expired on January 1, 2015. The FAA explained that after that date, no applicant training for an instrument rating under part 61 may use more than 10 hours of instrument time in an ATD toward the minimum aeronautical experience requirements required to take the practical test for an instrument rating.5 In addition, no instrument rating course approved under appendix C to part 141 may credit more than 10% of training in ATDs toward the total flight training hour requirements of the course (unless that program has been approved in accordance with § 141.55(d) or (e)).6

5 Under § 61.65, a person who applies for an instrument rating must have completed 40 hours of actual or simulated instrument time of which 15 hours must have been with an authorized instructor who holds the appropriate instrument rating.

6 Under appendix C, each approved course for an instrument rating must include 35 hours of instrument training for an initial instrument rating or 15 hours of instrument training for an additional instrument rating.

To address the discrepancy between the level of ATD credit allowed historically by LOA and the lower allowances placed in the regulations, the FAA published a direct final rule that would have amended the regulations governing the use of ATDs.7 The direct final rule would have increased the use of these devices for instrument training requirements above the levels established in the 2009 final rule. In developing this direct final rule, the FAA noted that ATD development has advanced to an impressive level of capability. Many ATDs can simulate weather conditions with variable winds, variable ceilings and visibility, icing, turbulence, high definition (HD) visuals, hundreds of different equipment failure scenarios, navigation specific to current charts and topography, specific navigation and communication equipment use, variable “aircraft specific” performance, and more. The visual and motion component of some of these devices permit maneuvers that require outside visual references in an aircraft to be successfully taught in an AATD. Many of these simulation capabilities were not possible in previously approved devices (such as PCATDs).

7 79 FR 71634, Dec. 3, 2014, withdrawn at 80 FR 2001, Jan. 15, 2015 (RIN 2120-AK62).

In the direct final rule, the FAA stated its belief that permitting pilots to log increased time in ATDs would encourage pilots to practice maneuvers until they are performed to an acceptable level of proficiency. In an ATD, a pilot can replay the training scenario, identify any improper action, practice abnormal/emergency procedures, and determine corrective actions without undue hazard or risk to persons or property. In this fashion, a pilot can continue to practice tasks and maneuvers in a safe, effective, and cost efficient means of maintaining proficiency.

IV. The Direct Final Rule

As described in the previous section, to address the discrepancy between FAA regulations and prior policy, on December 3, 2014, the FAA published a direct final rule that would have increased the allowed use of ATDs. The FAA received 20 comments to the direct final rule.8

8 The direct final rule and the comments received thereto may be found in FAA Docket No. FAA-2014-0987 at http://www.regulations.gov.

Credit for aeronautical experience requirements for an instrument rating: The direct final rule would have increased the maximum time that may be credited in an ATD toward the aeronautical experience requirements for an instrument rating under § 61.65(i). The direct final rule would have permitted a person to credit a maximum of 20 hours of aeronautical experience acquired in an approved ATD toward the requirements for an instrument rating. Devices that qualify as AATDs would have been authorized for up to 20 hours of experience to meet the instrument time requirements. Devices that qualify as BATDs would have been authorized for a maximum of 10 hours of experience to meet the instrument time requirements.

Approved instrument rating courses: The direct final rule also would have amended appendix C to part 141 to increase the limit on the amount of training hours that may be accomplished in an ATD in an approved course for an instrument rating. An ATD would have been permitted to be used for no more than 40% of the total flight training hour requirements in an approved instrument rating course.

Comments received: The FAA received 20 comments regarding these provisions. Eighteen comments supported the provisions. However, two commenters raised concerns. As those comments were adverse to the direct final rule, the FAA was required to withdraw the direct final rule, 80 FR 2001, (Jan. 15, 2015). 14 CFR 11.13. The comments received to the direct final rule and FAA's responses were discussed in the notice of proposed rulemaking published June 16, 2015. 80 FR 34338.

View-limiting devices: Under § 61.51(g), a person may log instrument time only for that flight time when the person operates an aircraft solely by reference to the instruments under actual or simulated conditions. When instrument time is logged in an aircraft, a pilot wears a view-limiting device to simulate instrument conditions and ensure that he or she is flying without utilizing outside visual references. Currently, § 61.65(i) requires a pilot who is logging instrument time in an ATD to wear a view-limiting device. The direct final rule would have revised § 61.65(i)(4) to eliminate the requirement that pilots accomplishing instrument time in an ATD wear a view-limiting device.

The purpose of a view-limiting device is to prevent a pilot (while training in an aircraft during flight) from having outside visual references that would naturally be present otherwise. These references are not available in a training device and a pilot has no opportunity to look outside for any useful visual references pertaining to the simulation. The FAA recognizes that the majority of these devices have a simulated visual display that can be configured to be unavailable or represent “limited visibility” conditions that preclude any need for a view-limiting device to be worn by the student. This lack of visual references requires the pilot to give his or her full attention to the flight instruments which is the goal of any instrument training or experience. The FAA believes that using a training device can be useful because it trains the pilot to focus on, appropriately scan and interpret the flight instruments. Since these devices incorporate a visual system that can be configured to the desired visibility level, use of a view-limiting device would have no longer been required by the direct final rule.

When the FAA introduced § 61.65(i)(4) requiring view-limiting devices in the 2009 final rule, the preamble was silent as to why a view-limiting device was necessary. 74 FR 42500, 42523. Based on comments from industry, the FAA has determined that due to the sophistication of the flight visual representation for ATDs and the capability of presenting various weather conditions appropriate to the training scenario, a view-limiting device is unnecessary. Because persons operating an ATD can simulate both instrument and visual conditions, FAA LOAs specifically reference § 61.51 that stipulates a pilot can log instrument time only when operating the aircraft solely by reference to the instruments in actual or simulated instrument flight conditions.9

9 AC 61-136A Appendix 4, Training Content and Logging Provisions references limitations for logging instrument time.

Comments received: The FAA received one comment in response to this provision in the direct final rule. The comment received to the direct final rule and FAA's response were discussed in the notice of proposed rulemaking published June 16, 2015. 80 FR 34338.

V. The Proposed Rule

After consideration of the comments received to the direct final rule, on June 16, 2015, the FAA published a notice of proposed rulemaking (80 FR 34338) proposing the following changes to 14 CFR parts 61 and 141. These changes were the same as in the direct final rule, 79 FR 71634, (Dec. 3, 2014), withdrawn at 80 FR 2001, (Jan. 15, 2015).

The FAA received a total of 60 comments to the notice of proposed rulemaking, 50 from individuals; five from flight schools; three from organizations representing pilots and flight instructors, including the Society of Aviation and Flight Educators (SAFE), the Aircraft Owners and Pilots Association (AOPA), and the National Association of Flight Instructors (NAFI); one from an anonymous commenter purporting to represent Garmin International; and one from ATD manufacturer Redbird Flight Simulations. The proposed provisions, the comments received, and FAA's responses are discussed in the following sections.

A. Credit for the Aeronautical Experience Requirements for an Instrument Rating and Approved Instrument Rating Courses

The FAA proposed to increase the maximum time that may be credited in an ATD toward the instrument time requirements for an instrument rating under § 61.65(i). A person would be permitted to credit a maximum of 20 hours of instrument time in an approved ATD toward the requirements for an instrument rating.10 Devices that qualify as AATDs would be authorized for up to 20 hours of instrument time. Devices that qualify as BATDs would be authorized for a maximum of 10 hours of instrument time. In light of this difference, pilots must—as required by current regulations—include in their logbooks the type and identification of any ATD that is used to accomplish aeronautical experience requirements for a certificate, rating, or recent flight experience. 14 CFR 61.51(b)(1)(iv). The FAA is retaining the existing limit of 20 hours of combined time in FFSs, FTDs, and ATDs that may be credited towards the aeronautical experience requirements for an instrument rating.

10 As required under § 61.51(g)(4), to log instrument time in an ATD for the purpose of a certificate or rating, an authorized instructor must be present.

The FAA also proposed to amend appendix C to part 141 to increase the limit on the amount of training hours that may be accomplished in an ATD in an approved course for an instrument rating. An ATD could be used for no more than 40% of the total flight training hour requirements in an instrument rating course. The proposed rule did not change the current provisions in appendix C which limit credit for training in FFSs, FTDs, and ATDs, that if used in combination, cannot exceed 50% of the total flight training hour requirements of an instrument rating course.

In addition, the FAA proposed to amend § 141.41 to clarify the existing qualification and approval requirement for FSTDs and to add the qualification and approval of ATDs by the FAA, which is currently conducted pursuant to § 61.4(c).

1. Comments Supporting the Proposed Provisions

The FAA received 57 comments in support of these proposed provisions, with 47 from individuals and 10 from organizations. Of the 57 comments received in support of the proposed rule, five recommended changes to the proposed regulations.

Nineteen individual commenters provided general support for the proposed rule. Nine commenters who identified themselves as pilots who had used ATDs for their own training provided support for the rule. They emphasized the value of being able to have a flight instructor pause the training, discuss the scenario, provide instant feedback and additional instruction, and then continue the training session. These individuals also believed that their training was enhanced by the ability to focus on the specific training tasks and ensure accurate, appropriate learning of the lesson. Commenters also noted that in an ATD instructors can focus solely on teaching rather than dividing their focus between teaching important instrument skills and general aircraft operations.

Commenters also emphasized the value of being presented with training scenarios that cannot be accomplished safely in the aircraft. Commenters cited emergency procedures, flight into thunderstorms, icing, and turbulent conditions as primary examples of conditions that can be simulated safely in ATDs.

SAFE, NAFI, and Redbird Flight Simulations also noted the ability of current ATDs to simulate a variety of aircraft types and configurations, as well as to simulate various conditions inside and outside the aircraft.

A number of individual commenters also noted the value, both financial and time saving, of accomplishing more repetitions in the same amount of time when using an ATD as opposed to using an aircraft. Two individual commenters estimated that time in an approved simulator with an instructor costs about $100 per hour, while dual time in an instrument flight rules-certified aircraft is $200 per hour or more. These commenters asserted that adding an extra 10 hours of simulator time cuts $1,000 from the overall training cost. NAFI also noted that because the training is independent of weather and air traffic control conditions, a training syllabus can be followed more closely with use of the ATDs and the student can avoid unplanned, non-productive time delays when attempting to practice a procedure.

Thirteen commenters who identified themselves as flight instructors supported the rule. They echoed the sentiments of those commenters who identified themselves as pilots who had used ATDs for their own training. Commenters discussed the belief that ATDs save lives, reduce training time and cost, reduce atmospheric and noise pollution, and produce safer pilots. They particularly noted the ability to train scenarios that would not be trained using an aircraft—thunderstorms, icing, etc. They emphasized the value of scenario-based training, followed closely by training in an aircraft. These commenters noted the importance of being able to train students regarding emergency procedures using meaningful repetition, until the commenters confirm the student's mastery of those skills. AOPA supported this view, stating that simulator training for an instrument rating allows instructors to provide a safer, more effective training experience. Redbird Flight Simulations also supported this view, stating that the ATD is the ideal place to learn, ask questions and practice, and the aircraft is the place where the student demonstrates what he or she has learned and can focus on gaining real-world flying experience with the basic fundamental instrument skills already engrained.

A few commenters noted that students whom they had trained initially in ATDs found the experience so useful that they returned for recurrent training in those same ATDs. One commenter noted FAA's inferred endorsement of the use of AATDs in Instrument Practical Test Standard (FAA-S-8081-4E, Chg 5) by the inclusion of tasks for an instrument proficiency check which may be credited using an AATD.

Five commenters commenting on behalf of flight schools also concurred with these comments. These commenters discussed the ability for pilots to practice situations and procedures that would not “normally” be possible to accomplish safely in an aircraft, including various weather conditions and simulated instrument failures. Commenters focused on the unique training that ATDs allow instructors to provide. As two commenters noted,

Aircraft are not classrooms and as such they are poor environments for learning. The AATDs allow for students experiencing difficult learning situations the opportunity to repeat the lesson easily, safely and as frequently as needed. Importantly, the instructor is able to focus entirely on teaching rather than splitting his/her attention on traffic, ATC instructions and safe aircraft operation.11

11 Stephen Cunningham, Docket No. FAA-2015-1846-0034. Anonymous, Docket No. FAA-2015-1846-0038.

These commenters emphasized that ATDs are only one component of the training curriculum and process, and that all learning in an ATD would be accompanied by training in the aircraft. They also noted that ATDs and aircraft do not replace each other. NAFI agreed, pointing out that a significant portion of training would still be required in an aircraft under the proposed regulations.

Commenters, including SAFE and several individuals, noted the use of simulators by other industries, including the United States military and air carriers. SAFE specifically cited a 1998 United States Air Force study regarding the transfer of training effectiveness.12

12 Carretta, Thomas R., and Dunlap, Ronald D. “Transfer of Training Effectiveness in Flight Simulation: 1986-1997.” United States Air Force Research Laboratory, 1998. http://www.dtic.mil/get-tr-doc/pdf?AD=ADA362818.

FAA Response: The FAA agrees with the commenters who support increased training time allowances in ATDs, including the statements discussing the increased dynamic training capability of these devices, cost savings, time savings, effective use of scenario-based training, and recent technical advancements that enhance the capabilities of ATDs. With over 30 years of experience evaluating, approving, and providing oversight for FSTDs and over 10 years approving ATDs, the FAA recognizes their evolving capabilities, safety benefits, and improved design justifying their increased use and credit for minimum pilot experience requirements.

One commenter noted the safety benefit of ATDs related to decommissioning of very high frequency omni-directional radio range (VORs), non-directional beacons (NDBs), the scarcity of localizer back-courses, and scarcity of outer markers. The commenter noted that the practical test standards still require the demonstration of a VOR approach for an instrument candidate. As the commenter explained:

Thus, instrument instructors must use a more limited set of VORs to conduct VOR instrument approach training, resulting in greater congestion around VORs during training maneuvers. Numerous FAA publications suggest avoiding concentrations around VORS, such as FAA-P-8740-51, `How to Avoid a Midair Collision.' When one considers finding VOR approaches located on the airport (without a final approach fix) and those conducted off airport (those with a final approach fix), the amount of time an instructor must spend exposed to the risk of a midair collision is quite large. The risk of a midair collision is non-existent in an ATD.13

13 Anonymous, Docket No. FAA-2015-1846-0035.

FAA Response: The FAA agrees with the commenter that ATDs provide for unlimited choices when practicing electronic navigation, including instrument approaches, and the safety advantages afforded in these training devices. Traffic conflicts and geographic location are not a limitation when training in an FSTD or ATD. ATDs come with a database affording significant navigational choices. Advantages include executing navigation or instrument approach procedures to an airport that a pilot may not have experienced or executed in flight before.

2. Comments Providing Institutional Research Related to the Notice of Proposed Rulemaking

In the NPRM, the FAA specifically sought “. . . comment regarding any additional relevant data or institutional research that supports the training and safety advantages when using ATDs, or establishes that such devices do not enhance pilot training and flight safety.” 14

14 80 FR 34338 at 34342.

The FAA received two comments that specifically addressed this request.

One individual commenter cited an unpublished dissertation 15 that the commenter believed supported the use of ATDs. The commenter stated:

15 Kearns, S. (2007). “The Effectiveness of Guided Mental Practice in a Computer-Based Single Pilot Resource Management (SRM) Training,” Ph.D. Dissertation, Capella University).

In her dissertation study, Kearns compared simulators far less capable then [sic] ATDs to a guided mental practice experimental technique. Though her results did not specifically evaluate ATDs, Kearn [sic] demonstrated how ATD-level simulators (and guided mental practice) effectively train skills enhancing mental workload and situational awareness.16

16 Anonymous, Docket No. FAA-2015-1846-0035.

FAA Response: The FAA obtained and reviewed the unpublished Kearns dissertation.

The study author described the study as follows:

The purpose of this investigation was to assess the feasibility of guided mental practice, as an instructional strategy, embedded within an asynchronous computer-based non-technical training program for pilots. Two asynchronous computer-based single pilot resource management (SRM) training programs were developed for the study, varying only in the method of active practice. One version incorporated hands-on practice and another utilized a form of mental practice, termed guided mental practice. The term guided mental practice was developed to describe the process of mental practice which is facilitated by a computer-based training program, such as through the presentation of a video of a flight simulator scenario.17

17 Kearns, at 80.

The study author defined guided mental practice as:

. . . practice that took place without any hands-on interaction yet was facilitated by a computer-based flight simulator scenario embedded within an asynchronous online SRM training program. Participants were asked to view a video of a flight simulator in a particular scenario and imagine themselves as the pilot of the flight. Guided mental practice differs from traditional mental practice, which is typically an entirely internal process, as an external medium guides the learner through the practice exercise.18

18 Kearns, at 12.

Three groups were formed in the study (a) SRM training with hands-on practice, (b) SRM training with mental practice, and (c) a control group that received no training. The study used a sample size of 12 participants per condition.19 All three groups of participants completed a high-fidelity flight simulator evaluation in which metrics assessed their situation awareness and mental workload, the two constructs targeted in the SRM training program.

19 Kearns, at 63.

The study found that although no difference existed between the practice conditions, groups that completed training with either hands-on or mental practice demonstrated improved situation awareness over the group that did not receive any training as measured by the situation awareness global assessment technique (SAGAT). Significant findings were not found with either of the metrics meant to assess workload: The National Aeronautics and Space Administration's task load index (NASA-TLX), and secondary task (ST) metrics.20

20 Kearns, at 82-83.

While this study did not directly address whether ATDs or other simulators provide benefit by increasing learning of piloting skills, it does appear to indicate that deliberate practice is important to pilot training, and that any practice, whether in a simulator or watching a video of a simulation and imagining oneself as the pilot, is more beneficial than no use of simulation at all in advance of the skill evaluation. While the FAA believes that this study may provide useful information for its area of interest, the study was not focused on the decision point the FAA was considering regarding whether to move forward with this regulatory change—that is, data or institutional research that supports the training and safety advantages when using ATDs, or establishes that such devices do not enhance pilot training and flight safety. Situational awareness is one of many elements to be considered in evaluating pilot training and safety. The study did not consider whether skill sets were better learned by use of either guided mental practice or hands-on use of a simulator as compared with training in an aircraft only.

SAFE asserted that research shows that when properly utilized as part of a comprehensive training program such training devices actually speed up the learning process by allowing students to bypass areas of successful understanding and to concentrate on areas where more understanding and practice is required.21

21 Carretta, Thomas R., and Dunlap, Ronald D. “Transfer of Training Effectiveness in Flight Simulation: 1986-1997.” United States Air Force Research Laboratory, 1998. http://www.dtic.mil/get-tr-doc/pdf?AD=ADA362818.

FAA Response: The abstract of the study cited by SAFE reads as follows:

The purpose of this report was to review recent studies regarding the effectiveness of flight simulators as augmentation for “hands-on” flying training. Simulation-based training has been proposed to reduce costs, extend aircraft life, maintain flying proficiency, and provide more effective training, especially in areas difficult to train in operational aircraft. A review of the literature from 1986 to 1997 identified 67 articles, conference papers, and technical reports regarding simulator flying training and transfer. Of these, only 13 were related directly to transfer of training from the simulator to the aircraft. Studies of simulator effectiveness for training landing skills constituted a majority of the transfer studies, although a few examined other flying skills such as radial bombing accuracy and instrument and flight control. Results indicate that simulators are useful for training landing skills, bombing accuracy, and instrument and flight control. Generally, as the number of simulated sorties increases, performance improves, but this gain levels off after approximately 25 missions. Further, several studies indicate that successful transfer may not require high-fidelity simulators or whole-task training, thus reducing simulator development costs.

Evaluation of this literature is difficult for many reasons. Typically, researchers fail to report sufficient detail regarding research methods, training characteristics, and simulator fidelity. In addition to these methodological concerns, there is a lack of true simulator-to-aircraft transfer studies involving complex pilot skills. This may be due to problems such as inadequate simulator design, cost, and availability, and access to simulators in operational flying units. Future directions in simulator transfer of training are discussed.22

22 Ibid.

Their literature review found that numerous studies conducted between 1986 and 1997 indicated that simulators were found to be useful for training landing skills. As the number of simulated sorties increased, performance increased, but the performance gain appeared to level off after approximately 25 missions. Two other studies considered for the literature review suggest that simulators provide an effective means to train instrument procedures and flight control. The results suggest that in order to produce transfer to the aircraft it may be necessary to train only the critical components of the task rather than the whole task. Authors emphasized the limitations of the literature review, including a lack of information regarding the simulator fidelity characteristics, research methods, and training characteristics among other challenges.

While the FAA found this literature review to provide some limited support for the agency's position, the review did not provide significant support for this position. Given the lack of information regarding simulators used, the effectiveness of the skills transfer, and the age of the review itself, it is likely that the literature review cannot be used to directly support the FAA's position. The FAA notes that FSTD and ATD technology has evolved significantly since this literature review was written and for that reason alone it is possible that studies conducted today would show different conclusions regarding the effectiveness of skill transfer, as simulators at all levels are more realistic and have greater information from which to provide simulation than that which existed 20 years ago.

Nonetheless, the FAA agrees that the use of ground based training devices in advance of flight training in an aircraft speeds up the overall process of learning. The FAA believes that practice decreases the time required in an actual aircraft to reach a level of proficiency required to successfully complete a practical test for a pilot certificate or rating. The Air Force research paper referenced by SAFE supports this assertion, but does not directly address the current capabilities of ATDs.

The individual commenter also believed that allowing increased hours in ATDs would increase economic demand for ATDs, thereby increasing competition and resulting in lower ATD prices and increased ATD innovation. The commenter cited a textbook that he or she believed supported this position.23 The commenter further asserted that this increased competition will increase the quality of ATDs. The commenter compared the current situation regarding the use of ATDs to digital chart maturation,24 arguing that when regulation is applied inappropriately, innovation may be stifled. Thus, the commenter asserted, expanded use of ATDs has derivative benefits consistent with a long-term view of aviation and safety.

23 Vasigh, B., Fleming, K., Tacker, T. (2008) Introduction to Air Transport Economics: From Theory to Applications. Burlington, VT: Ashgate). http://www.ashgate.com/default.aspx?page=637&calcTitle=1&isbn=9781409454878&lang=cy-GB.

24 Tuccio, W.A. (2013). Aviation Approach Charts in an iPad World. Journal of Navigation, 66(1). Retrieved from http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=8777261&fileId=S0373463312000409.

FAA Response: The FAA generally agrees that permitting the greater use of ATDs may increase the demand for ATDs. In turn, the increased demand for ATDs may result in more firms entering the market, increasing competition, and perhaps in more technical innovation in ATDs. The FAA, however, restricts the economic impact analysis to the initial impact, as each succeeding economic impact is more speculative.

As noted previously, the intent of the specific request for information was to seek any additional relevant data or institutional research that supports the training and safety advantages when using ATDs, or establishes that such devices do not enhance pilot training and flight safety. The intent of this regulation is not to foster development of ATDs. The FAA emphasizes that even without this regulation persons are permitted to use ATDs and FSTDs to gain further experience in addition to any time that may be expressly creditable when using ATDs or FSTDs under the regulations.

Finally, the commenter asserted that economic growth of ATDs will offer enhanced applications of ATDs by researchers and innovators, contributing to aviation safety.25 The commenter argued that ATD maturation in operational training environments will enable such forward-thinking training frameworks.

25 Tuccio, W.A. (2011). Heuristics to Improve Human Factors Performance in Aviation. Journal of Aviation/Aerospace Education & Research, 20(3). from http://commons.erau.edu/jaaer/vol20/iss3/8.

FAA Response: The FAA agrees that it is likely that the purchase and use of ATDs will increase with the additional FAA allowances provided for minimum pilot experience requirements. Additionally, the Tuccio research paper referenced by the commenter generally supports the use of simulation in aviation pilot training specific to heuristics 26 but does not speak directly to any particular simulator design or capability.

26 Heuristics Merriam-Webster definition: Involving or serving as an aid to learning, discovery, or problem-solving by experimental and especially trial-and-error methods <heuristic techniques> <a heuristic assumption>; also: Of or relating to exploratory problem-solving techniques that utilize self-educating techniques (as the evaluation of feedback) to improve performance <a heuristic computer program>.

3. Comments Supporting the Proposed Provisions With Changes

The FAA received five comments supporting the proposed rule but recommending changes to the proposed regulations. One commenter noted that in the proposed rule the FAA differentiated between the number of hours that were proposed to be credited toward the aeronautical experience requirements in an AATD (20 hours) versus a BATD (10 hours). The commenter noted that these differences were not stipulated in the proposed text of 14 CFR 61.65(i) regarding credit for aeronautical experience for the instrument rating, and that no differentiation was made between AATDs and BATDs in part 141 regarding approved instrument rating courses—either in the preamble or the regulatory text.

FAA Response: The FAA agrees with the commenter and believes that providing explicit and separate regulatory allowances for BATDs and AATDs, as currently provided in the FAA LOAs, is appropriate. Specificity in the regulation will better inform individuals receiving instrument training as to the appropriate allowances for the different levels of ATDs. Therefore, in this final rule the FAA is revising § 61.65 and appendix C to part 141 to include a specified allowance of 10 hours for BATDs and 20 hours for AATDs in part 61 (combined use not to exceed 20 hours), and 25% of creditable time in BATDs and 40% of creditable time for AATDs under part 141 (not to exceed 40% total time) for the instrument rating.

Currently, under the conditions and limitations set forth in the LOAs, training providers must provide copies of LOAs to people who receive training in the device. By providing a copy of the LOA, pilots who receive training will know the amount of training that may be logged in the device for the purpose of meeting the aeronautical experience requirements for a certificate or rating.

The same commenter believed that there could be confusion regarding the amount of time that can be credited when using a BATD, and when using percentages of simulator, FTD, AATD and BATD time that can be used in combination. For example, the commenter asserted that under appendix C to part 141, section 4(b)(4) as proposed, providing 40% of the required training in a BATD and 10% in a simulator would satisfy the letter of the rule.

FAA Response: As discussed previously, the FAA agrees with the commenter and is providing for separate specific regulatory allowances for BATDs and AATDs and clarifying the total creditable percentages of time when using BATDs and AATDs in combination with other FAA approved training devices.

The same commenter believed that the FAA was being inconsistent in its treatment of time that could be credited when using a BATD in part 61 versus part 141. The commenter noted that the FAA had proposed that 10 hours of the 40 hours required could be obtained using a BATD under part 61 (25% of the hours needed), whereas the FAA had proposed that 10% of the hours could be credited in a BATD under part 141 (3.5 hours).27 Based on the commenter's understanding of the FAA proposal, the commenter recommended that the total number of hours that could be credited when using a BATD under part 141 be increased to 20% of the total hours (7 hours of the 35 hours required).

27 The 3.5 hours reflects 10% of the 35 hours of instrument training that is the minimum curriculum hours under appendix C to part 141.

FAA Response: The FAA agrees with the commenter and will provide a consistent allowance in the regulation for ATD credit when using a BATD or AATD under part 61 and part 141. To provide a consistent allowance under part 141 training requirements for the instrument rating, in this final rule the FAA is allowing up to a 25% credit (8.75 hours) when using a BATD for the minimum training time requirements.

One commenter noted that the FAA does not differentiate regarding the use of AATDs versus BATDs anywhere else in part 141. The commenter believed that by differentiating AATDs from BATDs, it would now be possible to allow credit for AATD use toward flight times for private pilot, commercial pilot, flight instructor and additional rating courses. Another commenter requested that the FAA consider expanding the utilization of these devices for the private pilot rating as well from the current 2.5 hours to 10 hours. Another commenter requested that appendix G of part 141 be revised to permit flight instructors to use AATDs in their own training. The commenter asserted that if instrument instructors are to teach effectively in ATDs, then it is logical those same instructors should use ATDs during their own training in order to realize economic and safety benefits of ATDs similar to those provided by the new rule under appendix C to part 141, and learn effective ATD training techniques. Yet another commenter suggested expanding the creditable use of ATDs to all certificates—airline transport pilot, commercial, private, flight instructor, etc.

FAA Response: The FAA agrees with the commenters and is providing separate regulatory allowances for BATDs and AATDs as described previously and clarifying the amount of creditable time when BATDs and AATDs are used in combination with FSTDs for instrument training. The FAA notes that part 61 provides time allowances for private pilot, commercial pilot, and airline transport pilot in an FSTD that is representative of the aircraft category, class, and type if appropriate. Currently, the FAA approves the use of ATDs for private pilot, commercial pilot, and airline transport pilot certification through the issuance of LOAs under the Administrator's authority in § 61.4(c). The FAA will consider this comment concerning specific regulatory credit for ATDs to meet the requirements for pilot certificates and may address it in other rulemakings as appropriate.

One commenter asserted that current regulations regarding the use of ATDs for instrument proficiency checks under 14 CFR 61.57 is confusing. The commenter noted that § 61.57(d)(1)(i) specifies that the instrument proficiency check must be conducted in an aircraft while the Instrument Practical Test Standard specifies that both FSTDs or AATDs may be used for part or all of the instrument proficiency check. The commenter recommended that the regulations be clarified to correspond to the practical test standard.

FAA Response: This comment is outside the scope of the proposed rule. The FAA notes, however, that § 61.57(d)(1)(ii) provides an allowance for use of an FSTD that is representative of the aircraft category when conducting the instrument proficiency check. The FAA will consider this comment concerning the use of an ATD for the instrument proficiency check and the reference in the Instrument Practical Test that allows its use and will address it in other rulemakings as appropriate.

One commenter requested a variety of changes to § 61.57(c) regarding instrument experience and recency for pilots in command. The commenter highlighted differences between current requirements for completing instrument experience using an ATD to maintain instrument experience (§ 61.57(c)(3)); completing instrument recency experience using a combination of an aircraft and a full flight simulator, FTD, and ATD (§ 61.57(c)(4)); and completing instrument experience using a combination of a flight simulator or FTD, and an ATD (§ 61.57(c)(5)).

FAA Response: These comments are beyond the scope of this rulemaking. The FAA will consider these comments and may address them in other rulemakings as appropriate.

Finally, one commenter recommended changes to permit ground instructors to use ATDs to train their students.

FAA Response: The FAA allows ground instructors certain privileges. This includes training for aeronautical knowledge typically in a classroom environment and authorizing students for knowledge tests. While a ground instructor may use an ATD to illustrate ground training concepts, such training may not be logged to meet the aeronautical experience requirements for certificates and ratings. Providing flight training—or training in FSTDs or ATDs that can substitute for some of the required flight training—is a privilege reserved for flight instructors who have been evaluated during a practical test on the ability to provide flight training. Expanding this privilege to ground instructors is beyond the scope of this rulemaking.

4. Comments Opposing the Proposed Provisions

Three commenters opposed the proposed provisions.

One commenter, who identified himself as a flight instructor, believed that new instrument pilots need the stress, noise, and feeling of the real airplane when forming their habits and acquiring their skills, not the quiet, controlled, sterile atmosphere of a simulator. While the commenter supported the use of simulators later, he did not believe they are appropriate for new pilots.

FAA Response: The FAA somewhat disagrees with this commenter's general statement that pilots “. . . need the stress and noise and feeling of the real item when forming their habits and acquiring their skills, not the quiet controlled sterile atmosphere of a SIM.” The FAA contends that training in an ATD allows reduction in unnecessary distractions during initial training and permits focus on the important fundamental instrument skills and tasks necessary for safe and controlled instrument flight. This includes practicing emergency procedures and other maneuvers that cannot be safely accomplished in an aircraft. Practice in an FSTD or ATD until a pilot performs a particular segment of a procedure or action correctly, before attempting to do the same complex tasks in an aircraft, is an acceptable and desirable practice.

The FAA also contends that because a significant portion of the instrument time must be accomplished in an aircraft, the stress and noise experience and the feeling for the real environment discussed by the commenter will be provided during that time. Additionally, the FAA notes that § 61.65(d)(2)(i) (airplane) and § 61.65(e)(2)(i) (helicopter) currently require that three hours of training must be accomplished in an aircraft within two months of the practical test. The required instrument training on cross country procedures under instrument flight rules, including a flight of 250 nautical miles with at least three different instrument approaches and an instrument approach at each airport, must also be accomplished in an aircraft.

The FAA believes that training in FSTDs and ATDs, when used in conjunction with training in an aircraft, teach an instrument student to trust the appropriate sense, vision, in order to successfully operate an aircraft in low visibility conditions. Training in an ATD reinforces this necessary skill. Any reliance on “sounds or feel” may ultimately lead to loss of control when operating an aircraft in instrument meteorological conditions (IMC). Because ignoring the postural senses involves relying on visual clues, the ATD provides an excellent platform for a pilot to develop this portion of his or her instrument flying skills. A person must use his or her vision and focus on the flight instruments to successfully operate an aircraft, FSTD, or ATD in IMC conditions. The FAA recognizes that training devices do not require motion in order to be approved as an ATD; thus, these devices are limited in that they cannot completely train the pilot to ignore outside sensory perceptions. However, the FAA finds that a pilot can develop this ability during the aeronautical experience that an applicant for an instrument rating must obtain in an aircraft.

Another commenter, who also identified himself as a flight instructor, believed that FTDs and simulators do a good job at pretending to be an airplane in terms of learning procedures, but they are not an airplane. The commenter believed that an ATD cannot give the true feeling of transitioning from visual meteorological conditions (VMC) to IMC, especially while climbing or turning. The commenter asserted that unless a provision is added to the rule to require the student to have more flight training in IMC conditions (the commenter recommended 5 hours), adding 10 hours of ATD time will only make the instrument pilots of the future less capable of flying in IMC.

FAA Response: The FAA agrees with the commenter that these trainers (ATDs) do a great job for learning procedures, but disagrees that ATDs cannot adequately provide for simulated transitions from VMC to IMC. Very often a pilot does not “feel” anything in an aircraft during these transitions. The FAA has evaluated hundreds of ATD visual systems and has found them to have adequate fidelity and capabilities, as required in AC 61-136A, to simulate visibility transition scenarios. In fact, many of the FAA approved visual systems provide for numerous scenarios including flying through multiple layers of clouds and varying visibility conditions. This commenter fails to provide an adequate explanation to support his or her position. Additionally, the commenter's discussion of FFSs, FTDs and PCATDs is outside the scope of this ATD rulemaking.

The third commenter addressed specific comments relating to a particular ATD. The commenter referenced Redbird ATDs, and asserted that:

[T]heir panels are limiting in the sense that switches are not the same in the simulator as it is [sic] in the airplane. . . . The Redbird simulator does not provide a volume knob for either the COM or NAV which contains the ID mode. This is a required step in order to properly identify a VOR station. . . . The standby instruments is graphically depicted but the position of these instruments does not reflect the real location of where these instruments are installed.28

28 Anonymous, Docket No. FAA-2015-1846-0031.

The commenter also expressed concern regarding updated databases to these training devices. The commenter believed that any ATD should be required to have the latest navigation database running on the ATD.

FAA response: The FAA notes that the commenter's discussion is concentrated on the dislike of the functionality of the Redbird trainer, rather than the ATD allowances for the proposed rule. The FAA agrees, however, that ATDs (the FAA assumes that the commenter is discussing a particular Redbird AATD based on the content of his initial statements) are not identical to the actual aircraft. The FAA emphasizes that, assuming the ATD in question received a LOA from the FAA, it met or exceeded the minimum fidelity and capability requirements specified for such devices in AC 61-136A. ATD fidelity requirements do not require that ATDs be exactly like that of the aircraft. The FAA notes that the Redbird Flight Simulations ATDs the FAA has approved through LOA do provide for the ability to update the database to reflect current instrument approach procedures. Appendix 2 of the AC states: The ATD must have at least a navigational area database that is local to the training facility to allow reinforcement of procedures learned during actual flight in that area. All navigational data must be based on procedures as published per 14 CFR part 97 (STANDARD INSTRUMENT PROCEDURES). The FAA has evaluated many of the Redbird training devices and finds that they meet the standards in AC 61-136A for ATD approval. If one were to prefer greater fidelity or more exacting duplication of certain aircraft configurations, then the FAA would suggest the use of a higher fidelity FAA approved training device such as an FTD or FFS. However, the FAA standards set forth in AC 61-136A are appropriate to training instrument procedures as described in Appendix 4, Training Content and Logging Provisions. This describes what instrument tasks can be successfully taught in ATDs.

5. Comments Opposing the Process

Two commenters expressed strong objections to the path the FAA took regarding this rulemaking. They objected to the withdrawal of the direct final rule, and believed that the adverse comments the FAA received during the comment period for the direct final rule should not have caused the agency to withdraw the rulemaking. They also believed the FAA should have acted more quickly once the original discrepancy between the regulations and policy was identified.

FAA Response: Part 11 of title 14 of the Code of Federal Regulations mandates the process and responsibilities associated with rulemaking. The FAA is required to follow those requirements even if viewed as unnecessary or inconvenient by a segment of the public. The Administrative Procedure Act requires the FAA to provide the public an opportunity to comment on proposed rulemakings, allowing the public to influence or suggest changes to those proposals. The FAA is committed to regulate fairly, promote safety, and works diligently within the confines of the rulemaking process.

B. View-Limiting Device

The FAA proposed to revise § 61.65(i)(4) to eliminate the requirement that pilots accomplishing instrument time in an ATD wear a view-limiting device. The FAA emphasizes, however, that a pilot—whether in an aircraft, FFS, FTD, or ATD—may log instrument time only when the pilot is operating solely by reference to the instruments under actual or simulated conditions. If a pilot is using an ATD and the device is providing visual references upon which the pilot is relying, this would not constitute instrument time under § 61.51(g).

Comments received: The FAA received six comments from SAFE, NAFI, and four individuals, supporting the elimination of the requirement that pilots accomplishing instrument time in an ATD wear a view-limiting device. SAFE explained its support for removal of the provision, noting that a benefit of using ATDs is simulation of the cockpit environment. SAFE asserted that that benefit is lost when the student is required to wear such a device. SAFE asserted that most students quickly become so immersed in the ATD experience that there is no need for a view-limiting device to further focus them on the instrument panel. All other commenters provided general support and did not explain or further justify their support for removal of this requirement.

FAA response: As the FAA stated when discussing the support it received for removing this requirement in the direct final rule, the FAA agrees that it is unnecessary for a student to wear a view-limiting device when using an ATD. The FAA finds that this requirement is not necessary because ATDs do not afford relevant outside references. Therefore, the FAA is revising 14 CFR 61.65(i)(4) to eliminate the requirement that pilots accomplishing instrument time in an ATD wear a view-limiting device.

C. Conforming Amendments and Nomenclature Change

While considering these changes, the FAA became aware that other appendices in part 141 reference § 141.41(a) when discussing FFS, and § 141.41(b) when discussing FTDs and ATDs. As this rule consolidates requirements related to FFS and FTDs into § 141.41(a), and adds new paragraph (b) related to ATDs, the FAA is correcting cross-references in appendices C, D, E, F, G, J, K, and M.

Further, while considering these regulatory changes, the FAA noted that the nomenclature regarding flight simulators has changed. The definition as found in § 1.1 references a “full flight simulator” whereas the regulations often use the older nomenclature “flight simulator.” Therefore, in the sections the FAA has determined need to be revised as part of the final rule, the FAA is removing the words “flight simulator” wherever they appear and replacing them with the words “full flight simulator.”

VI. Advisory Circulars and Other Guidance Materials

To further implement this rule, the FAA is revising the following FAA Order: FAA Order 8900.1, Flight Standards Information Management System, Volume 11, Chapter 10, Section 1, (Basic and Advanced Aviation Training Device) Approval and Authorized Use under 14 CFR parts 61 and 141.

VII. Regulatory Notices and Analyses A. Regulatory Evaluation

Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 and Executive Order 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in 5 U.S.C. 603 et seq., requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39), as amended, 19 U.S.C. Chapter 13, prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, this Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), as codified in 2 U.S.C. Chapter 25, requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this final rule.

In conducting these analyses, FAA has determined that this rule: (1) Has benefits that justify its costs; (2) is not an economically “significant regulatory action” as defined in section 3(f) of Executive Order 12866; (3) is not “significant” as defined in DOT's Regulatory Policies and Procedures; (4) will not have a significant economic impact on a substantial number of small entities; (5) will not create unnecessary obstacles to the foreign commerce of the United States; and (6) will not impose an unfunded mandate on State, local, or tribal governments, or on the private sector by exceeding the threshold identified above. These analyses are summarized below.

Department of Transportation DOT Order 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If the expected cost impact is so minimal that a proposed or final rule does not warrant a full evaluation, this order permits that a statement to that effect and the basis for it be included in the preamble if a full regulatory evaluation of the costs and benefits is not prepared. Such a determination has been made for this final rule. The reasoning for this determination follows.

The provisions included in this rule are either relieving or voluntary. The elimination of the requirement to use a view-limiting device is a relieving provision. The other two provisions are voluntary and cost relieving—additional ATD credit for instrument time for an instrument rating and additional ATD credit for approved instrument courses, if acted upon, is less expensive than flight training time. The FAA made the same cost-benefit determination as part of the direct final rule (79 FR 71634, Dec. 3, 2014) and on this part of the notice of proposed rulemaking (80 FR 34338, Jun. 16, 2015) and received no comments.

Two commenters, both of whom identified themselves as private pilots working toward their instrument ratings, discussed the potential for cost relief provided by the proposed rule. Both commenters estimated that time in an approved simulator with an instructor costs about $100 per hour, while dual time in an instrument flight rules-certified aircraft is $200 per hour or more. These commenters asserted that adding an extra 10 hours of simulator time reduces $1,000 from the overall training cost.

Persons who use the new provisions will do so only if the benefit they will accrue from their use exceeds the costs they might incur to comply. Given the hundreds of LOAs issued, industry's high usage of ATDs, and SAFE's, AOPA's, and NAFI's endorsements of ATDs, the change in requirements is likely to be relieving. Benefits will exceed the costs of a voluntary rule if just one person voluntarily complies.

Since this rule will offer a lower cost alternative, will provide regulatory relief for the use of view-limiting devices, and will allow greater voluntary use of ATDs, the expected outcome will be cost relieving to minimal impact with positive net benefits.

B. Regulatory Flexibility Determination

The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.

Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA.

However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

Most of the parties affected by this rule will be small businesses such as flight instructors, aviation schools, and fixed base operators. The general lack of publicly available financial information from these small businesses precludes a financial analysis of these small businesses. While there is likely a substantial number of small entities affected, the provisions of this rule are either relieving (directly provides cost relief) or voluntary (provides benefits or costs only if a person voluntarily chooses to use the rule provision). Thus, the FAA determines that this rule will not have a significant economic impact on a substantial number of small entities. The FAA made the same determination as part of the direct final rule (79 FR 71634, Dec. 3, 2014) and as part of the notice of proposed rulemaking (80 FR 34338, Jun. 16, 2015) and, in both cases, we requested, but did not receive, any comments.

If an agency determines that a rulemaking will not result in a significant economic impact on a substantial number of small entities, the head of the agency may so certify under section 605(b) of the RFA. Therefore, as provided in section 605(b), the head of the FAA certifies that this rulemaking will not result in a significant economic impact on a substantial number of small entities.

C. International Trade Impact Assessment

The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards.

The FAA has assessed the potential effect of this rule and determined that it will have only a domestic impact and therefore will not create unnecessary obstacles to the foreign commerce of the United States.

D. Unfunded Mandates Assessment

Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $155.0 million in lieu of $100 million.

This rule does not contain such a mandate. Therefore, the requirements of Title II of the Act do not apply.

E. Paperwork Reduction Act

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this rule.

F. International Compatibility and Cooperation

In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has reviewed the corresponding ICAO Standards and Recommended Practices and has identified no differences with these regulations.

G. Environmental Analysis

FAA Order 1050.1F identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 5-6.6 and involves no extraordinary circumstances.

VII. Executive Order Determinations A. Executive Order 13132, Federalism

The FAA has analyzed this rule under the principles and criteria of Executive Order 13132, Federalism. The agency has determined that this action will not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, would not have Federalism implications.

B. Executive Order 13211, Regulations That Significantly Affect Energy Supply, Distribution, or Use

The FAA analyzed this rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it will not be a “significant energy action” under the executive order and will not be likely to have a significant adverse effect on the supply, distribution, or use of energy.

C. Executive Order 13609, Promoting International Regulatory Cooperation

Executive Order 13609, Promoting International Regulatory Cooperation, (77 FR 26413, May 4, 2012) promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609, and has determined that this action would have no effect on international regulatory cooperation.

VIII. Additional Information A. Availability of Rulemaking Documents

An electronic copy of rulemaking documents may be obtained from the Internet by—

• Searching the Federal eRulemaking Portal (http://www.regulations.gov);

• Visiting the FAA's Regulations and Policies Web page at http://www.faa.gov/regulations_policies, or

• Accessing the Government Publishing Office's Web page at http://www.fdsys.gov.

Copies may also be obtained by sending a request (identified by docket or amendment number of the rule) to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9677.

All documents the FAA considered in developing this rule, including economic analyses and technical reports, may be accessed from the Internet through the Federal eRulemaking Portal referenced previously.

B. Comments Submitted to the Docket

Comments received may be viewed by going to http://www.regulations.gov and following the online instructions to search the docket number for this action. Anyone is able to search the electronic form of all comments received into any of the FAA's dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.).

C. Small Business Regulatory Enforcement Fairness Act

The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official, or the person listed under the FOR FURTHER INFORMATION CONTACT heading at the beginning of the preamble. To find out more about SBREFA on the Internet, visit http://www.faa.gov/regulations_policies/rulemaking/sbre_act/.

List of Subjects 14 CFR Part 61

Aircraft, Airmen, Aviation safety, Teachers.

14 CFR Part 141

Airmen, Educational facilities, Reporting and recordkeeping requirements, Schools.

The Amendment

In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations as follows:

PART 61—CERTIFICATION: PILOTS, FLIGHT INSTRUCTORS, AND GROUND INSTRUCTORS 1. The authority citation for part 61 continues to read as follows: Authority:

49 U.S.C. 106(f), 106(g), 40113, 44701-44703, 44707, 44709-44711, 44729, 44903, 45102-45103, 45301-45302.

2. Amend § 61.65 as follows: a. In paragraphs (a)(5), (a)(8)(ii), (c) introductory text, and (h), remove the words “flight simulator” and add in their place the words “full flight simulator”; and, b. Revise paragraph (i) and add paragraph (j).

The revision and addition read as follows:

§ 61.65 Instrument rating requirements.

(i) Use of an aviation training device. A maximum of 10 hours of instrument time received in a basic aviation training device or a maximum of 20 hours of instrument time received in an advanced aviation training device may be credited for the instrument time requirements of this section if—

(1) The device is approved and authorized by the FAA;

(2) An authorized instructor provides the instrument time in the device; and

(3) The FAA approved the instrument training and instrument tasks performed in the device.

(j) Except as provided in paragraph (h)(1) of this section, a person may not credit more than 20 total hours of instrument time in a full flight simulator, flight training device, aviation training device, or a combination towards the instrument time requirements of this section.

PART 141—PILOT SCHOOLS 3. The authority citation for part 141 continues to read as follows: Authority:

49 U.S.C. 106(f), 106(g), 40113, 44701-44703, 44707, 44709, 44711, 45102-45103, 45301-45302.

4. Revise § 141.41 to read as follows:
§ 141.41 Full flight simulators, flight training devices, aviation training devices, and training aids.

An applicant for a pilot school certificate or a provisional pilot school certificate must show that its full flight simulators, flight training devices, aviation training devices, training aids, and equipment meet the following requirements:

(a) Full flight simulators and flight training devices. Each full flight simulator and flight training device used to obtain flight training credit in an approved pilot training course curriculum must be:

(1) Qualified under part 60 of this chapter, or a previously qualified device, as permitted in accordance with § 60.17 of this chapter; and

(2) Approved by the Administrator for the tasks and maneuvers.

(b) Aviation training devices. Each basic or advanced aviation training device used to obtain flight training credit in an approved pilot training course curriculum must be evaluated, qualified, and approved by the Administrator.

(c) Training aids and equipment. Each training aid, including any audiovisual aid, projector, mockup, chart, or aircraft component listed in the approved training course outline, must be accurate and relevant to the course for which it is used.

5. In appendix B to part 141, revise paragraph (c) in section 4 to read as follows: Appendix B to Part 141—Private Pilot Certification Course

4. Flight training. * * *

(c) For use of full flight simulators or flight training devices:

(1) The course may include training in a full flight simulator or flight training device, provided it is representative of the aircraft for which the course is approved, meets the requirements of this paragraph, and the training is given by an authorized instructor.

(2) Training in a full flight simulator that meets the requirements of § 141.41(a) may be credited for a maximum of 20 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(3) Training in a flight training device that meets the requirements of § 141.41(a) may be credited for a maximum of 15 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(4) Training in full flight simulators or flight training devices described in paragraphs (c)(2) and (3) of this section, if used in combination, may be credited for a maximum of 20 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit for training in a flight training device that meets the requirements of § 141.41(a) cannot exceed the limitation provided for in paragraph (c)(3) of this section.

6. In appendix C to part 141, revise paragraph (b) in section 4 to read as follows: Appendix C to Part 141—Instrument Rating Course

4. Flight training. * * *

(b) For the use of full flight simulators, flight training devices, or aviation training devices—

(1) The course may include training in a full flight simulator, flight training device, or aviation training device, provided it is representative of the aircraft for which the course is approved, meets the requirements of this paragraph, and the training is given by an authorized instructor.

(2) Credit for training in a full flight simulator that meets the requirements of § 141.41(a) cannot exceed 50 percent of the total flight training hour requirements of the course or of this section, whichever is less.

(3) Credit for training in a flight training device that meets the requirements of § 141.41(a), an advanced aviation training device that meets the requirements of § 141.41(b), or a combination of these devices cannot exceed 40 percent of the total flight training hour requirements of the course or of this section, whichever is less. Credit for training in a basic aviation training device that meets the requirements of § 141.41(b) cannot exceed 25 percent of the total training hour requirements permitted under this paragraph.

(4) Credit for training in full flight simulators, flight training devices, and aviation training devices if used in combination, cannot exceed 50 percent of the total flight training hour requirements of the course or of this section, whichever is less. However, credit for training in a flight training device or aviation training device cannot exceed the limitation provided for in paragraph (b)(3) of this section.

7. In appendix D to part 141, revise paragraph (c) in section 4 to read as follows: Appendix D to Part 141—Commercial Pilot Certification Course

4. Flight training. * * *

(c) For the use of full flight simulators or flight training devices:

(1) The course may include training in a full flight simulator or flight training device, provided it is representative of the aircraft for which the course is approved, meets the requirements of this paragraph, and is given by an authorized instructor.

(2) Training in a full flight simulator that meets the requirements of § 141.41(a) may be credited for a maximum of 30 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(3) Training in a flight training device that meets the requirements of § 141.41(a) may be credited for a maximum of 20 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(4) Training in the flight training devices described in paragraphs (c)(2) and (3) of this section, if used in combination, may be credited for a maximum of 30 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit for training in a flight training device that meets the requirements of § 141.41(a) cannot exceed the limitation provided for in paragraph (c)(3) of this section.

8. In appendix E to part 141, revise paragraph (b) in section 4 to read as follows: Appendix E to Part 141—Airline Transport Pilot Certification Course

4. Flight training. * * *

(b) For the use of full flight simulators or flight training devices—

(1) The course may include training in a full flight simulator or flight training device, provided it is representative of the aircraft for which the course is approved, meets the requirements of this paragraph, and the training is given by an authorized instructor.

(2) Training in a full flight simulator that meets the requirements of § 141.41(a) may be credited for a maximum of 50 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(3) Training in a flight training device that meets the requirements of § 141.41(a) may be credited for a maximum of 25 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(4) Training in full flight simulators or flight training devices described in paragraphs (b)(2) and (3) of this section, if used in combination, may be credited for a maximum of 50 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit for training in a flight training device that meets the requirements of § 141.41(a) cannot exceed the limitation provided for in paragraph (b)(3) of this section.

9. In appendix F to part 141, revise paragraph (b) in section 4 to read as follows: Appendix F to Part 141—Flight Instructor Certification Course

4. Flight training. * * *

(b) For the use of flight simulators or flight training devices:

(1) The course may include training in a full flight simulator or flight training device, provided it is representative of the aircraft for which the course is approved, meets the requirements of this paragraph, and the training is given by an authorized instructor.

(2) Training in a full flight simulator that meets the requirements of § 141.41(a), may be credited for a maximum of 10 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(3) Training in a flight training device that meets the requirements of § 141.41(a), may be credited for a maximum of 5 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(4) Training in full flight simulators or flight training devices described in paragraphs (b)(2) and (3) of this section, if used in combination, may be credited for a maximum of 10 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit for training in a flight training device that meets the requirements of § 141.41(a) cannot exceed the limitation provided for in paragraph (b)(3) of this section.

10. In appendix G to part 141, revise paragraph (b) in section 4 to read as follows: Appendix G to Part 141—Flight Instructor Instrument (For an Airplane, Helicopter, or Powered-Lift Instrument Instructor Rating, as Appropriate) Certification Course

4. Flight training. * * *

(b) For the use of full flight simulators or flight training devices:

(1) The course may include training in a full flight simulator or flight training device, provided it is representative of the aircraft for which the course is approved for, meets requirements of this paragraph, and the training is given by an instructor.

(2) Training in a full flight simulator that meets the requirements of § 141.41(a), may be credited for a maximum of 10 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(3) Training in a flight training device that meets the requirements of § 141.41(a), may be credited for a maximum of 5 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(4) Training in full flight simulators or flight training devices described in paragraphs (b)(2) and (3) of this section, if used in combination, may be credited for a maximum of 10 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit for training in a flight training device that meets the requirements of § 141.41(b) cannot exceed the limitation provided for in paragraph (b)(3) of this section.

11. In appendix J to part 141, revise paragraph (b) in section 4 to read as follows: Appendix J to Part 141—Aircraft Type Rating Course, For Other Than an Airline Transport Pilot Certificate

4. Flight training. * * *

(b) For the use of full flight simulators or flight training devices:

(1) The course may include training in a full flight simulator or flight training device, provided it is representative of the aircraft for which the course is approved, meets requirements of this paragraph, and the training is given by an authorized instructor.

(2) Training in a full flight simulator that meets the requirements of § 141.41(a), may be credited for a maximum of 50 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(3) Training in a flight training device that meets the requirements of § 141.41(a), may be credited for a maximum of 25 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(4) Training in the full flight simulators or flight training devices described in paragraphs (b)(2) and (3) of this section, if used in combination, may be credited for a maximum of 50 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit training in a flight training device that meets the requirements of § 141.41(a) cannot exceed the limitation provided for in paragraph (b)(3) of this section.

12. In appendix K to part 141, revise section 4 to read as follows: Appendix K to Part 141—Special Preparation Courses

4. Use of full flight simulators or flight training devices. (a) The approved special preparation course may include training in a full flight simulator or flight training device, provided it is representative of the aircraft for which the course is approved, meets requirements of this paragraph, and the training is given by an authorized instructor.

(b) Except for the airline transport pilot certification program in section 13 of this appendix, training in a full flight simulator that meets the requirements of § 141.41(a), may be credited for a maximum of 10 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(c) Except for the airline transport pilot certification program in section 13 of this appendix, training in a flight training device that meets the requirements of § 141.41(a), may be credited for a maximum of 5 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(d) Training in the full flight simulators or flight training devices described in paragraphs (b) and (c) of this section, if used in combination, may be credited for a maximum of 10 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit for training in a flight training device that meets the requirements of § 141.41(a) cannot exceed the limitation provided for in paragraph (c) of this section.

13. In appendix M to part 141, revise paragraph (c) of section 4 to read as follows: Appendix M to Part 141—Combined Private Pilot Certification and Instrument Rating Course

4. Flight training.

(c) For use of full flight simulators or flight training devices:

(1) The course may include training in a combination of full flight simulators, flight training devices, and aviation training devices, provided it is representative of the aircraft for which the course is approved, meets the requirements of this section, and the training is given by an authorized instructor.

(2) Training in a full flight simulator that meets the requirements of § 141.41(a) may be credited for a maximum of 35 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(3) Training in a flight training device that meets the requirements of § 141.41(a) or an aviation training device that meets the requirements of § 141.41(b) may be credited for a maximum of 25 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less.

(4) Training in a combination of flight simulators, flight training devices, or aviation training devices, described in paragraphs (c)(2) and (3) of this section, may be credited for a maximum of 35 percent of the total flight training hour requirements of the approved course, or of this section, whichever is less. However, credit for training in a flight training device and aviation training device, that meets the requirements of § 141.41(b), cannot exceed the limitation provided for in paragraph (c)(3) of this section.

Issued in Washington, DC, under the authority of 49 U.S.C. 106(f), 44701(a)(5), and 44703(a), on April 4, 2016. Michael P. Huerta, Administrator.
[FR Doc. 2016-08388 Filed 4-8-16; 11:15 am] BILLING CODE 4910-13-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2015-1126] RIN 1625-AA08 Special Local Regulation; Chesapeake Bay, Between Sandy Point and Kent Island, MD AGENCY:

Coast Guard, DHS.

ACTION:

Temporary final rule.

SUMMARY:

The Coast Guard is establishing special local regulations for certain waters of the Chesapeake Bay. This action is necessary to provide for the safety of life on these navigable waters located between Sandy Point, Anne Arundel County, MD and Kent Island, Queen Anne's County, MD, during a paddling event on May 14, 2016. This rulemaking will prohibit persons and vessels from being in the regulated area unless authorized by the Captain of the Port Baltimore or Coast Guard Patrol Commander.

DATES:

This rule is effective from 7:30 a.m. on May 14, 2016 through 12:30 p.m. on May 15, 2016.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2015-1126 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this rule, call or email Mr. Ronald Houck, U.S. Coast Guard Sector Baltimore, MD; telephone 410-576-2674, email [email protected]

SUPPLEMENTARY INFORMATION:

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

On December 28, 2015, ABC Events, Inc. notified the Coast Guard that from 8 a.m. until noon on May 14, 2016, it will be conducting the Bay Bridge Paddle race in the Chesapeake Bay, under and between the north and south spans of the William P. Lane, Jr. (US-50/301) Memorial Bridges, located between Sandy Point, Anne Arundel County, MD and Kent Island, Queen Anne's County, MD. In response, on February 12, 2016, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Special Local Regulation; Chesapeake Bay, between Sandy Point and Kent Island, MD” in the Federal Register (81 FR 7481). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this paddle race. During the comment period that ended March 14, 2016, we received 2 comments. No public meeting was requested, and none was held.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The COTP Baltimore has determined that potential hazards associated with the paddle race on May 14, 2016 will be a safety concern for anyone intending to operate within certain waters of the Chesapeake Bay between Sandy Point and Kent Island, MD. The purpose of this rule is to protect event participants, spectators and transiting vessels on certain waters of the Chesapeake Bay before, during, and after the scheduled event.

IV. Discussion of Comments, Changes, and the Rule

As noted above, we received 2 comments on our NPRM published on February 12, 2016. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

One commenter, the Sailing Club of the Chesapeake, stated that the regulated area for this event would impact its planned annual sailing regatta held on the Chesapeake Bay, between a location south of the south span of the William P. Lane, Jr. (US-50/301) Memorial Bridges and a location north of the north span.

The COTP Baltimore had no prior notifications of this annual sailing regatta in previous years. The Coast Guard will only enforce the regulated area during the enforcement period. However, should the event sponsor develop a schedule that would help predict when and where gaps in the race course may exist during the event, and vessel traffic would be able to safely transit the regulated area once the Coast Guard Patrol Commander deems it safe to do so, then such actions could be permitted after authorization is obtained.

The second commenter, the Baltimore Port Alliance, stated that, as proposed, the regulated area for this event would block ship access to and from the Port of Baltimore for five hours, and that any restrictions on vessel traffic in or out of the port could result in a significant economic hardship for port stakeholders by disrupting committed schedules. Additionally, the commenter recommended redesigning the paddle race course as to not block the main shipping channel or to change the date of the paddle race to coincide with the annual Great Chesapeake Bay Swim event a month later, so that only one blockage of the main shipping channel would occur.

The Coast Guard agrees that waterway restrictions, when necessary, should be as limited in scope and duration. For this event, enough notice has been provided for persons to schedule, coordinate and adjust their ship schedules. As it currently does with the annual Great Chesapeake Bay Swim event, the Coast Guard will work with the port stakeholders to monitor potential impacts to commercial vessel movements in the vicinity of the event area. Additionally, it is impractical to conduct the events concurrently; as the two events are of different types, each having hundreds of participants occupying the same navigable waters. Since the times for the Great Chesapeake Bay Swim event are also dependent upon tidal current predictions, the possibility exists, should both events be conducted on the same day, the waterway restrictions would last for a significantly longer period of time having a greater impact on the public and the use of the waterway.

This rule establishes special local regulations from 7:30 a.m. until 12:30 p.m. on May 14, 2016, and, if necessary due to inclement weather, from 7:30 a.m. until 12:30 p.m. on May 15, 2016. The regulated area will cover all navigable waters of the Chesapeake Bay between and adjacent to the spans of the William P. Lane Jr. Memorial Bridges from shoreline to shoreline, bounded to the north by a line drawn parallel and 500 yards north of the north bridge span that originates from the western shoreline at latitude 39°00′36″ N., longitude 076°23′05″ W. and thence eastward to the eastern shoreline at latitude 38°59′14″ N., longitude 076°20′00″ W., and bounded to the south by a line drawn parallel and 500 yards south of the south bridge span that originates from the western shoreline at latitude 39°00′16″ N., longitude 076°24′30″ W. and thence eastward to the eastern shoreline at latitude 38°58′38.5″ N., longitude 076°20′06″ W. The duration of the regulated area is intended to ensure the safety of vessels and these navigable waters before, during, and after the event, currently scheduled to being at 8 a.m. and last until noon. Except for Bay Bridge Paddle participants, no vessel or person will be permitted to enter the regulated area without obtaining permission from the COTP Baltimore or designated Coast Guard Patrol Commander.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

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

This regulatory action determination is based on the size and duration of the regulated area, which would impact a small designated area of the Chesapeake Bay for only 5 hours. Although the regulated area cuts off one portion of the Chesapeake Bay from the other, the closure is temporary, and notice has been provided well in advance to permit mariners to plan their transit. The Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the status of the regulated area. Moreover, the rule would allow vessels to seek permission to enter the regulated area, and vessel traffic would be able to safely transit the regulated area once the Coast Guard Patrol Commander deems it safe to do so.

B. Impact on Small Entities

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

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

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

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

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

E. Unfunded Mandates Reform Act

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

F. Environment

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves implementation of regulations within 33 CFR part 100 applicable to organized marine events on the navigable waters of the United States that could negatively impact the safety of waterway users and shore side activities in the event area lasting for 5 hours. The category of water activities includes but is not limited to sail boat regattas, boat parades, power boat racing, swimming events, crew racing, canoe and sail board racing. It is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

G. Protest Activities

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

List of Subjects in 33 CFR Part 100

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority:

33 U.S.C. 1233.

2. Add a temporary § 100.35-T05-1126 to read as follows:
§ 100.35-T05-1126 Special Local Regulation; Chesapeake Bay, between Sandy Point and Kent Island, MD.

(a) Regulated area. The following location is a regulated area: All navigable waters of the Chesapeake Bay between and adjacent to the spans of the William P. Lane Jr. Memorial Bridges from shoreline to shoreline, bounded to the north by a line drawn parallel and 500 yards north of the north bridge span that originates from the western shoreline at latitude 39°00′36″ N., longitude 076°23′05″ W. and thence eastward to the eastern shoreline at latitude 38°59′14″ N., longitude 076°20′00″ W., and bounded to the south by a line drawn parallel and 500 yards south of the south bridge span that originates from the western shoreline at latitude 39°00′16″ N., longitude 076°24′30″ W. and thence eastward to the eastern shoreline at latitude 38°58′38.5″ N., longitude 076°20′06″ W. All coordinates reference Datum NAD 1983.

(b) Definitions. (1) Captain of the Port Baltimore means the Commander, U.S. Coast Guard Sector Baltimore, Maryland or any Coast Guard commissioned, warrant or petty officer who has been authorized by the Captain of the Port to act on his behalf.

