Federal Register Vol. 81, No.115,

Federal Register Volume 81, Issue 115 (June 15, 2016)

Page Range38881-39174
FR Document

81_FR_115
Current View
Page and SubjectPDF
81 FR 39171 - Flag Day and National Flag Week, 2016PDF
81 FR 38936 - James Zadroga 9/11 Victim Compensation Fund Reauthorization ActPDF
81 FR 39044 - Sunshine Act NoticePDF
81 FR 39069 - Xcel Energy, Monticello Nuclear Generating Plant Independent Spent Fuel Storage InstallationPDF
81 FR 39076 - Request for Information on the Development of the 2017 National Plan for Civil Earth Observations; CorrectionPDF
81 FR 39023 - Request for Nominations of Members To Serve on the Census Scientific Advisory CommitteePDF
81 FR 39094 - Pilot Test of DS-2031 Into International Trade Data SystemPDF
81 FR 38950 - Privacy Act of 1974; ImplementationPDF
81 FR 39032 - Privacy Act of 1974; System of RecordsPDF
81 FR 38963 - Finding of Failure To Submit a State Implementation Plan; New Jersey; Interstate Transport Requirements for 2008 8-Hour National Ambient Air Quality Standards for OzonePDF
81 FR 39041 - Human Studies Review Board; Notification of Public MeetingsPDF
81 FR 38965 - Unlicensed Use of TV Band and 600 MHz Band SpectrumPDF
81 FR 39042 - Proposed Information Collection Request; Comment Request; RadNet (Renewal)PDF
81 FR 39043 - Notification of a Public Teleconference of the Chartered Clean Air Scientific Advisory Committee (CASAC) and the CASAC Particulate Matter PanelPDF
81 FR 39025 - Opportunity To Enter Into a Joint Venture With the National Technical Information Service for Data Innovation SupportPDF
81 FR 38893 - Cotton Board Rules and Regulations: Amending Importer Line-Item De MinimisPDF
81 FR 38975 - Tart Cherries Grown in the States of Michigan, et al.; Revision of Optimum Supply Requirements and Establishment of Inventory Release ProceduresPDF
81 FR 39076 - New Postal ProductPDF
81 FR 38952 - Mail Classification SchedulePDF
81 FR 39035 - Manual for Courts-Martial; Publication of Supplementary MaterialsPDF
81 FR 39065 - Proposed Information Collection; Comment Request; Miscellaneous Tariff Bill (MTB) Petition Submission and Comment FormsPDF
81 FR 39040 - Proposed Agency Information CollectionPDF
81 FR 39022 - Request for Nominations of Members To Serve on the National Advisory Committee on Racial, Ethnic, and Other PopulationsPDF
81 FR 39021 - Plant Variety Protection Board; Open MeetingPDF
81 FR 38885 - Marketing Order Regulating the Handling of Spearmint Oil Produced in the Far West; Salable Quantities and Allotment Percentages for the 2016-2017 Marketing YearPDF
81 FR 39104 - Agency Information Collection Activities: Information Collection Renewal; Submission for OMB Review; Lending LimitsPDF
81 FR 39066 - Division of Longshore and Harbor Workers' Compensation Proposed Extension of Existing Collection; Comment RequestPDF
81 FR 39025 - Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Application for Exempted Fishing PermitsPDF
81 FR 39067 - Advisory Board on Toxic Substances and Worker Health: Subcommittee on Evidentiary Requirements for Part B Lung DiseasePDF
81 FR 39067 - Office of Disability Employment Policy; Advisory Committee on Increasing Competitive Integrated Employment for Individuals With Disabilities; Notice of MeetingPDF
81 FR 39030 - Privacy Act of 1974; System of RecordsPDF
81 FR 39060 - Navigation Safety Advisory Council; VacanciesPDF
81 FR 39047 - Notice of Agreements FiledPDF
81 FR 38881 - Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas; Relaxation of Container and Pack RequirementsPDF
81 FR 38894 - Christmas Tree Promotion, Research, and Information Order; Late Payment and Interest Charges on Past Due AssessmentsPDF
81 FR 38883 - Avocados Grown in South Florida; Increased Assessment RatePDF
81 FR 39040 - Combined Notice of Filings #1PDF
81 FR 39029 - Office of Federal Sustainability Employee Charging GuidancePDF
81 FR 39021 - Hood and Willamette Resource Advisory CommitteePDF
81 FR 39097 - Buy America Waiver NotificationPDF
81 FR 39098 - Qualification of Drivers; Exemption Applications; VisionPDF
81 FR 39100 - Qualification of Drivers; Exemption Applications; VisionPDF
81 FR 39053 - Tobacco Product Manufacturing Facility VisitsPDF
81 FR 39056 - Menu Labeling Public Workshops; Public MeetingsPDF
81 FR 39068 - Arts Advisory Panel MeetingsPDF
81 FR 38906 - Policy on the Non-Aeronautical Use of Airport HangarsPDF
81 FR 39094 - Louisiana Disaster #LA-00064PDF
81 FR 39096 - Emergency Deletion of National Network Route-Kentucky Route 151PDF
81 FR 39022 - Agenda and Notice of Public Meeting of the West Virginia Advisory CommitteePDF
81 FR 39062 - Endangered and Threatened Wildlife and Plants; Incidental Take Permit Application; Proposed Low-Effect Habitat Conservation Plan and Associated Documents; Community of San Pedro, City of Los Angeles, CaliforniaPDF
81 FR 39030 - Update to Notice of Intent to the Joint Environmental Impact Statement and Environmental Impact Report for Development of the Oro Verde Solar ProjectPDF
81 FR 39014 - Train Crew StaffingPDF
81 FR 39103 - Canadian Pacific Railway's Request for Positive Train Control Safety Plan Approval and System CertificationPDF
81 FR 39104 - Port Authority Trans-Hudson Corporation's Request for Positive Train Control Safety Plan Approval and System CertificationPDF
81 FR 39102 - Petition for Approval of Product Safety PlanPDF
81 FR 39044 - Agency Information Collection Activities: Submission for OMB Review; Comment Request (3064-0001, -0174, -0188 & -0191)PDF
81 FR 39052 - Information Collection; Report of ShipmentPDF
81 FR 39061 - Individuals and Households Program Unified GuidancePDF
81 FR 38979 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 38980 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 38983 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 38978 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 38981 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 38982 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 39105 - Proposed Collection; Comment Request for Regulation ProjectPDF
81 FR 38984 - Styrene Information and Research Center; Filing of Food Additive PetitionPDF
81 FR 38957 - Indiana; Ohio; Disapproval of Interstate Transport Requirements for the 2008 Ozone NAAQSPDF
81 FR 38992 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Philadelphia County Reasonably Available Control Technology Under the 1997 8-Hour Ozone National Ambient Air Quality StandardsPDF
81 FR 38999 - Air Plan Approval; CT; NOXPDF
81 FR 39064 - Renewal of Approved Information Collection; Control No. 1004-0119PDF
81 FR 39049 - Energy Transfer Equity, L.P. and The Williams Companies, Inc.; Analysis To Aid Public CommentPDF
81 FR 39048 - Practice Fusion, Inc.; Analysis of Proposed Consent Order To Aid Public CommentPDF
81 FR 39064 - Notice of Proposed Withdrawal Extension for Edson Creek Park and Opportunity for Public Meeting, OregonPDF
81 FR 39047 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
81 FR 39047 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
81 FR 38969 - Fisheries of the Northeastern United States; Amendment 17 to the Atlantic Surfclam and Ocean Quahog Fishery Management PlanPDF
81 FR 39089 - Self-Regulatory Organizations; NYSE MKT LLC; Suspension of and Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change To Modify the NYSE Amex Options Fee Schedule With Respect to Fees, Rebates, and Credits for Transactions in the Customer Best Execution AuctionPDF
81 FR 39078 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Exchange's Pricing Schedule Under Section VIIIPDF
81 FR 39081 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change To Amend FINRA Rules 2210 (Communications With the Public), 2213 (Requirements for the Use of Bond Mutual Fund Volatility Ratings), and 2214 (Requirements for the Use of Investment Analysis Tools)PDF
81 FR 39092 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fee Schedule To Make Non-Substantive Clerical AmendmentsPDF
81 FR 39016 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Resources of the Gulf of Mexico; Recreational Management Measures; Control DatePDF
81 FR 39017 - Atlantic Highly Migratory Species (HMS); Porbeagle Shark Management MeasuresPDF
81 FR 38948 - Allocation of Assets in Single-Employer Plans; Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Valuing and Paying BenefitsPDF
81 FR 38966 - Atlantic Highly Migratory Species; North Atlantic Swordfish FisheryPDF
81 FR 38951 - Special Local Regulation; Annual Kennewick, Washington, Columbia Unlimited Hydroplane RacesPDF
81 FR 39046 - Notice of Termination; 10243 Bank of Florida-Tampa Bay; Tampa, FloridaPDF
81 FR 39047 - Notice of Termination; 10241 Bank of Florida-Southeast, Ft. Lauderdale, FloridaPDF
81 FR 38951 - Drawbridge Operation Regulation; Mullica River, Green Bank, NJPDF
81 FR 38931 - Inflation Catch-Up Adjustment of Civil Monetary Penalty AmountsPDF
81 FR 39058 - Submission for OMB Review; 30-Day Comment Request; Women's Health Initiative (NHLBI)PDF
81 FR 39059 - National Institute of General Medical Sciences; Notice of Closed MeetingsPDF
81 FR 39060 - National Institute on Deafness and Other Communication Disorders; Notice of Closed MeetingPDF
81 FR 39059 - National Institute on Aging; Notice of Closed MeetingPDF
81 FR 39057 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 39044 - Notice to All Interested Parties of the Termination of the Receivership of 10009 First Heritage Bank, N.A., Newport Beach, CaliforniaPDF
81 FR 39039 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; International Computer and Information Literacy Study (ICILS 2018) Field Test and Recruitment for Main StudyPDF
81 FR 39106 - Notice of Availability of a Draft Environmental Impact Statement for the Reconfiguration of VA Black Hills Health Care System; Comment Period ExtensionPDF
81 FR 38986 - Air Plan Approval; North Carolina; Regional Haze Progress ReportPDF
81 FR 39002 - Air Plan Approval; Kentucky; Source Specific Revision for Louisville Gas and ElectricPDF
81 FR 39003 - Freedom of Information RegulationsPDF
81 FR 39054 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 042PDF
81 FR 38911 - Use of Symbols in LabelingPDF
81 FR 38901 - Airworthiness Directives; GROB Aircraft AG AirplanesPDF
81 FR 39107 - Discrimination on the Basis of SexPDF
81 FR 39061 - Cybersecurity Information Sharing Act of 2015 Final Guidance Documents-Notice of AvailabilityPDF
81 FR 38897 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 38903 - Airworthiness Directives; Saab AB, Saab Aeronautics (Formerly Known as Saab AB, Saab Aerosystems)PDF

Issue

81 115 Wednesday, June 15, 2016 Contents Agricultural Marketing Agricultural Marketing Service RULES Cotton Board Rules and Regulations: Importer Line-Item De Minimis, 38893-38894 2016-14174 Increased Assessment Rates: Avocados Grown in South Florida, 38883-38885 2016-14149 Marketing Order Regulating the Handling of Spearmint Oil Produced in the Far West; Salable Quantities and Allotment Percentages for the 2016-2017 Marketing Year, 38885-38892 2016-14163 Promotion, Research, and Information Orders: Christmas Trees; Late Payment and Interest Charges on Past Due Assessments, 38894-38897 2016-14150 Relaxation of Container and Pack Requirements: Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas, 38881-38883 2016-14151 PROPOSED RULES Optimum Supply Requirements and Establishment of Inventory Release Procedures: Tart Cherries Grown in Michigan, etc., 38975-38978 2016-14173 NOTICES Meetings: Plant Variety Protection Board, 39021 2016-14164 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Forest Service

AIRFORCE Air Force Department NOTICES Environmental Impact Statements; Availability, etc.: Development of the Oro Verde Solar Project, 39030 2016-14125 Army Army Department NOTICES Privacy Act; Systems of Records, 39030-39032 2016-14155 Census Bureau Census Bureau NOTICES Requests for Nominations: Census Scientific Advisory Committee, 39023-39024 2016-14185 National Advisory Committee on Racial, Ethnic, and Other Populations, 39022-39023 2016-14167 Civil Rights Civil Rights Commission NOTICES Meetings: West Virginia Advisory Committee, 39022 2016-14128 Coast Guard Coast Guard RULES Drawbridge Operations: Mullica River, Green Bank, NJ, 38951-38952 2016-14064 Special Local Regulations: Annual Kennewick, WA, Columbia Unlimited Hydroplane Races, 38951 2016-14067 NOTICES Requests for Nominations: Navigation Safety Advisory Council, 39060-39061 2016-14154 Commerce Commerce Department See

Census Bureau

See

National Oceanic and Atmospheric Administration

See

National Technical Information Service

Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Lending Limits, 39104-39105 2016-14162 Council Environmental Council on Environmental Quality NOTICES Guidance for Industry: Office of Federal Sustainability Employee Charging, 39029 2016-14144 Defense Department Defense Department See

Air Force Department

See

Army Department

RULES Privacy Act; Implementation, 38950-38951 2016-14183 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Report of Shipment, 39052-39053 2016-14119 Manual for Courts-Martial; Publication of Supplementary Materials, 39035-39039 2016-14170 Privacy Act; Systems of Records, 39032-39035 2016-14182
Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: International Computer and Information Literacy Study Field Test and Recruitment for Main Study, 39039-39040 2016-14050 Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 39040 2016-14168
Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Indiana; Ohio; Disapproval of Interstate Transport Requirements for the 2008 Ozone NAAQS, 38957-38963 2016-14103 New Jersey; Interstate Transport Requirements for 2008 8-hour National Ambient Air Quality Standards for Ozone, 38963-38965 2016-14180 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Connecticut; NOx Emission Trading Orders as Single Source State Implementation Plan Revisions, 38999-39001 2016-14100 Kentucky; Source Specific Revision for Louisville Gas and Electric, 39002-39003 2016-14032 North Carolina; Regional Haze Progress Report, 38986-38992 2016-14036 Pennsylvania; Philadelphia County Reasonably Available Control Technology under the 1997 8-Hour Ozone National Ambient Air Quality Standards, 38992-38999 2016-14102 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: RadNet; Renewal, 39042-39043 2016-14177 Meetings: Chartered Clean Air Scientific Advisory Committee and the CASAC Particulate Matter Panel, 39043-39044 2016-14176 Human Studies Review Board, 39041-39042 2016-14179 Equal Equal Employment Opportunity Commission NOTICES Meetings; Sunshine Act, 39044 2016-14236 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Airbus Airplanes, 38897-38901 2016-13741 GROB Aircraft AG Airplanes, 38901-38903 2016-13853 Saab AB, Saab Aeronautics (Formerly Known as Saab AB, Saab Aerosystems), 38903-38906 2016-13740 Policy on the Non-aeronautical Use of Airport Hangars, 38906-38911 2016-14133 PROPOSED RULES Airworthiness Directives: Airbus Airplanes; Extension of Comment Period, 38979-38981 2016-14115 2016-14116 The Boeing Company Airplanes; Extension of Comment Period, 38978-38979, 38981-38984 2016-14111 2016-14112 2016-14113 2016-14114 Federal Communications Federal Communications Commission RULES Unlicensed Use of TV Band and 600 MHz Band Spectrum, 38965-38966 2016-14178 Federal Contract Federal Contract Compliance Programs Office RULES Discrimination on the Basis of Sex, 39108-39169 2016-13806 Federal Deposit Federal Deposit Insurance Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 39044-39046 2016-14120 Receivership Terminations: Bank of Florida, Southeast, Ft. Lauderdale, FL, 39047 2016-14065 Bank of Florida, Tampa Bay, Tampa, FL, 39046-39047 2016-14066 Receiver for First Heritage Bank, N.A., Newport Beach, CA, 39044 2016-14051 Federal Emergency Federal Emergency Management Agency NOTICES Individuals and Households Program Unified Guidance, 39061 2016-14118 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 39040-39041 2016-14146 Federal Highway Federal Highway Administration NOTICES Buy America Waivers, 39097-39098 2016-14142 Emergency Deletion of National Network Route—Kentucky Route 151, 39096-39097 2016-14129 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 39047 2016-14153 Federal Motor Federal Motor Carrier Safety Administration NOTICES Qualification of Drivers; Exemption Applications: Vision, 39098-39102 2016-14140 2016-14141 Federal Railroad Federal Railroad Administration PROPOSED RULES Train Crew Staffing, 39014-39015 2016-14124 NOTICES Petitions for Approval of Product Safety Plan, 39102-39103 2016-14121 Positive Train Control Safety Plan Approval and System Certification: Canadian Pacific Railway, 39103 2016-14123 Port Authority Trans-Hudson Corp., 39104 2016-14122 Federal Reserve Federal Reserve System NOTICES Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company, 39047 2016-14089 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 39047-39048 2016-14088 Federal Trade Federal Trade Commission NOTICES Analysis of Proposed Consent Order to Aid Public Comment: Practice Fusion, Inc., 39048-39049 2016-14091 Analysis to Aid Public Comment: Energy Transfer Equity LP and Williams Cos., Inc., 39049-39052 2016-14092 Fish Fish and Wildlife Service NOTICES Incidental Take Permit Applications: Proposed Low-Effect Habitat Conservation Plan and Associated Documents; Community of San Pedro, City of Los Angeles, CA, 39062-39063 2016-14126 Food and Drug Food and Drug Administration RULES Use of Symbols in Labeling, 38911-38931 2016-13989 PROPOSED RULES Styrene Information and Research Center; Filing of Food Additive Petition, 38984-38986 2016-14107 NOTICES Food and Drug Administration Modernization Act: Modifications to the List of Recognized Standards, Recognition List Number: 042, 39054-39056 2016-13990 Meetings: Menu Labeling Public Workshops, 39056-39057 2016-14138 Tobacco Product Manufacturing Facility Visits, 39053-39054 2016-14139 Forest Forest Service NOTICES Meetings: Hood and Willamette Resource Advisory Committee, 39021-39022 2016-14143 General Services General Services Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Report of Shipment, 39052-39053 2016-14119 Health and Human Health and Human Services Department See

Food and Drug Administration

See

National Institutes of Health

PROPOSED RULES Freedom of Information Regulations, 39003-39014 2016-13994
Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

NOTICES Guidance: Cybersecurity Information Sharing Act Final Guidance Documents, 39061-39062 2016-13742
Housing Housing and Urban Development Department RULES Inflation Catch-up Adjustment of Civil Monetary Penalty Amounts, 38931-38936 2016-14060 Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

Internal Revenue Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 39105-39106 2016-14109 International Trade Com International Trade Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Miscellaneous Tariff Bill Petition Submission and Comment Forms, 39065-39066 2016-14169 Justice Department Justice Department RULES James Zadroga 9/11 Victim Compensation Fund Reauthorization Act, 38936-38948 2016-14259 Labor Department Labor Department See

Federal Contract Compliance Programs Office

See

Workers Compensation Programs Office

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 39066-39067 2016-14161 Meetings: Advisory Committee on Increasing Competitive Integrated Employment for Individuals with Disabilities, 39067 2016-14158
Land Land Management Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 39064 2016-14093 Withdrawal Extension for Edson Creek Park and Opportunity for Public Meeting, Oregon, 39064-39065 2016-14090 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Report of Shipment, 39052-39053 2016-14119 National Endowment for the Arts National Endowment for the Arts NOTICES Meetings: Arts Advisory Panel, 39068-39069 2016-14137 National Foundation National Foundation on the Arts and the Humanities See

National Endowment for the Arts

National Institute National Institutes of Health NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Women's Health Initiative, 39058-39059 2016-14057 Meetings: Center for Scientific Review, 39057-39058 2016-14053 National Institute of General Medical Sciences, 39059-39060 2016-14056 National Institute on Aging, 39059 2016-14054 National Institute on Deafness and Other Communication, 39060 2016-14055 National Oceanic National Oceanic and Atmospheric Administration RULES Atlantic Highly Migratory Species: North Atlantic Swordfish Fishery, 38966-38969 2016-14068 Fisheries of the Northeastern United States: Amendment 17 to the Atlantic Surfclam and Ocean Quahog Fishery Management Plan, 38969-38974 2016-14087 PROPOSED RULES Atlantic Highly Migratory Species: Porbeagle Shark Management Measures, 39017-39020 2016-14081 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Reef Fish Resources of the Gulf of Mexico; Recreational Management Measures; Control Date, 39016 2016-14082 NOTICES Exempted Fishing Permit Applications, 39025 2016-14160 National Technical National Technical Information Service NOTICES Opportunity to Enter into a Joint Venture for Data Innovation Support, 39025-39029 2016-14175 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Xcel Energy, Monticello Nuclear Generating Plant Independent Spent Fuel Storage Installation, 39069-39076 2016-14188 Pension Benefit Pension Benefit Guaranty Corporation RULES Allocation of Assets in Single-Employer Plans Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Valuing and Paying Benefits, 38948-38950 2016-14076 Postal Regulatory Postal Regulatory Commission RULES Mail Classification Schedule, 38952-38957 2016-14171 NOTICES New Postal Products, 39076 2016-14172 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: Flag Day and National Flag Week (Proc. 9460), 39171-39174 2016-14343 Science Technology Science and Technology Policy Office NOTICES Development of the 2017 National Plan for Civil Earth Observations; Correction, 39076-39078 2016-14186 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: BOX Options Exchange LLC, 39092-39094 2016-14083 Financial Industry Regulatory Authority, Inc., 39081-39089 2016-14084 NASDAQ PHLX LLC, 39078-39081 2016-14085 NYSE MKT LLC, 39089-39092 2016-14086 Small Business Small Business Administration NOTICES Disaster Declarations: Louisiana, 39094 2016-14131 State Department State Department NOTICES Pilot Test of DS-2031 into International Trade Data System, 39094-39096 2016-14184 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Motor Carrier Safety Administration

See

Federal Railroad Administration

Treasury Treasury Department See

Comptroller of the Currency

See

Internal Revenue Service

Veteran Affairs Veterans Affairs Department NOTICES Environmental Impact Statements; Availability, etc.: Reconfiguration of VA Black Hills Health Care System, 39106 2016-14049 Workers' Workers Compensation Programs Office NOTICES Meetings: Advisory Board on Toxic Substances and Worker Health, 39067-39068 2016-14159 Separate Parts In This Issue Part II Labor Department, Federal Contract Compliance Programs Office, 39108-39169 2016-13806 Part III Presidential Documents, 39171-39174 2016-14343 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.

81 115 Wednesday, June 15, 2016 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 906 [Doc. No. AMS-SC-16-0021; SC16-906-1 IR] Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas; Relaxation of Container and Pack Requirements AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Interim rule with request for comments.

SUMMARY:

This rule implements a recommendation from the Texas Valley Citrus Committee (Committee) to relax the container and pack requirements currently prescribed under the Texas Citrus Marketing Order (order). The order regulates the handling of oranges and grapefruit grown in the Lower Rio Grande Valley in Texas. The Committee locally administers the order and is comprised of producers and handlers operating within the production area. This rule adds the word “approximate” to the size specifications of three regulated containers to make the language consistent with other containers specified under the order. This change provides uniformity in the descriptions of containers and helps prevent potential compliance violations stemming from slight variations in container dimensions.

DATES:

Effective June 16, 2016; comments received by August 15, 2016 will be considered prior to issuance of a final rule.

ADDRESSES:

Interested persons are invited to submit written comments concerning this rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet: http://www.regulations.gov. All comments should reference the document number and the date and page number of this issue of the Federal Register and will be made available for public inspection in the Office of the Docket Clerk during regular business hours, or can be viewed at: http://www.regulations.gov. All comments submitted in response to this rule will be included in the record and will be made available to the public. Please be advised that the identity of the individuals or entities submitting the comments will be made public on the Internet at the address provided above.

FOR FURTHER INFORMATION CONTACT:

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

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

SUPPLEMENTARY INFORMATION:

This rule is issued under Marketing Agreement and Order No. 906, as amended (7 CFR part 906), regulating the handling of oranges and grapefruit grown in the Lower Rio Grande Valley in Texas, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.

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

This rule relaxes container requirements currently prescribed under the order by adding the word “approximate” to the size specifications of three regulated containers to make the language consistent with other containers specified under the order. This change provides uniformity in the descriptions of containers and helps prevent potential compliance violations stemming from slight variations in container dimensions. The Committee unanimously recommended the change at a meeting on November 17, 2015.

Section 906.40(d) of the order authorizes the issuance of regulations to fix the size, weight, capacity, dimensions, or pack of the container or containers which may be used in the packaging, transportation, sale, shipment, or other handling of fruit. Section 906.340 specifies the container, pack, and container marking regulations under the order. This section specifies, in part, the containers and dimensions currently authorized under the order.

The Committee's Container Subcommittee (subcommittee) reviewed the list of containers authorized under the order and recommended that the Committee modify the descriptions of three of the containers. The subcommittee informed the Committee that the descriptions of three of the authorized containers specify exact dimensions whereas the remainder of the containers provide approximate dimensions. They stated that with the containers with specific dimensions container manufacturers could inadvertently generate containers that have a small variance in size from the specific requirements of the order causing a handler to be out of compliance with order requirements. The subcommittee noted that the remainder of the containers allow for such an occurrence by using the word “approximate” when providing the dimensions. Consequently, the Committee unanimously voted to add the word “approximate” in the description of the container sizes of the three containers with specific dimensions to make the language consistent with the descriptions of the other containers. The Committee believes this change will provide uniformity in the descriptions of all regulated containers and help prevent potential compliance violations stemming from slight variations in container dimensions.

Initial Regulatory Flexibility Analysis

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

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

There are approximately 170 producers of oranges and grapefruit in the production area and 13 handlers subject to regulation under the order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

According to Committee data and information from the National Agricultural Statistics Service, the average grower price for Texas citrus during the 2014-15 season was around $9.53 per box and total shipments were near 7.8 million boxes. Using the average grower price and shipment information, and assuming a normal distribution of production among all producers, the majority of producers would have annual receipts of less than $750,000. In addition, based on Committee information, the majority of handlers have annual receipts of less than $7,500,000 and could be considered small businesses under SBA's definition. Thus, the majority of Texas citrus producers and handlers may be classified as small entities.

This rule changes § 906.340 of the container, pack, and container marking requirements currently prescribed under the order. This rule adds the word “approximate” to the size specifications of three regulated containers to make the language consistent with other containers specified under the order. This change provides uniformity in the descriptions of containers and helps prevent potential compliance violations stemming from slight variations in container dimensions. Authority for this change is provided in § 906.40.

This action is not expected to impose any additional costs on the industry. However, it is anticipated that this action will have a beneficial impact. Adding the word “approximate” to the dimension requirements for the containers with specific dimensions could prevent possible order violations or potential extra costs associated with replacing incorrect cartons should container manufacturers inadvertently generate containers that do not meet order requirements. The benefits of this rule are expected to be equally available to all fresh orange and grapefruit growers and handlers, regardless of their size.

Regarding alternatives to this action, the Committee considered making no changes to the container dimensions, but determined that making the recommended change provides consistency in the descriptions of all regulated containers and would help prevent potential order violations. Therefore, the Committee rejected this alternative.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0189, Generic Fruit Crops. No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.

This rule will not impose any additional reporting or recordkeeping requirements on either small or large Texas citrus handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

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

In addition, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule.

Further, the Committee's meeting was widely publicized throughout the Texas citrus industry and all interested persons were invited to attend the meeting and participate in Committee deliberations. Like all Committee meetings, the November 17, 2015, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue.

Also, the Committee has a number of appointed subcommittees to review certain issues and make recommendations to the Committee. The Committee's Container Subcommittee met on November 11, 2015, and discussed this issue in detail. That meeting was also a public meeting and both large and small entities were able to participate and express their views. Finally, interested persons are invited to submit comments on this interim rule, including the regulatory and informational impacts of this action on small businesses.

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

This rule invites comments on a change to the container and pack requirements currently prescribed under the Texas citrus marketing order. Any comments received will be considered prior to finalization of this rule.

After consideration of all relevant material presented, including the Committee's recommendation, and other information, it is found that this interim rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because: (1) This action relaxes the current container and pack requirements; (2) the industry is currently shipping oranges and grapefruit; (3) the Committee unanimously recommended these changes at a public meeting and interested parties had an opportunity to provide input; and (4) this rule provides a 60-day comment period and any comments received will be considered prior to finalization of this rule.

List of Subjects in 7 CFR Part 906

Grapefruit, Marketing agreements, Oranges, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, 7 CFR part 906 is amended as follows:

PART 906—ORANGES AND GRAPEFRUIT GROWN IN LOWER RIO GRANDE VALLEY IN TEXAS 1. The authority citation for 7 CFR part 906 continues to read as follows: Authority:

7 U.S.C. 601-674.

2. In § 906.340, paragraphs (a)(1)(i) through (iii) are revised to read as follows:
§ 906.340 Container, pack, and container marking regulations.

(a) * * *

(1) * * *

(i) Closed fiberboard carton with approximate inside dimensions of 131/4 × 101/2 × 71/4 inches: Provided, That the container has a Mullen or Cady test of at least 200 pounds;

(ii) Closed fully telescopic fiberboard carton with approximate inside dimensions of 161/2 × 103/4 × 91/2 inches:

(iii) Closed fiberboard carton with approximate inside dimensions of 20 × 131/4 inches and a depth from 93/4 to 13 inches: Provided, That the container has a Mullen or Cady test of at least 250 pounds: And Provided further, That the container may be used to pack any poly or mesh bags authorized in this section;

Dated: June 10, 2016. Elanor Starmer, Administrator, Agricultural Marketing Service.
[FR Doc. 2016-14151 Filed 6-14-16; 8:45 am] BILLING CODE P
DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 915 [Doc. No. AMS-SC-15-0083; SC16-915-2 FR] Avocados Grown in South Florida; Increased Assessment Rate AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Final rule.

SUMMARY:

This rule implements a recommendation from the Avocado Administrative Committee (Committee) for an increase of the assessment rate established for the 2016-17 and subsequent fiscal periods from $0.30 to $0.35 per 55-pound bushel container of Florida avocados handled under the marketing order (order). The Committee locally administers the order and is comprised of growers and handlers of avocados operating within the area of production. Assessments upon Florida avocado handlers are used by the Committee to fund reasonable and necessary expenses of the program. The fiscal period began on April 1 and ends March 31. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.