(2) Coast Guard Patrol Commander means a commissioned, warrant, or petty officer of the U.S. Coast Guard who has been designated by the Commander, Coast Guard Sector Baltimore.

(3) Official Patrol means any vessel assigned or approved by Commander, Coast Guard Sector Baltimore with a commissioned, warrant, or petty officer on board and displaying a Coast Guard ensign.

(4) Participant means all persons and vessels participating in the Bay Bridge Paddle event under the auspices of the Marine Event Permit issued to the event sponsor and approved by Commander, Coast Guard Sector Baltimore.

(c) Special local regulations. (1) The Coast Guard Patrol Commander may forbid and control the movement of all vessels and persons, including event participants, in the regulated area. When hailed or signaled by an official patrol, a vessel or person in the regulated area shall immediately comply with the directions given. Failure to do so may result in expulsion from the area, citation for failure to comply, or both. The Coast Guard Patrol Commander may terminate the event, or the operation of any support vessel participating in the event, at any time it is deemed necessary for the protection of life or property.

(2) Except for participants and vessels already at berth, mooring, or anchor, all persons and vessels within the regulated area at the time it is implemented are to depart the regulated area.

(3) Persons desiring to transit the regulated area must first obtain authorization from the Captain of the Port Baltimore or Coast Guard Patrol Commander. Prior to the enforcement period, to seek permission to transit the area, the Captain of the Port Baltimore can be contacted at telephone number 410-576-2693 or on Marine Band Radio, VHF-FM channel 16 (156.8 MHz). During the enforcement period, to seek permission to transit the area, the Coast Guard Patrol Commander can be contacted on Marine Band Radio, VHF-FM channel 16 (156.8 MHz) for direction.

(4) The Coast Guard may be assisted in the patrol and enforcement of the regulated area by other Federal, State, and local agencies. The Coast Guard Patrol Commander and official patrol vessels enforcing this regulated area can be contacted on marine band radio VHF-FM channel 16 (156.8 MHz) and channel 22A (157.1 MHz).

(5) The Coast Guard will publish a notice in the Fifth Coast Guard District Local Notice to Mariners and issue a marine information broadcast on VHF-FM marine band radio announcing specific event date and times.

(d) Enforcement period. This section will be enforced from 7:30 a.m. until 12:30 p.m. on May 14, 2016, and, if necessary due to inclement weather, from 7:30 a.m. until 12:30 p.m. on May 15, 2016.

Dated: March 31, 2016. Lonnie P. Harrison, Jr., Captain, U.S. Coast Guard, Captain of the Port Baltimore.
[FR Doc. 2016-08380 Filed 4-11-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0293] Drawbridge Operation Regulation; Connecticut River, East Haddam, 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 Route 82 Bridge across the Connecticut River, mile 16.8, at East Haddam, Connecticut. This deviation is necessary to allow the bridge owner to perform emergency repairs at the bridge.

DATES:

This deviation is effective from 7 a.m. on April 18, 2016 to 3 p.m. on June 30, 2016.

ADDRESSES:

The docket for this deviation, [USCG-2016-0293] is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this temporary deviation, call or email Judy Leung-Yee, Project Officer, First Coast Guard District, telephone (212) 514-4330, email [email protected]

SUPPLEMENTARY INFORMATION:

The Route 82 Bridge, mile 16.8, across the Connecticut River, has a vertical clearance in the closed position of 22 feet at mean high water and 25 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.205(c).

The waterway is transited by seasonal recreational traffic and some commercial barge traffic of various sizes.

The bridge owner, Connecticut Department of Transportation, requested a temporary deviation from the normal operating schedule to perform emergency repairs at the bridge.

Under this temporary deviation, the Route 82 Bridge shall open on signal from April 18, 2016 to June 30, 2016, Monday to Friday between 7 a.m. and 3 p.m. if at least two-hour notice is given by calling the number posted at the bridge.

Vessels able to pass under the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.

The Coast Guard will inform the users of the waterways through our Local Notice and Broadcast to Mariners of the change in operating schedule for the bridge so that vessel operations can arrange their transits to minimize any impact caused by the temporary deviation.

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

Dated: April 6, 2016. C.J. Bisignano, Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2016-08296 Filed 4-11-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 9 RIN 2900-AN40 Servicemembers' Group Life Insurance and Veterans' Group Life Insurance—Slayer's Rule Exclusion AGENCY:

Department of Veterans Affairs.

ACTION:

Final rule.

SUMMARY:

The Department of Veterans Affairs adopts as final, without change, the final rule seeking comments published on October 3, 2012, amending its regulations governing Servicemembers' Group Life Insurance (SGLI) and Veterans' Group Life Insurance (VGLI). Specifically, this rule prohibits paying insurance proceeds because of the death of a person (decedent) whose life was insured under SGLI or VGLI, or paying a SGLI Traumatic Injury Protection (TSGLI) benefit to a person (slayer) convicted of intentionally and wrongfully killing the decedent or determined in a civil proceeding to intentionally and wrongfully killing the decedent. This prohibition of payment also applies to any family member of the slayer who is not related to the decedent and to any person who assisted the slayer in causing the death of the decedent. Additionally, the term “domestic partner” is removed from the definition of “member of the family”.

DATES:

Effective Date: This final rule is effective April 12, 2016.

FOR FURTHER INFORMATION CONTACT:

Monica Keitt, Attorney/Advisor, Department of Veterans Affairs, Insurance Center, 5000 Wissahickon Avenue, Philadelphia, PA 19144, (215) 842-2000, ext. 2905. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION:

On October 3, 2012, VA published in the Federal Register (77 FR 60304) a final rule seeking comments that amended 38 CFR 9.1 and 9.5 to prevent certain persons from receiving insurance proceeds through the SGLI, VGLI, or TSGLI program as beneficiaries. The rule prevents payment of proceeds to any persons (slayer) found criminally or civilly liable for intentionally and wrongfully killing a person (decedent) insured under SGLI or VGLI or who is eligible for a TSGLI benefit. It also prevents payment to any persons found criminally or civilly liable for assisting or aiding such a slayer and any member of the slayer's family who is not related to the decedent by blood, legal adoption, or marriage. In a proposed rule published on December 13, 2011, (76 FR 77455), “domestic partner” was added to the definition of “member of the family” in 38 CFR 9.1(l) for the purposes of 38 CFR 9.5(e) to prevent unjust enrichment of persons who are domestic partners of the slayer based on the rationale that these persons are often in relationships with the slayer equivalent to being “relatives” of the slayer. Then, in the final rule published on October 3, 2012, VA removed the term “domestic partner” from the definition of “member of the family” for the purposes of § 9.5(e) “due to the unsettled legal landscape surrounding the recognition of such partnerships”. 77 FR at 60305. VA explained that because recognition of the legality of such relationships varies from state to state, VA determined that including such partnerships in this part would cause an undue administrative burden. Interested persons were invited to submit, on or before December 3, 2012, written comments regarding removing the term “domestic partner” from the definition. VA received comments from three individuals objecting to removing the term.

Public Comments Regarding Removal of the Term “Domestic Partner”

Two commenters noted that some federal agencies, including VA, have expanded their program definitions of family members to include domestic partners. One commenter noted that a Presidential Memorandum directed Federal agencies to extend certain benefits currently available to Federal employees' spouses and their children to Federal employees' same-sex domestic partners and their children. See Presidential Memorandum—Extension of Benefits to Same-Sex Domestic Partners of Federal Employees (June 2, 2010). One commenter noted that other Federal agencies, such as the General Services Administration, have established through regulations definitions of family members that include domestic partners.

One commenter also stated that failure to include domestic partners in the definition of “member of the family” would allow a same-sex domestic partner of a slayer to circumvent the regulation, while prohibiting heterosexual spouses of a slayer from receiving insurance benefits. This commenter also stated that “. . . [i]ncluding domestic partners is important to prevent an aberration in the rule . . .” and to “. . . prevent[ ] the unjust collection of life insurance benefits.”

Two commenters noted that the Department of Defense changed its military policies regarding openly gay and lesbian servicemembers, thus VA should change its policy here, since VA is a related agency that serves servicemembers and their families.

Two commenters also noted that VA has recognized domestic partnerships in other VA related matters. Specifically, the commenters pointed to VA's hospital visitation policy allowing persons designated as domestic partners to be beneficiaries for SGLI and VGLI benefits.

Lastly, one commenter noted that removal of the term domestic partner “sends a message that VA may not be willing to recognize domestic partners as family in any context.” However, recent Supreme Court cases and the United States Attorney General help to clarify legally accepted definitions. On June 26, 2013, the Supreme Court in United States v. Windsor, 133 S. Ct. 2675 (2013), held that the Defense of Marriage Act (DOMA), Sec. 3, Public Law 104-199, 110 Stat. 2419, defining “marriage” and “spouse” for purposes of federal law to preclude recognition of marriages of same-sex couples, is unconstitutional because it violates Fifth Amendment principles by discriminating against same-sex couples who are legally married under state law. VA administers federal benefits and programs that require defining “spouse” and “surviving spouse.” For purposes of VA benefits, 38 U.S.C. 101(3) and 101(31) define “surviving spouse” and “spouse” as persons “of the opposite sex.” However these definitions (codified separately from DOMA) were not specifically addressed in the Supreme Court's Windsor decision. Then on September 4, 2013, the United States Attorney General announced that the President had directed the Executive Branch to cease enforcement of 38 U.S.C. 101(3) and 101(31), to the extent they preclude provision of veterans' benefits to same-sex married couples, but was silent as to “domestic partners”. Accordingly, VA ceased to enforce the definitional provisions in title 38 to the extent they preclude provision of veterans' benefits, including SGLI, VGLI, and TSGLI benefits, to same-sex married couples. As a result, VA administers spousal and survivors' benefits to same-sex married couples, provided the marriages meet the requirements of 38 U.S.C. 103(c). Section 103(c) provides that, for purposes of all laws administered by VA, a veteran's marriage is to be recognized according to the law of the place where the parties resided at the time of the marriage or the law of the place where the parties resided when the right to benefits accrued.

On June 26, 2015, the Supreme Court in Obergefell v. Hodges, 135 S. Ct. 2584 (2015), held that the Fourteenth Amendment of the U.S. Constitution requires a state to license a marriage between two people of the same sex and to recognize a marriage between two people of the same sex when their marriage was lawfully licensed and performed out-of-state, but again did not include “domestic partners”. Accordingly, VA now recognizes all lawful same-sex marriages for VA purposes.

In light of Windsor and Obergefell, VA no longer enforces the title 38 definitions of “spouse” and “surviving spouse” to the extent that they exclude the recognition of same-sex married couples. However, In other words, VA provides benefits to all same-sex “spouses” and “surviving spouses” of veterans or, in the case of insurance benefits, of servicemembers or former servicemembers, to the extent they are otherwise eligible, based on a State's recognition of the validity of the marriage. However, VA does not currently provide all the same spousal benefits to either same-sex or opposite-sex domestic partners of veterans or, in the case of insurance benefits, of servicemembers or former servicemembers.

The comments we received essentially concern equal treatment of same-sex couples and opposite-sex couples. The Supreme Court in Windsor and Obergefell accomplished that with regard to marriages but did not address other relationships, such as domestic partnerships or legal unions. Thus, those decisions do not affect VA's decision to remove “domestic partner” from the § 9.1(l) definition of “member of the family.” Windsor and Obergefell have not changed the unsettled legal landscape surrounding the recognition of both same-sex and opposite-sex domestic partnerships. For instance, recognition of the legality of domestic partnerships continues to vary from state to state and, because the term is not used consistently from state to state, there remains inter-jurisdictional confusion regarding use of that term. Therefore, including domestic partnerships, of both same-sex couples and opposite-sex couples, in the definition of “member of the family” in § 9.1(l) would cause an undue administrative burden in applying 38 CFR 9.5(e).

Two commenters suggested that VA could establish its own uniform definition of “domestic partnership” rather than relying upon varying state laws. The commenters pointed to regulations of other federal agencies establishing definitions of “domestic partnerships.” We decline that suggestion for the following reasons. First, it would create inconsistency between VA's recognition of marriages, which, under 38 U.S.C. 103(c), is expressly based on state laws recognizing marriages, and VA's recognition of domestic partnerships or civil unions, which, under the commenters' suggestion, could be inconsistent with state laws governing recognition of such relationships. Second, defining the term “domestic partner” without regard to state law would require VA to undertake difficult and burdensome fact-finding actions under imprecise standards. We note that the other agency regulations cited by the commenters are varied and often employ vague and subjective standards, such as requiring a finding that the individuals are in a “committed relationship” or “agree to be responsible for each other's common welfare,” which may lead to inconsistency in application. Third, VA likely would face difficulty in developing evidence to establish that such standards are satisfied. The primary evidence of whether individuals were in a “committed relationship” often may be the testimony of the individuals in that relationship. Such evidence may be difficult to obtain or may be unreliable in relation to this rule, which, unlike the examples cited by the commenters, would preclude, rather than extend, benefits based upon the relationship.

Regarding a comment that excluding domestic partnerships from the definition of “family members” may result in unjust enrichment to certain domestic partners of persons causing the death of an insured individual, we acknowledge that this is a potential consequence of the rule. However, the alternative standards we have considered, including following varied state laws governing domestic partnerships or establishing our own definition of “domestic partnership” based in part on subjective standards, would also pose a risk of yielding inconsistent results and possibly allowing unjust enrichment to certain individuals in specific cases. We believe we have appropriately balanced those risks with the interests of clarity, consistency, and administrative efficiency in determinations made under this rule. Accordingly, VA declines to make any changes to this rulemaking based on the above comments.

Justification for the Final Rule Seeking Comments

One commenter noted that VA failed to provide good cause for dispensing with advance public notice and the opportunity for public comment. Specifically, the commenter stated that VA failed to provide a sufficient justification for citing “public interest” and “impracticability” as reasons for proceeding without providing an opportunity for advance notice and comment. We correctly identified public interest as grounds for proceeding with final rule seeking comments, but could have been clearer in explaining that it would have been against the public's interest to delay implementation of the slayer provisions for the purpose of receiving comments on the definition of “member of the family.” We designed the rule to prevent slayers from benefiting from their wrongdoing, and any delay in finalizing the rule would have potentially permitted slayers to receive benefits in violation of public policy and ethical concerns. Nonetheless, on October 3, 2012, VA provided the public formal notice and an opportunity to comment on the exclusion of the term “domestic partner” through publication of the final rule seeking comments. VA received comments on the exclusion, and we considered those comments in issuing this final rule. Additionally, we note that, since the publication of the October 3, 2012, rule, no case has been affected by the exclusion of “domestic partner” from the definition of “member of the family.”

Based on the rationale set forth above and the preamble in the final rule seeking comments, VA adopts, without change, the rule published on October 3, 2012, at 77 FR 60304.

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 an 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.

Paperwork Reduction Act

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

Executive Orders 12866 and 13563

Executive Orders 12866 and 13563 direct agencies to assess the 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 effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action” requiring review by the Office of Management and Budget (OMB), unless OMB waives such review, as “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.”

The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. 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 Web site at http://www.va.gov/orpm/, by following the link for “VA Regulations Published from FY 2004 Through Fiscal Year to Date.”

Regulatory Flexibility Act

The Secretary of Veterans Affairs hereby certifies that 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 directly affect only individuals and will not directly affect any small entities. Therefore, this rulemaking is also exempt pursuant to 5 U.S.C. 605(b), from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance number and title for the program affected by this document is 64.103, Life Insurance for Veterans.

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. On April 6, 2016, Robert D. Snyder, Chief of Staff, Department of Veterans Affairs, approved this document for publication.

List of Subjects in 38 CFR Part 9

Life insurance, Military personnel, Veterans.

Dated: April 7, 2016. William F. Russo, Director, Office of Regulation Policy & Management, Office of the General Counsel, Department of Veterans Affairs.

For the reasons set forth out in the preamble, VA adopts the final rule seeking comments published in the Federal Register at 77 FR 60304 on October 3, 2012, as final without change.

[FR Doc. 2016-08381 Filed 4-11-16; 8:45 am] BILLING CODE 8320-01-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R08-OAR-2015-0493; FRL-9942-84-Region 8] Approval and Promulgation of Air Quality Implementation Plans; Colorado; Revisions to Common Provisions and Regulation Number 3; Corrections AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Correcting amendments.

SUMMARY:

The Environmental Protection Agency (EPA) published in the January 25, 2016 Federal Register a document concerning the approval of Air Quality State Implementation Plan (SIP) revisions to Colorado Common Provisions and Regulation Number 3. Inadvertently, the publication date of January 25, 2016 was listed in the regulatory text under the heading “EPA Effective Date” instead of the effective date of February 24, 2016. The correct EPA effective date was provided in the rule preamble. This document corrects the “EPA Effective Date” within the regulatory text to February 24, 2016.

DATES:

This correcting amendment is effective on April 12, 2016.

FOR FURTHER INFORMATION CONTACT:

Jaslyn Dobrahner, Air Program, U.S. Environmental Protection Agency (EPA), Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6252, [email protected]

SUPPLEMENTARY INFORMATION:

The EPA published a document in the January 25, 2016 Federal Register (81 FR 3963) concerning air quality SIP revisions to Colorado's Common Provisions and Regulation Number 3. These revisions became effective on February 24, 2016 as correctly noted in the rule preamble. The “EPA Effective Date” within the regulatory text for this action was inadvertently listed as January 25, 2016. This correction revises the “EPA Effective Date” within the regulatory text to reflect the actual EPA effective date of February 24, 2016.

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Greenhouse gases, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

Accordingly, 40 CFR part 52 is corrected by making the following correcting amendments:

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

42 U.S.C. 7401 et seq.

Subpart G—Colorado
2. Section 52.320(c), the Table is amended: a. Under “5 CCR 1001-02 Common Provision Regulation” by revising entries “I” and “II”; b. Under “5 CCR 1001-05, Regulation Number 3, Part A, Concerning General Provisions Applicable to Reporting and Permitting” by revising entries “I”, “II”, “V”, “VI”, “VIII”, and “Appendix B”; c. Under “5 CCR 1001-05, Regulation Number 3, Part B, Concerning Construction Permits” by revising entries “II” and “III”; and d. Under “5 CCR 1001-05, Regulation Number 3, Part D, Concerning Major Stationary Source New Source Review and Prevention of Significant Deterioration” by revising entries “I”, “II”, “III”, “V”, “VI”, “X” “XIII”, “XIV”, and “XV”.

The revisions read as follows:

§ 52.320 Identification of plan.

(c) * * *

Title State effective date EPA effective date Final rule
  • citation/date
  • Comments
    *         *         *         *         *         *         * 5 CCR 1001-02, Common Provisions Regulation I. Definitions, Statement of Intent, and General Provisions Applicable to all Emission Control Regulations adopted by the Colorado Air Quality Control Commission 1/30/10
  • 12/15/10
  • 2/24/16 81 FR 3963,
  • 1/25/16
  • Except I.G. Definitions, “Construction” and “Day”
    II. General 1/30/10 2/24/16 81 FR 3963,
  • 1/25/16
  • Except II.I; II.J.5.
    *         *         *         *         *         *         * 5 CCR 1001-05, Regulation Number 3, Part A, Concerning General Provisions Applicable to Reporting and Permitting I. Applicability 12/15/2010
  • 12/15/2011
  • 2/15/2013
  • 2/24/16 81 FR 3963,
  • 1/25/16
  • Except I.B.31.c. and I.B.31.d.
    II. Air Pollutant Emission Notice (APEN) Requirements 12/15/2010
  • 12/15/2011
  • 2/15/2013
  • 2/24/16 81 FR 3963,
  • 1/25/16
  • *         *         *         *         *         *         * V. Certification and Trading of Emission Reduction Credits Offset and Netting Transactions 12/15/2010
  • 2/15/2013
  • 2/24/16 81 FR 3963,
  • 1/25/16
  • VI. Fees 12/15/2010
  • 2/15/2013
  • 2/24/16 81 FR 3963,
  • 1/25/16
  • *         *         *         *         *         *         * VIII. Technical Modeling and Monitoring Requirements 12/15/2010 2/24/16 81 FR 3963,
  • 1/25/16
  • *         *         *         *         *         *         * Appendix B, Non-criteria Reportable Pollutants (Sorted by BIN) 12/15/2010
  • 2/15/2013
  • 2/24/16 81 FR 3963,
  • 1/25/16
  • 5 CCR 1001-05, Regulation Number 3, Part B, Concerning Construction Permits *         *         *         *         *         *         * II. General Requirements for Construction Permits 12/15/2010
  • 12/15/2011
  • 2/24/16 81 FR 3963,
  • 1/25/16
  • III. Construction Permit Review Procedures 12/15/2010
  • 12/15/2011
  • 2/15/2013
  • 2/24/16 81 FR 3963,
  • 1/25/16
  • 5 CCR 1001-05, Regulation Number 3, Part D, Concerning Major Stationary Source New Source Review and Prevention of Significant Deterioration I. Applicability 12/15/2010
  • 2/15/2013
  • 2/24/16 81 FR 3963,
  • 1/25/16
  • II. Definitions 12/15/2010
  • 12/15/2011
  • 2/15/2013
  • 2/24/16 81 FR 3963,
  • 1/25/16
  • Except II.A.26.d., the phrase “and only PM2.5 emissions can be used to evaluate the net emissions increase for PM2.5
    III. Permit Review Procedures 12/15/2011 2/24/16 81 FR 3963,
  • 1/25/16
  • *         *         *         *         *         *         * V. Requirements Applicable to Nonattainment Areas 12/15/2011
  • 2/15/2013
  • 2/24/16 81 FR 3963,
  • 1/25/16
  • VI. Requirements applicable to attainment and unclassifiable areas and pollutants implemented under Section 110 of the Federal Act (Prevention of Significant Deterioration Program) 12/15/2010
  • 12/15/2011
  • 2/15/2013
  • 2/24/16 81 FR 3963,
  • 1/25/16
  • Except for VI.A.1.c., the phrase “for phases that commence construction more than 18 months after the initial granting of the permit”; VI.A.2., the phrase “either Section VI.A.2.a. or b., as clarified for any relevant air pollutant, in Section VI.A.2.c.”; VI.A.2.c.; VI.B.3.a.(iii) in reference to PM2.5 monitoring exemption; and VI.B.3.d.
    *         *         *         *         *         *         * X. Air Quality Limitations 12/15/2011 2/24/16 81 FR 3963,
  • 1/25/16
  • *         *         *         *         *         *         * XIII. Federal Class I Areas 12/15/2011 2/24/16 81 FR 3963,
  • 1/25/16
  • XIV. Visibility 12/15/2010 2/24/16 81 FR 3963,
  • 1/25/16
  • XV. Actuals PALs 12/15/2010 2/24/16 81 FR 3963,
  • 1/25/16
  • *         *         *         *         *         *         *
    Dated: March 24, 2016. Shaun L. McGrath, Regional Administrator, Region 8.
    [FR Doc. 2016-08274 Filed 4-11-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R10-OAR-2016-0003; FRL-9944-83-Region 10] Approval and Promulgation of Implementation Plans; Spokane, Washington: Second 10-Year PM10 Limited Maintenance Plan AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving the limited maintenance plan submitted on January 4, 2016, by the State of Washington for the Spokane area, which includes the cities of Spokane, Spokane Valley, Millwood and surrounding unincorporated areas in Spokane County, Washington. This plan addresses the second 10-year maintenance period for particulate matter with an aerodynamic diameter less than or equal to a nominal 10 micrometers (PM10). A limited maintenance plan is used to meet Clean Air Act requirements for formerly designated nonattainment areas that meet certain qualification criteria. The EPA determined that Washington's submittal meets the limited maintenance plan criteria. The Spokane area currently has monitored PM10 levels well below the National Ambient Air Quality Standards (NAAQS) and levels have not increased since the area was redesignated to attainment in 2005. The EPA is also approving minor updates to the Spokane Regional Clean Air Agency (SRCAA) regulations controlling PM10 related to the maintenance plan.

    DATES:

    This final rule is effective May 12, 2016.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R10-OAR-2016-0003. All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information the disclosure of which is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the Air Programs Unit, Office of Air, Waste and Toxics, EPA Region 10, 1200 Sixth Avenue, Seattle, WA, 98101. The EPA requests that if at all possible, you contact the individual listed in the FOR FURTHER INFORMATION CONTACT section to view the hard copy of the docket. You may view the hard copy of the docket Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    For information please contact Jeff Hunt at (206) 553-0256, [email protected], or by using the above EPA, Region 10 address.

    SUPPLEMENTARY INFORMATION: Table of Contents I. Background Information II. Final Action III. Incorporation by Reference IV. Statutory and Executive Orders Review I. Background Information

    On February 26, 2016, the EPA proposed to approve the limited maintenance plan submitted by the State of Washington, on January 4, 2016, for the Spokane PM10 area, including minor regulatory changes associated with the limited maintenance plan (81 FR 9793). An explanation of the Clean Air Act requirements, a detailed analysis of the submittal, and the EPA's reasons for proposing approval were provided in the notice of proposed rulemaking, and will not be restated here. The public comment period for this proposed rule ended on March 28, 2016. The EPA received no comments on the proposal.

    II. Final Action

    The EPA is approving the limited maintenance plan submitted by the State of Washington, on January 4, 2016, for the Spokane PM10 area. The EPA's approval of this limited maintenance plan satisfies the Clean Air Act requirements for the second 10-year period in the Spokane PM10 area. Additionally, the EPA is approving and incorporating by reference updated versions of supporting regulations, specifically SRCAA Regulation I, sections 6.05, 6.14, and 6.15. These regulatory changes update and clarify the general PM10 control measures, including minor revisions to the emission reduction strategies for both paved and unpaved roads.

    III. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the regulations described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available electronically through http://www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

    IV. Statutory and Executive Orders Review

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

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

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

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

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

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

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

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

    • is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because this action does not involve technical standards; and

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

    In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not impose substantial direct costs on tribal governments or preempt tribal law. This SIP revision is not approved to apply in Indian reservations in the State or any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. Consistent with EPA policy, the EPA provided a consultation opportunity to the Spokane Tribe in a letter dated May 21, 2015. The EPA did not receive a request for consultation.

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

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 13, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

    List of Subjects in 40 CFR Part 52

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

    Dated: April 1, 2016. Dennis J. McLerran, Regional Administrator, Region 10.

    For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart WW—Washington 2. In § 52.2470: a. Amend paragraph (c), Table 9 “Additional Regulations Approved for Spokane Regional Clean Air Agency (SRCAA) Jurisdiction “, by revising entries “6.05”, “6.14”, and “6.15”. b. Amend paragraph (e), Table 2 “Attainment, Maintenance, and Other Plans”, by adding an entry to the end of the table.

    The revisions and addition read as follows:

    § 52.2470 Identification of plan.

    (c) * * *

    Table 9—Additional Regulations Approved for the Spokane Regional Clean Air Agency (SRCAA) Jurisdiction [Applicable in Spokane County, excluding facilities subject to Energy Facilities Site Evaluation Council (EFSEC) jurisdiction, Indian reservations and any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, and facilities subject to the applicability sections of WAC 173-400-700, 173-405-012, 173-410-012, and 173-415-012] State/local citation Title/subject State/local
  • effective date
  • EPA approval date Explanations
    Spokane Regional Clean Air Agency Regulations Regulation I—Article VI—Emissions Prohibited 6.05 Particulate Matter and Preventing Particulate Matter from Becoming Airborne 04/10/04 04/12/16 [Insert Federal Register citation] Except 6.05(A). 6.14 Standards for Control of Particulate Matter on Paved Surfaces 06/03/07 04/12/16 [Insert Federal Register citation] 6.15 Standards for Control of Particulate Matter on Unpaved Roads 06/03/07 04/12/16 [Insert Federal Register citation] *         *         *         *         *         *         *

    (e) * * *

    Table 2—Attainment, Maintenance, and Other Plans Name of SIP Provision Applicable geographic or nonattainment area State submittal date EPA approval date Explanations *         *         *         *         *         *         * Particulate Matter (PM10) 2nd 10-Year Limited Maintenance Plan Spokane 1/4/16 4/12/16 [Insert Federal Register citation]
    [FR Doc. 2016-08272 Filed 4-11-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0449; FRL-9944-11] 1,2-Propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl] propoxy]-; Exemption From the Requirement of a Tolerance AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes an exemption from the requirement of a tolerance for residues of 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- (CAS Reg. No. 70280-68-1) when used as an inert ingredient (antifoaming agent) in pesticide formulations applied to growing crops at a maximum concentration not to exceed 5% by weight. Exponent, on behalf of ISK Biosciences submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-.

    DATES:

    This regulation is effective April 12, 2016. Objections and requests for hearings must be received on or before June 13, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0449, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

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

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

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0449 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before June 13, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0449, by one of the following methods:

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

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

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

    Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    II. Petition for Exemption

    In the Federal Register of April 6, 2015 (80 FR 18327) (FRL-9924-00), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-10699) by Exponent, on behalf of ISK Biosciences, 7470 Auburn Road, Suite A, Concord, OH 44077. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- (CAS Reg. No. 70280-68-1) when used as an inert ingredient (antifoaming agent) in pesticide formulations applied to growing crops at a maximum concentration not to exceed 10% in formulation. That document referenced a summary of the petition prepared by Exponent, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

    Based upon review of the data supporting the petition, EPA has modified the limitation on the maximum concentration in the pesticide formulation from 10% to 5%. This limitation is based on the Agency's risk assessment which can be found at http://www.regulations.gov in document, “1,2-Propanediol, 3-[3-[1,3,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-; Human health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pre-harvest Pesticide Products Under 40 CFR 180.920” in docket ID number EPA-HQ-OPP-2014-0449.

    III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

    IV. Aggregate Risk Assessment and Determination of Safety

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

    EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

    Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- follows.

    A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

    There is currently limited data available for 1,2-propanediol, 3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-. The Agency received three studies specifically testing 1,2-propanediol, 3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-: acute oral toxicity, acute dermal toxicity, and an Ames assay. Those studies showed that 1,2-propanediol, 3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]- was non-toxic via acute oral and acute dermal exposures and was negative for mutagenicity. To assess the remaining potential toxicity of 1,2-propanediol, 3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-, the Agency relied on data for a suitable cluster of structurally related linear short chain siloxane (Si-2 to Si-5) compounds. Based on the similar structures and physicochemical properties of these compounds to 1,2-propanediol, 3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-, which primarily differ only in the number of siloxane units, the Agency has determined that the toxicological properties of these compounds is representative of the toxicity of 3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-. The Agency has also determined that these data adequately address the physicochemical, mammalian metabolism, mammalian toxicological, and environmental fate endpoints of 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-.

    Oral repeat dose toxicity studies are available for structurally similar linear short chain siloxane chemicals, for durations ranging from 28 days up to one year in rats, rabbits, and dogs. The lowest NOAELs were in the 25 milligram/kilogram/day (mg/kg/day) range for two 28-day oral repeat dose rat studies and a 90-day dog study. LOAELs for these studies were based mainly on liver effects which were present in all of these studies.

    Dermal repeated dose toxicity studies are available for two of the structurally similar linear short chain siloxane compounds. A 28-day dermal toxicity study in rats and rabbits showed no adverse effects up to limit dose of 1,000 mg/kg/day. The NOAEL was 1,000 mg/kg/day; the highest dose tested in both studies.

    Inhalation repeated dose toxicity studies are available for three of the structurally similar linear short chain siloxane compounds. Both 28-day and 90-day rat inhalation studies are available as well as a one-year chronic inhalation study. The lowest inhalation NOAEL was 3.9 milligrams per Liter (mg/L) in a 90-day study, equivalent to a dose of greater than 1,000 mg/kg/day, a limit dose value.

    A carcinogenicity study is available on one structurally-related short chain siloxane compound. An increase incidence of Leydig cell tumors (LCTs) in males was observed at all doses. However, due to the high background incidence of LCTs in Fischer 344 rats, this effect has been determined to not be treatment-related. Renal tubular adenomas and carcinomas were also observed in the study but are attributable to male rat specific alpha-2μ-globulin mediated nephrotoxicity and therefore not relevant to cancer risk concerns in humans. Genotoxicity studies on 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]- and structurally-related compounds were negative for genotoxic effects. A DEREK (structure-activity modeling) analysis was conducted and identified no structural alerts for possible carcinogenicity among the linear short chain siloxane compounds. Therefore, based on the lack of human-relevant carcinogenicity in the available study, and the results of the genotoxicity studies and DEREK analysis, 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]- is not expected to be carcinogenic.

    Reproductive and developmental toxicity studies with linear short chain siloxane compounds demonstrated no adverse effects at doses at or below limit dose levels. No evidence of immunotoxicity or neuro toxicity at doses below the limit dose was observed in the available studies for the structurally related linear short chain siloxane (Si-2 to Si-5) compounds at up to limit dose levels.

    There are currently no publically-available metabolism studies for 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-, however, the expected mammalian metabolic pathways which may be involved in the degradation of 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]- include a combination of ether hydrolysis followed by ß-oxidation of the carbon chain followed by methyl oxidation of the silyl methyl groups. Methyl oxidation would result in the formation of a mixture of primary and alcohol metabolites. The more polar primary alcohol functionalities can both be conjugated and excreted directly or further oxidized to form a mixture of more polar carboxylic acid metabolites that are readily conjugated and excreted.

    Specific information on the studies received and the nature of the adverse effects caused by 1,2-propanediol,3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]- as well as the NOAEL and the LOAEL from the toxicity studies can be found at http://www.regulations.gov in document, “1,2-Propanediol,3-[3-[1,3,3,3-tetraamethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pre-harvest Pesticide Products Under 40 CFR 180.920” in docket ID number EPA-HQ-OPP-2014-0449.

    B. Toxicological Points of Departure/Levels of Concern

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

    A summary of the toxicological endpoints for 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- used for human risk assessment is shown in Table 1 of this unit.

    The 28-day studies in rats the NOAEL was 25 mg/kg/day with a LOAEL of 250 mg/kg/day based on based on increases in absolute liver weights, hepatocellular hypertrophy and protoporphyrin accumulation with associated bile duct proliferation and periportal chronic inflammation. A 90-day dog study had a NOAEL of 24 mg/kg/day with a LOAEL of 77 mg/kg/day based on increased relative liver weight in females and lower relative testes weight in males with slight testicular atrophy or hypoplasia in males. A NOAEL of 25 mg/kg/day was selected for use as the endpoint for dietary exposure in this risk assessment. An additional uncertainty factor of 3X was applied for the use of shorter term study for a chronic risk assessment.

    Dermal and inhalation exposure endpoints were not selected as there were no adverse effects observed up to limit dose levels in both rat and rabbit dermal and inhalation toxicity studies.

    Table 1—Summary of Toxicological Doses and Endpoints for 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- for Use in Human Risk Assessment Exposure/scenario Point of departure and
  • uncertainty/safety factors
  • RfD, PAD, LOC for risk
  • assessment
  • Study and toxicological
  • effects
  • Acute dietary (All populations) An acute effect was not found in the database therefore an acute dietary assessment is not necessary. Chronic dietary (All populations) NOAEL= 25 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 3x
  • Chronic RfD = 0.08 mg/kg/day
  • cPAD = 0.08 mg/kg/day
  • 28-Day oral toxicity study-rat LOAEL = 250 mg/kg/day based on protoporphyrin accumulation in the liver.
    Incidental oral short-term (1 to 30 days) NOAEL= 25 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 3x
  • LOC for MOE = 300 28-Day oral toxicity study-rat LOAEL = 250 mg/kg/day based on protoporphyrin accumulation in the liver.
    Incidental oral intermediate-term (1 to 6 months) NOAEL= 25 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 3x
  • LOC for MOE = 300 28-Day oral toxicity study-rat LOAEL = 250 mg/kg/day based on protoporphyrin accumulation in the liver.
    Cancer (Oral, dermal, inhalation) Not likely to be carcinogenic to humans based on the lack of increased incidence of tumor formation compared to controls in the 1-year carcinogenicity study, lack of mutagenicity, and no structural alerts for genotoxicity or carcinogenicity identified in a qualitative structure activity relationship (SAR) database, DEREK. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). UFS = use of a short-term study for long-term risk assessment.
    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- in food as follows:

    i. Acute Exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide chemical, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-; therefore, a quantitative acute dietary exposure assessment is unnecessary.

    ii. Chronic exposure. The chronic dietary exposure assessment for this inert ingredient utilizes the Dietary Exposure Evaluation Model Food Commodity Intake Database (DEEM-FCID), Version 3.16, EPA, which includes food consumption information from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, “What We Eat In America”, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. In the absence of actual residue data, the inert ingredient evaluation is based on a highly conservative model which assumes that the residue level of the inert ingredient would be no higher than the highest established tolerance for an active ingredient on a given commodity. Implicit in this assumption is that there would be similar rates of degradation between the active and inert ingredient (if any) and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient. The model assumes 100 percent crop treated (PCT) for all crops and that every food eaten by a person each day has tolerance-level residues. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

    2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

    Residential use patterns are possible for pesticide products containing 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-. Residential exposure could occur via the dermal and inhalation routes of exposure. However, there are no concerns for dermal or inhalation exposure because no effects were seen in dermal or inhalation toxicity studies up to the limit dose. Incidental oral exposure for children is possible either by hand-to-mouth or object-to-mouth ingestion resulting from contact with treated surfaces.

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

    EPA has not found 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- to share a common mechanism of toxicity with any other substances, and 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

    D. Safety Factor for Infants and Children

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

    2. Prenatal and postnatal sensitivity. Although some adverse reproductive effects were observed in the inhalation developmental/reproductive toxicity studies, these effects were at dose levels far in excess of the clear NOAEL established in the oral reproductive and developmental screening study and the regulatory doses used in the risk assessment were selected to be protective of these effects.

    3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 3x to account for the use of a subchronic study to derive a chronic reference dose. That decision is also based on the following findings:

    i. Although only limited data on 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- is available, the Agency has reliable data based on the structurally related linear short chain siloxane (Si-2 to Si-5) compounds to adequately characterize the toxicity and assess the risk from dietary exposure to 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-.

    ii. There is no indication that 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- is a neurotoxic chemical at doses below the limit dose and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.

    iii. There is no indication that 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- is a immunotoxic chemical and there is no need for a immunotoxicity study or additional UFs to account for immunotoxicity.

    iv. As discussed in Unit IV.D.2., there is no need to retain the FQPA 10x to address any concern for potential increased susceptibility in infants and children from prenatal or postnatal exposure to 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-.

    v. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on a highly conservative model that assumes 100 percent crop treated (PCT) for all crops and that every food eaten by a person each day has residues of inert ingredient equivalent to the residue level of the highest established tolerance for an active ingredient on a given commodity. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]-.

    E. Aggregate Risks and Determination of Safety

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

    1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- is not expected to pose an acute risk.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- from food and water will utilize 88.3% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in this unit regarding residential use patterns, chronic residential exposure to residues of 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- is not expected.

    3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

    1,2-Propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- may be used as an inert ingredient in pesticide products that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Although short-term residential exposure is possible, there was no endpoint of concern identified in both dermal and inhalation toxicity studies. However the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures for children. EPA has concluded the combined short-term aggregated food, water, and residential exposures results in an aggregate MOE of 334 for children. Children's aggregate MOE combines average food and water exposure from the chronic dietary exposure with residential exposure associated with contact with treated lawns (hand-to-mouth + object-to-mouth). As the level of concern is for MOEs that are lower than 300, these MOEs are not of concern.

    4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

    1,2-Propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- may be used as an inert ingredient in pesticide products that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Although intermediate-term residential exposure is possible, there was no endpoint of concern identified in both dermal and inhalation toxicity. However the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures for children. EPA has concluded the combined intermediate-term aggregated food, water, and residential exposures results in an aggregate MOE of 342 for children. Children's aggregate MOE combines average food and water exposure from the chronic dietary exposure with residential exposure associated with contact with treated lawns (hand-to-mouth + object-to-mouth). As the level of concern is for MOEs that are lower than 300, these MOEs are not of concern.

    5. Aggregate cancer risk for U.S. population. As discussed in Unit IV.A., EPA does not expect 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- to pose a cancer risk to humans.

    6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- residues.

    V. Other Considerations A. Analytical Enforcement Methodology

    Although EPA is establishing a limitation on the amount of 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- that may be used in pesticide formulations, an analytical enforcement methodology is not necessary for this exemption from the requirement of tolerance. The limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will not register any pesticide for sale or distribution for use on growing crops with concentrations of 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- exceeding 5% by weight of the formulation.

    B. Revisions to Petitioned-For Tolerances

    Based upon an evaluation of the data included in the petition, EPA is establishing an exemption from the requirement of a tolerance for residues of 1,2-propanediol 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- when used in pesticide formulations as an inert ingredient (antifoaming agent), not to exceed 5% by weight of the formulation, instead of the 10% limit requested. The basis for this revision can be found at http://www.regulations.gov in document, “1,2-Propanediol,3-[3-[1,3,3,3-tetraamethyl-1-[(trimethylsilyl)oxy]-1-disiloxanyl]propoxy]-; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pre-harvest Pesticide Products Under 40 CFR 180.920” in docket ID number EPA-HQ-OPP-2014-0449.

    VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.920 for 1,2-propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- (CAS Reg. No. 70280-68-1) when used as an inert ingredient (antifoaming agent) in pesticide formulations applied to growing crops at a maximum concentration not to exceed 5% by weight in formulation.

    VII. Statutory and Executive Order Reviews

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

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

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

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

    VIII. Congressional Review Act

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

    List of Subjects in 40 CFR Part 180

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

    Dated: March 31, 2016. G. Jeffrey Herndon, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

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

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

    2. In § 180.920, add alphabetically the inert ingredient to the table to read as follows:
    § 180.920 Inert ingredients used pre-harvest; exemptions from the requirement of a tolerance. Inert ingredients Limits Uses *         *         *         *         *         *         * 1,2-Propanediol, 3-[3-[1, 3, 3, 3-tetramethyl-1-[(trimethylsilyl)oxy]-1-disiloxyanyl] propoxy]- (CAS Reg. No. 70280-68-1) Not to exceed 5% by weight of pesticide formulation Antifoaming agent. *         *         *         *         *         *         *
    [FR Doc. 2016-08282 Filed 4-11-16; 8:45 am] BILLING CODE 6560-50-P
    GULF COAST ECOSYSTEM RESTORATION COUNCIL 40 CFR Part 1800 [Docket Number: 104122016-1111-01] RESTORE Act Spill Impact Component Allocation AGENCY:

    Gulf Coast Ecosystem Restoration Council.

    ACTION:

    Notice of effective date of final rule.

    SUMMARY:

    This document confirms that on April 4, 2016, the United States District Court for the Eastern District of Louisiana entered a consent decree (Consent Decree) among the United States; the states of Alabama, Florida, Louisiana, Mississippi and Texas; and BP Exploration and Production Inc. with respect to the civil penalty and natural resource damages in case number MDL No. 2179. The Gulf Coast Ecosystem Restoration Council (Council) regulation (Spill Impact Regulation) that implements the Spill Impact Component Allocation of the Resources and Ecosystems Sustainability, Tourist Opportunities, and Revived Economies of the Gulf Coast States Act of 2012 (RESTORE Act) is effective as of the date of publication of this document.

    DATES:

    The Spill Impact Regulation is effective on April 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Will Spoon at (504) 239-9814.

    SUPPLEMENTARY INFORMATION:

    Background

    On December 15, 2015, the Council published the Spill Impact Regulation in the Federal Register (80 FR 77580), to be effective on the date that the Council publishes this document in the Federal Register confirming that the United States District Court for the Eastern District of Louisiana has entered the Consent Decree.

    On April 4, 2016, the United States District Court for the Eastern District of Louisiana entered the Consent Decree. The Council confirms such entry by publication of this document, and the Spill Impact Regulation is therefore effective.

    For more information on the Spill Impact Regulation, please see the final rule (80 FR 77580, December 15, 2015).

    Procedural Requirements Regulatory Planning and Review (Executive Orders 12866 and 13563)

    As an independent Federal entity that is comprised, in part, of the Secretaries of the Departments of the Interior, Agriculture, Commerce and Homeland Security; the Secretary of the Army; and the Administrator of Environmental Protection Agency, the requirements of Executive Orders 12866 and 13563 do not apply to this document.

    Paperwork Reduction Act

    This document contains no collection of information requirements. Therefore the Paperwork Reduction Act does not apply to this document.

    (Authority: 33 U.S.C. 1321(t).) Justin R. Ehrenwerth, Executive Director, Gulf Coast Ecosystem Restoration Council.
    [FR Doc. 2016-08319 Filed 4-11-16; 8:45 am] BILLING CODE 6560-58-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 447 [CMS-2328-F2] RIN 0938-AS89 Medicaid Program; Deadline for Access Monitoring Review Plan Submissions AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Final rule.

    SUMMARY:

    In the November 2, 2015 Federal Register, we published a final rule with comment period entitled “Medicaid Program: Methods for Assuring Access to Covered Medicaid Services.” The final rule with comment period established that states must develop and submit to CMS an access monitoring review plan by July 1, 2016. This document revises the deadline for states' access monitoring review plan submission to CMS until October 1, 2016.

    DATES:

    Effective Date: These regulations are effective on April 8, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Jeremy Silanskis, (410) 786-1592.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In the November 2, 2015 Federal Register (80 FR 67576), we published the “Medicaid Program: Methods for Assuring Access to Covered Medicaid Services” final rule with comment period that outlined a transparent data-driven process for states to document whether Medicaid payments are sufficient to enlist providers to assure beneficiary access to covered care and services consistent with section 1902(a)(30)(A) of the Social Security Act (the Act). This final rule with comment period included new § 447.203(b)(1) through (8) and revisions to § 447.203(b). These regulations established that states must develop and submit to CMS an access monitoring review plan by July 1, 2016 for the following service categories: Primary care services (including those provided by a physician, FQHC, clinic or dental care); physician specialist services (for example, cardiology, urology, radiology); behavioral health services (including mental health and substance use disorder); pre- and post-natal obstetric services, including labor and delivery; and home health services.

    II. Discussion and Provisions of This Final Regulation

    In the November 2, 2015 final rule with comment period, we solicited comments on § 447.203(b)(5). Specifically, we solicited comments on the scope of services required for ongoing review in the review plans, the elements of review required through the plans, whether we should allow exemptions to the rule based on state program characteristics (for example, high managed care enrollment), and the deadline for submission of the initial access monitoring review plan. We received many comments that were outside of the scope of issues on which we solicited comments. Several commenters raised concerns over CMS's characterization in the regulatory preamble of the Supreme Court Decision: Armstrong v. Exceptional Child Center, Inc., 135 S. Ct. 1378 (2015). Though we did not solicit comments on this issue, we agree with commenters that the decision is subject to judicial interpretation and we did not intend to imply an interpretation by the agency.

    The following is a summary of the comments and our responses on § 447.203(b)(5).

    Comment: We received many comments requesting that CMS not allow exemptions based on high managed care enrollment or other program features.

    Response: While we continue to consider whether exemptions might be warranted in some circumstances, we believe that further experience with the access monitoring review system set forth in the final rule with comment period is necessary to determine the appropriate circumstances. The commenters did not offer consistent suggestions or supporting evidence to set a threshold that could exempt states, nor any suggestions for alternatives states might use to demonstrate compliance with section 1902(a)(30)(A) of the Act outside of the final rule with comment period requirements.

    Comment: A number of commenters recommended that CMS expand the services that CMS requires states to review in access monitoring plans.

    Response: Commenters that requested additional services did not provide sufficient data to compel us to modify the list of core services subject to the ongoing access reviews. The core services included in the final rule with comment period (that is, primary care services, physician specialist services, behavioral health services, pre- and post-natal obstetric services and home health services) were selected because they are frequently used services in Medicaid and access to these services indicates that an individual has primary sources of care, which may increase the likelihood of having their care needs met. We also note the final rule with comment period provides providers an opportunity and mechanism to bring access concerns to the attention of state Medicaid agencies and provide feedback on rate changes that may have a negative effect on access before states submit proposals to CMS.

    Comment: Several commenters requested CMS change the due date by which states are required to develop and submit the initial Access Monitoring Review Plans. Commenters noted that state agency staff may have difficulty developing and submitting the initial review plans within the July 1, 2016 timeframe for first year reviews. These commenters offered several different dates as an alternative, including: January 1, 2017, July 1, 2017, and 6 months following the close of the state's next legislative session. A number of other commenters requested CMS maintain the timelines established in the final rule.

    Response: We established the July 1, 2016 deadline for developing and submitting the access monitoring review plans in the final rule with comment period after careful consideration of issues raised through comments on the notice of proposed rulemaking (76 FR 26342) and after weighing all of the policies discussed in the final rule. Since issuing the final rule with comment period, we have been working closely with states on developing the access monitoring review plans. States are actively engaged in developing plans and have raised significant concerns over fulfilling the requirements of the rule by the July 1, 2016 deadline. Several states have noted that additional time will allow them to develop more robust and proficient review plans, and leave them better prepared to analyze and monitor compliance with section 1902(a)(30)(A) of the Act. We agree with this assessment and believe that there are programmatic benefits to revising the due date and making conforming changes to the deadline for submission in subsequent review periods.

    Revision to the Access Monitoring Review Plan Timeframe: Based on concerns raised by commenters, in this final rule we are revising the deadline for submission effective date of the initial access monitoring review plan timeframe provision at § 447.203(b)(5) introductory text until October 1, 2016. A conforming change will also be made to the deadline for submission in subsequent review periods at § 447.203(b)(5)(i) to October 1.

    III. Waiver of Proposed Rulemaking and Delayed Effective Date

    Under section 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rule in the Federal Register before the provisions of a rule take effect. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rule in the Federal Register and provide a period of not less than 60 days for public comment. In addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of the Act mandate a 30-day delay in effective date after issuance or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the APA notice and comment, and delay in effective date requirements; similarly, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide exceptions from the notice and comment, and delay in effective date requirements of the Act. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal notice and comment rulemaking procedures for good cause if the agency makes a finding that the notice and comment process is impracticable, unnecessary, or contrary to the public interest; and includes a statement of the finding and the reasons for it in the notice. In addition, both section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and the agency includes in the rule a statement of the finding and the reasons for it.

    Because the deadlines for submission of access monitoring review plans are rules of procedure, the notice and comment requirements of 5 U.S.C. 553 do not apply to this delay of the submission date. See 5 U.S.C. 553(b)(3)(A). To the extent that section 553 applies in these circumstances however, CMS finds that the action comes within the provision's good cause exceptions because obtaining additional public comment is impracticable, unnecessary, and contrary to the public interest. See 5 U.S.C. 553(b)(3)(B). Given the imminence of the submission date, and the need for states to plan and allocate resources in advance, seeking public comment and having a delayed effective date for this short delay in the deadline for submission of access monitoring review plans is impracticable. And, because we provided an opportunity for public comment on issues that included the submission deadlines, further opportunity is not necessary. Moreover, we believe that delay of the submission deadlines would further the public interest in orderly implementation of regulatory requirements, and in ensuring development of viable access monitoring review plans in light of assertions by commenters that compliance with the original submission deadlines might be infeasible or disruptive.

    IV. Collection of Information Requirements

    The November 2, 2015 final rule with comment period stipulated that states must develop and submit (to CMS) their initial access monitoring review plan by July 1, 2016. We are now extending the submission deadline to October 1, 2016. Similarly, we are revising the deadline for subsequent review periods from July 1 to October 1. Otherwise, this final rule does not impose any new or revised information collection requirements or burden. The November 2, 2015, information collection requirements and burden are approved by OMB under control number 0938-1134 (CMS-10391).

    V. Regulatory Impact Statement

    In the November 2, 2015 final rule with comment period, we discussed the impact of the access monitoring review plan requirements on states. We do not believe this delay of the deadline for submission of the access monitoring review plans will change any of the discussion in the impact statement of the November 2, 2015 final rule with comment period.

    In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.

    List of Subjects in 42 CFR Part 447

    Accounting, Administrative practice and procedure, Drugs, Grant programs-health, Health facilities, Health professions, Medicaid, Reporting and recordkeeping requirements, Rural areas.

    For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below:

    PART 447—PAYMENTS FOR SERVICES 1. The authority citation for part 447 continues to read as follows: Authority:

    Sec. 1102 of the Social Security Act (42 U.S.C. 1302).

    § 447.203 [Amended]
    2. Section 447.203 is amended by: a. In paragraph (b)(5) introductory text, removing the date “July 1, 2016” and adding in its place the date “October 1, 2016”. b. In paragraph (b)(5)(i), removing all instances of the date “July 1” and adding in their place the date “October 1”. Dated: March 11, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. Dated: April 6, 2016. Sylvia M. Burwell, Secretary, Department of Health and Human Services.
    [FR Doc. 2016-08368 Filed 4-8-16; 4:15 pm] BILLING CODE 4120-01-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 20 [Docket No. FWS-HQ-MB-2015-0034; FF09M21200-167-FXMB1231099BPP0] RIN 1018-BA70 Migratory Bird Hunting; Final Frameworks for Migratory Bird Hunting Regulations AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Final rule; correction.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service, published a final rule in the Federal Register on March 28, 2016, that prescribes final frameworks from which States may select season dates, limits, and other options for the 2016-17 migratory bird hunting seasons. In that rule, we made an error in the daily bag limit for canvasbacks in Alaska. We intended to increase the daily bag limit for canvasbacks in Alaska, as we did for the rest of the United States, to 2 birds. We also included an incorrect description for the Special Early Canada Goose Unit in South Dakota. With this document, we correct our errors.

    DATES:

    This correction is effective April 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Ron W. Kokel, (703) 358-1714.

    SUPPLEMENTARY INFORMATION:

    In a final rule that published in the Federal Register on March 28, 2016, at 81 FR 17302, the following corrections are made:

    Final Regulations Frameworks for 2016-17 Hunting Seasons on Certain Migratory Game Birds [Corrected]

    1. On page 17317, in the second column, under the heading “Alaska” and the subheading “Daily Bag and Possession Limits,” the third sentence under “Ducks:” is amended by removing the words “1 canvasback”' and adding in their place the words “2 canvasbacks”.

    2. On page 17330, in the first column, under the heading “South Dakota” and the subheading “Early Canada Goose Seasons,” remove the entire paragraph beginning with the words “Special Early Canada Goose Unit:” and add in its place the following paragraph: “Special Early Canada Goose Unit: The Counties of Campbell, Marshall, Roberts, Day, Clark, Codington, Grant, Hamlin, Deuel, Walworth; that portion of Perkins County west of State Highway 75 and south of State Highway 20; that portion of Dewey County north of Bureau of Indian Affairs Road 8, Bureau of Indian Affairs Road 9, and the section of U.S. Highway 212 east of the Bureau of Indian Affairs Road 8 junction; that portion of Potter County east of U.S. Highway 83; that portion of Sully County east of U.S. Highway 83; portions of Hyde, Buffalo, Brule, and Charles Mix counties north and east of a line beginning at the Hughes-Hyde County line on State Highway 34, east to Lees Boulevard, southeast to State Highway 34, east 7 miles to 350th Avenue, south to Interstate 90 on 350th Avenue, south and east on State Highway 50 to Geddes, east on 285th Street to U.S. Highway 281, and north on U.S. Highway 281 to the Charles Mix-Douglas County boundary; that portion of Bon Homme County north of State Highway 50; those portions of Yankton and Clay Counties north of a line beginning at the junction of State Highway 50 and 306th Street/County Highway 585 in Bon Homme County, east to U.S. Highway 81, then north on U.S. Highway 81 to 303rd Street, then east on 303rd Street to 444th Avenue, then south on 444th Avenue to 305th Street, then east on 305th Street/Bluff Road to State Highway 19, then south to State Highway 50 and east to the Clay/Union County Line; McPherson, Edmunds, Kingsbury, Brookings, Lake, Moody, Miner, Faulk, Hand, Jerauld, Douglas, Hutchinson, Turner, Aurora, Beadle, Davison, Hanson, Sanborn, Spink, Brown, Harding, Butte, Lawrence, Meade, Oglala Lakota (formerly Shannon), Jackson, Mellette, Todd, Jones, Haakon, Corson, Ziebach, and McCook Counties; and those portions of Minnehaha and Lincoln counties outside of an area bounded by a line beginning at the junction of the South Dakota-Minnesota State line and Minnehaha County Highway 122 (254th Street) west to its junction with Minnehaha County Highway 149 (464th Avenue), south on Minnehaha County Highway 149 (464th Avenue) to Hartford, then south on Minnehaha County Highway 151 (463rd Avenue) to State Highway 42, east on State Highway 42 to State Highway 17, south on State Highway 17 to its junction with Lincoln County Highway 116 (Klondike Road), and east on Lincoln County Highway 116 (Klondike Road) to the South Dakota-Iowa State line, then north along the South Dakota-Iowa and South Dakota-Minnesota border to the junction of the South Dakota-Minnesota State line and Minnehaha County Highway 122 (254th Street).”

    Dated: April 6, 2016. Tina A. Campbell, Chief, Division of Policy, Performance, and Management Programs, U.S. Fish and Wildlife Service.
    [FR Doc. 2016-08326 Filed 4-11-16; 8:45 am] BILLING CODE 4310-55-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 635 [Docket No. 150121066-5717-02] RIN 0648-XE539 Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries AGENCY:

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

    ACTION:

    Temporary rule; closure of Angling category southern area trophy fishery.

    SUMMARY:

    NMFS closes the southern area Angling category fishery for large medium and giant (“trophy” (i.e., measuring 73 inches curved fork length or greater)) Atlantic bluefin tuna (BFT). This action is being taken to prevent any further overharvest of the Angling category southern area trophy BFT subquota.

    DATES:

    Effective 11:30 p.m., local time, April 10, 2016, through December 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Sarah McLaughlin or Brad McHale, 978-281-9260.

    SUPPLEMENTARY INFORMATION:

    Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq.) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq.) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) among the various domestic fishing categories, per the allocations established in the 2006 Consolidated Atlantic Highly Migratory Species Fishery Management Plan (2006 Consolidated HMS FMP) (71 FR 58058, October 2, 2006), as amended by Amendment 7 to the 2006 Consolidated HMS FMP (Amendment 7) (79 FR 71510, December 2, 2014), and in accordance with implementing regulations.

    NMFS is required, under § 635.28(a)(1), to file a closure notice with the Office of the Federal Register for publication when a BFT quota is reached or is projected to be reached. On and after the effective date and time of such notification, for the remainder of the fishing year or for a specified period as indicated in the notification, retaining, possessing, or landing BFT under that quota category is prohibited until the opening of the subsequent quota period or until such date as specified in the notice.

    Angling Category Large Medium and Giant Southern “Trophy” Fishery Closure

    The 2016 BFT fishing year, which is managed on a calendar-year basis and subject to an annual calendar-year quota, began January 1, 2016. The Angling category season opened January 1, 2016, and continues through December 31, 2016. The currently codified Angling category quota is 195.2 mt, of which 4.5 mt is allocated for the harvest of large medium and giant (trophy) BFT from the regulatory area by vessels fishing under the Angling category quota, with 1.5 mt allocated for each of the following areas: North of 39°18′ N. lat. (off Great Egg Inlet, NJ); south of 39°18′ N. lat. and outside the Gulf of Mexico; and in the Gulf of Mexico. Trophy BFT measure 73 inches (185 cm) curved fork length or greater.

    As of April 4, 2016, reported landings from the NMFS Automated Catch Reporting System and the North Carolina Tagging Program total approximately 1.6 mt. NMFS has determined that the codified Angling category southern area trophy BFT subquota has been reached and that a closure of the southern area trophy BFT fishery is warranted at this time. Therefore, retaining, possessing, or landing large medium or giant BFT south of 39°18′ N. lat. and outside the Gulf of Mexico by persons aboard vessels permitted in the HMS Angling category and the HMS Charter/Headboat category must cease at 11:30 p.m. local time on April 10, 2016. This closure will remain effective through December 31, 2016. This action is intended to prevent any further overharvest of the Angling category southern area trophy BFT subquota, and is taken consistent with the regulations at § 635.28(a)(1).

    If needed, subsequent Angling category adjustments will be published in the Federal Register. Information regarding the Angling category fishery for Atlantic tunas, including daily retention limits for BFT measuring 27 inches (68.5 cm) to less than 73 inches and any further Angling category adjustments, is available at hmspermits.noaa.gov or by calling (978) 281-9260.

    HMS Angling and HMS Charter/Headboat category permit holders may catch and release (or tag and release) BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. Anglers are also reminded that all BFT that are released must be handled in a manner that will maximize survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at www.nmfs.noaa.gov/sfa/hms/.

    Classification

    The Assistant Administrator for NMFS (AA) finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:

    The regulations implementing the 2006 Consolidated HMS FMP, as amended, provide for inseason retention limit adjustments and fishery closures to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. The closure of the southern area Angling category trophy fishery is necessary to prevent any further overharvest of the southern area trophy fishery subquota. NMFS provides notification of closures by publishing the notice in the Federal Register, emailing individuals who have subscribed to the Atlantic HMS News electronic newsletter, and updating the information posted on the Atlantic Tunas Information Line and on hmspermits.noaa.gov.

    These fisheries are currently underway and delaying this action would be contrary to the public interest as it could result in excessive trophy BFT landings that may result in future potential quota reductions for the Angling category, depending on the magnitude of a potential Angling category overharvest. NMFS must close the southern area trophy BFT fishery before additional landings of these sizes of BFT accumulate. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For all of the above reasons, there is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.

    This action is being taken under 50 CFR 635.28(a)(1), and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 971 et seq. and 1801 et seq.

    Dated: April 7, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-08386 Filed 4-7-16; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150916863-6211-02] RIN 0648-XE558 Fisheries of the Exclusive Economic Zone off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area AGENCY:

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

    ACTION:

    Temporary rule; reallocation.

    SUMMARY:

    NMFS is exchanging unused rock sole Community Development Quota (CDQ) for yellowfin sole CDQ acceptable biological catch (ABC) reserves in the Bering Sea and Aleutian Islands management area. This action is necessary to allow the 2016 total allowable catch of rock sole, and yellowfin sole in the Bering Sea and Aleutian Islands management area to be harvested.

    DATES:

    Effective April 12, 2016, through December 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Steve Whitney, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

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

    The 2016 rock sole and yellowfin sole CDQ reserves specified in the BSAI are 6,110 mt, and 15,408 mt as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016). The 2016 rock sole and yellowfin sole CDQ ABC reserves are 11,128 mt and 7,244 mt as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016).

    The Norton Sound Economic Development Corporation has requested that NMFS exchange 400 mt of rock sole CDQ reserves for 400 mt of yellowfin sole CDQ ABC reserves under § 679.31(d). Therefore, in accordance with § 679.31(d), NMFS exchanges 400 mt of rock sole CDQ reserves for 400 mt of yellowfin sole CDQ ABC reserves in the BSAI. This action also decreases and increases the TACs and CDQ ABC reserves by the corresponding amounts. Tables 11 and 13 of the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016) are revised as follows:

    Table 11—Final 2016 Community Development Quota (CDQ) Reserves, Incidental Catch Amounts (ICAS), and Amendment 80 Allocations of the Aleutian Islands Pacific Ocean Perch, and BSAI Flathead Sole, Rock Sole, and Yellowfin Sole Tacs [Amounts are in metric tons] Sector Pacific Ocean perch Eastern
  • Aleutian
  • District
  • Central
  • Aleutian
  • District
  • Western
  • Aleutian
  • District
  • Flathead
  • sole
  • BSAI Rock
  • sole
  • BSAI Yellowfin
  • sole
  • BSAI
    TAC 7,900 7,000 9,000 21,000 56,700 144,400 CDQ 845 749 963 2,247 5,710 15,808 ICA 200 75 10 5,000 6,000 3,500 BSAI trawl limited access 685 618 161 0 0 14,979 Amendment 80 6,169 5,558 7,866 13,753 44,990 110,113 Alaska Groundfish Cooperative 3,271 2,947 4,171 1,411 11,129 43,748 Alaska Seafood Cooperative 2,898 2,611 3,695 12,342 33,861 66,365 Note: Sector apportionments may not total precisely due to rounding.
    Table 13—Final 2016 and 2017 ABC Surplus, Community Development Quota (CDQ) ABC Reserves, and Amendment 80 ABC Reserves in the BSAI for Flathead Sole, Rock Sole, and Yellowfin Sole [Amounts are in metric tons] Sector 2016
  • Flathead
  • sole
  • 2016
  • Rock
  • sole
  • 2016
  • Yellowfin
  • sole
  • 2017
  • Flathead
  • sole
  • 2017
  • Rock
  • sole
  • 2017
  • Yellowfin
  • sole
  • ABC 66,250 161,100 211,700 64,580 145,000 203,500 TAC 21,000 56,700 144,400 21,000 57,100 144,000 ABC surplus 45,250 104,400 67,300 43,580 87,900 59,500 ABC reserve 45,250 104,400 67,300 43,580 87,900 59,500 CDQ ABC reserve 4,842 11,528 6,844 4,663 9,405 6,367 Amendment 80 ABC reserve 40,408 92,872 60,456 38,917 78,495 53,134 Alaska Groundfish Cooperative for 2016 1 4,145 22,974 24,019 n/a n/a n/a Alaska Seafood Cooperative for 2016 1 36,263 69,898 36,437 n/a n/a n/a 1 The 2017 allocations for Amendment 80 species between Amendment 80 cooperatives and the Amendment 80 limited access sector will not be known until eligible participants apply for participation in the program by November 1, 2016.
    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the flatfish exchange by the Norton Sound Economic Development Corporation in the BSAI. Since these fisheries are currently open, it is important to immediately inform the industry as to the revised allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet as well as processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 31, 2016.

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

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

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: April 7, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-08419 Filed 4-11-16; 8:45 am] BILLING CODE 3510-22-P
    81 70 Tuesday, April 12, 2016 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5462; Directorate Identifier 2015-NM-131-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Airbus Model A330-200, -200 Freighter and -300 series airplanes, and Model A340-200 and -300 series airplanes. This proposed AD was prompted by reports of spurious terrain awareness warning system (TAWS) alerts during approach and takeoff for airplanes fitted with the terrain and traffic collision avoidance system with transponder (T3CAS) when the T3CAS is constantly powered “ON” for more than 149 hours. This proposed AD would require repetitive on-ground power cycle of the T3CAS. We are proposing this AD to prevent spurious TAWS alerts (Collision Prediction and Alerting (CPA), or missing legitimate CPA), which could increase flight crew workload during critical landing or takeoff phases, and possibly result in reduced control of the airplane.

    DATES:

    We must receive comments on this proposed AD by May 27, 2016.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email [email protected]; Internet http://www.airbus.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5462; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149.

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-5462; Directorate Identifier 2015-NM-131-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

    Discussion

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2015-0125, dated July 1, 2015, corrected on July 3, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-200, -200 Freighter and -300 series airplanes, and Model A340-200 and -300 series airplanes. The MCAI states:

    Cases were reported of spurious Terrain Awareness Warning System (TAWS) alerts during approach and take off, with aeroplane fitted with the Terrain and Traffic Collision Avoidance System with Transponder (T3CAS). Investigations on the unit were launched with the manufacturer of the system (ACSS). The results of the laboratory investigation confirmed that an internal frozen Global Positioning System position anomaly occurs when the T3CAS is constantly powered `ON' for more than 149 hours. The origin for this defect was identified as a counter limitation related to a T3CAS internal software misbehaviour, not self-detected.

    This condition, if not corrected, could lead to spurious TAWS alerts (Collision Prediction and Alerting (CPA), or missing legitimate CPA), which could increase flight crew workload during critical landing or take off phases, possibly resulting in reduced control of the aeroplane.

    Prompted by these reports, Airbus issued Alert Operators Transmission (AOT) A34L003-13 to provide instructions to accomplish an on ground repetitive power cycle of the T3CAS before exceeding 120 hours of continuous power, and EASA issued AD 2014-0242 to require repetitive on ground power cycles of the T3CAS unit.

    Since that [EASA] AD was issued, the AOT A34L003-13 revision 1 has been issued which extend[s] the applicability to A340 aeroplanes modified in-service in accordance with Airbus SB 34-4282 (T3CAS std 1.2 unit installation). It was also identified that [EASA] AD 2014-0242 does not refer to affected A330 in-service aeroplanes on which SB A330-34-3271 or SB A330-34-3286 or SB A330-34-3301 have been embodied.

    For the reason described above, this [EASA] AD retains the same required actions as EASA AD 2014-0242, which is superseded, expands the Applicability of the [EASA] AD to include post SB A330-34-3271, post SB A330-34-3286 and post SB A330-34-3301 A330 aeroplanes, and post SB A340-34-4282 A340 aeroplanes.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5462.

    Related Service Information Under1 CFR Part 51

    Airbus has issued AOT A34L003-13, Revision 1, dated May 26, 2015. The service information describes procedures for an on-ground power cycle of the T3CAS. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

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

    Costs of Compliance

    We estimate that this proposed AD affects 3 airplanes of U.S. registry.

    We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $0 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $255, or $85 per product.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Airbus: Docket No. FAA-2016-5462; Directorate Identifier 2015-NM-131-AD. (a) Comments Due Date

    We must receive comments by May 27, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to the following Airbus airplanes, certificated in any category.

    (1) Airbus Model A330-201, -202, -203, -223, -243, -223F, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes, all manufacturer serial numbers on which Airbus Modification 202097 (T3CAS standard 1.1) or Modification 202849 (T3CAS standard 1.2) has been embodied in production, or Airbus Service Bulletin A330-34-3271, Airbus Service Bulletin A330-34-3286, or Airbus Service Bulletin A330-34-3301 have been embodied in-service.

    (2) Airbus Model A340-211, -212, -213, -311, -312, and -313 airplanes, all manufacturer serial numbers on which Airbus Service Bulletin A340-34-4282 (T3CAS standard 1.2) has been embodied in-service.

    (d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

    (e) Reason

    This AD was prompted by reports of spurious terrain awareness warning system (TAWS) alerts during approach and take off for airplanes fitted with the terrain and traffic collision avoidance system with transponder (T3CAS) when the T3CAS is constantly powered “ON” for more than 149 hours. We are issuing this AD to prevent spurious TAWS alerts (Collison Prediction and Alerting (CPA), or missing legitimate CPA), which could increase flight crew workload during critical landing or take off phases, and possibly result in reduced control of the airplane.

    (f) Compliance

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

    (g) Ground Power Cycle

    For Model A330 and A340 airplanes equipped with a T3CAS unit having a part number specified in paragraphs (g)(1) or (g)(2) of this AD: Within 30 days after the effective date of this AD, or within 120 hours of continuous power of the T3CAS after installation of the T3CAS, as specified in any applicable service information in paragraph (h) of this AD, whichever occurs later, do an on-ground power cycle of the T3CAS, in accordance with the instructions of Airbus Alert Operators Transmission (AOT) A34L003-13, Revision 1, dated May 26, 2015. Thereafter, repeat the on-ground power cycle of the T3CAS, at intervals not to exceed 120 hours of continuous power of the T3CAS.

    (1) Affected T3CAS Units are those having part number (P/N) 9005000-10101, Software Standard 1.1.

    (2) Affected T3CAS Units are those having P/N 9005000-10202, Software Standard 1.2.

    (h) Service Information Used To Install Part Affected

    Paragraphs (h)(1) through (h)(4) of this AD identify the service information that was used to install the T3CAS, as specified in paragraph (g) of this AD.

    (1) Airbus Service Bulletin A330-34-3271.

    (2) Airbus Service Bulletin A330-34-3286.

    (3) Airbus Service Bulletin A330-34-3301.

    (4) Airbus Service Bulletin A340-34-4282.

    (i) Parts Installation Limitations

    As of the effective date of this AD, installation on an airplane of a T3CAS unit having a part number specified in paragraph (g) of this AD is acceptable, provided that, following installation, the T3CAS unit is power cycled on a recurrent basis, as required by paragraph (g) of this AD.

    (j) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Airbus AOT A34L003-13, dated November 25, 2013, which is not incorporated by reference in this AD.

    (k) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1138; fax 425-227-1149. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

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

    (l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2015-0125, dated July 1, 2015, corrected on July 3, 2015, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5462.

    (2) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email [email protected]; Internet http://www.airbus.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on March 30, 2016. Victor Wicklund, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-08255 Filed 4-11-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5460; Directorate Identifier 2015-NM-188-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for all Airbus Model A330-200 Freighter, -200, and -300 series airplanes. This proposed AD was prompted by a report of a manufacturing defect that affects the durability of affected parts in the cargo and cabin compartment. This proposed AD would require an inspection of affected structural parts in the cargo and cabin compartments to determine if proper heat-treatment has been done, and replacement if necessary. We are proposing this AD to prevent crack initiation and propagation, which could result in reduced structural integrity of the fuselage.

    DATES:

    We must receive comments on this proposed AD by May 27, 2016.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Airbus SAS, Airworthiness Office-EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email: [email protected]; Internet: http://www.airbus.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5460; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone: 425-227-1138; fax: 425-227-1149.

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-5460; Directorate Identifier 2015-NM-188-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

    Discussion

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued European Airworthiness Directive 2015-0212, dated November 4, 2015, to correct an unsafe condition for all Airbus Model A330-200 Freighter, -200, and -300 series airplanes. The MCAI states:

    Airbus quality controls identified that several structural parts, intended for cargo or cabin compartment installation, were manufactured from improperly heat-treated materials. Subsequent review identified that some of those parts were installed on airplanes manufactured between November 2011 and February 2013. From February 2013, Airbus implemented measures into manufacturing processes to ensure detection and to prevent installation of such non-conforming parts.

    A detailed safety assessment was accomplished to identify the possible impact of affected parts on the airplane structure. The result of this structural analysis demonstrated the capability of the affected structure to sustain static limit loads, but failed to confirm that the affected structures met the certified fatigue life.

    This condition, if not detected and corrected, could lead to crack initiation and propagation, possibly resulting in reduced structural integrity of the fuselage.

    To address this potentially unsafe condition, Airbus issued [Mandatory] Service Bulletin (SB) SB A330-53-3227 and SB A330-53-3228 to provide inspection instructions for affected cargo and cabin structural parts respectively.

    For the reasons described above, this [EASA] AD requires a one-time Special Detailed Inspection (SDI) [eddy current inspection] to measure the electrical conductivity of affected structural parts, to identify the presence or absence of heat treatment, and, depending on findings, corrective action [replacement].

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5460.

    Related Service Information Under 1 CFR Part 51

    Airbus has issued the following service information:

    • Airbus Mandatory Service Bulletin A330-53-3227, dated August 18, 2015. The service information describes procedures to inspect affected structural parts in the cargo compartment to determine if proper heat-treatment has been done, and replacement of parts; and

    • Airbus Mandatory Service Bulletin A330-53-3228, dated August 18, 2015. The service information describes procedures to inspect affected structural parts in the cabin compartment to determine if proper heat-treatment has been done, and replacement of parts.

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

    FAA's Determination and Requirements of This Proposed AD

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

    Differences Between This Proposed AD and the Service Information

    Figure A-GFAAA, Sheet 01, “Inspection Flowchart,” of Airbus Mandatory Service Bulletin A330-53-3227, dated August 18, 2015; and Figure A-GFAAA, Sheet 01, “Inspection Flowchart” of Airbus Mandatory Service Bulletin A330-53-3228, dated August 18, 2015, note that if any other measured (conductivity) value is found, to check the non-destructive test (NDT) tool and perform a new measurement; and if that measured value is confirmed, contact Airbus for further instructions. This proposed AD would require that if a measured value is confirmed that is outside the measurements specified in the service information, a repair must be done using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA Design Organization Approval (DOA).

    Costs of Compliance

    We estimate that this proposed AD affects 20 airplanes of U.S. registry.

    We also estimate that it will take about 11 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $18,700, or $935 per product.

    In addition, we estimate that any necessary follow-on actions would take about 45 work-hours for a cost of $3,825 per product. We have received no definitive data that would enable us to provide cost of the parts for the on-condition actions specified in this proposed AD. We have no way of determining the number of aircraft that might need this action.

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

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Airbus: Docket No. FAA-2016-5460; Directorate Identifier 2015-NM-188-AD. (a) Comments Due Date

    We must receive comments by May 27, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Airbus Model A330-223F and -243F airplanes; A330-201, -202, -203, -223, and -243 airplanes; A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes, certificated in any category, manufacturer serial numbers 1175, 1180, 1287 through 1475 inclusive, 1478, 1480, 1483, and 1506.

    (d) Subject

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

    (e) Reason

    This AD was prompted by a report of a manufacturing defect (i.e. improperly heat-treated materials) that affects the durability of affected parts in the cargo and cabin compartment. We are issuing this AD to prevent crack initiation and propagation, which could result in reduced structural integrity of the fuselage.

    (f) Compliance

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

    (g) Inspection of Affected Structure in the Cargo Compartment

    Within 72 months since first flight of the airplane, do an eddy current inspection (i.e., conductivity measurement) of affected structural parts in the cargo compartment to determine if proper heat treatment has been done as identified in, and in accordance with, the Accomplishment Instructions of Airbus Service Bulletin A330-53-3227, dated August 18, 2015.

    (h) Replacement of Non-Conforming Parts in the Cargo Compartment

    If, during the inspection required by paragraph (g) of this AD, an affected structural part in the cargo compartment is identified to have a measured value greater than 26 megasiemens per meter (MS/m) or greater than 44.8% International Annealed Copper Standard (IACS), before further flight, replace the affected structural part with a serviceable part, in accordance with the Accomplishment Instructions of Airbus Mandatory Service Bulletin A330-53-3227, dated August 18, 2015.

    (i) Repair of Non-Conforming Parts in the Cargo Compartment

    If, during the inspection required by paragraph (g) of this AD, an affected structural part in the cargo compartment is identified to have a measured value other than those specified in Figure A-GFAAA, Sheet 01, “Inspection Flowchart,” of Airbus Mandatory Service Bulletin A320-53-3227, dated August 18, 2015, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).

    (j) Inspection of Affected Structure in the Cabin Compartment

    Within 72 months since first flight of the airplane, do an eddy current inspection of affected structural parts in the cargo compartment to determine if proper heat treatment has been done as identified in, and in accordance with, the Accomplishment Instructions of Airbus Mandatory Service Bulletin A330-53-3228, dated August 18, 2015.

    (k) Replacement of Non-Conforming Parts in the Cabin Compartment

    If, during the inspection required by paragraph (j) of this AD, an affected structural part in the cabin compartment is identified to have a measured value greater than 26 MS/m or greater than 44.8% IACS, before further flight, replace the affected structural part with a serviceable part, in accordance with the Accomplishment Instructions of Airbus Mandatory Service Bulletin A330-53-3228, dated August 18, 2015.

    (l) Repair of Non-Conforming Parts in the Cargo Compartment

    If, during the inspection required by paragraph (j) of this AD, an affected structural part in the cargo compartment is identified to have a measured value other than those specified in Figure A-GFAAA, Sheet 01, “Inspection Flowchart,” of Airbus Service Bulletin A320-53-3228, dated August 18, 2015, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA).

    (m) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone: 425-227-1138; fax: 425-227-1149. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

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

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

    (n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2015-0212, dated November 4, 2015, for related information. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5460.

    (2) For service information identified in this AD, contact Airbus SAS, Airworthiness Office-EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email: [email protected]; Internet: http://www.airbus.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on March 30, 2016. Victor Wicklund, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-08253 Filed 4-11-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5578; Directorate Identifier 2016-CE-005-AD] RIN 2120-AA64 Airworthiness Directives; Pacific Aerospace Limited Airplanes AGENCY:

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

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Pacific Aerospace Limited Model 750XL (type certificate previously held by Pacific Aerospace Corporation Ltd.) airplanes that would supersede AD 2006-13-05. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as some critical rivets on the wing not being fully age-hardened and being installed in specific locations where reduction in rivet strength reduces wing strength. We are issuing this proposed AD to require actions to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by May 27, 2016.

    ADDRESSES:

    You may send comments by any of the following methods:

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

    Fax: (202) 493-2251.

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

    Hand Delivery: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    For service information identified in this proposed AD, contact Pacific Aerospace Limited, Airport Road, Hamilton, Private Bag 3027, Hamilton 3240, New Zealand; telephone: +64 7 843 6144; facsimile: +64 7 843 6134; email: [email protected]; Internet: www.aerospace.co.nz. You may review copies of the referenced service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5578; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4123; fax: (816) 329-4090; email: [email protected].

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-5578; Directorate Identifier 2016-CE-005-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

    We will post all comments we receive, without change, to http://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

    On June 12, 2006, we issued AD 2006-13-05, Amendment 39-14658 (71 FR 35509, June 21, 2006) (“AD 2006-13-05”). That AD required actions intended to address an unsafe condition on certain Pacific Aerospace Corporation Ltd. Model 750XL airplanes and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country.

    Since we issued AD 2006-13-05, additional airplanes have been identified that need to be added to the applicability of the AD.

    The Civil Aviation Authority (CAA), which is the aviation authority for New Zealand, has issued AD No. DCA/750XL/7B, dated February 25, 2016 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

    DCA/750XL/7B revised to introduce PACSB/XL/018 issue 4, dated 20 January 2016, which reduces the applicability to S/N 101 through to 131 with no change to the requirements. Aircraft with S/N 132 onwards have been modified in accordance with PACSB/XL/018 at manufacture, which is a terminating action for the requirements of this AD.

    This proposed AD would require you to remove rivets that have not been fully age hardened and replace them with bolts, washers, and nuts in specific locations where reduction in rivet strength affects overall structural capability. The proposed AD would retain the airplane weight AFM limitations until the rivets are replaced with the bolts, washers, and nuts. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5578. Related Service Information Under 1 CFR Part 51

    Pacific Aerospace Limited has issued Service Bulletin PACSB/XL/018, Issue 4, dated January 20, 2016. The service bulletin describes procedures for removing rivets (part number (P/N) MS20470 DD6) and installing bolts (P/N NAS 6203-7X or NAS 6203-6X), washers (P/N AN960-10), and nuts (P/N MS21044N3) in place of the rivets to restore airplane to full take-off weight of 7,500 pounds. The service bulletin 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 of this NPRM.

    FAA's Determination and Requirements of the Proposed AD

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

    Costs of Compliance

    We estimate that this proposed AD will affect 9 products of U.S. registry. We also estimate that it would take about 32 work-hours per product to comply with the replacement requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $519 per product.

    Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $29,151, or $3,239 per product.

    AD 2006-13-05 affected 8 of the 9 U.S. registered airplanes reflected in the above cost information. This proposed AD would only increase the cost already required by AD 2006-13-05 by one additional airplane. The FAA has a report that the additional airplane is already in compliance, thus the proposed AD would impose no additional cost impact on U.S. operators.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by removing Amendment 39-14658 (71 FR 35509, June 21, 2006), and adding the following new AD: Pacific Aerospace Limited: Docket No. FAA-2016-5578; Directorate Identifier 2016-CE-005-AD. (a) Comments Due Date

    We must receive comments by May 27, 2016.

    (b) Affected ADs

    This AD replaces AD 2006-13-05, Amendment 39-14658 (71 FR 35509, June 21, 2006) (“AD 2006-13-05”).

    (c) Applicability

    This AD applies to the following Pacific Aerospace Limited Model 750XL airplanes (type certificate previously held by Pacific Aerospace Corporation Ltd.), that are certificated in any category.

    (1) Airplanes previously affected by AD 2006-13-05: Serial numbers 101, 102, 104 through 120, and 125.

    (2) Airplanes new to this AD: Serial numbers 103, 121, 122, 123, 124, and 126 to 131.

    (d) Subject

    Air Transport Association of America (ATA) Code 57: Wings.

    (e) Reason

    This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as some critical rivets on the wing not being fully age-hardened and being installed in specific locations where reduction in rivet strength reduces wing strength. We are issuing this AD to add airplanes to the Applicability section, paragraph (c) of this AD, and to ensure wing ultimate load requirements are met. If wing ultimate load requirements are not met, wing failure could result with consequent loss of control.

    (f) Actions and Compliance

    Unless already done, do the following actions:

    (1) Insert the following information into the Limitations section of the airplane flight manual (AFM) at the compliance time specified in paragraphs (f)(1)(i) and (f)(1)(ii) of this AD. You may do this by inserting a copy of this AD into the Limitations section of the AFM: “The maximum takeoff weight is reduced from 7,500 pounds to 7,125 pounds.” The owner/operator holding at least a private pilot certificate as authorized by section 43.7 of the Federal Aviation Regulations (14 CFR 43.7) may do the flight manual changes requirement of this AD. Make an entry in the aircraft records showing compliance with this portion of the AD following section 43.9 of the Federal Aviation Regulations (14 CFR 43.9).

    (i) For airplanes previously affected by AD 2006-13-05: Before further flight after January 16, 2006 (the effective date retained from AD 2005-26-53, Amendment 39-14451 (71 FR 2453, January 17, 2006), which was replaced by AD 2006-13-05).

    (ii) For airplanes new to this AD: Before further flight after the effective date of this AD.

    (2) Remove rivets, part number (P/N) MS20470 DD6, on the main spar web and replace with bolts, P/N NAS 6203-6X or -7X, as indicated for the position, assembled with washers, P/N AN960-10, and nut, P/N MS21044N3, at the compliance time specified in paragraphs (f)(2)(i) and (f)(2)(ii) of this AD.

    (i) For airplanes previously affected by AD 2006-13-05: Within the next 100 hours time-in-service (TIS) after July 31, 2006 (the effective date retained from AD 2006-13-05). Do the removal and replacement actions following Pacific Aerospace Corporation Ltd. Service Bulletin PACSB/XL/018, Issue 3, dated December 23, 2005, and amended January 16, 2006.

    (ii) For airplanes new to this AD: Within the next 100 hours TIS after the effective date of this AD or within the next 12 months after the effective date of this AD, whichever occurs first. Do the removal and replacement actions following Pacific Aerospace Limited Service Bulletin PACSB/XL/018, Issue 4, dated January 20, 2016.

    (3) For all affected airplanes: Before further flight after doing the action required in paragraph (f)(2) of this AD, remove the restrictive information from the Limitations section of the AFM that you were required to insert in paragraph (f)(1) of this AD. The owner/operator holding at least a private pilot certificate as authorized by section 43.7 of the Federal Aviation Regulations (14 CFR 43.7) may do the flight manual changes requirement of this AD.

    (g) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4123; fax: (816) 329-4090; email: [email protected]. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.

    (2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.

    (h) Related Information

    Refer to MCAI Civil Aviation Authority (CAA) AD No. DCA/750XL/7B, dated February 25, 2016, for related information. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5578. For service information related to this AD, contact Pacific Aerospace Limited, Airport Road, Hamilton, Private Bag 3027, Hamilton 3240, New Zealand; telephone: +64 7 843 6144; facsimile: +64 7 843 6134; email: [email protected]; Internet: www.aerospace.co.nz. You may review copies of the referenced service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

    Issued in Kansas City, Missouri, on April 4, 2016. Pat Mullen, Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-08261 Filed 4-11-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5459; Directorate Identifier 2015-NM-148-AD] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc. Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc. Model BD-700-1A10 and BD-700-1A11 airplanes. This proposed AD was prompted by a design review, which found that the burst pressure of the flexible hose used to vent oxygen from the high-pressure relief valve of the oxygen cylinder overboard is lower than the opening pressure of the high-pressure relief valve. This pressure difference could cause the flexible hose to burst before it is able to vent excess oxygen overboard. This proposed AD would require replacement of flexible relief hoses for the crew oxygen bottles with new metal design relief hoses. We are proposing this AD to prevent the accumulation of excess oxygen in an enclosed space, which could, if near a source of ignition, cause an uncontrolled oxygen-fed fire.

    DATES:

    We must receive comments on this proposed AD by May 27, 2016.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email [email protected]; Internet http://www.bombardier.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5459; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Fabio Buttitta, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7303; fax 516-794-5531.

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-5459; Directorate Identifier 2015-NM-148-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

    Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2015-25, dated September 10, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model BD-700-1A10 and BD-700-1A11 airplanes. The MCAI states:

    A design review found that the burst pressure of the flexible hose used to vent oxygen from the high-pressure relief valve of the oxygen cylinder overboard is lower than the opening pressure of the high-pressure relief valve. This could cause the flexible hose to burst before it is able to vent the excess oxygen overboard. If an ignition source is present, the accumulation of oxygen in an enclosed space may result in an uncontrolled oxygen-fed fire.

    This [Canadian] AD mandates the replacement of the oxygen [flexible] hose assembly with a new design oxygen [metal] hose assembly.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5459.

    Related Service Information Under 1 CFR Part 51

    Bombardier, Inc. has issued the following service information:

    • Service Bulletin 700-35-013, Revision 01, dated July 22, 2015;

    • Service Bulletin 700-35-5001, Revision 01, dated July 22, 2015;

    • Service Bulletin 700-35-6001, Revision 01, dated July 22, 2015;

    • Service Bulletin 700-1A11-35-012, Revision 01, dated July 22, 2015.

    The service information describes procedures to replace the flexible oxygen hoses with metal hoses. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

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

    Costs of Compliance

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

    We also estimate that it will take about 3 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $14,483 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $1,075,874, or $14,738 per product.

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

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Bombardier, Inc.: Docket No. FAA-2016-5459; Directorate Identifier 2015-NM-148-AD. (a) Comments Due Date

    We must receive comments by May 27, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Bombardier, Inc. Model BD-700-1A10 and BD-700-1A11 airplanes, certificated in any category, having serial numbers (S/Ns) 9002 through 9704 inclusive and 9998.

    (d) Subject

    Air Transport Association (ATA) of America Code 35, Oxygen.

    (e) Reason

    This AD was prompted by a design review, which found that the burst pressure of the flexible hose used to vent oxygen from the high-pressure relief valve of the oxygen cylinder overboard is lower than the opening pressure of the high-pressure relief valve. This pressure difference could cause the flexible hose to burst before it is able to vent excess oxygen overboard. We are issuing this AD to prevent the accumulation of excess oxygen in an enclosed space, which could, if near a source of ignition, cause an uncontrolled oxygen-fed fire.

    (f) Compliance

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

    (g) Modification

    Within 2,500 flight hours or 42 months, whichever occurs first, after the effective date of this AD, incorporate Bombardier Modsum R700T400542 by replacing the oxygen flexible relief hoses for the crew oxygen bottles with new metal design hoses, in accordance with the Accomplishment Instructions of the applicable service information specified in paragraphs (g)(1) through (g)(4) of this AD. Airplanes with serial numbers listed in table 1 of paragraph 1, “Planning information,” of the service information specified in paragraphs (g)(2) and (g)(4) of this AD have incorporated Modsum R700T400542 and meet the requirements of this paragraph.

    (1) For Model BD-700-1A10 airplanes having S/Ns 9002 through 9312 inclusive, 9314 through 9380 inclusive, and 9384 through 9429 inclusive: Bombardier Service Bulletin 700-35-013, Revision 01, dated July 22, 2015.

    (2) For Model BD-700-1A10 airplanes having S/Ns 9313, 9381, and 9432 through 9704 inclusive: Bombardier Service Bulletin 700-35-6001, Revision 01, dated July 22, 2015.

    (3) For Model BD-700-1A11 airplanes having S/Ns 9127 through 9383 inclusive, 9389 through 9400 inclusive, 9404 through 9431 inclusive, and 9998: Bombardier Service Bulletin 700-1A11-35-012, Revision 01, dated July 22, 2015.

    (4) For Model BD-700-1A11 airplanes having S/Ns 9386, 9401, and 9445 through 9702 inclusive: Bombardier Service Bulletin 700-35-5001, Revision 01, dated July 22, 2015.

    (h) Parts Installation Prohibition

    As of the effective date of this AD, no person may install oxygen hoses in the low pressure/high pressure discharge system with part numbers listed in the “Used Part No.” column of Section 3.A, “Kit,” of the applicable service information specified in paragraphs (g)(1) through (g)(4) of this AD.

    (i) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using the applicable service information identified in paragraphs (i)(1) through (i)(4) of this AD, which are not incorporated by reference in this AD.

    (1) Bombardier Service Bulletin 700-35-013, dated February 20, 2015;

    (2) Bombardier Service Bulletin 700-35-5001, dated February 20, 2015;

    (3) Bombardier Service Bulletin 700-35-6001, dated February 20, 2015; and

    (4) Bombardier Service Bulletin 700-1A11-35-012, dated February 20, 2015.

    (j) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New York Aircraft Certification Office (ACO), ANE-170, 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 ACO, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; fax 516-794-5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, New York ACO, ANE-170, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If approved by the DAO, the approval must include the DAO-authorized signature.

    (k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2015-25, dated September 10, 2015, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5459.

    (2) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email [email protected]; Internet http://www.bombardier.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on March 30, 2016. Victor Wicklund, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-08270 Filed 4-11-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-5807; Directorate Identifier 2015-SW-063-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Helicopters AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for Airbus Helicopters Model AS355NP helicopters with certain fire extinguishing systems. This proposed AD would require removing and installing the fire extinguishing system so that each squib on the engine compartment fire extinguisher is controlled by a matching control button. This proposed AD is prompted by the discovery that the left-hand discharge system of the fire extinguishing system was incorrectly connected to the right-hand engine compartment and the right-hand discharge system was incorrectly connected to the left-hand engine compartment. The proposed actions would correct the connections and would prevent the fire extinguishing system discharging to the wrong engine compartment, failure of the fire extinguishing system to control a fire, and subsequent loss of control of the helicopter.

    DATES:

    We must receive comments on this proposed AD by June 13, 2016.

    ADDRESSES:

    You may send comments by any of the following methods:

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

    Fax: 202-493-2251.

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

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

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-5807; or in person at the Docket Operations Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the European Aviation Safety Agency (EASA AD), the economic evaluation, any comments received, and other information. The street address for the Docket Operations Office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    For service information identified in this proposed rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at http://www.airbushelicopters.com/techpub.

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

    FOR FURTHER INFORMATION CONTACT:

    George Schwab, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, 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, issued EASA Emergency AD No. 2011-0192-E, dated October 4, 2011, to correct an unsafe condition for Eurocopter (now Airbus Helicopters) Model AS355NP helicopters equipped with an Arrius 1A1 engine fire extinguishing system through production modification OP-3931. EASA advises that during an inspection of the engine fire extinguishing system on an AS355NP helicopter, the left hand (LH) fire extinguisher discharge system was found connected to the right hand (RH) engine compartment and the RH discharge system was connected to the LH engine compartment. An investigation showed that this erroneous installation was inherent in Eurocopter production modification OP-3931. According to EASA, this condition, if not detected and corrected, could lead to the discharge of the fire extinguisher in the wrong engine compartment in the event of a fire. Pending the development of a modified extinguishing system, EASA Emergency AD No. 2011-0192-E required installing a placard warning the flight crew of the erroneous installation until the squibs on each fire extinguisher are exchanged.

    After EASA issued Emergency AD No. 2011-0192-E, Airbus Helicopters developed a permanent modification of the discharge system to reconfigure the position of the squibs on each fire extinguisher to line up with the control buttons. EASA subsequently issued superseding EASA AD No. 2015-0181, dated August 31, 2015, to retain the requirements of its previous Emergency AD and require the modification of the engine fire extinguishing discharge system within 12 months.

    FAA's Determination

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

    Related Service Information Under 1 CFR Part 51

    We reviewed Airbus Helicopters Alert Service Bulletin No. AS355-26.00.10, Revision 0, dated July 2, 2015 (ASB AS355-26.00.10). ASB AS355-26.00.10 provides procedures for removing the fire extinguishing system and re-installing it in a configuration where the squibs match the positioning of the fire extinguisher discharge heads. ASB AS355-26.00.10 also specifies removing any previously-affixed placard on the instrument panel and installing new discharge system pipes. Helicopters with modification 07-3990 installed have already complied with ASB AS355-26.00.10.

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

    Other Related Service Information

    We also reviewed Eurocopter Emergency Alert Service Bulletin No. 26.00.09, Revision 0, dated September 15, 2011 (EASB 26.00.09), issued prior to the permanent modification developed by Airbus Helicopters. EASB 26.00.09 provided procedures for interchanging the squibs on each fire extinguisher. Until this was accomplished, EASB 26.00.09 specified affixing a label on the instrument panel to make the flight crew aware of the crossed connection.

    Proposed AD Requirements

    This proposed AD would require within 600 hours time-in-service or at the next annual inspection, whichever occurs first, removing and correctly installing the fire extinguishing system, and removing any placards on the instrument panel if installed.

    Differences Between This Proposed AD and the EASA AD

    The EASA AD requires installing a placard on the instrument panel to warn the flight crew of the erroneous installation until the squibs on each fire extinguisher are exchanged, and then, within 12 months, removing and re-installing the fire extinguishing system to position the squibs in line with the control buttons. This proposed AD would not require installation of the placards or the temporary exchange of the squibs. Also, this proposed AD would require removing and re-installing the fire extinguisher system within 600 hours TIS or at the next annual inspection, whichever occurs first.

    Costs of Compliance

    We estimate that this proposed AD would affect 2 helicopters of U.S. Registry and that labor costs average $85 per work hour. We expect that removing and installing the fire extinguishing system would require 24 work hours and required parts would cost $6,367. Based on these estimates, we expect a total cost of $8,407 per helicopter and $16,814 for the U.S. fleet.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

    For the reasons discussed, I certify this proposed regulation:

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

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

    3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Airbus Helicopters: Docket No. FAA-2015-5807; Directorate Identifier 2015-SW-063-AD. (a) Applicability

    This AD applies to Airbus Helicopters Model AS355NP helicopters, certificated in any category, with an Arrius 1A1 fire extinguishing system installed.

    (b) Unsafe Condition

    This AD defines the unsafe condition as an incorrectly connected fire extinguishing discharge system. This condition could result in the fire extinguishing system discharging to the wrong engine compartment, failure of the fire extinguishing system to contain a fire, and loss of control of the helicopter.

    (c) Comments Due Date

    We must receive comments by June 13, 2016.

    (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 600 hours time-in-service or at the next annual inspection, whichever occurs first, remove and install the fire extinguishing system, and remove any placards on the instrument panel if installed, in accordance with the Accomplishment Instructions, paragraph 3.B. and 3.B.1 through 3.B.2, of Airbus Helicopters Alert Service Bulletin No. AS355-26.00.10, Revision 0, dated July 2, 2015.

    (f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs for this AD. Send your proposal to: George Schwab, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, 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

    (1) Eurocopter Emergency Alert Service Bulletin No. 26.00.09, Revision 0, dated September 15, 2011, which is not incorporated by reference, contains additional information about the subject of this AD. For service information identified in this AD, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at http://www.airbushelicopters.com/techpub. You may review the referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177.

    (2) The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2015-0181, dated August 31, 2015. You may view the EASA AD on the Internet at http://www.regulations.gov in the AD Docket.

    (h) Subject

    Joint Aircraft Service Component (JASC) Code: 2620, Extinguishing System.

    Issued in Fort Worth, Texas, on April 4, 2016. Scott A. Horn, Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
    [FR Doc. 2016-08247 Filed 4-11-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5044; Directorate Identifier 2014-NM-166-AD] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc. Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc. Model DHC-8-102, -103, and -106 airplanes, and Model DHC-8-200 and -300 series airplanes. This proposed AD was prompted by a report of heat damage found on a nacelle firewall after an unsuccessful engine ground start and several events of heat damage found on direct current starter/generator terminal block assemblies. This proposed AD would require an inspection for damage on the nacelle firewalls and the terminal block assemblies and to make sure the insulating sleeves are installed and have no damage, and corrective action if necessary. We are proposing this AD to prevent arcing between the firewall and terminal blocks that are missing insulating sleeves on the conductive bushings, which could, in combination with a fuel or hydraulic fluid leak, be an ignition source for a fire.

    DATES:

    We must receive comments on this proposed AD by May 27, 2016.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-375-4000; fax 416-375-4539; email [email protected]; Internet http://www.bombardier.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5044; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Assata Dessaline, Aerospace Engineer, Avionics and Flight Test Branch, ANE-172, FAA, New York Aircraft Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7301; fax 516-794-5531.

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-5044; Directorate Identifier 2014-NM-166-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

    Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2014-03R1, dated July 24, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model DHC-8-102, -103, and -106 airplanes, and Model DHC-8-200 and -300 series airplanes. The MCAI states:

    There has been one in-service report of heat damage on a nacelle firewall found after an unsuccessful engine ground start. There have also been several reports of heat damage found on Direct Current Starter/Generator terminal block assemblies, part number (P/N) 82450075-001.

    The investigation determined that in all cases, the heat damage was caused by arcing between the firewall and terminal blocks with missing insulating sleeves on the conductive bushings. The insulating sleeves may have been inadvertently omitted during the incorporation of Modsum 8/1926, or during the installation of terminal blocks P/N 82450075-001.

    Arcing with the firewall becomes an ignition source, creating a potential fire hazard when combined with a fuel or hydraulic fluid leak.

    The original issue of this [Canadian] AD mandated the [detailed visual] inspection [for damage to the nacelle firewalls and to make sure the insulating sleeves are installed and have no damage] and rectification [corrective actions such as installing or replacing insulating sleeves, or replacing a terminal block], as required, of the nacelle firewall and terminal block assembly P/N 82450075-001 installed with Modsum 8/1926.

    Revision 1 of this [Canadian] AD is issued to revise the Applicability to ensure that the terminal blocks have the insulating sleeves installed.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5044.

    Relevant Service Information Under 1 CFR Part 51

    Bombardier has issued Service Bulletin 8-24-92, Revision A, dated April 11, 2014. This service information describes procedures for an inspection for damage on the nacelle firewalls and the terminal block assemblies and to make sure the insulating sleeves are installed and have no damage, and corrective action if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

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

    Costs of Compliance

    We estimate that this proposed AD affects 75 airplanes of U.S. registry.

    We also estimate that it would take about 2 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $12,750, or $170 per product.

    In addition, we estimate that any necessary follow-on actions would take about 1 work-hour and require parts costing $551, for a cost of $636 per product. We have no way of determining the number of aircraft that might need these actions.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Bombardier, Inc.: Docket No. FAA-2016-5044; Directorate Identifier 2014-NM-166-AD. (a) Comments Due Date

    We must receive comments by May 27, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Bombardier, Inc. airplanes identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD, certificated in any category, serial numbers 003 through 672 inclusive, on which terminal block part number 82450075-001 is installed.

    (1) Model DHC-8-102, -103, and -106 airplanes.

    (2) Model DHC-8-201 and -202 airplanes.

    (3) Model DHC-8-301, -311, and -315 airplanes.

    (d) Subject

    Air Transport Association (ATA) of America Code 24, Electrical Power.

    (e) Reason

    This AD was prompted by a report of one event of heat damage found on a nacelle firewall after an unsuccessful engine ground start and several events of heat damage found on direct current starter/generator terminal block assemblies. We are issuing this AD to prevent arcing between the firewall and terminal blocks that are missing insulating sleeves on the conductive bushings, which could, in combination with a fuel or hydraulic fluid leak, be an ignition source for a fire.

    (f) Compliance

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

    (g) Inspection and Corrective Action

    Within 2,500 flight cycles or 14 months after the effective date of this AD, whichever occurs first, perform a detailed visual inspection of the right-hand side and left-hand side nacelle firewalls and terminal block assemblies, as defined in Bombardier Service Bulletin 8-24-92, Revision A, dated April 11, 2014, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 8-24-92, Revision A, dated April 11, 2014.

    (1) If the inspection finds no damage on the engine firewalls and the terminal blocks, and that the insulating sleeves are installed on both terminal blocks, no further action is required by this AD.

    (2) If the inspection finds that no insulating sleeves are installed, or the existing sleeves are damaged, and there is no damage to the nacelle firewall and terminal block, before further flight, install the replacement insulating sleeves, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 8-24-92, Revision A, dated April 11, 2014.

    (3) If the inspection finds that no insulating sleeves are installed, or any existing sleeve is damaged, and there is no damage to the nacelle firewall, but there is damage to the terminal block, before further flight, replace the terminal block assembly (which includes insulating sleeves), in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 8-24-92, Revision A, dated April 11, 2014.

    (4) If the inspection finds that no insulating sleeves are installed and there is damage to the nacelle firewall and the terminal block, repair the damage using a method approved by the Manager, New York Aircraft Certification Office (ACO), ANE-170, Engine and Propeller Directorate, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval Organization (DAO).

    (h) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Bombardier Service Bulletin 8-24-92, dated September 25, 2013, which is not incorporated by reference in this AD.

    (i) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New York ACO, ANE-170, 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 ACO, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; fax 516-794-5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, New York ACO, ANE-170, Engine and Propeller Directorate, FAA; or TCCA; or Bombardier, Inc.'s TCCA DAO. If approved by the DAO, the approval must include the DAO-authorized signature.

    (j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2014-03R1, dated July 24, 2014, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5044.

    (2) For service information identified in this AD, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-375-4000; fax 416-375-4539; email [email protected]; Internet http://www.bombardier.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on March 26, 2016. Jeffrey E. Duven, Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-08266 Filed 4-11-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5468; Directorate Identifier 2015-NM-021-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 737-600, -700, -700C, -800, and -900 series airplanes. This proposed AD was prompted by reports of paint deterioration on the surface of the main landing gear (MLG) and the early onset of corrosion in the trunnion bore of the MLG outer cylinder. This proposed AD would require identifying affected parts, repetitive external surface detailed inspection for damage of affected parts, and related investigative and corrective actions if necessary. For certain airplanes, this AD also would require a detailed inspection and bushing replacement of the trunnion bore, and related investigative and corrective action if necessary. We are proposing this AD to prevent stress corrosion cracking of the external surfaces of the MLG, which could result in a fracture of the MLG and consequent MLG collapse.

    DATES:

    We must receive comments on this proposed AD by May 27, 2016.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5468.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5468; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Alan Pohl, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6450; fax: 425-917-6590; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-5468; Directorate Identifier 2015-NM-021-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD 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 received reports from several operators of paint deterioration on the surface of the MLG and early onset of corrosion in the trunnion bore of the MLG outer cylinder. A maintenance repair and overhaul (MRO) facility observed forward trunnion bore corrosion on a right MLG while installing new bushings. Another MRO disclosed that between 2007 and 2010, the primer used on the landing gear components did not comply with Boeing Material Specification (BMS) 10-79. Also, paint chip and trunnion bore analysis showed that unqualified primer was used; primer application was up to 5 times too thick while enamel was too thin; there was early deterioration of the fillet seal at the trunnion bore; and the trunnion bushing installation process, which may have damaged the finish on the bore, did not follow the standard overhaul practices manual. This condition, if not corrected, could result in a fracture of the MLG and consequent MLG collapse.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015. The service information describes procedures for identifying affected parts, repetitive external surface detailed inspection for damage of affected parts, and related investigative and corrective actions if necessary. For certain airplanes, this AD also would require a detailed inspection and bushing replacement of the trunnion bore, and related investigative and corrective action if necessary. The service information also describes procedures for certain airplanes that include a detailed inspection of the trunnion bore, and corrective 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 these same type designs.

    Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between this Proposed AD and the Service Information.”

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

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

    Differences Between This Proposed AD and the Service Information

    Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, specifies to contact the manufacturer for instructions on how to repair certain conditions, but this proposed AD would require repairing those conditions in one of the following ways:

    • In accordance with a method that we approve; or

    • Using data that meet the certification basis of the airplane, and that have been approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) whom we have authorized to make those findings.

    While the effectivity of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, is limited to those airplanes that are listed, the applicability of this AD affects all The Boeing Company Model 737-600, -700, -700C, -800, and -900 series airplanes.

    Clarification of Affected MLGs

    An MLG overhauled by SAFRAN Messier-Bugatti-Dowty outside of the Boeing Exchange program from June 1, 2009, to July 31, 2013, would also be affected by this proposed AD.

    Costs of Compliance

    We estimate that this proposed AD affects 33 airplanes of U.S. registry.

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

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • External surface detailed Inspection Up to 16 work-hours × $85 per hour = $1,360 per inspection cycle $0 $1,360 per inspection cycle Up to $44,880 per inspection cycle. Outer Cylinder assembly trunnion bore detailed inspection and bushing replacement (G1-2, configuration 1) 70 work-hours × $85 per hour = $5,950 Negligible $5,950 $196,350.

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

    On-Condition Costs Action Labor cost Cost per
  • product
  • Outer cylinder assembly replacement (if required as a result of the outer cylinder trunnion bore detailed inspection) 28 work-hours × $85 per hour = $2,380 $2,380

    We have received no definitive data that would enable us to provide cost estimates for certain on-condition actions (MLG external surface repair, MLG component replacement, outer cylinder repair, and MLG replacement) specified in this proposed AD.

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

    The previous info is based on known airplanes. However, the MLG may have been overhauled outside of the Boeing Exchange Program as specified in the Clarification of Affected MLGs section of 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.

    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-2016-5468; Directorate Identifier 2015-NM-021-AD. (a) Comments Due Date

    We must receive comments by May 27, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all The Boeing Company Model 737-600, -700, -700C, -800, and -900 series airplanes, certificated in any category.

    (d) Subject

    Air Transport Association (ATA) of America Code 32, Landing Gear.

    (e) Unsafe Condition

    This AD was prompted by reports of paint deterioration on the surface of the main landing gear (MLG) and early onset of corrosion in the trunnion bore of the MLG outer cylinder. We are issuing this AD to prevent stress corrosion cracking of the external surfaces of the MLG, which could result in a fracture of the MLG and consequent MLG collapse.

    (f) Compliance

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

    (g) Inspection for Affected Part/Serial Numbers

    At the applicable time specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, except as required by paragraph (k)(1) of this AD: Do the actions specified in paragraphs (g)(1) and (g)(2) of this AD in order to identify affected parts.

    (1) Inspect the MLG to determine if it has any component installation or side strut assembly having a part number and serial number listed in Appendix D of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015; except that the “Variable Number” column of Appendix D is to be disregarded in determining affected part and serial numbers. A MLG that has any MLG component installation or side strut assembly having a part number and serial number listed in Appendix D of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, is an affected part. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number and serial number of the MLG component installation and side strut assembly can be conclusively identified from that review.

    (2) Do a records review to determine if the MLG has been overhauled by SAFRAN Messier-Bugatti-Dowty outside of the Boeing Exchange program from June 1, 2009 to July 31, 2013. If the MLG has been overhauled by SAFRAN Messier-Bugatti-Dowty outside of the Boeing Exchange program from June 1, 2009 to July 31, 2013, that MLG is an affected part. If the records review cannot conclusively determine that an overhauled MLG was overhauled by an MRO other than SAFRAN Messier-Bugatti-Dowty, or if the records review cannot conclusively determine that an MLG overhauled by SAFRAN Messier-Bugatti-Dowty was part of the Boeing Exchange program from June 1, 2009 to July 31, 2013; that MLG is an affected part.

    (h) Requirements for Affected Parts

    If any affected part is identified during the inspection or records review required by paragraph (g) of this AD: At the applicable time specified in table 3 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, except as required by paragraph (k)(1) of this AD: Do detailed inspections of the external surfaces of the MLG, and do all applicable related investigative and corrective actions, in accordance with Parts 1, 3, and 4 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, except as required by paragraph (k)(2) of this AD. Repeat the inspections thereafter at the applicable time specified in table 3 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015. All applicable related investigative and corrective actions must be done before further flight.

    (i) Additional Actions for Groups 1 and 2, Configuration 1

    For airplanes that are identified as Groups 1 and 2, Configuration 1, in Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, and that have an affected part identified during the inspection or records review required by paragraph (g) of this AD: At the applicable time specified in table 4 of Paragraph 1.E, “Compliance,” of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, except as required by paragraph (k)(1) of this AD, do a detailed inspection and bushing replacement of the MLG trunnion bore, and do all applicable related investigative and corrective actions, in accordance with Parts 2, 5, and 6 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, except as required by paragraph (k)(2) of this AD.

    (j) Terminating Action

    (1) MLG replacement in accordance with Part 8 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, terminates the requirements of paragraphs (g), (h), and (i) of this AD for that MLG only.

    (2) MLG component replacement in accordance with Part 4 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, terminates the requirements of paragraph (h) of this AD for that component only.

    (3) MLG outer cylinder replacement in accordance with Part 7 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, terminates the requirements of paragraph (i) of this AD for that component only.

    (k) Exceptions to Service Information Specifications

    (1) Where paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, specifies a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.

    (2) Although Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015, specifies to contact Boeing for repair instructions, and specifies that action as “RC” (Required for Compliance), this AD requires repair before further flight using a method approved in accordance with the procedures specified in paragraph (m) of this AD.

    (l) Parts Installation Prohibition

    As of the effective date of this AD, no person may install the following on any airplane identified in paragraph (c) of this AD, unless the MLG has been overhauled using a method approved in accordance with the procedures specified in paragraph (m) of this AD:

    (1) An MLG having a part number and serial number identified in Appendix D to Boeing Special Attention Service Bulletin 737-32-1486, dated November 6, 2014, as revised by Boeing Special Attention Service Bulletin 737-32-1486, Revision 1, dated April 1, 2015.

    (2) An MLG that was overhauled from June 1, 2009, to July 31, 2013, by SAFRAN Messier-Bugatti-Dowty.

    (m) Alternative Methods of Compliance (AMOCs)

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

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

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

    (4) Except as required by paragraph (k)(2) of this AD: For service information that contains steps that are labeled as RC, the provisions of paragraphs (m)(4)(i) and (m)(4)(ii) of this AD apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

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

    (n) Related Information

    (1) For more information about this AD, contact Alan Pohl, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6450; fax: 425-917-6590; email: [email protected]

    (2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet https://www.myboeingfleet.com. For information on the availability of this material at the FAA, You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on March 31, 2016. Victor Wicklund, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-08349 Filed 4-11-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5579; Directorate Identifier 2016-CE-010-AD] RIN 2120-AA64 Airworthiness Directives; Textron Aviation Inc. Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to supersede Airworthiness Directive (AD) 2008-15-06, which applies to certain Textron Aviation Inc. Models 175 and 175A airplanes (type certificate previously held by Cessna Aircraft Company). AD 2008-15-06 currently requires checking the airplane logbook to determine if the original engine mounting brackets have been replaced. If the original engine mounting brackets are still installed, the AD requires repetitively inspecting those brackets for cracks and replacing any cracked engine mounting bracket until all four original engine mounting brackets are replaced. Replacing all four original engine mounting brackets terminates the actions required in AD 2008-15-06. Since we issued AD 2008-15-06, we have determined that the applicability needs to be changed to add a serial number and take one out. This proposed AD would retain the actions required in AD 2008-15-06 and would change the Applicability section. We are proposing this AD to correct the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by May 27, 2016.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Cessna Aircraft Company, Product Support, P.O. Box 7706, Wichita, Kansas 67277; telephone: (316) 517-5800; fax: (316) 942-9006; Internet: www.cessna.txtav.com. You may review copies of the referenced service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5579; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Gary Park, Aerospace Engineer, Wichita Aircraft Certification Office, 1801 Airport Road, Room 100, Wichita, Kansas 67209; telephone: (316) 946-4123; fax: (316) 946-4107, email: [email protected]

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-5579; Directorate Identifier 2016-CE-010-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD 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

    On July 15, 2008, we issued AD 2008-15-06, Amendment 39-15618 (73 FR 43845, July 29, 2008), (“AD 2008-15-06”), for certain Textron Aviation Inc. Models 175 and 175A airplanes (type certificate previously held by Cessna Aircraft Company). AD 2008-15-06 requires you to check the airplane logbook to determine if the original engine mounting brackets have been replaced. If the original engine mounting brackets are still installed, this AD requires you to repetitively inspect those brackets for cracks and replace any cracked engine mounting bracket. After replacing all four original engine mounting brackets, no further action will be required by this AD. AD 2008-15-06 resulted from a report of the engine detaching from the firewall on a Cessna Model 175 airplane during landing. We issued AD 2008-15-06 to detect and correct cracks in the engine mounting brackets, which could result in failure of the engine mounting bracket. This failure could lead to the engine detaching from the firewall.

    Actions Since AD 2008-15-06 Was Issued

    Since we issued AD 2008-15-06, we have determined that the applicability for Model 175A airplanes needs to be changed. We have determined that a serial number has been inadvertently included in the applicability and a serial number has been inadvertently omitted from the applicability.

    Related Service Information Under 1 CFR Part 51

    We reviewed Cessna Single Engine Service Bulletin SEB07-2, Revision 2, dated June 18, 2007. The service information describes procedures for inspecting the upper and lower engine mounting brackets on both the left and right sides for cracks and replacing cracked engine mounting brackets. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination

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

    Proposed AD Requirements

    This proposed AD would retain the requirements of AD 2008-15-06 and would add a serial number to the applicability and take one out.

    Costs of Compliance

    We estimate that this AD would affect 1,218 airplanes in the U.S. registry.

    We estimate the following costs to do each proposed inspection:

    Labor cost Parts cost Total cost per airplane Total cost on U.S. operators 7.5 work-hours × $80 per hour = $600 Not applicable $600 $730,800

    We estimate the following costs to do any necessary proposed replacements:

    Labor cost Parts cost Total cost per airplane 3 work-hours per bracket × $80 per hour = $240 per bracket. 4 brackets per airplane × $240 per bracket = $960 $200 per bracket. 4 × $200 = $800 for all 4 brackets $440 per bracket. $1,760 to replace all 4 brackets.

    There is no estimated cost of compliance difference between this proposed AD and AD 2008-15-06 since there is no change in the number of affected airplanes or in the proposed actions. The cost impact on the public would be in the removal of serial number 691 and the addition of serial number 619.

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by removing Airworthiness Directive (AD) 2008-15-06, Amendment 39-15618 (73 FR 43845, July 29, 2008), and adding the following new AD: Textron Aviation Inc.: Docket No. FAA-2016-5579; Directorate Identifier 2016-CE-010. (a) Comments Due Date

    The FAA must receive comments on this AD action by May 27, 2016.

    (b) Affected ADs

    This AD replaces AD 2008-15-06, Amendment 39-15618 (73 FR 43845, July 29, 2008) (“AD 2008-15-06”).

    (c) Applicability

    This AD applies to the following Textron Aviation Inc. airplane models and serial numbers (type certificate previously held by Cessna Aircraft Company) that are certificated in any category.

    (1) Airplanes previously affected by AD 2008-15-06

    Model Serial Nos. Year
  • manufactured
  • (1) 175 55001 through 55703 1958. (2) 175 55704 through 56238 1959. (3) 175 28700A, 626, and 640 1958 and 1959. (4) 175A 56239 through 56777 1960.

    (2) New airplane affected by this AD:

    Model Serial Nos. Year
  • manufactured
  • 175A 619 1960.
    (d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 71, Power Plant.

    (e) Unsafe Condition

    This AD was prompted by the determination that an airplane needs to be added to the Applicability section and an airplane needs to be removed from the Applicability section. We are issuing this AD to detect and correct cracks in the engine mounting brackets, which could result in failure of the engine mounting bracket. This failure could lead to the engine detaching from the firewall.

    (f) Compliance

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

    (g) Airplane Logbook Check

    (1) Check the airplane logbook to determine if all four of the original engine mounting brackets have been replaced. Do the logbook check at the following compliance time, as applicable. The owner/operator holding at least a private pilot certificate as authorized by section 43.7 may do this action.

    (i) For airplanes previously affected by AD 2008-15-06: Within the next 30 days after September 2, 2008 (the effective date retained from AD 2008-15-06).

    (ii) For the new airplane affected by this AD: Within the next 30 days after the effective date of this AD.

    (2) If you can positively determine that all four of the original engine mounting brackets have been replaced, no further action is required. Make an entry into the aircraft logbook showing compliance with this portion of the AD in accordance with 14 CFR 43.9. The owner/operator holding at least a private pilot certificate as authorized by section 43.7 may do this action.

    (3) If you cannot positively determine that all four of the original engine mounting brackets have been replaced, inspect each of the upper and lower engine mounting brackets on both the left and right sides for cracks following Cessna Single Engine Service Bulletin SEB07-2, Revision 2, dated June 18, 2007. Do the inspections at the following compliance times, as applicable.

    (i) For airplanes previous affected by AD 2008-15-06: Initially inspect within the next 12 months after September 2, 2008 (the effective date retained from AD 2008-15-06). If no cracks are found, repetitively inspect thereafter at intervals not to exceed 500 hours time-in-service (TIS) until all four of the original engine mounting brackets are replaced.

    (ii) For the new airplane affected by this AD: Initially inspect within the next 12 months after the effective date of this AD. If no cracks are found, repetitively inspect thereafter at intervals not to exceed 500 hours TIS until all four of the original engine mounting brackets are replaced.

    (h) Engine Mounting Bracket Replacement

    For all airplanes affected by this AD: If cracks are found in any of the engine mounting brackets during any inspection required in paragraph (g)(3) of this AD, including all subparagraphs, before further flight after the inspection in which cracks are found, replace the cracked engine mounting bracket(s) following Cessna Single Engine Service Bulletin SEB07-2, Revision 2, dated June 18, 2007. Replacing the cracked engine mounting bracket terminates the repetitive inspections required in paragraphs (g)(3)(i) and (g)(3)(ii) of this AD only for the replaced engine mounting bracket.

    (i) Terminating Action

    To terminate the repetitive inspections required in paragraphs (g)(3)(i) and (g)(3)(ii) of this AD, you may replace all four original engine mounting brackets following Cessna Single Engine Service Bulletin SEB07-2, Revision 2, dated June 18, 2007, at the following compliance times, as applicable.

    (1) For airplanes previous affected by AD 2008-15-06: At any time before or after the initial inspection required in paragraph (g)(3)(i) of this AD.

    (2) For the new airplane affected by this AD: At any time before or after the initial inspection required in paragraph (g)(3)(ii) of this AD.

    (j) Engine Mounting Bracket Disposal

    For all airplanes affected by this AD: Before further flight after the engine mounting bracket is removed for replacement, dispose of every replaced bracket following 14 CFR 43.10, paragraph (c)(6), which states the following: “Mutilation. The part may be mutilated to deter its installation in a type certificated product. The mutilation must render the part beyond repair and incapable of being reworked to appear to be airworthy.”

    (k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (l) of this AD.

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

    (3) AMOCs approved for AD 2008-15-06 are approved as AMOCs for the corresponding provisions of this AD.

    (l) Related Information

    (1) For more information about this AD, contact Gary Park, Aerospace Engineer, Wichita ACO, 1801 Airport Road, Room 100, Wichita, Kansas 67209; telephone: (316) 946-4123; fax: (316) 946-4107, email: [email protected]

    (2) For service information identified in this AD, contact Cessna Aircraft Company, Product Support, P.O. Box 7706, Wichita, Kansas 67277; telephone: (316) 517-5800; fax: (316) 942-9006; Internet: www.cessna.txtav.com. You may view this referenced service information at the FAA, FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148.

    Issued in Kansas City, Missouri, on April 4, 2016. Pat Mullen, Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-08259 Filed 4-11-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5463; Directorate Identifier 2016-NM-013-AD] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc. Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, & 702), Model CL-600-2D15 (Regional Jet Series 705), Model CL-600-2D24 (Regional Jet Series 900), and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. This proposed AD was prompted by reports of corrosion found on the slat and flap torque tubes in the slat and flap control system. This proposed AD would require replacement of the slat and flap torque tubes in the slat and flap control system. We are proposing this AD to prevent rupture of a corroded slat or flap torque tube. This condition could result in an inoperative slat or flap system and consequent reduced controllability of the airplane.

    DATES:

    We must receive comments on this proposed AD by May 27, 2016.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone: 514-855-5000; fax: 514-855-7401; email: [email protected]; Internet: http://www.bombardier.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5463; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Cesar Gomez, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone: 516-228-7318; fax: 516-794-5531.

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-5463; Directorate Identifier 2016-NM-013-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

    Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2016-03R1, dated February 18, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, & 702), Model CL-600-2D15 (Regional Jet Series 705), Model CL-600-2D24 (Regional Jet Series 900), and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The MCAI states:

    There have been a number of reports of corrosion found on the torque tubes in the slat and flap control system. Investigation revealed that the current design of the flap and slat torque tubes do not have proper corrosion protection and are not entirely sealed which leads to moisture ingress and internal corrosion. A corroded tube may rupture resulting in an inoperative slat or flap system, or in a worst case scenario, could result in reduced controllability of the aeroplane. This [Canadian] AD mandates the replacement of affected slat and flap system torque tubes with [new or] modified torque tubes.

    This [Canadian] AD was revised to add the statement that accomplishment of the initial Service Bulletin (SB) 670BA-27-067, dated 15 January 2015 also meets the requirements of this AD and to correct the editorial error for the release date of SB 670BA-27-067, Revision A.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5463.

    Related Service Information Under 1 CFR Part 51

    We reviewed Bombardier Service Bulletin 670BA-27-067, Revision A, dated February 23, 2015. This service information describes procedures for replacement of the slat and flap torque tubes in the slat and flap control system. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

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

    Costs of Compliance

    We estimate that this proposed AD affects 509 airplanes of U.S. registry.

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

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S. operators
    Replacement of the slat and flap torque tubes 34 work-hours × $85 per hour = $2,890 $105,000 $107,890 $54,916,010

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

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Bombardier, Inc.: Docket No. FAA-2016-5463; Directorate Identifier 2016-NM-013-AD. (a) Comments Due Date

    We must receive comments by May 27, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to the airplanes, certificated in any category, identified in paragraphs (c)(1), (c)(2), (c)(3), and (c)(4) of this AD.

    (1) Bombardier, Inc. Model CL-600-2C10 (Regional Jet Series 700, 701, & 702) airplanes, serial numbers 10002 through 10342 inclusive.

    (2) Bombardier, Inc. Model CL-600-2D15 (Regional Jet Series 705) airplanes, serial numbers 15001 through 15361 inclusive.

    (3) Bombardier, Inc. Model CL-600-2D24 (Regional Jet Series 900) airplanes, serial numbers 15001 through 15361 inclusive.

    (4) Bombardier, Inc. Model CL-600-2E25 (Regional Jet Series 1000) airplanes, serial numbers 19001 through 19041 inclusive.

    (d) Subject

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

    (e) Reason

    This AD was prompted by reports of corrosion found on the slat and flap torque tubes in the slat and flap control system. We are issuing this AD to prevent rupture of a corroded slat or flap torque tube. This condition could result in an inoperative slat or flap system and consequent reduced controllability of the airplane.

    (f) Compliance

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

    (g) Replace Slat and Flap Torque Tubes in the Slat and Flap Control System

    Within the compliance times specified in paragraph (g)(1), (g)(2), or (g)(3) of this AD, as applicable: Replace the slat and flap torque tubes in the slat and flap control system with new or modified slat and flap torque tubes, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 670BA-27-067, Revision A, dated February 23, 2015.

    (1) For airplanes that have accumulated 28,000 total flight hours or less as of the effective date of this AD, or with 137 months or less since the date of issuance of the original Canadian certificate of airworthiness or date of issuance of the original Canadian export certificate of airworthiness as of the effective date of this AD: Before the accumulation of 34,000 total flight hours or within 167 months since the date of issuance of the original Canadian certificate of airworthiness or date of issuance of the original Canadian export certificate of airworthiness, whichever occurs first.

    (2) For airplanes that have accumulated more than 28,000 total flight hours but not more than 36,000 total flight hours as of the effective date of this AD, and with more than 137 months but not more than 176 months since the date of issuance of the original Canadian certificate of airworthiness or date of issuance of the original Canadian export certificate of airworthiness as of the effective date of this AD: At the earlier of the times specified in paragraphs (g)(2)(i) and (g)(2)(ii) of this AD.

    (i) Within 6,000 flight hours or 30 months, whichever occurs first, after the effective date of this AD.

    (ii) Before the accumulation of 38,000 total flight hours, or within 186 months since the date of issuance of the original Canadian certificate of airworthiness or date of issuance of the original Canadian export certificate of airworthiness, whichever occurs first.

    (3) For airplanes that have accumulated more than 36,000 total flight hours as of the effective date of this AD, or with more than 176 months since the date of issuance of the original Canadian certificate of airworthiness or date of issuance of the original Canadian export certificate of airworthiness as of the effective date of this AD: Within 2,000 flight hours or 10 months, whichever occurs first, after the effective date of this AD.

    (h) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Bombardier Service Bulletin 670BA-27-067, dated January 15, 2015, which is not incorporated by reference in this AD.