DATES:

Effective June 16, 2016.

FOR FURTHER INFORMATION CONTACT:

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

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

SUPPLEMENTARY INFORMATION:

This rule is issued under Marketing Order No. 915, as amended (7 CFR part 915), regulating the handling of avocados grown in South Florida, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, Florida avocado handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable Florida avocados beginning on April 1, 2016, and continue until amended, suspended, or terminated.

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

This rule increases the assessment rate established for the Committee for the 2016-17 and subsequent fiscal periods from $0.30 to $0.35 per 55-pound bushel container of avocados.

The Florida avocado marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers and handlers of Florida avocados. They are familiar with the Committee's needs and with the costs for goods and services in their local area, and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 2013-14 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.

The Committee met on December 9, 2015, and recommended 2016-17 expenditures of $302,553 and an assessment rate of $0.35 per 55-pound bushel container of avocados. In comparison, last year's budgeted expenditures were $602,553. The assessment rate of $0.35 is $0.05 higher than the rate currently in effect. During the 2015-16 season, the Committee used its authorized reserves to fund several large research projects to address the Laurel Wilt fungus, which can infect and kill avocado trees. This substantially reduced the funds in the Committee's reserves to $214,733. Further, at the current assessment rate, assessment income would equal only $300,000, an amount insufficient to cover the Committee's anticipated expenditures of $302,553. By increasing the assessment rate by $0.05, assessment income will be approximately $350,000. This amount should provide sufficient funds to meet 2016-2017 anticipated expenses and add money back into the Committee's authorized reserves.

The major expenditures recommended by the Committee for the 2016-17 year include $119,483 for salaries, $51,500 for employee benefits, and $25,500 for insurance and bonds. Budgeted expenses for these items in 2015-16 were $119,483, $51,500, and $25,500, respectively.

The assessment rate recommended by the Committee was derived by reviewing anticipated expenses, expected shipments of Florida avocados, and the level of funds in reserve. As mentioned earlier, avocado shipments for the year are estimated at one million 55-pound bushel containers which should provide $350,000 in assessment income. Income derived from handler assessments, along with interest income, should be adequate to cover budgeted expenses. Funds in the reserve (currently $214,733) will be kept within the maximum permitted by the order (approximately three fiscal periods' expenses as authorized in § 915.42).

The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.

Although this assessment rate will be in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's 2016-17 budget and those for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA.

Final Regulatory Flexibility Analysis

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

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

There are approximately 400 producers of Florida avocados in the production area and approximately 25 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

According to the National Agricultural Statistical Service (NASS), the average grower price paid for Florida avocados during the 2014-15 season was approximately $18.00 per 55-pound bushel container and total shipments were slightly higher than 1.2 million 55-pound bushels. Based on this information, the majority of avocado producers would have annual receipts less than $750,000. In addition, based on Committee information, the majority of Florida avocado handlers could be considered small business under SBA's definition. Thus, the majority of Florida avocado producers and handlers may be classified as small entities.

This rule increases the assessment rate established for the Committee and collected from handlers for the 2016-17 and subsequent fiscal periods from $0.30 to $0.35 per 55-pound bushel container of avocados. The Committee recommended 2016-17 expenditures of $302,553 and an assessment rate of $0.35 per 55-pound bushel container. The assessment rate of $0.35 is $0.05 higher than the previous rate. The quantity of assessable avocados for the 2016-17 season is estimated at one million 55-pound bushel containers. Thus, the $0.35 rate should provide $350,000 in assessment income and be adequate to meet this year's expenses.

The major expenditures recommended by the Committee for the 2016-17 fiscal period include $119,483 for salaries, $51,500 for employee benefits, and $25,500 for insurance and bonds. Budgeted expenses for these items in 2015-16 were $119,483, $51,500, and $25,500, respectively.

During the 2015-16 season, the Committee used its authorized reserves to fund several large research projects to address the Laurel Wilt fungus. This substantially reduced the funds in the Committee's reserves. Further, at the current assessment rate and with the 2016-17 crop estimated to be one million 55-pound bushel containers, assessment income would equal only $300,000, an amount insufficient to cover the Committee's anticipated expenditures of $302,553. By increasing the assessment rate by $0.05, assessment income will be approximately $350,000. This amount should provide sufficient funds to meet 2016-17 anticipated expenses and add money back into the Committee's authorized reserves. Consequently, the Committee recommended increasing the assessment rate.

Prior to arriving at this budget and assessment rate, the Committee considered information from various sources, such as the Committee's Budget and Personnel Committee. Alternative expenditure levels were discussed by this group, based upon the relative value of various activities to the South Florida avocado industry. The Committee ultimately determined that 2016-17 expenditures of $302,553 were appropriate, and the recommended assessment rate, along with interest income, would generate sufficient revenue to meet its expenses.

A review of historical information and preliminary information pertaining to the upcoming season indicates that the grower price for the 2016-17 season should be around $18 per 55-pound bushel container of avocados. Therefore, the estimated assessment revenue for the 2016-17 fiscal period as a percentage of total grower revenue would be approximately two percent.

This action increases the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. Additionally, these costs are offset by the benefits derived by the operation of the marketing order. In addition, the Committee's meeting was widely publicized throughout the Florida avocado industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the December 9, 2015, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0189 (Generic Fruit Crops). No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.

This rule imposes no additional reporting or recordkeeping requirements on either small or large Florida avocado handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule.

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

A proposed rule concerning this action was published in the Federal Register on March 16, 2016 (81 FR 14019). Copies of the proposed rule were also mailed or sent via facsimile to all Florida avocado handlers. Finally, the proposal was made available through the Internet by USDA and the Office of the Federal Register. A 30-day comment period ending April 15, 2016, was provided for interested persons to respond to the proposal. One comment was received in support of the proposal. Accordingly, no changes will be made to the rule as proposed, based on the comment received.

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

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

Pursuant to 5 U.S.C. 553, it is also found and determined that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because handlers are already receiving 2016-17 crop avocados from growers, and the fiscal period began on April 1, 2016, and the assessment rate applies to all Florida avocados received during the 2016-17 and subsequent seasons. Further, handlers are aware of this rule which was recommended at a public meeting. Also, a 30-day comment period was provided for in the proposed rule.

List of Subjects in 7 CFR Part 915

Avocados, Marketing agreements, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, 7 CFR part 915 is amended as follows:

PART 915—AVOCADOS GROWN IN SOUTH FLORIDA 1. The authority citation for 7 CFR part 915 continues to read as follows: Authority:

7 U.S.C. 601-674.

2. Section 915.235 is revised to read as follows:
§ 915.235 Assessment rate.

On and after April 1, 2016, an assessment rate of $0.35 per 55-pound container or equivalent is established for avocados grown in South Florida.

Dated: June 10, 2016.

Elanor Starmer, Administrator, Agricultural Marketing Service.
[FR Doc. 2016-14149 Filed 6-14-16; 8:45 am] BILLING CODE P
DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 985 [Doc. No. AMS-FV-15-0074; FV16-985-1 FR] Marketing Order Regulating the Handling of Spearmint Oil Produced in the Far West; Salable Quantities and Allotment Percentages for the 2016-2017 Marketing Year AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Final rule.

SUMMARY:

This rule implements a recommendation from the Far West Spearmint Oil Administrative Committee (Committee) to establish the quantity of spearmint oil produced in the Far West, by class, that handlers may purchase from, or handle on behalf of, producers during the 2016-2017 marketing year, which begins on June 1, 2016. The Far West production area includes the states of Washington, Idaho, and Oregon, and designated parts of Nevada and Utah. This rule establishes salable quantities and allotment percentages for Class 1 (Scotch) spearmint oil of 958,711 pounds and 45 percent, respectively, and for Class 3 (Native) spearmint oil of 1,209,546 pounds and 50 percent, respectively. The Committee locally administers the marketing order for spearmint oil produced in the Far West and recommended these salable quantities and allotment percentages to help maintain stability in the spearmint oil market.

DATES:

June 16, 2016.

FOR FURTHER INFORMATION CONTACT:

Dale Novotny, Marketing Specialist, or Gary Olson, Regional Director, Northwest Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (503) 326-2724, Fax: (503) 326-7440, or Email: [email protected] or [email protected]

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

SUPPLEMENTARY INFORMATION:

This final rule is issued under Marketing Order No. 985 (7 CFR part 985), as amended, regulating the handling of spearmint oil produced in the Far West (Washington, Idaho, Oregon, and designated parts of Nevada and Utah), hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this final rule in conformance with Executive Orders 12866, 13563, and 13175.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This final rule is not intended to have retroactive effect. Under the order now in effect, salable quantities and allotment percentages may be established for classes of spearmint oil produced in the Far West. This final rule will establish the quantity of spearmint oil produced in the Far West, by class, which handlers may purchase from, or handle on behalf of, producers during the 2016-2017 marketing year, which begins on June 1, 2016.

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

The Committee meets annually in the fall to adopt a marketing policy for the ensuing marketing year or years. In determining such marketing policy, the Committee considers a number of factors, including, but not limited to, the current and projected supply, estimated future demand, production costs, and producer prices for all classes of spearmint oil. Input from spearmint oil handlers and producers regarding prospective marketing conditions for the upcoming year is considered as well.

If the Committee's marketing policy considerations indicate a need for limiting the quantity of any or all classes of spearmint oil marketed, the Committee subsequently recommends to USDA the establishment of a salable quantity and allotment percentage for such class or classes of oil in the forthcoming marketing year. Recommendations for volume control are intended to ensure that market requirements for Far West spearmint oil are satisfied and orderly marketing conditions are maintained.

The salable quantity represents the total amount of each class of spearmint oil that handlers may purchase from, or handle on behalf of, producers during the marketing year. The allotment percentage is the percentage used to calculate each producer's prorated share of the salable quantity. It is derived by dividing the salable quantity for each class of spearmint oil by the total of all producers' allotment bases for the same class of oil. Each producer's annual allotment of salable spearmint oil is calculated by multiplying their respective total allotment base by the allotment percentage for each class of spearmint oil. A producer's allotment base is their quantified share of the spearmint oil market based on a statistical representation of past spearmint oil production, with accommodation for reasonable, normal adjustments to such base as prescribed by the Committee and approved by USDA.

Salable quantities and allotment percentages are established at levels intended to fulfill market requirements and to maintain orderly marketing conditions. Committee recommendations for volume control are made well in advance of the period in which the regulations are to be effective, thereby allowing producers the chance to adjust their production decisions accordingly.

Pursuant to authority in §§ 985.50, 985.51, and 985.52 of the order, the full eight-member Committee met on October 21, 2015, and recommended salable quantities and allotment percentages for both classes of oil for the 2016-2017 marketing year. By a vote of 6-1, the Committee recommended the establishment of a salable quantity and allotment percentage for Scotch spearmint oil of 958,711 pounds and 45 percent, respectively. With a unanimous vote, the Committee recommended the establishment of a salable quantity and allotment percentage for Native spearmint oil of 1,209,546 pounds and 50 percent, respectively. One Committee member did not vote in either motion.

This final rule establishes the amount of Scotch and Native spearmint oil that handlers may purchase from, or handle on behalf of, producers during the 2016-2017 marketing year, which begins on June 1, 2016. Salable quantities and allotment percentages have been placed into effect each season since the order's inception in 1980.

Class 1 (Scotch) Spearmint Oil

As noted above, the Committee recommended a salable quantity of Scotch spearmint oil of 958,711 pounds and an allotment percentage of 45 percent for the upcoming 2016-2017 marketing year. Motions for allotments of 41, 43, 46, 47, and 48 percent were made by members during the meeting but were ultimately not carried due to insufficient votes or a lack of seconding by other Committee members. To arrive at these recommendations, the Committee utilized 2016-2017 sales estimates for Scotch spearmint oil, as provided by several of the industry's handlers, historical and current Scotch spearmint oil production, inventory statistics, and international market data obtained from consultants for the spearmint oil industry.

Trade demand for Far West Scotch spearmint oil is expected to decrease from the 1,000,000 pounds anticipated in the 2015-2016 marketing year to 900,000 pounds in 2016-2017. Industry reports indicate that the decreased trade demand estimate is the result of decreased consumer demand for spearmint flavored products, especially chewing gum in China and India, as fruit flavors are gaining consumer preference. Strong, recovering production of spearmint oil in competing markets, most notably Canada, has also factored into the Committee's assessment of the market.

Production of Far West Scotch spearmint oil increased from 1,093,740 pounds in 2014 to an estimated 1,229,258 pounds for 2015. This increase in production, along with a simultaneous decrease in the demand estimate for the forthcoming 2016-2017 marketing year, is consistent with the Committee's desire to bolster the Scotch spearmint oil salable reserve inventory to ensure that the market is fully supplied. With the reserve pool of Scotch spearmint oil nearly exhausted, salable carry-in would be the only cushion to any unanticipated supply shocks that may affect the industry.

The Committee estimates that there will be 233,752 pounds of salable carry-in of Scotch spearmint oil on June 1, 2016. This figure, which is the primary measure of excess supply, would be up dramatically from the 4,494 pounds carried-in the previous year on June 1, 2015. The Committee further estimates that salable carry-in will grow to 292,463 pounds at the beginning of the 2017-2018 marketing year, if current market conditions and projections are maintained. This anticipated level of carry-in would be above the quantity that the Committee considers favorable (generally 150,000 pounds). However, without any Scotch spearmint oil in the reserve pool, the Committee believes that this higher salable carry-in is manageable.

The 2016-2017 Scotch spearmint oil salable quantity of 958,711 pounds recommended by the Committee represents a decrease of 306,914 pounds from the salable quantity established the previous marketing year (1,265,625 pounds). Of the total salable quantity established for the 2015-2016 marketing year, the Committee believes that 36,367 pounds of annual allotment will go unfilled as a result of producers who did not produce their entire annual allotment and who do not have any Scotch spearmint oil in the reserve pool to fill the deficiency. Therefore, the Committee estimates the total available supply for the 2015-2016 marketing year to be just 1,233,752 pounds (4,494 pounds of carry-in plus 1,265,625 pounds of salable quantity less the 36,367 pounds of anticipated unused annual allotment).

The Committee estimates the 2016-2017 marketing year trade demand for Scotch spearmint oil at 1,000,000 pounds. When considered in conjunction with the 2015-2016 marketing year total available supply, the Committee expects that there will be 233,752 pounds of available carry-in of Scotch spearmint oil on June 1, 2016. That carry-in, when combined with the recommended 2016-2017 marketing year salable quantity of 958,711 pounds, will result in a total supply of 1,192,463 pounds of Scotch spearmint oil for the 2016-2017 marketing year. This quantity is expected to fully satisfy estimated market demand of 900,000 pounds.

The Committee's stated intent in the use of marketing order volume control regulations for Scotch spearmint oil is to keep adequate supplies available to meet market needs and maintain orderly marketing conditions. The recommended salable quantity of Scotch spearmint oil for the upcoming marketing year is less than the 1,265,853 pound salable quantity established for the previous year. Even so, the Committee expects that the market will be fully supplied for the 2016-2017 marketing year. In addition, the Committee expects that Scotch spearmint oil inventories will be replenished after being completely exhausted during the 2013-2014 marketing year.

The Committee believes that the recommended salable quantity will adequately meet demand, as well as result in a larger carry-in for the following year. The Committee developed its recommendation for Scotch spearmint oil salable quantity and allotment percentage for the 2016-2017 marketing year based on the information discussed above, as well as the computational data outlined below.

(A) Estimated carry-in of Scotch spearmint oil on June 1, 2016: 233,752 pounds. This figure is the difference between the revised 2015-2016 marketing year total available supply of 1,233,752 pounds and the estimated 2015-2016 marketing year trade demand of 1,000,000 pounds.

(B) Estimated trade demand of Scotch spearmint oil for the 2016-2017 marketing year: 900,000 pounds. This estimate was established by the Committee and is based on input from producers at six Scotch spearmint oil production area meetings held in mid-October 2015, as well as estimates provided by handlers and other meeting participants at the main meeting held October 21, 2015. The average estimated trade demand derived from the six production area producer meetings was 1,027,666 pounds, which is 6,084 pounds less than the average of trade demand estimates submitted by handlers. Far West Scotch spearmint oil sales have averaged 1,023,729 pounds per year over the last three years, and 954,578 pounds over the last five years. Given the anticipated market conditions for the coming year, the Committee decided it was prudent to anticipate the lower trade demand at 900,000 pounds. Should the initially established volume control levels prove insufficient to adequately supply the market, the Committee has the authority to recommend intra-seasonal increases, as were undertaken in the 2014-2015 marketing year, and several other previous marketing years.

(C) Salable quantity of Scotch spearmint oil required from the 2016-2017 marketing year production: 666,248 pounds. This figure is the difference between the estimated 2016-2017 marketing year trade demand (900,000 pounds) and the estimated carry-in on June 1, 2016 (233,752 pounds). This salable quantity represents the minimum amount of Scotch spearmint oil that may be needed to satisfy estimated demand for the coming year.

(D) Total estimated allotment base of Scotch spearmint oil for the 2016-2017 marketing year: 2,130,469 pounds. This figure represents a one-percent increase over the revised 2015-2016 total allotment base of 2,109,375 pounds as prescribed by the order under § 985.53(d)(1). The one-percent increase equals 21,094 pounds of Scotch spearmint oil. This total estimated allotment base is generally revised each year on June 1 due to producer base being lost because of the bona fide effort production provisions of § 985.53(e). The adjustment is usually minimal.

(E) Computed Scotch spearmint oil allotment percentage for the 2016-2017 marketing year: 31.3 percent. This percentage is computed by dividing the minimum required salable quantity (666,248 pounds) by the total estimated allotment base (2,130,469 pounds).

(F) Recommended Scotch spearmint oil allotment percentage for the 2016-2017 marketing year: 45 percent. This is the Committee's recommendation and is based on the computed allotment percentage (31.3 percent), and input from producers and handlers at the October 21, 2015 meeting. The recommended 45 percent allotment percentage reflects the Committee's belief that the computed percentage (31.3 percent) may not adequately supply the potential 2016-2017 Scotch spearmint oil market demand.

(G) Recommended Scotch spearmint oil salable quantity for the 2016-2017 marketing year: 958,711 pounds. This figure is the product of the recommended salable allotment percentage (45 percent) and the total estimated allotment base (2,130,469 pounds) for the 2016-2017 marketing year.

(H) Estimated total available supply of Scotch spearmint oil for the 2016-2017 marketing year: 1,192,463 pounds. This figure is the sum of the 2016-2017 recommended salable quantity (958,711 pounds) and the estimated carry-in on June 1, 2016 (233,752 pounds).

Class 3 (Native) Spearmint Oil

The Committee also recommended a 2016-2017 Native spearmint oil salable quantity of 1,209,546 pounds and an allotment percentage of 50 percent at the October 21, 2015, meeting. These figures represent a decrease of 131,723 pounds and 5 percent, respectively, from the previous marketing year. To formulate this recommendation, the Committee utilized Native spearmint oil sales estimates for the 2016-2017 marketing year, as provided by several of the industry's handlers, as well as historical and current Native spearmint oil market statistics.

The Committee estimates that there will be 609,603 pounds of Native spearmint oil in the reserve pool on June 1, 2016. This figure, which is the excess Native spearmint oil production held in reserve by producers, is up from the previous industry peak of 606,942 pounds on June 1, 2011. The 2016-2017 estimate is 163,765 pounds higher than the previous year's reserve pool level. Reserve pool levels of Native spearmint oil had been slowly moving toward the level that the Committee believes is optimal for the industry prior to the spike that is expected for the 2015-2016 marketing year. The increase in Native spearmint oil held in reserve is the direct result of greatly increased production and only moderately increased industry trade demand.

Far West Native spearmint oil production was 1,274,926 pounds in 2014, but jumped to 1,510,936 pounds in 2015, an 18.5 percent increase in just one year. In contrast, sales of Native spearmint oil have only been growing at around a 3 percent rate over the past five years. The Committee hopes that Native spearmint oil reserve pool inventory will reverse its current trend over the course of the 2016-2017 marketing year and begin to decrease to levels that are deemed optimal for the industry as producers curtail excess production and utilize their reserve pool stock to fill some of their annual allotments.

As mentioned previously, Committee statistics indicate that demand for Far West Native spearmint oil has been slightly increasing in recent years, peaking at 1,390,984 pounds for the full 2014-2015 marketing year; the most recent full marketing year recorded. In addition, recorded sales for June through October of 2015 are running ahead of the same period last year. This trend is expected to continue even as imports of spearmint oil are also rising. Canada has more than doubled shipments of spearmint oil into the U.S. market from 2014 to 2015, and Chinese shipments are up 14 percent over the same period.

The one exception in imports, India, has reduced shipments during the last year. Recent reports used by the Committee indicate that spearmint oil produced in India is improving in quality, yet decreasing in acreage. Indian spearmint oil is increasingly regarded as an alternative to high quality, Far West Native spearmint oil, but production problems have limited importation into the U.S. market. As a result, imports from India, while still in demand, decreased in the past year. However, spearmint oil from India may return as a major threat to the Far West Native spearmint oil industry's domestic market share in the future.

During a recent tour of U.S. end-user companies, the chairperson and Committee staff received input that indicated sales of mint products both domestically and abroad have slowed down. This is largely the result of slowing economies in Europe and Asia. End-users also felt the inventories of Native spearmint oil that they currently have on hand are adequate for the time being. The end-users did indicate that they intend to continue to rely on Far West production as their main source of high quality Native spearmint oil, but such demand may be at lower quantities moving forward in response to current market factors.

As such, spearmint oil handlers, who regularly help predict trade demand for Far West Native spearmint oil, estimate demand to range between 1,000,000 and 1,400,000 pounds (with a weighted average of 1,350,000 pounds) for the upcoming 2016-2017 marketing year. The Committee used the handlers' input when it established the estimated 2016-2017 marketing year Native spearmint oil trade demand of 1,275,000 pounds. The estimated carry-in of 142,657 pounds of Native spearmint oil on June 1, 2016, in conjunction with the Committee-recommended salable quantity of 1,209,546 pounds, will result in an estimated total available supply of 1,352,203 pounds of Native spearmint oil during the 2016-2017 marketing year. The Committee expects that 77,203 pounds of salable Native spearmint oil will be carried into the 2017-2018 marketing year, a reduction of 65,454 pounds.

Carry-in spearmint oil is distinct from reserve pool spearmint oil and represents the amount of salable spearmint oil produced, but not marketed, in a previous year or years, but is available for sale in the current year under a previous year's annual allotment. It is the primary measure of excess spearmint oil supply under the order as it represents overproduction in prior years that is currently available to the market without restriction. Reserve pool oil, on the other hand, represents the amount of excess spearmint oil production held off the market under marketing order provisions and can only be marketed under certain conditions.

The Committee's stated intent in the use of marketing order volume control regulations for Native spearmint oil is to keep adequate supplies available to meet market needs while maintaining orderly marketing conditions. With that in mind, the Committee developed its recommendation for Native spearmint oil salable quantity and allotment percentage for the 2016-2017 marketing year based on the information discussed above, as well as the data outlined below.

(A) Estimated carry-in of Native spearmint oil on June 1, 2016: 142,657 pounds. This figure is the difference between the revised 2015-2016 marketing year total available supply of 1,465,990 pounds and the estimated 2015-2016 marketing year trade demand of 1,323,333 pounds.

(B) Estimated trade demand of Native spearmint oil for the 2016-2017 marketing year: 1,275,000 pounds. This estimate was established by the Committee and is based on input from producers at six Native spearmint oil production area meetings held in mid-October 2015, as well as estimates provided by handlers and other meeting participants at the October 21, 2015, meeting. This figure represents a decrease of 31,500 pounds from the previous year's estimate. The average estimated trade demand for Native spearmint oil from the six production area meetings was 1,323,333 pounds, whereas the handlers' estimates ranged from 1,000,000 to 1,400,000 pounds. The average of Far West Native spearmint oil sales over the last three years is 1,340,045 pounds. The Committee chose to be conservative in the establishment of its trade demand estimate to avoid oversupplying the market in the face of increasing production.

(C) Salable quantity of Native spearmint oil needed from the 2016-2017 marketing year production: 1,132,343 pounds. This figure is the difference between the estimated 2016-2017 marketing year estimated trade demand (1,275,000 pounds) and the estimated carry-in on June 1, 2016 (142,657 pounds). This is the minimum amount of Native spearmint oil that the Committee believes will be required to meet the anticipated 2016-2017 marketing year trade demand.

(D) Total estimated allotment base of Native spearmint oil for the 2016-2017 marketing year: 2,419,091 pounds. This figure represents a one-percent increase over the revised 2015-2016 total allotment base of 2,395,140 pounds as prescribed by the order in § 985.53(d)(1). The one-percent increase equals 23,951 pounds of Native spearmint oil. This estimate is generally revised each year on June 1 due to producer base being lost because of the bona fide effort production provisions of § 985.53(e). The revision is usually minimal.

(E) Computed Native spearmint oil allotment percentage for the 2016-2017 marketing year: 46.8 percent. This percentage is calculated by dividing the required salable quantity (1,132,343 pounds) by the total estimated allotment base (2,419,091 pounds) for the 2016-2017 marketing year.

(F) Recommended Native spearmint oil allotment percentage for the 2016-2017 marketing year: 50 percent. This is the Committee's recommendation based on the computed allotment percentage (46.8 percent), the average of the computed allotment percentage figures from the six production area meetings (47.3 percent), and input from producers and handlers at the October 21, 2015, main meeting. The recommended 50 percent allotment percentage is also based on the Committee's belief that the computed percentage (46.8 percent) may not adequately supply the potential market for Native spearmint oil in the 2016-2017 marketing year.

(G) Recommended Native spearmint oil 2016-2017 marketing year salable quantity: 1,209,546 pounds. This figure is the product of the recommended allotment percentage (50 percent) and the total estimated allotment base (2,419,091 pounds).

(H) Estimated available supply of Native spearmint oil for the 2016-2017 marketing year: 1,352,203 pounds. This figure is the sum of the 2016-2017 recommended salable quantity (1,209,546 pounds) and the estimated carry-in on June 1, 2016 (142,657 pounds).

The salable quantity is the total quantity of each class of spearmint oil that handlers may purchase from, or handle on behalf of, producers during a marketing year. Each producer is allotted a share of the salable quantity by applying the allotment percentage to the producer's allotment base for the applicable class of spearmint oil.

The Committee's recommended Scotch and Native spearmint oil salable quantities and allotment percentages of 958,711 pounds and 45 percent, and 1,209,546 pounds and 50 percent, respectively, are based on the goal of maintaining market stability. The Committee anticipates that this goal will be achieved by matching the available supply of each class of spearmint oil to the estimated demand of each, thus avoiding extreme fluctuations in inventories and prices.

The salable quantities presented in this rule are not expected to cause a shortage of spearmint oil supplies. Any unanticipated or additional market demand for spearmint oil which may develop during the marketing year could be satisfied by an intra-seasonal increase in the salable quantity. The order contains a provision in § 985.51 for intra-seasonal increases to allow the Committee the flexibility to respond quickly to changing market conditions.

Under volume regulation, producers who produce more than their annual allotments during the marketing year may transfer such excess spearmint oil to producers who have produced less than their annual allotment. In addition, on December 1 of each year, producers that have not transferred their excess spearmint oil to other producers must place their excess spearmint oil production into the reserve pool to be released in the future in accordance with market needs and under the Committee's direction.

This regulation is similar to regulations issued in prior seasons. The average initial allotment percentage for the five most recent marketing years for Scotch spearmint oil is 50.4 percent, while the average initial allotment percentage in the same five-year period for Native spearmint oil is 51.4 percent.

Costs to producers and handlers resulting from this rule are expected to be offset by the benefits derived from a more stable market and increased returns. In conjunction with the issuance of this final rule, USDA has reviewed the Committee's marketing policy statement for the 2016-2017 marketing year. The Committee's marketing policy statement, a requirement whenever the Committee recommends volume regulation, fully meets the intent of §§ 985.50 and 985.51 of the order.

During its discussion of potential 2016-2017 salable quantities and allotment percentages, the Committee considered: (1) The estimated quantity of salable oil of each class held by producers and handlers; (2) the estimated demand for each class of oil; (3) the prospective production of each class of oil; (4) the total of allotment bases of each class of oil for the current marketing year and the estimated total of allotment bases of each class for the ensuing marketing year; (5) the quantity of reserve oil, by class, in storage; (6) producer prices of oil, including prices for each class of oil; and (7) general market conditions for each class of oil, including whether the estimated season average price to producers is likely to exceed parity. Conformity with USDA's “Guidelines for Fruit, Vegetable, and Specialty Crop Marketing Orders” (http://www.ams.usda.gov/publications/content/1982-guidelines-fruit-vegetable-marketing-orders) has also been reviewed and confirmed.

The establishment of these salable quantities and allotment percentages would allow for anticipated market needs. In determining anticipated market needs, the Committee considered historical sales, as well as changes and trends in production and demand. This rule also provides producers with information on the amount of spearmint oil that should be produced for the 2016-2017 season in order to meet anticipated market demand.

Final Regulatory Flexibility Analysis

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

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

There are eight spearmint oil handlers subject to regulation under the order, approximately 38 producers of Scotch spearmint oil, and approximately 92 producers of Native spearmint oil in the regulated production area. Small agricultural service firms are defined by the Small Business Administration (SBA) as those having annual receipts of less than $7,500,000, and small agricultural producers are defined as those having annual receipts of less than $750,000 (13 CFR 121.201).

Based on the SBA's definition of small entities, the Committee estimates that two of the eight handlers regulated by the order could be considered small entities. Most of the handlers are large corporations involved in the international trading of essential oils and the products of essential oils. In addition, the Committee estimates that 12 of the 38 Scotch spearmint oil producers, and 28 of the 92 Native spearmint oil producers could be classified as small entities under the SBA definition. Thus, a majority of handlers and producers of Far West spearmint oil may not be classified as small entities.

The Far West spearmint oil industry is characterized by producers whose farming operations generally involve more than one commodity, and whose income from farming operations is not exclusively dependent on the production of spearmint oil. A typical spearmint oil producing operation has enough acreage for rotation such that the total acreage required to produce the crop is about one-third spearmint and two-thirds rotational crops. Thus, the typical spearmint oil producer has to have considerably more acreage than is planted to spearmint during any given season. Crop rotation is an essential cultural practice in the production of spearmint oil for purposes of weed, insect, and disease control. To remain economically viable with the added costs associated with spearmint oil production, a majority of spearmint oil producing farms fall into the SBA category of large businesses.