    (i) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, New York Aircraft Certification Office (ACO), ANE-170, 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 ACO, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-7300; fax: 516-794-5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

    (2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, New York ACO, ANE-170, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If approved by the DAO, the approval must include the DAO-authorized signature.

    (j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian AD CF-2016-03R1, dated February 18, 2016, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5463.

    (2) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone: 514-855-5000; fax: 514-855-7401; email: [email protected]; Internet: http://www.bombardier.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on March 31, 2016. Victor Wicklund, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-08250 Filed 4-11-16; 8:45 am] BILLING CODE 4910-13-P
    POSTAL REGULATORY COMMISSION 39 CFR Part 3020 [Docket No. RM2016-8; Order No. 3213] Mail Classification Schedule AGENCY:

    Postal Regulatory Commission.

    ACTION:

    Proposed rulemaking.

    SUMMARY:

    The Commission is proposing rules which amend existing rules related to the Mail Classification Schedule and its associated product lists. The proposed rules revise some existing rules in order to better conform with current Commission practices related to the Mail Classification Schedule. The Commission invites public comment on the proposed rules.

    DATES:

    Comments are due: May 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    David A. Trissell, General Counsel, at 202-789-6820.

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Introduction II. History III. Rule Modifications IV. Public Representative V. Invitation of Comments VI. Ordering Paragraphs I. Introduction

    This rulemaking is initiated by the Postal Regulatory Commission (Commission) to fulfill its responsibilities under the Postal Accountability and Enhancement Act (PAEA), Public Law 109-435, 120 Stat. 3198 (2006). The proposed rules amend existing rules concerning the Mail Classification Schedule (MCS) and the associated market dominant and competitive product lists. The proposals amend existing rules to conform to the current practice of publishing the MCS on the Commission's Web site at www.prc.gov, noticing changes to the market dominant and competitive product lists in the Federal Register, and publishing the market dominant and competitive product lists in the Code of Federal Regulations (CFR).

    The proposed rules replace existing 39 CFR part 3020, subpart A in its entirety. Conforming changes also are proposed for 39 CFR part 3020, subparts B, C, and D. The proposed text for these rules appears after the signature of this Order.

    II. History

    On October 29, 2007, the Commission issued Order No. 43, which in part established rules concerning the MCS, and the market dominant and competitive product lists.1 It also directed publication of an MCS outline in the CFR that was limited to a table of contents and the market dominant and competitive product lists. Order No. 43, Appendix A. These rules, including the appendix, were codified at 39 CFR part 3020.

    1 Docket No. RM2007-1, Order Establishing Ratemaking Regulations for Market Dominant and Competitive Products, October 29, 2007, at 99-108, 138-154 (Order No. 43); 72 FR 64155, November 15, 2007.

    The Commission, in Docket No. RM2007-1, also began the process of developing a comprehensive MCS.2 This task was not complete at the time the Commission issued Order No. 43.

    2 Docket No. RM2007-1, Order No. 26, Order Proposing Regulations to Establish a System of Ratemaking, August 15, 2007, at 2, 82-83; 72 FR 50744, September 4, 2007. See also Order No. 43 at 99.

    When an initial proposed MCS was complete, the Commission initiated Docket No. RM2011-8 to incorporate it into the CFR.3 The proposed MCS was to replace the existing outline of the MCS. The Commission solicited and received comments on both the proposed MCS and the corresponding rules. The suggestions provided in the comments were extremely helpful in further developing the MCS and have been incorporated into the rule proposals appearing in the instant rulemaking.

    3 Docket No. RM2011-8, Order No. 666, Notice of Proposed Rulemaking Concerning Mail Classification Schedule, February 7, 2011; Docket No. RM2011-8, Order No. 758, Notice of Proposed Rulemaking Concerning Mail Classification Schedule (Revising Order No. 666), July 12, 2011; 76 FR 51311 (Aug. 18, 2011) (to be codified at 39 CFR part 3020, subpart A).

    From an administrative perspective, the rulemaking also required the Commission to develop internal procedures for implementing the proposed rules. This included procedures for publishing timely updates to the MCS and the associated product lists appearing in the CFR. Because of the continuous flow of Postal Service proposals to add or modify products, the Commission recognized that keeping the CFR-published MCS and the associated product lists current would require updates on a weekly, if not daily, basis. With the procedures envisioned and the anticipated frequency of updates, the Commission concluded that it would incur prohibitive publication costs and challenging resource burdens.4

    4 The Commission also explored a “publication by reference” approach with the Federal Register. This approach presented an equal number of challenges to the Commission and was dropped from consideration.

    In the interim, the Postal Service and the Commission each maintained versions of the MCS. The Postal Service used its version when presenting price and classification proposals to the Commission for evaluation. This required the Commission to first resolve any differences between the Commission's version of the MCS and the Postal Service's version of the MCS before considering the Postal Service's proposals.

    On April 1, 2013, the Commission published its version of the MCS to the Commission's Web site.5 This provided visibility to all interested persons participating in Commission proceedings as to current prices and classifications. From this point forward, the Postal Service submitted its proposed price and classification changes based on this version of the MCS.

    5 Notice of Posting Draft Mail Classification Schedule to the Commission's Web site, April 1, 2013. At this stage in the development of the MCS, the Commission's version and the Postal Service's version were nearly identical.

    The Commission developed internal procedures for updating the draft MCS appearing on its Web site on approximately a monthly basis. The Commission displays all changes in redline, as had been requested by the Postal Service. The redline changes are incorporated, and a new baseline MCS created, at the conclusion of major price or classification proceedings. All prior versions of the MCS are archived and available on the Web site for reference.

    The Commission also developed internal procedures for publishing product list changes in the Federal Register and for updating the outline MCS appearing in the CFR. The Commission, at that time, removed the table of contents from the outline MCS and simply provided current market dominant and competitive product lists.6 The Commission also elected to notice product list changes in the Federal Register and update the product lists in the CFR on approximately a quarterly basis. Internal Commission procedures were implemented to compile product list changes directed by Commission orders by calendar quarter. The compiled list of changes are noticed in the Federal Register and are used to update the outline MCS appearing in the CFR shortly after the close of each calendar quarter.

    6 The table of contents was hopelessly outdated and contradicted the table of contents appearing in the MCS appearing on the Commission's Web site.

    The instant rulemaking proposes to codify the current practice, as described in the above procedures. The MCS appearing on the Web site has proven effective in documenting current prices and classifications and in facilitating communications of the Postal Service's proposed price and classification changes to the Commission. The procedures for noticing product list changes in the Federal Register and updating product lists in the CFR fulfill the statutory requirements for publishing revised product lists.

    The effect of the rulemaking is to make the version of the MCS appearing on the Commission's Web site the authoritative and most up to date comprehensive source for price and classification information for Postal Service products.7 In keeping with current practice, the proposed rules codify that product lists will continue to be published in the CFR, with notice of changes published in the Federal Register. The proposed rules no longer indicate that the MCS will be published in the CFR.

    7 The proposed rules recognize the immediate binding effect of the Commission's final orders on the Postal Service, subject to statutory challenge, and the inherent time lag in updating product lists and the MCS.

    III. Rule Modifications

    The Commission's existing rules concerning the MCS, which include the associated market dominant and the competitive product lists, are codified at 39 CFR part 3020, subpart A—Mail Classification Schedule. An abridged version of the MCS (which only includes the market dominant and competitive product lists) is codified at 39 CFR part 3020, Appendix A to subpart A—Mail Classification Schedule.

    This rulemaking codifies current practice. The product lists and the MCS will be treated as separate items. Only the product lists are noticed in the Federal Register and published in the CFR. The MCS will be available on the Commission's Web site.8 Conforming changes are also required in 39 CFR part 3020, subparts B, C, and D.

    8 For the convenience of the reader, the MCS will include copies of the market dominant and competitive product lists.

    The title of subpart A is changed from “Mail Classification Schedule” to “Product Lists and Mail Classification Schedule.” The addition of “Product Lists” to the title more accurately describes the content of subpart A.

    The existing § 3020.1, “Applicability,” specifies that the market dominant and competitive product lists are to be included as part of the MCS. The proposed § 3020.1 describes the product lists and the MCS as separate items.

    Proposed § 3020.1(a) clarifies that it is the Commission's responsibility to establish and maintain lists of Postal Service products and a MCS.

    Proposed § 3020.1(b) replaces existing § 3020.1(a). Both specify that the starting point for the product lists are the market dominant products identified in 39 U.S.C. 3621(a) and the competitive products identified in 39 U.S.C. 3631(a). Proposed § 3020.1(b) expands upon this requirement by including products within the product lists identified as market tests pursuant to 39 U.S.C. 3641 and nonpostal pursuant to 39 U.S.C. 404(e). This flows from the requirement for the Postal Service to properly categorize market tests as either market dominant or competitive (39 U.S.C. 3641(b)(2)) and the Commission to properly categorize nonpostal services as either market dominant or competitive (39 U.S.C. 404(e)(5)).9

    9 This change was adopted at the suggestion of the Docket No. RM2011-8 Public Representative. Docket No. RM2011-8, Public Representative Comments on Notice of Proposed Rulemaking Concerning Mail Classification Schedule, March 24, 2011, at 5.

    Proposed § 3020.1(c) states the purpose of the MCS as providing current price and classification information applicable to the products appearing on the market dominant and competitive product lists.

    Proposed § 3020.1(d) modifies the material previously included in existing § 3020.1(b) by addressing the product lists and the MCS as two separate items. The proposed section provides that either item may be modified subject to the procedures in 39 CFR part 3020.

    Proposed § 3020.2 directs that the market dominant and competitive product lists shall be published in the Federal Register as appendix A to subpart A of part 3020 and appendix B to subpart A of part 3020, respectively. Currently, an abridged version of the MCS, which includes only the market dominant and competitive product lists, is published in the Federal Register as appendix A to subpart A of part 3020. The intent of the existing rule was to eventually publish the entire MCS in the Federal Register. The intent of the proposed rule is to implement current practice and only publish the market dominant and competitive product lists in the Federal Register. Providing a separate appendix for each product list is intended to potentially reduce Federal Register publication costs when modifications are required of one product list but not the other.

    Proposed § 3020.3 explains how product lists are modified and how the public is notified of such changes. This section replaces and expands upon the material previously appearing in existing § 3020.14. Generally, § 3020.3 implements the publication requirement appearing in 39 U.S.C. 3642(d)(2), which requires Federal Register notice of product list changes.

    Proposed § 3020.3(a) explains that the requirement to publish notice of a product list change is triggered by a Commission final order that directs such changes.

    The current practice of the Commission is to accumulate all final orders involving changes to product lists and to file a product list update with the Federal Register on a quarterly basis. Proposed § 3020.3(b) sets a maximum 6-month deadline for filing the quarterly update. This essentially provides a maximum of 3 months from the quarterly accumulation cutoff date to process and submit the changes to the Federal Register.

    The Commission's position is that Commission orders issued within its jurisdiction are binding upon the Postal Service when issued, unless challenged pursuant to 39 U.S.C. 3663. Accordingly, § 3020.3(c) specifies that changes to product lists are effective upon issuance of the final order, and not upon publication in the Federal Register, which generally occurs at a later date.

    Proposed § 3020.3(d) specifies the content of the Federal Register notice consistent with the requirements of 39 U.S.C. 3642(d)(2). This material previously appeared in existing § 3020.14.

    Since April 1, 2013, the MCS has been available on the Commission's Web site at www.prc.gov. Proposed § 3020.4(a) directs the Commission to publish the authoritative version of the MCS on its Web site. Proposed § 3020.4(b) describes the minimum required content of the MCS. This material previously appeared in existing § 3020.13.

    Proposed § 3020.5 explains that modifications to the MCS are triggered by Commission final orders directing such changes.

    The current practice of the Commission is to accumulate all final orders involving changes to the MCS and to update it on a monthly basis. Proposed § 3020.5(b) sets a maximum 3-month deadline for filing the quarterly update. This essentially provides a maximum of 2 months from the quarterly accumulation cutoff date to process and post a revised MCS to the Web site.

    The Commission's position is that its orders are binding upon the Postal Service when issued, unless challenged pursuant to 39 U.S.C. 3663. Accordingly, § 3020.3(c) specifies that changes to the MCS are effective upon issuance of the final order, and not once the MCS is actually modified, which generally occurs at a later date.

    The titles to 39 CFR part 3020, subparts B, C, and D and §§ 3020.30, 3020.50, and 3020.70 refer to the product lists as being within the MCS. Conforming changes are proposed to remove this reference.

    IV. Public Representative

    Pursuant to 39 U.S.C. 505, Kenneth E. Richardson is appointed to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this docket.

    V. Invitation of Comments

    The Commission invites public comment on the proposed rules. Comments by interested persons are due 30 days after publication in the Federal Register.

    VI. Ordering Paragraphs

    It is ordered:

    1. Docket No. RM2016-8 is established for the purpose of receiving comments on the Commission's proposed rules.

    2. The Commission proposes to amend its rules as described below. The proposed amendments involve amending 39 CFR part 3020, subpart A—Mail Classification Schedule, and conforming amendments to subparts B, C, and D.

    3. Pursuant to 39 U.S.C. 505, the Commission appoints Kenneth E. Richardson to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.

    4. Interested persons may submit comments no later than 30 days after the date of publication of this Order in the Federal Register.

    5. The Secretary shall arrange for publication of this Order in the Federal Register.

    By the Commission.

    Stacy L. Ruble, Secretary.
    List of Subjects in 39 CFR Part 3017

    Administrative practice and procedure.

    For the reasons discussed in the preamble, the Commission proposes to amend chapter III of title 39 of the Code of Federal Regulations as follows:

    PART 3020—PRODUCT LISTS 1. The authority citation for part 3020 continues to read as follows: Authority:

    39 U.S.C. 503; 3622; 3631; 3642; 3682.

    2. Revise subpart A of part 3020 to read as follows: Subpart A—Product Lists and the Mail Classification Schedule Sec. 3020.1 Applicability. 3020.2 Product lists. 3020.3 Notice of product list change. 3020.4 Mail Classification Schedule. 3020.5 Modifications to the Mail Classification Schedule. Appendix A to Subpart A of Part 3020—Market Dominant Product List Appendix B to Subpart A of Part 3020—Competitive Product List
    § 3020.1 Applicability.

    (a) The rules in this part require the Postal Regulatory Commission to establish and maintain lists of Postal Service products and a Mail Classification Schedule.

    (b) The product lists shall categorize postal products as either market dominant or competitive. As established, the market dominant and competitive product lists—shall be consistent with the market dominant products identified in 39 U.S.C. 3621(a) and the competitive products identified in 39 U.S.C. 3631(a). The market dominant and competitive product lists shall also include products identified as market tests pursuant to 39 U.S.C. 3641 and nonpostal pursuant to 39 U.S.C. 404(e).

    (c) The Mail Classification Schedule shall provide current price and classification information applicable to the products appearing on the market dominant and competitive product lists.

    (d) Once established, the product lists and the Mail Classification Schedule may be modified subject to the procedures specified in this part.

    § 3020.2 Product lists.

    (a) Market dominant product list. The market dominant product list shall be published in the Federal Register at Appendix A to subpart A of part 3020—Market Dominant Product List.

    (b) Competitive product list. The competitive product list shall be published in the Federal Register at Appendix B to subpart A of part 3020—Competitive Product List.

    § 3020.3 Notice of product list change.

    (a) Whenever the Postal Regulatory Commission issues a final order that modifies the list of products in the market dominant category or the competitive category, it shall cause notice of such change to be published in the Federal Register.

    (b) Notice shall be submitted to the Federal Register for publication within 6 months of the issue date of the applicable final order that affects the change.

    (c) Modifications pending publication in the Federal Register are effective immediately upon written direction from the Postal Regulatory Commission.

    (d) The Federal Register notice shall:

    (i) Identify modifications to the current list of market dominant products and the current list of competitive products; and

    (ii) Indicate how and when the previous product lists have been modified.

    § 3020.4 Mail Classification Schedule.

    (a) The Postal Regulatory Commission shall publish a Mail Classification Schedule (including both current and previous versions) on its Web site at http://www.prc.gov. Copies of the Mail Classification Schedule also shall be available during regular business hours for reference and public inspection at the Postal Regulatory Commission located at 901 New York Avenue NW., Suite 200, Washington, DC 20268-0001.

    (b) The Mail Classification Schedule shall include, but shall not be limited to: (1) Front matter, including:

    (i) A cover page identifying the title of the document as the Mail Classification Schedule, the source of the document as the Postal Regulatory Commission (including Commission seal), and the publication date;

    (ii) A table of contents;

    (iii) A table specifying the revision history of the Mail Classification Schedule; and

    (iv) A table identifying Postal Service trademarks; and

    (2) Information concerning market dominant products, including:

    (i) A copy of the Market Dominant Product List;

    (ii) Descriptions of each market dominant product organized by the class of product, including:

    (A) Where applicable, the general characteristics, size and weight limitations, minimum volume requirements, price categories, and available optional features of each market dominant product;

    (B) A schedule listing the rates and fees for each market dominant product;

    (C) Where applicable, the identification of a product as a special classification within the meaning of 39 U.S.C. 3622(c)(10) for market dominant products;

    (D) Where applicable, the identification of a product as an experimental product undergoing a market test; and

    (E) Where applicable, the identification of a product as a nonpostal product; and

    (3) Information concerning competitive products, including:

    (i) A copy of the competitive product list; and

    (ii) Descriptions of each competitive product, including:

    (A) Where applicable, the general characteristics, size and weight limitations, minimum volume requirements, price categories, and available optional features of each competitive product;

    (B) A schedule listing the current rates and fees for each competitive product of general applicability;

    (C) The identification of each product not of general applicability within the meaning of 39 U.S.C. 3632(b)(3) for competitive products;

    (D) Where applicable, the identification of a product as an experimental product undergoing a market test; and

    (E) Where applicable, the identification of a product as a nonpostal product; and

    (4) A glossary of terms and conditions; and

    (5) A list of country codes for international mail prices.

    § 3020.5 Modifications to the Mail Classification Schedule.

    (a) Whenever the Postal Regulatory Commission issues a final order that modifies the Mail Classification Schedule, it shall update the Mail Classification Schedule appearing on its Web site at http://www.prc.gov.

    (b) Modification to the Mail Classification Schedule shall be incorporated within 3 months of the issue date of the final order.

    (c) Modifications pending incorporation into the Mail Classification Schedule are effective immediately upon written direction from the Postal Regulatory Commission.

    Appendix A to Subpart A of Part 3020—Market Dominant Product List (An asterisk (*) indicates an organizational group, not a Postal Service product.) First-Class Mail * Single-Piece Letters/Postcards Presorted Letters/Postcards Flats Parcels Outbound Single-Piece First-Class Mail International Inbound Letter Post Standard Mail (Commercial and Nonprofit) * High Density and Saturation Letters High Density and Saturation Flats/Parcels Carrier Route Letters Flats Parcels Every Door Direct Mail—Retail Periodicals * In-County Periodicals Outside County Periodicals Package Services * Alaska Bypass Service Bound Printed Matter Flats Bound Printed Matter Parcels Media Mail/Library Mail Special Services * Ancillary Services International Ancillary Services Address Management Services Caller Service Credit Card Authentication International Reply Coupon Service International Business Reply Mail Service Money Orders Post Office Box Service Customized Postage Stamp Fulfillment Services Negotiated Service Agreements * Domestic * PHI Acquisitions, Inc. Negotiated Service Agreement International * Inbound Market Dominant Multi-Service Agreements with Foreign Postal Operators 1 Inbound Market Dominant Exprés Service Agreement 1 Nonpostal Services * Alliances with the Private Sector to Defray Cost of Key Postal Functions Philatelic Sales Market Tests * Appendix B to Subpart A of Part 3020—Competitive Product List (An asterisk (*) indicates an organizational class or group, not a Postal Service product.) Domestic Products * Priority Mail Express Priority Mail Parcel Select Parcel Return Service First-Class Package Service Retail Ground International Products * Outbound International Expedited Services Inbound Parcel Post (at UPU rates) Outbound Priority Mail International International Priority Airmail (IPA) International Surface Air List (ISAL) International Direct Sacks—M-Bags Outbound Single-Piece First-Class Package International Service Negotiated Service Agreements * Domestic * Priority Mail Express Contract 8 Priority Mail Express Contract 15 Priority Mail Express Contract 16 Priority Mail Express Contract 17 Priority Mail Express Contract 18 Priority Mail Express Contract 19 Priority Mail Express Contract 20 Priority Mail Express Contract 21 Priority Mail Express Contract 22 Priority Mail Express Contract 23 Priority Mail Express Contract 24 Priority Mail Express Contract 25 Priority Mail Express Contract 26 Priority Mail Express Contract 27 Priority Mail Express Contract 28 Priority Mail Express Contract 29 Priority Mail Express Contract 30 Priority Mail Express Contract 31 Priority Mail Express Contract 32 Priority Mail Express Contract 33 Priority Mail Express Contract 34 Priority Mail Express Contract 35 Parcel Return Service Contract 5 Parcel Return Service Contract 6 Parcel Return Service Contract 7 Parcel Return Service Contract 8 Parcel Return Service Contract 9 Parcel Return Service Contract 10 Priority Mail Contract 24 Priority Mail Contract 29 Priority Mail Contract 33 Priority Mail Contract 56 Priority Mail Contract 57 Priority Mail Contract 58 Priority Mail Contract 59 Priority Mail Contract 60 Priority Mail Contract 61 Priority Mail Contract 62 Priority Mail Contract 63 Priority Mail Contract 64 Priority Mail Contract 65 Priority Mail Contract 66 Priority Mail Contract 67 Priority Mail Contract 70 Priority Mail Contract 71 Priority Mail Contract 72 Priority Mail Contract 73 Priority Mail Contract 74 Priority Mail Contract 75 Priority Mail Contract 76 Priority Mail Contract 77 Priority Mail Contract 78 Priority Mail Contract 79 Priority Mail Contract 80 Priority Mail Contract 81 Priority Mail Contract 82 Priority Mail Contract 83 Priority Mail Contract 84 Priority Mail Contract 85 Priority Mail Contract 86 Priority Mail Contract 87 Priority Mail Contract 88 Priority Mail Contract 89 Priority Mail Contract 90 Priority Mail Contract 91 Priority Mail Contract 92 Priority Mail Contract 93 Priority Mail Contract 94 Priority Mail Contract 95 Priority Mail Contract 96 Priority Mail Contract 97 Priority Mail Contract 98 Priority Mail Contract 99 Priority Mail Contract 100 Priority Mail Contract 101 Priority Mail Contract 102 Priority Mail Contract 103 Priority Mail Contract 104 Priority Mail Contract 105 Priority Mail Contract 106 Priority Mail Contract 107 Priority Mail Contract 108 Priority Mail Contract 109 Priority Mail Contract 110 Priority Mail Contract 111 Priority Mail Contract 112 Priority Mail Contract 113 Priority Mail Contract 114 Priority Mail Contract 115 Priority Mail Contract 116 Priority Mail Contract 117 Priority Mail Contract 118 Priority Mail Contract 119 Priority Mail Contract 120 Priority Mail Contract 121 Priority Mail Contract 122 Priority Mail Contract 123 Priority Mail Contract 124 Priority Mail Contract 125 Priority Mail Contract 126 Priority Mail Contract 127 Priority Mail Contract 128 Priority Mail Contract 129 Priority Mail Contract 130 Priority Mail Contract 131 Priority Mail Contract 132 Priority Mail Contract 133 Priority Mail Contract 134 Priority Mail Contract 135 Priority Mail Contract 136 Priority Mail Contract 137 Priority Mail Contract 138 Priority Mail Contract 139 Priority Mail Contract 140 Priority Mail Contract 141 Priority Mail Contract 142 Priority Mail Contract 143 Priority Mail Contract 144 Priority Mail Contract 145 Priority Mail Contract 146 Priority Mail Contract 147 Priority Mail Contract 148 Priority Mail Contract 149 Priority Mail Contract 150 Priority Mail Contract 151 Priority Mail Contract 152 Priority Mail Contract 153 Priority Mail Contract 154 Priority Mail Contract 155 Priority Mail Contract 156 Priority Mail Contract 157 Priority Mail Contract 158 Priority Mail Contract 159 Priority Mail Contract 160 Priority Mail Contract 161 Priority Mail Contract 162 Priority Mail Contract 163 Priority Mail Contract 164 Priority Mail Contract 165 Priority Mail Contract 166 Priority Mail Contract 167 Priority Mail Contract 168 Priority Mail Contract 169 Priority Mail Contract 170 Priority Mail Contract 171 Priority Mail Contract 172 Priority Mail Contract 173 Priority Mail Contract 174 Priority Mail Contract 175 Priority Mail Contract 176 Priority Mail Contract 177 Priority Mail Contract 178 Priority Mail Contract 179 Priority Mail Contract 180 Priority Mail Contract 181 Priority Mail Contract 182 Priority Mail Contract 183 Priority Mail Contract 184 Priority Mail Contract 185 Priority Mail Contract 186 Priority Mail Contract 187 Priority Mail Contract 188 Priority Mail Contract 189 Priority Mail Contract 190 Priority Mail Contract 191 Priority Mail Contract 192 Priority Mail Contract 193 Priority Mail Contract 194 Priority Mail Contract 195 Priority Mail Contract 196 Priority Mail Contract 197 Priority Mail Contract 198 Priority Mail Contract 199 Priority Mail Contract 200 Priority Mail Express & Priority Mail Contract 10 Priority Mail Express & Priority Mail Contract 12 Priority Mail Express & Priority Mail Contract 13 Priority Mail Express & Priority Mail Contract 14 Priority Mail Express & Priority Mail Contract 16 Priority Mail Express & Priority Mail Contract 17 Priority Mail Express & Priority Mail Contract 18 Priority Mail Express & Priority Mail Contract 19 Priority Mail Express & Priority Mail Contract 20 Priority Mail Express & Priority Mail Contract 21 Priority Mail Express & Priority Mail Contract 22 Priority Mail Express & Priority Mail Contract 23 Priority Mail Express & Priority Mail Contract 24 Priority Mail Express & Priority Mail Contract 25 Priority Mail Express & Priority Mail Contract 26 Priority Mail Express & Priority Mail Contract 27 Priority Mail Express & Priority Mail Contract 28 Parcel Select & Parcel Return Service Contract 3 Parcel Select & Parcel Return Service Contract 5 Parcel Select Contract 2 Parcel Select Contract 5 Parcel Select Contract 7 Parcel Select Contract 8 Parcel Select Contract 9 Parcel Select Contract 10 Parcel Select Contract 11 Parcel Select Contract 12 Parcel Select Contract 13 Parcel Select Contract 14 Priority Mail—Non-Published Rates Priority Mail—Non-Published Rates 1 First-Class Package Service Contract 35 First-Class Package Service Contract 36 First-Class Package Service Contract 37 First-Class Package Service Contract 38 First-Class Package Service Contract 39 First-Class Package Service Contract 40 First-Class Package Service Contract 41 First-Class Package Service Contract 42 First-Class Package Service Contract 43 First-Class Package Service Contract 44 First-Class Package Service Contract 45 First-Class Package Service Contract 46 First-Class Package Service Contract 47 Priority Mail Express, Priority Mail & First-Class Package Service Contract 2 Priority Mail Express, Priority Mail & First-Class Package Service Contract 3 Priority Mail Express, Priority Mail & First-Class Package Service Contract 4 Priority Mail Express, Priority Mail & First-Class Package Service Contract 5 Priority Mail Express, Priority Mail & First-Class Package Service Contract 6 Priority Mail Express, Priority Mail & First-Class Package Service Contract 7 Priority Mail Express, Priority Mail & First-Class Package Service Contract 8 Priority Mail Express, Priority Mail & First-Class Package Service Contract 9 Priority Mail & First-Class Package Service Contract 2 Priority Mail & First-Class Package Service Contract 3 Priority Mail & First-Class Package Service Contract 4 Priority Mail & First-Class Package Service Contract 5 Priority Mail & First-Class Package Service Contract 6 Priority Mail & First-Class Package Service Contract 7 Priority Mail & First-Class Package Service Contract 8 Priority Mail & First-Class Package Service Contract 9 Priority Mail & First-Class Package Service Contract 10 Priority Mail & First-Class Package Service Contract 11 Priority Mail & First-Class Package Service Contract 12 Priority Mail & First-Class Package Service Contract 13 Priority Mail & First-Class Package Service Contract 14 Priority Mail & First-Class Package Service Contract 15 Priority Mail & First-Class Package Service Contract 16 Outbound International * Global Expedited Package Services (GEPS) Contracts GEPS 3 Global Bulk Economy (GBE) Contracts Global Plus Contracts Global Plus 1C Global Plus 2C Global Reseller Expedited Package Contracts Global Reseller Expedited Package Services 1 Global Reseller Expedited Package Services 2 Global Reseller Expedited Package Services 3 Global Reseller Expedited Package Services 4 Global Expedited Package Services (GEPS)—Non-Published Rates Global Expedited Package Services (GEPS)—Non-Published Rates 2 Global Expedited Package Services (GEPS)—Non-Published Rates 3 Global Expedited Package Services (GEPS)—Non-Published Rates 4 Global Expedited Package Services (GEPS)—Non-Published Rates 5 Global Expedited Package Services (GEPS)—Non-Published Rates 6 Global Expedited Package Services (GEPS)—Non-Published Rates 7 Global Expedited Package Services (GEPS)—Non-Published Rates 8 Global Expedited Package Services (GEPS)—Non-Published Rates 9 Global Expedited Package Services (GEPS)—Non-Published Rates 10 Priority Mail International Regional Rate Boxes—Non-Published Rates Outbound Competitive International Merchandise Return Service Agreement with Royal Mail Group, Ltd. Priority Mail International Regional Rate Boxes Contracts Priority Mail International Regional Rate Boxes Contracts 1 Competitive International Merchandise Return Service Agreements with Foreign Postal Operators Competitive International Merchandise Return Service Agreements with Foreign Postal Operators 1 Competitive International Merchandise Return Service Agreements with Foreign Postal Operators 2 Inbound International * International Business Reply Service (IBRS) Competitive Contracts International Business Reply Service Competitive Contract 1 International Business Reply Service Competitive Contract 3 Inbound Direct Entry Contracts with Customers Inbound Direct Entry Contracts with Foreign Postal Administrations Inbound Direct Entry Contracts with Foreign Postal Administrations Inbound Direct Entry Contracts with Foreign Postal Administrations 1 Inbound EMS Inbound EMS 2 Inbound Air Parcel Post (at non-UPU rates) Royal Mail Group Inbound Air Parcel Post Agreement Inbound Competitive Multi-Service Agreements with Foreign Postal Operators 1 Special Services * Address Enhancement Services Greeting Cards, Gift Cards, and Stationery International Ancillary Services International Money Transfer Service—Outbound International Money Transfer Service—Inbound Premium Forwarding Service Shipping and Mailing Supplies Post Office Box Service Competitive Ancillary Services Nonpostal Services * Advertising Licensing of Intellectual Property other than Officially Licensed Retail Products (OLRP) Mail Service Promotion Officially Licensed Retail Products (OLRP) Passport Photo Service Photocopying Service Rental, Leasing, Licensing or other Non-Sale Disposition of Tangible Property Training Facilities and Related Services USPS Electronic Postmark (EPM) Program Market Tests * International Merchandise Return Service (IMRS)—Non-Published Rates Customized Delivery
    Subpart B—Requests Initiated by the Postal Service To Modify the Product Lists 3. Revise the heading of subpart B to read as set forth above. 4. Revise § 3020.30 to read as follows:
    § 3020.30 General.

    The Postal Service, by filing a request with the Commission, may propose a modification to the market dominant product list or the competitive product list. For purposes of this part, modification shall be defined as adding a product to a list, removing a product from a list, or moving a product from one list to the other list.

    Subpart C—Requests Initiated by Users of the Mail To Modify the Product Lists 5. Revise the heading of subpart C as set forth above. 6. Revise § 3020.50 to read as follows:
    § 3020.50 General.

    Users of the mail, by filing a request with the Commission, may propose a modification to the market dominant product list or the competitive product list. For purposes of this part, modification shall be defined as adding a product to a list, removing a product from a list, or transferring a product from one list to the other list.

    Subpart D—Proposal of the Commission To Modify the Product Lists 7. Revise the heading of subpart D as set forth above. Subpart D—Proposal of the Commission To Modify the Product Lists 8. Revise § 3020.70 to read as follows:
    § 3020.70 General.

    The Commission, of its own initiative, may propose a modification to the market dominant product list or the competitive product list. For purposes of this part, modification shall be defined as adding a product to a list, removing a product from a list, or transferring a product from one list to the other list.

    [FR Doc. 2016-08322 Filed 4-11-16; 8:45 am] BILLING CODE 7710-FW-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 65 [WC Docket Nos. 10-90, 14-58; CC Docket No. 01-92; FCC 16-33] Connect America Fund, ETC Annual Reports and Certification; Developing a Unified Intercarrier Compensation Regime AGENCY:

    Federal Communications Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    In this document, the Federal Communications Commission (Commission) proposes targeted rule changes to our existing accounting and affiliate transaction rules to eliminate inefficiencies and provide guidance to rate-of-return carriers regarding our expectations for appropriate expenditures.

    DATES:

    Comments are due on or before May 12, 2016 and reply comments are due on or before June 13, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this document, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    You may submit comments, identified by either WC Docket No. 10-90, WC Docket No. 14-58 or CC Docket No. 01-92, by any of the following methods:

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

    Federal Communications Commission's Web site: http://fjallfoss.fcc.gov/ecfs2/. Follow the instructions for submitting comments.

    People with Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by email: [email protected] or phone: (202) 418-0530 or TTY: (202) 418-0432.

    For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Alexander Minard, Wireline Competition Bureau, or Suzanne Yelen, Wireline Competition Bureau, (202) 418-7400 or TTY: (202) 418-0484.

    SUPPLEMENTARY INFORMATION:

    This is a synopsis of the Commission's Further Notice of Proposed Rulemaking (FNPRM) in WC Docket Nos. 10-90, 14-58 and CC Docket No. 01-92; FCC 16-33, adopted on March 23, 2016 and released on March 30, 2016. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY-A257, 445 12th St. SW., Washington, DC 20554 or at the following Internet address: http://transition.fcc.gov/Daily_Releases/Daily_Business/2016/db0330/FCC-16-33A1.pdf. The Report and Order, Order and Order on Reconsideration that was adopted concurrently with the FNPRM are published elsewhere in this issue of the Federal Register.

    I. Introduction

    1. With this Further Notice of Proposed Rulemaking (FNPRM) and concurrently adopted Report and Order, Order, Order on Reconsideration, the Commission adopts significant reforms to place the universal service program on solid footing for the next decade to “preserve and advance” voice and broadband service in areas served by rate-of-return carriers. In 2011, the Commission unanimously adopted transformational reforms to modernize universal service for the 21st century, creating programs to support explicitly broadband-capable networks. In this Report and Order, Order, Order on Reconsideration, and FNPRM, the Commission takes necessary and crucial steps to reform our rate-of-return universal service mechanisms to fulfill our statutory mandate of ensuring that all consumers “have access to . . . advanced telecommunications and information services.” In particular, after extensive coordination and engagement with carriers and their associations, the Commission modernizes the rate-of-return program to support the types of broadband offerings that consumers increasingly demand, efficiently target support to areas that need it the most, and establish concrete deployment obligations to ensure demonstrable progress in connecting unserved consumers. This will provide the certainty and stability that carriers seek in order to invest for the future in the years to come. The Commission welcomes ongoing input and partnership as they move forward to implementing these reforms.

    2. Rate-of-return carriers play a vital role in the high-cost universal service program. Many of them have made great strides in deploying 21st century networks in their service territories, in spite of the technological and marketplace challenges to serving some of the most rural and remote areas of the country. At the same time, millions of rural Americans remain unserved. In 2011, the Commission unanimously concluded that extending broadband service to those communities that lacked any service was one of core objectives of reform. At that time, it identified a rural-rural divide, observing that “some parts of rural America are connected to state-of-the art broadband, while other parts of rural America have no broadband access.” The Commission focuses now on the rural divide that exists within areas served by rate-of-return carriers. According to December 2014 Form 477 data, an estimated 20 percent of the housing units in areas served by rate-of-return carriers lack access to 10 Mbps downstream/1 Mbps upstream (10/1 Mbps) terrestrial fixed broadband service. It is time to close the gap, and take action to bring service to the consumers served by rate-of-return carriers that lack access to broadband. The Commission needs to modernize comprehensively the rate-of-return universal service program in order to benefit rural consumers throughout the country.

    3. For years, the Commission has worked with active engagement from a wide range of interested stakeholders to develop new rules to support broadband-capable networks. One shortcoming of the current high-cost rules identified by rate-of-return carriers is that support is not provided if consumers choose to drop voice service, often referred to as “stand-alone broadband” or “broadband-only” lines. In the April 2014 Connect America FNPRM, 79 FR 39196, July 9, 2014, the Commission unanimously articulated four general principles for reform to address this problem, indicating that new rules should provide support within the established budget for areas served by rate-of-return carriers; distribute support equitably and efficiently, so that all rate-of-return carriers have the opportunity to extend broadband service where it is cost-effective to do so; support broadband-capable networks in a manner that is forward looking; and ensure no double-recovery of costs. The package of reforms outlined below solve the stand-alone broadband issue and update the rate-of-return program consistent with those principles. The Commission also takes important steps to act on the recommendation of the Governmental Accountability Office to ensure greater accountability and transparency in the high-cost program.

    4. In the FNPRM, the Commission proposes targeted rule changes to our existing accounting and affiliate transaction rules to eliminate inefficiencies and provide guidance to rate-of-return carriers regarding our expectations for appropriate expenditures. Consumers are harmed when “universal service provides more support than necessary to achieve our goals.” The statute requires that universal service funds be used for their intended purposes—maintaining and upgrading supported facilities and services. The Commission proposes to eliminate a number of expenses from inclusion in a rate-of-return carrier's revenue requirement and calculations of high-cost support. The Commission also seeks comment on establishing measures governing prudent or reasonable expense levels for certain expense categories. The FNPRM further seeks comment on ways in which the cost allocation procedures between regulated and non-regulated activities and the affiliate transaction rules can be improved to reduce the potential for a carrier to shift costs from non-regulated to regulated services or to the regulated affiliate.

    5. Second, the Commission seeks comment in the FNPRM on additional options for disaggregating support for those discrete areas that are served by an unsubsidized competitor and other issues associated with implementation of the competitive overlap rule.

    6. Third, the FNPRM seeks comment on proposals to adopt a mechanism to provide additional support to unserved Tribal lands. The Commission has long recognized the distinct challenges in bringing communications service to Tribal lands.

    7. Fourth, the FNPRM seeks comment on other measures that the Commission could take within the existing budget to encourage further broadband deployment by rate-of-return carriers.

    8. Lastly, the FNPRM seeks comment on additional proposals to modify or potentially eliminate certain eligible telecommunications carriers' (ETC) certifications and reporting obligations so as to streamline ETC reporting requirements.

    9. The actions the Commission takes today, combined with the rate-of-return reforms undertaken in the past two years, will allow us to continue to advance the goal of ensuring deployment of advanced telecommunications and information services networks throughout “all regions of the nation.” Importantly, they build on proposals from and collaboration with the carriers and their associations. Through the coordinated reforms the Commission takes today, they will provide rate-of-return carriers with equitable and sustainable support for investment in the deployment and operation of 21st century broadband networks throughout the country, providing stability for the future. Achieving universal access to broadband will not occur overnight, but today marks another step on the path toward that goal.

    II. Further Notice of Proposed Rulemaking A. Permitted Expenses, Cost Allocation and Affiliate Transactions

    10. With this Notice, the Commission commences a review of the extent to which certain investments and expenses incurred by a regulated local exchange carrier may be included in its rate base and revenue requirement for ratemaking and universal service fund (USF) purposes. The Commission's rules provide that local exchange carriers may not include expenses in their revenue requirement unless such expenses are “recognized by the Commission as necessary to the provision” of interstate telecommunications services. Similarly, high-cost support provided to an ETC must be used “only for the provision, maintenance, and upgrading of facilities and services for which the support is intended.”

    11. The Commission has not comprehensively reviewed the continued reasonableness of its existing rules regarding permissible investments and expenses for local exchange carriers since the passage of the Telecommunications Act of 1996. Market and regulatory conditions have changed substantially since that time. Notably, regulated telecommunications carriers have expanded into the provision of retail broadband services, either directly or through affiliated entities. Regulated carriers also increasingly face competition, for both voice and broadband services, in portions of their incumbent territory from other facilities-based providers, such as cable and wireless providers. These changing conditions may impact the types of costs carriers attempt to include in their revenue requirement and the ways in which carriers allocate costs between regulated and non-regulated services and affiliates.

    12. Moreover, with steady demands on the high-cost program and a shrinking contribution base, it is more important than ever that these limited funds be used solely for their intended purposes. Likewise, amidst challenging economic conditions, it simply is not right to expect consumers across the country, including those in rural areas, to reimburse rate-of-return carriers—through the regulated rates for interstate service—for excessive or otherwise inappropriate expenses.

    13. While the Commission believes that most rate-of-return carriers properly record their costs and seek support only for the intended purposes, through audits, inquiries and other investigations, the Commission has recently been made aware of alleged abuses by rate-of-return carriers of the used and useful principles and its cost allocation rules. These situations involve rate-of-return carriers, for example, including questionable expenses in their revenue requirement, using support for purposes unrelated to the provision of services, and misallocating expenses among affiliates, or between regulated and non-regulated activities. Against that backdrop, the Commission concludes it is time to reevaluate the types of expenses that should be permitted—both in a carrier's revenue requirement and for recovery through high-cost support. Looking into the expenses permitted and the allocation of those expenses will help ensure that carriers are only recovering costs that are used and useful and prudently incurred, and in the case of high cost support, only costs that are necessary to the provision of interstate telecommunications services.

    1. Discussion a. Review of Permitted Expenses

    14. The Commission begins our reevaluation of a rate-of-return carrier's ability to include certain types of expenses in their revenue requirement and high-cost support with consideration of the appropriate standard to be applied. As noted above, the Commission has used different terms in different situations—“used and useful,” “prudent expenditure,” and “necessary to the provision of.” The Commission believes that these terms should be read consistently to describe those expenses that a carrier may appropriately include in its interstate rate base, interstate revenue requirement, and cost studies used to calculate high-cost support. Thus, they should reflect a business operation that is run efficiently to provide telecommunications services. The costs should include amounts of long-term investment and current expenditures that a business would reasonably incur to provide telecommunications services, taking into account current and reasonably forecasted operating conditions and business levels. The Commission invites parties to comment on these standards and whether they should be viewed as applying a consistent standard to regulated, tariffed services and to expenditures that are recovered through high-cost support. To the extent that a party believes different standards should be applied, it should specify the situations in which such differences should apply, what the differences are, and how they should be treated within the accounting and cost allocation processes of the Commission. As parties respond to the issues raised below, they should consider the application of the standards in their comments.

    15. The Commission recently indicated that ETCs may not recover certain types of expenses through high-cost support. Those expenses include the following: Personal travel; entertainment; alcohol; food, including but not limited to meals to celebrate personal events, such as weddings, births, or retirements; political contributions; charitable donations; scholarships; penalties or fines for statutory or regulatory violations; penalties or fees for any late payments on debt, loans, or other payments; membership fees and dues in clubs and organizations; sponsorships of conferences or community events; gifts to employees; and, personal expenses of employees, board members, family members of employees and board members, contractors, or any other individuals affiliated with the ETC, including but not limited to personal expenses for housing, such as rent or mortgages.

    16. The Commission seeks comment on explicitly prohibiting the inclusion of any of these expenses in a carrier's interstate revenue requirement, which would supersede any existing rules or precedent that might otherwise suggest these are legitimate expenditures. The Commission tentatively concludes that these expenditures are unnecessary to the provision of regulated interstate services and thus are not appropriately included in a rate-of-return carrier's interstate revenue requirement, just as they are not appropriately included in calculating the level of high-cost support a carrier receives. Recognizing that some of these enumerated types of expenditures are quite broad, however, the Commission invites parties to indicate whether there is a definable subset of expenses within any of the categories that should not be excluded from a carrier's interstate revenue requirement. Parties believing there are specific types of expenses that should be included in the interstate revenue requirement should provide examples of such expenses, the reasons they are necessary, as well as specific language that would allow the Commission to distinguish these expenses from those that are appropriately excluded. The Commission also seeks comment on whether, if the Commission ultimately decides some of these expense categories, or a portion of them, should be allowed in a carrier's interstate revenue requirement, whether similar treatment should be accorded those expenses for purposes of high-cost support.

    17. In addition to the expenses identified in the High Cost Oct. 19, 2015 Public Notice, the Commission proposes to prohibit additional expenses from inclusion in a carrier's interstate revenue requirement and also preclude their recovery through high-cost support. The additional expenses that the Commission proposes to disallow for these purposes include: Artwork and other objects which possess aesthetic value; corporate aircraft, watercraft, and other motor vehicles designed for off-road use, except insofar as necessary to access inhabited portions of the study area not reachable by motor vehicles travelling on roads; any vehicles for personal use; tangible property not logically related or necessary to the offering of voice or broadband services; childcare; cafeterias and dining facilities; and, housing allowances or other forms of mortgage or rent assistance for employees. Like the expenses listed above, the Commission is concerned that some carriers may incur additional expenses of this nature that are not necessary to the provision of the supported service—voice telephony—and not necessary to the provision of regulated interstate services. If adopted, such a rule would overturn any existing rule or precedent that might suggest such expenditures are permissible.

    18. The Commission invites parties to comment on whether there is any reason that these expense categories should not be completely excluded from a carrier's revenue requirement or its high-cost support. Parties making an argument for inclusion of these expenses in a carrier's revenue requirement should explain clearly why such expenses are necessary to the provision of a supported service or to the provision of a regulated interstate telecommunications service. The Commission invites parties to indicate whether there is a definable subset of expenses within any of the categories that should not be excluded from a carrier's interstate revenue requirement or high-cost support. Parties believing that to be the case should provide examples of such expenses, the reason they are necessary, as well as specific language that would allow the Commission to distinguish these expenses from those that are appropriately excluded.

    19. The Commission also invites parties to identify additional expenses that should be excluded from either a carrier's interstate revenue requirement, from calculations of high-cost support, or both. Parties identifying additional expenses to be excluded should address the reasons they are unnecessary to the provision of telecommunications service or to the provision of supported services. Parties seeking additional exclusions should also provide language that would allow the Commission to exclude such items if it elects to do so. With respect to ensuring the appropriate use of high-cost funds for certain expenses, our proposals apply to both price cap and rate-of-return carriers. Our proposals concerning permitted expenses for the revenue requirement would primarily apply to rate-of-return carriers, but they would also apply to price cap carriers in limited circumstances.

    20. In addition to these categories, the Commission has seen instances in which “companies maintain comparatively high compensation portfolios for their executives.” The Commission expressed concern that these and other expenses were not reasonable and necessary given a number of considerations. The Commission seeks comment on how to address potential concerns regarding such expenses for executives, those with close relationships to those executives, and a carrier's other employees and contractors.

    21. The Commission is also aware of at least one instance in which costly benefits were sought to be provided to board members. Are there circumstances under which compensation for board members, including fees per-meeting, for special duties assumed, and for travel and per diem expenses should be deemed unreasonable? If so, on what basis? Is additional evaluation warranted where board members have a close relationship to someone in the company?

    22. The Commission seeks comment on whether the costs that may be included in a carrier's revenue requirement for buildings purchased or rented by regulated telecommunications carriers should be limited. For example, in cases where excessive square footage of office or warehouse space is purchased by a regulated carrier in order to earn a rate of return on that space, should part of the price paid for the building be excluded from the revenue requirement? How should “excessive” be defined for this purpose? Are there objective metrics available on the square footage of office space per employee that is reasonable, or on the square footage of warehouse space that a carrier should reasonably require given the number of loops the carrier provides and the density of its service area? Are there objective metrics on the price per square foot that should be paid for office or warehouse space in specific locations?

    23. Section 32.2002 provides that plant held for future use must be utilized within two years. This plant is included in the carrier's rate base. The Commission is concerned that carriers may have incentives to place excess capacity in the interstate regulated rate base that will not be used in the foreseeable future, with ratepayers bearing the cost. The Commission reminds carriers that the benefit from a used and useful investment must be realized within a reasonable amount of time. Thus, the Commission invites parties to comment on whether they should adopt a rule that would prohibit a regulated carrier from leasing capacity from its unregulated affiliate that is not presently utilized in the provision of voice or broadband services. Alternatively, could this concern be addressed by defining more precisely what constitutes reasonable projections of use and/or requiring that such capacity be used within a shorter timeframe than two years? Parties are invited to address the types of uses that should be considered to meet the requirement that excess capacity be used in the foreseeable future.

    24. As explained above, carriers record their financial transactions in the USOA books of account as they occur. These amounts then flow through the allocation procedures in Parts 64, 36, and 69 with the implied assumption that the recorded amounts are reasonable, and thus prudently incurred. While the used and useful and prudent expenditure standards apply to all investments and expenses of the carrier, the principles considered under this standard have been interpreted only in limited, specific cases. The Commission now seeks comment on whether the Commission should adopt more precise guidance regarding what constitutes a used and useful or otherwise prudent expenditure.

    25. The Commission notes that transactions between non-affiliated parties that are negotiated at arm's length are generally presumed to produce commercially reasonable prices. Affiliate transactions, however, are not negotiated at arm's length and thus, may result in unreasonable prices absent standards governing how those transactions should be priced; that is why the Commission adopted rules for the pricing of affiliate transactions decades ago. The Commission now invites parties to comment on whether there are circumstances surrounding transactions between non-affiliated parties that might raise concerns about whether the resulting prices are reasonable. For example, would a close family relationship or cross-participation on boards of directors be situations that warrant more scrutiny of the price? The Commission invites parties to discuss these examples and to identify other examples that might raise concerns. Parties are invited to discuss whether presumptions concerning what would be a prudent expenditure could be employed to ensure that prices are reasonable.

    26. The Commission's rules require a carrier in specified situations to record the purchase of a good or service from an affiliate at fair market value. The Commission invites parties to comment on whether the affiliate transaction standard should also be applied to goods and services acquired from non-affiliated entities. If not, parties should propose an alternative standard and explain why it is a preferable approach. The Commission also invites parties to comment on the factors that should be considered in determining whether a transaction is a prudent expenditure or is a reasonable market price in evaluating prices in situations identified as warranting a closer look. Are there circumstances where a prudent expenditure might be something other than the absolute lowest identified price? Parties are invited to identify other metrics beside cost and reliability that are relevant in determining whether an investment or expense is prudent for the purposes of our rules. Finally, are there specific circumstances under which a carrier should be required to make a good faith determination of fair market value for a good or service obtained from a non-affiliate, prior to incurring such expenses, for instance when the total aggregate annual value of the good(s) or service(s) reaches or exceeds a specified threshold for purchases from a non-affiliate, as is done under section 32.27(b)(3) and (c)(3) for affiliates?

    27. Finally, the Commission invites parties to comment on the best manner of implementing any decision to exclude the expenses identified in this section. Specifically, parties should address whether it would be sufficient to adopt an order simply identifying and defining which costs are not allowed, as has generally been the process in the past, or whether some rule revisions are necessary. If rule revisions are thought necessary, parties should address where in the process they can best be implemented. Part 32 excludes certain investments and expenses as non-regulated, while Part 64 allocates investments and expenses used to provide both regulated and non-regulated activities that are recorded in the regulated accounts of Part 32 between regulated and non-regulated activities. In addition, for purposes of determining whether a carrier's realized rate-of-return exceeds the maximum allowable rate of return, Part 65 specifies the determination of earnings and rate base. Parties are encouraged to address whether some cost disallowances would be better achieved through revisions to the Part 32 rules, while other cost disallowances could best be addressed through revisions to other rules in Parts 64, 65, 69, or some combination of these rules. The Commission is providing state commissions with notice of this in compliance with the requirements of section 220(i) of the Act in the event they decide to make some revisions to Part 32. In other words, is it better to first enumerate which expenses should be excluded from the revenue requirement as not used and useful in the provision of regulated services and then proceed with allocating costs, or is it better to rely on the cost allocation procedures in Part 64 to exclude such expenses? One of the goals of the USOA at the time it was adopted was that it remain stable over time. How should this be factored into the decision of where to make certain disallowances? Parties are invited to submit proposed language to accomplish the approach they recommend. Lastly, the Commission invites parties to comment on whether they should require rate-of-return carriers to identify their cost consultants, if any, in their FCC Form 481s.

    b. Issues Related to Cost Allocation and Affiliate Transactions

    28. Rate-of-return carriers are subject to the Commission's longstanding Part 64 rules regarding the allocation of costs between regulated and non-regulated activities and to the affiliate transaction rules in Part 32. Under these rules, carriers currently apply broad principles in making such allocations, and the lack of specificity in the rules gives carriers a degree of discretion in making these allocation decisions. Therefore, there is an incentive to interpret the allocation rules in order to allocate as many costs as possible to their regulated activities, both to justify a higher interstate revenue requirement and to receive additional high-cost support. For instance, marketing costs could be recorded solely as regulated expenses, even though those marketing activities are designed to increase subscribership of retail broadband, i.e., non-regulated services. Given the lack of specific guidance, the additional costs associated with the provision of retail broadband services, and the incentive to allocate costs to regulated activities, the Commission concludes that it is time to revisit our allocation rules in order to provide greater clarity to rate-of-return carriers regarding how to determine the relative allocation of costs between regulated and non-regulated activities and affiliates.

    29. As noted, the Commission's existing cost allocation rules relating to regulated versus non-regulated activities generally provide that costs shall be directly assigned to either regulated or non-regulated activities where possible, and common costs are to be allocated according to a hierarchy of principles. To the extent costs cannot be allocated on direct or indirect cost causation principles, they are allocated based on a ratio of all expenses directly assigned or attributed to regulated and non-regulated activities. In certain cases, the affiliate transaction rule requires fully distributed costs to be used to determine the charge to the affiliate or the carrier.

    30. The Commission seeks comment on adopting new rules to improve the process of allocating costs among regulated and non-regulated services and between affiliates. The Commission also seeks a better understanding of how to detect cases of misallocation. Our goal is to reduce the potential ability of carriers to include expenses associated with non-regulated services in their regulated revenue requirements, and to preclude carriers from artificially inflating their high-cost support through such actions. To this end, the Commission seeks comment on adopting a rule that would classify certain costs, such as general and administrative expenses, as common costs for purposes of applying the Part 64 and affiliate transaction rules when an entity provides broadband services directly, or through an affiliated entity. Are there other costs that should be treated as common costs in applying these allocation rules? Under such an approach, carriers would be precluded from including all of these expenses in their regulated revenue requirement, and instead, would be required to exclude some expenses based on the prescribed manner of allocation. Accordingly, the Commission also seeks comment on adopting rules that would prescribe the manner of allocation of common costs in particular situations. For example, are there certain common costs that the Commission should specify by rule that they should be allocated on the basis of the relative number of regulated lines compared to the total number of lines (both regulated and non-regulated) for the rate-of-return carrier and its broadband affiliate, if any? Are there other instances in which relative revenues or some other measure would be a better allocator, taking into account the ease of administering any such rule?

    31. The Commission is concerned about the potential for carriers to provide shared operational services to their affiliates under fully-distributed cost (FDC) allocation procedures that do not include all of the associated costs. The affiliate transaction rules employ a higher of cost or market standard when applicable, or a FDC standard to ensure that all costs of services provided by a regulated telecommunications company are recovered from its affiliates. The general nature of the FDC allocation guidelines, however, allows carriers significant discretion in performing the FDC cost study. This discretion allows carriers to exclude expenses associated with providing shared functions to their non-regulated affiliates, especially to those affiliates that then sell retail broadband services to end users on an unregulated basis, thus recovering these costs from rate payers. The Commission seeks comment on clarifying or adopting new rules to ensure the proper application of the affiliate transaction rules in light of provision of retail broadband by affiliates in certain telecommunications markets.

    32. Our accounting and high-cost universal service support rules rely on proper allocation of costs to work as intended. The Commission seeks comment on specific instances in which additional rules or further clarification could minimize potential misallocations and thereby protect ratepayers of regulated services. Are there other methods that would help ensure proper allocation of costs between regulated and non-regulated services?

    33. The Commission is also concerned that problems similar to those associated with regulated versus non-regulated allocations may arise in the application of the FDC process in connection with affiliate transactions. Section 32.27 of the Commission's rules requires an incumbent LEC to record assets or services received from its affiliated entities at the lesser of FDC or fair market value when no tariff rate, prevailing price, or publicly filed agreement exists. FDC may be over-inclusive, however, if it includes investment and expenses of the affiliate that would not properly be included in a carrier's revenue requirement or calculations for high-cost support. While the used and useful and prudent expenditure standards apply to costs included in affiliate transactions, the Commission seeks comment on whether they should adopt a rule that explicitly prohibits carriers from including in the FDC of an affiliate any costs that are disallowed from the regulated rate base or revenue requirement, or considered not to be used and useful or prudent expenditures. Without such a rule, carriers could shift costs to an affiliate and then effectively recover those disallowed costs through payments to the affiliate. The Commission invites parties to comment on how such an approach could be implemented, and whether there are circumstances under which these costs of affiliates should be properly included in the regulated rate base or costs used to calculate high-cost support.

    34. The Commission seeks comment on whether additional data would assist in enforcement of the Commission's accounting and cost allocation rules, while minimizing ETC reporting burden.

    c. Compliance Issues

    35. Finally, the Commission seeks comment on the most effective way to ensure compliance with the proposed rules for universal service support and tariffing purposes. Rate-of-return affiliates of price cap carriers would be subject to any revised rules in establishing their tariffed rates for interstate services. In addition, if a price cap carrier is required to make a cost-based showing in the future, any expense rules adopted in this proceeding would apply to such showings. The Commission invites parties to comment on whether they should require carriers to certify that they have not included any prohibited expenses in their cost submissions used to calculate high-cost support. If so, is there a current certification that can be modified to encompass this aspect, or is a new rule necessary? Because audit findings can be used to recover overpayments of high-cost support, the Commission also invites parties to comment on how the Commission should implement any requirements it may adopt. Are there other proposals or considerations that the Commission should consider to ensure compliance with any revised requirements?

    36. Ensuring compliance with any revised investment, expense, or cost allocation rules in the tariffing context raises different challenges. Rate-of-return carrier tariffs must be filed in advance of their effective date, and pursuant to section 204 of the Act, the Commission, during the notice period, may suspend the effectiveness of a tariff and initiate an investigation to determine whether the tariff is just and reasonable. Section 204(a)(3) provides that local exchange carrier tariffs that take effect on 7-days notice after filing (when rates are reduced) or 15-days notice (for any other change) after filing are “deemed lawful” unless rejected or suspended and investigated by the Commission. If a tariff investigation has not been completed within five months of the tariff's specified effective date, the proposed tariff goes into effect subject to the results of the investigation. At the conclusion of the investigation, the Commission may prescribe rates prospectively and order refunds as necessary for any period in which the tariff was in effect. With these constraints on timing and prohibition on retroactive relief, the Commission invites parties to comment on steps the Commission could take to ensure that carriers follow these requirements. As a starting point, the Commission proposes to require a certification and seek comment on what it should entail. The Commission also invites parties to comment on what sanctions should be used to give some meaning to the certifications.

    37. The Commission invites parties to comment on whether, and if so, when an exception to the “deemed lawful” provision of section 204 of the Act would apply where a carrier violated these rules. The Commission notes that in ACS v. FCC, the D.C. Circuit indicated that although the “deemed lawful” language is unambiguous, “[w]e do not, of course, address the case of a carrier that furtively employs improper accounting techniques in a tariff filing, thereby concealing potential rate of return violations. The Order here makes no claim of such misconduct.” The D.C. Circuit thus acknowledged that there may be extenuating circumstances (such as using improper accounting techniques or willfully misrepresenting expenses) that warrant an exception to the deemed lawful language. The Commission proposes to adopt a rule that would find an exception to the deemed lawful rule when a carrier incorrectly certifies that its revenue requirements are compliant with the applicable standards. The Commission invites parties to comment on this proposal. In particular, parties should address the amount of the discrepancy in actual and projected costs that must exist before such an exception would be invoked. The Commission also asks parties to comment on how any cost recovery should be returned to customers. For example, should it be used to reduce the revenue requirement for the following tariff period? Should there be an interest component to what must be returned to the customers. If so, what should the applicable interest rate be—the authorized rate of return, the corporate tax underpayment rate, or something else? Are there other mechanisms the Commission should consider to deter inclusion of inappropriate expenses in a rate-of-return carrier's revenue requirement?

    38. The vast majority of rate-of-return carriers are members of the NECA pool, and their costs are combined to establish pool rates. The Commission invites parties to comment on NECA's role in enforcing these rules. Should carriers be barred from pool participation if determined to be including expenses prohibited by Commission rules? How should the magnitude of the violation be determined? What percent level of prohibited cost inclusion should be required before immediate expulsion from pool participation is deemed necessary? Are there any other metrics that should be considered in making this determination? Should carrier violations for inclusion of prohibited expenses have a “repeated occurrences” component, or should one time inclusion of a certain percentage of prohibited expenses impact pool participation?

    B. Reducing Support in Competitive Areas

    39. In section II.B of the concurrently adopted Report and Order, the Commission concludes that CAF BLS should not be provided in areas served by a qualifying unsubsidized competitor. The Commission adopts several methods of disaggregating Connect America Fund Broadband Loop Support (CAF BLS) for areas found to be competitively service, and allow carriers to select which method will be used. USTelecom and NTCA propose that in addition to the methods they specifically presented, carriers should also have the option of disaggregating support based on a “method approved by the Commission.” Here, the Commission invites commenters to propose other methods of disaggregation of support that can be implemented with minimal administrative burden for affected carriers and USAC. The Commission seeks to avoid complex allocations of the cost of facilities that that serve both competitive and non-competitive areas, which could be burdensome for rate-of-return carriers to implement.

    40. The Commission also invites parties to comment on how the non-supported amount is to be recovered by the carrier, assuming such expenses remain regulated expenses for ratemaking purposes. At the outset, the Commission notes that rate-of-return carriers currently receive compensation for interstate loop costs through a combination of end-user charges, e.g., SLCs and universal service support. The SLCs most rate-of-return carriers assess are at the maximum levels. Thus, in many situations, carriers would be prohibited by our current rules from increasing SLC rates to recover investment and associated expenses that will not be supported under the high-cost program in competitive areas. The Commission invites parties to comment on the two approaches for recovery of those amounts.

    41. First, the Commission could treat the non-supported expenses as being outside the tariffed regulated revenue requirement and allow carriers to assess a detariffed regulated rate to recover those non-supported costs. This would remove those costs from the NECA pooling process. The Commission invites parties to comment on whether the detariffed rates would be outside the prohibition on tariffing deaveraged rates in a study area, or whether a new rule should be adopted. The Commission invites parties to comment on this alternative. Does it present any opportunities for carriers to game the tariffing process?

    42. A second option would be to raise the SLC caps for a particular study area to permit the recovery of the amounts not supported by the high-cost program. The Commission invites parties to comment on this alternative, including whether any SLC increases should be allowed only in the competitive area or should apply to the entire study area. In the former case, a modification of the rule prohibiting deaveraging within the study area would need to be made. Parties should particularly address the effects of deaveraging on the NECA pooling and tariffing processes. The Commission also invites parties to comment on the effects of deaveraging on carriers' billing and operation support systems. Are there other alternatives that the Commission should consider for recovery of the non-supported investment and associated expenses?

    C. Tribal Support

    43. Discussion. Given the difficulties that some carriers have experienced in deploying basic telecommunications services on Tribal lands, the Commission recognizes the important role of universal service support to foster the deployment of broadband in unserved areas. Therefore, the Commission seeks comment on adopting rules to increase support to rate-of-return carriers for census blocks that include Tribal lands and unserved with broadband meeting the Commission's current requirements.

    44. The Commission recognizes the distinct challenges in bringing communications services to Tribal lands and seek comment on how best to achieve broadband deployment on Tribal lands commensurate with that in other areas. However, the Commission has acknowledged that there are areas throughout the United States that are expensive to serve and that face challenges in demographics, weather, and geography.

    45. NTTA proposes that a TBF be applied to any non-model-based rate-of-return mechanism that the Commission adopts. In light of the other changes adopted today, including measures to provide a larger capital investment allowance for carriers that are below average in terms of broadband deployment, and defined deployment obligations for all rate-of-return carriers, is there a need for a separate mechanism for Tribal lands? The Commission seeks comment on whether a multiplier applied to the revised ICLS (i.e. CAF BLS) mechanism would foster broadband deployment on Tribal lands and ensure “universal service funds are used for their intended purposes.” Are there other approaches that would better advance of our goals?

    46. If the Commission determines that a multiplier of support amounts under CAF BLS is an appropriate mechanism, what factor is appropriate? NTTA provides little support of why 1.25x is the appropriate factor to ensure broadband deployment on Tribal lands, other than pointing to the 25 percent credit the Commission provided in the Tribal Mobility Fund Phase I. The Commission seeks comment on the appropriate figure for the multiplier, if they were to adopt such an approach. When providing comment on the appropriate multiplier, specific data and figures are encouraged. The Commission also emphasizes that high-cost universal service support is a finite resource that must be equitably distributed in a manner that effectuates the goals of section 254. Therefore, the Commission seeks comment on how implementation of Tribal-specific additional support may affect the resources available to extend broadband deployment to non-Tribal rate-of-return service areas with equally minimal broadband build out and located in geographies as equally hard to serve as Tribal lands.

    47. The Commission also seeks comment on how best to target Tribal land-specific support to Tribal lands most in need of broadband deployment. NTTA recommends offering TBF support to all rate-of-return carriers serving Tribal lands and limiting the applicability of the TBF to specific census blocks that include Tribal lands. As noted above, broadband deployment differs substantially among Tribal lands. In light of this, should all Tribal lands be eligible for additional support, or only those with lower levels of deployment? Above, the Commission adopts a mechanism to allow a larger allowable loop expenditure for carriers below the average and to limit the allowable loop expenditure for those above the average. The Commission notes that the weighted average nationwide for rate-of-return carrier deployment of 10/1 Mbps service is currently 68 percent. Should Tribal-specific support only be provided to those rate-of-return carriers that are serving Tribal lands that report broadband deployment lower than the weighted average, based on Form 477 data? If so, should eligibility for Tribal-specific support be determined annually or on a less frequent basis? Should it be provided for a specified period of time, and if so, what is the appropriate time period?

    48. If a rate-of-return carrier's study area is mostly non-Tribal, should that carrier be eligible to receive additional Tribal-specific support? Should there be some threshold percentage, for example 50 percent, of a carrier's service area is on Tribal lands in order to qualify for additional Tribal-specific support? The Commission also seeks comment on the appropriate data source to use to determine whether a census block contains Tribal lands. For example, should the Commission utilize maps and data distributed by the U.S. Census Bureau, or would maps and data provided by the Bureau of Indian Affairs be more appropriate? What other sources of data might the Commission use? The Commission notes that the Commission is currently engaged in consultation with the Tribal Nations of Oklahoma on the operational functionality and use of the Oklahoma Historical Map at the local and individual Tribal Nation level as part of the Lifeline rulemaking proceeding. The Commission seeks comment on how this process may affect our determination of which census blocks would be eligible for Tribal-specific support.

    49. In addition, the Commission seeks comment on what specific broadband deployment obligations should be established, if they were to adopt a mechanism to provide additional support on Tribal lands that lag behind. NTTA supports tying build-out obligations to additional support, and proposes specific build-out obligations tied to a sliding scale based on current broadband deployment levels to “meaningfully improve broadband connectivity on Tribal lands . . . particularly in areas that are unserved today.” For instance, it proposes that recipients of TBF that currently have deployed 10/1 Mbps to less than 10 percent of their locations be required to provide 4/1 Mbps service to at least 25 percent of their locations within three years, and 10/1 Mbps to at least 10 percent of locations, within three years; for those that already have deployed 10/1 Mbps to at least 10 percent but not 25 percent of their locations, they would be required to offer 4/1 Mbps service to 50 percent of their locations and 10/1 Mbps service to 25 percent of locations within three years. If the Commission were to adopt some form of additional Tribal-specific support, how should these proposals be harmonized with the mandatory deployment obligations they adopt above for all rate-of-return carriers?

    50. NTTA recommends that participation in the TBF be voluntary. The Commission seeks comment on whether carriers should have the option to decline Tribal-specific support if the Commission determines that the provision of additional support to Tribal lands is necessary to close the broadband deployment gap in such areas. NTTA suggests that if acceptance of Tribal-specific support is conditioned on build-out obligations, such support presents a “unique opportunity to promote greater deployment of broadband to Tribal lands.” Should participation in such a program be mandatory?

    51. In the USF/ICC Transformation Order, 76 FR 73830, November 29, 2011, the Commission required that ETCs serving Tribal lands must meaningfully engage with Tribal governments in their supported areas. The Commission seeks comment on whether the offer of additional voluntary Tribal-specific support would encourage more robust ETC engagement by carriers with Tribal governments on whose lands they provide service.

    52. Finally, the Commission asks whether carriers that serve Tribal lands, in whole or in part, should not be subject to the measures to limit operating expenses and the overall budget control mechanism concurrently adopted in the Report and Order. Parties have noted, for instance, that Tribal lands may pose unique challenges for obtaining permitting and other authorizations. If the Commission were to exempt such providers from those opex and overall budget limitations, how should they determine the providers subject to such limitations? For instance, to be eligible for such an exemption, should 50 percent or more of the carrier's study area be Tribal lands? What would the budgetary impact be on other rate-of-return carriers that remain on legacy support mechanisms if the Commission were to adopt such exemptions?

    D. Other Measures To Improve the Operation of the Current Rate-of-Return System

    53. Some companies have informed us they have been unable to extend broadband despite their sincere desire to do so due to lack of access to capital. Some companies have seen declining support under the existing legacy mechanisms, and others are not eligible for high cost loop support (HCLS) support due to the prior “race to the top” that the Commission took steps to address in December 2014.

    54. In the April 2014 Connect America Fund FNPRM, the Commission questioned the long term viability of HCLS and ICLS in their current form; that is why they encouraged stakeholders to focus on creating a Connect America Fund for cost recovery that would be consistent with our core principles for reform. As noted in the concurrently adopted Report and Order, the Commission expect the voluntary path to the model to be an attractive option for some of the carriers that no longer receive HCLS. Moreover, our reforms to the existing interstate common line support (ICLS) mechanism will enable carriers that are, relatively speaking, lower cost than some of their peers to obtain more high-cost support for broadband only lines from CAF BLS than they would have received for voice-broadband lines under the existing HCLS mechanism. This may provide an incentive for them to migrate customers to broadband-only lines.

    55. The Commission intends to monitor the impact of these reforms over time. The Commission are optimistic that together, these two paths will provide sufficient options for carriers to make a business case to extend broadband service where it is lacking, while minimizing disruption for those carriers that prefer to remain under the reformed legacy mechanisms. The Commission invites commenters to submit into the record any other proposals or ideas for steps the Commission should take to provide appropriate incentives for broadband deployment to unserved areas working within the framework of the existing budget for rate-of-return areas.

    56. As the Commission evaluates ways to improve the overall framework governing rate-of-return carriers, they also believe it is appropriate to ensure that the administration of the current rate-of-return system, a function largely performed by NECA, is as efficient as possible to ensure that the costs of administration, ultimately borne by consumers, are reasonable. The role of NECA has changed over the last few decades due to a number of factors, including market changes, significant regulatory reforms, and the creation of USAC as the Administrator for the federal universal service mechanisms. The Commission asks parties to address whether and how the Commission should amend subpart G of Part 69 to reflect these changes. The Commission also seeks comment on whether they should adopt rule changes to facilitate transparency into and evaluation of whether NECA's functions are accomplished in an efficient, cost effective, and neutral manner.

    E. Streamlining ETC Annual Reporting Requirements

    57. In addition to the modifications to ETC annual reporting obligations adopted above, the Commission seeks comment on certain, narrowly-tailored reporting changes to improve the Commission's ability to protect against waste, fraud, and abuse. The Commission also seeks comment on additional ways to lessen regulatory reporting burdens on ETCs, particularly those that are small businesses.

    58. Here, the Commission seeks comment on whether to modify or eliminate five sets of requirements: specifically, the requirements by ETCs to provide outage information, unfulfilled service requests, the number of complaints per 1,000 subscribers for both voice and broadband service, pricing for both voice and broadband, and certification that it is complying with applicable service quality standards. What are the regulatory costs associated with requiring such information to be included in the annual Form 481, particularly for those categories of information that may be collected in some fashion through other means (the Commission's outage reporting system and consumer complaint system)? In the case of outage reporting, the Commission notes that all carriers are under a separate obligation to report outages under part 4 of our rules. Are the ETC-specific rules therefore duplicative, and can other means of collection be improved?

    59. To the extent commenters believe such information should continue to be collected from ETCs, the Commission asks for specific suggestions on how to modify these requirements so that the information is more useful to analyze, both on an individual ETC and aggregate basis.

    60. The underlying purpose of the unfulfilled service request reporting rule was to monitor rate-of-return carriers' progress in deploying broadband pursuant to the reasonable request standard. The Commission has concerns, however, that the rule, as implemented, is not adequately advancing that purpose. Similarly, the Commission has found the information regarding complaints to be of limited value, in large part because it is not clear that ETCs are reporting such information in a consistent fashion. If the Commission were to retain some form of reporting requirements for complaints and unfulfilled requests, should they implement more specific standardized instructions regarding the reporting of complaints and unfulfilled requests so that the information can be analyzed and aggregated in a more useful fashion? For the reporting of pricing information, would it be less burdensome if ETCs were to report only the price offering that meets or exceeds our minimum requirements, and not the full range of service offerings?

    61. The Commission also seeks comment on whether, in light of our experience with the reporting requirements to date, they should modify or eliminate the requirement that an ETC certify it is complying with applicable service quality standards and consumer protection rules. Absent greater specificity, affected ETCs may not know what standards and rules are “applicable.” Should the Commission clarify that the obligation applies only to legally binding rules and/or voluntary guidelines with which the ETC has agreed to comply? If so, how should the ETC report its compliance? Are other clarifications or modifications to the rule appropriate?

    62. Above the Commission directs USAC to establish an online tool to permit access to all information submitted by ETCs, including Form 481 data. USAC shall ensure that state regulators, and Tribal governments where applicable, will have access full Form 481 data filings, including any data marked confidential. In light of that change, the Commission proposes to eliminate ETCs' requirement to file a duplicate copy of Form 481 with states and/or Tribal governments. Instead, they would make a single filing with USAC, and both the Commission and other regulators would obtain the information through online access. The Commission tentatively concludes that centralizing all filing requirements with USAC would be beneficial for states and Tribal governments as it would reduce the need to sort through, in some cases, dozens of paper documents containing the same information that would be available more readily through an online tool. Interested parties have suggested that the Commission should reduce or eliminate duplicate filings of the same information. Having one place for ETCs to file their annual reports, instead of three or more, may reduce the filing burden on ETCs. The Commission seeks comment on this tentative conclusion.

    63. Lastly, the Commission seeks comment on modifying or eliminating any other reporting requirements applicable to all ETCs that have broadband obligations as a condition of receiving high-cost support in order to further improve the alignment of carriers' obligations with our ability to monitor them through our reporting requirements.

    III. Procedural Matters A. Paperwork Reduction Act Analysis

    64. This document contains new information collection requirements subject to the PRA. It will be submitted to the Office of Management and Budget (OMB) for review under section 3507(d) of the PRA. OMB, the general public, and other Federal agencies are invited to comment on the new information collection requirements contained in this proceeding. In addition, the Commission notes that pursuant to the Small Business Paperwork Relief Act of 2002, the Commission previously sought specific comment on how the Commission might further reduce the information collection burden for small business concerns with fewer than 25 employees. The Commission describes impacts that might affect small businesses, which includes most businesses with fewer than 25 employees, in the Final Regulatory Flexibility Analysis (FRFA) in Appendix B, infra.

    B. Initial Regulatory Flexibility Analysis

    65. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities from the policies and rules proposed in this Further Notice of Proposed Rulemaking. The Commission requests written public comment on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments on the Further Notice provided on Further Notice of Proposed Rulemaking and the concurrently adopted Report and Order, Order and Order on Reconsideration. The Commission will send a copy of the Further Notice, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). In addition, the Further Notice and IRFA (or summaries thereof) will be published in the Federal Register.

    1. Need for, and Objectives of, the Proposed Rules

    66. In the Further Notice, the Commission commences a review of the extent to which certain investments and expenses incurred by a rate-of-return regulated local exchange carrier may be included in its rate base and revenue requirement for ratemaking and USF purposes. The Commission notes that there may be very limited circumstances where our proposed reforms would impact price cap regulated carriers' use of high-cost USF support. The Commission has not comprehensively reviewed the continued reasonableness of its existing rules regarding permissible investments and expenses for regulated local exchange carriers since the passage of the Telecommunications Act of 1996. Market and regulatory conditions have changed substantially since that time. Regulated telecommunications carriers have expanded into the provision of retail broadband services, either directly or through affiliated entities. Regulated carriers also increasingly face competition, for both voice and broadband services, in portions of their incumbent territory from other facilities-based providers, such as cable and wireless providers. These changing conditions may affect the incentives regarding the types of costs carriers attempt to include in their revenue requirement and the ways in which carriers allocate costs between regulated and non-regulated services and affiliates.

    67. Through audits, inquiries, and other investigations, the Commission has recently become aware of alleged abuses by rate-of-return carriers of the used and useful principles and its cost allocation rules. The Commission therefore concluded that it is time to reevaluate the types of expenses that should be permitted—both in a carrier's revenue requirement and for recovery through high-cost support. Looking into the expenses permitted and the allocation of those expenses will help ensure that carriers are only recovering costs that are used and useful and prudently incurred, and in the case of high cost support, only costs that are necessary to the provision of interstate telecommunications services.

    68. In the concurrently adopted Order, the Commission determined that universal service support should be targeted more specifically to those areas where support is most needed to ensure consumers are served with voice and broadband service. Therefore, the Commission adopted a process for identifying those areas served by an unsubsidized competitor and several methods of disaggregating support to those areas. However, the Commission seeks comment on other methods for disaggregating support that would be minimally burdensome on carriers and how the non-supported amount should be recovered.

    69. The Commission recognizes that Tribal lands may need additional financial support to ensure the availability of broadband in these areas. Therefore, the Further Notice seeks comment on whether a separate mechanism is needed to support broadband in Tribal lands and, if so, how such a mechanism should be structured.

    70. Some companies have informed the Commission that they are unable to extend broadband due to a lack of access to capital. Other carriers have seen declining support or are ineligible for certain types of support, such as HCLS. In the concurrently adopted Order, the Commission has adopted reforms to its high-cost universal service support to support broadband deployment. The Further Notice seeks comment on other proposals to expand broadband services in those areas served by rate-of-return carriers and any changes needed to make the administration of federal universal service programs more efficient.

    71. The Commission also seeks to modify its ETC annual reporting obligations to improve the Commission's ability to protect against waste, fraud, and abuse. The Further Notice seeks comment on how best to make the information collected more useful while minimizing the burdens on those carriers subject to these reporting requirements.

    2. Review of Permitted Expenses

    72. The Further Notice begins by reevaluating a rate-of-return carrier's ability to include certain types of expenses in its revenue requirement and high-cost support with consideration of the appropriate standard to be applied. The Commission believes that the terms “used and useful,” “prudent expenditure,” and “necessary to the provision of” should be read consistently to describe those expenses that a carrier may appropriately include in its interstate rate base, interstate revenue requirement, and cost studies used to calculate high-cost support. The costs should include amounts of long-term investment and current expenditures that a business would reasonably incur to provide telecommunications services, taking into account current and reasonably forecasted operating conditions and business levels. Accordingly, the Commission seeks comment on a variety of expenses, and whether such expenses should be included when making these calculations.

    3. Issues Related to Cost Allocation and Affiliate Transactions

    73. Rate-of-return carriers are subject to the Commission's longstanding Part 64 rules regarding the allocation of costs between regulated and non-regulated activities and to the affiliate transaction rules in Part 32. Under these rules, carriers currently apply broad principles in making such allocations, and the lack of specificity in the rules gives carriers a degree of discretion in making these allocation decisions. Carriers have an incentive to interpret the allocation rules in order to allocate as many costs as possible to their regulated activities, both to justify a higher interstate revenue requirement and to receive additional high-cost support. Given the lack of specific guidance, the additional costs associated with the provision of retail broadband services, and the incentive to allocate costs to regulated activities, the Commission concludes that it is time to revisit the allocation rules to provide greater clarity to rate-of-return carriers regarding how to determine the relative allocation of costs between regulated and non-regulated activities and affiliates. The Commission seeks comment on adopting new rules to improve the process of allocating costs among regulated and non-regulated services and among affiliates, and also seeks comment regarding how to detect cases of misallocation.

    4. Compliance Issues

    74. Additionally, the Commission seeks comment on the most effective way to ensure compliance with the proposed rules for universal service support and tariffing purposes. For example, the Commission seeks comment on what, if any, certification or reporting requirements should be implemented.

    5. Reducing Support in Competitive Areas

    75. In the Further Notice, the Commission seeks comment on alternative methods of reducing support for areas served by an unsubsidized competitor. In the concurrently adopted Order, the Commission adopts several methods of disaggregating CAF BLS for areas found to be competitively served and allow carriers to select which method will be used. However, the Commission invites commenters to propose other methods of disaggregation of support that can be implemented with minimal administrative burden for affected carriers and USAC. The Commission seeks to avoid complex allocations of the cost of facilities that serve both competitive and non-competitive areas, which could be burdensome for rate-of-return carriers to implement.

    76. The Commission also invites parties to comment on how the non-supported amount is to be recovered by the carrier, assuming such expenses remain regulated expenses for ratemaking purposes. The Commission notes that rate-of-return carriers currently receive compensation for interstate loop costs through a combination of end-user charges, e.g., SLCs, and universal service support. The SLCs most rate-of-return carriers assess are at the maximum levels. Thus, in many situations, carriers would be prohibited by our current rules from increasing SLC rates to recover investment and associated expenses that will not be supported under the high-cost program in competitive areas. Therefore, the Commission invites parties to comment on two approaches for recovery of those amounts.

    6. Tribal Support

    77. In the Further Notice, the Commission seeks comment on a proposal to adopt a mechanism to provide additional support to unserved Tribal lands, and alternative approaches. The Commission has observed that communities on Tribal lands have historically had less access to telecommunications services than any other segment of the population, and that greater financial support therefore may be needed in order to ensure the availability of broadband on Tribal lands. Therefore, the Commission seeks comment on adopting rules to increase support to rate-of-return carriers for census blocks that include Tribal lands and are unserved with broadband meeting the Commission's current requirements. The Commission also recognizes that broadband deployment differs substantially among Tribal lands. To assist small rate-of-return carriers that serve Tribal areas with minimal infrastructure build out, the Commission also seeks comment on how best to target Tribal land-specific support to Tribal areas most in need of broadband deployment.

    7. Other Measures To Improve the Operation of the Current Rate-of-Return System

    78. Additionally, in the Further Notice, the Commission invites commenters to submit into the record any other proposals or ideas for steps the Commission should take to provide appropriate incentives for broadband deployment to unserved areas working within the framework of the existing budget for rate-of-return areas. Some companies have indicated they have been unable to extend broadband despite their sincere desire to do so due to lack of access to capital, while other companies have seen declining support under the existing legacy mechanisms. Dome carriers are not eligible for HCLS support due to the prior “race to the top” that the Commission took steps to address in December 2014. The Commission expects our reforms to the existing ICLS mechanism and addition of a voluntary path to the model will provide options for carriers to extend broadband where it is lacking. While the Commission intends to monitor the impact of these reforms over time, they invite commenters to submit into the record any other proposals or ideas for steps the Commission should take to provide appropriate incentives for broadband deployment to unserved areas while minimizing disruption for those carriers that prefer to remain under the reformed legacy mechanisms.

    8. Streamlining ETC Annual Reporting Requirements

    79. Lastly, with respect to ETC reporting requirements, the Commission seeks comment on additional ways to lessen regulatory reporting burdens on ETCs, particularly those that are small businesses. In the concurrently adopted Order, the Commission updates our annual reporting requirements for rate-of-return ETCs as a necessary component of our ongoing efforts to update the support mechanisms for such ETCs to reflect our dual objectives of supporting existing voice and broadband service, while extending broadband to those areas of the country where it is lacking. To further lessen the regulatory burden on ETCs, many of whom are small rate-of-return carriers, and to improve on the Commission's ability to protect against waste, fraud, and abuse, the Commission seeks comment on certain, narrowly-tailored reporting changes. Specifically, the Commission seeks comment on whether to modify or eliminate five sets of requirements: the requirements to provide outage information, unfulfilled service requests, the number of complaints per 1,000 subscribers for both voice and broadband service, pricing for both voice and broadband, and certification of compliance with applicable service quality standards.

    9. Legal Basis

    80. The legal basis for any action that may be taken pursuant to the Notice is contained in sections 1, 2, 4(i), 5, 10, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, and 405 of the Communications Act of 1934, as amended, and section 706 of the Telecommunications Act of 1996, 47 U.S.C. 151, 152, 154(i), 155, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, 405, 1302, and sections 1.1, 1.3, 1.421, 1.427, and 1.429 of the Commission's rules, 47 CFR 1.1, 1.3, 1.421, 1.427, and 1.429.

    10. Description and Estimate of the Number of Small Entities To Which the Rules Would Apply

    81. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small-business concern” under the Small Business Act. A small-business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).

    11. Total Small Entities

    82. Our proposed action, if implemented, may, over time, affect small entities that are not easily categorized at present. The Commission therefore describes here, at the outset, three comprehensive, statutory small entity size standards. First, nationwide, there are a total of approximately 28.2 million small businesses, according to the SBA, which represents 99.7% of all businesses in the United States. In addition, a “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” Nationwide, as of 2007, there were approximately 1,621,215 small organizations. Finally, the term “small governmental jurisdiction” is defined generally as “governments of cities, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” Census Bureau data for 2011 indicate that there were 90,056 local governmental jurisdictions in the United States. The Commission estimates that, of this total, as many as 89,327 entities may qualify as “small governmental jurisdictions.” Thus, the Commission estimates that most governmental jurisdictions are small.

    12. Broadband Internet Access Service Providers

    83. The rules adopted in the concurrently adopted Order apply to broadband Internet access service providers. The Economic Census places these firms, whose services might include Voice over Internet Protocol (VoIP), in either of two categories, depending on whether the service is provided over the provider's own telecommunications facilities (e.g., cable and DSL ISPs), or over client-supplied telecommunications connections (e.g., dial-up ISPs). The former are within the category of Wired Telecommunications Carriers, which has an SBA small business size standard of 1,500 or fewer employees. These are also labeled “broadband.” The latter are within the category of All Other Telecommunications, which has a size standard of annual receipts of $32.5 million or less. These are labeled non-broadband. According to Census Bureau data for 2007, there were 3,188 firms in the first category, total, that operated for the entire year. Of this total, 3144 firms had employment of 999 or fewer employees, and 44 firms had employment of 1,000 employees or more. For the second category, the data show that 2,383 firms operated for the entire year. Of those, 2,346 had annual receipts below $32.5 million per year. Consequently, the Commission estimates that the majority of broadband Internet access service provider firms are small entities.

    84. The broadband Internet access service provider industry has changed since this definition was introduced in 2007. The data cited above may therefore include entities that no longer provide broadband Internet access service, and may exclude entities that now provide such service. To ensure that this FRFA describes the universe of small entities that our action might affect, the Commission discusses in turn several different types of entities that might be providing broadband Internet access service. The Commission notes that, although they have no specific information on the number of small entities that provide broadband Internet access service over unlicensed spectrum, they include these entities in our Final Regulatory Flexibility Analysis.

    13. Wireline Providers

    85. Incumbent Local Exchange Carriers (Incumbent LECs). Neither the Commission nor the SBA has developed a small business size standard specifically for incumbent LEC services. The closest applicable size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 1,307 carriers reported that they were incumbent LEC providers. Of these 1,307 carriers, an estimated 1,006 have 1,500 or fewer employees and 301 have more than 1,500 employees. Consequently, the Commission estimates that most providers of incumbent LEC service are small businesses that may be affected by rules adopted pursuant to the concurrently adopted Order.

    86. Competitive Local Exchange Carriers (Competitive LECs), Competitive Access Providers (CAPs), Shared-Tenant Service Providers, and Other Local Service Providers. Neither the Commission nor the SBA has developed a small business size standard specifically for these service providers. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 1,442 carriers reported that they were engaged in the provision of either competitive local exchange services or competitive access provider services. Of these 1,442 carriers, an estimated 1,256 have 1,500 or fewer employees and 186 have more than 1,500 employees. In addition, 17 carriers have reported that they are Shared-Tenant Service Providers, and all 17 are estimated to have 1,500 or fewer employees. In addition, 72 carriers have reported that they are Other Local Service Providers. Of the 72, seventy have 1,500 or fewer employees and two have more than 1,500 employees. Consequently, the Commission estimates that most providers of competitive local exchange service, competitive access providers, Shared-Tenant Service Providers, and other local service providers are small entities that may be affected by rules adopted pursuant to the concurrently adopted Order.

    87. The Commission has included small incumbent LECs in this present RFA analysis. As noted above, a “small business” under the RFA is one that, inter alia, meets the pertinent small business size standard (e.g., a telephone communications business having 1,500 or fewer employees), and “is not dominant in its field of operation.” The SBA's Office of Advocacy contends that, for RFA purposes, small incumbent LECs are not dominant in their field of operation because any such dominance is not “national” in scope. The Commission has therefore included small incumbent LECs in this RFA analysis, although the Commission emphasizes that this RFA action has no effect on Commission analyses and determinations in other, non-RFA contexts.

    88. Interexchange Carriers. Neither the Commission nor the SBA has developed a small business size standard specifically for providers of interexchange services. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 359 carriers have reported that they are engaged in the provision of interexchange service. Of these, an estimated 317 have 1,500 or fewer employees and 42 have more than 1,500 employees. Consequently, the Commission estimates that the majority of IXCs are small entities that may be affected by rules adopted pursuant to the concurrently adopted Order.

    89. Operator Service Providers (OSPs). Neither the Commission nor the SBA has developed a small business size standard specifically for operator service providers. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 33 carriers have reported that they are engaged in the provision of operator services. Of these, an estimated 31 have 1,500 or fewer employees and two have more than 1,500 employees. Consequently, the Commission estimates that the majority of OSPs are small entities that may be affected by rules adopted pursuant to the concurrently adopted Order.

    90. Prepaid Calling Card Providers. Neither the Commission nor the SBA has developed a small business size standard specifically for prepaid calling card providers. The appropriate size standard under SBA rules is for the category Telecommunications Resellers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 193 carriers have reported that they are engaged in the provision of prepaid calling cards. Of these, an estimated all 193 have 1,500 or fewer employees and none have more than 1,500 employees. Consequently, the Commission estimates that the majority of prepaid calling card providers are small entities that may be affected by rules adopted pursuant to the concurrently adopted Order.

    91. Local Resellers. The SBA has developed a small business size standard for the category of Telecommunications Resellers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 213 carriers have reported that they are engaged in the provision of local resale services. Of these, an estimated 211 have 1,500 or fewer employees and two have more than 1,500 employees. Consequently, the Commission estimates that the majority of local resellers are small entities that may be affected by rules adopted pursuant to the concurrently adopted Order.

    92. Toll Resellers. The SBA has developed a small business size standard for the category of Telecommunications Resellers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 881 carriers have reported that they are engaged in the provision of toll resale services. Of these, an estimated 857 have 1,500 or fewer employees and 24 have more than 1,500 employees. Consequently, the Commission estimates that the majority of toll resellers are small entities that may be affected by rules adopted pursuant to the concurrently adopted Order.

    93. Other Toll Carriers. Neither the Commission nor the SBA has developed a size standard for small businesses specifically applicable to Other Toll Carriers. This category includes toll carriers that do not fall within the categories of interexchange carriers, operator service providers, prepaid calling card providers, satellite service carriers, or toll resellers. The closest applicable size standard under SBA rules is for Wired Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. According to Commission data, 284 companies reported that their primary telecommunications service activity was the provision of other toll carriage. Of these, an estimated 279 have 1,500 or fewer employees and five have more than 1,500 employees. Consequently, the Commission estimates that most Other Toll Carriers are small entities that may be affected by the rules and policies adopted pursuant to the Order.

    94. 800 and 800-Like Service Subscribers. Neither the Commission nor the SBA has developed a small business size standard specifically for 800 and 800-like service (toll free) subscribers. The appropriate size standard under SBA rules is for the category Telecommunications Resellers. Under that size standard, such a business is small if it has 1,500 or fewer employees. The most reliable source of information regarding the number of these service subscribers appears to be data the Commission collects on the 800, 888, 877, and 866 numbers in use. According to our data, as of September 2009, the number of 800 numbers assigned was 7,860,000; the number of 888 numbers assigned was 5,588,687; the number of 877 numbers assigned was 4,721,866; and the number of 866 numbers assigned was 7,867,736. The Commission does not have data specifying the number of these subscribers that are not independently owned and operated or have more than 1,500 employees, and thus are unable at this time to estimate with greater precision the number of toll free subscribers that would qualify as small businesses under the SBA size standard. Consequently, the Commission estimates that there are 7,860,000 or fewer small entity 800 subscribers; 5,588,687 or fewer small entity 888 subscribers; 4,721,866 or fewer small entity 877 subscribers; and 7,867,736 or fewer small entity 866 subscribers.

    14. Wireless Providers—Fixed and Mobile

    95. The broadband Internet access service provider category covered by the concurrently adopted Order may cover multiple wireless firms and categories of regulated wireless services. Thus, to the extent the wireless services listed below are used by wireless firms for broadband Internet access service, the proposed actions may have an impact on those small businesses as set forth above and further below. In addition, for those services subject to auctions, the Commission notes that, as a general matter, the number of winning bidders that claim to qualify as small businesses at the close of an auction does not necessarily represent the number of small businesses currently in service. Also, the Commission does not generally track subsequent business size unless, in the context of assignments and transfers or reportable eligibility events, unjust enrichment issues are implicated.

    96. Wireless Telecommunications Carriers (except Satellite). Since 2007, the Census Bureau has placed wireless firms within this new, broad, economic census category. Under the present and prior categories, the SBA has deemed a wireless business to be small if it has 1,500 or fewer employees. For the category of Wireless Telecommunications Carriers (except Satellite), census data for 2007 show that there were 1,383 firms that operated for the entire year. Of this total, 1,368 firms had employment of 999 or fewer employees and 15 had employment of 1,000 employees or more. Since all firms with fewer than 1,500 employees are considered small, given the total employment in the sector, the Commission estimates that the vast majority of wireless firms are small.

    97. Wireless Communications Services. This service can be used for fixed, mobile, radiolocation, and digital audio broadcasting satellite uses. The Commission defined “small business” for the wireless communications services (WCS) auction as an entity with average gross revenues of $40 million for each of the three preceding years, and a “very small business” as an entity with average gross revenues of $15 million for each of the three preceding years. The SBA has approved these definitions.

    98. 218-219 MHz Service. The first auction of 218-219 MHz spectrum resulted in 170 entities winning licenses for 594 Metropolitan Statistical Area (MSA) licenses. Of the 594 licenses, 557 were won by entities qualifying as a small business. For that auction, the small business size standard was an entity that, together with its affiliates, has no more than a $6 million net worth and, after federal income taxes (excluding any carry over losses), has no more than $2 million in annual profits each year for the previous two years. In the 218-219 MHz Report and Order and Memorandum Opinion and Order, 64 FR 59656, November 3, 1999, the Commission established a small business size standard for a “small business” as an entity that, together with its affiliates and persons or entities that hold interests in such an entity and their affiliates, has average annual gross revenues not to exceed $15 million for the preceding three years. A “very small business” is defined as an entity that, together with its affiliates and persons or entities that hold interests in such an entity and its affiliates, has average annual gross revenues not to exceed $3 million for the preceding three years. These size standards will be used in future auctions of 218-219 MHz spectrum.

    99. 2.3 GHz Wireless Communications Services. This service can be used for fixed, mobile, radiolocation, and digital audio broadcasting satellite uses. The Commission defined “small business” for the wireless communications services (“WCS”) auction as an entity with average gross revenues of $40 million for each of the three preceding years, and a “very small business” as an entity with average gross revenues of $15 million for each of the three preceding years. The SBA has approved these definitions. The Commission auctioned geographic area licenses in the WCS service. In the auction, which was conducted in 1997, there were seven bidders that won 31 licenses that qualified as very small business entities, and one bidder that won one license that qualified as a small business entity.

    100. 1670-1675 MHz Services. This service can be used for fixed and mobile uses, except aeronautical mobile. An auction for one license in the 1670-1675 MHz band was conducted in 2003. One license was awarded. The winning bidder was not a small entity.

    101. Wireless Telephony. Wireless telephony includes cellular, personal communications services, and specialized mobile radio telephony carriers. As noted, the SBA has developed a small business size standard for Wireless Telecommunications Carriers (except Satellite). Under the SBA small business size standard, a business is small if it has 1,500 or fewer employees. According to Commission data, 413 carriers reported that they were engaged in wireless telephony. Of these, an estimated 261 have 1,500 or fewer employees and 152 have more than 1,500 employees. Therefore, a little less than one third of these entities can be considered small.

    102. Broadband Personal Communications Service. The broadband personal communications services (PCS) spectrum is divided into six frequency blocks designated A through F, and the Commission has held auctions for each block. The Commission initially defined a “small business” for C- and F-Block licenses as an entity that has average gross revenues of $40 million or less in the three previous calendar years. For F-Block licenses, an additional small business size standard for “very small business” was added and is defined as an entity that, together with its affiliates, has average gross revenues of not more than $15 million for the preceding three calendar years. These small business size standards, in the context of broadband PCS auctions, have been approved by the SBA. No small businesses within the SBA-approved small business size standards bid successfully for licenses in Blocks A and B. There were 90 winning bidders that claimed small business status in the first two C-Block auctions. A total of 93 bidders that claimed small business status won approximately 40 percent of the 1,479 licenses in the first auction for the D, E, and F Blocks. On April 15, 1999, the Commission completed the reauction of 347 C-, D-, E-, and F-Block licenses in Auction No. 22. Of the 57 winning bidders in that auction, 48 claimed small business status and won 277 licenses.

    103. On January 26, 2001, the Commission completed the auction of 422 C and F Block Broadband PCS licenses in Auction No. 35. Of the 35 winning bidders in that auction, 29 claimed small business status. Subsequent events concerning Auction 35, including judicial and agency determinations, resulted in a total of 163 C and F Block licenses being available for grant. On February 15, 2005, the Commission completed an auction of 242 C-, D-, E-, and F-Block licenses in Auction No. 58. Of the 24 winning bidders in that auction, 16 claimed small business status and won 156 licenses. On May 21, 2007, the Commission completed an auction of 33 licenses in the A, C, and F Blocks in Auction No. 71. Of the 12 winning bidders in that auction, five claimed small business status and won 18 licenses. On August 20, 2008, the Commission completed the auction of 20 C-, D-, E-, and F-Block Broadband PCS licenses in Auction No. 78. Of the eight winning bidders for Broadband PCS licenses in that auction, six claimed small business status and won 14 licenses.

    104. Specialized Mobile Radio Licenses. The Commission awards “small entity” bidding credits in auctions for Specialized Mobile Radio (SMR) geographic area licenses in the 800 MHz and 900 MHz bands to firms that had revenues of no more than $15 million in each of the three previous calendar years. The Commission awards “very small entity” bidding credits to firms that had revenues of no more than $3 million in each of the three previous calendar years. The SBA has approved these small business size standards for the 900 MHz Service. The Commission has held auctions for geographic area licenses in the 800 MHz and 900 MHz bands. The 900 MHz SMR auction began on December 5, 1995, and closed on April 15, 1996. Sixty bidders claiming that they qualified as small businesses under the $15 million size standard won 263 geographic area licenses in the 900 MHz SMR band. The 800 MHz SMR auction for the upper 200 channels began on October 28, 1997, and was completed on December 8, 1997. Ten bidders claiming that they qualified as small businesses under the $15 million size standard won 38 geographic area licenses for the upper 200 channels in the 800 MHz SMR band. A second auction for the 800 MHz band was held on January 10, 2002 and closed on January 17, 2002 and included 23 BEA licenses. One bidder claiming small business status won five licenses.

    105. The auction of the 1,053 800 MHz SMR geographic area licenses for the General Category channels began on August 16, 2000, and was completed on September 1, 2000. Eleven bidders won 108 geographic area licenses for the General Category channels in the 800 MHz SMR band and qualified as small businesses under the $15 million size standard. In an auction completed on December 5, 2000, a total of 2,800 Economic Area licenses in the lower 80 channels of the 800 MHz SMR service were awarded. Of the 22 winning bidders, 19 claimed small business status and won 129 licenses. Thus, combining all four auctions, 41 winning bidders for geographic licenses in the 800 MHz SMR band claimed status as small businesses.

    106. In addition, there are numerous incumbent site-by-site SMR licenses and licensees with extended implementation authorizations in the 800 and 900 MHz bands. The Commission does not know how many firms provide 800 MHz or 900 MHz geographic area SMR service pursuant to extended implementation authorizations, nor how many of these providers have annual revenues of no more than $15 million. One firm has over $15 million in revenues. In addition, the Commission does not know how many of these firms have 1,500 or fewer employees, which is the SBA-determined size standard. The Commission assumes, for purposes of this analysis, that all of the remaining extended implementation authorizations are held by small entities, as defined by the SBA.

    107. Lower 700 MHz Band Licenses. The Commission previously adopted criteria for defining three groups of small businesses for purposes of determining their eligibility for special provisions such as bidding credits. The Commission defined a “small business” as an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $40 million for the preceding three years. A “very small business” is defined as an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $15 million for the preceding three years. Additionally, the lower 700 MHz Service had a third category of small business status for Metropolitan/Rural Service Area (MSA/RSA) licenses—“entrepreneur”—which is defined as an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $3 million for the preceding three years. The SBA approved these small size standards. An auction of 740 licenses (one license in each of the 734 MSAs/RSAs and one license in each of the six Economic Area Groupings (EAGs)) commenced on August 27, 2002, and closed on September 18, 2002. Of the 740 licenses available for auction, 484 licenses were won by 102 winning bidders. Seventy-two of the winning bidders claimed small business, very small business or entrepreneur status and won a total of 329 licenses. A second auction commenced on May 28, 2003, closed on June 13, 2003, and included 256 licenses: 5 EAG licenses and 476 Cellular Market Area licenses. Seventeen winning bidders claimed small or very small business status and won 60 licenses, and nine winning bidders claimed entrepreneur status and won 154 licenses. On July 26, 2005, the Commission completed an auction of 5 licenses in the Lower 700 MHz band (Auction No. 60). There were three winning bidders for five licenses. All three winning bidders claimed small business status.

    108. In 2007, the Commission reexamined its rules governing the 700 MHz band in the 700 MHz Second Report and Order, 72 FR 48814, August 24, 2007. An auction of 700 MHz licenses commenced January 24, 2008 and closed on March 18, 2008, which included, 176 Economic Area licenses in the A Block, 734 Cellular Market Area licenses in the B Block, and 176 EA licenses in the E Block. Twenty winning bidders, claiming small business status (those with attributable average annual gross revenues that exceed $15 million and do not exceed $40 million for the preceding three years) won 49 licenses. Thirty three winning bidders claiming very small business status (those with attributable average annual gross revenues that do not exceed $15 million for the preceding three years) won 325 licenses.

    109. Upper 700 MHz Band Licenses. In the 700 MHz Second Report and Order, the Commission revised its rules regarding Upper 700 MHz licenses. On January 24, 2008, the Commission commenced Auction 73 in which several licenses in the Upper 700 MHz band were available for licensing: 12 Regional Economic Area Grouping licenses in the C Block, and one nationwide license in the D Block. The auction concluded on March 18, 2008, with 3 winning bidders claiming very small business status (those with attributable average annual gross revenues that do not exceed $15 million for the preceding three years) and winning five licenses.

    110. 700 MHz Guard Band Licensees. In 2000, in the 700 MHz Guard Band Order, 65 FR 17594, April 4, 2000, the Commission adopted size standards for “small businesses” and “very small businesses” for purposes of determining their eligibility for special provisions such as bidding credits and installment payments. A small business in this service is an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $40 million for the preceding three years. Additionally, a very small business is an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $15 million for the preceding three years. SBA approval of these definitions is not required. An auction of 52 Major Economic Area licenses commenced on September 6, 2000, and closed on September 21, 2000. Of the 104 licenses auctioned, 96 licenses were sold to nine bidders. Five of these bidders were small businesses that won a total of 26 licenses. A second auction of 700 MHz Guard Band licenses commenced on February 13, 2001, and closed on February 21, 2001. All eight of the licenses auctioned were sold to three bidders. One of these bidders was a small business that won a total of two licenses.

    111. Cellular Radiotelephone Service. Auction 77 was held to resolve one group of mutually exclusive applications for Cellular Radiotelephone Service licenses for unserved areas in New Mexico. Bidding credits for designated entities were not available in Auction 77. In 2008, the Commission completed the closed auction of one unserved service area in the Cellular Radiotelephone Service, designated as Auction 77. Auction 77 concluded with one provisionally winning bid for the unserved area totaling $25,002.

    112. Private Land Mobile Radio (“PLMR”). PLMR systems serve an essential role in a range of industrial, business, land transportation, and public safety activities. These radios are used by companies of all sizes operating in all U.S. business categories, and are often used in support of the licensee's primary (non-telecommunications) business operations. For the purpose of determining whether a licensee of a PLMR system is a small business as defined by the SBA, the Commission uses the broad census category, Wireless Telecommunications Carriers (except Satellite). This definition provides that a small entity is any such entity employing no more than 1,500 persons. The Commission does not require PLMR licensees to disclose information about number of employees, so the Commission does not have information that could be used to determine how many PLMR licensees constitute small entities under this definition. The Commission notes that PLMR licensees generally use the licensed facilities in support of other business activities, and therefore, it would also be helpful to assess PLMR licensees under the standards applied to the particular industry subsector to which the licensee belongs.

    113. As of March 2010, there were 424,162 PLMR licensees operating 921,909 transmitters in the PLMR bands below 512 MHz. The Commission notes that any entity engaged in a commercial activity is eligible to hold a PLMR license, and that any revised rules in this context could therefore potentially impact small entities covering a great variety of industries.

    114. Rural Radiotelephone Service. The Commission has not adopted a size standard for small businesses specific to the Rural Radiotelephone Service. A significant subset of the Rural Radiotelephone Service is the Basic Exchange Telephone Radio System (BETRS). In the present context, the Commission will use the SBA's small business size standard applicable to Wireless Telecommunications Carriers (except Satellite), i.e., an entity employing no more than 1,500 persons. There are approximately 1,000 licensees in the Rural Radiotelephone Service, and the Commission estimates that there are 1,000 or fewer small entity licensees in the Rural Radiotelephone Service that may be affected by the rules and policies proposed herein.

    115. Air-Ground Radiotelephone Service. The Commission has previously used the SBA's small business size standard applicable to Wireless Telecommunications Carriers (except Satellite), i.e., an entity employing no more than 1,500 persons. There are approximately 100 licensees in the Air-Ground Radiotelephone Service, and under that definition, the Commission estimates that almost all of them qualify as small entities under the SBA definition. For purposes of assigning Air-Ground Radiotelephone Service licenses through competitive bidding, the Commission has defined “small business” as an entity that, together with controlling interests and affiliates, has average annual gross revenues for the preceding three years not exceeding $40 million. A “very small business” is defined as an entity that, together with controlling interests and affiliates, has average annual gross revenues for the preceding three years not exceeding $15 million. These definitions were approved by the SBA. In May 2006, the Commission completed an auction of nationwide commercial Air-Ground Radiotelephone Service licenses in the 800 MHz band (Auction No. 65). On June 2, 2006, the auction closed with two winning bidders winning two Air-Ground Radiotelephone Services licenses. Neither of the winning bidders claimed small business status.

    116. Aviation and Marine Radio Services. Small businesses in the aviation and marine radio services use a very high frequency (VHF) marine or aircraft radio and, as appropriate, an emergency position-indicating radio beacon (and/or radar) or an emergency locator transmitter. The Commission has not developed a small business size standard specifically applicable to these small businesses. For purposes of this analysis, the Commission uses the SBA small business size standard for the category Wireless Telecommunications Carriers (except Satellite), which is 1,500 or fewer employees. Census data for 2007, which supersede data contained in the 2002 Census, show that there were 1,383 firms that operated that year. Of those 1,383, 1,368 had fewer than 100 employees, and 15 firms had more than 100 employees. Most applicants for recreational licenses are individuals. Approximately 581,000 ship station licensees and 131,000 aircraft station licensees operate domestically and are not subject to the radio carriage requirements of any statute or treaty. For purposes of our evaluations in this analysis, the Commission estimates that there are up to approximately 712,000 licensees that are small businesses (or individuals) under the SBA standard. In addition, between December 3, 1998 and December 14, 1998, the Commission held an auction of 42 VHF Public Coast licenses in the 157.1875-157.4500 MHz (ship transmit) and 161.775-162.0125 MHz (coast transmit) bands. For purposes of the auction, the Commission defined a “small” business as an entity that, together with controlling interests and affiliates, has average gross revenues for the preceding three years not to exceed $15 million dollars. In addition, a “very small” business is one that, together with controlling interests and affiliates, has average gross revenues for the preceding three years not to exceed $3 million dollars. There are approximately 10,672 licensees in the Marine Coast Service, and the Commission estimates that almost all of them qualify as “small” businesses under the above special small business size standards and may be affected by rules adopted pursuant to the concurrently adopted Order.

    117. Advanced Wireless Services (AWS) (1710-1755 MHz and 2110-2155 MHz bands (AWS-1); 1915-1920 MHz, 1995-2000 MHz, 2020-2025 MHz and 2175-2180 MHz bands (AWS-2); 2155-2175 MHz band (AWS-3)). For the AWS-1 bands, the Commission has defined a “small business” as an entity with average annual gross revenues for the preceding three years not exceeding $40 million, and a “very small business” as an entity with average annual gross revenues for the preceding three years not exceeding $15 million. For AWS-2 and AWS-3, although the Commission does not know for certain which entities are likely to apply for these frequencies, they note that the AWS-1 bands are comparable to those used for cellular service and personal communications service. The Commission has not yet adopted size standards for the AWS-2 or AWS-3 bands but proposes to treat both AWS-2 and AWS-3 similarly to broadband PCS service and AWS-1 service due to the comparable capital requirements and other factors, such as issues involved in relocating incumbents and developing markets, technologies, and services.

    118. 3650-3700 MHz band. In March 2005, the Commission released a Report and Order and Memorandum Opinion and Order that provides for nationwide, non-exclusive licensing of terrestrial operations, utilizing contention-based technologies, in the 3650 MHz band (i.e., 3650-3700 MHz). As of April 2010, more than 1270 licenses have been granted and more than 7433 sites have been registered. The Commission has not developed a definition of small entities applicable to 3650-3700 MHz band nationwide, non-exclusive licensees. However, the Commission estimates that the majority of these licensees are Internet Access Service Providers (ISPs) and that most of those licensees are small businesses.

    119. Fixed Microwave Services. Microwave services include common carrier, private-operational fixed, and broadcast auxiliary radio services. They also include the Local Multipoint Distribution Service (LMDS), the Digital Electronic Message Service (DEMS), and the 24 GHz Service, where licensees can choose between common carrier and non-common carrier status. At present, there are approximately 36,708 common carrier fixed licensees and 59,291 private operational-fixed licensees and broadcast auxiliary radio licensees in the microwave services. There are approximately 135 LMDS licensees, three DEMS licensees, and three 24 GHz licensees. The Commission has not yet defined a small business with respect to microwave services. For purposes of the FRFA, the Commission will use the SBA's definition applicable to Wireless Telecommunications Carriers (except satellite)—i.e., an entity with no more than 1,500 persons. Under the present and prior categories, the SBA has deemed a wireless business to be small if it has 1,500 or fewer employees. The Commission does not have data specifying the number of these licensees that have more than 1,500 employees, and thus is unable at this time to estimate with greater precision the number of fixed microwave service licensees that would qualify as small business concerns under the SBA's small business size standard. Consequently, the Commission estimates that there are up to 36,708 common carrier fixed licensees and up to 59,291 private operational-fixed licensees and broadcast auxiliary radio licensees in the microwave services that may be small and may be affected by the rules and policies adopted herein. The Commission notes, however, that the common carrier microwave fixed licensee category includes some large entities.

    120. Offshore Radiotelephone Service. This service operates on several UHF television broadcast channels that are not used for television broadcasting in the coastal areas of states bordering the Gulf of Mexico. There are presently approximately 55 licensees in this service. The Commission is unable to estimate at this time the number of licensees that would qualify as small under the SBA's small business size standard for the category of Wireless Telecommunications Carriers (except Satellite). Under that SBA small business size standard, a business is small if it has 1,500 or fewer employees. Census data for 2007, which supersede data contained in the 2002 Census, show that there were 1,383 firms that operated that year. Of those 1,383, 1,368 had fewer than 100 employees, and 15 firms had more than 100 employees. Thus, under this category and the associated small business size standard, the majority of firms can be considered small.

    121. 39 GHz Service. The Commission created a special small business size standard for 39 GHz licenses—an entity that has average gross revenues of $40 million or less in the three previous calendar years. An additional size standard for “very small business” is: an entity that, together with affiliates, has average gross revenues of not more than $15 million for the preceding three calendar years. The SBA has approved these small business size standards. The auction of the 2,173 39 GHz licenses began on April 12, 2000 and closed on May 8, 2000. The 18 bidders who claimed small business status won 849 licenses. Consequently, the Commission estimates that 18 or fewer 39 GHz licensees are small entities that may be affected by rules adopted pursuant to the concurrently adopted Order.

    122. Broadband Radio Service and Educational Broadband Service. Broadband Radio Service systems, previously referred to as Multipoint Distribution Service (MDS) and Multichannel Multipoint Distribution Service (MMDS) systems, and “wireless cable,” transmit video programming to subscribers and provide two-way high speed data operations using the microwave frequencies of the Broadband Radio Service (BRS) and Educational Broadband Service (EBS) (previously referred to as the Instructional Television Fixed Service (ITFS)). In connection with the 1996 BRS auction, the Commission established a small business size standard as an entity that had annual average gross revenues of no more than $40 million in the previous three calendar years. The BRS auctions resulted in 67 successful bidders obtaining licensing opportunities for 493 Basic Trading Areas (BTAs). Of the 67 auction winners, 61 met the definition of a small business. BRS also includes licensees of stations authorized prior to the auction. At this time, the Commission estimates that of the 61 small business BRS auction winners, 48 remain small business licensees. In addition to the 48 small businesses that hold BTA authorizations, there are approximately 392 incumbent BRS licensees that are considered small entities. After adding the number of small business auction licensees to the number of incumbent licensees not already counted, the Commission finds that there are currently approximately 440 BRS licensees that are defined as small businesses under either the SBA or the Commission's rules.

    123. In 2009, the Commission conducted Auction 86, the sale of 78 licenses in the BRS areas. The Commission offered three levels of bidding credits: (i) A bidder with attributed average annual gross revenues that exceed $15 million and do not exceed $40 million for the preceding three years (small business) received a 15 percent discount on its winning bid; (ii) a bidder with attributed average annual gross revenues that exceed $3 million and do not exceed $15 million for the preceding three years (very small business) received a 25 percent discount on its winning bid; and (iii) a bidder with attributed average annual gross revenues that do not exceed $3 million for the preceding three years (entrepreneur) received a 35 percent discount on its winning bid. Auction 86 concluded in 2009 with the sale of 61 licenses. Of the ten winning bidders, two bidders that claimed small business status won 4 licenses; one bidder that claimed very small business status won three licenses; and two bidders that claimed entrepreneur status won six licenses.

    124. In addition, the SBA's Cable Television Distribution Services small business size standard is applicable to EBS. There are presently 2,436 EBS licensees. All but 100 of these licenses are held by educational institutions. Educational institutions are included in this analysis as small entities. Thus, the Commission estimates that at least 2,336 licensees are small businesses. Since 2007, Cable Television Distribution Services have been defined within the broad economic census category of Wired Telecommunications Carriers; that category is defined as follows: “This industry comprises establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or a combination of technologies.” The SBA has developed a small business size standard for this category, which is: all such firms having 1,500 or fewer employees. To gauge small business prevalence for these cable services the Commission must, however, use the most current census data that are based on the previous category of Cable and Other Program Distribution and its associated size standard; that size standard was: all such firms having $13.5 million or less in annual receipts. According to Census Bureau data for 2007, there were a total of 996 firms in this category that operated for the entire year. Of this total, 948 firms had annual receipts of under $10 million, and 48 firms had receipts of $10 million or more but less than $25 million. Thus, the majority of these firms can be considered small.

    125. Narrowband Personal Communications Services. In 1994, the Commission conducted an auction for Narrowband PCS licenses. A second auction was also conducted later in 1994. For purposes of the first two Narrowband PCS auctions, “small businesses” were entities with average gross revenues for the prior three calendar years of $40 million or less. Through these auctions, the Commission awarded a total of 41 licenses, 11 of which were obtained by four small businesses. To ensure meaningful participation by small business entities in future auctions, the Commission adopted a two-tiered small business size standard in the Narrowband PCS Second Report and Order, 65 FR 35843, June 6, 2000. A “small business” is an entity that, together with affiliates and controlling interests, has average gross revenues for the three preceding years of not more than $40 million. A “very small business” is an entity that, together with affiliates and controlling interests, has average gross revenues for the three preceding years of not more than $15 million. The SBA has approved these small business size standards. A third auction was conducted in 2001. Here, five bidders won 317 (Metropolitan Trading Areas and nationwide) licenses. Three of these claimed status as a small or very small entity and won 311 licenses.

    126. Paging (Private and Common Carrier). In the Paging Third Report and Order, 64 FR 33762, June 24, 1999, the Commission developed a small business size standard for “small businesses” and “very small businesses” for purposes of determining their eligibility for special provisions such as bidding credits and installment payments. A “small business” is an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $15 million for the preceding three years. Additionally, a “very small business” is an entity that, together with its affiliates and controlling principals, has average gross revenues that are not more than $3 million for the preceding three years. The SBA has approved these small business size standards. According to Commission data, 291 carriers have reported that they are engaged in Paging or Messaging Service. Of these, an estimated 289 have 1,500 or fewer employees, and two have more than 1,500 employees. Consequently, the Commission estimates that the majority of paging providers are small entities that may be affected by our action. An auction of Metropolitan Economic Area licenses commenced on February 24, 2000, and closed on March 2, 2000. Of the 2,499 licenses auctioned, 985 were sold. Fifty-seven companies claiming small business status won 440 licenses. A subsequent auction of MEA and Economic Area (“EA”) licenses was held in the year 2001. Of the 15,514 licenses auctioned, 5,323 were sold. One hundred thirty-two companies claiming small business status purchased 3,724 licenses. A third auction, consisting of 8,874 licenses in each of 175 EAs and 1,328 licenses in all but three of the 51 MEAs, was held in 2003. Seventy-seven bidders claiming small or very small business status won 2,093 licenses. A fourth auction, consisting of 9,603 lower and upper paging band licenses was held in the year 2010. Twenty-nine bidders claiming small or very small business status won 3,016 licenses.

    127. 220 MHz Radio Service—Phase I Licensees. The 220 MHz service has both Phase I and Phase II licenses. Phase I licensing was conducted by lotteries in 1992 and 1993. There are approximately 1,515 such non-nationwide licensees and four nationwide licensees currently authorized to operate in the 220 MHz band. The Commission has not developed a small business size standard for small entities specifically applicable to such incumbent 220 MHz Phase I licensees. To estimate the number of such licensees that are small businesses, the Commission applies the small business size standard under the SBA rules applicable to Wireless Telecommunications Carriers (except Satellite). Under this category, the SBA deems a wireless business to be small if it has 1,500 or fewer employees. The Commission estimates that nearly all such licensees are small businesses under the SBA's small business size standard that may be affected by rules adopted pursuant to the concurrently adopted Order.

    128. 220 MHz Radio Service—Phase II Licensees. The 220 MHz service has both Phase I and Phase II licenses. The Phase II 220 MHz service is subject to spectrum auctions. In the 220 MHz Third Report and Order, 62 FR 15978, April 3, 1997, the Commission adopted a small business size standard for “small” and “very small” businesses for purposes of determining their eligibility for special provisions such as bidding credits and installment payments. This small business size standard indicates that a “small business” is an entity that, together with its affiliates and controlling principals, has average gross revenues not exceeding $15 million for the preceding three years. A “very small business” is an entity that, together with its affiliates and controlling principals, has average gross revenues that do not exceed $3 million for the preceding three years. The SBA has approved these small business size standards. Auctions of Phase II licenses commenced on September 15, 1998, and closed on October 22, 1998. In the first auction, 908 licenses were auctioned in three different-sized geographic areas: three nationwide licenses, 30 Regional Economic Area Group (EAG) Licenses, and 875 Economic Area (EA) Licenses. Of the 908 licenses auctioned, 693 were sold. Thirty-nine small businesses won licenses in the first 220 MHz auction. The second auction included 225 licenses: 216 EA licenses and 9 EAG licenses. Fourteen companies claiming small business status won 158 licenses.

    15. Satellite Service Providers

    129. Satellite Telecommunications Providers. Two economic census categories address the satellite industry. The first category has a small business size standard of $30 million or less in average annual receipts, under SBA rules. The second has a size standard of $30 million or less in annual receipts.

    130. The category of Satellite Telecommunications “comprises establishments primarily engaged in providing telecommunications services to other establishments in the telecommunications and broadcasting industries by forwarding and receiving communications signals via a system of satellites or reselling satellite telecommunications.” For this category, Census Bureau data for 2007 show that there were a total of 570 firms that operated for the entire year. Of this total, 530 firms had annual receipts of under $30 million, and 40 firms had receipts of over $30 million. Consequently, the Commission estimates that the majority of Satellite Telecommunications firms are small entities that might be affected by our action.

    131. The second category of Other Telecommunications comprises, inter alia, “establishments primarily engaged in providing specialized telecommunications services, such as satellite tracking, communications telemetry, and radar station operation. This industry also includes establishments primarily engaged in providing satellite terminal stations and associated facilities connected with one or more terrestrial systems and capable of transmitting telecommunications to, and receiving telecommunications from, satellite systems.” For this category, Census Bureau data for 2007 show that there were a total of 1,274 firms that operated for the entire year. Of this total, 1,252 had annual receipts below $25 million per year. Consequently, the Commission estimates that the majority of All Other Telecommunications firms are small entities that might be affected by our action.

    16. Cable Service Providers

    132. Because section 706 requires us to monitor the deployment of broadband using any technology, the Commission anticipates that some broadband service providers may not provide telephone service. Accordingly, the Commission describes below other types of firms that may provide broadband services, including cable companies, MDS providers, and utilities, among others.

    133. Cable and Other Program Distributors. Since 2007, these services have been defined within the broad economic census category of Wired Telecommunications Carriers; that category is defined as follows: “This industry comprises establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or a combination of technologies.” The SBA has developed a small business size standard for this category, which is: all such firms having 1,500 or fewer employees. To gauge small business prevalence for these cable services the Commission must, however, use current census data that are based on the previous category of Cable and Other Program Distribution and its associated size standard; that size standard was: all such firms having $13.5 million or less in annual receipts. According to Census Bureau data for 2007, there were a total of 2,048 firms in this category that operated for the entire year. Of this total, 1,393 firms had annual receipts of under $10 million, and 655 firms had receipts of $10 million or more. Thus, the majority of these firms can be considered small.

    134. Cable Companies and Systems. The Commission has also developed its own small business size standards, for the purpose of cable rate regulation. Under the Commission's rules, a “small cable company” is one serving 400,000 or fewer subscribers, nationwide. Industry data that there are currently 4,600 active cable systems in the United States. Of this total, all but nine cable operators are small under the 400,000 subscriber size standard. In addition, under the Commission's rules, a “small system” is a cable system serving 15,000 or fewer subscribers. Current Commission records show 4,945 cable systems nationwide. Of this total, 4,380 cable systems have less than 20,000 subscribers, and 565 systems have 20,000 or more subscribers, based on the same records. Thus, under this standard, the Commission estimates that most cable systems are small entities.

    135. Cable System Operators. The Communications Act of 1934, as amended, also contains a size standard for small cable system operators, which is “a cable operator that, directly or through an affiliate, serves in the aggregate fewer than 1 percent of all subscribers in the United States and is not affiliated with any entity or entities whose gross annual revenues in the aggregate exceed $250,000,000.” The Commission has determined that an operator serving fewer than 677,000 subscribers shall be deemed a small operator, if its annual revenues, when combined with the total annual revenues of all its affiliates, do not exceed $250 million in the aggregate. Based on available data, the Commission finds that all but ten incumbent cable operators are small entities under this size standard. The Commission notes that the Commission neither requests nor collects information on whether cable system operators are affiliated with entities whose gross annual revenues exceed $250 million, and therefore they are unable to estimate more accurately the number of cable system operators that would qualify as small under this size standard.

    136. The open video system (“OVS”) framework was established in 1996, and is one of four statutorily recognized options for the provision of video programming services by local exchange carriers. The OVS framework provides opportunities for the distribution of video programming other than through cable systems. Because OVS operators provide subscription services, OVS falls within the SBA small business size standard covering cable services, which is “Wired Telecommunications Carriers.” The SBA has developed a small business size standard for this category, which is: all such firms having 1,500 or fewer employees. According to Census Bureau data for 2007, there were a total of 955 firms in this previous category that operated for the entire year. Of this total, 939 firms had employment of 999 or fewer employees, and 16 firms had employment of 1,000 employees or more. Thus, under this second size standard, most cable systems are small and may be affected by rules adopted pursuant to the concurrently adopted Order. In addition, the Commission notes that they have certified some OVS operators, with some now providing service. Broadband service providers (“BSPs”) are currently the only significant holders of OVS certifications or local OVS franchises. The Commission does not have financial or employment information regarding the entities authorized to provide OVS, some of which may not yet be operational. Thus, again, at least some of the OVS operators may qualify as small entities.

    17. Electric Power Generators, Transmitters, and Distributors

    137. Electric Power Generators, Transmitters, and Distributors. The Census Bureau defines an industry group comprised of “establishments, primarily engaged in generating, transmitting, and/or distributing electric power. Establishments in this industry group may perform one or more of the following activities: (1) Operate generation facilities that produce electric energy; (2) operate transmission systems that convey the electricity from the generation facility to the distribution system; and (3) operate distribution systems that convey electric power received from the generation facility or the transmission system to the final consumer.” The SBA has developed a small business size standard for firms in this category: “A firm is small if, including its affiliates, it is primarily engaged in the generation, transmission, and/or distribution of electric energy for sale and its total electric output for the preceding fiscal year did not exceed 4 million megawatt hours.” Census Bureau data for 2007 show that there were 1,174 firms that operated for the entire year in this category. Of these firms, 50 had 1,000 employees or more, and 1,124 had fewer than 1,000 employees. Based on this data, a majority of these firms can be considered small.

    18. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements for Small Entities

    138. Permitted Expenses. In the Further Notice, when reviewing permitted expenses, the Commission seeks comment on whether it should require rate-of-return carriers to identify their cost consultants, if any, in their FCC Form 481s.

    139. Cost Allocation and Affiliate Transactions. The Commission seeks comment on adopting a rule that would classify certain costs, such as general and administrative expenses, as common costs for purposes of applying the Part 64 and affiliate transaction rules when an entity provides broadband services directly, or through an affiliated entity. Additionally, the Commission asks whether it should clarify or adopt new rules to ensure the proper application of the affiliate transaction rules in light of the provision of retail broadband by affiliates in certain telecommunications markets. More generally, the Commission seeks comment on instances in which additional rules or further clarification could minimize potential misallocations and thereby protect ratepayers of regulated services. While the Commission notes that the used and useful and prudent expenditure standards apply to costs included in affiliate transactions, it seeks comment on whether it should adopt a rule that explicitly prohibits carriers from including in the fully distributed cost of an affiliate any costs that are disallowed from the regulated rate base or revenue requirement, or considered not to be used and useful or prudent expenditures. Finally, the Commission seeks comment on whether additional data would assist in enforcement of the Commission's accounting and cost allocation rules, while minimizing ETC reporting burden, and if so, what kind of reporting requirements should be implemented.