Small spearmint oil producers generally are not as extensively diversified as larger ones and, as such, are more at risk from market fluctuations. Such small producers generally need to market their entire annual production of spearmint oil and are not financially able to hold spearmint oil for sale in future years. In addition, small producers generally do not have a large assortment of other crops to cushion seasons with poor spearmint oil returns.

Conversely, large, diversified producers have the potential to endure one or more seasons of poor spearmint oil markets because income from alternate crops could support their operation for a period of time. Reasonable assurance of a stable price and market provides all producing entities with the ability to maintain proper cash flow and to meet annual expenses. The benefits for this rule are expected to be equally available to all producers and handlers regardless of their size.

This final rule establishes the quantity of spearmint oil produced in the Far West, by class, which handlers may purchase from, or handle on behalf of, producers during the 2016-2017 marketing year. The Committee recommended this rule to help maintain stability in the spearmint oil market by matching supply to estimated demand, thereby avoiding extreme fluctuations in supplies and prices. Establishing quantities that may be purchased or handled during the marketing year through volume regulations allows producers to coordinate their spearmint oil production with the expected market demand. Authority for this action is provided in §§ 985.50, 985.51, and 985.52 of the order.

Instability in the spearmint oil sub-sector of the mint industry is much more likely to originate on the supply side than the demand side. Fluctuations in yield and acreage planted from season-to-season tend to be larger than fluctuations in the amount purchased by handlers. Historically, demand for spearmint oil tends to change slowly from year to year.

Demand for spearmint oil at the farm level is derived from retail demand for spearmint-flavored products such as chewing gum, toothpaste, and mouthwash. The manufacturers of these products are by far the largest users of spearmint oil. However, spearmint flavoring is generally a very minor component of the products in which it is used, so changes in the raw product price have little impact on the retail prices for those goods.

In 2013, 2014, and 2015, the Committee set salable percentages at levels that resulted in most, if not all, of the spearmint oil production being made available to the market. This was in response to the increased demand for spearmint oil from the Far West due to increased utilization by end-users and the reduced supply of spearmint oil coming from other production areas, both domestic and foreign.

Although there is still strong demand for spearmint oil, competing areas (mainly Canada) have experienced better than expected production in 2015 and will create some marketing pressure for spearmint oil from the Far West. In addition, the slowing of international markets for spearmint flavored products has negatively impacted the demand for domestically produced spearmint oil. Thus, the lower salable quantities and allotment percentages recommended by the Committee for the 2016-2017 marketing year are intended to be responsive to the changing environment of the spearmint oil market.

In the late 1990's, the Committee recommended higher than normal salable percentages in hopes of gaining market share. This approach did not work, and in the following years the salable percentage was reduced in order to work through the excess spearmint oil production and resulting build-up of inventory. In order to avoid a similar scenario moving forward, the Committee, relying heavily on the information provided to it by spearmint oil handlers during the October 21, 2015, meeting, ultimately recommended reducing the 2016-2017 marketing year salable percentages from the previous year to better align the available supply with market demand. The Committee reported that recent producer prices for spearmint oil are $18.00 to $20.00 per pound.

Spearmint oil production tends to be cyclical. Prior to the inception of the marketing order in 1980, extreme variability in producer prices was common. For example, the season average producer price for Washington Native spearmint oil in 1971 was $3.00 per pound. By 1975, the producer price had risen to $11.00 per pound, an increase of over 260 percent in just four years. Such fluctuations were not unusual in the spearmint oil industry in the years leading up to the promulgation of the order. For most producers, this was an untenable situation. Years of relatively high spearmint oil production, with demand remaining relatively stable, led to periods in which large producer stocks of unsold spearmint oil depressed producer prices. Shortages and high prices followed in subsequent years, as producers responded to price signals by cutting back production.

After establishment of the order, the supply and price variability in the spearmint oil market moderated. During the 20-year period from 1987 to 2006, the season average producer price for Native spearmint oil ranged from a high of $11.10 to a low $9.10 per pound, or a difference of 22 percent. No change in producer price from one year to the next during this period was more than $1.00 per pound. This is a remarkable record of price stability. From 2006 to 2008, prices jumped by $3.80 per pound as contracts tied to input costs were prevalent in the industry. During this time period, prices for fuel, fertilizer, and labor increased dramatically, resulting in higher contracted producer prices, and a resulting concurrent increase in the overall season average producer price for the industry.

The significant variability of the spearmint oil market is illustrated by the fact that the coefficient of variation (a standard measure of variability; “CV”) of Far West spearmint oil producer prices for the period 1980-2014 (since the marketing order has been in effect) is 0.23, compared to 0.36 for the decade prior to the promulgation of the order (1970-79) and 0.49 for the prior 20-year period (1960-79). The coefficient of variation, as presented herein, was calculated by USDA from information provided by the Committee and the National Agricultural Statistics Service. This analysis provides an indication of the price stabilizing impact of the marketing order as higher CV values correspond to greater variability.

According to information compiled by the Committee, production in the shortest marketing year since the establishment of the order was about 47 percent of the 34-year average (1.92 million pounds from 1980 through 2014) and the largest crop was approximately 160 percent of the 34-year average. A key consequence is that, in years of oversupply and low prices, the season average producer price of spearmint oil is below the average cost of production (as measured by the Washington State University Cooperative Extension Service).

The wide fluctuations in supply and prices that result from the cyclical nature of the spearmint oil industry, which were even more pronounced before the creation of the order, can create liquidity problems for some producers. The order was designed to reduce the price impacts of the cyclical swings in production. However, producers have been less able to weather these cycles in recent years because of increases to production costs. While prices for spearmint oil have been relatively steady, the cost of production has increased to the extent that plans to plant spearmint may be postponed or vacated indefinitely. Producers may also be enticed by the prices of alternative crops and their lower cost of production.

In an effort to stabilize prices, the spearmint oil industry uses the volume control mechanisms authorized under the order. This authority allows the Committee to recommend a salable quantity and allotment percentage for each class of oil for the upcoming marketing year. The salable quantity for each class of oil is the total volume of oil that producers may sell during the marketing year. The allotment percentage for each class of spearmint oil is derived by dividing the salable quantity by the total allotment base.

Each producer is then issued an annual allotment certificate, in pounds, for the applicable class of oil. This is calculated by multiplying the producer's allotment base by the applicable allotment percentage. This is the amount of oil of each applicable class that the producer can market.

By December 1 of each year, the Committee identifies any oil that individual producers have produced above the volume specified on their annual allotment certificates. Prior to December 1, such excess oil can be transferred to another producer to fill a deficiency in that producer's annual allotment as provided for in § 985.156(a).

The order allows limited quantities of excess oil to be sold by one producer to another producer to fill production deficiencies during a marketing year. A deficiency occurs when on-farm production is less than a producer's annual allotment. When a producer has a deficiency, the producer's own reserve oil can be utilized to fill that deficiency, or excess production (production of spearmint oil in excess of the producer's annual allotment) from another producer may also be secured to fill the deficiency. As mentioned previously, all of these provisions need to be exercised prior to December 1 of each year.

Excess spearmint oil not transferred to another producer to fill a deficiency is held in storage and, on December 1, is added to the reserve pool administered by the Committee pursuant to § 985.157. The Committee maintains the reserve pool for each class of spearmint oil. Once spearmint oil is placed in the reserve pool, such spearmint oil cannot enter the market during that marketing year unless USDA approves a Committee recommendation to increase the salable quantity and allotment percentage for a certain class of oil, subsequently making a portion of the reserve pool of that class of spearmint oil available to the market. Without an increase in the salable quantity and allotment percentage, spearmint oil placed in the reserve pool cannot be removed from the reserve pool and marketed in the marketing year in which it is initially placed in the reserve pool. However, producers may dispose of reserve spearmint oil from their own production, and held in their own account, under certain provisions in subsequent marketing years under the supervision of the Committee.

While the Committee administers the reserve pool of spearmint oil, ownership and physical possession of spearmint oil held in reserve does not transfer to the Committee. The Committee accounts for, and controls the release of, reserve spearmint oil, but does not take title to, or dispose of, any such oil of its own accord. Producers, at their sole discretion, make the decisions regarding the disposition of oil held in the reserve pool under any one of three possible mechanisms. First, producers may utilize reserve oil from their own production to fill intra-seasonal increases in the allotment percentage and salable quantity. Second, producers may fill an ensuing year's annual allotment from spearmint oil held in the reserve pool. Lastly, producers may exchange salable oil of the same class and quantity of reserve oil from their own production to rotate stock, so long as the Committee is properly notified and the oil is properly identified.

In any given year, the total available supply of spearmint oil is composed of current production plus salable carryover stocks from the previous crop. The Committee seeks to maintain market stability by balancing supply and demand, and to close the marketing year with an appropriate level of salable spearmint oil to carry over into the subsequent marketing year. If the industry has production in excess of the salable quantity, the reserve pool absorbs the surplus quantity of spearmint oil, thereby withholding it from the market, unless such oil is needed to fill unanticipated intra-seasonal increases in demand. In this way, excess spearmint oil is not allowed to oversupply the market and create price instability. Likewise, if production is insufficient in any given year to fully supply the market with spearmint oil, the reserve pool oil can be released to satisfy the market demand until production can be increased.

Therefore, under its provisions, the order may attempt to stabilize prices by (1) limiting supply and establishing reserves in high production years, thus minimizing the price-depressing effect that excess producer stocks have on unsold spearmint oil, and (2) ensuring that stocks are available in short supply years when prices would otherwise increase dramatically. Reserve pool stocks, which increase in high production years, are drawn down in years where the crop is short.

An econometric model generated by USDA was used to assess the impact that volume control has on the prices producers receive for their commodity. Without volume control, spearmint oil markets would likely be over-supplied. This could result in low producer prices and a large volume of oil stored and carried over to the next crop year. The model estimates how much lower producer prices would likely be in the absence of volume controls.

The Committee estimated trade demand for the 2016-2017 marketing year for both classes of oil at 2,175,000 pounds, and that the expected combined salable carry-in will be 376,409 pounds. This results in a combined required salable quantity of 1,798,591 pounds (2,175,000 pounds of trade demand less 376,409 pounds of carry-in). Under volume control, total sales of spearmint oil by producers for the 2016-2017 marketing year will be limited to 2,544,666 pounds (the recommended salable quantity for both classes of spearmint oil of 2,168,257 pounds plus 376,409 of carry-in). This total available supply of 2,544,666 pounds should be more than adequate to supply the 2,175,000 pounds of anticipated trade demand for spearmint oil.

The recommended allotment percentages, upon which 2016-2017 producer allotments are based, are 45 percent for Scotch spearmint oil and 50 percent for Native spearmint oil. Without volume controls, producers would not be limited to these allotment levels, and could produce and sell an unrestricted quantity of spearmint oil. The USDA econometric model estimated that the season average producer price per pound (from both classes of spearmint oil) would decline about $1.45 per pound as a result of the higher quantities of spearmint oil that would be produced and marketed without volume control. The surplus situation for the spearmint oil market that would exist without volume controls in 2016-2017 also would likely dampen prospects for improved producer prices in future years because of the buildup in stocks.

The use of volume control allows the industry to fully supply spearmint oil markets while avoiding the negative consequences of over-supplying these markets. The use of volume control is believed to have little or no effect on consumer prices of products containing spearmint oil and should not result in fewer retail sales of such products.

The Committee discussed alternatives to the recommendations submitted for approval for both classes of spearmint oil. The Committee discussed and rejected the idea of not regulating any volume for both classes of spearmint oil because of the severe price-depressing effects that would likely occur without volume control. The alternative to establish salable quantities and allotment percentages at the 2015-2016 marketing year's levels was discussed, but not put to any motion, for both classes of oil. The Committee also considered salable quantities and allotment percentages that were above and below the levels that were ultimately recommended for Scotch spearmint oil. Ultimately, the action taken by the Committee was to decrease the salable quantities and allotment percentages for both Class 1 and Class 3 spearmint oil from the 2015-2016 marketing year levels.

As noted earlier, the Committee's recommendation to establish salable quantities and allotment percentages for both classes of spearmint oil was made after careful consideration of all available information including: (1) The estimated quantity of salable oil of each class held by producers and handlers; (2) the estimated demand for each class of oil; (3) the prospective production of each class of oil; (4) the total of allotment bases of each class of oil for the current marketing year and the estimated total of allotment bases of each class for the ensuing marketing year; (5) the quantity of reserve oil, by class, in storage; (6) producer prices of oil, including prices for each class of oil; and (7) general market conditions for each class of oil, including whether the estimated season average price to producers is likely to exceed parity.

Based on its review, the Committee believes that the salable quantities and allotment percentages will achieve the objectives sought. The Committee also believes that if there is no volume regulation in effect for the upcoming marketing year, the Far West spearmint oil industry would return to the pronounced cyclical price patterns that occurred prior to the promulgation of the order. As previously stated, annual salable quantities and allotment percentages have been issued for both classes of spearmint oil since the order's inception. The salable quantities and allotment percentages established herein are expected to facilitate the goal of maintaining orderly marketing conditions for Far West spearmint oil for 2016-2017 and future marketing years.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0178, Vegetable and Specialty Crops. No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.

This rule establishes the salable quantities and allotment percentages for Class 1 (Scotch) spearmint oil and Class 3 (Native) spearmint oil produced in the Far West during the 2016-2017 marketing year. Accordingly, this action will not impose any additional reporting or recordkeeping requirements on either small or large spearmint oil producers or handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this final rule.

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

The Committee's meeting was widely publicized throughout the spearmint oil industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the October 21, 2015, meeting was a public meeting and all entities, both large and small, were able to express views on the issues presented. A proposed rule concerning this action was published in the Federal Register on March 23, 2016 (81 FR 15450). A copy of the rule was provided to Committee staff, who in turn made it available to all Far West spearmint oil producers, handlers, and interested persons. Finally, the rule was made available through the internet by USDA and the Office of the Federal Register. A 15-day comment period ending April 7, 2016, was provided to allow interested persons to respond to the proposal. No comments were received.

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

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

It is further found that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register (5 U.S.C. 553) because the 2016-2017 marketing year starts on June 1, 2016, and handlers will need to begin purchasing the spearmint oil allotted under this rulemaking. Further, handlers are aware of this rule, which was recommended at a public meeting. Finally, a 15-day comment period was provided for in the proposed rule, and no comments were received.

List of Subjects in 7 CFR Part 985

Marketing agreements, Oils and fats, Reporting and recordkeeping requirements, Spearmint oil.

For the reasons set forth in the preamble, 7 CFR part 985 is amended as follows:

PART 985—MARKETING ORDER REGULATING THE HANDLING OF SPEARMINT OIL PRODUCED IN THE FAR WEST 1. The authority citation for 7 CFR part 985 continues to read as follows: Authority:

7 U.S.C. 601-674.

2. Section 985.235 is added to read as follows:
§ 985.235 Salable quantities and allotment percentages—2016-2017 marketing year.

The salable quantity and allotment percentage for each class of spearmint oil during the marketing year beginning on June 1, 2016, shall be as follows:

(a) Class 1 (Scotch) oil—a salable quantity of 958,711 pounds and an allotment percentage of 45 percent.

(b) Class 3 (Native) oil—a salable quantity of 1,209,546 pounds and an allotment percentage of 50 percent.

Dated: June 10, 2016. Elanor Starmer, Administrator, Agricultural Marketing Service.
[FR Doc. 2016-14163 Filed 6-14-16; 8:45 am] BILLING CODE P
DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 1205 [Doc. No. AMS-CN-14-0037] Cotton Board Rules and Regulations: Amending Importer Line-Item De Minimis AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Final rule.

SUMMARY:

The Agricultural Marketing Service (AMS) is amending the Cotton Board Rules and Regulations to remove the cotton import de minimis provision. The Cotton Research and Promotion (R&P) Program assesses U.S. cotton producers and importers of cotton and cotton-containing products. Importers are exempt from paying the cotton import assessment (known commonly among importers as the “cotton fee”) if a line item on U.S. Customs and Border Protection (CBP) documentation is $2.00 or less. The exemption was initially established to lessen the administrative burden of collecting an import assessment, which was originally estimated to be $2.00 per line item, in instances in which the transactions costs of the collection would exceed the actual value of the assessment; however, technological advances in the CBP documentation process significantly reduced the transactions costs associated with collecting import assessments, and CBP has since stopped charging USDA for the processing and collecting of assessments. Given that transactions costs no longer exceed assessment rates of $2.00 or less, AMS is removing this de minimis provision from the regulations. In addition, the definition of cotton with respect to procedures for conducting the sign-up period is being modified.

DATES:

Effective Date: July 15, 2016.

FOR FURTHER INFORMATION CONTACT:

Shethir M. Riva, Chief, Research and Promotion Staff, Cotton and Tobacco Program, AMS, USDA, 100 Riverside Parkway, Suite 101, Fredericksburg, Virginia, 22406, telephone (540) 361-2726, facsimile (540) 361-1199, or email at [email protected].

SUPPLEMENTARY INFORMATION: Executive Orders 12866 and 13563

Executive Orders 12866 and 13563 direct agencies to access all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects, distributive impacts and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This action has been designated as a “non-significant regulatory action” under section 3(f) of Executive Order 12866 and therefore has not been reviewed by the Office of Management and Budget.

Executive Order 13175

This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation would not have substantial and direct effects on Tribal governments and would not have significant Tribal implications.

Executive Order 12988

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. The Cotton Research and Promotion Act (7 U.S.C. 2101-2118) (Act) provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 12 of the Act, any person subject to an order may file with the Secretary of Agriculture (Secretary) a petition stating that the order, any provision of the plan, or any obligation imposed in connection with the order is not in accordance with law and requesting a modification of the order or to be exempted therefrom. Such person is afforded the opportunity for a hearing on the petition. After the hearing, the Secretary would rule on the petition. The Act provides that the District Court of the United States in any district in which the person is an inhabitant, or has his principal place of business, has jurisdiction to review the Secretary's ruling, provided a complaint is filed within 20 days from the date of the entry of ruling.

Regulatory Flexibility Act and Paperwork Reduction Act

In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has examined the economic impact of this rule on small entities. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such action so that small businesses will not be unduly or disproportionately burdened. The Small Business Administration defines, in 13 CFR part 121, small agricultural producers as those having annual receipts of no more than $750,000 and small agricultural service firms (importers) as having receipts of no more than $7,500,000. An estimated 17,000 importers are subject to the rules and regulations issued pursuant to the Cotton Research and Promotion Order. Most are considered small entities as defined by the Small Business Administration.

This rule only affects importers of cotton and cotton-containing products whose calculated assessment for any line item entry of cotton appearing on a CBP entry document is two dollars ($2.00) or less. While data allowing for estimates of the number of importers that will be impacted does not exist, it is estimated that a very small portion of the estimated 17,000 importers will be affected by eliminating the de minimis exemption. The additional burden placed on those importers will be limited to two dollars ($2.00) per line item entry that would otherwise have qualified for the exemption. Importers were already required to self-report on all line items being imported, therefore no additional transactions costs or administrative burden will be borne by these importers. Such importers may now be eligible to participate in a sign-up period to determine whether they and eligible producers favor the conduct of referendum on the continuance of the 1991 amendments to the Order.

In compliance with Office of Management and Budget (OMB) regulations (5 CFR part 1320) which implement the Paperwork Reduction Act (PRA) (44 U.S.C. chapter 35) the information collection requirements contained in the amended regulation have been previously approved by OMB and were assigned control number 0581-0093, National Research, Promotion, and Consumer Information Programs. This rule does not result in a change to the information collection and recordkeeping requirements previously approved.

Background

Amendments to the Cotton Research and Promotion Act (7 U.S.C. 2101-2118) (Act) were enacted by Congress under Subtitle G of Title XIX of the Food, Agriculture, Conservation, and Trade Act of 1990 (Pub. L. 101-624, 104 stat. 3909, November 28, 1990). These amendments contained two provisions that authorize changes in the funding procedures for the Cotton Research and Promotion Program. These provisions provide for: (1) The assessment of imported cotton and cotton products; and (2) termination of refunds to cotton producers. (Prior to the 1990 amendments to the Act, producers could request assessment refunds.)

As amended, the Cotton Research and Promotion Order (7 CFR part 1205) (Order) was approved by producers and importers voting in a referendum held July 17-26, 1991, and the amended Order was published in the Federal Register on December 10, 1991, (56 FR 64470). A proposed rule implementing the amended Order was published in the Federal Register on December 17, 1991, (56 FR 65450). Implementing rules were published on July 1 and 2, 1992, (57 FR 29181 and 57 FR 29431, respectively).

The total value of assessment levied on cotton imports is the sum of two parts. The first part of the assessment is based on the weight of cotton imported—levied at a rate of $1 per bale of cotton, which is equivalent to 500 pounds, or $1 per 226.8 kilograms of cotton. The second part of the import assessment (referred to as the supplemental assessment) is based on the value of imported cotton lint or the cotton contained in imported cotton products—levied at a rate of five-tenths of one percent of the value of domestically produced cotton. The current assessment on imported cotton is $0.012013 per kilogram of imported cotton.

The Act provides that “Any de minimis figure as established under this paragraph shall be such as to minimize the burden in administering the assessment provision but still provide for the maximum participation of imports of cotton in the assessment provisions of this chapter.” 7 U.S.C. 2116(c)(2). The Import Assessment Table in paragraph (b)(3) of § 1205.510 of the Cotton Research and Promotion Rules and Regulations indicates the total assessment rate ($ per kilogram) due for each Harmonized Tariff Schedule (HTS) number that is subject to assessment. Subparagraph (i) of this same paragraph provides for an exemption from assessment for any line item entry of cotton appearing on U.S. Customs and Border Protection (CBP) entry documentation whose calculated assessment is two dollars ($2.00) or less. This de minimis exemption was established to minimize the administrative burden of collecting import assessments, which was originally estimated to be $2.00 per line item, where administrative costs would exceed the actual value of the assessment.

The de minimis figure is an estimate of administrative burden, which is equivalent to the transactions costs of collecting the cotton fee. The de minimis provision was necessary to avoid instances where the transactions costs of collecting the cotton fee exceeded the cotton fee being collected.

In January 2014, AMS became aware of CBP's automation processes in connection with documenting and collecting assessments. CBP indicated that the documentation and collection process is automated and costs have been significantly decreased. Taking into account technological advancements in the fee collection process, CBP no longer charges USDA for the collection of assessments on agricultural commodities. This has eliminated the administrative burden associated with the collection of assessments.

AMS is striking subparagraph (i) under paragraph § 1205.510(b)(3) of the Cotton Research and Promotion Rules and Regulations and appending to the paragraph section the language currently in subparagraph (ii). This action reflects the technological efficiencies of the CBP import documentation process by eliminating the de minimis provisions in the regulations, and, therefore, helps to ensure that the assessments collected on imported cotton and the cotton content of imported products will be the same as those paid on domestically produced cotton. In addition, AMS is modifying the definition of cotton in § 1205.12 to include imported cotton that previously was exempted due to the de minimis exemption. With this action, importers who previously imported de minimis amounts of cotton may now be eligible to participate in the sign-up period for a continuance referendum that would determine whether a continuance referendum is favored.

Summary of Comments

A proposed rule was published in the Federal Register on December 16, 2014, with a comment period of December 11, 2015, through January 11, 2016 (80 FR 76873). No comments were received by AMS. The proposed rule may be viewed at www.regulations.gov.

List of Subjects in 7 CFR Part 1205

Advertising, Agricultural research, Cotton, Marketing agreements, Reporting and Recordkeeping requirements.

For the reasons set forth in the preamble, 7 CFR part 1205 is amended as follows:

PART 1205—COTTON RESEARCH AND PROMOTION 1. The authority citation for part 1205 continues to read as follows: Authority:

7 U.S.C. 2101-2118.

2. Revise § 1205.12 to read as follows:
§ 1205.12 Cotton.

The term cotton means all Upland cotton harvested in the United States and all imports of Upland cotton, including the Upland cotton content of products derived thereof.

3. In § 1205.510, paragraph (b)(3) is revised to read as set forth below (the Import Assessment Table remains unchanged):
§ 1205.510 Levy of assessments.

(b) * * *

(3) The following table contains Harmonized Tariff Schedule (HTS) classification numbers and corresponding conversion factors and assessments. The left column of the following table indicates the HTS classifications of imported cotton and cotton-containing products subject to assessment. The center column indicates the conversion factor for determining the raw fiber content for each kilogram of the HTS. HTS numbers for raw cotton have no conversion factor in the table. The right column indicates the total assessment per kilogram of the article assessed. In the event that any HTS number subject to assessment is changed and such change is merely a replacement of a previous number and has no impact on the physical properties, description, or cotton content of the product involved, assessments will continue to be collected based on the new number.

Dated: June 10, 2016. Elanor Starmer, Administrator.
[FR Doc. 2016-14174 Filed 6-14-16; 8:45 am] BILLING CODE 3410-02-P
DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 1214 [Document Number AMS-SC-15-0072] Christmas Tree Promotion, Research, and Information Order; Late Payment and Interest Charges on Past Due Assessments AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Final rule.

SUMMARY:

This rule prescribes late payment and interest charges on past due assessments under the Christmas Tree Promotion, Research, and Information Order (Order). The Order is administered by the Christmas Tree Promotion Board (Board) with oversight by the U.S. Department of Agriculture (USDA). Under the Order, assessments are collected from domestic producers and importers and used for research and promotion projects designed to maintain and expand the market for fresh cut Christmas trees. This rule implements authority contained in the Order that allows the Board to collect late payment and interest charges on past due assessments. Late payment and interest charges will begin to accrue on unpaid assessments beginning 30 days after the effective date of this rule. This action contributes to effective administration of the program. This rule also provides authority for the crop year and fiscal period to be changed through administrative action. These changes were unanimously recommended by the Board.

DATES:

Effective June 16, 2016.

FOR FURTHER INFORMATION CONTACT:

Victoria Carpenter, Marketing Specialist, Promotion and Economics Division, Specialty Crops Program, AMS, USDA, Stop 0244, 1400 Independence Avenue SW., Room 1406-S, Washington, DC 20250-0244; telephone: (202) 720-9915; facsimile: (202) 205-2800; or electronic mail: [email protected].

SUPPLEMENTARY INFORMATION:

This rule is issued under the Order (7 CFR part 1214). The Order is authorized under the Commodity Promotion, Research, and Information Act of 1996 (1996 Act)(7 U.S.C. 7411-7425).

Executive Order 12866 and Executive Order 13563

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules and promoting flexibility. This action has been designated as a “non-significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget (OMB) has waived the review process.

Executive Order 13175

This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.

Executive Order 12988

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. Section 524 of the 1996 Act provides that it shall not affect or preempt any other Federal or State law authorizing promotion or research relating to an agricultural commodity.

Under section 519 of the 1996 Act (7 U.S.C. 7418), a person subject to an order may file a written petition with USDA stating that an order, any provision of an order, or any obligation imposed in connection with an order, is not established in accordance with the law, and request a modification of an order or an exemption from an order. Any petition filed challenging an order, any provision of an order, or any obligation imposed in connection with an order, shall be filed within two years after the effective date of an order, provision, or obligation subject to challenge in the petition. The petitioner will have the opportunity for a hearing on the petition. Thereafter, USDA will issue a ruling on the petition. The 1996 Act provides that the district court of the United States for any district in which the petitioner resides or conducts business shall have the jurisdiction to review a final ruling on the petition, if the petitioner files a complaint for that purpose not later than 20 days after the date of the entry of USDA's final ruling.

Background

This rule prescribes late payment and interest charges on past due assessments. The Order is administered by the Board with oversight by USDA. Under the Order, assessments are collected from domestic producers and importers and used for research and promotion projects designed to maintain and expand the market for fresh cut Christmas trees. This rule implements authority contained in the Order and the 1996 Act that allows the Board to collect late payment and interest charges on past due assessments. This action was unanimously recommended by the Board and will contribute to effective administration of the program.

Section 1214.52(a) of the Order specifies that the funds to cover the Board's expenses shall be paid from assessments on producers and importers, donations from persons not subject to assessments, and from other funds available to the Board. Paragraphs (b) and (c) specify that the collection of assessments on Christmas trees that are cut and sold or imported will be the responsibility of the producer who produces the Christmas trees or causes them to be cut, or the importer who imports Christmas trees for marketing in the United States.

Section 1214.52(e) specifies that “a late payment charge, may be imposed on any producer or importer who fails to remit to the Board, the total amount for which any such producer or importer is liable on or before the due date established by the Board. In addition to the late payment charge, an interest charge may be imposed on the outstanding amount for which the producer or importer is liable. The rate for late payment and interest charges shall be specified by the Secretary through rulemaking.”

The Order was implemented in November 2011, but immediately stayed. The stay was lifted on April 7, 2014, and the program is currently in effect. Domestic assessments were due February 15, 2016. This will be the first assessment collection by the Board. Importers will be responsible for paying the assessment directly to the Board 30 calendar days after importation. U.S. Customs and Border Protection (Customs) will not be collecting on imports for the 2015 season. Producers or importers who domestically produce or import less than 500 trees annually are exempt from assessment.

This rule implements authority contained in the Order and the 1996 Act that allows the Board to collect late payment and interest charges on past due assessments.

Late payment and interest charges will begin to accrue on unpaid assessments beginning 30 days after the effective date of the final rule. A late payment charge of $250 will be applied to any unpaid assessments for producers and importers that are delinquent in paying their assessment. If the assessment is paid after February 15, but up to 29 days after the effective date of this final rule, no late payment charge will be imposed. The late payment charge will be increased to $500 after 90 days after the effective date of this final rule. Additionally, a 1.5 percent interest charge per month will be imposed on unpaid assessments and fees owed, beginning 30 days after the effective date of this final rule. The delay of the imposition of late payment and interest charges only applies to the initial period of assessment collection. Assessment funds are used by the Board for activities designed to benefit all industry members. Thus, it is important that all assessed entities pay their assessments in a timely manner. Entities who fail to pay their assessments on time would be able to reap the benefits of Board programs at the expense of others. In addition, they would be able to utilize funds for their own use that should otherwise be paid to the Board to finance Board programs.