    140. Compliance. To ensure compliance with the proposed rules for universal service support and tariffing purposes, the Commission invites parties to comment on whether carriers should be required to certify that they have not included any prohibited expenses in their cost submissions used to calculate high-cost support. Additionally, the Commission asked parties to comment on NECA's role in enforcing these rules, and whether carriers should be subject to any additional reporting requirements.

    141. Reducing Support in Competitive Areas. In the Further Notice, the Commission also seeks comment on methods of disaggregation of support that can be implemented with minimal administrative burden for affected carriers and USAC. The Commission seeks to avoid complex allocations of the cost of facilities that that serve both competitive and non-competitive areas, which could be burdensome for rate-of-return carriers to implement.

    142. Additionally, the Commission asks how the non-supported amount is to be recovered by the carrier, assuming such expenses remain regulated expenses for ratemaking purposes. Specifically, the Commission invites parties to comment on two approaches for recovery of those amounts. First, the Commission could treat the non-supported expenses as being outside the tariffed regulated revenue requirement and allow carriers to assess a detariffed regulated rate to recover those non-supported costs. This would remove those costs from the NECA pooling process. The Commission invites parties to comment on whether the detariffed rates would be outside the prohibition on tariffing deaveraged rates in a study area, or whether a new rule should be adopted. A second option would be to raise the SLC caps for a particular study area to permit the recovery of the amounts not supported by the high-cost program. The Commission invites parties to comment on this alternative, including whether any SLC increases should be allowed only in the competitive area or should apply to the entire study area. Either of these alternatives would create new compliance requirements that could create administrative burdens for small rate-of-return carriers.

    143. Tribal Support. The Commission seeks comment on adopting rules to increase support to rate-of-return carriers for census blocks that include Tribal lands and unserved with broadband meeting the Commission's current requirements. As part of this line of questioning, the Commission asks how to how best to target Tribal land-specific support to Tribal areas most in need of broadband deployment, which may require filing on behalf of Tribal entities. Additionally, the Commission seeks comment on what specific broadband deployment obligations should be established, if the Commission were to adopt a mechanism to provide additional support on Tribal lands. Identification of specific areas to deploy and the associated deployment obligations could place an administrative and resource burden on small rate-of-return carriers serving Tribal lands.

    144. Other Measures To Improve the Operation of the Current Rate-of-Return System. The Commission invites commenters to submit into the record any other proposals or ideas for steps the Commission should take to provide appropriate incentives for broadband deployment to unserved areas working within the framework of the existing budget for rate-of-return areas. This line of questioning by the Commission is intended to gather new ideas or proposals for further consideration. Therefore, the Commission does not foresee any major burdens being placed on carriers as a result of this portion of the Further Notice.

    145. Streamlining ETC Annual Reporting Requirements. Lastly, the Commission seeks comment on whether to modify or eliminate five sets of requirements for ETCS to provide: outage information, unfulfilled service requests, the number of complaints per 1,000 subscribers for both voice and broadband service, pricing for both voice and broadband, and certification that they are complying with applicable service quality standards. Elimination of these ETC reporting requirements would relieve the administrative burden on small rate-of-return carriers.

    19. Steps Taken To Minimize the Significant Economic Impact on Small Entities and Significant Alternatives Considered

    146. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include (among others) the following four alternatives: (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities. The Commission expects to consider all of these factors when they have received substantive comment from the public and potentially affected entities.

    147. With respect to the costs of implementing the proposals to restrict permitted expenses, the Commission seeks comment on the least costly means of implementing any revisions, which would minimize burdens on carriers. The Commission notes that many of the proposals with respect to cost allocation would most likely change the way cost allocation is completed, but would not necessarily be any more burdensome. The proposal of identifying cost consultants would add a minimal burden on small entities if adopted because carriers should typically utilize cost consultants to submit information to NECA for purposes of pooling.

    148. In discussing potential compliance procedures, the Commission asks whether there is a current certification that can be modified to encompass a certification that only permitted expenses are included. This methodology seeks to reduce the burden on smaller entities by making a small change instead of creating a new, more involved compliance mechanism.

    149. In the concurrently adopted Order, the Commission adopts several methods of disaggregating CAF BLS for areas found to be competitively served and allow carriers to select which method will be used. However, in seeking comment on other methods of disaggregation of support that can be implemented with minimal administrative burden for affected carriers and USAC, the Commission takes further steps to reduce administrative and resource burdens on small rate-of-return carriers. The Commission seeks to avoid complex allocations of the cost of facilities that that serve both competitive and non-competitive areas, which could be burdensome for rate-of-return carriers to implement.

    150. The Commission also invites parties to comment on how the non-supported amount is to be recovered by the carrier, assuming such expenses remain regulated expenses for ratemaking purposes. The Commission invites parties to comment on the two approaches for recovery of those amounts. The Commission seeks to minimize administrative burden under any approach.

    151. The Commission also invites commenters to submit into the record any other proposals or ideas for steps the Commission should take to provide appropriate incentives for broadband deployment to unserved areas working within the framework of the existing budget for rate-of-return areas. The Commission is cognizant of the many compliance burdens small rate-of-return carriers face and seeks to minimize these burdens overall with this line of questioning.

    152. In the concurrently adopted Order, the Commission updates our annual reporting requirements for rate-of-return ETCs as a necessary component of our ongoing efforts to update the support mechanisms for such ETCs to reflect our dual objectives of supporting existing voice and broadband service, while extending broadband to those areas of the country where it is lacking. To further lessen the regulatory burden on small rate-of-return carriers, and to improve on the Commission's ability to protect against waste, fraud, and abuse they Commission seeks comment on certain, narrowly-tailored reporting changes. Specifically, the sets of requirements the Commission seeks comment on whether to modify or eliminate would reduce rate-of-returns ETCs' compliance burden.

    153. More generally, the Commission expects to consider the economic impact on small entities, as identified in comments filed in response to the Notice and this IRFA, in reaching its final conclusions and taking action in this proceeding. The proposals and questions laid out in the Further Notice were designed to ensure the Commission has a complete understanding of the benefits and potential burdens associated with the different actions and methods.

    20. Federal Rules That May Duplicate, Overlap, or Conflict With the Proposed Rules

    154. None.

    C. Congressional Review Act

    155. The Commission will send a copy of the concurrently adopted Report and Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

    D. Ex Parte Presentations

    156. Permit-But-Disclose. The proceeding this Second FNPRM initiates shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda, or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with rule 1.1206(b). In proceedings governed by rule 1.49(f) or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format (e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

    E. Comment Filing Procedures

    157. Comments and Replies. Pursuant to sections 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

    • Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS: http://apps.fcc.gov/ecfs.

    • Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.

    Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

    • All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW., Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.

    • Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.

    • U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW., Washington, DC 20554.

    158. People with Disabilities. To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

    159. Comments and reply comments must include a short and concise summary of the substantive arguments raised in the pleading. Comments and reply comments must also comply with section 1.49 and all other applicable sections of the Commission's rules. The Commission directs all interested parties to include the name of the filing party and the date of the filing on each page of their comments and reply comments. All parties are encouraged to utilize a table of contents, regardless of the length of their submission. The Commission also strongly encourages parties to track the organization set forth in the FNPRM in order to facilitate our internal review process.

    160. Additional Information. For additional information on this proceeding, contact Suzanne Yelen of the Wireline Competition Bureau, Industry Analysis and Technology Division, [email protected], (202) 418-7400 or Alexander Minard of the Wireline Competition Bureau, Technology Access Policy Division, [email protected], (202) 418-7400.

    IV. Ordering Clauses

    161. Accordingly, IT IS ORDERED, pursuant to the authority contained in sections 1, 2, 4(i), 5, 10, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, and 405 of the Communications Act of 1934, as amended, and section 706 of the Telecommunications Act of 1996, 47 U.S.C. 151, 152, 154(i), 155, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, 405, 1302, and sections 1.1, 1.3, 1.421, 1.427, and 1.429 of the Commission's rules, 47 CFR 1.1, 1.3, 1.421, 1.427, and 1.429, that this Further Notice of Proposed Rulemaking and the concurrently adopted Report and Order, Order and Order on Reconsideration IS ADOPTED. It is our intention in adopting these rules that if any of the rules that the Commission retains, modifies, or adopts herein, or the application thereof to any person or circumstance, are held to be unlawful, the remaining portions of the rules not deemed unlawful, and the application of such rules to other persons or circumstances, shall remain in effect to the fullest extent permitted by law.

    162. IT IS FURTHER ORDERED that, pursuant to the authority contained in sections 1, 2, 4(i), 5, 10, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, and 405 of the Communications Act of 1934, as amended, and section 706 of the Telecommunications Act of 1996, 47 U.S.C. 151, 152, 154(i), 155, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, 405, 1302, and sections 1.1, 1.3, 1.421, 1.427, and 1.429 of the Commission's rules, 47 CFR 1.1, 1.3, 1.421, 1.427, and 1.429, NOTICE IS HEREBY GIVEN of the proposals and tentative conclusions described in this Further Notice of Proposed Rulemaking.

    163. IT IS FURTHER ORDERED that the Commission SHALL SEND a copy of this Further Notice of Proposed Rulemaking and the concurrently adopted Report and Order, Order and Order on Reconsideration to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

    164. IT IS FURTHER ORDERED, that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, SHALL SEND a copy of this Further Notice of Proposed Rulemaking and the concurrently adopted Report and Order, Order and Order on Reconsideration, including the Initial Regulatory Flexibility Analysis and the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

    List of Subjects in 47 CFR Part 65

    Administrative practice and procedure, Communications common carriers, Reporting and recordkeeping requirements, Telephone.

    Federal Communications Commission. Marlene H. Dortch, Secretary. Proposed Rules

    For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 65 as follows:

    PART 65—INTERSTATE RATE OF RETURN PRESCRIPTION PROCEDURES AND METHODOLOGIES 1. The authority citation for part 65 is revised to read as follows: Authority:

    47 U.S.C. 151, 154, 201, 202, 203, 204, 205, 218, 219, 220, 403.

    2. Amend § 65.450 by revising paragraph (d) and adding paragraph (e) to read as follows:
    § 65.450 Net income.

    (d) Except for the allowance for funds used during construction and interest related to customer deposits, the amounts recorded as nonoperating income and expenses and taxes (Account 7300 and 7400) and interest and related items (Account 7500) and extraordinary items (Account 7600) shall not be included unless this Commission specifically determines that particular items recorded in those accounts shall be included.

    (e) For purposes of determining whether an expense is recognized by the Commission as “necessary to the provision of these services” under paragraph (a) of this section, the expense must be used and useful and a prudent expenditure. The Commission specifically provides that the following expenses are not necessary to the provision of interstate telecommunications services regulated by the Commission:

    (1) Personal travel; gifts to employees; childcare; housing allowances or other forms of mortgage or rent assistance for employees; personal expenses of employees, board members, family members of employees and board members, contractors, or any other individuals affiliated with the incumbent LEC, including but not limited to personal expenses for housing, such as rent or mortgages; personal use of company-owned housing, buildings, or facilities used for entertainment purposes by employees, board members, family members of employees and board members, contractors, or any other individuals affiliated with the incumbent local exchange carrier;

    (2) Entertainment; artwork and other objects which possess aesthetic value; tangible property not logically related or necessary to the offering of voice or broadband services;

    (3) Aircraft, watercraft, and other motor vehicles designed for off-road use, except insofar as necessary to access inhabited portions of the study area not reachable by motor vehicles travelling on roads; any vehicles provided to employees, board members, family members of employees and board members, contractors, or any other individuals affiliated with the incumbent local exchange carrier for personal use;

    (4) Cafeterias and dining facilities; alcohol and food, including but not limited to meals to celebrate personal events, such as weddings, births, or retirements, except that a reasonable amount for food shall be allowed for work-related travel;

    (5) Political contributions; charitable donations; scholarships; membership fees and dues in clubs and organizations; sponsorships of conferences or community events; and

    (6) Penalties or fines for statutory or regulatory violations; penalties or fees for any late payments on debt, loans, or other payments.

    3. Add paragraph (d) to § 65.830 to read as follows:
    § 65.830 Deducted items.

    (d) The following assets shall also be deducted from the interstate rate base:

    (1) Artwork and other objects which possess aesthetic value;

    (2) Tangible property not logically related or necessary to the offering of voice or broadband services;

    (3) Personal residences and property used for entertainment purposes;

    (4) Aircraft, watercraft, and other motor vehicles designed for off-road use, except insofar as necessary to access inhabited portions of the study area not reachable by motor vehicles travelling on roads;

    (5) Any vehicles provided to employees, board members, family members of employees and board members, contractors, or any other individuals affiliated with the incumbent local exchange carrier for personal use; and

    (6) Cafeterias and dining facilities.

    [FR Doc. 2016-08376 Filed 4-11-16; 8:45 am] BILLING CODE 6712-01-P
    81 70 Tuesday, April 12, 2016 Notices DEPARTMENT OF AGRICULTURE Rural Utility Service Submission for OMB Review; Comment Request April 6, 2016.

    The Department of Agriculture has submitted the following information collection requirement(s) to Office of Management and Budget (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; (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 May 12, 2016 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.

    Rural Utilities Service

    Title: 7 CFR 1778, Emergency and Imminent Community Water Assistance Grants.

    OMB Control Number: 0572-0110.

    Summary of Collection: The Rural Utilities Service (RUS) is authorized under Section 306A of the Consolidated Farm and Rural Development Act, (7 U.S.C. 1926(a)) to provide grants to rural areas and small communities to secure adequate quantities of safe water. There are two levels of grant limits—$500,000 and $150,000. Grants made under this program shall be made for 100 percent of the project's cost, can serve rural areas with population not in excess of 5,000, and household income should not exceed 100 percent of a State's non-metropolitan median household income. Grants under this program may be made to public bodies and private nonprofit corporations serving rural areas.

    Need and Use of the Information: RUS will collect the information from applicants applying for grants under 7 CFR 1778. The information is unique to each borrower and emergency situation. Applicants must demonstrate that there is an imminent emergency or that a decline occurred within 2 years of the date the application was filed with Rural Development.

    Description of Respondents: State, Local or Tribal Government; Not-for-profit institutions.

    Number of Respondents: 100.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 400.

    Charlene Parker, Departmental Information Collection Clearance Officer.
    [FR Doc. 2016-08339 Filed 4-11-16; 8:45 am] BILLING CODE 3410-15-P
    CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD Sunshine Act Meeting TIME AND DATE:

    April 20, 2016, 1:00 p.m. EDT

    PLACE:

    U.S. Chemical Safety Board, 1750 Pennsylvania Ave. NW., Suite 910, Washington, DC 20006.

    STATUS:

    Open to the public.

    MATTERS TO BE CONSIDERED:

    The Chemical Safety and Hazard Investigation Board (CSB) will convene a public meeting on April 20, 2016, starting at 1:00 p.m. EDT in Washington, DC, at the CSB offices located at 1750 Pennsylvania Avenue NW., Suite 910. The Board will discuss the status of open investigations; an update on audits from the Office of the Inspector General; financial and organizational updates; a review of the agency's action plan; and a calendared notation item related to recommendations 2001-01-H-R9 and 2001-01-H-R10 from the 2002 study on Improving Reactive Hazard Management. An opportunity for public comment will be provided.

    Additional Information

    The meeting is free and open to the public. If you require a translator or interpreter, please notify the individual listed below as the “Contact Person for Further Information,” at least three business days prior to the meeting.

    A conference call line will be provided for those who cannot attend in person. Please use the following dial-in number to join the conference: 1-(888) 466-9863, passcode 6069134#.

    The CSB is an independent federal agency charged with investigating accidents and hazards that result, or may result, in the catastrophic release of extremely hazardous substances. The agency's Board Members are appointed by the President and confirmed by the Senate. CSB investigations look into all aspects of chemical accidents and hazards, including physical causes such as equipment failure as well as inadequacies in regulations, industry standards, and safety management systems.

    Public Comment

    The time provided for public statements will depend upon the number of people who wish to speak. Speakers should assume that their presentations will be limited to three minutes or less, but commenters may submit written statements for the record.

    Contact Person for Further Information

    Hillary Cohen, Communication Manager, at [email protected] or (202) 446-8094. Further information about this public meeting can be found on the CSB Web site at: www.csb.gov.

    Dated: April 8, 2016. Kara A. Wenzel, Acting General Counsel, Chemical Safety and Hazard Investigation Board.
    [FR Doc. 2016-08526 Filed 4-8-16; 4:15 pm] BILLING CODE 6350-01-P
    COMMISSION ON CIVIL RIGHTS Sunshine Act Meeting Notice AGENCY:

    United States Commission on Civil Rights.

    ACTION:

    Notice of Commission business meeting.

    DATES:

    Friday, April 15, 2016, at 10:00 a.m. EST.

    ADDRESSES:

    Place: National Place Building, 1331 Pennsylvania Ave. NW., 11th Floor, Suite 1150, Washington, DC 20245 (Entrance on F Street NW.).

    FOR FURTHER INFORMATION CONTACT:

    Gerson Gomez, Media Advisor at telephone: (202) 376-8371, TTY: (202) 376-8116 or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    This business meeting is open to the public. If you would like to listen to the business meeting, please contact the above for the call-in information. Hearing-impaired persons who will attend the briefing and require the services of a sign language interpreter should contact Pamela Dunston at (202) 376-8105 or at [email protected] at least seven business days before the scheduled date of the meeting.

    Meeting Agenda I. Approval of Agenda II. Business Meeting A. Program Planning • Discussion on Commissioner Concept Papers and Statutory Enforcement Report for 2017 • Discussion and vote on Commission statement concerning North Carolina law on LGBT rights • Discussion and vote on Commission statement concerning disparate impact that the Countering Violent Extremism (CVE) program will have on the Muslim community in the U.S. • Discussion and vote on Commission statement concerning Parallel Construction (NSA data-sharing) B. Advisory Committees • Presentation by Nebraska State Advisory Committee Chair on report about impact of state law denying state services to individuals who cannot present documentation of legal status. C. Management and Operations • Staff Director's Report III. State Advisory Committee (SAC) Appointments • Georgia • Maine IV. Adjourn Meeting Dated: April 8, 2016. David Mussatt, Regional Programs Unit Chief, U.S. Commission on Civil Rights.
    [FR Doc. 2016-08477 Filed 4-8-16; 4:15 pm] BILLING CODE 6335-01-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security Information Systems, Technical Advisory Committee; Notice of Partially Closed Meeting

    The Information Systems Technical Advisory Committee (ISTAC) will meet on April 27 and 28, 2016, 9:00 a.m., in the Herbert C. Hoover Building, Room 3884, 14th Street between Constitution and Pennsylvania Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration on technical questions that affect the level of export controls applicable to information systems equipment and technology.

    Wednesday, April 27 Open Session 1. Welcome and Introductions 2. Working Group Reports 3. Old Business 4. Industry Presentations 5. New Business Thursday, April 28 Closed Session

    6. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 sections 10(a)(1) and 10(a)(3).

    The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at [email protected], no later than April 20, 2016.

    A limited number of seats will be available for the public session. Reservations are not accepted. To the extent time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the Committee suggests that public presentation materials or comments be forwarded before the meeting to Ms. Springer.

    The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on January 7, 2016, pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 section (10)(d)), that the portion of the meeting concerning trade secrets and commercial or financial information deemed privileged or confidential as described in 5 U.S.C. 552b(c)(4) and the portion of the meeting concerning matters the disclosure of which would be likely to frustrate significantly implementation of an agency action as described in 5 U.S.C. 552b(c)(9)(B) shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 sections 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.

    For more information, call Yvette Springer at (202) 482-2813.

    Yvette Springer, Committee Liaison Officer.
    [FR Doc. 2016-08373 Filed 4-11-16; 8:45 am] BILLING CODE 3510-JT-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security Materials Technical Advisory Committee; Notice of Partially Closed Meeting

    The Materials Technical Advisory Committee will meet on May 5, 2016, 10:00 a.m., Herbert C. Hoover Building, Room 3884, 14th Street between Constitution & Pennsylvania Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration with respect to technical questions that affect the level of export controls applicable to materials and related technology.

    Agenda Open Session

    1. Opening remarks and Introductions.

    2. Remarks from the Bureau of Industry and Security senior management.

    3. Report by regime representatives.

    4. Report by working groups (Composite Working Group, Biological Working Group, Pump and Valves Working Group, and the Chemicals Working Group).

    5. Public Comments and New Business.

    Closed Session

    6. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3).

    The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at [email protected], no later than April 28, 2016.

    A limited number of seats will be available during the public session of the meeting. Reservations are not accepted. To the extent time permits, members of the public may present oral statements to the Committee. Written statements may be submitted at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the materials should be forwarded prior to the meeting to Ms. Springer via email.

    The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on November 5, 2015, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 § 10(d)), that the portion of the meeting dealing with pre-decisional changes to the Commerce Control List and the U.S. export control policies shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.

    For more information, call Yvette Springer at (202) 482-2813.

    Dated: April 6, 2016. Yvette Springer, Committee Liaison Officer.
    [FR Doc. 2016-08371 Filed 4-11-16; 8:45 am] BILLING CODE 3510-JT-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security Sensors and Instrumentation Technical Advisory Committee; Notice of Partially Closed Meeting

    The Sensors and Instrumentation Technical Advisory Committee (SITAC) will meet on April 26, 2016, 9:30 a.m., in the Herbert C. Hoover Building, Room 3884, 14th Street between Constitution and Pennsylvania Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration on technical questions that affect the level of export controls applicable to sensors and instrumentation equipment and technology.

    Agenda Public Session

    1. Welcome and Introductions.

    2. Remarks from the Bureau of Industry and Security Management.

    3. Industry Presentations.

    4. New Business.

    Closed Session

    5. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3).

    The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at [email protected] no later than April 19, 2016.

    A limited number of seats will be available during the public session of the meeting. Reservations are not accepted. To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to the Committee members, the Committee suggests that the materials be forwarded before the meeting to Ms. Springer.

    The Assistant Secretary for Administration, with the concurrence of the General Counsel, formally determined on November 5, 2015 pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 § 10(d), that the portion of this meeting dealing with pre-decisional changes to the Commerce Control List and U.S. export control policies shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.

    For more information contact Yvette Springer on (202) 482-2813.

    Dated: April 6, 2016. Yvette Springer, Committee Liaison Officer.
    [FR Doc. 2016-08372 Filed 4-11-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security Transportation and Related Equipment Technical Advisory Committee; Notice of Partially Closed Meeting

    The Transportation and Related Equipment Technical Advisory Committee will meet on May 4, 2016, 9:30 a.m., in the Herbert C. Hoover Building, Room 3884, 14th Street between Constitution & Pennsylvania Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration with respect to technical questions that affect the level of export controls applicable to transportation and related equipment or technology.

    Agenda Public Session

    1. Welcome and Introductions.

    2. Status reports by working group chairs.

    3. Public comments and Proposals.

    Closed Session

    4. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 sections 10(a)(1) and 10(a)(3).

    The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at [email protected] no later than April 27, 2016.

    A limited number of seats will be available during the public session of the meeting. Reservations are not accepted. To the extent time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.

    The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on November 5, 2015, pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 section (10)(d)), that the portion of the meeting dealing with pre-decisional changes to the Commerce Control List and U.S. export control policies shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 sections 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.

    For more information, call Yvette Springer at (202) 482·2813.

    Dated: April 6, 2016. Yvette Springer, Committee Liaison Officer.
    [FR Doc. 2016-08379 Filed 4-11-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE International Trade Administration [A-549-821] Polyethylene Retail Carrier Bags From Thailand: Preliminary Results of Antidumping Duty Administrative Review; 2014-2015 AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on polyethylene retail carrier bags (PRCBs) from Thailand. The period of review (POR) is August 1, 2014, through July 31, 2015. We preliminarily find that subject merchandise has been sold at less than normal value by K. International Packaging Co., Ltd. (K. International Packaging).1

    1 We initiated a review of 45 companies and subsequently rescinded the review with respect to 44 companies pursuant to a timely withdrawal of the request for review. See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 80 FR 60356 (October 6, 2015); see also Polyethylene Retail Carrier Bags From Thailand: Rescission of Antidumping Duty Administrative Review in Part; 2014-2015, 80 FR 45952 (August 3, 2015); see also, See the Memorandum from Andre Gziryan to James Maeder titled “Polyethylene Retail Carrier Bags from Thailand: Selection of Respondents for Individual Examination” at footnote 5 for clarification on the company name (K. International Packaging Co., Ltd.is also known as “K. International Packing Co., Ltd.”).

    DATES:

    Effective Date: April 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Andre Gziryan, 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) 482-2201.

    SUPPLEMENTARY INFORMATION: Scope of the Order

    The merchandise subject to this order is polyethylene retail carrier bags, which are currently classified under subheading 3923.21.0085 of the Harmonized Tariff Schedule of the United States (HTSUS). While the HTSUS subheadings are provided for convenience and customs purposes, the written description is dispositive. A full description of the scope of the order is contained in the Preliminary Decision Memorandum.2

    2See the Memorandum from Deputy Assistant Secretary Christian Marsh to Acting Assistant Secretary Ronald K. Lorentzen entitled, “Preliminary Decision Memorandum for the Administrative Review of the Antidumping Duty Order on Polyethylene Retail Carrier Bags from Thailand” dated concurrently with and hereby adopted by this notice (Preliminary Decision Memorandum).

    Tolling of Deadline of Preliminary Results of Review

    As explained in the memorandum from the Acting Assistant Secretary for Enforcement and Compliance, the Department has exercised its discretion to toll all administrative deadlines due to the recent closure of the Federal Government. All deadlines in this segment of the proceeding have been extended by four business days. The revised deadline for the preliminary results of this review is now May 6, 2016.3

    3See Memorandum to the Record from Ron Lorentzen, Acting A/S for Enforcement & Compliance, regarding “Tolling of Administrative Deadlines As a Result of the Government Closure During Snowstorm Jonas” dated January 27, 2016.

    Methodology

    We have relied on total facts available with respect to K. International Packaging, the sole company subject to this review. Because this company did not act to the best of its ability to respond to the Department's requests for information, we have drawn an adverse inference in selecting from among the facts otherwise available.4 We have preliminarily determined to apply a 122.88 percent rate as adverse facts available for K. International Packaging.5

    4See sections 776(a) and (b) of the Tariff Act of 1930, as amended (the Act).

    5 For a full description of the methodology underlying our conclusions, see Preliminary Decision Memorandum.

    Preliminary Results of Review

    As a result of our review, we preliminarily determine that a weighted-average dumping margin of 122.88 percent exists for K. International Packaging Co., Ltd. on PRCBs from Thailand for the period August 1, 2014, through July 31, 2015.

    Public Comment

    Pursuant to 19 CFR 351.309(c), interested parties may submit case briefs not later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case briefs.6 Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue, (2) a brief summary of the argument, and (3) a table of authorities.7

    6See 19 CFR 351.309(d).

    7See 19 CFR 351.309(c)(2) and (d)(2).

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically filed document must be received successfully in its entirety by the Department's electronic records system, ACCESS, by 5:00 p.m. Eastern Time within 30 days after the date of publication of this notice.8 Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs. The Department will issue the final results of this administrative and new shipper review, including the results of its analysis of the issues raised in any written briefs, not later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act.

    8See 19 CFR 351.310(c).

    Assessment Rates

    Upon issuance of the final results, the Department shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review. For the final results, if we continue to rely on total adverse facts available to establish K. International Packaging's weighted-average dumping margin, we will instruct CBP to apply an ad valorem assessment rate of 122.88 percent to all entries of subject merchandise during the POR which were produced and/or exported by K. International Packaging.

    We intend to issue liquidation instructions to CBP 15 days after publication of the final results of review.

    Cash Deposit Requirements

    The following deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of PRCBs from Thailand entered, or withdrawn from warehouse, for consumption on or after the date of publication, as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for the reviewed company will be the rate established in the final results of this review; (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value investigation but the manufacturer is, the cash deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; (4) if neither the exporter nor the manufacturer has its own rate, the cash deposit rate will be 4.69 percent.9 These deposit requirements, when imposed, shall remain in effect until further notice.

    9See Section 129 Determination.

    Notifications to Importer

    This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

    These preliminary results of administrative review are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.

    Dated: April 6, 2016. Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance. Appendix List of Topics Discussed in the Preliminary Decision Memorandum Summary Background Scope of the Order Discussion of the Methodology A. Use of Facts Available B. Application of Facts Available With an Adverse Inference C. Selection and Corroboration of Information Used as Facts Available Recommendation
    [FR Doc. 2016-08385 Filed 4-11-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-570-938] Citric Acid and Certain Citrate Salts From the People's Republic of China: Notice of Court Decision Not in Harmony With Final Results of Countervailing Duty Administrative Review and Notice of Amended Final Results Pursuant to Court Decision; 2011 AGENCY:

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

    SUMMARY:

    On March 30, 2016, the United States Court of International Trade (CIT) sustained the Department of Commerce's (Department's) final results of redetermination,1 which recalculated the subsidy rate for RZBC Group Shareholding Co., Ltd., RZBC Co., Ltd., RZBC Imp. & Exp. Co., Ltd., and RZBC (Juxian) Co., Ltd. (collectively, RZBC Companies) in the administrative review of the countervailing duty (CVD) order on citric acid and certain citrate salts (citric acid) from the People's Republic of China for the period January 1, 2011, through December 31, 2011,2 pursuant to the CIT's remand order in RZBC Companies v. United States. 3 Consistent with the decision of the United States Court of Appeals for the Federal Circuit (CAFC) in Timken, 4 as clarified by Diamond Sawblades, 5 the Department is notifying the public that the Court's final judgment in this case is not in harmony with the Final Results and that the Department is amending the Final Results with respect to the RZBC Companies.

    1See RZBC Group Shareholding Co., Ltd., RZBC Co., Ltd., RZBC Imp. & Exp. Co., Ltd., and RZBC (Juxian) Co., Ltd. v. United States, Court No. 14-00041 (CIT March 30, 2016) (Court Order affirming remand redetermination) (RZBC Companies v. United States II).

    2See Citric Acid and Certain Citrate Salts From the People's Republic of China: Final Results of Countervailing Duty Administrative Review; 2011, 79 FR 108 (January 2, 2014) (Final Results) and accompanying Issues and Decision Memorandum (Final IDM).

    3See RZBC Group Shareholding Co., Ltd., RZBC Co., Ltd., RZBC Imp. & Exp. Co., Ltd., and RZBC (Juxian) Co., Ltd. v. United States, Court No. 14-00041, Slip Op. 15-83 (August 5, 2015) (RZBC Companies v. United States).

    4See Timken Co. v. United States, 893 F.2d 337 (Fed. Cir. 1990) (Timken).

    5See Diamond Sawblades Mfrs. Coalition v. United States, 626 F.3d 1374 (Fed. Cir. 2010) (Diamond Sawblades).

    DATES:

    Effective Date: April 9, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Patricia M. Tran, AD/CVD Operations, Office III, Enforcement and Compliance, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-1503.

    SUPPLEMENTARY INFORMATION: Background

    In the Final Results, the Department elected to simple-average all available benchmark data for steam coal, sulfuric acid, and calcium carbonate because they were not reported in a uniform manner.6 The CIT remanded for the Department to reevaluate the world benchmarks for steam coal, sulfuric acid, and calcium carbonate subsidies. Specifically, the CIT instructed the Department to consider whether to calculate world-average prices using weighted or simple-averages in light of small-quantity, high-price transactions in the underlying data, and to comply with the mandate to measure the adequacy of remuneration in light of prevailing market conditions in the country subject to review.7 The CIT also directed the Department to recalculate the respondents' countervailing duty rate consistent with any reevaluated benchmark prices for steam coal, sulfuric acid, and calcium carbonate.8

    6See Final Results and Final IDM at Comment 13E.

    7See RZBC Companies v. United States, Slip Op. at 40.

    8Id.

    In its final results of redetermination pursuant to RZBC Companies v. United States, the Department reopened and placed on the record in the remand proceeding world benchmark information for steam coal, sulfuric acid, and calcium carbonate. The Department then calculated weighted-average monthly world benchmarks for sulfuric acid and calcium carbonate. For steam coal, we weight-averaged the weightable data 9 on the record while continuing to utilize the data from other unweightable 10 sources.

    9 Weightable data contains benchmark prices and quantity.

    10 Unweightable data contains only benchmark prices.

    On March 30, 2016, the CIT sustained the Department's final results of redetermination pursuant to remand.11

    11See RZBC Companies v. United States II.

    Timken Notice

    In its decision in Timken, as clarified by Diamond Sawblades, the CAFC held that, pursuant to section 516A(e) of the Tariff Act of 1930, as amended (the Act), the Department must publish a notice of a court decision that is not “in harmony” with a Department determination and must suspend liquidation of entries pending a “conclusive” court decision. The CIT's opinion in RZBC Companies v. United States II, issued on March 30, 2016, sustaining the Department's final results of redetermination constitutes a final decision of the court that is not in harmony with the Department's Final Results. This notice is published in fulfillment of the publication requirements of Timken. Accordingly, the Department will continue the suspension of liquidation of the subject merchandise pending the expiration of the period of appeal or, if appealed, pending a final and conclusive court decision.

    Amended Final Results of Review

    Because there is now a final court decision with respect to the Final Results, the Department amends its Final Results. The Department finds that the following revised net countervailable subsidy rate is:

    Company Net countervailable subsidy rate RZBC Group Shareholding Co., Ltd., RZBC Co., Ltd., RZBC Imp. & Exp. Co., Ltd., and RZBC (Juxian) Co., Ltd. (collectively, RZBC Companies) 18.28 percent ad valorem.

    Since the Final Results, the Department established a new cash deposit rate for RZBC Companies.12 Therefore, the cash deposit rate for RZBC Companies does not need to be updated as a result of these amended final results. In the event that the CIT's ruling is not appealed, or if appealed, upheld by the CAFC, the Department will instruct U.S. Customs and Border Protection to liquidate entries of subject merchandise that were exported by RZBC Companies, and which were entered, or withdrawn from warehouse, for consumption during the period January 1, 2011, through December 31, 2011, at the revised rate of 18.28 percent ad valorem.

    12See Citric Acid and Certain Citrate Salts: Final Results of Countervailing Duty Administrative Review; 2013, 80 FR 77318 (December 14, 2015).

    This notice is issued and published in accordance with sections 516A(e)(l), 75l(a)(l), and 777(i)(l) of the Act.

    Dated: April 5, 2016. Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-08387 Filed 4-11-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [Application No. 84-26A12] Export Trade Certificate of Review ACTION:

    Notice of issuance of an amended Export Trade Certificate of Review to the Northwest Fruit Exporters of Washington (“NFE”), Application No. (84-26A12).

    SUMMARY:

    The Secretary of Commerce, through the Office of Trade and Economic Analysis (“OTEA”), issued an amended Export Trade Certificate of Review to NFE of California on March 21, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Joseph E. Flynn, Director, Office of Trade and Economic Analysis, International Trade Administration, by telephone at (202) 482-5131 (this is not a toll-free number) or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. The regulations implementing title III are found at 15 CFR part 325 (2016).

    OTEA is issuing this notice pursuant to 15 CFR 325.6(b), which requires the Secretary of Commerce to publish a summary of the certification in the Federal Register. Under section 305(a) of the Act and 15 CFR 325.11(a), any person aggrieved by the Secretary's determination may, within 30 days of the date of this notice, bring an action in any appropriate district court of the United States to set aside the determination on the ground that the determination is erroneous.

    Description of Amended Certificate

    NFE's Export Trade Certificate of Review has been amended to:

    Description of Amendments to the Certificate 1. Under the heading Products, add “fresh pears.” 2. Under the heading Export Trade Activities and Methods of Operation, add “fresh pears” to the subtitles of sections 1 and 3. 3. Add coverage for Export Trade Activities and Methods of Operation relating to “fresh pears” for the following existing Members of the Certificate (within the meaning of section 325.2(l) of the regulations (15 CFR 325.2(l))): Apple House Warehouse & Storage, Inc. Blue Bird, Inc. Blue Star Growers, Inc. Borton & Sons, Inc. Chelan Fruit Cooperative Congdon Packing Co. L.L.C. Conrad & Adams Fruit L.L.C. Crane & Crane, Inc. Diamond Fruit Growers Inc. Gold Digger Apples, Inc. Hansen Fruit & Cold Storage Co., Inc. Highland Fruit Growers, Inc. HoneyBear Growers, LLC Matson Fruit Company McDougall & Sons, Inc. Stadelman Fruit, L.L.C. Stemilt Growers, LLC Strand Apples, Inc. The Dalles Fruit Company, LLC Valley Fruit III L.L.C. 4. Add the following new Members of the Certificate (within the meaning of section 325.2(l) of the regulations (15 CFR 325.2(l))), for Export Trade Activities and Methods of Operation relating to “fresh pears”: Duckwall Fruit Naumes, Inc. Peshastin Hi-Up Growers Underwood Fruit & Warehouse Co. 5. Add the following new Members of the Certificate for Export Trade Activities and Methods of Operation relating to apples: Piepel Premium Fruit Packing LLC Ron LeFore, d/b/a Ron LeFore Apple Farms Western Traders LLC 6. Remove the following companies as Members of the Certificate: Blue Mountain Growers, Inc. (Milton-Freewater, OR), and Obert Cold Storage (Zillah, WA); and 7. Change the name of the following existing Members: The Apple House, Inc. (Brewster, WA) is now Apple House Warehouse & Storage, Inc. (Brewster, WA); C&M Fruit Packers (Yakima, WA) is now Columbia Fruit Packers/Airport Division (Yakima, WA); Domex Marketing (Yakima, WA) is now Domex Superfresh Growers LLC (Yakima, WA); and Stemilt Growers Inc. is now Stemilt Growers, LLC.

    NFE's complete Membership covered by the amended Export Trade Certificate of Review is listed below:

    1. Allan Bros., Naches, WA 2. AltaFresh L.L.C. dba Chelan Fresh Marketing, Chelan, WA 3. Apple House Warehouse & Storage, Inc., Brewster, WA 4. Apple King, L.L.C., Yakima, WA 5. Auvil Fruit Co., Inc., Orondo, WA 6. Baker Produce, Inc., Kennewick, WA 7. Blue Bird, Inc., Peshastin, WA 8. Blue Star Growers, Inc., Cashmere, WA 9. Borton & Sons, Inc., Yakima, WA 10. Brewster Heights Packing & Orchards, LP, Brewster, WA 11. Broetje Orchards LLC, Prescott, WA 12. C.M. Holtzinger Fruit Co., Inc., Yakima, WA 13. Chelan Fruit Cooperative, Chelan, WA 14. Chiawana, Inc. dba Columbia Reach Pack, Yakima, WA 15. Columbia Fruit Packers, Inc., Wenatchee, WA 16. Columbia Fruit Packers/Airport Division, Yakima, WA 17. Columbia Marketing International Corp., Wenatchee, WA 18. Columbia Valley Fruit, L.L.C., Yakima, WA 19. Congdon Packing Co. L.L.C., Yakima, WA 20. Conrad & Adams Fruit L.L.C., Grandview, WA 21. Cowiche Growers, Inc., Cowiche, WA 22. CPC International Apple Company, Tieton, WA 23. Crane & Crane, Inc., Brewster, WA 24. Custom Apple Packers, Inc., Brewster, Quincy, and Wenatchee, WA 25. Diamond Fruit Growers, Odell, OR 26. Domex Superfresh Growers LLC, Yakima, WA 27. Douglas Fruit Company, Inc., Pasco, WA 28. Dovex Export Company, Wenatchee, WA 29. Duckwall Fruit, Odell, OR 30. E. Brown & Sons, Inc., Milton-Freewater, OR 31. Evans Fruit Co., Inc., Yakima, WA 32. E.W. Brandt & Sons, Inc., Parker, WA 33. Frosty Packing Co., LLC, Yakima, WA 34. G&G Orchards, Inc., Yakima, WA 35. Garrett Ranches Packing, Wilder, ID 36. Gilbert Orchards, Inc., Yakima, WA 37. Gold Digger Apples, Inc., Oroville, WA 38. Hansen Fruit & Cold Storage Co., Inc., Yakima, WA 39. Henggeler Packing Co., Inc., Fruitland, ID 40. Highland Fruit Growers, Inc., Yakima, WA 41. HoneyBear Growers, Inc., (Brewster, WA) 42. Honey Bear Tree Fruit Co., LLC, Wenatchee, WA 43. Hood River Cherry Company, Hood River, OR 44. Ice Lakes LLC, E. Wenatchee, WA 45. JackAss Mt. Ranch, Pasco, WA 46. Jenks Bros Cold Storage Packing (Royal City, WA) 47. Kershaw Fruit & Cold Storage, Co., Yakima, WA 48. L&M Companies, Selah, WA 49. Larson Fruit Co., Selah, WA 50. Manson Growers Cooperative, Manson, WA 51. Matson Fruit Company, Selah, WA 52. McDougall & Sons, Inc., Wenatchee, WA 53. Monson Fruit Co.—Apple operations only, Selah, WA 54. Morgan's of Washington dba Double Diamond Fruit, Quincy, WA 55. Naumes, Inc., Medford, OR 56. Northern Fruit Company, Inc., Wenatchee, WA 57. Olympic Fruit Co., Moxee, WA 58. Oneonta Trading Corp., Wenatchee, WA 59. Orchard View Farms, Inc., The Dalles, OR 60. Pacific Coast Cherry Packers, LLC, Yakima, WA 61. Peshastin Hi-Up Growers, Peshastin, WA 62. Phillippi Fruit Company, Inc., Wenatchee, WA 63. Piepel Premium Fruit Packing, LLC, East Wenatchee, W 64. Polehn Farm's Inc., The Dalles, OR 65. Price Cold Storage & Packing Co., Inc., Yakima, WA 66. Pride Packing Company, Wapato, WA 67. Quincy Fresh Fruit Co., Quincy, WA 68. Rainier Fruit Company, Selah, WA 69. Roche Fruit, Ltd., Yakima, WA 70. Ron Lefore, d/b/a Ron Lefore Apple Farms, Milton-Freewater, OR 71. Sage Fruit Company, L.L.C., Yakima, WA 72. Smith & Nelson, Inc., Tonasket, WA 73. Stadelman Fruit, L.L.C., Milton-Freewater, OR, and Zillah, WA 74. Stemilt Growers, LLC, Wenatchee, WA 75. Strand Apples, Inc., Cowiche, WA 76. Symms Fruit Ranch, Inc., Caldwell, ID 77. The Dalles Fruit Company, LLC, Bingen, WA 78. Underwood Fruit & Warehouse Co., Dallesport, WA 79. Valicoff Fruit Co., Inc., Wapato, WA 80. Valley Fruit III L.L.C., Wapato, WA 81. Washington Cherry Growers, Peshastin, WA 82. Washington Fruit & Produce Co., Yakima, WA 83. Western Sweet Cherry Group, LLC, Yakima, WA 84. Western Traders, LLC, East Wenatchee, WA 85. Whitby Farms, Inc. dba: Farm Boy Fruit Snacks LLC, Mesa, WA 86. Yakima Fresh, Yakima, WA 87. Yakima Fruit & Cold Storage Co., Yakima, WA 88. Zirkle Fruit Company, Selah, WA Dated: April 5, 2016. Joseph E. Flynn, Director, Office of Trade and Economic Analysis.
    [FR Doc. 2016-08390 Filed 4-11-16; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE International Trade Administration Quarterly Update to Annual Listing of Foreign Government Subsidies on Articles of Cheese Subject to an In-Quota Rate of Duty AGENCY:

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

    DATES:

    Effective Date: April 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Stephanie Moore, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Ave. NW., Washington, DC 20230, telephone: (202) 482-3692.

    SUPPLEMENTARY INFORMATION:

    Section 702 of the Trade Agreements Act of 1979 (as amended) (the Act) requires the Department of Commerce (the Department) to determine, in consultation with the Secretary of Agriculture, whether any foreign government is providing a subsidy with respect to any article of cheese subject to an in-quota rate of duty, as defined in section 702(h) of the Act, and to publish quarterly updates to the type and amount of those subsidies. We hereby provide the Department's quarterly update of subsidies on articles of cheese that were imported during the periods October 1, 2015, through December 31, 2015.

    The Department has developed, in consultation with the Secretary of Agriculture, information on subsidies, as defined in section 702(h) of the Act, being provided either directly or indirectly by foreign governments on articles of cheese subject to an in-quota rate of duty. The appendix to this notice lists the country, the subsidy program or programs, and the gross and net amounts of each subsidy for which information is currently available. The Department will incorporate additional programs which are found to constitute subsidies, and additional information on the subsidy programs listed, as the information is developed.

    The Department encourages any person having information on foreign government subsidy programs which benefit articles of cheese subject to an in-quota rate of duty to submit such information in writing to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce, 14th Street and Constitution Ave. NW., Washington, DC 20230.

    This determination and notice are in accordance with section 702(a) of the Act.

    Dated: April 5, 2016. Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance. Appendix Subsidy Programs on Cheese Subject to an In-Quota Rate of Duty Country Program(s) Gross 1
  • subsidy
  • ($/lb)
  • Net 2
  • subsidy
  • ($/lb)
  • 28 European Union Member States 3 European Union Restitution Payments 0.00 0.00 Canada Export Assistance on Certain Types of Cheese 0.46 0.46 Norway Indirect (Milk) Subsidy 0.00 0.00 Consumer Subsidy 0.00 0.00  Total 0.00 0.00 Switzerland Deficiency Payments 0.00 0.00 1 Defined in 19 U.S.C. 1677(5). 2 Defined in 19 U.S.C. 1677(6). 3 The 28 member states of the European Union are: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.
    [FR Doc. 2016-08389 Filed 4-11-16; 8:45 am] BILLING CODE 3510-DS-P
    CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Sunshine Act Notice

    The Board of Directors of the Corporation for National and Community Service gives notice of the following meeting:

    DATE AND TIME:

    Friday, April 22, 2016, 11:00 a.m.-12:15 p.m. (ET).

    PLACE:

    Corporation for National and Community Service, 250 E Street SW., Suite 4026, Washington, DC 20525 (Please go to the first floor lobby reception area for escort).

    CALL-IN INFORMATION:

    This meeting is available to the public through the following toll-free call-in number: 888-390-3401 conference call access code number 2572123. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and CNCS will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Replays are generally available one hour after a call ends. The toll-free phone number for the replay is 866-479-2459. TTY: 800-833-3722. The end replay date is May 6, 2016 at 10:59 p.m. (CT).

    STATUS:

    Open.

    MATTERS TO BE CONSIDERED:

    I. Chair's Opening Comments a. Call to Order, Welcome, and Preview of Today's Meeting Agenda b. Introduction and Acknowledgements c. Summary Status of Board Interaction II. CEO Report III. Guest Speaker: The September 11th National Day of Service and Remembrance IV. Public Comments V. Final Comments and Adjournment

    Members of the public who would like to comment on the business of the Board may do so in writing or in person. Individuals may submit written comments to [email protected] subject line: APRIL 2016 CNCS BOARD MEETING by 4:00 p.m. (ET) on April 20, 2016. Individuals attending the meeting in person who would like to comment will be asked to sign-in upon arrival. Comments are requested to be limited to 2 minutes.

    REASONABLE ACCOMMODATIONS:

    The Corporation for National and Community Service provides reasonable accommodations to individuals with disabilities where appropriate. Anyone who needs an interpreter or other accommodation should notify David Premo at [email protected] or 202-606-6717 by 5 p.m. (ET) on April 15, 2016.

    CONTACT PERSON FOR MORE INFORMATION:

    Dave Premo, Program Support Specialist, Corporation for National and Community Service, 250 E Street SW., Washington, DC 20525. Phone: 202-606-6717. Fax: 202-606-3460. TTY: 800-833-3722. Email: [email protected]

    Dated: April 8, 2016. Jeremy Joseph, General Counsel.
    [FR Doc. 2016-08548 Filed 4-8-16; 4:15 pm] BILLING CODE 6050-28-P
    DEPARTMENT OF DEFENSE Department of the Air Force US Air Force Exclusive Patent License AGENCY:

    Department of the Air Force, Air Force Research Laboratory Information Directorate, Rome, New York, DOD.

    ACTION:

    Notice of intent to issue an exclusive patent license.

    SUMMARY:

    Pursuant to the provisions of part 404 of Title 37, Code of Federal Regulations, which implements Public Law 96-517, as amended, the Department of the Air Force announces its intention to grant The Curators of the University of Missouri, a public corporation of Missouri having a place of business at the Office of Technology Management and Industry Relations, 1601 S. Providence Road, #124, Columbia, Missouri 65211, an exclusive license in any right, title and interest the United States Air Force has in: In U.S. Patent No. 14/795,953 entitled “SYSTEM AND METHOD FOR STATIC AND MOVING OBJECT DETECTION”, filed July 10, 2015.

    FOR FURTHER INFORMATION CONTACT:

    An exclusive license for this patent will be granted unless a written objection is received within fifteen (15) days from the date of publication of this Notice. Written objections should be sent to: Air Force Research Laboratory, Office of the Staff Judge Advocate, AFRL/RIJ, 26 Electronic Parkway, Rome, New York 13441-4514. Telephone: (315) 330-2087; Facsimile (315) 330-7583.

    Henry Williams Jr., Acting Air Force Federal Register Liaison Officer.
    [FR Doc. 2016-08378 Filed 4-11-16; 8:45 am] BILLING CODE 5001-10-P
    DEPARTMENT OF EDUCATION Applications for New Awards; Advanced Placement Test Fee Program AGENCY:

    Office of Elementary and Secondary Education, Department of Education.

    ACTION:

    Notice.

    Overview Information Advanced Placement Test Fee Program

    Notice inviting applications for new awards for fiscal year (FY) 2016.

    Catalog of Federal Domestic Assistance (CFDA) Number: 84.330B.

    DATES:

    Applications Available: April 12, 2016.

    Deadline for Transmittal of Applications: May 12, 2016.

    Deadline for Intergovernmental Review: July 11, 2016.

    Full Text of Announcement I. Funding Opportunity Description

    Purpose of Program: The Advanced Placement Test Fee (APTF) Program awards grants to State educational agencies (SEAs) to enable them to pay all or a portion of advanced placement test fees on behalf of eligible low-income students who (1) are enrolled in an advanced placement course; and (2) plan to take an advanced placement exam. The program is designed to increase the number of low-income students who take advanced placement tests and receive scores for which college academic credit is awarded.

    Program Authority:

    The Elementary and Secondary Education Act of 1965 (ESEA), as amended by the No Child Left Behind Act of 2001 (NCLB) (20 U.S.C. 6531-6537).

    Note:

    On December 10, 2015, the President signed into law the Every Student Succeeds Act (ESSA), Public Law 114-95, which reauthorized the ESEA, as amended by NCLB. Under section 5(c) of the ESSA, APTF Program grants awarded in FY 2016 and earlier years will operate in accordance with the requirements of the ESEA, as amended by NCLB.

    Applicable Regulations: (a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 75, 77, 79, 81, 82, 84, 97, 98, and 99. (b) The OMB Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement) in 2 CFR part 180, as adopted and amended as regulations of the Department in 2 CFR part 3485. (c) The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards in 2 CFR part 200, as adopted and amended as regulations of the Department in 2 CFR part 3474. (d) The regulations in 34 CFR part 299.

    Note:

    The regulations in 34 CFR part 79 apply to all applicants except federally recognized Indian tribes.

    II. Award Information

    Type of Award: Discretionary grants.

    Estimated Available Funds: $28,483,000.

    Estimated Range of Awards: $13,235-$10,757,186.

    Estimated Average Size of Awards: $694,710.

    Estimated Number of Awards: 41.

    Note:

    The Department is not bound by any estimates in this notice.

    Project Period: Up to 12 months.

    III. Eligibility Information

    1. Eligible Applicants: SEAs in any State, including the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, and the freely associated states of the Republic of the Marshall Islands, the Federated States of Micronesia, and the Republic of Palau (subject to continued eligibility).

    Note:

    For the purposes of this program, the Bureau of Indian Education in the U.S. Department of the Interior is treated as an SEA.

    2.a. Cost Sharing or Matching: This program does not require cost sharing or matching.

    b. Supplement-Not-Supplant: This program involves supplement, not supplant, funding requirements. Section 1706 of the ESEA, as amended by NCLB, requires that grant funds provided under the APTF Program supplement, and not supplant, other non-Federal funds that are available to assist low-income individuals in paying for the cost of advanced placement test fees.

    IV. Application and Submission Information

    1. Address to Request Application Package: You can obtain an application package via the Internet or from the program office.

    To obtain a copy via the Internet, use the following address: http://www2.ed.gov/programs/apfee/applicant.html.

    To obtain a copy from the program office, contact: Francisco Ramirez, U.S. Department of Education, 400 Maryland Avenue SW., Room 3E310, Washington, DC 20202-6200. Telephone: (202) 260-1541 or by email: [email protected]

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

    Individuals with disabilities can obtain a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) by contacting the program contact person listed in this section.

    2. Content and Form of Application Submission: Requirements concerning the content of an application, together with the forms you must submit, are in the application package for this competition.

    3. Submission Dates and Times:

    Applications Available: April 12, 2016.

    Deadline for Transmittal of Applications: May 12, 2016.

    Applications for grants under this competition must be submitted electronically using the Grants.gov Apply site (Grants.gov). For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to Other Submission Requirements in section IV of this notice.

    We do not consider an application that does not comply with the deadline requirements.

    Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice. If the Department provides an accommodation or auxiliary aid to an individual with a disability in connection with the application process, the individual's application remains subject to all other requirements and limitations in this notice.

    Deadline for Intergovernmental Review: July 11, 2016.

    4. Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this competition.

    5. Funding Restrictions: We reference regulations outlining funding restrictions in the Applicable Regulations section of this notice.

    6. Data Universal Numbering System Number, Taxpayer Identification Number, and System for Award Management: To do business with the Department of Education, you must—

    a. Have a Data Universal Numbering System (DUNS) number and a Taxpayer Identification Number (TIN);

    b. Register both your DUNS number and TIN with the System for Award Management (SAM) (formerly the Central Contractor Registry), the Government's primary registrant database;

    c. Provide your DUNS number and TIN on your application; and

    d. Maintain an active SAM registration with current information while your application is under review by the Department and, if you are awarded a grant, during the project period.

    You can obtain a DUNS number from Dun and Bradstreet at the following Web site: http://fedgov.dnb.com/webform. A DUNS number can be created within one to two business days.

    If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow two to five weeks for your TIN to become active.

    The SAM registration process can take approximately seven business days, but may take upwards of several weeks, depending on the completeness and accuracy of the data you enter into the SAM database. Thus, if you think you might want to apply for Federal financial assistance under a program administered by the Department, please allow sufficient time to obtain and register your DUNS number and TIN. We strongly recommend that you register early.

    Note:

    Once your SAM registration is active, it may be 24 to 48 hours before you can access the information in, and submit an application through, Grants.gov.

    If you are currently registered with SAM, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your registration annually. This may take three or more business days.

    Information about SAM is available at www.SAM.gov. To further assist you with obtaining and registering your DUNS number and TIN in SAM or updating your existing SAM account, we have prepared a SAM.gov Tip Sheet, which you can find at: http://www2.ed.gov/fund/grant/apply/sam-faqs.html.

    In addition, if you are submitting your application via Grants.gov, you must (1) be designated by your organization as an Authorized Organization Representative (AOR); and (2) register yourself with Grants.gov as an AOR. Details on these steps are outlined at the following Grants.gov Web page: www.grants.gov/web/grants/register.html.

    7. Other Submission Requirements: Applications for grants under this competition must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section.

    a. Electronic Submission of Applications

    Applications for grants under the APTF Program, CFDA number 84.330B, must be submitted electronically using the Governmentwide Grants.gov Apply site at www.Grants.gov. Through this site, you will be able to download a copy of the application package, complete it offline, and then upload and submit your application. You may not email an electronic copy of a grant application to us.

    We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement and submit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section under Exception to Electronic Submission Requirement.

    You may access the electronic grant application for the APTF Program at www.Grants.gov. You must search for the downloadable application package for this competition by the CFDA number. Do not include the CFDA number's alpha suffix in your search (e.g., search for 84.330, not 84.330B).

    Please note the following:

    • When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation.

    • Applications received by Grants.gov are date and time stamped. Your application must be fully uploaded and submitted and must be date and time stamped by the Grants.gov system no later than 4:30:00 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not accept your application if it is received—that is, date and time stamped by the Grants.gov system—after 4:30:00 p.m., Washington, DC time, on the application deadline date. We do not consider an application that does not comply with the deadline requirements. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date and time stamped by the Grants.gov system after 4:30:00 p.m., Washington, DC time, on the application deadline date.

    • The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the submission process through Grants.gov.

    • You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov under News and Events on the Department's G5 system home page at www.G5.gov. In addition, for specific guidance and procedures for submitting an application through Grants.gov, please refer to the Grants.gov Web site at: www.grants.gov/web/grants/applicants/apply-for-grants.html.

    • You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.

    • You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications.

    • You must upload any narrative sections and all other attachments to your application as files in a read-only, non-modifiable Portable Document Format (PDF). Do not upload an interactive or fillable PDF file. If you upload a file type other than a read-only, non-modifiable PDF (e.g., Word, Excel, WordPerfect, etc.) or submit a password-protected file, we will not review that material. Please note that this could result in your application not being considered for funding because the material in question—for example, the project narrative—is critical to a meaningful review of your proposal. For that reason it is important to allow yourself adequate time to upload all material as PDF files. The Department will not convert material from other formats to PDF.

    • Your electronic application must comply with any page-limit requirements described in this notice.

    • After you electronically submit your application, you will receive from Grants.gov an automatic notification of receipt that contains a Grants.gov tracking number. This notification indicates receipt by Grants.gov only, not receipt by the Department. Grants.gov will also notify you automatically by email if your application met all the Grants.gov validation requirements or if there were any errors (such as submission of your application by someone other than a registered Authorized Organization Representative, or inclusion of an attachment with a file name that contains special characters). You will be given an opportunity to correct any errors and resubmit, but you must still meet the deadline for submission of applications.

    Once your application is successfully validated by Grants.gov, the Department will retrieve your application from Grants.gov and send you an email with a unique PR/Award number for your application.

    These emails do not mean that your application is without any disqualifying errors. While your application may have been successfully validated by Grants.gov, it must also meet the Department's application requirements as specified in this notice and in the application instructions. Disqualifying errors could include, for instance, failure to upload attachments in a read-only, non-modifiable PDF; failure to submit a required part of the application; or failure to meet applicant eligibility requirements. It is your responsibility to ensure that your submitted application has met all of the Department's requirements.

    • We may request that you provide us original signatures on forms at a later date.

    Application Deadline Date Extension in Case of Technical Issues with the Grants.gov System: If you are experiencing problems submitting your application through Grants.gov, please contact the Grants.gov Support Desk, toll free, at 1-800-518-4726. You must obtain a Grants.gov Support Desk Case Number and must keep a record of it.

    If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30:00 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically or by hand delivery. You also may mail your application by following the mailing instructions described elsewhere in this notice.

    If you submit an application after 4:30:00 p.m., Washington, DC time, on the application deadline date, please contact the person listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice and provide an explanation of the technical problem you experienced with Grants.gov, along with the Grants.gov Support Desk Case Number. We will accept your application if we can confirm that a technical problem occurred with the Grants.gov system and that the problem affected your ability to submit your application by 4:30:00 p.m., Washington, DC time, on the application deadline date. We will contact you after we determine whether your application will be accepted.

    Note:

    The extensions to which we refer in this section apply only to the unavailability of, or technical problems with, the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the application deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system.

    Exception to Electronic Submission Requirement: You qualify for an exception to the electronic submission requirement, and may submit your application in paper format, if you are unable to submit an application through the Grants.gov system because—

    • You do not have access to the Internet; or

    • You do not have the capacity to upload large documents to the Grants.gov system;

    and

    • No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application.

    If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.

    Address and mail or fax your statement to: Francisco Ramirez, U.S. Department of Education, 400 Maryland Avenue SW., Room 3E310, Washington, DC 20202-6200. FAX: (202) 260-8969.

    Your paper application must be submitted in accordance with the mail or hand-delivery instructions described in this notice.

    b. Submission of Paper Applications by Mail

    If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.330B), LBJ Basement Level 1, 400 Maryland Avenue SW., Washington, DC 20202-4260.

    You must show proof of mailing consisting of one of the following:

    (1) A legibly dated U.S. Postal Service postmark.

    (2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.

    (3) A dated shipping label, invoice, or receipt from a commercial carrier.

    (4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.

    If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:

    (1) A private metered postmark.

    (2) A mail receipt that is not dated by the U.S. Postal Service.

    Note:

    The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.

    We will not consider applications postmarked after the application deadline date.

    c. Submission of Paper Applications by Hand Delivery

    If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.330B), 550 12th Street SW., Room 7039, Potomac Center Plaza, Washington, DC 20202-4260.

    The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.

    Note for Mail or Hand Delivery of Paper Applications:

    If you mail or hand deliver your application to the Department—

    (1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and

    (2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288.

    V. Application Review Information

    1. Review and Selection Process: The Department intends to fund, at some level, all applications that meet the requirements for approving applications described in the application package for this program and that demonstrate a need for new or additional funds to pay advanced placement exam fees on behalf of low-income students for school year 2015-16.

    Under section 1707(1) of the ESEA, as amended by NCLB, “advanced placement test” means an advanced placement test administered by the College Board or approved by the Secretary. For FY 2016, advanced placement tests administered by the College Board include Advanced Placement (AP) Seminar and AP Research under the College Board's new AP Capstone program. In addition, for FY 2016, the Secretary approves the following advanced placement tests:

    (a) Diploma Programme tests administered by the International Baccalaureate Organization (IBO);

    (b) Advanced Subsidiary (AS) Level tests administered by Cambridge International Examinations, including Global Perspectives and Research Test; and

    (c) Advanced (A) Level tests administered by Cambridge International Examinations; including Global Perspectives and Research Test.

    For FY 2016, the Department expects to award approximately $28,483,000 in new grants under this program. Based on the anticipated number of applications and other available information (including any expected fee reductions for low-income students), the Department expects this amount to be sufficient to pay all but $15 of the cost of each advanced placement exam taken by low-income students.

    Accordingly, SEAs may use APTF Program funds to cover a portion of the cost of each approved advanced placement exam taken by low-income students in school year 2015-16, as follows: (a) Up to $38 for each AP test administered by the College Board that is not an AP Seminar or AP Research exam under the College Board's AP Capstone program; (b) up to $85 for each AP Seminar test administered by the College Board under its AP Capstone program; (c) up to $85 for each AP Research test administered by the College Board under its AP Capstone program; (d) up to $98 for each Diploma Programme test administered by the IBO; (e) up to $69.10 for each AS Level test administered by Cambridge International Examinations that is not a Global Perspectives and Research exam; (f) up to $112.90 for each A Level test administered by Cambridge International Examinations that is not a Global Perspectives and Research exam; (g) up to $134.73 for each AS Level Global Perspectives and Research test administered by Cambridge International Examinations; and (h) up to $226.50 for each A Level Global Perspectives and Research test administered by Cambridge International Examinations.

    Note:

    APTF Program funds may not be used to pay registration fees on behalf of low-income students. Therefore, advanced placement test registration fees, including the student registration fees charged by the IBO, are not allowable costs under this program.

    Further information and instructions on how to request funds for school year 2015-16 are included in the application package for this competition.

    Also, in determining whether to approve an application for a new award (including the amount of the award) from an applicant with a current grant under this program, the Department will consider the amount of any unexpended funds under the existing grant and the applicant's use of funds under previous APTF Program grant awards.

    We remind potential applicants that in reviewing applications in any discretionary grant competition, the Secretary may consider, under 34 CFR 75.217(d)(3), the past performance of the applicant in carrying out a previous award, such as the applicant's use of funds, achievement of project objectives, and compliance with grant conditions. The Secretary may also consider whether the applicant failed to submit a timely performance report or submitted a report of unacceptable quality.