Board Recommendation

The Board met on July 17, 2015, and unanimously recommended specifying rates of late payment charges and interest on past due assessments in the Order's regulations. Specifically, the Board recommended that a late payment charge of $250 be applied to late assessments for producers and importers that are delinquent in paying their assessment 30 days after the due date. The late payment charge will increase to $500 after 90 days of delinquency. Additionally, a 1.5 percent interest charge per month will be imposed on late assessments and fees owed, beginning 30 days after the assessment due date. This fee structure is not overtly burdensome on small producers or importers, but does create the incentive to promote timely payment of assessments due. This action contributes to the efficient administration of the program.

This action will help facilitate program administration by providing an incentive for entities to remit assessments in a timely manner, with the intent of creating a fair and equitable process among all assessed entities. Accordingly, a new Subpart C is added to the Order for rules and regulations, and a new section 1214.520 is added to Subpart C.

This rule also makes one additional change to the Order. This rule revises the definition of crop year and fiscal period as defined in sections 1214.5 and 1214.8, respectively. The Board recommended this change because USDA revised the crop year and fiscal period during the promulgation process from what was originally proposed by the industry. The Board wants the flexibility to change these dates if necessary. The terms crop year and fiscal period will be revised by adding language to allow the Board to change the crop year or fiscal period administratively through Board action.

Final Regulatory Flexibility Act Analysis

In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS is required to examine the impact of this rule on small entities. Accordingly, AMS has considered the economic impact of this action on such entities.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be disproportionately burdened. The Small Business Administration (SBA) defines, in 13 CFR part 121, small agricultural producers as those having annual receipts of no more than $750,000 and small agricultural service firms (producers and importers) as those having annual receipts of no more than $7.5 million.

According to the 2012 Census of Agriculture published by the National Agricultural Statistics Service (NASS), it is estimated that there are 15,494 farms that sold cut Christmas trees in the United States. According to NASS, the value of cut Christmas trees sold in 2012 was $808,644,000. Dividing that value by the number of farms yields an average annual producer revenue of $52,191. Therefore it is estimated that all farms that sold Christmas trees had revenue under $750,000.

Likewise, based on Customs data, it is estimated there are 153 importers of Christmas trees. Using 2014 Customs data, all importers import less than $7.5 million worth of Christmas trees annually. Thus, all domestic producers and importers of Christmas trees would be considered small entities.

Regarding the value of the commodity, as mentioned above, based on 2012 NASS Census of Agriculture data, the value of the domestic cut Christmas trees was about $808.6 million. According to Customs data, the value of 2014 imports was about $25.8 million.

This rule prescribes late payment and interest charges on past due assessments under the Order. The Order is administered by the Board with oversight by USDA. Under the Order, assessments are collected from producers and importers of Christmas trees that are cut and sold or imported.

This rule will add a new section 1214.520 that will specify a late payment charge of $250 to be applied to late assessments for producers and importers that are delinquent in paying their assessment 30 days after the due date. The late payment charge will be increased to $500 after 90 days of delinquency. Additionally, a 1.5 percent interest charge per month will be imposed on late assessments and fees owed, beginning 30 days after the assessment due date. This section will be included in a new Subpart C—Provisions Implementing the Christmas Tree Promotion, Research, and Information Order. This action was unanimously recommended by the Board and is authorized under section 1214.52(e) of the Order and section 517(e) of the 1996 Act.

In addition, one other change is being made to the Order. It will revise the definition of crop year and fiscal period as defined in sections 1214.5 and 1214.8, respectively. The Board recommended this change because USDA revised the crop year and fiscal period during the promulgation process from what was originally proposed by the industry. The Board wants the flexibility to change these dates if necessary. The terms crop year and fiscal period will be revised by adding language to allow the Board to change the crop year or fiscal period administratively through Board action.

Regarding the economic impact of this rule on affected entities, this action imposes no costs on producers and importers who pay their assessments on time. It merely provides an incentive for entities to remit their assessments in a timely manner. For all entities who are delinquent in paying assessments, both large and small, the charges will be applied uniformly. As for the impact on the industry as a whole, this action will help facilitate program administration by providing an incentive for entities to remit their assessments in a timely manner, with the intent of creating a fair and equitable process among all assessed entities.

Additionally, as previously mentioned, the Order provides for an exemption for entities that produce or import less than 500 Christmas trees.

Regarding alternatives, one option to the action is to maintain the status quo and not prescribe late payment and interest charges for past due assessments. However, the Board determined that implementing such charges would help facilitate program administration by encouraging entities to pay their assessments in a timely manner. The Board reviewed rates of late payment and interest charges prescribed in other research and promotion programs and concluded that the late payment charge and the interest charge contained in this rule are appropriate.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the information collection and recordkeeping requirements that are imposed by the Order have been approved under OMB control number 0581-0093. This rule results in no changes to the information collection and recordkeeping requirements previously approved and imposes no additional reporting and recordkeeping burden on domestic producers and importers of Christmas trees.

As with all Federal promotion programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. Finally, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

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

Regarding outreach efforts, the Board met on July 17, 2015, and unanimously recommended these changes to the Order. All of the Board's meetings, including meetings held via teleconference, are open to the public and interested persons are invited to participate and express their views.

A proposed rule concerning this action was published in the Federal Register on March 1, 2016 (81 FR 10530). The proposal was made available through the Internet by USDA and the Office of the Federal Register. A 15-day comment period ending March 16, 2016, was provided to allow interested persons to submit comments. No comments were received.

After consideration of all relevant matters presented, including the information and recommendation submitted by the Board and other available information, it is hereby found that this rule, as hereinafter set forth, is consistent with and will effectuate the purposes of the 1996 Act.

It is further found that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register (5 U.S.C. 553) because this is the initial year for the collection of assessments under the Order, on the 2015 harvest, and assessments were due on February 15, 2016. Importers are responsible for paying assessments directly to the Board 30 calendar days after importation. The Board would like to implement this incentive as soon as possible to facilitate the initial collection of assessments. Additionally, this action was unanimously recommended by the Board. Further, a 15-day comment period was provided for in the proposed rule and no comments were received.

List of Subjects in 7 CFR Part 1214

Administrative practice and procedure, Advertising, Consumer information, Christmas trees, Marketing agreements, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, 7 CFR part 1214 is amended as follows:

PART 1214—CHRISTMAS TREE PROMOTION, RESEARCH, AND INFORMATION ORDER 1. The authority citation for 7 CFR part 1214 continues to read as follows: Authority:

7 U.S.C. 7411-7425; 7 U.S.C. 7401.

2. Section 1214.5 is revised to read as follows:
§ 1214.5 Crop year.

Crop year means the period August 1 through July 31 or such other period approved by the Secretary.

3. Section 1214.8 is revised to read as follows:
§ 1214.8 Fiscal period.

Fiscal period means the period August 1 through July 31 or such other period approved by the Secretary.

4. Subpart C, consisting of § 1214.520, is added to read as follows: Subpart C—Provisions Implementing the Christmas Tree Promotion, Research, and Information Order
§ 1214.520 Late payment and interest charges for past due assessments.

(a) A late payment charge shall be imposed on any producer or importer who fails to make timely remittance to the Board of the total assessments for which such producer or importer is liable. The late payment charge will be imposed on any assessments not received within 30 calendar days of the date they are due. This one-time late payment charge shall be $250 and will be increased to $500 after 90 days of delinquency.

(b) In addition to the late payment charge, 1.5 percent per month interest on the outstanding balance, including any late payment charge and accrued interest, will be added to any accounts for which payment has not been received by the Board within 30 calendar days after the date the assessments are due. Such interest will continue to accrue monthly until the outstanding balance is paid to the Board.

Dated: June 10, 2016. Elanor Starmer, Administrator.
[FR Doc. 2016-14150 Filed 6-14-16; 8:45 am] BILLING CODE P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-3635; Directorate Identifier 2015-NM-037-AD; Amendment 39-18553; AD 2016-12-04] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

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

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for all Airbus Model A318 series airplanes; A319 series airplanes; A320-211, -212, -214, -231, -232, and -233 airplanes; and A321 series airplanes. This AD was prompted by an evaluation by the design approval holder (DAH) indicating that certain structural repair manual (SRM) inspection requirements for the fuselage skin repairs are insufficient to detect cracks. This AD requires an inspection to determine whether any fuselage external skin (doubler) repairs have been accomplished, an inspection for cracking of certain repaired external fuselage skin areas in the fuselage, and repair if necessary. We are issuing this AD to detect and correct fatigue cracking of the fuselage skin, which could result in reduced structural integrity of the airplane.

DATES:

This AD becomes effective July 20, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of July 20, 2016.

ADDRESSES:

For service information identified in this final rule, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; 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. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-3635.

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-2015-3635; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149.

SUPPLEMENTARY INFORMATION: Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus Model A318 series airplanes; A319 series airplanes; A320-211, -212, -214, -231, -232, and -233 airplanes; and A321 series airplanes. The NPRM published in the Federal Register on September 28, 2015 (80 FR 58226) (“the NPRM”). The NPRM was prompted by an evaluation by the DAH indicating that the fuselage skin repairs are subject to WFD. The NPRM proposed to require an inspection to determine whether any fuselage external skin (doubler) repairs have been accomplished, an inspection for cracking of certain repaired external fuselage skin areas in the fuselage, and repair if necessary. We are issuing this AD to detect and correct fatigue cracking of the fuselage skin, which could result in reduced structural integrity of the airplane.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0036R1, dated March 31, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on all Airbus Model A318 series airplanes; A319 series airplanes; A320-211, -212, -214, -231, -232, and -233 airplanes, and A321 series airplanes. The MCAI states:

During A320 family Extended Service Goal full scale fatigue tests, it was demonstrated that the inspection thresholds defined in the current Structural Repair Manual (SRM) for the A320 family skin repairs are insufficient to detect possible cracks becoming after repairs. The findings are limited to 1.2 [millimeter] (mm) fuselage skin and cover for all cut-out external repairs. The internal repairs are not affected.

This condition, if not detected and corrected, could affect the structural integrity of the fuselage at the repaired skin area(s).

To address this potential unsafe condition, Airbus issued Alert Operators Transmission (AOT) A53N007-14 to provide inspection instructions.

For the reasons described above, EASA issued AD 2015-0036 [http://www.casa.gov.au/scripts/nc.dll?WCMS:OLDASSET::svPath=/ADFiles/over/a320/,svFileName=2015-0036.pdf] to require a one-time inspection of the affected areas and, depending on findings, accomplishment of applicable repair instructions.

Since that [EASA] AD was issued, operators have questioned the inspection threshold for A318 aeroplanes (not yet in the Airbus AOT), which is actually identical to that for A319 aeroplanes. In addition, an error has been detected in paragraph (1) [of the EASA AD], since external doublers may have been installed in the affected area by a modification that may not be recorded as repair.

Such doubler installations are also subject to the inspection requirements of this [EASA] AD, which is therefore revised to provide clarifications, correcting paragraph (1) [of the EASA AD] and introducing a Note.

Required actions include an inspection to determine whether any fuselage external skin (doubler) repairs have been accomplished, an external ultrasonic inspection or an internal low/high frequency eddy current inspection for cracking of certain repaired external fuselage skin areas in the fuselage, and repair if necessary. The compliance times vary depending on airplane configuration. The earliest compliance time is within 25,200 flight cycles since last repair, or within 350 flight cycles after the effective date of the AD, whichever occurs later. The latest compliance time is within 45,000 flight cycles since last repair; within 1,500 flight cycles from the effective date of the AD, without exceeding 49,100 flight cycles since last repair; or within 350 flight cycles since the effective date of the AD; whichever occurs latest. 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-2015-3635.

Comments

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

Support for the NPRM

Mr. Bryant Kerr stated that the NPRM is an excellent idea, and it is always worth improving safety on airplanes.

Request To Revise Applicability

United Airlines (UAL) requested that we revise the NPRM applicability to apply only to airplanes having repairs that were completed before May 1, 2015, the date of the revised service repair manual (SRM). UAL stated that any new airplane deliveries or external repairs accomplished after the updated SRM thresholds will presumably have the correct thresholds contained in the maintenance/inspection program.

We partially agree with UAL's request. We agree that airplanes with repairs accomplished using the updated SRM will be in compliance with certain sections of this AD, such as the timescale for the inspection, which is a subset of the AD requirements. However, the SRM update will not replace the remaining AD requirements, which must be applicable to all airplanes identified in paragraph (c) of this AD. We have not changed this AD in this regard.

Request To Exclude Inspected Airplanes

Delta Airlines (DAL) stated that since certain repairs and modifications on its airplanes have already had their first inspection prior to the compliance time specified in the NPRM, the NPRM requirements should not apply. DAL also stated that if an operator's maintenance/inspection program is more stringent than the requirements of paragraph (m) of the proposed AD, the operator should be excluded from the NPRM requirements.

We disagree with DAL's request. Accomplishment of the first inspection is only part of the actions required by this AD. Paragraph (m) of this AD requires revision of the post-repair inspection threshold(s) in the operator's maintenance program or inspection program. This AD includes the minimum requirements for mitigating the identified unsafe condition. However, under the provisions of paragraph (n)(1) of this AD, we will consider requests for approval of different methods of compliance if sufficient data are submitted to substantiate that the change would provide an acceptable level of safety. We have not changed this AD in this regard.

Request To Revise Compliance Time

DAL requested a compliance time extension from 350 flight cycles to 6 months. DAL stated that depending on the fleet utilization, an operator of a large, older fleet could be required to accomplish the compliance rework within a few months, thereby creating a significant impact on its available resources. DAL also stated that it is possible that several airplanes will be grounded because it may not have enough resources to comply with the 350-flight-cycle limit.

We do not agree with DAL's request. DAL's rationale for a compliance time extension does not provide an acceptable level of safety. The compliance time of this AD is based on a risk assessment. Some safety issues are more time sensitive than others. We have considered the compliance time established by EASA, and the overall risk to the fleet, including the severity of the identified unsafe condition and the likelihood of the occurrence of the unsafe condition, to determine the compliance time. However, under the provisions of paragraph (n)(1) of this AD, operators may apply for an extension of the compliance time by providing a satisfactory rationale explaining why a compliance time extension provides an acceptable level of safety. We have not changed this final rule in this regard.

Request To Clarify Requirements and Approve Certain Repair Information Sources

DAL requested that we make a distinction that the NPRM requirements apply only to external repair fasteners common to the 1.2-millimeter (mm) skin. DAL also stated that we should approve category B repairs done using the latest revision of the SRM and any repair design approval sheet (RDAS) approved after July 1, 2014. DAL stated that the applicable Airbus SRM repair inspection thresholds have been revised this year to address certain inadequacies.

We do not agree with DAL's requests. Paragraph (g) of this AD already requires an inspection to determine whether any fuselage doubler repairs have been accomplished on affected fuselage sections with a skin thickness of 1.2 mm. DAL did not substantiate how the corrective actions in any RDAS for category “B” repairs approved after July 1, 2014, and the latest revision of the SRMs would adequately address the unsafe condition. However, the commenter may use the provisions of paragraph (n)(2) of this AD for obtaining corrective actions from a manufacturer. We have not changed this AD in this regard.

Request To Clarify Inspection Timeframes

UAL requested clarification on how the NPRM addresses detection of cracking in the timeframe between the inspection threshold specified in the NPRM and Airbus Alert Operators Transmission A53N007-14, dated July 22, 2014, and the repetitive inspections specified in the SRM. UAL stated that the compliance time has a short threshold if the repair records are inconclusive, which is as early as 350 flight cycles from the effective date of the AD; therefore, the initial inspection could be accomplished much earlier than the crack detection period.

We agree to clarify the inspection timeframes. The 350-flight-cycle compliance time is a second option to the compliance time specified in Airbus Alert Operators Transmission A53N007-14, dated July 22, 2014. The compliance time is based on a risk assessment that takes into consideration the fatigue crack length propagation. We have considered the compliance time established by EASA, and the overall risk to the fleet, including the severity of the identified unsafe condition and the likelihood of the occurrence of the unsafe condition. No change to the AD is necessary in this regard.

Request To Correct Non-Destructive Testing Manual (NTM) Task Numbers

DAL stated that Airbus Alert Operators Transmission A53N007-14, dated July 22, 2014, references incorrect formatting of NTM task numbers. DAL stated the formatting should be “51-10-15-270-801-A01” and “51-10-16-250-801-A01,” and not “51-10-15-270-801-A-01” and “51-10-16-250-801-A-01.”

We disagree with DAL's statement. NTM task numbers 51-10-15-270-801-A-01 and 51-10-16-250-801-A-01 are correctly referenced in Airbus Alert Operators Transmission A53N007-14, dated July 22, 2014, and in the Airbus A318/319/320/321 Non-Destructive Testing Manual. We have not changed this AD in this regard.

Clarification of Unsafe Condition Language

We revised the description of the precipitating event in the SUMMARY and paragraph (e) of this AD to correspond to the wording used in the MCAI AD.

Conclusion

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:

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

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

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

Related Service Information Under 1 CFR Part 51

Airbus has issued Alert Operators Transmission A53N007-14, dated July 22, 2014. The service information describes procedures for an inspection to detect cracking on repaired 1.2-millimeter fuselage skin areas on fuselage sections 11, 12, 13, 14, 16, and 17 at external doubler repairs. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

We estimate that this AD affects 940 airplanes of U.S. registry.

We also estimate that it will take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $159,800, or $170 per product.

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

Authority for This Rulemaking

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

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

Regulatory Findings

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2016-12-04 Airbus: Amendment 39-18553. Docket No. FAA-2015-3635; Directorate Identifier 2015-NM-037-AD. (a) Effective Date

This AD becomes effective July 20, 2016.

(b) Affected ADs

None.

(c) Applicability

This AD applies to the Airbus airplanes specified in paragraphs (c)(1) through (c)(4) of this AD, certificated in any category, all manufacturer serial numbers.

(1) Airbus Model A318-111, -112, -121, and -122 airplanes.

(2) Airbus Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes.

(3) Airbus Model A320-211, -212, -214, -231, -232, and -233 airplanes.

(4) Airbus Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes.

(d) Subject

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

(e) Reason

This AD was prompted by an evaluation by the design approval holder (DAH) indicating that certain structural repair manual (SRM) inspection requirements for the fuselage skin repairs are insufficient to detect cracks. We are issuing this AD to detect and correct fatigue cracking of the fuselage skin, which could result in reduced structural integrity of the airplane.

(f) Compliance

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

(g) Inspection To Determine Repair Areas

At the applicable time specified in paragraph (g)(1) or (g)(2) of this AD: Do an inspection to determine whether any fuselage external skin (doubler) repairs have been accomplished on fuselage sections 11, 12, 13, 14, 16, and 17 with a skin thickness of 1.2 millimeters. A review of airplane maintenance records is acceptable in lieu of this inspection if the identification of applicable repairs can be conclusively determined from that review.

(1) For Model A319, A320, and A321 series airplanes: Except as specified in paragraphs (h)(1) and (h)(2) of this AD, at the applicable time specified in paragraphs 4.1.1.b. and 4.1.1.c. of the “Accomplishment Timescale” of Airbus Alert Operators Transmission (AOT) A53N007-14, dated July 22, 2014, or within 350 flight cycles after the effective date of this AD, whichever occurs later.

(2) For Model A318 series airplanes: Except as specified in paragraphs (h)(1) and (h)(2) of this AD, at the Model A319 airplane time specified in paragraphs 4.1.1.b. and 4.1.1.c. of the “Accomplishment Timescale” of Airbus AOT A53N007-14, dated July 22, 2014, or within 350 flight cycles after the effective date of this AD, whichever occurs later.

(h) Exceptions to Service Information

(1) Where paragraphs 4.1.1.b. and 4.1.1.c. of the “Accomplishment Timescale” of Airbus AOT A53N007-14, dated July 22, 2014, specify “FC,” this AD specifies “flight cycles.”

(2) Where paragraphs 4.1.1.b. and 4.1.1.c. of the “Accomplishment Timescale” of Airbus AOT A53N007-14, dated July 22, 2014, specify “from AOT issuance,” this AD specifies “as of the effective date of this AD.”

(i) Inspection for Cracking

If, during the inspection required by paragraph (g) of this AD, it is determined that any fuselage external skin (doubler) repair has been accomplished on fuselage section 11, 12, 13, 14, 16, or 17: At the applicable time specified paragraph (g)(1) or (g)(2) of this AD, do an external ultrasonic inspection or an internal low frequency eddy current (LFEC) inspection for cracking of all of the repaired 1.2-millimeter (mm) fuselage skin areas, in accordance with the instructions specified in paragraph 4.2.2, “Inspection Requirements,” of Airbus AOT A53N007-14, dated July 22, 2014, except as provided by paragraph (j) of this AD.

(j) Optional Inspection for Cracking

As an optional method of compliance to the ultrasonic inspection or LFEC inspection required by paragraph (i) of this AD: Do a high frequency eddy current (HFEC) inspection for cracking in the cut-out surrounding the fastener area, at and in front (approximately 10-15 millimeters) of the fastener row, after doubler removal and before any new extended doubler installation, 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).

(k) Optional Repetitive Inspections

In lieu of doing the inspection required by paragraph (i) of this AD: Within the applicable compliance time specified in paragraph 4.1.1, “Accomplishment Timescale,” of Airbus AOT A53N007-14, dated July 22, 2014, after accomplishing the inspections required by paragraph (g) of this AD, do a detailed inspection or HFEC inspection and repeat the inspection thereafter within the applicable compliance times specified in paragraph 4.1.1, “Accomplishment Timescale,” of Airbus AOT A53N007-14, dated July 22, 2014. The inspections must be done in accordance with the instructions of paragraph 4.2.2, “Inspection Requirements,” of Airbus AOT A53N007-14, dated July 22, 2014. For Model A318 series airplanes, use the applicable compliance times and instructions specified in Airbus AOT A53N007-14, dated July 22, 2014, that are specified for Model A319 series airplanes.

(l) Repair

If any crack is found during any inspection required by paragraph (i), (j), or (k) of this AD: Before further flight, repair the cracking, in accordance with the instructions of paragraph 4.2.3, “Findings,” of Airbus AOT A53N007-14, dated July 22, 2014, except where Airbus AOT A53N007-14, dated July 22, 2014, specifies to contact Airbus for a repair design approval sheet or for further instructions, this AD requires repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA; or Airbus's EASA DOA.

(m) FAA-Approved Maintenance or Inspection Program Revision

Concurrently with the accomplishment of any repair required by paragraph (l) of this AD, revise the post-repair inspection threshold(s) in the applicable FAA-approved maintenance program or inspection program, as applicable, in accordance with the instructions specified in paragraph 4.1.1, “Accomplishment Timescale,” of Airbus AOT A53N007-14, dated July 22, 2014; except for Model A318 series airplanes use the instructions specified for Model A319 series airplanes.

(n) 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: Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; 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.

(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 EASA; or Airbus's EASA DOA. If approved by the DOA, the approval must include the DOA-authorized signature.

(o) Related Information

(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2015-0036R1, dated March 31, 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-2015-3635.

(p) Material Incorporated by Reference

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

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

(i) Airbus Alert Operators Transmission A53N007-14, dated July 22, 2014.

(ii) Reserved.

(3) For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email [email protected]; Internet http://www.airbus.com.

(4) 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.

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

Issued in Renton, Washington, on May 31, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-13741 Filed 6-14-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-7057; Directorate Identifier 2016-CE-017-AD; Amendment 39-18557; AD 2016-12-08] RIN 2120-AA64 Airworthiness Directives; GROB Aircraft AG Airplanes AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule; request for comments.

SUMMARY:

We are adopting a new airworthiness directive (AD) for GROB Aircraft AG Model G115EG airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as cracks in the bonded joint of the rear horizontal stabilizer frame. We are issuing this AD to require actions to address the unsafe condition on these products.

DATES:

This AD is effective July 20, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of July 20, 2016.

We must receive comments on this AD by August 1, 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 AD, contact GROB Aircraft AG, Product Support, Lettenbachstrasse 9, D-86874 Tussenhausen-Mattsies, Germany, telephone: + 49 (0) 8268-998-105; fax: + 49 (0) 8268-998-200; email: [email protected]; Internet: grob-aircraft.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. It is also available on the Internet at http://www.regulations.gov by searching for locating Docket No. FAA-2016-7057.

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-2016-7057; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The 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:

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD No.: 2016-0091, dated May 16, 2016 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

Cracks were found in the bonded joint of the rear horizontal stabiliser frame of G 115E aeroplanes.

This condition, if not detected and corrected, may lead to crack propagation into primary structural elements, with detrimental effect on the structural integrity of the aeroplane.

To address this potential unsafe condition, GROB issued Service Bulletin (SB) MSB1078-200 (hereafter referred to as “the SB” in this AD) to provide instructions for inspections and corrective action.

For the reason described above, this AD requires repetitive inspections of the rear horizontal stabilizer frame and modification of the affected structure.

You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-7057.

Related Service Information Under 1 CFR Part 51

GROB Aircraft AG has issued Service Bulletin No. MSB1078-200, dated February 25, 2016. The service information describes procedures for repetitive inspections of the rear horizontal stabilizer frame for cracks and procedures for repair 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 of the AD.

FAA's Determination and Requirements of the 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 issuing this AD because we evaluated all information provided by the State of Design Authority and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

FAA's Determination of the Effective Date

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because there are no airplanes currently on the U.S. registry and thus, does not have any impact upon the public. Therefore, we find that notice and opportunity for prior public comment are unnecessary.

Comments Invited

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-7057; Directorate Identifier 2016-CE-017-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this 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 AD.

Costs of Compliance

We estimate that this AD will affect 0 products 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 AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of the AD on U.S. operators to be $0, or $170 per product.

In addition, we estimate that any necessary follow-on actions would take about 15 work-hours and require parts costing $60, for a cost of $1,335 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 AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

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

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

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

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new AD: 2016-12-08 GROB Aircraft AG: Amendment 39-18557; Docket No. FAA-2016-7057; Directorate Identifier 2016-CE-017-AD. (a) Effective Date

This airworthiness directive (AD) becomes effective July 20, 2016.

(b) Affected ADs

None.

(c) Applicability

This AD applies to Grob Aircraft AG Models G115EG airplanes, serial numbers up to and including 82323/E, certificated in any category.

(d) Subject

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

(e) Reason

This AD was prompted by 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 cracks in the bonded joint of the rear horizontal stabilizer frame. We are issuing this AD to detect and correct cracks in the bonded joint of the rear horizontal stabilizer frame, which if not corrected could propagate into the primary structural elements of the airplane and affect its structural integrity.

(f) Actions and Compliance

Unless already done, do the actions in paragraphs (f)(1) through (6) of this AD.

(1) Within the next 50 hours time-in-service (TIS) after July 20, 2016 (the effective date of this AD), and repetitively thereafter at intervals not to exceed 50 hours, inspect the rear horizontal stabilizer frame following the Accomplishment Instructions in section 1.8, Part A, of GROB Aircraft AG Service Bulletin (SB) No. MSB1078-200, dated February 25, 2016.

(2) If any crack within the green area as defined in Figure 2 of the Accomplishment Instructions in section 1.8, Part A, of GROB Aircraft AG Service Bulletin (SB) No. MSB1078-200, dated February 25, 2016, is found during any inspection required in paragraph (f)(1) of this AD, before further flight, install a temporary placard stating “NO AEROBATICS, NO SPINS AND NO SIDE SLIPS ALLOWED” in full view of the pilot(s) and place a copy of this AD in the airplane flight manual (AFM); and after each day of flight operations, do a crack propagation inspection following the Accomplishment Instructions in Section 1.8, Part B, of GROB Aircraft AG SB No. MSB1078-200, dated February 25, 2016.

(3) If any crack within the red area as defined in Figure 2 of the Accomplishment Instructions in section 1.8, Part A, of GROB Aircraft AG Service Bulletin (SB) No. MSB1078-200, dated February 25, 2016, is found during any inspection required by this AD, before further flight, repair the affected area following the Accomplishment Instructions in Section 1.8, Part C, of GROB Aircraft AG SB No. MSB1078-200, dated February 25, 2016.

(4) Within the next 19 months after July 20, 2016 (the effective date of this AD), unless already done as required by paragraph (f)(3) of this AD, modify the airplane following the Accomplishment Instructions in Section 1.8, Part C, of GROB Aircraft AG SB No. MSB1078-200, dated February 25, 2016.

(5) After modification of the airplane as required by paragraph (f)(3) or (4) of this AD, remove the placard installed as required in paragraph (f)(2) of this AD and remove the copy of this AD from the applicable AFM.

(6) Modification of an airplane as required in paragraph (f)(3) or (4) of this AD, as applicable, constitutes terminating action for the repetitive inspections required in paragraph (f)(1) and (2) 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 European Aviation Safety Agency (EASA) AD No.: 2016-0091, dated May 16, 2016, for related. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-7057.

(i) Material Incorporated by Reference

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

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

(i) GROB Aircraft AG Service Bulletin No. MSB1078-200, dated February 25, 2016.

(ii) Reserved.

(3) For GROB Aircraft AG service information identified in this AD, contact GROB Aircraft AG, Product Support, Lettenbachstrasse 9, D-86874 Tussenhausen-Mattsies, Germany, telephone: + 49 (0) 8268-998-105; fax: + 49 (0) 8268-998-200; email: [email protected]; Internet: grob-aircraft.com.

(4) You may view this 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. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-7057.

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

Issued in Kansas City, Missouri, on June 6, 2016. Robert Busto, Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-13853 Filed 6-14-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-7524; Directorate Identifier 2014-NM-231-AD; Amendment 39-18554; AD 2016-12-05] RIN 2120-AA64 Airworthiness Directives; Saab AB, Saab Aeronautics (Formerly Known as Saab AB, Saab Aerosystems) AGENCY:

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

ACTION:

Final rule.

SUMMARY:

We are superseding Airworthiness Directive (AD) 2014-15-04 for certain Saab AB, Saab Aeronautics Model SAAB 2000 airplanes. AD 2014-15-04 required deactivating the potable water system, or alternatively filling and activating the potable water system. This new AD requires inspecting the in-line heater for correct brazing and corrective action if needed, and installing a shrinkable tube on the water line and a spray shield on the in-line heater. This AD was prompted by a report of rudder pedal restriction which was the result of water leakage at the inlet tubing of an in-line heater in the lower part of the forward fuselage. This AD was also prompted by the development of a modification that would address the unsafe condition. We are issuing this AD to prevent rudder pedal restriction due to the pitch control mechanism becoming frozen as the result of water spray, which could prevent disconnection of the pitch control mechanism and normal pitch control, and consequently result in reduced controllability of the airplane.

DATES:

This AD is effective July 20, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of July 20, 2016.

The Director of the Federal Register approved the incorporation by reference of certain other publications listed in this AD as of September 9, 2014 (79 FR 45337, August 5, 2014).

ADDRESSES:

For service information identified in this final rule, contact Saab AB, Saab Aeronautics, SE-581 88, Linköping, Sweden; telephone +46 13 18 5591; fax +46 13 18 4874; email [email protected]; Internet http://www.saabgroup.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-2015-7524.

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-2015-7524; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (telephone 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Shahram Daneshmandi, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1112; fax 425-227-1149.

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2014-15-04, Amendment 39-17906 (79 FR 45337, August 5, 2014) (“AD 2014-15-04”). AD 2014-15-04 applied to certain Saab AB, Saab Aeronautics Model SAAB 2000 airplanes. The NPRM published in the Federal Register on December 17, 2015 (80 FR 78702) (“the NPRM”). The NPRM was prompted by a report of rudder pedal restriction which was the result of water leakage at the inlet tubing of an in-line heater in the lower part of the forward fuselage. The NPRM was also prompted by the development of a modification that would address the unsafe condition. The NPRM proposed to continue to require deactivating the potable water system, or alternatively filling and activating the potable water system. The NPRM also proposed to require inspecting the in-line heater for correct brazing and corrective action if needed, and installing a shrinkable tube on the water line and a spray shield on the in-line heater. We are issuing this AD to prevent rudder pedal restriction due to the pitch control mechanism becoming frozen as the result of water spray, which could prevent disconnection of the pitch control mechanism and normal pitch control, and consequently result in reduced controllability of the airplane.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0255, dated November 25, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Saab AB, Saab Aeronautics Model SAAB 2000 airplanes. The MCAI states:

One occurrence of rudder pedal restriction was reported on a SAAB 2000 aeroplane. Subsequent investigation showed that this was the result of water leakage at the inlet tubing for the in-line heater (25HY) in the lower part of the forward fuselage (Zone 116). The in-line heater attachment was found ruptured, which resulted in water spraying in the area. Frozen water on the rudder control mechanism in Zone 116 then led to the rudder pedal restriction.

Analysis after the reported event indicated that the pitch control mechanism (including pitch disconnect/spring unit) may also be frozen as a result of water spray, which would prevent disconnection and normal pitch control.

This condition, if not corrected, could result in further occurrences of reduced control of an aeroplane.

To address this potential unsafe condition, SAAB issued Service Bulletin (SB) 2000-38-10 to provide instructions to deactivate the Potable Water System. Consequently, EASA issued [an EASA] Emergency AD * * * to require that action. That [EASA] Emergency AD was revised and republished as EASA AD 2013-0172R1 [(http://ad.easa.europa.eu/ad/2013-0172R1), which corresponds to FAA AD 2014-15-04, Amendment 39-17906 (79 FR 45337, August 5, 2014)], introducing a temporary alternative procedure for filling, which would allow reactivation and operation of the Potable Water System.

Since that [EASA] AD was issued, SAAB developed an in-line heater spray shield and a water line shrink tube to eliminate the consequences of a water spray leak in case of rupture of the in-line heater. SAAB also issued a SB 2000-38-011, providing instructions for inspection of the in-line heater and installation of a shrink tube and a spray shield.

For reasons described above, this [EASA] AD retains the requirements of EASA AD 2013-0172R1, which is superseded, and requires inspection [for correct brazing] of the in-line heater [and corrective action if needed] and installation of shrink tube [on water line] and spray shield [on in-line heater].

Corrective actions include repairing or replacing the in-line heater. 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-2015-7524.

Comments

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.

Conclusion

We reviewed the available data and determined that air safety and the public interest require adopting this AD as proposed, except for minor editorial changes. We have determined that these minor changes:

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

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

Related Service Information Under 1 CFR Part 51

We reviewed Saab Service Bulletin 2000-38-011, dated October 22, 2014. The service information describes procedures for inspecting for correct brazing of the in-line heater, repairing or replacing the in-line heater, and installing a shrinkable tube on the water line and a spray shield on the in-line heater. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

We estimate that this AD affects 1 airplane of U.S. registry.

The actions required by AD 2014-15-04, Amendment 39-17906 (79 FR 45337, August 5, 2014), and retained in this AD take about 1 work-hour per product, at an average labor rate of $85 per work-hour. Required parts cost $0 per product. Based on these figures, the estimated cost of the actions that are required by AD 2014-15-04 is $85 per product.

We also estimate that it takes about 6 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $3,650 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $4,160.

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by removing Airworthiness Directive (AD) 2014-15-04, Amendment 39-17906 (79 FR 45337, August 5, 2014), and adding the following new AD: 2016-12-05 Saab AB, Saab Aeronautics (Formerly Known as Saab AB, Saab Aerosystems): Amendment 39-18554. Docket No. FAA-2015-7524; Directorate Identifier 2014-NM-231-AD. (a) Effective Date

This AD is effective July 20, 2016.

(b) Affected ADs

This AD replaces AD 2014-15-04, Amendment 39-17906 (79 FR 45337, August 5, 2014) (“AD 2014-15-04”).

(c) Applicability

This AD applies to Saab AB, Saab Aeronautics (formerly known as Saab AB, Saab Aerosystems) Model SAAB 2000 airplanes, certificated in any category, serial numbers 004 through 016 inclusive, 018, 022, 023, 024, 026, 029, 031, 032, 033, 035 through 039 inclusive, 041 through 044 inclusive, 046, 047, 048, 051, and 053 through 063 inclusive.

(d) Subject

Air Transport Association (ATA) of America Code 38, Water/Waste.

(e) Reason

This AD was prompted by a report of rudder pedal restriction which was the result of water leakage at the inlet tubing of an in-line heater in the lower part of the forward fuselage. This AD was also prompted by the development of a modification that would address the unsafe condition. We are issuing this AD to prevent rudder pedal restriction due to the pitch control mechanism becoming frozen as the result of water spray, which could prevent disconnection of the pitch control mechanism and normal pitch control, and consequently result in reduced controllability of the airplane.

(f) Compliance

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

(g) Retained Deactivation of Potable Water System With New Exception

This paragraph restates the requirements of paragraph (g) of AD 2014-15-04, with a new exception. Except as provided by paragraph (l) of this AD, within 30 days after September 9, 2014 (the effective date of AD 2014-15-04), deactivate the potable water system, in accordance with the Accomplishment Instructions of Saab Service Bulletin 2000-38-010, dated July 12, 2013.

(h) Retained Alternative to Deactivation of Potable Water System With No Changes

This paragraph restates the requirements of paragraph (h) of AD 2014-15-04, with no changes. As an alternative, or subsequent, to the action required by paragraph (g) of this AD, during each filling of the potable water system after September 9, 2014, accomplish the temporary filling procedure, in accordance with the instructions in Saab Service Newsletter SN 2000-1304, Revision 01, dated September 10, 2013, including Attachment 1 Engineering Statement to Operator 2000PBS034334, Issue A, dated September 9, 2013.

(i) New Inspection and Installation

At the applicable compliance times specified in paragraphs (j)(1) and (j)(2) of this AD, concurrently accomplish the actions specified in paragraphs (i)(1) and (i)(2) of this AD, in accordance with the Accomplishment Instructions of Saab Service Bulletin 2000-38-011, dated October 22, 2014.

(1) Do a detailed inspection for correct brazing of the in-line heater, and if any discrepancy is found, before further flight, and before accomplishment of the modification required by paragraph (i)(2) of this AD, accomplish all applicable corrective actions.

(2) Install a shrink tube on the water line and a spray shield on the in-line heater.

(j) Compliance Times for Inspection and Installation

Do the actions specified in paragraph (i) of this AD at the applicable times specified in paragraphs (j)(1) and (j)(2) of this AD.

(1) For airplanes having had the potable water system reactivated and operated using the alternative filling procedure specified in Saab Service Newsletter SN 2000-1304, Revision 01, dated September 10, 2013, including Attachment 1 Engineering Statement to Operator 2000PBS034334, Issue A, dated September 9, 2013: Within 6 months after the effective date of this AD.

(2) For airplanes having the potable water system deactivated using procedures specified in the Accomplishment Instructions of Saab Service Bulletin 2000-38-010, dated July 12, 2013: Before further flight after the reactivation of the potable water system.

(k) Terminating Actions for the Deactivation of the Potable Water System

Accomplishing the actions required by paragraph (i) of this AD terminates the requirements of paragraphs (g) and (h) of this AD.

(l) Other FAA AD Provisions

The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, ANM-116, International Branch, 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: Shahram Daneshmandi, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1112; fax 425-227-1149. Information may be emailed to: [email protected]

(i) 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.

(ii) AMOCs approved previously in accordance with AD 2014-15-04 are approved as AMOCs for the corresponding provisions of paragraphs (g) and (h) of this AD.

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

(m) Related Information

Refer to Mandatory Continuing Airworthiness Information (MCAI) European Aviation Safety Agency Airworthiness Directive 2014-0255, dated November 25, 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-2015-7524.

(n) Material Incorporated by Reference

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

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

(3) The following service information was approved for IBR on July 20, 2016.

(i) Saab Service Bulletin 2000-38-011, dated October 22, 2014.

(ii) Reserved.

(4) The following service information was approved for IBR on September 9, 2014 (79 FR 45337, August 5, 2014).

(i) Saab Service Bulletin 2000-38-010, dated July 12, 2013.

(ii) Saab Service Newsletter SN 2000-1304, Revision 01, dated September 10, 2013, including Attachment 1 Engineering Statement to Operator 2000PBS034334, Issue A, dated September 9, 2013.

(5) For service information identified in this AD, contact Saab AB, Saab Aeronautics, SE-581 88, Linköping, Sweden; telephone +46 13 18 5591; fax +46 13 18 4874; email [email protected]; Internet http://www.saabgroup.com.

(6) 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.

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

Issued in Renton, Washington, on May 31, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-13740 Filed 6-14-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Chapter I [Docket No. FAA 2014-0463] Policy on the Non-Aeronautical Use of Airport Hangars AGENCY:

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

ACTION:

Notice of final policy.

SUMMARY:

This action clarifies the FAA's policy regarding storage of non-aeronautical items in airport facilities designated for aeronautical use. Under Federal law, airport operators that have accepted federal grants and/or those that have obligations contained in property deeds for property transferred under various Federal laws such as the Surplus Property Act generally may use airport property only for aviation-related purposes unless otherwise approved by the FAA. In some cases, airports have allowed non-aeronautical storage or uses in some hangars intended for aeronautical use, which the FAA has found to interfere with or entirely displace aeronautical use of the hangar. At the same time, the FAA recognizes that storage of some items in a hangar that is otherwise used for aircraft storage will have no effect on the aeronautical utility of the hangar. This action also amends the definition of aeronautical use to include construction of amateur-built aircraft and provides additional guidance on permissible non-aeronautical use of a hangar.”

DATES:

The policy described herein is effective July 1, 2017.

FOR FURTHER INFORMATION CONTACT:

Kevin C. Willis, Manager, Airport Compliance Division, ACO-100, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591, telephone (202) 267-3085; facsimile: (202) 267-4629.

ADDRESSES:

You can get an electronic copy of this Policy and all other documents in this docket using the Internet by:

(1) Searching the Federal eRulemaking portal (http://www.faa.gov/regulations/search);

(2) Visiting FAA's Regulations and Policies Web page at (http://www.faa.gov/regulations_policies); or

(3) Accessing the Government Printing Office's Web page at (http://www.gpoaccess.gov/index.html).

You can also get a copy by sending a request to the Federal Aviation Administration, Office of Airport Compliance and Management Analysis, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-3085. Make sure to identify the docket number, notice number, or amendment number of this proceeding.

SUPPLEMENTARY INFORMATION:

Authority for the Policy: This document is published under the authority described in Title 49 of the United States Code, Subtitle VII, part B, chapter 471, section 47122(a).

Background Airport Sponsor Obligations

In July 2014, the FAA issued a proposed statement of policy on use of airport hangars to clarify compliance requirements for airport sponsors, airport managers, airport tenants, state aviation officials, and FAA compliance staff. (79 Federal Register (FR) 42483, July 22, 2014).

Airport sponsors that have accepted grants under the Airport Improvement Program (AIP) have agreed to comply with certain Federal policies included in each AIP grant agreement as sponsor assurances. The Airport and Airway Improvement Act of 1982 (AAIA) (Pub. L. 97-248), as amended and recodified at 49 United States Codes (U.S.C.) 47107(a)(1), and the contractual sponsor assurances require that the airport sponsor make the airport available for aviation use. Grant Assurance 22, Economic Nondiscrimination, requires the sponsor to make the airport available on reasonable terms without unjust discrimination for aeronautical activities, including aviation services. Grant Assurance 19, Operation and Maintenance, prohibits an airport sponsor from causing or permitting any activity that would interfere with use of airport property for airport purposes. In some cases, sponsors who have received property transfers through surplus property and nonsurplus property agreements have similar federal obligations.

The sponsor may designate some areas of the airport for non-aviation use,1 with FAA approval, but aeronautical facilities of the airport must be dedicated to use for aviation purposes. Limiting use of aeronautical facilities to aeronautical purposes ensures that airport facilities are available to meet aviation demand at the airport. Aviation tenants and aircraft owners should not be displaced by non-aviation commercial uses that could be conducted off airport property.

1 The terms “non-aviation” and “non-aeronautical” are used interchangeably in this Notice.

It is the longstanding policy of the FAA that airport property be available for aeronautical use and not be available for non-aeronautical purposes unless that non-aeronautical use is approved by the FAA. Use of a designated aeronautical facility for a non-aeronautical purpose, even on a temporary basis, requires FAA approval. See FAA Order 5190.6B, Airport Compliance Manual, paragraph 22.6, September 30, 2009. The identification of non-aeronautical use of aeronautical areas receives special attention in FAA airport land use compliance inspections. See Order 5190.6B, paragraphs 21.6(f)(5).

Areas of the airport designated for non-aeronautical use must be shown on an airport's Airport Layout Plan (ALP). The AAIA, at 49 U.S.C. 47107(a)(16), requires that AIP grant agreements include an assurance by the sponsor to maintain an ALP in a manner prescribed by the FAA. Sponsor assurance 29, Airport Layout Plan, implements § 47107(a)(16) and provides that an ALP must designate non-aviation areas of the airport. The sponsor may not allow an alteration of the airport in a manner inconsistent with the ALP unless approved by the FAA. See Order 5190.6B, paragraph 7.18, and Advisory Circular 150/5070-6B, Airport Master Plans, Chapter 10.

Clearly identifying non-aeronautical facilities not only keeps aeronautical facilities available for aviation use, but also assures that the airport sponsor receives at least Fair Market Value (FMV) revenue from non-aviation uses of the airport. The AAIA requires that airport revenues be used for airport purposes, and that the airport maintain a fee structure that makes the airport as self-sustaining as possible. 49 U.S.C. 47107(a)(13)(A) and (b)(1). The FAA and the Department of Transportation Office of the Inspector General have interpreted these statutory provisions to require that non-aviation activities on an airport be charged a fair market rate for use of airport facilities rather than the aeronautical rate. See FAA Policies and Procedures Concerning the Use of Airport Revenue, (64 FR 7696, 7721, February 16, 1999) (FAA Revenue Use Policy).

If an airport tenant pays an aeronautical rate for a hangar and then uses the hangar for a non-aeronautical purpose, the tenant may be paying a below-market rate in violation of the sponsor's obligation for a self-sustaining rate structure and FAA's Revenue Use Policy. Confining non-aeronautical activity to designated non-aviation areas of the airport helps to ensure that the non-aeronautical use of airport property is monitored and allows the airport sponsor to clearly identify non-aeronautical fair market value lease rates, in order to meet their federal obligations. Identifying non-aeronautical uses and charging appropriate rates for these uses prevents the sponsor from subsidizing non-aviation activities with aviation revenues.

FAA Oversight

A sponsor's Grant Assurance obligations require that its aeronautical facilities be used or be available for use for aeronautical activities. If the presence of non-aeronautical items in a hangar does not interfere with these obligations, then the FAA will generally not consider the presence of those items to constitute a violation of the sponsor's obligations. When an airport has unused hangars and low aviation demand, a sponsor can request the FAA approval for interim non-aeronautical use of a hangars, until demand exists for those hangars for an aeronautical purpose. Aeronautical use must take priority and be accommodated over non-aeronautical use, even if the rental rate would be higher for the non-aeronautical use. The sponsor is required to charge a fair market commercial rental rate for any hangar rental or use for non-aeronautical purposes. (64 FR 7721).

The FAA conducts land use inspections at 18 selected airports each year, at least two in each of the nine FAA regions. See Order 5190.6B, paragraph 21.1. The inspection includes consideration of whether the airport sponsor is using designated aeronautical areas of the airport exclusively for aeronautical purposes, unless otherwise approved by the FAA. See Order 5190.6B, paragraph 21.6.

The Notice of Proposed Policy

In July 2014, the FAA issued a notice of proposed policy on use of hangars and related facilities at federally obligated airports, to provide a clear and standardized guide for airport sponsors and FAA compliance staff. (79 FR 42483, July 22, 2014). The FAA received more than 2,400 comments on the proposed policy statement, the majority from persons who have built or are in the process of building an amateur-built aircraft. The FAA also received comments from aircraft owners, tenants and owners of hangars, and airport operators. The Aircraft Owners and Pilots Association (AOPA) and the Experimental Aircraft Association (EAA) also provided comments on behalf of their membership. Most of the comments objected to some aspect the proposed policy statement. Comments objecting to the proposal tended to fall into two general categories:

• The FAA should not regulate the use of hangars at all, especially if the hangar is privately owned.

• While the FAA should have a policy limiting use of hangars on federally obligated airports to aviation uses, the proposed policy is too restrictive in defining what activities should be allowed.

Discussion of Comments and Final Policy

The following summary of comments reflects the major issues raised and does not restate each comment received. The FAA considered all comments received even if not specifically identified and responded to in this notice. The FAA discusses revisions to the policy based on comments received. In addition, the FAA will post frequently asked Questions and Answers regarding the Hangar Use Policy on www.faa.gov/airport compliance. These Questions and Answers will be periodically updated until FAA Order 5190.6B is revised to reflect the changes in this notice.

1. Comment: Commenters stated that the FAA should defer to local government and leave all regulation of hangar use to the airport operator.

Response: The FAA has a contract with the sponsor of an obligated airport, either through AIP grant agreements or a surplus property deed, to limit the use of airport property to certain aviation purposes. Each sponsor of an obligated airport has agreed to these terms. The FAA relies on each airport sponsor to comply with its obligations under this contract. To maintain a standardized national airport system and standardized practices in each of the FAA's nine regional offices, the agency issues guidance on its interpretation of the requirements of the AIP and surplus property agreements. It falls to the local airport sponsor to implement these requirements. The FAA allows airport sponsors some flexibility to adapt compliance to local conditions at each airport.

However, some airport sponsors have adopted hangar use practices that led to airport users to complain to the FAA. Some airport users have complained that sponsors are too restrictive, and fail to allow reasonable aviation-related uses of airport hangars. More commonly, aircraft owners have complained that hangar facilities are not available for aircraft storage because airport sponsors have allowed the use of hangars for purposes that are unrelated to aviation, such as operating a non-aviation business or storing multiple vehicles. By issuing the July 2014 notice, the FAA intended to resolve both kinds of complaints by providing guidance on appropriate management of hangar use. The agency continues to believe that FAA policy guidance is appropriate and necessary to preserve reasonable access to aeronautical facilities on federally obligated airports. However, the final policy has been revised in response to comments received on the proposal.

2. Comment: Commenters, including AOPA, stated that the FAA lacks the authority to regulate the use of privately owned hangars.

Response: The FAA has a statutory obligation to assure that facilities on aeronautically designated land at federally obligated airports are reasonably available for aviation use. Designated aeronautical land on a federally obligated airport is a necessary part of a national system of aviation facilities. Land designated for aeronautical use offers access to the local airfield taxiway and runway system. Land designated for aeronautical use is also subject to certain conditions, including FAA policies concerning rates and charges (including rental rates) which were designed to preserve access for aeronautical users and to support aeronautical uses. A person who leases aeronautical land on the airport to build a hangar accepts conditions that come with that land in return for the special benefits of the location. The fact that the tenant pays the sponsor for use of the hangar or the land does not affect the agreement between the FAA and the sponsor that the land be used for aeronautical purposes. (In fact, most hangar owners do not have fee ownership of the property; typically airport structures revert to ownership of the airport sponsor upon expiration of the lease term). An airport sponsor may choose to apply different rules to hangars owned by the sponsor than it does to privately constructed hangars, but the obligations of the sponsor Grant Assurances and therefore the basic policies on aeronautical use stated in this notice, will apply to both.

3. Comment: Commenters believe that a policy applying the same rules to all kinds of aeronautical structures, and to privately owned hangars as well as sponsor-owned hangars, is too general. The policy should acknowledge the differences between categories of airport facilities.

Response: A number of commenters thought that rules for use of privately constructed and owned hangars should be less restrictive than rules for hangars leased from the airport sponsor. The Leesburg Airport Commission commented that there are different kinds of structures on the airport, with variations in rental and ownership interests, and that the FAA's policy should reflect those differences. The FAA acknowledges that ownership or lease rights and the uses made of various aeronautical facilities at airports will vary. The agency expects that airport sponsors' agreements with tenants would reflect those differences. The form of property interest, be it a leasehold or ownership of a hangar, does not affect the obligations of the airport sponsor under the Grant Assurances. All facilities on designated aeronautical land on an obligated airport are subject to the requirement that the facilities be available for aeronautical use.

4. Comment: Commenters agree that hangars should be used to store aircraft and not for non-aviation uses, but, they argue the proposed policy is too restrictive on the storage of non-aviation related items in a hangar along with an aircraft. A hangar with an aircraft in it still has a large amount of room for storage and other incidental uses, and that space can be used with no adverse effect on the use and storage of the aircraft.

Response: In response to the comments, the final policy deletes the criteria of “incidental” or “de minimis” use and simply requires that non-aviation storage in a hangar not interfere with movement of aircraft in or out of the hangar, or impede access to other aeronautical contents of the hangar. The policy lists specific conditions that would be considered to interfere with aeronautical use. Stored non-aeronautical items would be considered to interfere with aviation use if they:

○ Impede the movement of the aircraft in and out of the hangar;

○ Displace the aeronautical contents of the hangar. (A vehicle parked at the hangar while the vehicle owner is using the aircraft will not be considered to displace the aircraft);

○ Impede access to aircraft or other aeronautical contents of the hangar;

○ Are used for the conduct of a non-aeronautical business or municipal agency function from the hangar (including storage of inventory); or

○ Are stored in violation of airport rules and regulations, lease provisions, building codes or local ordinances.

Note: Storage of equipment associated with an aeronautical activity (e.g., skydiving, ballooning, gliding) would be considered an aeronautical use of a hangar.

5. Comment: Commenters stated the policy should apply different rules to situations where there is no aviation demand for hangars, especially when hangars are vacant and producing no income for the sponsor.

Response: At some airports, at some times, there will be more hangar capacity than needed to meet aeronautical demand, and as a result there will be vacant hangars. The FAA agrees that in such cases it is preferable to make use of the hangars to generate revenue for the airport, as long as the hangar capacity can be recovered on relatively short notice for aeronautical use when needed. See Order 5190.6B, paragraph 22.6. The final policy adopts a provision modeled on a leasing policy of the Los Angeles County Airport Commission, which allows month-to-month leases of vacant hangars for any purpose until a request for aeronautical use is received. The final policy requires that a sponsor request FAA approval before implementing a similar leasing plan:

• The airport sponsor may request FAA approval of a leasing plan for the lease of vacant hangars for non-aeronautical use on a month-to-month basis.

• The plan may be implemented only when there is no current aviation demand for the vacant hangars.

• Leases must require the non-aeronautical tenant to vacate the hangar on 30 days' notice, to allow aeronautical use when a request is received.

• Once the plan is approved, the sponsor may lease vacant hangars on a 30 days' notice without further FAA approval.

The agency believes this will allow airports to obtain some financial benefit from vacant hangars no, while allowing the hangars to be quickly returned to aeronautical use when needed. FAA pre-approval of a month-to-month leasing plan will minimize the burden on airport sponsors and FAA staff since it is consistent with existing interim use guidance.

6. Comment: Commenter indicates that the terms “incidental use” and “insignificant amount of space” are too vague and restrictive.

Response: The FAA has not used these terms in the final policy. Instead, the policy lists specific prohibited conditions that would be considered to interfere with aeronautical use of a hangar.

7. Comment: Commenter states Glider operations require storage of items at the airport other than aircraft, such as tow vehicles and towing equipment. This should be an approved use of hangars.

Response: Tow bars and glider tow equipment have been added to the list of examples of aeronautical equipment. Whether a vehicle is dedicated to use for glider towing is a particular fact that can be determined by the airport sponsor in each case. Otherwise the general rules for parking a vehicle in a hangar would apply.

8. Comment: Commenter states it should be clear that it is acceptable to park a vehicle in the hangar while the aircraft is out of the hangar being used.

Response: The final policy states that a vehicle parked in the hangar, while the vehicle owner is using the aircraft will not be considered to displace the aircraft, and therefore is not prohibited.

9. Comment: Commenters, including Experimental Aircraft Association (EAA), stated that aviation museums and non-profit organizations that promote aviation should not be excluded from hangars.

Response: Aviation museums and other non-profit aviation-related organizations may have access to airport property at less than fair market rent, under section VII.E of the FAA Policy and Procedures Concerning the Use of Airport Revenue. (64 FR 7710, February 16, 1999). However, there is no special reason for such activities to displace aircraft owners seeking hangar space for storage of operating aircraft, unless the activity itself involves use and storage of aircraft. Accordingly, aviation museums and non-profit organizations will continue to have the same access to vacant hangar space as other activities that do not actually require a hangar for aviation use, that is, when there is no aviation demand (aircraft storage) for those hangars and subject to the discretion of the airport operator.

10. Comment: Commenters suggest that the policy should allow a `grace period' for maintaining possession of an empty hangar for a reasonable time from the sale of an aircraft to the purchase or lease of a new aircraft to be stored in the hangar.

Response: The FAA assumes that airport lease terms would include reasonable accommodation for this purpose and other reasons a hangar might be empty for some period of time, including the aircraft being in use or at another location for maintenance. The reasons for temporary hangar vacancy and appropriate “grace periods” for various events depend on local needs and lease policies, and the FAA has not included any special provision for grace periods in the final policy.

11. Comment: Commenters believe that the policy should allow some leisure spaces in a hangar, such as a lounge or seating area and kitchen, in recognition of the time many aircraft owners spend at the airport, and the benefits of an airport community.

Response: The final policy does not include any special provision for lounge areas or kitchens, either specifically permitting or prohibiting these areas. The policy requires only that any non-aviation related items in a hangar not interfere in any way with the primary use of the hangar for aircraft storage and movement. The airport sponsor is expected to have lease provisions and regulations in place to assure that items located in hangars do not interfere with this primary purpose.

12. Comment: Commenters, including EAA, stated that all construction of an aircraft should be considered aeronautical for the purpose of hangar use, because building an aircraft is an inherently aeronautical activity. The policy should at least allow for use of a hangar at a much earlier stage of construction than final assembly.

Response: The FAA has consistently held that the need for an airport hangar in manufacturing or building aircraft arises at the time the components of the aircraft are assembled into a completed aircraft. Prior to that stage, components can be assembled off-airport in smaller spaces. This determination has been applied to both commercial aircraft manufacturing as well as homebuilding of experimental aircraft.

A large majority of the more than 2,400 public comments received on the notice argued that aircraft construction at any stage is an aeronautical activity. The FAA recognizes that the construction of amateur-built aircraft differs from large-scale, commercial aircraft manufacturing. It may be more difficult for those constructing amateur-built or kit-built aircraft to find alternative space for construction or a means to ultimately transport completed large aircraft components to the airport for final assembly, and ultimately for access to taxiways for operation.

Commenters stated that in many cases an airport hangar may be the only viable location for amateur-built or kit-built aircraft construction. Also, as noted in the July 2014 notice, many airports have vacant hangars where a lease for construction of an aircraft, even for several years, would not prevent owners of operating aircraft from having access to hangar storage.

Accordingly, the FAA will consider the construction of amateur-built or kit-built aircraft as an aeronautical activity. Airport sponsors must provide reasonable access to this class of users, subject to local ordinances and building codes. Reasonable access applies to currently available facilities; there is no requirement for sponsors to construct special facilities or to upgrade existing facilities for aircraft construction use.

Airport sponsors are urged to consider the appropriate safety measures to accommodate aircraft construction. Airport sponsors leasing a vacant hangar for aircraft construction also are urged to incorporate progress benchmarks in the lease to ensure the construction project proceeds to completion in a reasonable time. The FAA's policy with respect to commercial aircraft manufacturing remains unchanged.

13. Comment: Commenter suggests that the time that an inoperable aircraft can be stored in a hangar should be clarified, because repairs can sometimes involve periods of inactivity.

Response: The term “operational aircraft” in the final policy does not necessarily mean an aircraft fueled and ready to fly. All operating aircraft experience downtime for maintenance and repair, and for other routine and exceptional reasons. The final policy does not include an arbitrary time period beyond which an aircraft is no longer considered operational. An airport operator should be able to determine whether a particular aircraft is likely to become operational in a reasonable time or not, and incorporate provisions in the hangar lease to provide for either possibility.

14. Comment: Commenter suggests that the FAA should limit use of hangars on an obligated airport as proposed in the July 2014 notice. Airport sponsors frequently allow non-aeronautical use of hangars now, denying the availability of hangar space to aircraft owners.

Response: Some commenters supported the relatively strict policies in the July 2014 notice, citing their experience with being denied access to hangars that were being used for non-aviation purposes. The FAA believes that the final policy adopted will allow hangar tenants greater flexibility than the proposed policy in the use of their hangars, but only to the extent that there is no impact on the primary purpose of the hangar. The intent of the final policy is to minimize the regulatory burden on hangar tenants and to simplify enforcement responsibilities for airport sponsors and the FAA, but only as is consistent with the statutory requirements for use of federally obligated airport property.