    In addition, in making a competitive grant award, the Secretary also requires various assurances, including those applicable to Federal civil rights laws that prohibit discrimination in programs or activities receiving Federal financial assistance from the Department of Education (34 CFR 100.4, 104.5, 106.4, 108.8, and 110.23).

    2. Risk Assessment and Special Conditions: Consistent with 2 CFR 200.205, before awarding grants under this competition the Department conducts a review of the risks posed by applicants. Under 2 CFR 3474.10, the Secretary may impose special conditions and, in appropriate circumstances, high-risk conditions on a grant if the applicant or grantee is not financially stable; has a history of unsatisfactory performance; has a financial or other management system that does not meet the standards in 2 CFR part 200, subpart D; has not fulfilled the conditions of a prior grant; or is otherwise not responsible.

    VI. Award Administration Information

    1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN); or we may send you an email containing a link to access an electronic version of your GAN. We may notify you informally, also.

    If your application is not evaluated or not selected for funding, we notify you.

    2. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice.

    We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant.

    3. Reporting: (a) If you apply for a grant under this competition, you must ensure that you have in place the necessary processes and systems to comply with the reporting requirements in 2 CFR part 170 should you receive funding under the competition. This does not apply if you have an exception under 2 CFR 170.110(b).

    (b) At the end of your project period, you must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multiyear award, you must submit an annual performance report that provides the most current performance and financial expenditure information as directed by the Secretary under 34 CFR 75.118. The Secretary may also require more frequent performance reports under 34 CFR 75.720(c). For specific requirements on reporting, please go to www.ed.gov/fund/grant/apply/appforms/appforms.html.

    (c) Under 34 CFR 75.250(b), the Secretary may provide a grantee with additional funding for data collection analysis and reporting. In this case the Secretary establishes a data collection period.

    4. Performance Measures: Under the Government Performance and Results Act of 1993, the Department has developed five performance measures to evaluate the overall effectiveness of the APTF Program: (1) The number of advanced placement tests taken by low-income public school students nationally; (2) The number of advanced placement tests taken by minority (Hispanic, Black, Native American) public school students nationally; (3) The percentage of advanced placement tests passed (for AP tests, scores of 3-5) by low-income public school students nationally; (4) The number of advanced placement tests passed (for AP tests, scores of 3-5) by low-income public school students nationally; and (5) The cost per passing advanced placement test taken by a low-income public school student. The information provided by grantees in their final performance reports will be one source of data for the measures. Other sources of data include the College Board, IBO, and Cambridge International Examinations.

    VII. Agency Contact FOR FURTHER INFORMATION CONTACT:

    Francisco Ramirez, U.S. Department of Education, 400 Maryland Avenue SW., Room 3E310, Washington, DC 20202-6200. Telephone: (202) 260-1541 or by email: [email protected]

    If you use a TDD or a TTY, call the FRS, toll free, at 1-800-877-8339.

    VIII. Other Information

    Accessible Format: Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT in section VII of this notice.

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

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

    Dated: April 7, 2016. Ann Whalen, Senior Advisor to the Secretary Delegated the Duties of Assistant Secretary for the Office of Elementary and Secondary Education.
    [FR Doc. 2016-08396 Filed 4-11-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0012] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Indian Education Professional Development Grants Program: GPRA and Service Payback Data Collection AGENCY:

    Office of Elementary and Secondary Education (OESE), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before May 12, 2016.

    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-2016-ICCD-0012. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 2E-105, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact John Cheek, 202-401-0274.

    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: Indian Education Professional Development Grants Program: GPRA and Service Payback Data Collection.

    OMB Control Number: 1810-0698.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 1,740.

    Total Estimated Number of Annual Burden Hours: 2,728.

    Abstract: The Indian Education Professional Development (IEPD) Grants program provides grants to prepare and train Indians (i.e., American Indians/Alaska Natives) to serve as teachers and administrators. The specific goals of the IEPD program are to: (1) Increase the number of qualified individuals in professions that serve American Indians/Alaska Natives; (2) provide training to qualified American Indians/Alaska Natives to become teachers, administrators, teacher aides, social workers, and ancillary education personnel; and (3) improve the skills of those qualified American Indians/Alaska Natives who already serve in these capacities. Individuals trained under this program must perform work related to their training and that benefits American Indian/Alaska Native people, or repay all or a prorated portion of the assistance received under the program.

    This data collection serves three purposes: First, data from three sources (grantees, project participants, and employers) are necessary to assess the performance of the IEPD program on its Government Performance Results Act (GPRA) measures. Second, data from all three sources are necessary to determine if IEPD participants are fulfilling the terms of their service/cash payback requirements. Finally, budget and project-specific performance data are collected from IEPD grantees for project-monitoring and compliance information. The forms and protocols contained in this package include the Grantee Reporting Form, the Participant Training Information and Employment Reporting Form, and the Employment Verification Form.

    Dated: April 7, 2016. Stephanie Valentine, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-08347 Filed 4-11-16; 8:45 am] BILLING CODE 4000-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0384] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written PRA comments should be submitted on or before June 13, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email to [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0384.

    Title: Sections 64.901, 64.904 and 64.905, Auditor's Attestation and Certification.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents and Responses: 1 respondent, 1 response.

    Estimated Time per Response: 5-250 hours.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority is contained in sections 1, 4, 201-205, 215, and 218-220 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154, 201-205, 215, and 218-220.

    Frequency of Response: On-occasion, biennial, and annual reporting requirements.

    Total Annual Burden: 255 hours.

    Total Annual Cost: $1,200,000.

    Privacy Act Impact Assessment: No impact(s).

    Nature of Extent of Confidentiality: This collection does not address information of a confidential nature.

    Needs and Uses: Section 64.904(a) states that each incumbent LEC required to file a cost allocation manual shall elect to either have an attest engagement performed by an independent auditor every two years, covering the prior two year period, or have a financial audit performed by an independent auditor biennially. In either case, the initial engagement shall be performed in the calendar year after the carrier is first required to file a cost allocation manual. See section 64.904(a)-(c). Instead of requiring mid-sized carriers to incur the expense of a biennial attestation engagement, they now file a certification with the Commission stating that they are in compliance with 47 CFR 64.901 of the Commission's rules, which sets out the rules regarding allocation of costs. The certification must be signed, under oath, by an officer of the incumbent LEC, and filed with the Commission on an annual basis. Such certification of compliance represents a less costly means of enforcing compliance with our cost allocation rules. See 47 CFR 64.905 of the Commission's rules. The requirements are imposed to ensure that the carriers are properly complying with Commission rules. They serve as an important aid in the Commission's monitoring program. Section 64.905 requires mid-sized LECs to file a certification with the Commission stating that they are complying with section 64.901. The certification must be signed, under oath, by an officer of the mid-sized LEC, and filed with the Commission on an annual basis at the time that the mid-sized incumbent LEC files the annual reports required by section 43.21(e)(2).

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2016-08374 Filed 4-11-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0439, 3060-0665, and 3060-0973] Information Collections Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written PRA comments should be submitted on or before June 13, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

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

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0439.

    Title: Section 64.201, Regulations Concerning Indecent Communications by Telephone.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities; Individuals or households.

    Number of Respondents and Responses: 10,200 respondents; 30,000 responses.

    Estimated Time per Response: 166 hours (10 minutes average per response).

    Frequency of Response: On occasion reporting requirements; Third party disclosure.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for the information collection requirements is found at Section 223 of the Communications Act of 1934, as amended (the Act), 47 U.S.C. 223, Obscene or Harassing Telephone Calls in the District of Columbia or in Interstate or Foreign Communications.

    Total Annual Burden: 4,980 hours.

    Total Annual Cost: None.

    Nature and Extent of Confidentiality: Confidentiality is an issue to the extent that individuals and households provide personally identifiable information, which is covered under the FCC's updated system of records notice (SORN), FCC/CGB-1, “Informal Complaints, Inquiries, and Request for Dispute Assistance”; published in the Federal Register on August 15, 2014, at 79 FR 48152, and became effective on September 24, 2014.

    Privacy Impact Assessment: The FCC completed a Privacy Impact Assessment (PIA) on June 28, 2007. The PIA may be reviewed at http://www.fcc.gov/omd/privacyact/Privacy_Impact_Assessment.html. The FCC is in the process of updating the PIA to incorporate various revisions made to the SORN.

    Needs and Uses: Under section 223 of the Act, common carriers are required, to the extent technically feasible, to prohibit access to obscene or indecent communications from the telephone of a subscriber who has not previously requested such access in writing, if the carrier collects charges from subscribers for such communications. 47 CFR 64.201 implements section 223 of the Act, and also include the following information collection requirements: (1) Adult message service providers notify their carriers in writing of the nature of their service; and (2) A provider of adult message services request that its carriers identify these services as such in bills to their subscribers. The information requirements are imposed on carriers, and on adult message service providers and those who solicit their services, to ensure that minors and anyone who has not consented to access such material are denied access to such material in adult message services.

    OMB Control Number: 3060-0665.

    Title: Section 64.707, Public Dissemination of Information by Providers of Operator Services.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents and Responses: 448 respondents; 448 responses.

    Estimated Time per Response: 4 hours (average per response).

    Frequency of Response: On occasion reporting requirements; Third party disclosure.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority citation for the information collection requirements is found at Section 226 of the Act, 47 U.S.C 226.

    Total Annual Burden: 1,792 hours.

    Total Annual Cost: $44,800.

    Nature and Extent of Confidentiality: An assurance of confidentiality is not offered because this information collection does not require the collection of personally identifiable information (PII) from individuals.

    Privacy Impact Assessment: No impact(s).

    Needs and Uses: Pursuant to 47 CFR 64.707, providers of operator services must regularly publish and make available at no cost to requesting consumers written materials that describe any recent changes in operator services and choices available to consumers. Consumers use the information to increase their knowledge of the choices available to them in the operator services marketplace.

    OMB Control Number: 3060-0973.

    Title: Section 64.1120(e), Verification of Orders for Telecommunications Service.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Businesses or other for-profit entities.

    Number of Respondents and Responses: 50 respondents; 150 responses.

    Estimated Time per Response: 1 to 5 hours (average per response).

    Frequency of Response: On occasion reporting requirements; Third-party disclosure requirement.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority citation for the information collection requirements is found at Section 258 of the Act, 47 U.S.C. 258.

    Total Annual Burden: 350 hours.

    Total Annual Cost: None.

    Nature and Extent of Confidentiality: An assurance of confidentiality is not offered because this information collection does not require the collection of personally identifiable information (PII) from individuals.

    Privacy Impact Assessment: No impact(s).

    Needs and Uses: Pursuant to 47 CFR 64.1120 (e), a carrier acquiring all or part of another carrier's subscriber base without obtaining each subscriber's authorization and verification will file a letter specifying certain information with the Commission, in advance of the transfer, and it will also certify that the carrier will comply with required procedures, including giving advance notice to the affected subscribers.

    These streamlined carrier change rules balance the protection of consumers' interests with ensuring that the Commission's rules do not unnecessarily inhibit routine business transactions.

    Federal Communications Commission. Marlene H. Dortch, Secretary. Office of the Secretary.
    [FR Doc. 2016-08377 Filed 4-11-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination; 10494 Syringa Bank, Boise, Idaho

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10494 Syringa Bank, Boise, Idaho (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Syringa Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective April 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: April 6, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-08343 Filed 4-11-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination; 10169 St. Stephen State Bank, St. Stephen, Minnesota

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10169 St. Stephen State Bank, St. Stephen, Minnesota (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of St. Stephen State Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective April 01, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: April 6, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-08342 Filed 4-11-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination; 10468 Westside Community Bank, University Place, Washington

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10468 Westside Community Bank, University Place, Washington (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Westside Community Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective April 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: April 7, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-08357 Filed 4-11-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meetings AGENCY:

    Federal Election Commission.

    DATE & TIME:

    Thursday, April 14, 2016 at 10:00 a.m.

    PLACE:

    999 E Street NW., Washington, DC (ninth floor).

    STATUS:

    This meeting will be open to the public.

    ITEMS TO BE DISCUSSED:

    Correction and Approval of Minutes for February 11, 2016 Correction and Approval of Minutes for February 25, 2016 Draft Advisory Opinion 2016-01: Ethiq, Inc. Draft Advisory Opinion 2016-02: Enable Midstream Services, LLC Draft Final Rule and Explanation and Justification for Technical Amendments to 2015 CFR Proposed Modifications to Program for Requesting Consideration of Legal Questions by the Commission Proposed Statement of Policy Regarding the Public Disclosure of Closed Enforcement Files Rulemaking Proposals: Motion to Open a Rulemaking to Assist Those Accepting Corporate Contributions or Making Corporate Expenditures in Complying with Existing Campaign Finance Law Motion Regarding Foreign National Rulemaking Management and Administrative Matters

    Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Shawn Woodhead Werth, Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.

    PERSON TO CONTACT FOR INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Shawn Woodhead Werth, Secretary and Clerk of the Commission.
    [FR Doc. 2016-08417 Filed 4-8-16; 11:15 am] BILLING CODE 6715-01-P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than April 27, 2016.

    A. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272:

    1. Deanna Alfred; Elizabeth Dippel Masser; Ted Christian Masser, as custodian for the TUTMA accounts for Ted Henry Masser and Katherine Elizabeth Masser; Kurt Andrew Alfred; Lauren Elizabeth Alfred, all of Brenham, Texas; and Corby Wade Alfred, Austin, Texas; all as members of the Alfred/Dippel/Voelter family group, and collectively acting as a group in concert; to retain voting shares of Brenham Bancshares, Inc., and thereby indirectly retain voting shares of Brenham National Bank, both in Brenham, Texas.

    Board of Governors of the Federal Reserve System, April 7, 2016. Michael J. Lewandowski, Associate Secretary of the Board.
    [FR Doc. 2016-08340 Filed 4-11-16; 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 May 6, 2016.

    A. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272:

    1. WestStar Bank Holding Company, Inc., El Paso, Texas; to merge with First Fabens Bancorporation, Inc., and thereby indirectly acquire First National Bank, both in Fabens, Texas.

    Board of Governors of the Federal Reserve System, April 7, 2016. Michael J. Lewandowski, Associate Secretary of the Board.
    [FR Doc. 2016-08341 Filed 4-11-16; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL TRADE COMMISSION Agency Information Collection Activities; Submission for OMB Review; Comment Request AGENCY:

    Federal Trade Commission.

    ACTION:

    Notice and request for comment.

    SUMMARY:

    In compliance with the Paperwork Reduction Act (PRA) of 1995, the FTC is seeking public comments on its request to OMB for a three-year extension of the current PRA clearance for the information collection requirements contained in the Mail, Internet, or Telephone Order Merchandise Rule (MITOR). This clearance expires on April 30, 2016.

    DATES:

    Comments must be received by May 12, 2016.

    ADDRESSES:

    Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write “Mail, Internet, or Telephone Order Merchandise Trade Regulation Rule: FTC File No. R511929” on your comment, and file your comment online at https://ftcpublic.commentworks.com/ftc/mitorpra2 by following the instructions on the Web-based form. If you prefer to file your comment on paper, mail or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the proposed information requirements should be addressed to Jock Chung, Attorney, Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW., Washington, DC 20580, (202) 326-2984.

    SUPPLEMENTARY INFORMATION:

    Title: Mail, Internet, or Telephone Order Merchandise Rule (MTOR or Rule), 16 CFR part 435.

    OMB Control Number: 3084-0106.

    Type of Review: Extension of a currently approved collection.

    Abstract: Generally, the MITOR requires a merchant to: (1) Have a reasonable basis for any express or implied shipment representation made in soliciting the sale (if no express time period is promised, the implied shipment representation is 30 days); (2) notify the consumer and obtain the consumer's consent to any delay in shipment; and (3) make prompt and full refunds when the consumer exercises a cancellation option or the merchant is unable to meet the Rule's other requirements.

    The notice provisions in the Rule require a merchant who is unable to ship within the promised shipment time or 30 days to notify the consumer of a revised date and his or her right to cancel the order and obtain a prompt refund. Delays beyond the revised shipment date also trigger a notification requirement to consumers. When the MITOR requires the merchant to make a refund and the consumer has paid by credit card, the Rule also requires the merchant to notify the consumer either that any charge to the consumer's charge account will be reversed or that the merchant will take no action that will result in a charge.

    On January 19, 2016, the Commission sought comment on the information collection requirements in MTOR. See 81 FR 2860. The Commission received two comments but neither one addressed the issues raised by the public comment request. As required by OMB regulations, 5 CFR part 1320, the FTC is providing this second opportunity for public comment.

    Likely Respondents: Businesses engaged in the sale of merchandise by mail or by telephone.

    Estimated Annual Hours Burden: 1,953,840 hours.

    Third Party Disclosure: [(33,267 established businesses × 50 hours) + (1,263 new entrants × 230 hours) = 1,953,840 hours.

    Estimated Annual Cost Burden: $44,879,705, which is derived from 1,953,840 hours × $22.97/hour.1

    1 This is the mean hourly income for workers in sales and related occupations according to the latest figures from the Department of Commerce's Bureau of Labor Statistics. See Table 1, National employment and wage data from the Occupational Employment Statistics survey by occupation, May 2015, at http://www.bls.gov/news.release/ocwage.t01.htm.

    Request for Comment

    You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before May 12, 2016. Write “Mail, Internet, or Telephone Order Merchandise Trade Regulation Rule: FTC File No. R511929” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

    Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, such as anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is . . . privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

    If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you are required to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c). Your comment will be kept confidential only if the FTC General Counsel grants your request in accordance with the law and the public interest.

    Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comment online, or to send it to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/mitorpra2, by following the instructions on the Web-based form. If this Notice appears at http://www.regulations.gov, you also may file a comment through that Web site.

    If you file your comment on paper, write “Mail, Internet, or Telephone Order Merchandise Trade Regulation Rule: FTC File No. R511929” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

    The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before May 12, 2016. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.shtm.

    Comments on the information collection requirements subject to review under the PRA should also be submitted to OMB. If sent by U.S. mail, address comments to: Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission, New Executive Office Building, Docket Library, Room 10102, 725 17th Street NW., Washington, DC 20503. Comments sent to OMB by U.S. postal mail, however, are subject to delays due to heightened security precautions. Thus, comments instead should be sent by facsimile to (202) 395-5167.

    Christian S. White, Deputy General Counsel.
    [FR Doc. 2016-08369 Filed 4-11-16; 8:45 am] BILLING CODE 6750-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Emergency Funding for Puerto Rico Department of Health, Zika Virus Outbreak AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS).

    ACTION:

    This notice announces the Centers for Disease Control and Prevention's (CDC) intent to fund the Puerto Rico Department of Health with Prevention and Public Health Funds (PPHF).

    PPHF 2016: Epidemiology and Laboratory Capacity Program—Emergency Funding for Puerto Rico Department of Health, Zika virus Outbreak for Infectious Diseases (ELC)—financed solely by Prevention and Public Health Funds.

    FOA Number: CDC-RFA-CK14-140103CONTPPHF2016.

    SUMMARY:

    The U.S. Centers for Disease Control and Prevention (CDC) is providing $3,700,000 in urgent funding through the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) Cooperative Agreement to the Puerto Rico Department of Health (PRDOH) to combat the current outbreak of Zika virus.

    Project Description

    Puerto Rico is experiencing an approximate doubling of confirmed Zika virus cases per week—they are unique in the total number of cases, the level of local transmission, and the presence of the Zika-carrying vector. Currently, the PR DOH cannot sufficiently address necessary aspects of the outbreak response without additional support. In addition to equipment and supplies necessary for the increased testing for Zika virus, funds awarded to PRDOH will be used to support additional epidemiology and laboratory staff critical to the response efforts.

    Prevention Fund Reporting Requirements: This award requires the grantee to complete projects or activities which are funded under the Prevention and Public Health Fund (PPHF) (Section 4002 of Pub. L. 111-148) and to report on use of PPHF funds provided through this award. Information from these reports will be made available to the public.

    Grantees awarded a grant, cooperative agreement, or contract from such funds with a value of $25,000 or more shall produce reports on a semi-annual basis with a reporting cycle of January 1-June 30 and July 1-December 31; and email such reports to the CDC Web site (template and point of contact to be provided after award) no later than 20 calendar days after the end of each reporting period (i.e. July 20 and January 20, respectively). Grantee reports must reference the NoA number and title of the grant, and include a summary of the activities undertaken and identify any sub-awards (including the purpose of the award and the identity of each sub-recipient).

    Responsibilities for Informing Sub-recipients: Grantees agree to separately identify each sub-recipient, document the execution date sub-award, date(s) of the disbursement of funds, the Federal award number, any special CFDA number assigned for PPHF fund purposes, and the amount of PPHF funds. When a grantee awards PPHF funds for an existing program, the information furnished to sub-recipients shall distinguish the sub-awards of incremental PPHF funds from regular sub-awards under the existing program.

    DATES:

    Effective date is April 12, 2016.

    ADDRESSES:

    Alvin Shultz, MSPH, Division of Preparedness and Emerging Infectious, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Atlanta, GA 30333, Phone: 404-639-7028, E-Mail: [email protected].

    FOR FURTHER INFORMATION CONTACT:

    Alvin Shultz, MSPH, Division of Preparedness and Emerging Infectious, National Center for Emerging and Zoonotic Infectious, Diseases Centers for Disease Control and Prevention, 1600 Clifton Road NE., Atlanta, GA 30333. Phone: 404-639-7028. E-Mail: [email protected]

    Dated: March 25, 2016. Terrance Perry, Director, Office of Grants Services, Centers for Disease Control and Prevention.
    [FR Doc. 2016-08318 Filed 4-11-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-16-0217] Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

    Proposed Project

    NCHS Vital Statistics Training Application (OMB Control No. 0920-0217, exp. 5/31/2016)—Revision—National Center for Health Statistics NCHS), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    In the United States, legal authority for the registration of vital events, i.e., births, deaths, marriages, divorces, fetal deaths, and induced terminations of pregnancy, resides individually with the States (as well as cities in the case of New York City and Washington, DC) and Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. These governmental entities are the full legal proprietors of vital records and the information contained therein. As a result of this State authority, the collection of registration-based vital statistics at the national level, referred to as the U.S. National Vital Statistics System (NVSS), depends on a cooperative relationship between the States and the Federal government. This data collection, authorized by 42 U.S.C. 242k, has been carried out by NCHS since it was created in 1960.

    NCHS assists in achieving the comparability needed for combining data from all States into national statistics, by conducting a training program for State and local vital statistics staff to assist in developing expertise in all aspects of vital registration and vital statistics. The training offered under this program includes courses for registration staff, statisticians, and coding specialists, all designed to bring about a high degree of uniformity and quality in the data provided by the States. This training program is authorized by 42 U.S.C. 242b, section 304(a).

    NCHS notifies State and local vital registration officials, as well as Canadian counterparts, about upcoming training. Individual candidates for training then submit an application form including name, address, occupation, and other relevant information.

    In this revision, the application for the Vital Statistics Training is being updated to capture additional logistical information. The proposed changes include the addition of two questions (1) to identify the training personnel as either State or locally-based and (2) to determine if the registrant has previously attended the training. And if so, when? Likewise, the information listed for the NCHS contact person has been updated.

    NCHS is requesting a three-year OMB clearance to collect the necessary information using these training application forms. The total estimated annualized burden hours are 30. There is no cost to respondents other than their time.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • State, Local Health department and vital health Employees Annual Survey Training Needs 60 1 15/60 State, Local Health department and vital health Employees NCHS Vital Statistics Training Application 60 1 15/60
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-08297 Filed 4-11-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-R-153 and CMS-R-284] Agency Information Collection Activities: Submission for OMB Review; Comment Request ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments on the collection(s) of information must be received by the OMB desk officer by May 12, 2016.

    ADDRESSES:

    When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs; Attention: CMS Desk Officer; Fax Number: (202) 395-5806 OR Email: [email protected]

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    Reports Clearance Office at (410) 786-1326.

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

    1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicaid Drug Use Review (DUR) Program; Use: States must provide for a review of drug therapy before each prescription is filled or delivered to a Medicaid patient. This review includes screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, and clinical abuse/misuse. Pharmacists must make a reasonable effort to obtain, record, and maintain Medicaid patient profiles. These profiles must reflect at least the patient's name, address, telephone number, date of birth/age, gender, history, e.g., allergies, drug reactions, list of medications, and pharmacist's comments relevant to the individual's drug therapy.

    The State must conduct RetroDUR which provides for the ongoing periodic examination of claims data and other records in order to identify patterns of fraud, abuse, inappropriate or medically unnecessary care. Patterns or trends of drug therapy problems are identified and reviewed to determine the need for intervention activity with pharmacists and/or physicians. States may conduct interventions via telephone, correspondence, or face-to-face contact.

    Annual reports are submitted to CMS for the purposes of monitoring compliance and evaluating the progress of States' DUR programs. The information submitted by States is reviewed and results are compiled by CMS in a format intended to provide information, comparisons and trends related to States' experiences with DUR. The States benefit from the information and may enhance their programs each year based on State reported innovative practices that are compiled by CMS from the DUR annual reports. Form Number: CMS-R-153 (OMB control number: 0938-0659); Frequency: Yearly, quarterly, and occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 51; Total Annual Responses: 510; Total Annual Hours: 20,808. (For policy questions regarding this collection contact Renee Hilliard at 410-786-2991.)

    2. Type of Information Collection Request: Revision of a currently approved collection. Title of Information Collection: Medicaid Statistical Information System (MSIS) and Transformed—Medicaid Statistical Information System (T-MSIS); Use: The data reported in MSIS/T-MSIS are used by federal, state, and local officials, as well as by private researchers and corporations to monitor past and projected future trends in the Medicaid program. These data provide the only national level information available on enrollees, beneficiaries, and expenditures. They also provide the only national level information available on Medicaid utilization. This information is the basis for analyses and for cost savings estimates for the Department's cost sharing legislative initiatives to Congress. The collected data are also crucial to our actuarial forecasts. Form Number: CMS-R-284 (OMB control number: 0938-0345); Frequency: Quarterly and monthly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 51; Total Annual Responses: 804; Total Annual Hours: 8,040. (For policy questions regarding this collection contact Camiel Rowe at 410-786-0069.)

    Dated: April 5, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2016-08116 Filed 4-11-16; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects

    Title: Child Care and Development Fund Financial Report (ACF 696) for States and Territories.

    OMB No.: 0970-0163.

    Description: States and Territories use the Financial Report Form ACF-696 to report Child Care and Development Fund (CCDF) expenditures. Authority to collect and report this information is found in section 658G of the Child Care and Development Block Grant Act of 1990, as revised. In addition to the Program Reporting Requirements set forth in 45 CFR part 98, subpart H, the regulations at 45 CFR 98.65(g) and 98.67(c)(1) authorize the Secretary to require financial reports as necessary.

    The form provides specific data regarding claims and provides a mechanism for States to request Child Care grant awards and to certify the availability of State matching funds. Failure to collect this data would seriously compromise ACF's ability to monitor Child Care and Development Fund expenditures. This information is also used to estimate outlays and may be used to prepare ACF budget submissions to Congress.

    ACF has not made substantive revisions to the reporting form itself, but has revised the accompanying instructions to provide more detailed guidance to assist grantees with completing the form.

    Respondents: States and Territories.

    Annual Burden Estimates Instrument Number of
  • respondents
  • Number of
  • responses per respondent
  • Average
  • burden hours per response
  • Total burden hours
    ACF-696 56 4 5 1,120

    Estimated Total Annual Burden Hours: 1,120.

    In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address: [email protected] All requests should be identified by the title of the information collection.

    The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

    Robert Sargis, Reports Clearance Officer.
    [FR Doc. 2016-08263 Filed 4-11-16; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request

    Title: Responding to Intimate Violence in Relationship programs (RIViR)

    OMB No.: New Collection

    Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is proposing a data collection as part of the “Responding to Intimate Violence in Relationship programs” (RIViR) study. This notice addresses testing of intimate partner violence (IPV) and teen dating violence (TDV) screener/protocols, to be conducted with approximately 1,200 participants from approximately six Healthy Marriage and Relationship Education (HMRE) grantees funded by the Office of Family Assistance (OFA).

    There is little consensus on how HMRE programs should address IPV or TDV in their programs. To date, no IPV or TDV screening tools have been empirically tested among HMRE program participants. The objective of the proposed data collection is to test and validate IPV and TDV screening instruments among HMRE program participants. Findings from this data collection will be used to develop practical, responsive guidance on IPV and TDV screening and surrounding protocols for HMRE programs.

    Data collection will entail testing eight screening instruments: Six closed-ended screening instruments (three for IPV, three for TDV), and two open-ended instruments (one for IPV, one for TDV). It is anticipated that each participant will engage in four rounds of data collection, one round for each IPV or TDV instrument, at least two weeks apart. Data collection is expected to occur from Winter 2016/2017 through Spring 2017.

    Respondents: HMRE grantee program participants: 600 Youth (approximately ages 14-18) will participate in the TDV screener testing and 600 adults (ages 18 and older) will participate in the IPV screener testing.

    Annual Burden Estimates Instrument Total/annual number of

  • respondents
  • Number of
  • responses per respondent
  • Average
  • burden hours
  • per response
  • Annual burden hours Adult Closed-ended IPV Screening Tool #1 600 1 .25 150 Adult Closed-ended IPV Screening Tool #2 600 1 .25 150 Adult Closed-ended IPV Screening Tool #3 600 1 .25 150 Adult Open-ended IPV Screening Tool 600 1 .5 300 Youth Closed-ended TDV Screening Tool #1 600 1 .25 150 Youth Closed-ended TDV Screening Tool #2 600 1 .25 150 Youth Closed-ended TDV Screening Tool #3 600 1 .25 150 Youth Open-ended TDV Screening Tool 600 1 .5 300

    Estimated Total Annual Burden Hours: 1,500.

    In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded 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. Email address: [email protected] All requests should be identified by the title of the information collection.

    The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

    Robert Sargis, ACF Certifying Officer.
    [FR Doc. 2016-08363 Filed 4-11-16; 8:45 am] BILLING CODE 4184-73-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families National Child Care Hotline and Web site; Comment request; Correction AGENCY:

    Administration for Children and Families, Department of Health and Human Services.

    ACTION:

    Comment request; correction.

    SUMMARY:

    The Administration for Children and Families published a document in the Federal Register on March 8, 2016, requesting comments on a National toll-free hotline and Web site for child care. The document contained an incorrect email address for responses. Because the email address was incorrect, the Administration for Children and Families is extending the deadline for submission of comments as well.

    FOR FURTHER INFORMATION CONTACT:

    Paula Bendl Smith, 202-401-5616.

    Corrections

    (1) In the Federal Register of March 8, 2016, in FR Doc. 81-12105, on page 12105, in the right-hand column, correct the ADDRESSES caption to read:

    ADDRESSES: Submit comments to [email protected]

    (2) In the Federal Register of March 8, 2016, in FR Doc. 81-12105, on page 12105, in the right-hand column, correct the DATES caption to read:

    DATES: The deadline for receipt of comments is midnight, April 15, 2016. Dated: April 6, 2016. Shannon Rudisill, Associate Deputy Assistant Secretary for Early Childhood Development.
    [FR Doc. 2016-08283 Filed 4-11-16; 8:45 am] BILLING CODE 4184-43-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-2345] Determination of Regulatory Review Period for Purposes of Patent Extension; ADEMPAS AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) has determined the regulatory review period for ADEMPAS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

    DATES:

    Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by June 13, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by October 11, 2016. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2014-E-2345 for “Determination of Regulatory Review Period for Purposes of Patent Extension; ADEMPAS.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human drug product ADEMPAS (riociguat). ADEMPAS is indicated for treatment of adults with persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; and treatment of pulmonary arterial hypertension to improve exercise capacity, improve WHO functional class, and to delay clinical worsening. Subsequent to this approval, the USPTO received a patent term restoration application for ADEMPAS (U.S. Patent No. 7,173,037) from Bayer Intellectual Property GmbH, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 19, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ADEMPAS represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for ADEMPAS is 2,394 days. Of this time, 2,151 days occurred during the testing phase of the regulatory review period, while 243 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: March 22, 2007. FDA has verified the Bayer Intellectual Property GmbH claim that March 22, 2007, is the date the investigational new drug application (IND) became effective.

    2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: February 8, 2013. FDA has verified the applicant's claim that the new drug application (NDA) for ADEMPAS (NDA 204819) was initially submitted on February 8, 2013.

    3. The date the application was approved: October 8, 2013. FDA has verified the applicant's claim that NDA 204819 was approved on October 8, 2013.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,317 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: April 6, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08337 Filed 4-11-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-1904] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Comparing Food Safety Knowledge, Attitude and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by May 12, 2016.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910—New and title “Comparing Food Safety Knowledge, Attitude and Behavior Among English-dominant Hispanics, Spanish-dominant Hispanics, and Other Consumers.” Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Comparing Food Safety Knowledge, Attitude and Behavior Among English-Dominant Hispanics, Spanish-Dominant Hispanics, and Other Consumers—OMB Control Number 0910—NEW I. Background

    We conduct research and educational and public information programs relating to food safety and nutrition issued in our broad statutory authority, set forth in section 1003(b)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)), to protect the public health by ensuring that foods are “safe, wholesome, sanitary, and properly labeled,” and in section 1003(d)(2)(C) of the FD&C Act (21 U.S.C. 393(d)(2)(C)), to conduct research relating to foods, drugs, cosmetics, devices and tobacco products.

    Our current food safety education and outreach programs and materials generally are developed and provided for the English-speaking population in the United States (U.S.) (Ref. 1). To better protect public health and to help consumers practice safe food handling, we need empirical data on how different population groups understand, perceive and practice food safety and food handling. An emerging and important demographic trend in the United States is the increase in Hispanics. Recent estimates suggest that Hispanics (defined as those who identify themselves as of Hispanic or Latino origin) are the largest and fastest growing minority group in the nation; the proportion of the U.S. population that was Hispanic was 14 percent in 2005 and is projected to increase to 29 percent in 2050 (Ref. 2).

    Data from the Centers for Disease Control and Prevention (CDC) indicate that, in the past two decades, Hispanics were one of the population groups that often experienced higher incidence rates (per 100,000 population) of bacterial causes of foodborne illness than Caucasians (Ref. 3). These bacterial causes include Campylobacter, Listeria monocytogenes (Listeria), Shigella, and Salmonella. While some Hispanics living in the United States use the English language exclusively or more often than Spanish (English-dominant Hispanics), other U.S. Hispanics predominantly use the Spanish language in their daily lives (Spanish-dominant Hispanics) (Ref. 4). Since most U.S. food labels, including safe food handling instructions, are in English, Spanish-dominant Hispanics' understanding and use of safe food handling instructions may differ from that of English-dominant Hispanics and of non-Hispanics who use English exclusively. In addition, Hispanics may have certain food handling practices that may increase their risk of foodborne illness (Ref. 5).

    FDA needs an understanding of how different population groups perceive and behave in terms of food safety and food handling to inform development of possible measures that we may take to better protect public health and to help consumers practice safe food handling. FDA is aware of no consumer research on a nationwide level on how different population groups understand, perceive and practice food safety and food handling. This study is intended to provide initial answers to research questions such as whether and how much Spanish-dominant Hispanics, English-dominant Hispanics, and English-speaking non-Hispanics differ in their knowledge, attitude, and behavior toward food safety and food handling and the role that demographic and other factors may play in any differences.

    The proposed study will use a Web-based instrument to collect information from 3,000 adult members in online consumer panels maintained by a contractor. The study plans to randomly select 1,000 panel members in each of three groups: Spanish-dominant Hispanics, English-dominant Hispanics, and English-speaking non-Hispanics. Both English and Spanish questionnaires will be used, as appropriate. The study plans to include topics such as: (1) Food safety knowledge and attitude; and (2) food handling and consumption practice. To help us understand the data, the study will also collect information on respondents' background, including, but not limited to, health status and demographic characteristics, such as age, gender, education, and income, and degree of acculturation among Hispanic respondents using a measure developed by Marin et al. (Ref. 6).

    The study is part of our continuing effort to protect the public health. We will not use the results of the study to develop population estimates. We plan to use the results of the study to develop follow-up quantitative and qualitative research to gauge the prevalence and extent of differences in food safety knowledge and behaviors between the three mentioned population groups. We plan to use the results of the follow-up research to help inform the design of effective education and outreach initiatives aimed at helping reduce the risk of foodborne illness for the general U.S. population as well as Hispanics.

    In the Federal Register of November 28, 2014 (79 FR 70875), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses per respondent
  • Total annual responses Average burden per response Total hours
    Cognitive interview screener 72 1 72 0.083 (5 minutes) 6 Cognitive interview 9 1 9 1.5 (90 minutes) 14 Pretest invitation 1,440 1 1,440 0.033 (2 minutes) 48 Pretest 180 1 180 0.25 (15 minutes) 45 Study invitation 24,000 1 24,000 0.033 (2 minutes) 792 Study 3,000 1 3,000 0.25 (15 minutes) 750 Total 1,655 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimates on prior experience with research that is similar to this proposed study. We will use a cognitive interview screener with 72 individuals to recruit prospective interview participants. We estimate that it will take a screener respondent approximately 5 minutes (0.083 hours) to complete the cognitive interview screener, for a total of 5.976 hours, rounded to 6 hours. We will conduct cognitive interviews with nine participants. We estimate that it will take a participant approximately 90 minutes to complete the interview, for a total of 13.5 hours, rounded to 14 hours. We also plan to conduct a pretest to identify and resolve potential survey administration problems. We will send a pretest invitation to 1,440 prospective pretest participants and estimate that it will take a respondent approximately 2 minutes (0.033 hours) to complete the invitation, for a total of 47.52 hours, rounded to 48 hours. We will administer the pretest with 180 participants and estimate that it will take a participant 15 minutes (0.25 hours) to complete the pretest, for a total of 45 hours. We will send a study invitation to 24,000 prospective participants and estimate that it will take a respondent approximately 2 minutes (0.033 hours) to complete the invitation, for a total of 792 hours. We will administer the study with 3,000 participants and estimate that it will take a participant 15 minutes (0.25 hours) to complete the study, for a total of 750 hours. The total estimated burden for all the study activities is 1,655 hours; this estimate is 9 hours higher than that shown in the 60-day notice due to revised hours for cognitive interviews, from 30 minutes (0.5 hours) to 90 minutes (1.5 hours) each interview.

    II. References

    1. U.S. Food and Drug Administration. “Foodborne Illness & Contaminants.” June 9, 2014. (http://www.fda.gov/Food/FoodborneIllnessContaminants/default.htm).

    2. Passel, J.S. and C. D'Vera. “U.S. Population Projections: 2005-2050.” Pew Research Center. February 11, 2008. (http://pewhispanic.org/files/reports/85.pdf).

    3. Quinlan, J.J. “Foodborne Illness Incidence Rates and Food Safety Risks for Populations of Low Socioeconomic Status and Minority Race/Ethnicity: A Review of the Literature.” International Journal of Environmental Research and Public Health 10(8): 3634-3652, 2013.

    4. Taylor, P., M.H. Lopez, J. Martínez and G.Velasco. “Language Use Among Latinos.” Pew Research Center. April 4, 2012. (http://www.pewhispanic.org/2012/04/04/iv-language-use-among-latinos/).

    5. Henley, S.C., S.E. Stein and J.J. Quinlan. “Identification of Unique Food Handling Practices That Could Represent Food Safety Risks for Minority Consumers.” Journal of Food Protection 75: 2050-2054, 2012.

    6. Marin, G., F. Sabogal, B.V. Marin, et al. “Development of a Short Acculturation Scale for Hispanics.” Hispanic Journal of Behavioral Sciences 9(2): 183-205, 1987.

    Dated: April 6, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08332 Filed 4-11-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1101] EMD Serono; Withdrawal of Approval of a New Drug Application for LUVERIS AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is withdrawing approval of a new drug application (NDA) for LUVERIS (lutropin alpha for injection) held by EMD Serono, One Technology Place, Rockland, MA 02370. EMD Serono has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing.

    DATES:

    Effective April 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Emily Helms Williams, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-796-3381.

    SUPPLEMENTARY INFORMATION:

    FDA approved LUVERIS (lutropin alpha for injection) on October 8, 2004, under the Agency's accelerated approval regulations, 21 CFR part 314, subpart H. LUVERIS is indicated for concomitant administration with GONAL-F (follitropin alfa for injection) for stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound luteinizing hormone deficiency. In a letter dated April 30, 2012, EMD Serono requested that FDA withdraw approval of NDA 021322 for LUVERIS under § 314.150(c). In that letter, EMD Serono noted that, as had been previously discussed with the Agency, it was not feasible to complete a trial that the company had agreed to at the time of approval under subpart H. By letter dated December 8, 2014, FDA notified EMD Serono that, when studies that are required as a condition of approval under the Agency's accelerated approval regulations are not completed, the approval of an application is withdrawn according to the procedures set forth in §§ 314.530 and 314.150(d) rather than under § 314.150(c). FDA requested that EMD Serono submit a new withdrawal request under § 314.150(d).

    Following additional correspondence, by letter dated July 23, 2015, EMD Serono requested that FDA withdraw approval of NDA 021322 for LUVERIS under § 314.150(d) because a postmarketing study that was required as a condition of approval under subpart H was not completed. Because that study was required to verify and describe the clinical benefit of the drug product, the clinical benefit of LUVERIS has not been confirmed, and it has not been established to be safe and effective. In its July 23, 2015, letter, EMD Serono waived any opportunity for a hearing otherwise provided under §§ 314.150 and 314.530. FDA responded by letter dated September 2, 2015, acknowledging EMD Serono's request that FDA withdraw approval of LUVERIS under § 314.150(d). FDA also acknowledged that EMD Serono waived its opportunity for a hearing.

    Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and § 314.150(d), and under authority delegated by the Commissioner to the Director, Center for Drug Evaluation and Research, approval of NDA 021322, and all amendments and supplements thereto, is withdrawn (see DATES). Distribution of this product in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).

    Dated: April 6, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08336 Filed 4-11-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0560] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by May 12, 2016.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-0582. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable—OMB Control Number 0910-0582—Extension

    FDA's investigational device regulations are intended to encourage the development of new, useful devices in a manner that is consistent with public health, safety, and compliant with ethical standards. Investigators should have freedom to pursue the least burdensome means of accomplishing this goal. However, to ensure that the balance is maintained between product development and the protection of public health, safety, and ethical standards, FDA has established human subject protection regulations addressing requirements for informed consent and institutional review board (IRB) review that apply to all FDA-regulated clinical investigations involving human subjects. In particular, informed consent requirements further both safety and ethical considerations by allowing potential subjects to consider both the physical and privacy risks they face if they agree to participate in a trial.

    Under FDA regulations, clinical investigations using human specimens conducted in support of premarket submissions to FDA are considered human subject investigations (see 21 CFR 812.3(p)). Many investigational device studies are exempt from most provisions of part 812, Investigational Device Exemptions, under 21 CFR 812.2(c)(3), but FDA's regulations for the protection of human subjects (21 CFR parts 50 and 56) apply to all clinical investigations that are regulated by FDA (see 21 CFR 50.1, 21 CFR 56.101, 21 U.S.C. 360j(g)(3)(A), and 21 U.S.C. 360j(g)(3)(D)).

    FDA regulations do not contain exceptions from the requirements of informed consent on the grounds that the specimens are not identifiable or that they are remnants of human specimens collected for routine clinical care or analysis that would otherwise have been discarded. Nor do FDA regulations allow IRBs to decide whether or not to waive informed consent for research involving leftover or unidentifiable specimens.

    In a level 1 guidance document, entitled “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable,” issued under the Good Guidances Practices regulation, 21 CFR 10.115, FDA outlines the circumstances in which it intends to exercise enforcement discretion as to the informed consent regulations for clinical investigators, sponsors, and IRBs.

    The recommendations of the guidance impose a minimal burden on industry. FDA estimates that 700 studies will be affected annually. Each study will result in one annual record, estimated to take 4 hours to complete. This results in a total recordkeeping burden of 2,800 hours (700 × 4 = 2,800).

    In the Federal Register of October 23, 2015 (80 FR 64422), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Recordkeeping Burden 1 The FD&C Act section Number of
  • recordkeepers
  • Number of
  • records per
  • recordkeeper
  • Total annual
  • records
  • Average
  • burden per
  • recordkeeping
  • Total hours
    520(g) 700 1 700 4 2,800 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Dated: April 6, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08329 Filed 4-11-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0832] Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of opportunity for hearing.

    SUMMARY:

    The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), is proposing to withdraw approval of all new animal drug applications (NADAs) providing for use of carbadox in medicated swine feed. This action is based on CVM's determination that the use of carbadox under the approved conditions of use results in residues of carcinogenic concern in the edible tissues of the treated swine.

    DATES:

    Phibro Animal Health Corp. may submit a request for a hearing by May 12, 2016. Submit all data and analysis upon which the request for a hearing relies by July 11, 2016.

    ADDRESSES:

    The request for a hearing may be submitted by Phibro Animal Health Corp. by either of the following methods:

    Electronic Submission

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments to submit your request for hearing. Your request for a hearing submitted electronically, including any attachments to the request for hearing, to http://www.regulations.gov will be posted to the docket unchanged.

    Written/Paper Submission

    Mail/Hand delivery/Courier (for written/paper request for a hearing): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Because your request for a hearing will be made public, you are solely responsible for ensuring that your request does not include any confidential information that you may not wish to be publicly posted, such as confidential business information, e.g., a manufacturing process. The request for a hearing must include the Docket No. FDA-2016-N-0832 for “Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing.” The request for a hearing will be placed in the docket and publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Phibro Animal Health Corp. may submit all data and analysis upon which the request for a hearing relies in the same manner as the request for a hearing except as follows:

    • Confidential Submissions—To submit any data and analyses with confidential information that you do not wish to be made publicly available, submit your data and analyses only as a written/paper submission. You should submit two copies total of all data and analysis. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of any decisions on this matter. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov or available at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Submit both copies to the Division of Dockets Management. Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law.

    Comments Submitted by Other Interested Parties: For all comments submitted by other interested parties you may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-0832 for “Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Vernon Toelle, Center for Veterinary Medicine (HFV-230), 7519 Standish Pl., Rockville, MD 20855, 240-276-9200.

    SUPPLEMENTARY INFORMATION:

    I. Approved NADAs for Use of Carbadox in Swine Feed

    Carbadox, a quinoxaline derivative, is a synthetic organic acid antimicrobial. Currently, there are three approved NADAs for use of carbadox in medicated swine feed, either by itself or in combination with other approved new animal drugs. Phibro Animal Health Corp. (Phibro), 65 Challenger Rd., Ridgefield Park, NJ 07660, is currently the sponsor of all three approved NADAs.

    Carbadox is marketed as a Type A medicated article used to manufacture complete Type C medicated feeds that are administered ad libitum to swine. Carbadox is indicated for the control of dysentery and bacterial enteritis, and for growth promotion. A tolerance of 30 parts per billion (ppb) 1 has been established for residues of quinoxaline-2-carboxylic acid (QCA), the marker residue, in liver of swine (21 CFR 556.100).

    1 For consistency and readability throughout this document, concentrations are reported as parts per billion even though original references may report some concentrations as parts per trillion (ppt).

    The following three NADAs are approved for the use of carbadox:

    NADA 041-061, originally approved in 1972 (37 FR 20683, October 3, 1972), provides for the use of MECADOX 10 (carbadox) Type A medicated article to manufacture single-ingredient Type C medicated swine feeds for the following conditions of use:

    • Carbadox at 10 to 25 grams per ton (g/ton) of feed for increased rate of weight gain and improved feed efficiency; and

    • Carbadox at 50 g/ton of feed for control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); for control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); and for increased rate of weight gain and improved feed efficiency.

    Currently, the withdrawal period for these uses of carbadox is 42 days (§ 558.115(d)(1)(ii) and (d)(2)(ii) (21 CFR 558.115(d)(1)(ii) and (d)(2)(ii))).

    NADA 092-955, originally approved in 1975 (40 FR 45164, October 1, 1975), provides for the use of MECADOX 10 (carbadox) Type A medicated article with BANMINTH (pyrantel tartrate) Type A medicated article to manufacture two-way, combination drug Type C medicated swine feeds for the following conditions of use:

    • Carbadox at 50 g/ton of feed plus pyrantel tartrate at 96 g/ton of feed for control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dysentery); for control of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis); as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum) infections.

    The withdrawal period for the use of this drug combination is 70 days (§ 558.115(d)(3)(ii)).

    NADA 141-211, originally approved in 2004 (69 FR 51173, August 18, 2004), provides for the use of MECADOX 10 (carbadox) Type A medicated article with TERRAMYCIN 50, TERRAMYCIN 100, or TERRAMYCIN 200 (oxytetracycline) Type A medicated articles to manufacture two-way, combination drug Type C medicated swine feeds for the following conditions of use:

    • Carbadox at 10 to 25 g/ton of feed plus oxytetracycline at levels in feed to deliver 10 mg carbadox per pound of body weight for treatment of bacterial enteritis caused by Escherichia coli and S. choleraesuis susceptible to oxytetracycline; for treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; and for increased rate of weight gain and improved feed efficiency.

    The withdrawal period for the use of this animal drug combination is 42 days (§ 558.115(d)(4)(ii)).

    II. Basis for Withdrawal of Approval

    CVM is providing notice of an opportunity for a hearing (NOOH) on a proposal to withdraw approval of the NADAs providing for use of carbadox in medicated swine feeds. New evidence regarding carcinogenic residues in edible tissues of swine treated with carbadox raises serious questions about the human food safety of the drug. Grounds for withdrawing carbadox are twofold. First, new evidence demonstrates that the Delaney Clause in section 512(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b), which requires that no residue of a carcinogenic drug can be found in any edible portion of the animal after slaughter, applies because the Diethylstilbestrol (DES) Proviso exception is no longer met (see, Section III.C). Second, new evidence demonstrates that carbadox is not shown to be safe under the General Safety Clause (section 512(e)(1)(B) of the FD&C Act).

    During the review of a supplemental application to NADA 041-061 approved in January 1998, CVM made the following conclusions about the drug: (1) The parent compound carbadox is rapidly metabolized and carcinogenic residues of the drug are not identifiable in any edible tissues beyond 72 hours post dosing; (2) remaining unextracted residues of carbadox are noncarcinogenic residues related to the noncarcinogenic metabolite QCA; and (3) QCA is a reliable marker residue for carbadox and its metabolites (Ref. 1).

    Since the evaluation of information submitted by the sponsor in that supplemental application, CVM has become aware of new information that calls into question the basis for its previous conclusions. As described more fully in Section V., this includes new residue depletion data presented to the Joint FAO/WHO Expert Committee on Food Additives (JECFA) 2 in 2003 that shows that when the marker residue QCA reaches the approved tolerance of 30 ppb in liver, concentrations of the carcinogen desoxycarbadox (DCBX) in the liver would be approximately 4 times higher than the concentration that would be considered safe (Ref. 2 at pp. 16-17). In addition, the new residue depletion data presented to JECFA in 2003 call into question CVM's previously held conclusion that the unextracted residues of carbadox at the withdrawal period are noncarcinogenic compounds related to the QCA metabolite (Ref. 1). The Agency treats the unidentified residues—metabolites of a carcinogenic parent drug with demonstrated carcinogenic metabolites—as carcinogenic. Therefore, the drug is not shown to be safe under the General Safety Clause and the Delaney Clause applies to the drug, because the DES Proviso exception is no longer met.

    2 JECFA is an independent committee of international scientific experts administered jointly by the United Nations Food and Agriculture Organization (FAO) and the World Health Organization (WHO) for the purpose of providing independent scientific advice to the FAO, WHO, and member countries. It has been meeting since 1956 specifically to evaluate the safety of food additives, including the animal drug residues in edible tissues. See http://www.codexalimentarius.org/scientific-basis-for-codex/jecfa/en/ and http://www.who.int/foodsafety/areas_work/chemical-risks/jecfa/en/.

    Continued approval of carbadox would expose humans to concentrations of total residues of carcinogenic concern that are approximately 30 times higher (for the approved 42-day withdrawal period) or 11 times higher (for the approved 70-day withdrawal period) than the 0.915 ppb concentration of total residues of carcinogenic concern in liver that would be considered safe (Ref. 3 at p. 17, Table 8). Moreover, the sponsor has not identified an appropriate marker and analytical method to assure that residues of carcinogenic concern are below the level at which the residues present in the total human diet present no significant increase in the risk of cancer to people (the So).

    In addition to the new information presented to JECFA (Ref. 2), publications by Boison, et al., in 2009 (Ref. 4) and Baars, et al., in 1990 (Ref. 5) that were recently provided to CVM by the sponsor call into question the previous conclusion that QCA is an appropriate marker and that all residues of carcinogenic concern deplete within 72 hours after dosing.

    The new evidence from the 2003 JECFA report (Ref. 2) in conjunction with the publications by Boison, et al., in 2009 (Ref. 4) and Baars, et al., in 1991 (Ref. 6), erode the scientific justification for, and validity of, conclusions previously made about the drug in 1998. Based on this new information, evaluated together with the information available at the time of the approvals, CVM has determined that the drug is not shown to be safe under the General Safety Clause and that the Delaney Clause applies to the drug, because the DES Proviso exception is no longer met. Therefore, CVM proposes to withdraw approval of all NADAs for new animal drugs containing carbadox.

    III. Legal Context of the Proposed Action and Grounds for Withdrawal A. The Determination of Safety in Section 512

    Carbadox, for each of its uses in swine, is a new animal drug as defined in section 201(v) of the FD&C Act (21 U.S.C. 321(v)). As such, under sections 301, 501, 512, 571, and 572 of the FD&C Act (21 U.S.C. 331, 351, 360b, 360ccc, 360ccc-1), the drug cannot be legally introduced or delivered for introduction into interstate commerce in the absence of an NADA approval, a conditional approval, or an animal drug indexing. The requirements for approval of an NADA are set out in section 512(d)(2)(A) of the FD&C Act. Section 512(b)(1)(A) of the FD&C Act requires that a new animal drug must be shown to be safe and effective for its intended uses. Section 201(u) of the FD&C Act provides that “safe” as used in section 512 of the FD&C Act “has reference to the health of man or animal.” The determination of safety requires CVM to consider, among other relevant factors, “the probable consumption of such drug and any substance formed in or on food because of the use of such drug . . .” (section 512(d)(2)(A) of the FD&C Act). Accordingly, CVM must consider not only safety of the new animal drug to the target animal, but also the safety to humans of substances formed in or on food as a result of the use of the new animal drug.

    “Safe,” in the context of human food safety, means a “reasonable certainty of no harm.” The definition is derived from language in H. Rep. No. 85-2284, at 4-5 (1958), defining the term “safe” as it appears in section 409 of the FD&C Act, which governs food additives (21 U.S.C. 348). Until passage of the Animal Drug Amendments of 1968 (Pub. L. 90-399) (the 1968 amendments), substances formed in or on food due to the use of animal drugs in food-producing animals were regulated under the food additive provisions in section 409 of the FD&C Act. The 1968 amendments consolidated all of the existing statutory authorities related to animal drugs into section 512 of the FD&C Act, and the legislative history shows that the consolidation in no way changed the authorities with respect to the regulation of new animal drugs (S. Rep. No. 90-1308, at 1 (1968)). During the new animal drug application review process, CVM has consistently applied the “reasonable certainty of no harm” standard in determining the safety of substances formed in or on food as a result of the use of a new animal drug in a food-producing animal.

    In order to determine whether a new animal drug meets this standard, section 512(b)(1)(G)-(H) of the FD&C Act requires that whenever a drug may result in residues of the drug or its metabolites in food, an application must include not only full reports of investigations to show that the use of the drug is safe, but also a description of practicable methods for monitoring food to assure that there are no unsafe residues in human food attributable to the drug use, and a demonstration that the conditions of use are adequate to assure there are no unsafe residues.

    In sum, under section 512(d)(2) of the FD&C Act, the Agency is required, in the evaluation of the supporting safety data, among other things, to consider:

    • The probable consumption of such drug and of any substance formed in or on food because of the use of such drug (i.e., probable human consumption of residues including the parent drug and its metabolites);

    • The cumulative effect on man or animal of such drug, taking into account any chemically or pharmacologically related substance, i.e., toxicological effects of the compounds comprising the residues; and

    • Safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of such drugs, are appropriate for the use of animal experimentation data (i.e., establishing “safe” levels of residues using appropriate safety factors to extrapolate animal data on cumulative effects to humans).

    When establishing the human food safety of a noncarcinogenic new animal drug used in food-producing animals, CVM establishes a no observed effect level (NOEL) for the residues of that drug in edible tissues—namely, the highest dose of the drug that does not produce the most sensitive treatment-related toxic endpoint in test animals (Ref. 7). From the NOEL, CVM uses safety factors to calculate an acceptable daily intake, and consumption factors to calculate the safe concentration of residues in a particular edible tissue (Ref. 7 at p. 15; section 512(b)(1)(H) of the FD&C Act).

    Carbadox is both a genotoxic 3 and mutagenic carcinogen in animals. In the case of a genotoxic carcinogenic drug, establishing the human food safety of the compound via a NOEL is not feasible, therefore human food safety of carcinogenic compounds is ordinarily evaluated by using linear, low-dose extrapolation to evaluate the maximum concentration of total residues of carcinogenic concern that can be present in the total human diet without a significant increase in the risk of cancer to the human consumer (section 512(d)(1)(I) of the FD&C Act; 21 CFR 500.82 and 500.84). In both cases, the safe residue level of the drug is determined through an evaluation of the relevant data relating to the three factors listed above; viz., the probable consumption of the drug residue and its cumulative effect as determined through all relevant safety factors (section 512(d)(2) of the FD&C Act).

    3 Genotoxic refers to chemicals that react with DNA or chromosomes to cause damage. When the damage is not repaired and the effect is a heritable change (cell to cell or parent to offspring), it is also termed mutagenic. Thus not all genotoxic chemicals are mutagenic, but all mutagenic chemicals are genotoxic. Uncorrected mutagenesis is thought to be a key step in the development of cancer. “Mechanisms of Toxicity,” in Casarett & Doull's Toxicology: The Basic Science of Poisons, edited by Klassen, C.D., 8th Ed., pp. 49-123, 2013.

    B. Grounds for Withdrawal Under the FD&C Act

    Section 512(e)(1)(B) of the FD&C Act provides grounds for withdrawal of approval of an NADA if new evidence not contained in an approved application or not available to the Secretary of Health and Human Services until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved or that subparagraph (I) of paragraph (1) of subsection (d) applies to such drug. The Secretary of Health and Human Services has delegated this authority to the Commissioner of Food and Drugs. See FDA Staff Manual Guide 1410.10 (April 11, 2014).

    In other words, grounds for withdrawal exist where new evidence shows either that the Delaney Clause applies to the drug (“subparagraph (I) of paragraph (1) of subsection (d)”) or that the drug is not shown to be safe under the approved conditions of use (the General Safety Clause). As explained further, new evidence demonstrates that carbadox meets both grounds for withdrawal.

    In a proceeding to withdraw the approval of an NADA, the sponsor has the burden of proof to demonstrate that the product is safe and therefore that the NADA approval should remain in effect (21 CFR 12.87(d): (“At a hearing involving issuing, amending, or revoking a regulation or order relating to the safety or effectiveness of a drug . . . the participant who is contending that the product is safe or effective or both and who is . . . contesting withdrawal of approval has the burden of proof in establishing safety or effectiveness or both and thus the right to approval.”); (see also Rhone-Poulenc, Inc. v. FDA, 636 F.2d 750, 752 (D.C. Cir. 1980); Hess & Clark v. FDA, 495 F.2d 975, 992 (D.C. Cir. 1974)). Nevertheless, CVM bears an initial burden of showing that new evidence regarding the new animal drug raises serious questions about the safety of the new animal drug. See Rhone-Poulenc, 636 F.2d at 752. Once CVM has satisfied the initial burden, the burden shifts to the sponsor to establish the safety of the drug:

    In the Hess & Clark case we held that the “new evidence” requirement of the safety clause “plainly places on the [CVM] an initial burden to adduce the ‘new evidence’ and what that evidence ‘shows’. Only when the [CVM] has met this initial burden of coming forward with the new evidence is there a burden on the manufacturer to show that the drug is safe.” Rhone-Poulenc, 636 F.2d at 752 (quoting Hess & Clark, 495 F.2d at 992).

    To meet its initial burden of proof to withdraw approval of a new animal drug that is “not shown to be safe,” CVM must provide “a reasonable basis from which serious questions about the ultimate safety of [the drug] and the residues that may result from its use may be inferred.” See Diethylstilbestrol: Withdrawal of Approval of New Animal Drug Applications; Commissioner's Decision (44 FR 54852 at 54861, September 21, 1979) (hereinafter DES Commissioner Decision) (quoting Proposal to Withdraw Approval of New Animal Drug Applications for Diethylstilbestrol, ALJ Initial Decision, Docket No. FDA-1976-N-0028 (formerly 76N-0002), I.D. at 8 (September 21, 1978)), aff'd Rhone-Poulenc, 636 F.2d 750; see also Nitrofurans Commissioner Decision (56 FR 41902 at 41902, August 23, 1991). Serious questions can be raised where the evidence is not conclusive but merely suggestive of an adverse effect. See DES Commissioner Decision.

    C. Withdrawal Under the Delaney Clause and the DES Proviso

    Section 512(e)(1)(B) of the FD&C Act provides grounds for withdrawal of approval of an NADA if new evidence, tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available when the application was approved shows that the Delaney Clause, section 512(d)(1)(I) of the FD&C Act, applies to the drug. Under the Delaney Clause, the Secretary may not approve a new animal drug application if “such drug induces cancer when ingested by man or animal or, after tests which are appropriate for the evaluation of the safety of such drug, induces cancer in man or animal” (section 512 (d)(1)(I) of the FD&C Act). An exception to this general rule, referred to as the DES Proviso, allows for the approval of a carcinogenic new animal drug where FDA finds that, under the approved conditions of use: (1) The drug will not adversely affect the animals treated with the drug and (2) no residues of the drug will be found by an approved regulatory method in any edible tissues of or in any foods yielded by the animal (section 512(d)(1)(I)(i)-(ii) of the FD&C Act).

    FDA has issued implementing regulations that set the requirements for demonstrating that no residues of the drug will be found by an approved regulatory method in any edible tissues of or in any foods yielded from the animal (21 CFR part 500, subpart E). These regulations, referred to as the sensitivity of the method regulations (SOM regulations), describe how FDA determines whether the regulatory method proposed by a sponsor to detect no residues of the carcinogenic drug is sufficiently sensitive to ensure that residues of carcinogenic concern in edible tissues will not exceed concentrations that represent no significant increase in the risk of cancer to humans.

    Pursuant to these regulations, CVM determines for each drug and each drug metabolite (on the basis of the results of chronic bioassays and other information) whether the drug or any of its metabolites should be regulated as a carcinogen (§ 500.84(a)). For the drug and each metabolite determined to be carcinogenic, CVM calculates, based upon submitted assays, the concentration of the test compound in the total diet of the test animal that corresponds to a maximum lifetime risk of cancer in the test animal of 1 in 1 million (§ 500.84(c)(1)). CVM designates the lowest value thus calculated as the So (§ 500.84(c)(1)). The So corresponds to a concentration of residue of carcinogenic concern in the total human diet that represents no significant increase in the risk of cancer to people (§ 500.82(b). Residue of carcinogenic concern includes all compounds in the total residue of a demonstrated carcinogen excluding any compound judged by CVM not to present a carcinogenic risk (§ 500.82(b)). The total residues of carcinogenic concern (the drug and all of its metabolites less metabolites shown to be noncarcinogenic) are regulated based on the most potent carcinogenic residue (§ 500.84(c)(1)). This approach ensures that use of the drug does not present a significant increase in the risk of cancer when considering all residues in edible tissues.

    Because the total diet is not derived only from food-producing animals, the SOM regulations make adjustments for human food intake of edible tissues, and determine the concentration of residues of carcinogenic concern in a specific edible tissue that corresponds to no significant increase in the risk of cancer to the human consumer. CVM assumes for purposes of these regulations that this value will correspond to the concentration of residues in a specific edible tissue that corresponds to a maximum lifetime risk of cancer in test animals of 1 in 1 million. This value is termed the Sm (§§ 500.82(b) and 500.84(c)(1)).

    Based upon residue depletion data submitted by a sponsor, CVM selects a target tissue (the edible tissue selected to monitor for residues in the target animals) and a marker residue (a residue whose concentration is in a known relationship to the concentration of the residues of carcinogenic concern in the last tissue to deplete to the Sm) and designates the concentration of the marker residue that the regulatory method must be capable of detecting in the target tissue (§ 500.86(a)-(c)). This value, termed the Rm, is the concentration of a marker residue in the target tissue when the residue of carcinogenic concern is equal to Sm, such that the absence of the marker residue in the target tissue above Rm can be taken as confirmation that the residue of carcinogenic concern does not exceed Sm in each of the edible tissues (§§ 500.82(b) and 500.86(c)). When the marker residue is at or below the Rm, the residue of carcinogenic concern in the diet of people does not exceed So (§ 500.86(c)).

    A sponsor must submit a regulatory method that is able to detect the marker residue at or below the Rm ((§§ 500.88(b) and 500.84(c)(2)) (“The LOD [Limit of Detection for the regulatory method] must be less than or equal to Rm.”)). If a method cannot be developed that can detect the marker residue at or below the Rm, the requirements of the SOM regulations are not satisfied, and FDA cannot approve the drug. The DES Proviso and FDA's implementing regulations are satisfied where no marker residue is detectable using the approved regulatory method under the proposed conditions of use of the drug, including the proposed preslaughter withdrawal period (§ 500.84(c)(3)).

    As stated above, pursuant to section 512(e)(1)(B) of the FD&C Act, the Secretary shall, after due notice and an opportunity for a hearing, withdraw approval of an NADA if the Secretary finds that new evidence, tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available when the application was approved shows that the Delaney Clause applies to the drug. Evidence that the Delaney Clause applies to a drug exists where the drug has previously been determined to be a carcinogen and the new evidence shows CVM's prior establishment of an analytical method and residue tolerance under the DES proviso exception to the Delaney Clause is inadequate. An analytical method is inadequate where new evidence demonstrates that the method does not accurately detect the marker residue or where new evidence demonstrates that not all residues of carcinogenic concern have depleted at the approved tolerance level of the marker residue (see, e.g. , Rhone-Poulenc, 636 F.2d at 752-53.)

    In establishing that grounds for withdrawal of approval exist under this clause, CVM carries an initial burden to demonstrate that the new animal drug and/or any of its metabolites induces cancer when ingested by man or animals. Proposal to Withdraw New Animal Drug Applications for Furazolidone (NF-180) and Nitrofurazone (NF-7), ALJ Decision, FDA Docket No. FDA-1976-N-0511, at 73 (formerly 76N-0172; November 12, 1986) (hereinafter ALJ Decision, November 12, 1986). Once CVM has satisfied its initial burden, the sponsor bears the burden of showing that the drug satisfies the DES Proviso exception to the Delaney Clause and FDA's implementing regulations. ALJ Decision, November 12, 1986, at 73. (“Since furazolidone is also being challenged under the Delaney Clause, an additional issue . . . is whether new evidence put forth by the Center shows that furazolidone and/or its metabolites induces cancer when ingested by man or animal. If this burden is met, the sponsors must show [that the drug satisfies the DES proviso and FDA's implementing regulations]”); see also 21 CFR 500.92(b) (providing that for those compounds that FDA determines have been shown to induce cancer when ingested by man or animals, §§ 500.82 through 500.90 apply).

    In this case, CVM had previously determined, in the approval and supplemental approvals of new animal drugs containing carbadox, that carbadox and its metabolites, including DCBX, induce cancer in animals, but that the drug could be approved under the DES Proviso exception to the Delaney Clause. See Section IV. However, new evidence raises questions about whether the drug is properly approved under the DES Proviso to the Delaney Clause and FDA's implementing regulations. See Criteria and Procedures for Evaluating Assays for Carcinogenic Residues (44 FR 17070 at 17104, March 20, 1979) (reproposal of rules revoked in accordance with court order). (“[The FD&C Act] defines the new evidence that the Commissioner can consider in determining whether a previously approved compound is safe. [Proper analytical methods establishing residue levels] are necessary to show that a sponsored compound is safe under the FD&C Act. For that reason, the absence of data satisfying the [criteria in 512(e)(1)(B) of the FD&C Act], in conjunction with the evidence already available about a compound, clearly can support the withdrawal of approval of an application.”). In particular, new evidence indicating that an approved regulatory method can no longer be relied upon is sufficient to satisfy the Agency's burden to support withdrawal of approval under section 512(e)(1)(B) of the FD&C Act and the Delaney Clause:

    In the case of an approved NADA for a carcinogenic compound, if FDA determines based on new information that the approved analytical method for detecting residues is inadequate . . . FDA could withdraw the approval on the basis of the Delaney Clause. Faced with evidence that an approved method was inadequate, FDA could not make a finding that “no residue” of the sponsored compound would be found in the edible products of treated animals. The DES Proviso cannot begin to operate without that finding, and, accordingly, the Delaney Clause would preclude continued approval. See Sponsored Compounds in Food Producing Animals; Criteria and Procedures for Evaluating Safety of Carcinogenic Residues; Proposed Rule (50 FR 45530 at 45550, October 31, 1985); 4 see DES Commissioners' Decision (44 FR 54852 at 54859, September 21, 1979).

    4 Under FDA's regulations implementing the Delaney Clause for animal drugs, part 500, subpart E, a carcinogenic drug may not be approved if the regulatory method to test for the compound is not sufficiently sensitive. §§ 500.84(c)(2) and 500.88(b). A carcinogenic drug will be withdrawn if new evidence shows that an approved regulatory method is not sufficiently sensitive.

    In this case, new evidence raises serious questions both about the acceptability of the current method in determining levels of known carcinogenic residues of carbadox, and, further, demonstrates that previously unidentified carcinogenic metabolites exist that are entirely unaccounted for in current approved testing methodology. Because the current analytic method is inadequate to identify the level of known carcinogens and does not identify the residue level of unidentified metabolites of carcinogenic concern, the current method and tolerance are inadequate to satisfy the DES Proviso.

    D. Withdrawal Under the General Safety Clause

    The General Safety Clause in section 512(e) of the FD&C Act provides grounds for withdrawal of approval of an NADA if new evidence, tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available when the application was approved shows that the drug is “not shown to be safe for use under the conditions of use upon the basis of which the application was approved” (section 512(e)(1)(B) of the FD&C Act). CVM has the initial burden to present new evidence that raises serious questions about the safety of the drug. Only upon that showing is there a burden on the manufacturer to demonstrate that the drug is safe. See Rhone-Poulenc, 636 F.2d at 752-53; Hess & Clark, 495 F.2d 975, 992 (D.C. Cir. 1974).

    When evaluating a drug for withdrawal under the General Safety Clause, for CVM to satisfy its initial burden that new evidence raises serious human food safety questions, it must demonstrate a relationship between the drug residues found in edible tissues and risk to human health.

    [Without using] the Delaney Clause, it is not enough for the Commissioner merely to show that animal carcasses contain residues and that [the drug] is a carcinogen. Instead, the FDA must show that two different issues are resolved in its favor before it can shift to petitioners the burden of showing safety: (1) whether the detected residues are related to the use of [the drug]; (2) if so, whether the residues, because of their composition, and in the amounts present in the tissue, present some potential hazard to the public health. See Hess & Clark, 495 F.2d at 992 (D.C. Cir. 1974).

    Applying this test, the D.C. Circuit Court of Appeals has held that new evidence of drug residues in edible tissues in conjunction with evidence that any drug residues of the drug in question present safety concerns is sufficient to satisfy CVM's burden of raising serious questions regarding the safety of the drug. See Rhone-Poulenc, 636 F.2d at 752-53. CVM, acknowledging the Hess & Clark standard and its subsequent application, has withdrawn approval of a new animal drug under the General Safety Clause where new evidence showed that: (1) The new animal drug was carcinogenic; (2) some drug metabolites were mutagenic; and (3) residues left in edible tissues at the withdrawal time were unidentified. See Nitrofurans Commissioners' Decision, 56 FR 41902 at 41910, August 23, 1991 (“Since the nature of these residues and their toxicity were not evaluated, they cannot be regarded as safe . . . Contrary to the sponsors' assertions, the evidence fails to demonstrate that furazolidone's metabolites pose no health risk to the human consumers. Given all the other evidence in the record demonstrating that furazolidone is a carcinogen and that its metabolites are mutagens, I find that, contrary to the sponsors' assertions, the metabolites of furazolidone pose a potential health risk to human consumers.”) see also DES Commissioners' Decision, 44 FR 54852 at 54868 (explaining that, “[w]here new evidence shows that use of the drug results in residues of unidentified substances,” CVM must decide whether, despite this lack of knowledge, “the drug may be considered to be 'shown to be safe[,]' ” as the General Safety Clause requires). In other words, because residues of a mutagenic carcinogen are presumptively carcinogenic, and therefore presumptively unsafe, where new evidence demonstrates that unidentified residues of a mutagenic carcinogen remain at the time of withdrawal, the drug meets the standard set forth in Hess & Clark.

    Applying the Hess & Clark standard here, the new evidence regarding carbadox clearly meets both prongs of that test. New evidence demonstrates that previously unidentified mutagenic residues of carbadox, a known carcinogen, remain present well after the established withdrawal period. As discussed further in Section V.D., because carbadox is a mutagenic carcinogen and QCA is the only known quantified noncarcinogenic residue of carbadox, all other residues are of carcinogenic concern. The new evidence demonstrates that the total residues of carcinogenic concern at the established 42-day withdrawal period are much higher than previously thought because the residues are no longer shown to be residues related to a noncarcinogenic compound, QCA, as previously believed. See, infra, Section V.D. Thus, the new evidence demonstrates that: (1) The unidentified residues are related to the use of carbadox and (2) the residues pose a potential hazard to public health because of the amount present and because they are residues of carcinogenic concern.

    IV. Regulation of Residues of Carbadox A. 1972 and 1975 Approvals

    Carbadox is a carcinogen and was approved as a new animal drug pursuant to the DES Proviso exception to the Delaney Clause. At the time of the initial approval of carbadox in 1972, CVM (then the Bureau of Veterinary Medicine) recognized that carbadox is a carcinogen and therefore required that no residues of carbadox or its metabolite QCA be found in uncooked edible tissues of swine at the time of slaughter, as determined by the approved method of analysis. See 37 FR 20683, October 3, 1972, as amended by 37 FR 23906, November 10, 1972. This approval occurred prior to FDA's 1987 initial issue of regulations implementing the DES Proviso and therefore did not involve the development of a regulatory method sensitive enough to detect a marker residue that corresponded to a lifetime risk of cancer to test animals of 1 in 1 million (as described in Section III.C).

    In this initial approval, based upon the submission of studies showing the depletion of carbadox residues in edible tissues, CVM determined that “[a]ll tissues except the liver [were] free of all residues” of unchanged carbadox at 24 hours after withdrawal of treatment and that unchanged carbadox “ha[d] disappeared from the liver after 24 hours” (Ref. 8). CVM also determined from submitted studies that the carcinogenic parent drug was undetectable in liver at 24 hours (Id.). CVM further determined that a “restriction of use in the labeling provides a withdrawal period long enough [70 days] to assure no hazard to humans consuming residues in meat. In proper use there would be virtually no residues” of carbadox in tissues at slaughter (Ref. 9). The conclusions CVM made in 1972 regarding the rapid depletion of carcinogenic residues were later independently corroborated by a 1990 evaluation of carbadox by JECFA (Ref. 10 at p. 30).

    Labeled use restrictions, as the drug was approved in 1972, included an upper weight limit of 75 pounds body weight and a prohibition on mixing into complete feeds containing less than 15 percent crude protein, thus limiting the drug's use to young pigs. These use restrictions provided assurances that the 70-day withdrawal period would likely be followed in practice (Ref. 11).

    Similarly in 1975, FDA approved NADA 092-955 for the use of carbadox with pyrantel tartrate in Type C medicated swine feed (40 FR 45164, October 1, 1975). At that time, CVM reviewed drug residue studies of carbadox and pyrantel tartrate used in combination. The studies showed that, at 45 and 60 days withdrawal, concentrations of residues of carbadox in all tissues tested were undetectable using the previously approved analytical method with a 30 ppb limit of detection (Ref. 12 at p. 2).

    B. 1986 Citizen Petition

    On May 9, 1986, the Center for Science in the Public Interest submitted a citizen petition requesting that FDA withdraw approval of new animal drug applications for ipronidazole, dimetridazole, and carbadox (Ref. 13). The petition asserted that FDA must withdraw the approval of carbadox because carbadox and its metabolites DCBX and hydrazine were found to be carcinogenic, and the approved test method for carbadox residues is “unsuitable” (Ref. 13 at p. 20). The asserted unsuitability of the approved test method was based upon the fact that only a small portion of total residues had been positively identified and that the analytical method for carbadox residues was not sensitive enough to ensure that all residues had depleted.

    FDA responded to the 1986 citizen petition in 1995 after a review of new residue depletion data submitted by (the then sponsor) Pfizer as well as data previously submitted to the Agency as part of the carbadox NADAs. Based upon this review, FDA denied the petition as it related to carbadox because it determined that “if used according to label directions, residues of carbadox remaining in edible tissues of swine do not pose a human food safety risk to consumers” (Ref. 14 at p. 2). FDA based this safety determination on the following findings:

    1. At 70 days withdrawal, the drug-related residue in swine liver measured 13 ppb. 2. Ten percent of the drug-related residue was extractable and identified to be a noncarcinogenic metabolite, quinoxaline-2-carboxylic acid. 3. The remaining 90% of the drug-related residue was unextractable or bound residues. 4. The bound residues were related to quinoxaline-2-carbodoxaldehyde and quinoxaline-2-carboxylic acid, both of which are of no carcinogenic concern. (Ref. 14 at p. 1).

    C. Approval of 1998 Supplemental NADAs

    In 1998, FDA approved two supplemental applications to NADA 041-061. The first supplement, approved in January 1998, assigned the noncarcinogenic metabolite QCA as the marker residue and set a tolerance of 30 ppb QCA in swine liver (Ref. 1).

    Toxicology studies, including carcinogenicity bioassays with carbadox, DCBX (a primary metabolite of carbadox), and hydrazine were submitted as part of that supplemental application (Ref. 1 at pp. 1-5). The studies demonstrated the carcinogenicity of carbadox, DCBX, and hydrazine, and indicated that DCBX was the most potent of the three carcinogenic compounds (id.). Consequently, based on DCBX, CVM calculated an So of 0.061 ppb for total residues of carcinogenic concern for carbadox in the total diet (Ref. 1 at p. 5). CVM calculated an Sm value for total residues of carcinogenic concern in muscle at 0.305 ppb, in liver at 0.915 ppb, and in kidney and fat at 1.830 ppb (Ref. 1 at pp. 8-9).

    The SOM regulations, as they existed in 1998, directed CVM to establish an Rm for carcinogenic compounds used in food-producing animals. CVM did not establish an Rm because CVM concluded the parent carbadox was rapidly metabolized, carcinogenic residues were not detectable beyond 72 hours post dosing, and unextracted residues 5 were related to noncarcinogenic QCA and not of carcinogenic concern. Because the noncarcinogen QCA was the only detectable metabolite persisting beyond 72 hours post dosing, CVM assigned it as the marker residue (id.).

    5 Unextracted residues are residues of the drug that are not released when tissues are exposed to mild aqueous or organic extraction conditions. Guidance on analysis of unextracted total radiolabeled residue is provided in “Guidance for Industry: General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals (GFI #3),” 2006. Unextracted or bound residues can be either: (1) Endogenous components resulting from fragments of the radiolabeled compound being incorporated into naturally occurring molecules such as amino or nucleic acids or (2) covalently bound residues. Covalently bound residues are considered to be of toxicological concern and their availability for absorption into the human gastrointestinal tract is considered during an evaluation of human food safety. Residues incorporated into endogenous molecules are not considered bioavailable or to be of toxicological concern. However, CVM has determined that establishing a potentially carcinogenic compound is bound and not of carcinogenic concern can be complicated by the possibility of gastrointestinal binding and gastrointestinal carcinogenesis and consequently can involve a more comprehensive assessment of the bound compounds as described in GFI #3. Note that while CVM has recognized that carbadox residues have not been fully extracted and characterized, CVM has not made an assessment that the compounds are not carcinogenic because they are bound to endogenous molecules (Ref. 15 at pp. 3-4). Moreover, residue studies presented to JECFA in 2003 suggest that carcinogenic residues that had not been extracted when exposed to organic extraction were released by simulated digestive enzymes (Ref. 2 at pp. 7-8, Table 5).

    At the time it approved the supplement in January 1998, CVM said:

    The sponsor and academic researchers have conducted numerous studies evaluating the fate of carbadox in animals. These residue depletion data are summarized in FAO Food and Nutrition Paper 41/3 (Food and Agriculture Organization (FAO) of the United Nations, 1991) and show that carbadox, desoxycarbadox and hydrazine do not persist in edible tissue as detectable residues beyond 72 hours. The agency's evaluation of these data, and the new information provided by the sponsor, demonstrate that following administration, parent carbadox is rapidly metabolized; that the metabolism of carbadox is similar among species; that the in vivo metabolism of the compounds of carcinogenic concern is also rapid and irreversible such that the resulting metabolic products cannot regenerate compounds of carcinogenic concern; that the unextractable residues are related to non-carcinogenic compounds, quinoxaline-2-carboxylic acid [QCA] and quinoxaline-2-carboxaldehyde; and that quinoxaline-2-carboxylic acid [QCA] is the only residue detectable in the edible tissues beyond 72 hours post dosing. Thus, the agency concludes that the unextractable bound residue is not of carcinogenic concern and that QCA is a reliable marker residue for carbadox. (Ref. 1 at p. 9).

    CVM established a tolerance of 30 ppb for residues of QCA in liver, the tissue in which residues persist for the longest time. CVM concluded that the concentration of residues of carcinogenic concern in edible tissues was below the Sm when the concentration of QCA in liver had depleted to 30 ppb.6

    6 The SOM regulations, as they existed in 1998, permitted approval of a regulatory method that could detect the marker residue of the drug, as long as the marker residue would only be detected at or below the Rm under the proposed conditions of use. See § 500.86(c) (1998).

    Under FDA's operational definition of “no residue,” a residue of carcinogenic concern, so long as it does not exceed the So, may be detectable by an approved method. The residue data show that carbadox, desoxycarbadox and hydrazine do not persist in edible tissue as detectable residues beyond 72 hours. The in vivo metabolism of the compounds of carcinogenic concern is irreversible. Therefore, in this case, no residue of carcinogenic concern, even below the So, is detectable by any method. The unextracted residues are related to a noncarcinogenic compound, quinoxaline-2-carboxylic acid (QCA), and extractable QCA is the only residue detectable in the edible tissues 72 hours postdosing. Thus, the agency concludes that QCA is a reliable marker residue for carbadox and its metabolites.

    From these data, FDA has selected liver as the target tissue and quinoxaline-2-carboxylic acid (QCA) as the marker residue. FDA has determined that when QCA, the marker, is at or below 30 ppb in the target tissue, liver, that no residue of carcinogenic concern, above the So, is detectable in each of the edible tissues by any method.

    The sponsor has submitted a regulatory method capable of measuring QCA at and below 30 ppb in the target tissue. (Ref. 1 at p. 14).

    As part of their application supporting the January 1998 supplemental approval, the sponsor submitted a regulatory method for residues of QCA in swine liver. The regulatory method relies on a gas chromatograph assay with electron capture detection and has a limit of quantification of 5 ppb (Ref. 1 at p. 13), a 6-fold improvement of the sensitivity from the previously approved regulatory method (Ref 1.)

    In October 1998, FDA approved an additional supplement to NADA 041-061 changing the withdrawal period for carbadox medicated feeds from 70 days to 42 days. The supplement was approved based upon the previous approval of a tolerance of 30 ppb for QCA and a residue depletion study that showed that residues of QCA in liver depleted below 30 ppb by 42 days (Ref. 16).

    To summarize, in 1998, when FDA approved supplements to NADA 041-061 establishing a drug tolerance and shortening the withdrawal period, the evidence before CVM indicated:

    • A 0.915 ppb concentration of total residues of carcinogenic concern in liver is the concentration that represents no significant increase in the risk of cancer to people—total residues of carcinogenic concern in liver above 0.915 ppb under the drug's approved conditions of use are unsafe. Such residues would preclude continued approval because the drug would not be shown to be safe and because the exception to the Delaney Clause would not apply (Ref. 1 at pp. 8-9, 10, 14).

    • The parent compound carbadox is rapidly metabolized and carcinogenic residues of the drug are not identifiable in any edible tissues beyond 72 hours post dosing (Ref. 1 at p. 9).

    • Remaining unextracted residues of carbadox are noncarcinogenic residues related to the noncarcinogenic metabolite QCA (Ref. 1 at pp. 9, 14).

    • QCA is a reliable marker residue for carbadox and its metabolites; that is, measuring QCA residues in swine liver is a valid method for demonstrating the absence of residues of carcinogenic concern in edible tissues (id.).

    Based upon these conclusions, CVM found that under the conditions of use the drug did not result in unsafe residues of carcinogenic concern in edible tissues and that the use of carbadox, as approved in the NADA supplements, satisfied the DES Proviso exception to the Delaney Clause prohibition on carcinogenic animal drugs (id.).

    D. Approval of the 2004 Feed Use Combination

    In 2004, FDA approved a combination drug medicated feed containing carbadox and oxytetracycline under NADA 141-211 (Ref. 17). In accordance with section 512(d)(4)(A) of the FD&C Act, approval of a combination new animal drug, where the underlying new animal drugs have previously been separately approved for particular uses and conditions of use for which they are intended for use in the combination, will not be refused on human food safety grounds unless the application fails to establish that: (1) None of the animal drugs used in combination, at the longest withdrawal period for any of the drugs in the combination, exceeds its established tolerance or (2) none of the drugs in the combination interferes with the method of analysis for any of the other drugs in the combination (section 512(d)(4)(A)(i)-(ii) of the FD&C Act). In other words, in order to approve a combination new animal drug for a drug product that contains two previously approved new animal drugs, no new information needs to be supplied to establish the safety of either drug. Instead, the application need only demonstrate that use of the drugs in combination will not result in violative residues of any component drug or in drug assay interference.

    Both carbadox and oxytetracycline had been previously and separately approved by FDA for the same conditions of use proposed for their use in combination. See 21 CFR 558.450 (Oxytetracycline); § 558.115 (Carbadox). The sponsor, Phibro, provided tissue residue depletion data demonstrating that QCA residues did not exceed the tolerance of 30 ppb when carbadox was administered in conjunction with oxytetracycline to swine (Ref. 17). A pharmacokinetic study comparing blood levels of oxytetracycline when administered alone and when administered in conjunction with carbadox satisfied the need to demonstrate that residues of oxytetracycline would not exceed the oxytetracycline tolerance at 42 days (id.).

    The sponsor further provided data demonstrating noninterference of oxytetracycline with the method of analysis of QCA in liver (id.). Having made the required human food safety demonstrations for combination animal drugs, there was no basis to refuse approval of the product on human food safety grounds. The combination new animal drug was subsequently approved (id.).

    V. New Information Regarding Carcinogenic Residues in Edible Tissues

    Three sources provide new information regarding carcinogenic residues in edible tissues: Data submitted to the 2003 JECFA and the subsequent JECFA report (Ref. 2) and two publications in the peer-reviewed literature (Refs. 4 and 6).

    JECFA is an internationally recognized expert body, providing the scientific evaluations that become the basis for international food standards established by the Codex Alimentarius Commission and supporting international treaties such as the Sanitary Phytosanitary Agreement. JECFA experts are chosen based on expertise, reputation, assurance of lack of conflict of interest, and familiarity with the subject of that particular evaluation.

    In addition, pursuant to section 512(l)(1) of the FD&C Act,7 FDA ordered Phibro to provide it with the same data provided to the 2003 JECFA. CVM evaluated the submitted data and found that it raised questions regarding the safety of food resulting from swine treated with carbadox. Confidence in the information evaluated by the 2003 JECFA that is the basis for CVM's concern about carbadox was increased by the independent findings reported in the two publications discussed further.

    7 An order issued pursuant to section 512(l) of the FD&C Act, requires a sponsor to submit such data and information as FDA may find necessary to determine or facilitate a determination whether grounds to withdraw approval of an NADA under section 512(e) of the FD&C Act exist.

    A. New Information Provided to JECFA

    In 2003, at the request of the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF), JECFA reevaluated the recommended Maximum Residue Limits (MRLs) for carbadox that were based upon a 1990 JECFA evaluation of the new animal drug (Ref. 2). CCRVDF, which includes CVM as a participant, determines priorities for the consideration of residues of veterinary drugs in foods and recommends MRLs for veterinary drugs to the Codex Alimentarius Commission of the Food and Agriculture Organization and the World Health Organization of the United Nations. The Codex Alimentarius Commission develops harmonized international food standards, guidelines, and codes of practice to protect the health of the consumers and ensure fair practices in food trade (see footnote 2).

    Based on studies submitted to JECFA that showed the persistence of genotoxic, carcinogenic residues, JECFA could not determine an amount of residues of carbadox in human food that would have no adverse health effects in consumers. JECFA recommended that the Codex MRLs be withdrawn. CCRVDF concurred with JECFA's recommendation and proposed to the Commission that the MRLs be withdrawn. The Commission subsequently agreed and withdrew the Codex MRLs for carbadox (Ref. 18 at p. 120).

    As part of the JECFA reevaluation process, Phibro presented two new residue studies to JECFA in 2003. Only one of these studies involved measurement of the depletion of carcinogenic metabolites of carbadox in edible tissues. In that study, animals were fed for 14 days at the approved dose of 55 ppm carbadox in feed (Ref. 2 at pp. 6-10). Animals were euthanized at various time points between 0 hours and 15 days post treatment, and samples of swine muscle, liver, skin, and fat were collected (Ref. 2 at pp. 7-8, Table 5).

    Prior to analysis for residues, some of the tissue samples were exposed to human digestive enzymes 8 (Ref. 2 at p. 7). This in vitro model of bioavailability was designed to mimic effects of gastric fluid and intestinal fluid incubation in human stomach and small intestine to evaluate whether residues potentially could be released in the human gastrointestinal tract. To allow comparison, some tissue samples were left untreated while other tissue samples were incubated in simulated gastric fluid (with pepsin) or in simulated intestinal fluid (with pancreatin). Residues of carbadox, DCBX, and QCA were measured in the untreated tissues, in tissues that were incubated with enzymes, and in the supernatant of those tissues that were incubated with enzymes (id.).

    8 The use of enzymic preparations to characterize residues is described in section 2.3.4.3.2 of CVM Guidance for Industry (GFI) #205 VICH GL 46, “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study to Determine the Quantity and Identify the Nature of Residues (MRK),” Sept. 15, 2011 (Ref. 19).

    Residues of carbadox, DCBX, and QCA were measured by liquid chromatography-atmospheric pressure chemical ionization tandem mass spectrometry (LC/APCI-MS/MS). The tissue samples that were not incubated with enzymes were extracted with acetonitrile prior to analysis. The tissue samples that were incubated with enzymes were extracted with ethyl acetate prior to analysis. Supernatants of the enzyme digestion were analyzed directly without extraction. The limits of quantification for LC/APCI-MS/MS were 0.050 ppb for carbadox residues and 0.030 ppb for DCBX residues (id.). The detection capabilities of this methodology were greatly enhanced compared to the previous method for carbadox and DCBX (i.e., the method used for the previous analytical work had a detection limit of 2 ppb) (Ref. 20).

    The study presented to JECFA showed that residue concentrations of carbadox and DCBX were higher and persisted for a longer period post dosing in liver than in the other sampled tissues. In liver without treatment with simulated digestive fluids, carbadox was detectable (0.050 ppb) as long as 48 hours post dosing and DCBX was detectable (0.138 ppb) at the last sampling time point, which was 15 days post treatment (Ref. 2 at pp. 7-8, Table 5). Treatment of tissues with simulated digestive fluids resulted in measurement of significantly higher concentrations of DCBX. “Pretreatment of the samples with digestive fluids increased the amounts of carcinogenic residues found in all tissues. In liver the concentration of . . .[DCBX] increased by more than fourfold when the samples were treated with intestinal fluid, and large quantities were present 15 days after withdrawal . . .” (Ref. 2 at p. 17).

    In particular, the study showed that concentrations of approximately 35 ppb of DCBX at 0 hours post dosing and approximately 2.7 ppb of DCBX at 15 days post dosing were measured in liver treated with pancreatin (Ref. 2 at p. 8, Table 5). The significantly increased residues found in liver after treatment with intestinal enzymes show that enzymatic treatment was able to release carcinogenic residues that were not extractable by organic solvents, such as those used in tissue residue studies to support the original and supplemental approval of NADAs for use of carbadox.

    JECFA evaluated the percent recoveries of the analytes. Percent recovery is a measurement of accuracy of the analytical procedure and expresses the closeness of agreement between the true value of the analyte concentration and the mean value obtained by applying the analytical procedure (Ref. 21). JECFA reported that when carbadox, DCBX, and QCA were incubated for 4 hours with digestive enzymes, carbadox and DCBX were unstable (percent recovery decreased) in the samples treated with pepsin, but were stable in pancreatin (Ref. 2 at p. 16). JECFA also reported that the recoveries of the analytes from the liver samples were generally variable and decreased to low levels when digestive enzymes were used prior to extraction (Ref. 2 at pp. 17-18).

    After evaluating the residue study, JECFA concluded that the poor recoveries obtained with the enzyme experiments “showed that the true concentrations of the carcinogenic metabolites in tissues cannot yet be estimated with certainty, since an unknown portion of the releasable residue [of carbadox and DCBX] is destroyed during incubation [of liver tissues] with the [digestive] enzymes” (Ref. 2 at p. 18). JECFA therefore concluded that the measured values of DCBX and carbadox “represent[ed] a lower estimate of the total present in the tissue” (id.).

    Presented with data demonstrating both the depletion of QCA and depletion of the carcinogenic residue DCBX, JECFA established a relationship between the concentrations of QCA and DCBX in liver (Ref. 2 at p. 14). The statistical analysis of the data showed a linear relationship between the logarithms of the concentrations of QCA and DCBX (Ref. 2 at pp. 14, 18). This relationship allowed JECFA to use regression analysis to assess the concentrations of DCBX when QCA depleted to 30 ppb in liver (the Codex MRL and FDA approved tolerance for carbadox). JECFA determined that “[a]t the MRL [of 30 ppb] for QCA in liver, the average concentrations of the carcinogenic residue desoxy-carbadox in liver estimated by regression analysis were about 4 [ppb]” (Ref. 2 at pp. 14, 16-17). JECFA recognized that “tolerance limits for the concentration of desoxycarbadox were several times higher owing to the wide variation of the data” and thereby concluded that “QCA is not a suitable marker for monitoring carcinogenic metabolites of carbadox in liver . . . and QCA does not ensure the absence of carcinogenic residues” (Ref. 2 at p. 17).

    In contrast to the previous findings of JECFA, these new data show that carcinogenic residues, in particular DCBX, are present in edible tissues for a significant time during the depletion of parent carbadox (Ref. 2 at p. 18). Moreover, the study shows that treatment with simulated digestive enzymes releases higher levels of the carcinogenic residues DCBX than were recovered using organic extractions in the study. These higher concentrations provide evidence that the carbadox residues that were not extractable or identified in previous studies submitted to the Agency could include carcinogenic residues of carbadox that are releasable with enzymatic treatment of tissues. This evidence calls into question the Agency's previous conclusions that all unextracted and unidentified residues were noncarcinogenic residues related to QCA.

    After reviewing the new residue data, and considering the previously evaluated genotoxicity and carcinogenicity data, JECFA recommended withdrawal of the previously established Codex MRLs (Ref. 2 at p. 18). Codex subsequently agreed and withdrew the MRLs for carbadox (Ref. 18 at p. 120).

    In summary, the studies considered by JECFA during its 2003 review of the drug indicated that:

    • Residues of the carcinogenic metabolite of carbadox, DCBX, were measured in edible tissues for 15 days, which was the last sampling time point. DCBX was measured in swine liver after treatment with simulated digestive enzymes at concentrations as high as 2.69 ppb at 15 days post treatment (Ref. 2 at p. 8, Table 5).

    • Analysis of measured concentrations of QCA and DCBX in liver indicated that approximately 4 ppb of DCBX would be present in the liver of treated animals when QCA reached the Codex MRL and the FDA tolerance of 30 ppb in liver (Ref. 2 at pp. 14, 17). This concentration of DCBX alone is more than 4 times higher than the concentration of total residues of carcinogenic concern in liver that would present no significant increase in the risk of cancer to people.

    • Residues of carbadox previously unextracted from edible tissues could be released by gastric and intestinal fluids that mimic the human digestive process (Ref. 2 at p. 16). The enzymatic treatment used in the study significantly increased the recoveries of concentrations of DCBX and carbadox from edible tissues, thereby indicating that some portion of the previously unextracted and unidentified total residues is composed of carcinogenic compounds.

    B. Additional New Evidence

    Following the reports of the 2003 JECFA reevaluation of carbadox, CVM requested that Phibro also provide the carcinogenic residue depletion study to CVM. In 2005, in response to CVM's request for information, Phibro submitted a summary of the carcinogenic residue depletion study previously provided to JECFA. Upon review of the summary data, CVM asked Phibro to submit existing studies or provide new and complete studies that address the relationship of QCA at 30 ppb and carbadox and DCBX residues, and about the use of QCA as the marker residue for surveillance purposes. In 2006, CVM asked for and received from Phibro a timeline for submission of complete information that addresses concerns about the relationship of QCA at 30 ppb and carbadox and DCBX residues, and about the use of QCA as the marker residue for surveillance purposes. Between 2006 and 2011, interactions between CVM and Phibro continued, with protocols submitted and reviewed, method validation reports submitted and reviewed, informal communications by email, and informal discussions by telephone. The focus of the interactions was development and validation of methods to measure QCA and DCBX in a tissue residue depletion study. Despite the continued interaction between Phibro and CVM, Phibro has not submitted the requested information.

    In 2011, pursuant to section 512(l)(1) of the FD&C Act, FDA ordered Phibro to provide all information in its possession with respect to: (1) The persistence of DCBX in edible tissues; (2) the appropriateness of QCA as an analyte for residue monitoring and for establishing a withdrawal time for the use of carbadox in pigs; and (3) whether an analytical method for monitoring carbadox-related carcinogenic residues in edible tissues can be developed that would comply with part 500, subpart E.

    In response to the 2011 FDA order, Phibro provided CVM with the full study report and appendices, previously provided to JECFA in 2003.

    CVM has independently evaluated the data from the Phibro study of depletion of carcinogenic residues reviewed by JECFA in 2003, and in particular has reviewed the JECFA conclusion that when QCA reaches 30 ppb in liver, residues of DCBX in liver are “estimated by regression analysis to be about 4 [ppb]” (Ref. 2 at p. 18). CVM's statistical analysis of the residue concentrations of DCBX in liver treated with pancreatin (a simulated intestinal fluid) shows that concentrations of DCBX in liver, when QCA reaches the 30 ppb approved tolerance, would average 4 ppb and, based on the data in the JECFA report, could reasonably range from 1.4 ppb to 11 ppb, using a 95 percent prediction range. Based upon this analysis, DCBX alone—leaving aside additional, unidentified residues of carcinogenic concern—significantly exceeds the approved Sm when QCA, the approved marker residue, reaches the approved tolerance. The new evidence from the 2003 JECFA re-evaluation of carbadox, along with studies that were later submitted to CVM, undermine the human food safety conclusions that CVM had previously reached when considering the approval of the new animal drug applications for carbadox for its various uses. CVM has engaged with Phibro to evaluate the carbadox-associated safety concerns raised by the new evidence and repeatedly has asked Phibro to submit information that would address these safety concerns. Information provided by Phibro in response to these requests has not resolved CVM's human food safety concerns.

    1. Boison, et al., 2009

    In addition, a 2009 publication calls into question conclusions made by CVM when it approved the NADAs and supplemental NADAs for carbadox (Ref. 4). Boison, et al., 2009, demonstrates the availability of a sensitive analytical method for DCBX, and provides information from which serious questions about the safety of carbadox can be inferred, specifically whether DCBX may be present in edible tissues of treated swine above the Sm even when the marker residue (QCA) concentration is below the tolerance of 30 ppb (id.).

    Boison, et al., report: (1) QCA is not a suitable marker for the regulation of carbadox because while QCA is very stable under temperature conditions above 60 °C (i.e., 105 °C), DCBX is not (Ref. 4 at p. 133); (2) the existence of an analytical method capable of detecting DCBX below the Sm for porcine muscle and liver (Ref. 4 at p. 132, Table 5); and (3) detection of DCBX at a concentration greater than 0.050 ppb in the diaphragm (but not the liver) of 2 of 6 hogs fed carbadox, while QCA was not detected in the liver of those same hogs at a limit of quantitation (LOQ) of 0.500 ppb (Ref. 4 at pp. 132-33). The findings of Boison, et al., are significant for two reasons: (1) QCA appears not to be a reliable marker residue and (2) DCBX is reported to be sensitive to the processing temperature used in the analytical method.

    2. Baars, et al., 1991

    In 2012, in response to FDA's 2011 order under section 512(l) of the FD&C Act, Phibro sent CVM a letter citing Baars, et al., 1990 (Ref. 5), an abstract of a study not previously provided. CVM obtained the study report Baars, et al., 1991 (Ref. 6), which reports an analytical method with a limit of detection of 1 ppb that detects the presence of DCBX in edible tissues for greater than 72 hours after removal of feed containing carbadox. Specifically, Baars, et al., 1991, demonstrated the presence of DCBX for up to 7 days (~168 hours) in the kidney and 14 days (~336 hours) in the liver of swine fed carbadox (Ref. 5 at p. 3, Fig. 3; Ref. 6 at p. 290, Fig. 2). This observation called into question CVM's previous conclusion that all residues of carcinogenic concern deplete within 72 hours.

    C. New Evidence Calls Into Question Prior CVM Conclusions That Were the Basis of the 1998 Supplemental Approval

    CVM's prior conclusion that QCA is a reliable marker residue for carbadox and its metabolites was predicated on several underlying conclusions (Ref. 1 at pp. 13-14). These underlying conclusions are reviewed below in light of the new evidence presented above.

    1. Previous Conclusion 1: The residue data show that carbadox, DCBX, and hydrazine do not persist in edible tissues as detectable residues beyond 72 hours.9

    9 This underlying conclusion is described in the January 30, 1998, summary basis of approval under the Freedom of Information Act (FOI Summary) for NADA 041-061 (Ref. 1 at p. 9) and in the report of the 1990 JECFA meeting (Ref. 10 at p. 30).

    Since the time CVM made this previous conclusion, we have become aware of information that undermines the previous conclusion that carbadox and its carcinogenic metabolites do not persist in edible tissues beyond 72 hours. JECFA, in 2003, reviewed a study detecting DCBX in livers of swine up to 15 days after cessation of carbadox exposure. The study JECFA reviewed was limited to 15 days. The data presented to JECFA in 2003 provide new scientific evidence that DCBX persists in edible tissues of swine as a detectable residue beyond 72 hours (Ref. 2).

    Further, Baars, et al., 1991, reports detecting DCBX in liver up to Day 14 after cessation of exposure to carbadox using an analytical method with a detection limit of 1 ppb (Ref. 6). Baars, et al., 1991, provides new scientific evidence that DCBX persists as a detectable residue in edible tissues of swine for greater than 72 hours.

    Scientific evidence from JECFA's 2003 evaluation of submitted information and Baars, et al., 1991, demonstrate that DCBX, one residue of carcinogenic concern for carbadox, persists in edible tissues of swine beyond 72 hours. All of this evidence was first received by CVM after the 1998 approval of the supplemental application to NADA 041-061. Based on this new scientific evidence, the previous conclusion that DCBX does not persist in edible tissues of swine as a detectable residue beyond 72 hours is no longer justified.

    2. Previous Conclusion 2: The unextracted residues are related to a noncarcinogenic compound, QCA, and extractable QCA is the only residue detectable in the edible tissues of swine 72 hours post dosing.10

    10 This underlying conclusion is described in the January 30, 1998, summary basis of approval under the Freedom of Information Act (FOI Summary) for NADA 041-061 (Ref. 1 at p. 9) and in the report of the 1990 JECFA meeting (Ref. 10 at p. 30).

    At the time of the 1998 supplemental approval, CVM concluded that that unextracted residues were related to the noncarcinogenic compound, QCA, and that extractable QCA was the only residue detectable in the edible tissues after 72 hours post dosing. However, CVM is now aware of reports of extraction of residues being enhanced by pepsin or pancreatin digestion prior to organic extraction, making non-QCA residues previously thought to be unextractable currently extractable (Ref. 2). JECFA reports that some residues of carbadox previously identified as unextractable can now be extracted (id.). DCBX was found in the newly extractable residues. This scientific evidence demonstrates that some residues previously found to be unextractable are extractable and that the unextractable residues are not all related to QCA.

    As discussed above, residues of DCBX, a residue of carcinogenic concern, have been detected in edible tissues longer than 72 hours post dosing (Refs. 2, 5, and 6). The previous underlying conclusions that unextracted residues are related to noncarcinogenic compound, QCA, and extractable QCA is the only residue detectable in the edible tissues 72 hours post dosing is no longer justified based on new scientific evidence.

    3. Previous Conclusion 3: No residue of carcinogenic concern even below the S0, is detectable by any method beyond 72 hours.11

    11 This underlying conclusion is part of the basis of the January 1998 supplemental approval (FOI Summary) (Ref. 1 at pp. 13-14).

    Boison, et al., 2009, reports a method capable of detecting DCBX at 0.05 ppb, which is below the 0.061 ppb So and below the Sm of 0.305 ppb in muscle, 0.915 ppb in liver, and 1.83 ppb in kidney and fat. The method is also capable of measuring QCA at 0.500 ppb, below the current tolerance of 30 ppb (Ref. 4 at p. 132, Table 5). Consequently, measurement of the relationship of QCA to at least one residue of carcinogenic concern, DCBX, is now scientifically feasible at the time the last tissue depletes to its Sm. In fact, Boison, et al., 2009, reports the presence of DCBX at a concentration greater than 0.050 ppb in the diaphragm (muscle) of 2 of 6 market-weight hogs fed carbadox, when QCA was not detected, at a limit of quantitation of 0.50 ppb, in the livers of those same hogs (Ref. 4 at pp. 132-133). This evidence raises a serious question about whether QCA at 30 ppb is an appropriate marker residue for carbadox residues of carcinogenic concern. Based on this new scientific evidence, the previous underlying conclusion that no residue of carcinogenic concern, even below the SO, is detectable by any method beyond 72 hours is no longer justified.

    4. Previous Conclusion 4: QCA is a reliable marker residue for carbadox and its metabolites.12

    12 This underlying conclusion is part of the basis of the January 1998 supplemental approval (FOI Summary) (Ref. 1 at pp. 13-14).

    In light of the new evidence presented above, the conclusion that QCA is a reliable marker residue for carbadox and its metabolites is no longer justified because: (1) Previous conclusions made by the Agency are no longer scientifically justified and (2) the relationship of QCA to a carbadox residue of carcinogenic concern, DCBX, in the last tissue to deplete to its Sm is not known.

    D. CVM's Reanalysis of the Human Health Risk From Previously Submitted Residue Data

    CVM reevaluated the existing carbadox residue data as a result of discussions that took place during meetings in 2011 with Phibro about the composition of total residues of carbadox (Refs. 3 and 22). CVM also reexamined the residue data submitted in support of the 1998 NADA supplements in light of the new understanding from the 2003 JECFA report that carcinogenic residues of carbadox persisted in edible tissues for 15 days, which was the last sampling time point, and that the previously unextractable residues are not necessarily noncarcinogenic residues related to QCA (Ref. 2).

    Using data in the FOI Summary for the January 30, 1998, supplemental approval, CVM reviewed information on total residue concentrations (measured from total radioactivity present in tissue from swine administered the radiolabeled drug), as well as the percent of total residues represented by QCA—the only noncarcinogenic metabolite of carbadox identified and quantified in the total residues of carbadox (Ref. 1). CVM used the total residue data and the percent of total residues represented by QCA to calculate the total residue of carcinogenic concern present in liver. Under the SOM regulations, “residues of carcinogenic concern” in edible tissues are total residues of a carcinogenic drug minus identified residues that are judged by CVM to be noncarcinogenic (§ 500.82(b)). CVM previously excluded the unextracted portions of total residues from carcinogenic concern because it believed they were noncarcinogenic, QCA-related residues. The data presented to JECFA in 2003 now refute that conclusion, and CVM has no information, from Phibro or otherwise, that identifies or measures noncarcinogenic residues other than QCA in total residues of carbadox at the withdrawal period. As such, CVM now identifies the total residue of carcinogenic concern by subtracting QCA (identified residues that are confirmed to be noncarcinogenic) from total residues of carbadox. Determining the concentration of residues of carcinogenic concern present in the liver allowed CVM to compare that value with the Sm established for residues of carcinogenic concern in liver.

    CVM reviewed data regarding concentrations of total residues in swine tissues following 5 days of feeding 14C-carbadox contained in a residue depletion study (the same study submitted to JECFA for its 1990 evaluation of carbadox (Ref. 10 at p. 31)) submitted by the sponsor in support of the supplemental application to NADA 041-061 approved in January 1998 (Ref. 1, Study No. 1525N-60-87-005). The study measured concentrations of total residues of 14C-carbadox and residues of QCA. Using these data, the study reported QCA as a mean percentage of the total residues of carbadox. QCA represented 24.4 percent of the total residues at 30 days, 27.5 percent at 45 days, and 9.9 percent at 70 days post dosing (Ref. 1 at p. 13, Table 9).

    Table 1 presents total carbadox residues and total carbadox residues minus the noncarcinogenic QCA. Column 1 lists the sampling time point when swine were slaughtered following administration of the last dose of carbadox. Column 2 presents mean total residues measured in livers collected from swine slaughtered at each time point. Column 3 lists the mean QCA percentage of total residues at each time point. Column 4 lists the calculated mean total residues of carcinogenic concern based on a subtraction of QCA from the mean total residue values in Column 2.

    Table 1—Mean Total Residues Measured as 14C-Carbadox Equivalents, the Mean Percentage of Total Residues Represented by QCA, and Mean Total Residue of Carcinogenic Concern in Liver of Swine (n=3 or 4) Following 5 Days of Feeding 14C-Carbadox at 55 PPM Days post dosing Total residues (ppb) Percent QCA Total residue of carcinogenic concern (ppb) 1 30 74.5 24.4 56.3 45 20.0 27.5 14.5 70 13.3 9.9 11.98 1 Values calculated by subtracting noncarcinogenic QCA portion from total residues.

    FDA first approved the use of carbadox in 1972 prior to the issuance of the Agency's SOM regulations. CVM did not make a calculation comparing total residues less QCA to the Sm in approving the January 1998 NADA supplement because the data available at the time indicated that DCBX was not detectable beyond 72 hours post dosing (by the analytical method used at the time) and because CVM believed all unextractable residues were noncarcinogenic residues related to QCA (Ref. 1). No residue depletion data presented to the Agency in original or supplemental NADAs showed that carcinogenic residues persisted beyond 72 hours or that the unextractable residues were carcinogenic. As a result, CVM did not, at that time, ask for data regarding the composition of total residues beyond establishing QCA as an appropriate marker residue. New evidence presented to JECFA in 2003 and reported by Boison, et al., 2009, and Baars, et al., 1991, calls CVM's prior conclusions into question and places new significance on the concentrations of total residues of carcinogenic concern for carbadox (Refs. 2, 4, and 6).

    The individual data shown as mean values in Table 1 were used to predict total residues of carcinogenic concern at the approved 42-day withdrawal period for carbadox in NADAs 041-061 and 141-211, and the approved 70-day withdrawal period for carbadox in NADA 092-955. CVM analyzed the data using the logarithm of the dependent variable (carbadox-equivalents in liver). The logarithmic transformation or “exponential model” is consistent with the published JECFA analyses of carbadox and commonly observed elimination behavior of pharmaceuticals (Ref. 22). Using this modeling procedure, the total residues of carcinogenic concern at 42 days are estimated to be 27 ppb with a 95 percent prediction interval of 9 ppb to 80 ppb (Ref. 3 at p. 17, Table 8). These predictions can be compared with the Sm for swine liver of 0.915 ppb. The regression model predicts that swine liver concentrations of total carcinogenic residues will be significantly in excess of the Sm—approximately 30-fold (27 ppb ÷ 0.915 ppb = 29.51) greater residues of carcinogenic concern than the Sm at the approved 42-day withdrawal period for NADAs 041-061 and 141-211 (Ref. 3 at p. 16). Total residues of carcinogenic concern at 70 days are estimated to be 10 ppb with a 95 percent prediction interval of 3 ppb to 32 ppb (Ref. 3 at p. 17, Table 8). The analysis predicts that swine liver concentrations of total carcinogenic residues will be significantly in excess of the Sm—approximately 11-fold greater residues of carcinogenic concern than the Sm at the approved 70-day withdrawal period for NADA 092-955.

    Approval of a carcinogenic new animal drug under the DES Proviso to the Delaney Clause requires development of a sufficiently sensitive regulatory method that detects no residues of carcinogenic concern in the edible tissues of food-producing animals from the use of the animal drug. New evidence raises serious questions about whether the currently approved tolerance for uses of carbadox is adequate under the SOM regulations, and raises serious questions about the continued approval of the compound under the DES Proviso exception to the Delaney Clause due to the lack of a sufficiently sensitive regulatory method.

    Carbadox is currently approved based upon CVM's previous conclusion that unextractable residues were QCA related and noncarcinogenic. Given this conclusion and the fact that no residues of carcinogenic compounds were detectable by any method beyond 72 hours, CVM determined that QCA was an acceptable marker residue and established the tolerance at 30 ppb. New evidence presented to JECFA in 2003 undermines the conclusion that all unextractable residues at the withdrawal period are QCA related. As a result, under FDA's SOM regulations, all unextractable residues except for measured residues of QCA must be considered residues of carcinogenic concern (§ 500.82(b)). Under CVM's analysis (Table 1), concentrations of total residues of carcinogenic concern in liver are approximately 30 times higher than the Sm at the approved 42-day withdrawal period and 11 times higher at the approved 70-day withdrawal period (Ref. 3 at pp. 16-17). CVM would expect that total residues of carcinogenic concern would also exceed the Sm when QCA reaches the approved tolerance of 30 ppb in liver. CVM can no longer conclude that when QCA is at or below 30 ppb, the residues of carcinogenic concern are present at or below a concentration that would present no significant increase in the risk of cancer to humans (§ 500.86(c)).

    The new evidence indicates that QCA is not an appropriate marker residue for residues of carcinogenic concern and that QCA at 30 ppb in swine liver is not an appropriate tolerance. The new evidence also shows that the approved regulatory method for all approved carbadox NADAs is inadequate under the SOM regulations (part 500, subpart E). The inadequacy of the regulatory method is a basis for withdrawal of approval of all carbadox NADAs under section 512(e)(1)(B) of the FD&C Act. See Sponsored Compounds in Food-Producing Animals; Criteria and Procedures for Evaluating the Safety of Carcinogenic Residues, Proposed Rule, preamble to the proposed SOM regulations II (50 FR 45530 at 45550).

    Similarly, these findings demonstrate that carbadox is no longer shown to be safe under the General Safety Clause because residues of carcinogenic concern remain in swine tissue well past the established withdrawal period. Under the General Safety Clause, drug residues must be determined to be safe based on all available evidence. Where a drug is a known mutagenic carcinogen and new evidence shows that unidentified residues of carcinogenic concern are present at the established withdrawal time, the drug is no longer shown to be safe. See Section III.D.

    As stated previously, the new evidence presented to JECFA undermines the previously held conclusion that all unextracted residues are QCA related and noncarcinogenic. Because carbadox is a mutagenic carcinogen, all otherwise unidentified residues are treated as carcinogenic. No evidence has been presented to CVM by Phibro or any other source to show that the unidentified residues are noncarcinogenic or that the residues do not otherwise present a threat to public health. As a result, carbadox is not shown to be safe under the General Safety Clause.

    VI. Notice of Opportunity for a Hearing

    New evidence regarding carcinogenic residues in edible tissues of swine treated with carbadox raises serious questions about the human food safety of the drug. Therefore, CVM is proposing to withdraw approval of the three NADAs that provide for use of carbadox in swine feed because new evidence demonstrates that the drug no longer meets the DES Proviso exception to the Delaney Clause and because new evidence demonstrates that carbadox is not shown to be safe under the General Safety Clause.

    Therefore, notice is given to Phibro Animal Health Corp., 65 Challenger Rd., Ridgefield Park, NJ 07660, and to all other interested persons, that the Director of CVM proposes to issue an order under section 512(e) of the FD&C Act withdrawing approval of all NADAs providing for use of carbadox in medicated swine feed.

    In accordance with section 512 of the FD&C Act and part 514 (21 CFR part 514) and under the authority delegated to the Director of CVM, Phibro Animal Health Corp., the sponsor, is hereby given an opportunity for hearing to show why approval of NADAs 041-061, 092-955, and 141-211 should not be withdrawn.

    If the sponsor, Phibro Animal Health Corp., wishes to request a hearing the sponsor must file: (1) On or before [see DATES], a written notice of appearance and request for a hearing and (2) on or before [see DATES], the data, information, and analyses relied on to demonstrate that there is a genuine and substantial issue of fact to justify a hearing as specified in § 514.200. Any other interested person may also submit comments on this notice (see, ADDRESSES). Procedures and requirements governing this NOOH, a notice of appearance and request for a hearing, submission of data, information, and analyses to justify a hearing, other comments, and a grant of denial of a hearing, are contained in § 514.200 and 21 CFR part 12.

    The failure of a holder of an approval to file timely a written appearance and request for hearing as required by § 514.200 constitutes an election not to avail himself or herself of the opportunity for a hearing and a waiver of any contentions concerning the legal status of any such drug product, and the Director of CVM will summarily enter a final order withdrawing the approvals. Any new animal drug product marketed without an approved NADA is subject to regulatory action at any time.

    A request for a hearing may not rest upon mere allegations of denials, but must set forth specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. If it conclusively appears from the face of the data, information, and factual analyses in the request for hearing that there is no genuine and substantial issue of fact that precludes the withdrawal of approval of the applications, or when a request for hearing is not made in the required format or with the required analyses, the Commissioner of Food and Drugs will enter summary judgment against the person who requests a hearing, making findings and conclusions, and denying a hearing.

    If a hearing is requested and is justified by the sponsor's response to this NOOH, the issues will be defined, a presiding officer will be assigned, and a written notice of the time and place at which the hearing will commence will be issued as soon as practicable.

    This notice is issued under section 512 of the FD&C Act and under the authority delegated to the Director of CVM.

    VII. Environmental Impact

    The Agency has determined under 21 CFR 25.33(g) that this action is of a type that does not individually or cumulatively have a significant impact on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    VIII. Paperwork Reduction Act of 1995

    The collections of information requirements for this document are covered under OMB control numbers 0910-0032 and 0910-0184.

    IX. References

    The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)

    1. FDA, Freedom of Information (FOI) Summary, NADA 041-061, MECADOX 10 (carbadox) Type A medicated article, supplemental approval January 30, 1998. Available at http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/UCM429999.pdf (accessed on March 19, 2016). 2. JECFA, Report on Carbadox, 2003. Available at ftp://ftp.fao.org/ag/agn/jecfa/vetdrug/41-15-carbadox.pdf (accessed on March 19, 2016). 3. FDA, Memorandum to the File, Claycamp, H.G., “Preliminary Risk Characterization: Cancer Risk Estimation from Carbadox Residues in Pork from Swine Treated with Carbadox,” December 16, 2014. 4. Boison, J.O., S.C. Lee, and R.G. Gedir, “A Determinative and Confirmatory Method for Residues of the Metabolites of Carbadox and Olaquindox in Porcine Tissues,” Analytica Chimica Acta, 637:128-134, 2009. 5. Baars, A.J., L.A. van Ginkel, M.M.L. Aerts, et al., “Kinetics of Carbadox Residues in Pigs,” In: Proceedings of the EuroResidue Conference, Noorwijkerhout (Haagsma, N., A. Ruiter, and P.B. Czedik-Eysenberg, eds., May 21-23, 1990. 6. Baars, A.J., L.P. Jager, T.J. Spierenberg, et al., “Residues of Carbadox Metabolites in Edible Pork Products,” Archives of Toxicology Supplement, 14:288-92, 1991. 7. FDA, CVM Guidance for Industry (GFI) #3, “General Principles for Evaluating the Safety of Compounds Used in Food-Producing Animals,” July 25, 2006. Available at http://www.fda.gov/downloads/animalveterinary/guidancecomplianceenforcement/guidanceforindustry/ucm052180.pdf (accessed on March 19, 2016). 8. FDA, Memorandum to the File, from Director, Division of New Animal Drugs to Director, Bureau of Veterinary Medicine regarding NADA 41-061—Carbadox for Swine (September 22, 1972). 9. FDA, Memorandum to the File, S.H. Frazier, Jr., Division of Toxicology, to Director, Bureau of Veterinary Medicine, regarding Carbadox for Swine, August 27, 1970. 10. JECFA, Report on Carbadox, 1990. Available at ftp://ftp.fao.org/ag/agn/jecfa/vetdrug/41-3-carbadox.pdf (accessed on March 19, 2016). 11. FDA, Memorandum to the File, from Division of New Animal Drugs to Director, Bureau of Veterinary Medicine, regarding NADA 41-061, Carbadox for Swine (July 7, 1972). 12. FDA, Memorandum to the File, Approval of Original New Animal Drug Application NADA 92-955 (July 29, 1975). 13. Citizen Petition, Center for Science in the Public Interest, Docket No. FDA-1986-P-0299 (formerly 86P-0212), May 9, 1986. 14. FDA, Response to Citizen Petition, Center for Science in the Public Interest, Docket No. FDA-1986-P-0299 (formerly 86P-0212), May 30, 1995. 15. FDA, Memorandum to the File, from Residue Evaluation Branch, Division of Chemistry to Director, Division of Chemistry, regarding Review of Carbadox Metabolism (September 7, 1994). 16. FDA, Freedom of Information (FOI) Summary, NADA 041-061, MECADOX 10 (carbadox) Type A medicated article, supplemental approval October 5, 1998. Available at http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm064223.htm (accessed on March 19, 2016). 17. FDA, Freedom of Information (FOI) Summary, NADA 141-211, MECADOX 10 (carbadox) and TERRAMYCIN 50, 100, or 200 (oxytetracycline) in Type C medicated feed, original approval July 21, 2004. Available at http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/ucm118005.pdf (accessed on March 19, 2016). 18. Codex Alimentarius Commission, Twenty-Eighth Session, Headquarters, Food and Agriculture Organization, Rome, Italy, 2005. 19. FDA, CVM Guidance for Industry (GFI) #205, VICH GL 46, “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study to Determine the Quantity and Identify the Nature of Residues (MRK),” September 15, 2011. Available at http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM207939.pdf (accessed on March 19, 2016). 20. MacIntosh, A.I., G. Lauriault, and G.A. Neville, “Liquid Chromatographic Monitoring of the Depletion of Carbadox and its Metabolite Desoxycarbadox in Swine Tissues,” Journal—Association of Official Analytical Chemists, 68:665-71, 1985. 21. FDA, CVM Guidance for Industry (GFI) #208, VICH GL 49, “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies,” September 15, 2011. Available at http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM207942.pdf (accessed on March 19, 2016). 22. FDA, Memorandum to the File, Claycamp, H. G., Verification and Extension of the 2003 JECFA Carbadox Monograph Analyses, July 29, 2012. Dated: April 6, 2016. Tracey Forfa, Acting Director, Center for Veterinary Medicine.
    [FR Doc. 2016-08327 Filed 4-8-16; 11:15 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-1222] Determination of Regulatory Review Period for Purposes of Patent Extension; APOQUEL AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) has determined the regulatory review period for APOQUEL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that animal drug product.

    DATES:

    Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by June 13, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by October 11, 2016. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2014-E-1222 for “Determination of Regulatory Review Period for Purposes of Patent Extension; APOQUEL.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For animal drug products, the testing phase begins on the earlier date when either a major environmental effects test was initiated for the drug or when an exemption under section 512(j) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(j)) became effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the animal drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for an animal drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(4)(B).

    FDA has approved for marketing the animal drug product APOQUEL (oclacitinib). APOQUEL is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Subsequent to this approval, the USPTO received a patent term restoration application for APOQUEL (U.S. Patent No. 6,890,929) from Pfizer Inc., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated May 11, 2015, FDA advised the USPTO that this animal drug product had undergone a regulatory review period and that the approval of APOQUEL represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for APOQUEL is 2,226 days. Of this time, 2,172 days occurred during the testing phase of the regulatory review period, while 54 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: April 12, 2007. FDA has verified the applicant's claim that the date the investigational new animal drug application (INAD) became effective was on April 12, 2007.

    2. The date the application was initially submitted with respect to the animal drug product under section 512 of the FD&C Act (21 U.S.C. 360b): March 22, 2013. FDA has verified the applicant's claim that the new animal drug application (NADA) for APOQUEL (NADA 141-345) was submitted on March 22, 2013.

    3. The date the application was approved: May 14, 2013. FDA has verified the applicant's claim that NADA 141-345 was approved on May 14, 2013.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,139 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

    Dated: April 6, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08333 Filed 4-11-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-E-2337] Determination of Regulatory Review Period for Purposes of Patent Extension; APTIOM AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) has determined the regulatory review period for APTIOM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

    DATES:

    Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by June 13, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by October 11, 2016. See “Petitions” in the SUPPLEMENTARY INFORMATION section for more information.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2014-E-2337 for “Determination of Regulatory Review Period for Purposes of Patent Extension; APTIOM.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

    FDA has approved for marketing the human drug product APTIOM (eslicarbazepine acetate). APTIOM is indicated as an adjunctive treatment of partial-onset seizures. Subsequent to this approval, the USPTO received a patent term restoration application for APTIOM (U.S. Patent No. 5,753,646) from BIAL-PORTELA & CA, S.A., and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated March 19, 2015, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of APTIOM represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

    II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for APTIOM is 2,517 days. Of this time, 832 days occurred during the testing phase of the regulatory review period, while 1,685 days occurred during the approval phase. These periods of time were derived from the following dates:

    1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: December 20, 2006. FDA has verified the BIAL-PORTELA & CA, S.A. claim that December 20, 2006, is the date the investigational new drug application became effective.

    2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: March 30, 2009. The applicant claims March 29, 2009 as the date the NDA for APTIOM was initially submitted. However, FDA records indicate that NDA 22-416 was submitted on March 30, 2009.

    3. The date the application was approved: November 8, 2013. FDA has verified the applicant's claim that NDA 22-416 was approved on November 8, 2013.

    This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,826 days of patent term extension.

    III. Petitions

    Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

    Submit petitions electronically to http://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: April 6, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-08334 Filed 4-11-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1005] Safety Considerations for Product Design To Minimize Medication Errors; Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled “Safety Considerations for Product Design to Minimize Medication Errors.” The guidance is intended for sponsors of investigational new drug applications (INDs); applicants of new drug applications (NDAs), biologics licensing applications (BLAs), and abbreviated new drug applications (ANDAs); and manufacturers of prescription drugs marketed without an approved application or over-the-counter (OTC) monograph drugs. This guidance provides sponsors, applicants, and manufacturers with a set of principles to consider while developing drug products using a systems approach to minimize medication errors relating to product design and container closure design. The recommendations in this guidance document are intended to provide best practices on how to improve the drug product and container closure design for all prescription and nonprescription drug products. This guidance also provides examples of product designs that resulted in postmarketing error.

    DATES:

    Submit either electronic or written comments on Agency guidances at any time.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal:http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number,