Final Policy

In accordance with the above, the FAA is adopting the following policy statement on use of hangars at federally obligated airports:

Use of Aeronautical Land and Facilities Applicability

This policy applies to all aircraft storage areas or facilities on a federally obligated airport unless designated for non-aeronautical use on an approved Airport Layout Plan or otherwise approved for non-aviation use by the FAA. This policy generally refers to the use of hangars since they are the type of aeronautical facility most often involved in issues of non-aviation use, but the policy also applies to other structures on areas of an airport designated for aeronautical use. This policy applies to all users of aircraft hangars, including airport sponsors, municipalities, and other public entities, regardless of whether a user is an owner or lessee of the hangar.

I. General

The intent of this policy is to ensure that the federal investment in federally obligated airports is protected by making aeronautical facilities available to aeronautical users, and by ensuring that airport sponsors receive fair market value for use of airport property for non-aeronautical purposes. The policy implements several Grant Assurances, including Grant Assurance 5, Preserving Rights and Powers; Grant Assurance 22, Economic Nondiscrimination; Grant Assurance 24, Fee and Rental Structure; and Grant Assurance 25, Airport Revenues.

II. Standards for Aeronautical Use of Hangars

a. Hangars located on airport property must be used for an aeronautical purpose, or be available for use for an aeronautical purpose, unless otherwise approved by the FAA Office of Airports as described in Section III.

b. Aeronautical uses for hangars include:

1. Storage of active aircraft.

2. Final assembly of aircraft under construction.

3. Non-commercial construction of amateur-built or kit-built aircraft.

4. Maintenance, repair, or refurbishment of aircraft, but not the indefinite storage of nonoperational aircraft.

5. Storage of aircraft handling equipment, e.g., towbars, glider tow equipment, workbenches, and tools and materials used in the servicing, maintenance, repair or outfitting of aircraft.

c. Provided the hangar is used primarily for aeronautical purposes, an airport sponsor may permit non-aeronautical items to be stored in hangars provided the items do not interfere with the aeronautical use of the hangar.

d. While sponsors may adopt more restrictive rules for use of hangars, the FAA will generally not consider items to interfere with the aeronautical use of the hangar unless the items:

1. Impede the movement of the aircraft in and out of the hangar or impede access to aircraft or other aeronautical contents of the hangar.

2. Displace the aeronautical contents of the hangar. A vehicle parked at the hangar while the vehicle owner is using the aircraft will not be considered to displace the aircraft.

3. Impede access to aircraft or other aeronautical contents of the hangar.

4. Are used for the conduct of a non-aeronautical business or municipal agency function from the hangar (including storage of inventory).

5. Are stored in violation of airport rules and regulations, lease provisions, building codes or local ordinances.

e. Hangars may not be used as a residence, with a limited exception for sponsors providing an on-airport residence for a full-time airport manager, watchman, or airport operations staff for remotely located airports. The FAA differentiates between a typical pilot resting facility or aircrew quarters versus a hangar residence or hangar home. The former are designed to be used for overnight and/or resting periods for aircrew, and not as a permanent or even temporary residence. See FAA Order 5190.6B paragraph 20.5(b)

f. This policy applies regardless of whether the hangar occupant leases the hangar from the airport sponsor or developer, or the hangar occupant constructed the hangar at the occupant's own expense while holding a ground lease. When land designated for aeronautical use is made available for construction of hangars, the hangars built on the land are subject to the sponsor's obligations to use aeronautical facilities for aeronautical use.

III. Approval for Non-Aeronautical Use of Hangars

A sponsor will be considered to have FAA approval for non-aeronautical use of a hangar in each of the following cases:

a. FAA advance approval of an interim use: Where hangars are unoccupied and there is no current aviation demand for hangar space, the airport sponsor may request that FAA Office of Airports approve an interim use of a hangar for non-aeronautical purposes for a period of 3 to 5 years. The FAA will review the request in accordance with Order 5190.6B paragraph 22.6. Interim leases of unused hangars can generate revenue for the airport and prevent deterioration of facilities. Approved interim or concurrent revenue-production uses must not interfere with safe and efficient airport operations and sponsors should only agree to lease terms that allow the hangars to be recovered on a 30 days' notice for aeronautical purposes. In each of the above cases, the airport sponsor is required to charge non-aeronautical fair market rental fees for the non-aeronautical use of airport property, even on an interim basis. (64 FR 7721).

b. FAA approval of a month-to-month leasing plan: An airport sponsor may obtain advance written approval month-to-month leasing plan for non-aeronautical use of vacant facilities from the local FAA Office of Airports. When there is no current aviation demand for vacant hangars, the airport sponsor may request FAA approval of a leasing plan for the lease of vacant hangars for non-aeronautical use on a month-to-month basis. The plan must provide for leases that include an enforceable provision that the tenant will vacate the hangar on a 30-day notice. Once the plan is approved, the sponsor may lease vacant hangars on a 30-day notice basis without further FAA approval. If the airport sponsor receives a request for aeronautical use of the hangar and no other suitable hangar space is available, the sponsor will notify the month-to-month tenant that it must vacate.

A sponsor's request for approval of an interim use or a month-to-month leasing plan should include or provide for (1) an inventory of aeronautical and non-aeronautical land/uses, (2) information on vacancy rates; (3) the sponsor's procedures for accepting new requests for aeronautical use; and (4) assurance that facilities can be returned to aeronautical use when there is renewed aeronautical demand for hangar space. In each of the above cases, the airport sponsor is required to charge non-aeronautical fair market rental fees for the non-aeronautical use of airport property, even on an interim basis. (64 FR 7721).

c. Other cases: Advance written release by the FAA for all other non-aeronautical uses of designated aeronautical facilities. Any other non-aeronautical use of a designated aeronautical facility or parcel of airport land requires advance written approval from the FAA Office of Airports in accordance with Order 5190.6B chapter 22.

IV. Use of Hangars for Construction of an Aircraft

Non-commercial construction of amateur-built or kit-built aircraft is considered an aeronautical activity. As with any aeronautical activity, an airport sponsor may lease or approve the lease of hangar space for this activity without FAA approval. Airport sponsors are not required to construct special facilities or upgrade existing facilities for construction activities. Airport sponsors are urged to consider the appropriate safety measures to accommodate these users.

Airport sponsors also should consider incorporating construction progress targets in the lease to ensure that the hangar will be used for final assembly and storage of an operational aircraft within a reasonable term after project start.

V. No Right to Non-Aeronautical Use

In the context of enforcement of the Grant Assurances, this policy allows some incidental storage of non-aeronautical items in hangars that do not interfere with aeronautical use. However, the policy neither creates nor constitutes a right to store non-aeronautical items in hangars. Airport sponsors may restrict or prohibit storage of non-aeronautical items. Sponsors should consider factors such as emergency access, fire codes, security, insurance, and the impact of vehicular traffic on their surface areas when enacting rules regarding hangar storage. In some cases, permitting certain incidental non-aeronautical items in hangars could inhibit the sponsor's ability to meet obligations associated with Grant Assurance 19, Operations and Maintenance. To avoid claims of discrimination, sponsors should impose consistent rules for incidental storage in all similar facilities at the airport. Sponsors should ensure that taxiways and runways are not used for the vehicular transport of such items to or from the hangars.

VI. Sponsor Compliance Actions

a. It is expected that aeronautical facilities on an airport will be available and used for aeronautical purposes in the normal course of airport business, and that non-aeronautical uses will be the exception.

b. Sponsors should have a program to routinely monitor use of hangars and take measures to eliminate and prevent unapproved non-aeronautical use of hangars.

c. Sponsors should ensure that length of time on a waiting list of those in need of a hangar for aircraft storage is minimized.

d. Sponsors should also consider including a provision in airport leases, including aeronautical leases, to adjust rental rates to FMV for any non-incidental non-aeronautical use of the leased facilities. In other words, if a tenant uses a hangar for a non-aeronautical purpose in violation of this policy, the rental payments due to the sponsor would automatically increase to a FMV level.

e. FAA personnel conducting a land use or compliance inspection of an airport may request a copy of the sponsor's hangar use program and evidence that the sponsor has limited hangars to aeronautical use.

The FAA may disapprove an AIP grant for hangar construction if there are existing hangars at the airport being used for non-aeronautical purposes.

Issued in Washington, DC, on the 9th of June 2016. Robin K. Hunt, Acting Director, Office of Airport Compliance and Management Analysis.
[FR Doc. 2016-14133 Filed 6-14-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 660, 801, and 809 [Docket No. FDA-2013-N-0125] RIN 0910-AG74 Use of Symbols in Labeling AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA or the Agency) is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as “stand-alone symbols”) if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement “Rx only” or “℞ only” in the labeling for prescription devices.

DATES:

This rule is effective September 13, 2016.

FOR FURTHER INFORMATION CONTACT:

For information concerning the final rule as it relates to devices regulated by the Center for Devices and Radiological Health (CDRH): Antoinette (Tosia) Hazlett, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 5424, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6119, email: [email protected]

For information concerning the final rule as it relates to devices regulated by the Center for Biologics Evaluation and Research: Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Regulatory Action

The final rule explicitly permits the use of symbols in medical device labeling without adjacent explanatory text if certain requirements are met. The medical device industry has requested the ability to use stand-alone symbols on domestic device labeling, consistent with their current use on devices manufactured for European and other foreign markets. The final rule seeks to harmonize the U.S. device labeling requirements for symbols with international regulatory requirements, such as the Medical Device Directive 93/42/EEC of the European Union (EU) (the European Medical Device Directive) and global adoption of International Electrotechnical Commission (IEC) standard IEC 60417 and International Organization for Standardization (ISO) standard ISO 7000-DB that govern the use of device symbols in numerous foreign markets.

Summary of the Major Provisions of the Regulatory Action in Question

FDA has generally interpreted existing regulations not to allow the use of symbols in medical device labeling, except with adjacent English-language explanatory text and/or on in vitro diagnostic (IVD) devices intended for professional use. Under the final rule, symbols established in a standard developed by a standards development organization (SDO) may be used in medical device labeling without adjacent explanatory text as long as: (1) The standard is recognized by FDA under its authority under section 514(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d(c)) and the symbol is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, or alternatively, (2) if the symbol is not included in a standard recognized by FDA under section 514(c) or the symbol is in a standard recognized by FDA but is not used according to the specifications for use of the symbol set out in the FDA section 514(c) recognition, the device manufacturer otherwise determines that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the FD&C Act (21 U.S.C. 352(c)) and uses the symbol according to the specifications for use of the symbol set forth in the SDO-developed standard. In addition, in either case, the symbol must be explained in a paper or electronic symbols glossary that is included in the labeling for the medical device. Furthermore, the labeling on or within the package containing the device must bear a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used. As with text used in device labeling, the use of symbols must also comply with other applicable labeling requirements in the FD&C Act, such as section 502(a) and section 502(f), and relevant regulations such as 21 CFR part 801. In addition, the final rule allows the use of the symbol statement “Rx only” or “℞ only” for labeling of prescription devices.

Costs and Benefits

Benefits represent the reduction in costs associated with designing and redesigning the labeling for medical devices that are currently marketed in the United States and the EU. We estimate these annual cost savings to roughly range between $7.9 million and $25.5 million at a 3 percent discount rate, and $7.7 million to $25 million at a 7 percent discount rate. Costs represent the one-time administrative costs to redesign labeling to incorporate a new or changed symbol, to the one-time costs to create a symbols glossary that is included in the labeling for the device, and the recurring costs to revise these glossaries, as necessary. Annualized over a 20-year period, we estimate these costs to range from $1.1 million to $3.2 million. Annualized over a 20-year period, we estimate total annualized net to range from $6.8 million to $22.3 million at a 3 percent discount rate, and from $6.6 million to $21.7 million at a 7 percent discount rate.

The use of stand-alone symbols in device labeling is optional under the final rule. Those device manufacturers who now use labels without symbols, or who use symbols with adjacent explanatory text, may continue to do so. Therefore, medical device manufacturers would use stand-alone symbols as allowed by the final rule only if they expect a positive net benefit (estimated benefits minus estimated costs). Hence, the final rule is expected to provide a net benefit to manufacturers who opt to use the stand-alone symbols as allowed under this final rule.

Summary of costs and benefits of the proposed rule Total benefits annualized over 20 years
  • (in millions)
  • Total costs annualized over 20 years
  • (in millions)
  • Total net benefits annualized over 10 years
  • (in millions)
  • Total $7.7 to $25.5 $1.1 to $3.2 $6.6 to $22.3.
    Table of Contents I. Background II. Comments on the Proposed Rule and FDA's Responses A. Options for Using Stand-Alone Symbols B. Matters Relating to the Extent to Which Symbols Can Be Used C. Labeling Information Not Required by or Under the Authority of the FD&C Act D. Validation of Stand-Alone Symbols Contained in Standards Not Recognized by FDA or Recognized for Only a Subset of Symbols, Devices, or Users E. Symbols Glossary Requirement F. Implementation of the Final Rule G. Symbol Statement “Rx Only” or “℞ Only” III. Compliance and Enforcement IV. Legal Authority for the Final Rule V. Economic Analysis of Impacts VI. Paperwork Reduction Act of 1995 VII. Analysis of Environmental Impacts VIII. Effective Date IX. Federalism X. References I. Background

    FDA published a proposed rule to revise certain medical device and biological product labeling regulations by explicitly allowing labeling to contain certain stand-alone symbols. The proposed rule would allow stand-alone use of symbols in device labeling if the symbol is established as part of a standard developed by a nationally or internationally recognized standards organization, is part of a standard recognized by FDA for use in the labeling for medical devices, and is explained in a symbols glossary that contemporaneously accompanies the medical device (78 FR 23508, April 19, 2013). The preamble to the proposed rule describes the background and the purpose of the rule as well as discusses that FDA recognition of the standard in which the symbol is contained would be under its authority in section 514(c) of the FD&C Act (21 U.S.C. 360d(c)). We refer readers to that preamble for information about the development of the proposed rule. The Agency requested public comments on the proposed rule, and the comment period closed on June 18, 2013.

    As discussed further in section II.A, in this final rule FDA is making the following changes to the regulatory text of the final rule as compared to the proposed rule: (1) Deleting the term “standardized symbol” as that term was used in the proposed rule to refer only to symbols in FDA recognized standards and the scope of this final rule allows other alternatives; (2) providing that, in addition to symbols in a standard recognized by FDA under section 514(c) of the FD&C Act, the use of certain other SDO-established symbols is allowed; (3) clarifying that the symbols glossary must “be included in the labeling for the device,” in lieu of using the words “contemporaneously accompanies” the device, providing that such glossary can be in paper or electronic form, and that the labeling on or within the package containing the device must bear a prominent and conspicuous statement identifying the location of the symbols glossary; (4) adding a definition of what we mean by the term “standards development organization (SDO)” for purposes of this final rule; and (5) revising the definition of “symbols glossary” to mean a compiled listing of: (a) Each SDO-established symbol used in the labeling for the device; (b) the title and the designation number of SDO-developed standard containing the symbol; (c) the title of the symbol and its reference number, if any, in the standard; and (d) the meaning or explanatory text for the symbol as provided in the FDA recognition, or if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is not used according to the specifications of the FDA section 514(c) recognition, the explanatory text as provided in the standard. In addition, in this final rule, we renumbered 21 CFR 660.2(c), 660.28, 660.35, 660.45, and 660.55 to improve the readability of these sections. This final rule also contains conforming amendments to 21 CFR 660.20(a) and 660.50(a) that update references made in these sections to certain of the renumbered provisions. As stated previously, in the proposed rule, the Agency proposed to limit use of stand-alone symbols in device labeling only to those symbols that an SDO established in a standard that FDA recognized under its authority in section 514(c) of the FD&C Act. The reason for FDA's reliance on its recognition process in the proposed rule as a criterion for allowable stand-alone symbols was that the process offered FDA the opportunity to determine that the symbol was likely to be read and understood by the ordinary user under customary conditions of use as required by section 502(c) of the FD&C Act. In part, based on comments discussed in this document, which raised issues regarding some aspects of the section 514(c) recognition process, the Agency further considered the matter and concluded that its recognition process under section 514(c) of the FD&C Act is not the only way to ensure that the appropriate section 502(c) determination is made. FDA determined that, as an alternative to its section 514(c) recognition, manufacturers could themselves determine whether an SDO-established symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the FD&C Act. This would be consistent with what industry currently does when it uses text in labeling. We note, however, that FDA has the authority to make the definitive determination regarding compliance with the statute and can take enforcement action against violations, as warranted.

    As provided in section 514(c)(1)(B) of the FD&C Act, a person can use a standard recognized by FDA to meet a statutory requirement and submit a declaration of conformity to FDA to certify that the device is in conformity with the standard. Section 514(c)(1)(B) of the FD&C Act further provides that a person may elect to use data, or information, other than data required by a standard recognized by FDA to meet any requirement regarding devices under the FD&C Act. Apart from such compliance with the requirements of section 502(c) of the FD&C Act by conforming to a standard recognized for that purpose under section 514(c), the manufacturer must determine itself that the labeling also meets the other requirements of the FD&C Act, as it is the responsibility of all persons labeling devices to assure statutory and regulatory compliance. The final rule acknowledges the device manufacturer's responsibility to comply with the requirements of section 502(c) of the FD&C Act as well, by permitting the use of a stand-alone symbol in labeling that the manufacturer has determined meets such requirements. Accordingly, this final rule provides that a stand-alone symbol is allowed to be used in device labeling if: (1) The symbol is established in a standard developed by an SDO; and (2) the standard is recognized by FDA under its authority under section 514(c) of the FD&C Act and the symbol is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, or alternatively, if the symbol is not included in a standard recognized by FDA under section 514(c) or the symbol is in a standard recognized by FDA but is not used according to the specifications for use of the symbol set out in the FDA section 514(c) recognition, the device manufacturer otherwise determines that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the FD&C Act and uses the symbol according to the specifications for use of the symbol set forth in the SDO-developed standard. In addition, in either case, the symbol must be explained in a paper or electronic symbols glossary that is included in the labeling for the medical device. Furthermore, the labeling on or within the package containing the device must bear a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used. The additional option to use stand-alone symbols established in SDO-developed standards that FDA has not recognized, as permitted in the final rule, will result in more timely availability of stand-alone symbols for use in device labeling, more convenience for industry, and conserves limited Agency resources.

    See section III (Compliance and Enforcement) for our discussion to help manufacturers determine, if the symbol is not included in a standard or part of a standard that FDA has recognized under section 514(c) of the FD&C Act or if the symbol is used outside the specifications of the FDA section 514(c) recognition, whether the stand-alone use of the symbol in device labeling is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in accordance with section 502(c) of the FD&C Act. In section III, we also clarify that the other provisions of section 502 of the FD&C Act also apply to the use of stand-alone symbols, such as section 502(a) of the FD&C Act if use of the symbol in its labeling causes the labeling to be false or misleading and section 502(f) of the FD&C Act if use of the symbol in device labeling results in inadequate directions for use of the device. For clarity, in this final rule, we have set out the definition of an “SDO.” For purposes of this rule, we define an SDO as an organization that is nationally or internationally recognized and that follows a process for standard development that is transparent (i.e., open to public scrutiny), where the participation is balanced, where an appeals process is included, where the standard is not in conflict with any statute, regulation, or policy under which FDA operates, and where the standard is national or international in scope (see 76 FR 23508 at 23511). (See also FDA answer to Question 18 (What organizations can develop consensus standards for FDA recognition?) in the guidance document entitled “Frequently Asked Questions on Recognition of Consensus Standards; Guidance for Industry and FDA Staff” (September 2007), at. p. 7 (Ref. 1 and cited in the proposed rule (76 FR at 23508 at 23509)).

    II. Comments on the Proposed Rule and FDA's Responses

    We received submissions from 16 commenters, representing a cross-section of individuals, professional and trade associations, and device manufacturers. Almost all comments supported the objectives of the rule in whole or in part. The great majority of comments either suggested changes to specific elements of the proposed rule or requested clarification of matters discussed in the proposed rule.

    A. Options for Using Stand-Alone Symbols

    (Comment 1) Two comments raised the challenges and impracticality of FDA authorization of symbols via section 514(c) recognition of the standard in which the symbol is established. One of these comments expressed concern that, under the section 514(c) process, FDA recognition of certain symbols for certain devices within the standards will present challenges to industry. For instance, “if FDA does not recognize the newest revisions of the standards, discrepancies could require going back to define symbols in text on labels.” Another commenter claimed that by limiting the recognition of symbols to certain devices, the Agency would be falling considerably short of harmonizing with other regulatory bodies, which is one major goal of this rulemaking. The comment went on to state that the European Medical Device Directive does not limit the use of recognized symbols to certain devices, i.e., does not limit which symbols can be used nor does it limit the devices for which a symbol can be used as long as the symbol is explained elsewhere in the device labeling. The comment opined that requiring independent validation by FDA of the stand-alone symbols established in standards would be an unnecessary use of FDA resources.

    (Response 1) The changes in the final rule discussed previously will address many, if not most, of these commenters' concerns. The final rule gives the manufacturer the option of using a symbol contained in an FDA recognized standard or determining for itself that the SDO-established symbol is likely to be read and understood by the customary purchasers and users of the device. Under the final rule, if an FDA recognized standard is only for a subset of symbols or a subset of devices, the manufacturer could submit its declaration of conformity with that standard, and to address any symbols, devices, or users not included in the FDA recognition, could determine for itself that use of those symbols, on those devices, or for those users meets the requirements of section 502(c) of the FD&C Act. This would be consistent with what industry currently does when it uses text in labeling. We note, however, that FDA has the authority to make the definitive determination regarding compliance with the statute and can take enforcement action against violations, as warranted. Furthermore, manufacturers always have the option to request FDA recognition of certain standards if the manufacturer does not want to determine for itself the section 502(c) compliance of the use of the stand-alone symbol in device labeling. See Guidance for Industry and FDA Staff entitled “Frequently Asked Questions on Recognition of Consensus Standards” (Ref. 1). Because manufacturers are not limited to use of stand-alone symbols which are part of an FDA-recognized standard, the final rule should not present the challenges raised by the commenters.

    When the symbol is not contained in an FDA-recognized standard, this final rule requires that all stand-alone symbols used in device labeling be established in a standard developed by an SDO, as is the case for FDA recognition of standards under section 514(c) of the FD&C Act. Our definition of an SDO is intended to include the attributes that are required for voluntary consensus standards bodies, whose standards Federal Agencies are allowed to use for regulatory activities in lieu of a Government-developed standard. These attributes are openness, balance of interest, due process, an appeals process, and consensus (Refs. 2 and 3).

    The symbols established in standards developed by SDOs, as defined in this final rule, will ordinarily have undergone the SDO's written procedures for approval or issuance and validation, and the final rule does not impose any additional requirements to revalidate that the symbol meets the requirements of section 502(c) of the FD&C Act if it is established in an FDA-recognized standard or has been appropriately validated by the SDO. See section II.D (FDA response to comments 10 and 11). As explained in the preamble to the proposed rule, FDA considers whether symbols have been validated through the standards development organization process when determining whether to recognize the symbols (see 76 FR 23508 at 23511). We also note that, contrary to the commenters' assertion regarding independent FDA validation of stand-alone symbols in a standard, FDA, as part of its section 514(c) recognition process, does not independently validate the symbols. For symbols in standards recognized by FDA under its authority in section 514(c) of the FD&C Act, FDA will have determined that the standard containing the symbol was developed by an SDO and that the SDO used its validation procedures in establishing the standard.

    Under the final rule, a stand-alone symbol that is allowed to be used in device labeling is a symbol that: (1) Is established in a standard developed by an SDO; and (2) is contained in a standard that FDA recognizes under section 514(c) of the FD&C Act and is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, or alternatively, if the symbol is not contained in a standard recognized by FDA under section 514(c) of the FD&C Act or the symbol is contained in a standard recognized by FDA but is not used according to the specifications for use of the symbol set out in the FDA section 514(c) recognition, is determined by the manufacturer to be likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the FD&C Act and is used according to the specifications for use of such symbol as set forth in such standard. In addition, in either case, the stand-alone symbol must be explained in a paper or electronic symbols glossary that is included in the labeling for the device. Furthermore, the labeling on or within the package containing the device must bear a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used. In device labeling, symbols that do not satisfy these criteria must be accompanied by adjacent explanatory text.

    (Comment 2) Four comments requested that FDA authorize stand-alone use of all the symbols contained in ISO 15223-1:2012. One of these comments also encouraged the Agency to consider authorizing stand-alone use of the symbols in international standards ISO 7000, ISO 7010, and IEC 60417; another asked us to clarify that authorized stand-alone use will include the symbols in ANSI/AAMI ES60601-1:2005 and supersede IEC 60601-1. A separate comment recommended authorizing stand-alone use of the symbols in “ISO standard BS EN 980.”

    (Response 2) As explained earlier in the Background section and section II.A (FDA response to Comment 1), this final rule provides additional flexibility by permitting the stand-alone use, in device labeling, of symbols that are part of a standard recognized by FDA under section 514(c) of the FD&C Act, as specified in the proposed rule, or, alternatively, a manufacturer can use an SDO-established symbol not included in a standard recognized by FDA or a symbol in a standard recognized by FDA but not used in accordance with the specifications for use of the symbol set forth in FDA's section 514(c) recognition, if it otherwise determines that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the FD&C Act. Because FDA recognition of the underlying standard is not the only option for manufacturers, they are free to choose to select the additional option provided by the final rule with regard to using symbols established in the standards referenced in the comments. (See also section III regarding compliance and enforcement).

    (Comment 3) Three comments stated that stand-alone symbols, once recognized through the section 514(c) process, should be allowed for all medical devices, rather than limited to use on any subset of devices. All three commenters believed that the Agency's actions in authorizing stand-alone symbols for IVD devices in the guidance document entitled “Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use” (November 2004) (the “IVD Symbols Guidance”) at pp. 7-8 (Ref. 4), and in proposing for this rule that standardized symbols should be limited to a subset of devices, are confusing when limited use of stand-alone symbols is authorized based on device category and user groups.

    (Response 3) FDA plans to continue to recognize symbols under its authority in section 514(c) of the FD&C Act for subsets of devices and/or subsets of users, as appropriate. Because the final rule does not limit the use of symbols to those in FDA-recognized standards, manufacturers have the option to use stand-alone symbols in the labeling for any medical device, as long as the symbol is established in a standard developed by an SDO and explained in a symbols glossary as provided in the standard and the manufacturer determines that the stand-alone symbol on its particular device otherwise satisfies section 502(c) of the FD&C Act. Because the Agency is providing additional flexibility with regard to allowable stand-alone symbols, manufacturers are not limited as a result of FDA's recognition of a standard for only a subset of symbols, devices, or users. We note that use of stand-alone symbols beyond the specifications for use set out in FDA's recognition of the standard will require manufacturers to establish section 502(c) compliance for those symbols, devices, or users not included in FDA's recognition. If the manufacturer determines that the stand-alone symbol on its particular device otherwise satisfies section 502(c) of the FD&C Act, the manufacturer can use the stand-alone symbol in device labeling established in the standard only within the specifications for use of the symbol set out in the SDO-developed standard. Otherwise, a symbol used outside of the specifications for use set forth in the SDO-developed standard must be accompanied by adjacent explanatory text. See § 801.15(c)(1)(i)(C), as revised, in this final rule.

    CDRH encourages stakeholders to recommend appropriate standards for FDA recognition under section 514(c) of the FD&C Act by following the instructions located at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.htm.

    B. Matters Relating to the Extent to Which Symbols Can Be Used 1. Proprietary Symbols

    (Comment 4) One of the comments stated that medical device manufacturers should be permitted to use proprietary symbols as long as the meaning of the proprietary symbol is described in documentation supplied with the device. The comment points out that the European Medical Device Directive allows the use of a symbol not developed as part of a standard as long as the symbol is defined in the labeling for the product.

    (Response 4) We believe the commenter is referring to the provision in the EU's 1993 Medical Device Directive which states: “Any symbol or identification colours used must conform to the harmonized standards. In areas for which no standards exist, the symbols and colours must be described in the documentation supplied with the device.” That is, the comment refers to a proprietary symbol that is not contained in a standard. Under the proposed rule and this final rule, for the use of a stand-alone symbol in device labeling to be allowed, the symbol must be established as part of a standard. In the preamble to the proposed rule, the Agency stated that it does not intend to recognize proprietary symbols (78 FR 23508 at 23511). This referred to proprietary symbols contained in a standard.

    The Agency believes that proprietary symbols, whose use is subject to the symbol owner's exclusive rights and not freely available to the public, should be outside the SDO standards development process called for in the proposed rule and finalized in this rule. See the earlier discussion of SDO factors found in the National Technology Transfer and Advancement Act of 1995 (Ref. 2) and Circular A-119 (Ref. 3) to be considered when a Federal Agency uses standards developed outside the Government (Section I. (Background)).

    Circular A-119 also provides that the Government use for regulatory purposes of a standard developed by non-Government body must include provisions requiring that owners of relevant intellectual property have agreed to make that intellectual property available on a non-discriminatory, royalty-free, or reasonable royalty basis to all interested parties (63 FR 8553 at 8554). The term “proprietary symbol,” and the comment, begs the question of whether such symbol would be freely available to the public and whether the symbol's owner has retained its exclusive rights. Because this final rule is limited to symbols established in standards, it does not allow proprietary symbols for use as stand-alone symbols. We note, however, that the rule allows use of a proprietary symbol accompanied by explanatory text adjacent to the symbol.

    2. Pictograms

    (Comment 5) Two comments asked us to clarify that product graphics or pictograms included in labeling, for example graphics showing the steps for using a device, are outside the scope of the proposed rule. One of the comments went further to assert that pictograms do not require accompanying English text to explain their meaning.

    (Response 5) We agree that product graphics or pictograms included in labeling, for example graphics showing the steps for using a device, are outside this rulemaking. Symbols are not allowed for stand-alone use in this final rule unless they are established in a standard developed by an SDO and such graphics normally are not so established. Product graphics are typically unique to the individual product. They are not broadly applicable or used across a wide range of devices, and are unlikely to be established in an SDO-developed standard. Because the final rule is limited to symbols established in a standard, such product graphics are outside the scope of this final rule.

    The Agency has interpreted its regulations generally to allow graphics, pictures, or symbols to meet the labeling requirements of this regulation except where it specifies particular labeling language (78 FR 23508 at 23509). Having said that, if a stand-alone graphical representation communicates required labeling information, such as directions for use required by § 801.5, the product graphic alone is unlikely to satisfy regulatory requirements, even when used under this final rule with accompanying adjacent English text, and further labeling may be needed in addition to what this final rule requires to explain the meaning of the symbol (see amended §§ 660.2(c), 660.28, 660.35, 660.45, 660.55, 801.15(c)(1) and 809.10.

    3. Symbols Used on Non-Device Medical Products

    (Comment 6) One comment argued that if a symbol is authorized for stand-alone use in device labeling, then that symbol should be authorized for all medical products, including for drugs or combination products. According to the comment, “a standard FDA recognizes” means a standard adopted “for all Centers” and for all FDA-regulated products, not just devices. While acknowledging the “procedural issues” associated with extending the scope of the final rule to non-device medical products, the commenter recommended flexibility “through enforcement discretion” until the regulations for drugs and non-device biological products can be updated to conform to the use of stand-alone symbols on medical devices.

    (Response 6) The proposed rule would have authorized the stand-alone use of symbols explained in a symbols glossary included in the device labeling and contained in a standard recognized under section 514(c) of the FD&C Act, a provision applicable to medical devices only. The final rule also provides for the use in device labeling of stand-alone symbols if they are established in standards developed by an SDO, the manufacturer determines that the symbols are likely to be read and understood by the ordinary individual under customary conditions of use and purchase and the symbols are explained in a paper or electronic symbols glossary that is included in the labeling for the device. Because this rulemaking revises only the device and certain biological product labeling regulations, labeling for other FDA-regulated products is outside the scope of this rulemaking. Manufacturers considering the use of stand-alone symbols in labeling for other-FDA regulated products should contact the appropriate Center for the product regarding the permissibility of such use.

    4. Combination Products

    (Comment 7) One comment asked us to clarify how the rule applies to combination products, i.e., to medical products containing not only a device constituent but also a drug or biological product, for example, a drug/device combination.

    (Response 7) Stand-alone symbols may be used in accordance with the final rule in the labeling applicable to a combination product as a whole if the primary mode of action (PMOA) for the product (see 21 CFR 3.2(k) and (m)) is that of a device. Stand-alone symbols may also be used in any separate labeling for the device constituent part of a combination product, regardless of the PMOA for the combination product (e.g., any separate labeling for the device constituent part of a convenience kit or other copackaged combination product, see § 3.2(e)(2)).

    The appropriate use of stand-alone symbols in any other labeling associated with combination products is beyond the scope of this rulemaking. Manufacturers considering the use of stand-alone symbols in such other labeling for combination products should contact the lead Center for the product regarding the permissibility of the proposed use.

    C. Labeling Information Not Required by or Under the Authority of the FD&C Act

    (Comment 8) When adequate directions for use are known to the ordinary individual, some devices may be exempt from adequate directions for use (§ 801.116; see section 502(f)(1) of the FD&C Act). Some prescription devices are likewise not required to bear adequate directions for use if practitioners licensed by law to use the device are commonly aware of the directions, hazards, warnings, and other information necessary to use the device safely and for the purpose for which it is intended (§ 801.109(c)).

    Three comments suggested that manufacturers marketing devices that are exempt from adequate directions for use under § 801.116 or § 801.109(c) would needlessly be burdened under this final rule to create a symbols glossary to explain symbols that they are using voluntarily to display information that is not required “by or under” the FD&C Act.

    (Response 8) The final rule requires a symbols glossary when a stand-alone symbol is used to provide labeling information required by or under the authority of the FD&C Act. (§ 801.15(c)(1)). The commenters' understanding of FDA authority “by or under” the FD&C Act is too narrowly focused on the regulations concerning adequate directions for use under section 502(f)(1).

    A device that is exempt from section 502(f)(1) of the FD&C Act under § 801.116 or § 801.109(c) may still be required to include certain information in its labeling for other purposes in order to provide a reasonable assurance of the safety and effectiveness of the device. For example, a prescription device that is exempt from section 502(f)(1) of the FD&C Act must still include, under § 801.109(c), indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions in its labeling.

    Whether or not a medical device is exempt by regulation from section 502(f)(1) of the FD&C Act, the device is still subject to the other misbranding provisions of section 502. Consequently, we disagree that directions-for-use symbols voluntarily used on devices exempt from adequate directions for use under § 801.116 or § 801.109(c) should be categorically exempt from the symbols glossary requirement and the final rule.

    (Comment 9) In discussing the symbols glossary requirement, the preamble to the proposed rule stated therefore, any stand-alone symbol on the labeling for a device that conveys directions for use would be subject to the symbols glossary requirements (78 FR 23508 at 23511). One commenter interpreted this statement as limiting the symbols glossary requirement to symbols for directions-for-use information only. The commenter requested clarification that, under the final rule, use of a symbol that does not convey directions for use, such as “the manufacturing site symbol, lot symbol, etc.,” should therefore not trigger the symbols glossary requirement.

    (Response 9) The preamble statement quoted in the comment refers to directions-for-use symbols as an example, and not by way of limitation; but we agree that clarification is appropriate.

    FDA device labeling regulations specifically require information other than just directions for use, including the examples mentioned in the comment. For example, under § 801.1(a), the device label must identify the name and address of the manufacturer, packer, or distributor of the device. If an FDA-allowed stand-alone symbol is used, for example, in place of the wording “manufacturer:” or “manufacturing site:” followed by a name and address, the final rule requires that a symbols glossary must be included in the labeling for the device to explain the meaning of the symbol to the device's user. There are many FDA regulations that require device labeling information; and the final rule, including the symbols glossary requirement, applies to any device using a stand-alone symbol to provide such information.

    D. Validation of Stand-Alone Symbols Contained in Standards Not Recognized by FDA or Recognized for Only a Subset of Symbols, Devices, or Users

    (Comment 10) One comment asked the Agency to ensure that each stand-alone symbol authorized under this rule can be relied upon and be used by device manufacturers, without separate validation by the manufacturer for its use on a specific device. Another comment asked us to clarify that FDA would not unnecessarily use its resources to revalidate symbols established in an SDO-developed standard.

    (Response 10) The symbols established in standards developed by SDOs will ordinarily have undergone the SDO's written procedures for approval or issuance and validation (78 FR 23508 at 23511). In the validation process, studies can demonstrate end-user comprehension of the stand-alone symbol in the device labeling context; and validation data specifically applicable to medical devices may be submitted to the SDO for its review (78 FR 23508 at 23510, see for example AAMI/ANSI/ISO 15223-2:2010 (Part 2), Symbol Development, Selection and Validation).

    The final rule does not impose any additional requirements on device manufacturers to revalidate that such symbols meet the requirements of section 502(c) of the FD&C Act if the symbol is established in an FDA-recognized standard or has been appropriately validated by the SDO. FDA does not intend to invite requests for it to validate or to revalidate a symbol allowed under the rule, i.e., a stand-alone symbol established in an SDO-developed standard and explained in the device labeling. However, we will consider information as appropriate, including post-market surveillance data indicating that a symbol used on a particular device is not understood by device users (section 502(c) of the FD&C Act), or that it causes the labeling to be false or misleading (section 502(a)), results in inadequate directions for use of the device (section 502(f)), or otherwise causes the device labeling to violate the misbranding provisions of section 502.

    (Comment 11) One comment questioned why, if the validation process includes consumer testing, there was no analysis of this cost burden.

    (Response 11) The final rule does not impose any new requirements for public participation in the standards development processes of SDOs or for the establishment of symbols in SDO-developed standards. The final rule does not affect the paperwork burden or cost associated with the standards-development process establishing a symbol allowed by the final rule, and therefore, no cost estimate or economic analysis of the process is required.

    The final rule establishes certain procedures and conditions for device manufacturers to use a symbol as a stand-alone symbol on medical device labeling, including specifically, that the symbol must be explained in a symbols glossary that is included in the labeling for the device. The proposed and final rules do analyze the paperwork burden and economic cost of these procedures and conditions, including the required symbols glossary.

    The burden on persons seeking SDO development of standards establishing symbols, including the validation of those symbols in the standard, is a matter already considered under existing standards-development norms and is otherwise in the control of the relevant SDO. The final rule does not require the interested party to revalidate that the stand-alone symbol meets the requirements of section 502(c) of the FD&C Act if the symbol is established in an FDA-recognized standard or has been appropriately validated by the SDO. Any validation needed in order to comply with the requirements of section 502(c) of the FD&C Act is under the requirements of that statute, and is not being imposed by this final rule. Accordingly, there is no validation process required by the final rule, and no cost estimate or economic analysis is called for in the rule.

    E. Symbols Glossary Requirement

    (Comment 12) Four comments state that, in the case of stand-alone symbols established in an SDO-developed standard, a symbols glossary “contemporaneously accompanying” the device is unnecessary. Three of these comments specifically refer to the symbols contained in ISO 15223-1 and contend that the symbols glossary requirement does not harmonize with the European Medical Device Directive or with ISO 15233 because neither one requires an accompanying symbols glossary. Alternatively, one comment suggested that the final rule should establish a sunset limitation for the symbols glossary requirement, so that, for example, the glossary rule would expire 2 years after the publication of the final rule.

    (Response 12) FDA disagrees with the comments that its symbols glossary requirement is not necessary and does not harmonize with the European Medical Directive or with ISO 15233. The European Medical Device Directive states that “[i]n areas for which no standards exist, the symbols and colours must be described in the documentation supplied with the device.” The Directive does not otherwise preclude requiring documentation with such symbols. Many of the symbols contained in ISO 15223-1 explicitly restrict their use as follows: “In Europe, this symbol shall be explained in the information supplied by the manufacturer.” FDA is aware of many device manuals containing a symbols glossary that would comply with this final rule, and has in the past considered this a good practice. Furthermore, the IVD Symbols Guidance (Ref. 4) recommends that a glossary of terms accompany each IVD to define all the symbols used on that device's label and/or labeling (at pp. 7-8). Following the effective date of this final rule, FDA intends to withdraw the IVD Symbols Guidance.

    Concerning the comment recommending a sunset limitation on the symbols glossary requirement, the Agency disagrees. The symbols glossary is intended to allow users to become familiar with the meaning of the symbols and also acts as a reference for users to look up any definitions they may not recall. In these respects, the symbols glossary helps to satisfy, although it does not satisfy on its own, the requirements of section 502(c) of the FD&C Act by making it more likely that users under customary conditions of purchase and use have access to necessary reference materials to help them understand the symbols. Accordingly, we do not believe that a sunset limitation on the symbols glossary requirement is appropriate.

    (Comment 13) Four comments requested FDA to clarify the meaning of the term “contemporaneously accompanies the device” in the symbols glossary requirement of the rule, in particular whether the term includes “all varieties of written or electronic materials that are connected to a manufacturer's marketing and sale of a product, even when the materials are not physically with the medical device.” Two of these commenters believe that, in the case of prescription devices, the rule should permit electronic display of the symbols glossary under section 502(f) of the FD&C Act and that such electronic labeling should be treated as accompanying the device for purposes of the rule. One comment urged that a reference in the medical device labeling to an online FDA glossary should satisfy the glossary requirement. Another stated that electronic labeling is an accepted practice for IVDs in the EU.

    (Response 13) In the proposed rule, one of the requirements for use of stand-alone symbols was that such symbols be explained in a symbols glossary that contemporaneously accompanies the device. FDA understands that the term “contemporaneously accompanies” in the proposed rule may have prompted confusion, and we are revising the codified language of the final rule to clarify that a stand-alone symbol must be explained in a paper or electronic symbols glossary that is “included in the labeling for the device.” We agree that flexibility is possible and appropriate to satisfy the symbols glossary requirement. The new wording permits flexibility in the form of the symbols glossary, as long as the glossary is included in the labeling for the device.

    Furthermore, this final rule allows device manufacturers to provide the symbols glossary by electronic means. We have changed the codified to read “the symbol . . . is explained in a paper or electronic symbols glossary that is included in the labeling for the device.” (See amended §§ 660.2(c), 660.28, 660.35, 660.45, 660.55, and 801.15(c)(1), and new § 809.10(g).) That is, the symbols glossary can be provided by electronic means so long as the glossary is included in the labeling for the device. This change also takes into account the provisions of section 502(f) of the FD&C Act which provides that required labeling for certain prescription devices and certain IVD devices may be made available solely by electronic means. (See section 502(f) (“by electronic means”)).

    In the proposed rule, we inadvertently did not specify that the labeling of the device must direct the purchaser and user as to the location of the symbols glossary in the labeling for the device. Without directions as to the location of the symbols glossary in the labeling, the purpose of the symbols glossary would not be served. Therefore, this final rule provides that the symbol is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary. For example, the statement could read “The symbols glossary is provided [specify, e.g., in Section X of the package insert, as a separate insert within the package, on the side panel of the package, electronically at (insert URL address to symbols glossary on manufacturer's Web site)].” The statement must be in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used.

    In the proposed rule, the term “symbols glossary” was defined in the codified as “a compiled listing of each symbol used in the labeling of the device and of the meaning of or explanatory text for the symbol.” We are revising the codified language in the final rule to define “symbols glossary” as “compiled listing of: (1) Each SDO-established symbol used in the labeling for the medical device; (2) the title and designation number of the SDO-developed standard containing the symbol; (3) the title of the symbol and its reference number, if any, in the standard; and (4) the meaning or explanatory text for the symbol as provided in the FDA recognition, or if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, the explanatory text as provided in the standard (see amended §§ 660.2(c), 660.28, 660.35, 660.45, 660.55, and 801.15(c) and new § 809.10(g)). In finalizing the rule, we revised the “symbols glossary” definition to help accurately identify the SDO-developed standard containing the symbol and the symbol in the standard.

    (Comment 14) One comment argued that a single copy of the glossary should satisfy the rule when the same devices are shipped together in a multipack. Another comment argued that replacement parts or disposable components servicing the device with stand-alone symbols in their labeling should be exempt from the glossary rule because the customer would already have received the glossary information with the original purchase of the device.

    (Response 14) In both of these situations, the premise is that there is a stand-alone symbol that appears in the labeling for the individual device unit or the replacing component.

    Typically, a replacement part for a medical device or disposable component is used later in time than the replaced component. The glossary delivered to the user with the original equipment might no longer be available to explain the meaning of the stand-alone symbol on the labeling for a replacement part. “Any component, part, or accessory” of a device, if its intended use is to service the device, is itself a device (section 201(h) of the FD&C Act (21 U.S.C. 321(h))). Under the final rule, the symbols glossary requirement therefore applies separately to replacement or disposable components when the labeling for the replacing component bears a stand-alone symbol because the symbols glossary must be included in the labeling for the device.

    Additionally, the individual units of a multipack shipment, like replacement components, are likely to be used later such that the glossary delivered to the user of a multipack shipment might no longer be retained and available to explain the meaning of the stand-alone symbol on the labeling for the remaining individual units after the multipack is broken and the first unit or units are used. Under the final rule, the symbols glossary requirement therefore applies to the individual devices of a multipack shipment when the labeling for the individual units bears a stand-alone symbol because the symbols glossary must be included in the labeling for the device.

    To reduce the burden of the glossary requirement for individual devices of a multipack shipment, manufacturers should consider the final rule's provision for use of an electronic symbols glossary. Such electronic glossary, however, must be included in the labeling for the device. In such situations, FDA requires that the labeling for the device must prominently and conspicuously include the URL address for a Web site that displays the symbols glossary on the manufacturer's Web site explaining the meaning of the stand-alone symbols used on that device's labeling.

    F. Implementation of the Final Rule

    (Comment 15) One comment asked FDA to clarify how much time manufacturers will have to convert existing symbols in labeling to stand-alone symbols.

    (Response 15) In the final rule, there is no required conversion to stand-alone symbols. The final rule does not mandate the use of stand-alone symbols. The use of stand-alone symbols is an alternative to labeling without symbols and to the currently-allowed use of symbols with adjacent explanatory text. Effective beginning on September 13, 2016 (see section VIII), the final rule expressly provides for the use of symbols accompanied by adjacent explanatory text in the device labeling (amended §§ 660.2(c), 660.28, 660.35, 660.45, 660.55, and 801.15(c)(1) and new § 809.10(g)) and the use of stand-alone symbols that meet the requirements of the rule.

    (Comment 16) One comment asked FDA to clarify whether manufacturers need to file a new 510(k) notification under 21 CFR part 807, subpart E or a Premarket Approval (PMA) supplement under 21 CFR part 814 when they replace symbols currently used with adjacent English text with stand-alone symbols and a symbols glossary in the device labeling.

    (Response 16) In most cases, manufacturers who wish to update their device or product labeling only by substituting text with one or more stand-alone symbols allowed under the rule, or to remove explanatory text adjacent to such symbols (without making any changes to the meaning of the labeling), do not need to submit a new premarket submission prior to making that change. In some cases FDA may require, through regulation or order, through a special controls guideline, or on a case-by-case basis in reviewing premarket submissions, specific language in device labeling, or may require or prohibit use of symbols in a specific labeling context. For example, devices subject to a boxed-warning labeling requirement must strictly adhere to the exact language of the applicable regulation, and any use of symbols in the warning should be reviewed and specifically allowed by FDA in advance of such use.

    For medical devices with an approved PMA, manufacturers may generally replace required information in existing labeling with equivalent stand-alone symbols that are allowed under the rule without the need to submit a PMA supplement. PMA holders that implement this type of change should notify the Agency of the change in the next annual report to the PMA, in accordance with § 814.84. As with 510(k)-cleared devices, however, in some cases FDA may require, through regulation or order, or on a case-by-case basis during premarket review, specific language in device labeling, or may require or prohibit use of symbols in a specific labeling context.

    Similarly, applicable biologics license holders that replace required information with stand-alone symbols that are allowed under the rule on the labeling for licensed products also regulated as devices should notify the Agency of the change in the next annual report to the manufacturer's Biologics License Application (BLA), in accordance with 21 CFR 601.12(f)(3)(i)(A); and the Agency will consider the change to be an editorial or similar minor change.

    Manufacturers may substitute stand-alone symbols that are allowed under the rule for equivalent text on existing labels and labeling for medical devices that received premarket notification (510(k)) clearance without submitting a new 510(k) notification. For information on other labeling changes that might require submission of a new 510(k) notification, please see § 807.81(a)(3).

    (Comment 17) Three comments urged FDA to maintain close cooperation and communication with industry in order to implement timely updates of the list of symbols permitted for stand-alone use through its standards-recognition process and to keep up with the revision of current international standards.

    (Response 17) Under this final rule, any stand-alone symbol established in an SDO-developed standard and used in accordance with the specifications of the standard is allowed, regardless of whether or not FDA recognizes the standard or the part of the standard containing the symbol, under section 514(c) of the FD&C Act. Under the final rule, symbols established in a standard developed by an SDO may be used in medical device labeling without adjacent explanatory text as long as: (1) The standard is recognized by FDA under its authority under section 514(c) of the FD&C Act and the symbol is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, or alternatively, (2) if the symbol is not included in a standard recognized by FDA under section 514(c) of the FD&C Act or the symbol is in a standard recognized by FDA but is not used according to the specifications for use of the symbol set out in the FDA section 514(c) recognition, the device manufacturer otherwise determines that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the FD&C Act and uses the symbol according to the specifications for use of the symbol set forth in the SDO-developed standard. In addition, in either case, the symbol must be explained in a paper or electronic symbols glossary that is included in the labeling for the device. Furthermore, the labeling on or within the package containing the device must bear a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used. Although FDA will continue to participate with SDOs in the standards development process and some of those standards may involve symbols in device labeling, the final rule will not require the close industry coordination and communication with FDA in order for firms to comply with the rule because of its additional flexibility.

    (Comment 18) One comment recommended that when the Agency does not recognize all the symbols established in a standard for stand-alone use, it should clearly state why any rejected symbol is not included in order for interested parties to get “insights needed to validate the symbols.”

    (Response 18) Under the final rule, the fact that FDA does not recognize all the symbols established in a standard does not preclude a manufacturer from determining that the stand-alone use of the symbol is likely to be read and understood by the ordinary individual under customary conditions of use and purchase. Therefore, the Agency will not provide explanations of why it does not include certain symbols in a standard in its recognition under section 514(c) of the FD&C Act as requested by the commenter.

    G. Symbol Statement “Rx Only” or “℞ Only”

    (Comment 19) Two comments related to the provision of the rule authorizing use of the symbol statement “Rx Only.” One comment asked whether validation will be required in order to use “Rx Only” on a prescription device. The second comment asked whether FDA will be issuing guidance to support use of the symbol statement “Rx Only.”

    (Response 19) This final rule does not require validation by the device manufacturer in order for it to use the symbol statement “Rx Only” on its prescription device. The symbol statement “Rx Only” has a separate statutory and regulatory history unrelated to the use of standards as allowed in this final rule.

    As explained in the preamble to the proposed rule, section 126(a) of the FDA Modernization Act of 1997 (FDAMA) (Pub. L. 105-115), amending section 503(b)(4) of the FD&C Act (21 U.S.C. 353(b)(4)), allows use of this symbol statement on the labels of drug products in place of a full prescription use statement that indicates that the drug must be dispensed with a clinician's prescription. FDAMA did not explicitly make the permitted use of “Rx Only” applicable to medical devices; however, the Agency published the guidance document entitled “Alternative to Certain Prescription Device Labeling Requirements,” January 2000 (the Rx Only Statement Guidance) (Ref. 5) stating that FDA would exercise enforcement discretion for the use of “Rx Only” on prescription device labels. FDA's reason for issuing that guidance document was a desire to minimize the burden of creating device labels and to make it flexible consistent with the statutorily permitted use of the “Rx Only” symbol statement for prescription drug products. In this rule, FDA is expressly allowing for use of “Rx Only” for the labels of prescription devices to give device manufacturers the option to use “Rx Only” in lieu of the longer statement currently in the regulations. FDA has included this change in this rulemaking given the changes involving symbols that the final rule is making to other sections of FDA's labeling regulations.

    Because the statutory authority for using the symbol statement “Rx Only” for drug products, and our purpose and intent in this final rule extending it to prescription devices, are clear and satisfy the misbranding requirements of section 502 of the FD&C Act pertaining to the symbol statement “Rx Only,” the Agency does not intend to issue a new guidance document regarding the use of “Rx Only.” We only restate in this document what we said in the preamble to the proposed rule about using the symbol statement “Rx Only.” It is important to note that the word “only” must immediately follow the symbol “Rx.” However, the symbol statement “Rx only” does not necessarily need to be bracketed in quotation marks, and the word “only” may appear in upper or lower case letters, for example, Rx only, Rx Only, or Rx ONLY. As in the case of labels for prescription drugs, the new label statement for prescription medical devices may be printed as either “Rx only” or “℞ only.” (See 67 FR 4904, February 1, 2002.) The symbol statement “Rx only” in its entirety, or the ℞ symbol in the symbol statement “Rx only,” may be printed in bold or in regular type.

    III. Compliance and Enforcement

    Under the final rule, manufacturers may use symbols in labeling in the following scenarios. First, manufacturers may continue to use symbols with adjacent explanatory text. See, e.g., § 801.15(c)(1)(i)(C) in this final rule.

    Second, manufacturers may use a stand-alone symbol if the symbol is contained in a standard that FDA recognizes under its authority in section 514(c) of the FD&C Act for use on the labeling for medical devices (or on a subset of medical devices), is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, and is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary. See, e.g., § 801.15(c)(1)(i)(D) in this final rule. In this second scenario, FDA has, through the section 514(c) recognition process, made a determination that the symbol, is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the FD&C Act. In this second scenario where a manufacturer wishes to use a stand-alone symbol that is in an SDO standard that has been recognized by FDA under section 514(c) to meet a requirement under the FD&C Act, such manufacturer would submit a declaration of conformity to FDA that certifies that the device is in conformity with the standard.

    In a third scenario, the stand-alone symbol is not included in a standard that is recognized under FDA's section 514(c) authority or is in a standard that is recognized under FDA's section 514(c) authority but is not used according to the specifications for use of the symbol set forth in FDA's 514(c) recognition, manufacturers may use such symbol as a stand-alone symbol if the symbol has been established in a standard developed by an SDO, the manufacturer has made a determination that the symbol in the labeling for a particular device is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the FD&C Act, and such symbol is explained in a paper or electronic symbols glossary that is included in the labeling for the medical device, and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary. See, e.g., § 801.15(c)(1)(i)(E) in this final rule. In this third scenario where a manufacturer uses a symbol that has not been recognized by FDA under section 514(c) of the FD&C Act or uses a symbol from an FDA recognized standard but not in accordance with the specifications for use of the symbol set forth in FDA's section 514(c) recognition, the burden is on the manufacturer to determine that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use such that the use of the symbol in labeling is in compliance with section 502(c) of the FD&C Act. See, e.g., § 801.15(c)(1)(i)(E)(3).

    To clarify the requirements of the final rule, we include the following example:

    Standard Z is a standard developed by an SDO. The scope of Standard Z is cardiac devices according to the specifications for use of the standard set forth by the SDO. FDA recognizes the standard for use of symbols in labeling for cardiac stents under its section 514(c) authority. As such, FDA's recognition is for a subset of the devices covered by Standard Z. Manufacturer A wishes to use stand-alone symbols (symbols without adjacent explanatory text) from Standard Z on cardiac stents. Manufacturer B wishes to use stand-alone symbols from Standard Z on cardiac pacemakers. Manufacturer C wishes to use stand-alone symbols from Standard Z on biliary stents, which are not cardiac devices.

    Under the example, all the manufacturers could legally use the symbols from Standard Z with adjacent explanatory text. See, e.g., § 801.15(c)(1)(i)(C). Manufacturer A can legally use stand-alone symbols from Standard Z in the labeling for cardiac stents, consistent with FDA's recognition of Standard Z for cardiac stents. See, e.g., § 801.15(c)(1)(i)(D). Manufacturer A must explain the stand-alone symbols in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing Manufacturer A's device must bear a prominent and conspicuous statement identifying the location of the symbols glossary. See, e.g., § 801.15(c)(1)(i)(D)(3). The symbol must be used according to the specifications of FDA's section 514(c) recognition, including the same meaning or explanatory text for the symbol in the symbols glossary as provided in FDA's recognition of Standard Z. See, e.g., § 801.15(c)(1)(i)(D)(2). As discussed again later, if FDA subsequently withdraws recognition of Standard Z because the stand-alone symbol is not likely to be read and understood by the ordinary individual under customary conditions of purchase and use, Manufacturer A must stop using the stand-alone symbol. If FDA withdraws its recognition of Standard Z for other reasons, the Manufacturer A may continue to use the stand-alone symbols from Standard Z, that FDA no longer recognizes, for cardiac stents (see, e.g., § 801.15(c)(1)(i)(E)(2)); but the use must be consistent with the specifications of Standard Z, including use of the explanatory text as provided in Standard Z (see, e.g., § 801.15(c)(1)(i)(E)(4)), and the burden is on Manufacturer A to determine that the symbol's use is likely to be read and understood by the ordinary individual under customary conditions of purchase and use (see, e.g., § 801.15(c)(1)(i)(E)(3)).

    With regard to Manufacturer B, this manufacturer wishes to use a stand-alone symbol from Standard Z that would not be in accordance with the specifications for use of the symbol set forth in FDA's section 514(c) recognition. When FDA recognized Standard Z, the scope of which is cardiac devices, it limited the specifications for use of the symbols to cardiac stents. Manufacturer B wishes to use the stand-alone symbol from Standard Z on cardiac pacemakers. Under the final rule, Manufacturer B may use stand-alone symbols outside the scope of FDA recognition (see, e.g., § 801.15(c)(1)(i)(E)(2)), but within the specifications for use of Standard Z (see, e.g., § 801.15(c)(1)(i)(E)(4)). In this scenario where Manufacturer B uses a symbol from Standard Z that has not been recognized under section 514(c) of the FD&C Act, the burden is on Manufacturer B to determine that the symbol's use on cardiac pacemakers, outside the scope of the FDA recognition, is likely to be read and understood by the ordinary individual under customary conditions of purchase and use. See, e.g., § 801.15(c)(1)(i)(E)(3). The same is true and same provisions apply if Manufacturer A uses a stand-alone symbol on cardiac stents that is not in accordance with the specifications for use of FDA's section 514(c) recognition. In these cases, Manufacturer B (and Manufacturer A, if its use of the stand-alone symbol is not in accordance with the specifications for use set forth in FDA's section 514(c) recognition) must use the stand-alone symbols of Standard Z consistent with the specifications for use of the symbol set forth in Standard Z, including use of the explanatory text as provided in Standard Z. See, e.g., § 801.15(c)(1)(i)(E)(4).

    Finally, Manufacturer C wishes to use stand-alone symbols in Standard Z for biliary stents. Under this final rule, this stand-alone use is not allowed. As provided in this final rule, the use of stand-alone symbols must be in accordance with the specifications for use of the symbol set forth in the SDO-developed standard. Standard Z, as developed by the SDO, specifies that it applies to cardiac devices. As such, the use of stand-alone symbols from Standard Z in biliary stents would not be in accordance with the specifications for use of the symbols set forth in Standard Z. See, e.g., § 801.15(c)(1)(i)(E)(4) in this final rule that requires that a stand-alone symbol be used according to the specifications for use of the symbol set forth in the SDO-developed standard that FDA does not recognize. Accordingly, Manufacturer C's use of the symbols from Standard Z on biliary stents would require adjacent explanatory text. See, e.g., § 801.15(c)(1)(i)(C) in this final rule.

    The final rule does not require the manufacturer to validate for a particular device, the stand-alone use of a symbol established in an SDO-developed standard, or part of a standard, that FDA has recognized under section 514(c) of the FD&C Act. In addition, the final rule does not require manufacturers to validate any stand-alone symbol. At the same time, this final rule does not preclude device manufacturers from undertaking any validation studies needed to assure that the use of the stand-alone symbol is likely to be read and understood by customary purchasers and users (section 502(c)) and complies with the other misbranding requirements of section 502 of the FD&C Act.

    Manufacturers and importers should monitor complaints and adverse events that might be related to inadequate understanding of labeling, including misunderstanding about the meaning of stand-alone symbols used in the device labeling. Manufacturers must report adverse events as required by 21 CFR part 803. Reporting forms and instructions are available at http://www.fda.gov/medwatch/safety.htm. If, for example, postmarket surveillance data such as medical device reporting (MDR) suggests that the users of the device do not understand the meaning of a particular stand-alone symbol, and that such misunderstanding could lead to a safety issue, the Agency may take enforcement action against the device and device manufacturer.

    If FDA withdraws recognition of a standard (e.g., Standard Z in the example) because the stand-alone symbol is not likely to be read and understood by the ordinary individual under customary conditions of purchase and use, in that case, all manufacturers (both Manufacturers A and B) must stop using the stand-alone symbol upon withdrawal of recognition of the standard. FDA notes that it does not intend to take enforcement action under section 502(c) of the FD&C Act on the basis that the symbol is not likely to be read and understood by the ordinary individual under customary conditions of purchase and use that otherwise meets the requirements of this rule unless and until FDA issues either a notice of SDO-standard withdrawal applicable to the use or a symbol-specific Federal Register notice announcing FDA's determination that the symbol is not likely to be read and understood by the ordinary individual under customary conditions of purchase and use as required by section 502(c), and, as such, the future date on which FDA intends to take enforcement action against stand-alone use of such symbol.

    In situations where FDA withdraws recognition of a standard, or portion thereof, for reasons other than that the stand-alone symbol is not likely to be read and understood as required by section 502(c) of the FD&C Act, manufacturers may continue to use symbols within that standard without adjacent text if the manufacturer determines that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c). Therefore, in the example, if FDA withdraws its recognition of Standard Z for use of symbols in labeling for cardiac stents for a reason other than that the ordinary individual is not likely to read and understand the symbols under customary conditions of purchase and use in compliance with section 502(c) of the FD&C Act, Manufacturer A and Manufacturer B may continue to use their stand-alone symbols under § 801.15(c)(1)(i)(E) in this final rule. If FDA provided a meaning or explanatory text in its recognition of Standard Z, after the withdrawal Manufacturer A must use the symbols from Standard Z according to the specifications of Standard Z, including the same meaning or explanation in its symbols glossary as provided in Standard Z for any remaining permitted use under the FDA withdrawal notice. See, e.g., § 801.15(c)(1)(i)(E)(4) and (iii)(B) in this final rule.

    With regard to Manufacturer C, if it uses stand-alone symbols that are outside the scope of the SDO-developed standard, FDA intends to enforce compliance after the effective date of this final rule. See, e.g., § 801.15(c)(1)(ii) in this final rule.

    IV. Legal Authority for the Final Rule

    A device is misbranded under section 502(c) of the FD&C Act if any word, statement, or other information required by or under authority of this act to appear on the label or labeling is not in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. Additionally, a device is misbranded under section 502(a) of the FD&C Act if its labeling is false or misleading in any particular. A device is also misbranded under section 502(f) of the FD&C Act unless its labeling bears adequate directions for use.

    Under section 201(m) of the FD&C Act, the term “labeling” means all labels and other written, printed, or graphic matter: (1) Upon any article or any of its containers or wrappers or (2) accompanying such article. Under section 201(k) of the FD&C Act, the term “label” means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of the FD&C Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

    Section 514(c)(1)(A) of the FD&C Act authorizes FDA to recognize, by publication in the Federal Register, all or part of an appropriate standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet a premarket submission requirement or other requirement under the FD&C Act to which such standard is applicable. Section 514(c)(1)(B) of the FD&C Act further provides that a person may elect to use data, or information, other than data required by a standard recognized by FDA to meet any requirement regarding devices under the FD&C Act. Section 514(c)(2) of the FD&C Act allows FDA to withdraw recognition of a standard through publication of a notice in the Federal Register if FDA determines that the standard is no longer appropriate for meeting a device requirement under the FD&C Act.

    Section 701(a) of the FD&C Act (21 U.S.C. 371(a)) gives FDA the authority to issue regulations for the efficient enforcement of the FD&C Act.

    V. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. We believe that the final rule is not a significant regulatory action as defined by Executive Order 12866.

    The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule imposes no new burdens, we certify that the final rule would not have a significant economic impact on a substantial number of small entities.

    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.

    Summary

    The final rule would provide medical device manufacturers with the option to use symbols established in SDO-developed standards for stand-alone use in labeling to communicate information to end users. Under the final rule, manufacturers would be allowed to substitute labels containing only written statements (text-only labels) or symbols with adjacent explanatory text with a label containing stand-alone symbols, provided that such symbols are established in a standard developed by a SDO as long as: (1) The standard is recognized by FDA under its authority under section 514(c) of the FD&C Act and the symbol is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, or alternatively, (2) if the symbol is not included in a standard recognized by FDA under section 514(c) of the FD&C Act or the symbol is in a standard recognized by FDA but is not used according to the specifications for use of the symbol set out in the FDA section 514(c) recognition, the device manufacturer otherwise determines that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use and uses the symbol according to the specifications for use of the symbol set forth in the SDO-developed standard. In addition, in either case, the symbol must be explained in a written or electronic symbols glossary that is included in the labeling for the medical device. Furthermore, the labeling on or within the package containing the device must bear a prominent and conspicuous statement identifying the location of the glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used. The use of such symbols must also comply with other applicable labeling requirements of the FD&C Act, such as section 502(a) and section 502(f). In addition, the final rule allows the use of the symbol statement “Rx Only” or “℞ only” for labeling of prescription devices.

    Medical device manufacturers would only choose to use stand-alone symbols, as allowed by the final rule, if they expect a positive net benefit (estimated benefits minus estimated costs). Hence, the final rule is expected to provide a non-negative net benefit to each manufacturer that opts to use stand-alone symbols. Choosing to use stand-alone symbols under the final rule would potentially reduce the costs associated with designing and redesigning the labels on medical devices that are currently marketed in the United States and the EU. The estimated annual benefits range from $7.9 million to $25.5 million at a 3 percent discount rate, and $7.7 million to $25.0 million at a 7 percent discount rate. Those that opt to use stand-alone symbols under the rule would incur one-time administrative costs to redesign their labeling and create a symbols glossary that is included in the labeling for the device, and recurring costs to revise their glossaries, as necessary. Annualized over 20 years, we estimate total costs to range between $1.1 million to $3.2 million at a 3 percent discount rate, and from $1.1 million to $3.3 million at a 7 percent discount rate. Annualized over 20 years, net benefits range from $6.8 million to $22.3 million at a 3 percent discount rate, and from $6.6 million to $21.7 million at a 7 percent discount rate. The costs and benefits accrue to the same entities, however, so any firm making the change to stand-alone symbols would, on net, reduce costs.

    FDA also examined the economic implications of the final rule as required by the Regulatory Flexibility Act. If a rule will have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires Agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities. We estimated the final rule's approximate impact on small entities using the percent costs per device distinguishable by Universal Product Code (UPC): The ratio between unit labeling costs and revenues among small entities. Our estimates indicate that the average percent costs per UPC ranges from 0.01 to 0.46 percent. Because companies can choose whether or not to use stand-alone symbols under the final rule, the Agency concludes that this final rule would not have a significant adverse impact on any small entities. Furthermore, our analysis suggests that companies could reap moderate cost-savings by using stand-alone symbols in device labeling. On average, companies that use stand-alone symbols under this final rule could expect to receive an average annual cost savings ranging from $1,500 to $4,500 per UPC. Because using stand-alone symbols is expected to lower the marginal cost of producing exports, medical device manufacturers, including small entities, may be able to increase their production either by starting to export products or by exporting more products.

    The full analysis of economic impacts is available in the docket for this final rule (FDA-2013-N-0125) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 6).

    VI. Paperwork Reduction Act of 1995

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

    Title: Medical Devices: Use of Symbols in Labeling—Glossary to Support the Use of Symbols in Labeling.

    Description: FDA is issuing a final rule revising medical device and certain biological product labeling regulations by explicitly allowing for the optional use in medical device labeling of stand-alone symbols established in an SDO-developed standard.

    In particular, FDA will allow the use of stand-alone graphical representations of information, or symbols in the labeling for the medical devices, if the symbols are established in a standard developed by an SDO as long as: (1) The standard is recognized by FDA under its authority under section 514(c) of the FD&C Act and the symbol is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, or alternatively, (2) if the symbol is not included in a standard recognized by FDA under section 514(c) of the FD&C Act or the symbol is in a standard recognized by FDA but is not used according to the specifications for use of the symbol set out in the FDA section 514(c) recognition, the device manufacturer otherwise determines that the symbol is likely to be read and understood by the ordinary individual under customary conditions of purchase and use and uses the symbol according to the specifications for use of the symbol set forth in the SDO-developed standard. In addition, in either case, the symbol must be explained in a written or electronic symbols glossary that is included in the labeling for the medical device. Furthermore, the labeling on or within the package containing the device must bear a prominent and conspicuous statement identifying the location of the glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used. The use of such symbols must also comply with other applicable labeling requirements of the FD&C Act, such as section 502(a) and section 502(f). The final rule also allows the use of the symbol statement “Rx Only” or “℞ only.”

    Description of Respondents: The likely respondents for this collection of information are domestic and foreign device manufacturers who plan to use stand-alone symbols on the labels and/or labeling for their devices marketed in the United States.

    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
    Glossary 3,000 1 3,000 1 3,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information.
    Table 2—Estimated Annual Third-Party Disclosure Burden 1 Activity Number of
  • respondents
  • Number of
  • disclosures
  • per
  • respondent
  • Total
  • annual
  • disclosures
  • Average
  • burden per
  • disclosure
  • Total hours
    Glossary 3,000 1 3,000 4 12,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated burden is based on the data in a similar collection for recommended glossary and educational outreach approved under OMB control number 0910-0553 (Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use). As such, the PRA also covers the requirements of this final rule to submit the symbols glossary to FDA in otherwise required submissions during the premarket review process and to disclose it to third parties in otherwise required device labeling, which means adding to such submission or labeling a compiled listing of each SDO-established symbol used in the labeling for the device; the title and designation number of the SDO-developed standard containing the symbol; and the title of the symbol and its reference number, if any, in the standard; and the meaning or explanatory text for the symbol as provided in the FDA recognition or, if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is used not in accordance with the specifications for use of the symbol set out in the FDA section 514(c) recognition, the explanatory text as provided in the standard. We assume that the additional requirement of identifying in the symbols glossary the SDO-developed standard establishing the symbol and its reference number if any, not included in proposed rule, results in no significant additional cost burden.

    The information collection provisions in this final rule have been submitted to OMB (control number 0910-0740) for review as required by section 3507(d) of the Paperwork Reduction Act of 1995.

    Before the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions in this final rule. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    This final rule refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts A through E have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 801 and § 809.10 have been approved under OMB control number 0910-0485; and the collections of information in §§ 660.2, 660.28, 660.35, 660.45, and 660.55 have been approved under OMB control number 0910-0338.

    VII. Analysis of Environmental Impact

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

    VIII. Effective Date

    This rule is effective on September 13, 2016.

    IX. Federalism

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

    X. References

    The following references are on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    1. Frequently Asked Questions on Recognition of Consensus Standards; Guidance for Industry and FDA Staff, September 2007, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm074973.htm. 2. The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113), section 12(d), 110 Stat. 783. 3. Office of Management and Budget, OMB Circular A-119 (63 FR 8546, February 19, 1998) (Final Revision). 4. Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use; Guidance for Industry and FDA Staff, FDA, November 2004, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085404.htm. 5. Alternative to Certain Prescription Device Labeling Requirements; Guidance for Industry, FDA, January 2000, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072747.htm. 6. Use of Symbols in Medical Device Labeling: Final Regulatory Impact Analysis; Final Regulatory Flexibility Analysis; Unfunded Mandates Reform Act Analysis; available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm350746.htm. List of Subjects 21 CFR Part 660

    Biologics, Labeling, Reporting and recordkeeping requirements.

    21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping requirements.

    21 CFR Part 809

    Labeling, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq., as amended), the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 660, 801, and 809 are amended as follows:

    PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS 1. The authority citation for part 660 continues to read as follows: Authority:

    21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372; 42 U.S.C. 216, 262, 263, 263a, 264.

    2. Amend § 660.2 by revising paragraph (c) to read as follows:
    § 660.2 General requirements.

    (c) Labeling. (1) In addition to the items required by other applicable labeling provisions of this subchapter, the following shall also be included:

    (i) Indication of the source of the product immediately following the proper name on both the final container and package label, e.g., human, guinea pig.

    (ii) Name of the test method(s) recommended for the product on the package label and on the final container label when capable of bearing a full label (see § 610.60(a) of this chapter).

    (iii) A warning on the package label and on the final container label if capable of bearing a full label (see § 610.60(a) of this chapter) indicating that the product and antigen if supplied, shall be handled as if capable of transmitting hepatitis.

    (iv) If the product is dried, the final container label shall indicate “Reconstitution date: ___” and a statement indicating the period within which the product may be used after reconstitution.

    (v) The package shall include a package enclosure providing:

    (A) Adequate instructions for use;

    (B) A description of all recommended test methods; and

    (C) Warnings as to possible hazards, including hepatitis, in handling the product and any ancillary reagents and materials accompanying the product.

    (2) The applicant may provide the labeling information referenced in paragraph (c)(1) of this section in the form of:

    (i) A symbol accompanied by explanatory text adjacent to the symbol;

    (ii) A symbol not accompanied by adjacent explanatory text that:

    (A) Is contained in a standard that FDA recognizes under its authority in section 514(c) of the Federal Food, Drug, and Cosmetic Act;

    (B) Is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition; and

    (C) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used; or

    (iii) A symbol not accompanied by adjacent explanatory text that:

    (A) Is established in a standard developed by a standards development organization (SDO);

    (B) Is not contained in a standard that is recognized by FDA under its authority in section 514(c) of the Federal Food, Drug, and Cosmetic Act or is contained in a standard that is recognized by FDA but is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition;

    (C) Is determined by the manufacturer to be likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the Federal Food, Drug, and Cosmetic Act;

    (D) Is used according to the specifications for use of the symbol set forth in the SDO-developed standard; and

    (E) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used.

    (3) The use of symbols to provide the labeling information referenced in paragraph (c)(1) of this section which do not meet the requirements of paragraph (c)(2) of this section renders a device misbranded under section 502(c) of the Federal Food, Drug, and Cosmetic Act.

    (4) For purposes of paragraph (c)(2) of this section:

    (i) An SDO is an organization that is nationally or internationally recognized and that follows a process for standard development that is transparent, (i.e., open to public scrutiny), where the participation is balanced, where an appeals process is included, where the standard is not in conflict with any statute, regulation, or policy under which FDA operates, and where the standard is national or international in scope.

    (ii) The term “symbols glossary” means a compiled listing of:

    (A) Each SDO-established symbol used in the labeling for the device;

    (B) The title and designation number of the SDO-developed standard containing the symbol;

    (C) The title of the symbol and its reference number, if any, in the standard; and

    (D) The meaning or explanatory text for the symbol as provided in the FDA recognition or, if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, the explanatory text as provided in the standard.

    3. Amend § 660.20 by revising paragraph (a) to read as follows:
    § 660.20 Blood Grouping Reagent.

    (a) Proper name and definition. The proper name of this product shall be Blood Grouping Reagent and it shall consist of an antibody-containing fluid containing one or more of the blood grouping antibodies listed in § 660.28(a)(4).

    4. Revise § 660.28 to read as follows:
    § 660.28 Labeling.

    (a) In addition to the applicable labeling requirements of §§ 610.62 through 610.65 and § 809.10 of this chapter, and in lieu of the requirements in §§ 610.60 and 610.61 of this chapter, the following requirements shall be met:

    (1) Final container label—(i) Color coding. The final container label of all Blood Grouping Reagents shall be completely white, except that all or a portion of the final container label of the following Blood Grouping Reagents may be color coded with the specified color which shall be a visual match to a specific color sample designated by the Director, Center for Biologics Evaluation and Research. Printing on all final container labels shall be in solid black. A logo or company name may be placed on the final container label; however, the logo or company name shall be located along the bottom or end of the label, outside the main panel.

    Blood grouping reagent Color of
  • label paper
  • Anti-A Blue. Anti-B Yellow. Slide and rapid tube test blood grouping reagents only: Anti-C Pink. Anti-D Gray. Anti-E Brown. Anti-CDE Orange. Anti-c Lavender. Anti-e Green.

    (ii) Required information. The proper name “Blood Grouping Reagent” need not appear on the final container label provided the final container is distributed in a package and the package label bears the proper name. The final container label shall bear the following information:

    (A) Name of the antibody or antibodies present as set forth in paragraph (a)(4) of this section.

    (B) Name, address (including ZIP code), and license number of the manufacturer.

    (C) Lot number, including sublot designations.

    (D) Expiration date.

    (E) Source of product if other than human plasma or serum.

    (F) Test method(s) recommended.

    (G) Recommended storage temperature in degrees Celsius.

    (H) Volume of product if a liquid, or equivalent volume for a dried product if it is to be reconstituted.

    (I) If a dried product, to remind users to record the reconstitution date on the label, the statement “RECONSTITUTION DATE ___. EXPIRES 1 YEAR AFTER RECONSTITUTION DATE.”

    (iii) Lettering size. The type size for the specificity of the antibody designation on the labels of a final container with a capacity of less than 5 milliliters shall be not less than 12 point. The type size for the specificity of the antibody designations on the label of a container with a capacity of 5 milliliters or more shall be not less than 18 point.

    (iv) Visual inspection. When the label has been affixed to the final container, a sufficient area of the container shall remain uncovered for its full length or no less than 5 millimeters of the lower circumference to permit inspection of the contents. The label on a final product container for antibodies Anti-c, Anti-k, or Anti-s shall display a bar immediately over the specificity letter used in the name, i.e., Anti-c, Anti-k, or Anti-s.

    (2) Package label. The following information shall appear either on the package label or on the final container label if it is visible within the package.

    (i) Proper name of the product.

    (ii) Name of the antibody or antibodies present as set forth in paragraph (a)(4) of this section.

    (iii) Name, address (including ZIP Code), and license number of the manufacturer.

    (iv) Lot number, including sublot designations.

    (v) Expiration date.

    (vi) Preservative used and its concentration.

    (vii) Number of containers, if more than one.

    (viii) Volume or equivalent volume for dried products when reconstituted, and precautions for adequate mixing when reconstituting.

    (ix) Recommended storage temperature in degrees Celsius.

    (x) Source of the product if other than human serum or plasma.

    (xi) Reference to enclosed package insert.

    (xii) If a dried product, a statement indicating the period within which the product may be used after reconstitution.

    (xiii) The statement: “FOR IN VITRO DIAGNOSTIC USE.”

    (xiv) The statement: “MEETS FDA POTENCY REQUIREMENTS.”

    (xv) If human blood was used in manufacturing the product, the statement: “CAUTION: ALL BLOOD PRODUCTS SHOULD BE TREATED AS POTENTIALLY INFECTIOUS. SOURCE MATERIAL FROM WHICH THIS PRODUCT WAS DERIVED WAS FOUND NEGATIVE WHEN TESTED IN ACCORDANCE WITH CURRENT FDA REQUIRED TESTS. NO KNOWN TEST METHODS CAN OFFER ASSURANCE THAT PRODUCTS DERIVED FROM HUMAN BLOOD WILL NOT TRANSMIT INFECTIOUS AGENTS.”

    (xvi) A statement of an observable indication of an alteration of the product, e.g., turbidity, color change, precipitate, that may indicate possible deterioration of the product.

    (3) Package insert. Each final container of Blood Grouping Reagent shall be accompanied by a package insert meeting the requirements of § 809.10. If two or more final containers requiring identical package inserts are placed in a single package, only one package insert per package is required.

    (4) Names of antibodies.

    Blood Group Designation for Container Label Anti-A Anti-Jkb Anti-A1 Anti-Jsa Anti-A, B Anti-Jsb Anti-A and B Anti-K Anti-B Anti-k Anti-C Anti-Kpa Anti-Cw Anti-Kpb Anti- c Anti-Lea Anti-CD Anti-Leb Anti-CDE Anti-Lua Anti-Cob Anti-Lub Anti-D Anti-M Anti-DE Anti-Mg Anti-Dia Anti-N Anti-E Anti-P1 Anti-e Anti-S Anti-Fya Anti-s Anti-Fyb Anti-U Anti-I Anti-Wra Anti-Jka Anti-Xga

    (b) The applicant may provide the labeling information referenced in paragraph (a) of this section in the form of:

    (1) A symbol accompanied by explanatory text adjacent to the symbol;

    (2) A symbol not accompanied by adjacent explanatory text that:

    (i) Is contained in a standard that FDA recognizes under its authority in section 514(c) of the Federal Food, Drug, and Cosmetic Act;

    (ii) Is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition; and

    (iii) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used; or

    (3) A symbol not accompanied by adjacent explanatory text that:

    (i) Is established in a standard developed by a standards development organization (SDO);

    (ii) Is not contained in a standard that is recognized by FDA under its authority in section 514(c) of the Federal Food, Drug, and Cosmetic Act or is contained in a standard that is recognized by FDA but is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition;

    (iii) Is determined by the manufacturer to be likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the Federal Food, Drug, and Cosmetic Act;

    (iv) Is used according to the specifications for use of the symbol set forth in the SDO-developed standard; and

    (v) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used.

    (c) The use of symbols in device labeling to provide the labeling information referenced in paragraph (a) of this section which do not meet the requirements in paragraph (b) of this section renders a device misbranded under section 502(c) of the Federal Food, Drug, and Cosmetic Act.

    (d) For purposes of paragraph (b) of this section:

    (1) An SDO is an organization that is nationally or internationally recognized and that follows a process for standard development that is transparent, (i.e., open to public scrutiny), where the participation is balanced, where an appeals process is included, where the standard is not in conflict with any statute, regulation, or policy under which FDA operates, and where the standard is national or international in scope.

    (2) The term “symbols glossary” means a compiled listing of:

    (i) Each SDO-established symbol used in the labeling for the device;

    (ii) The title and designation number of the SDO-developed standard containing the symbol;

    (iii) The title of the symbol and its reference number, if any, in the standard; and

    (iv) The meaning or explanatory text for the symbol as provided in the FDA recognition or, if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, the explanatory text as provided in the standard.

    5. Revise § 660.35 to read as follows:
    § 660.35 Labeling.

    (a) In addition to the items required by § 809.10 of this chapter and other applicable labeling provisions of this chapter, the following information shall be included in the labeling:

    (1)(i) A logo or company name may be placed on the final container label, however, the logo or company name shall be located along the bottom or end of the label, outside of the main panel.

    (ii) If washing the cells is required by the manufacturer, the container label shall include appropriate instructions; if the cells should not be washed before use, e.g., if washing will adversely affect the product, the package insert shall explain.

    (2) The container label of Group O cells shall state:

    “FOR USE IN DETECTION OF UNEXPECTED ANTIBODIES” or “FOR USE IN IDENTIFICATION OF UNEXPECTED ANTIBODIES” or “NOT FOR USE IN DETECTION OR IDENTIFICATION OF UNEXPECTED ANTIBODIES”.

    (3) Except as provided in this section, the container and package labels shall state the percentage of red blood cells in the suspension either as a discrete figure with a variance of more than [+/−] 1 percentage unit or as a range the extremes of which differ by no more than 2 percentage units. If the stated red blood cell concentration is less than 2 percent, the variance shall be no more than [+/−] 0.5 percentage unit.

    (4) The words “pooled cells” shall appear on the container and package labels of products prepared from pooled cells. The package label or package insert shall state that pooled cells are not recommended for pre-transfusion tests, done in lieu of a major crossmatch, to detect unexpected antibodies in patients' samples.

    (5) The package insert of a pooled product intended for detection of unexpected antibodies shall identify the number of donors contributing to the pool. Products designed exclusively for ABO Serum Grouping and umbilical cord cells need not identify the number of donors in the pool.

    (6) When the product is a multicontainer product, e.g., a cell panel, the container label and package label shall be assigned the same identifying lot number, and shall also bear a number or symbol to distinguish one container from another. Such number or symbol shall also appear on the antigenic constitution matrix.

    (7) The package label or package insert shall state the blood group antigens that have been tested for and found present or absent on the cells of each donor, or refer to such information in an accompanying antigenic constitution matrix. Cells for ABO Serum Grouping are exempt from this requirement. The package insert or antigen constitution matrix shall list each of the antigens tested with only one source of antibody.

    (8) The package label or package insert shall bear the cautionary statement: “The reactivity of the product may decrease during the dating period.”

    (9) The package insert of a product intended for the detection or identification of unexpected antibodies shall note that the rate at which antigen reactivity (e.g., agglutinability) is lost is partially dependent upon individual donor characteristics that are neither controlled nor predicted by the manufacturer.

    (10) The package insert shall provide adequate directions for use.

    (11) The package insert shall bear the statement:

    “CAUTION: ALL BLOOD PRODUCTS SHOULD BE TREATED AS POTENTIALLY INFECTIOUS. SOURCE MATERIAL FROM WHICH THIS PRODUCT WAS DERIVED WAS FOUND NEGATIVE WHEN TESTED IN ACCORDANCE WITH CURRENT FDA REQUIRED TESTS. NO KNOWN TEST METHODS CAN OFFER ASSURANCE THAT PRODUCTS DERIVED FROM HUMAN BLOOD WILL NOT TRANSMIT INFECTIOUS AGENTS.”

    (12) The package insert or the antigenic constitution matrix for each lot of product shall specify the date of manufacture or the length of the dating period.

    (13) Manufacturers shall identify with a permanent donor code in the product labeling each donor of peripheral blood used for detection or identification of unexpected antibodies.

    (b) The applicant may provide the labeling information referenced in paragraph (a) of this section in the form of:

    (1) A symbol accompanied by explanatory text adjacent to the symbol;

    (2) A symbol not accompanied by adjacent explanatory text that:

    (i) Is contained in a standard that FDA recognizes under its authority in section 514(c) of the Federal Food, Drug, and Cosmetic Act;

    (ii) Is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition; and

    (iii) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used; or

    (3) A symbol not accompanied by adjacent explanatory text that:

    (i) Is established in a standard developed by a standards development organization (SDO);

    (ii) Is not contained in a standard that is recognized by FDA under its authority in section 514(c) of the Federal Food, Drug, and Cosmetic Act or is contained in a standard that is recognized by FDA but is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition;

    (iii) Is determined by the manufacturer to be likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the Federal Food, Drug, and Cosmetic Act;

    (iv) Is used according to the specifications for use of the symbol set forth in the SDO-developed standard; and

    (v) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used.

    (c) The use of symbols in device labeling to provide the labeling information referenced in paragraph (a) of this section which do not meet the requirements of paragraph (b) of this section renders a device misbranded under section 502(c) of the Federal Food, Drug, and Cosmetic Act.

    (d) For purposes of paragraph (b) of this section:

    (1) An SDO is an organization that is nationally or internationally recognized and that follows a process for standard development that is transparent, (i.e., open to public scrutiny), where the participation is balanced, where an appeals process is included, where the standard is not in conflict with any statute, regulation, or policy under which FDA operates, and where the standard is national or international in scope.

    (2) The term “symbols glossary” means a compiled listing of:

    (i) Each SDO-established symbol used in the labeling for the device;

    (ii) The title and designation number of the SDO-developed standard containing the symbol;

    (iii) The title of the symbol and its reference number, if any, in the standard; and

    (iv) The meaning or explanatory text for the symbol as provided in the FDA recognition or, if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, the explanatory text as provided in the standard.

    6. Revise § 660.45 to read as follows:
    § 660.45 Labeling.

    (a) In addition to the requirements of §§ 610.60, 610.61, and 809.10 of this chapter, the labeling shall bear the following:

    (1) The “d and y” antigen subtype and the source of the product to follow immediately the proper name on both the final container label and the package label. If the product is intended to identify antibodies to the “r and w” antigen subtype, the antigen subtype designation shall include the “r and w” antigen subtype.

    (2) The name of the test method(s) recommended for use of the product on the package label and on the final container label, when capable of bearing a full label (see § 610.60(a) of this chapter).

    (3) A warning on the package label and on the final container label stating that the product is capable of transmitting hepatitis and should be handled accordingly.

    (4) The package shall include a package insert providing:

    (i) Detailed instructions for use,

    (ii) An adequate description of all recommended test methods, and

    (iii) Warnings as to possible hazards, including hepatitis transmitted in handling the product and any ancillary reagents and materials accompanying the product.

    (b) The applicant may provide the labeling information referenced in paragraph (a) of this section in the form of:

    (1) A symbol accompanied by explanatory text adjacent to the symbol;

    (2) A symbol not accompanied by adjacent explanatory text that:

    (i) Is contained in a standard that FDA recognizes under its authority in section 514(c) of the Federal Food, Drug, and Cosmetic Act;

    (ii) Is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition; and

    (iii) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used; or

    (3) A symbol not accompanied by adjacent explanatory text that:

    (i) Is established in a standard developed by a standards development organization (SDO);

    (ii) Is not contained in a standard that is recognized by FDA under its authority in section 514(c) of the Federal Food, Drug, and Cosmetic Act or is contained in a standard that is recognized by FDA but is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition;

    (iii) Is determined by the manufacturer to be likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the Federal Food, Drug, and Cosmetic Act;

    (iv) Is used according to the specifications for use of the symbol set forth in the SDO-developed standard; and

    (v) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used.

    (c) The use of symbols in device labeling to provide the labeling information referenced in paragraph (a) of this section which do not meet the requirements of paragraph (b) of this section renders a device misbranded under section 502(c) of the Federal Food, Drug, and Cosmetic Act.

    (d) For purposes of paragraph (b) of this section:

    (1) An SDO is an organization that is nationally or internationally recognized and that follows a process for standard development that is transparent, (i.e., open to public scrutiny), where the participation is balanced, where an appeals process is included, where the standard is not in conflict with any statute, regulation, or policy under which FDA operates, and where the standard is national or international in scope.

    (2) The term “symbols glossary” means a compiled listing of:

    (i) Each SDO-established symbol used in the labeling for the device;

    (ii) The title and designation number of the SDO-developed standard containing the symbol;

    (iii) The title of the symbol and its reference number, if any, in the standard; and

    (iv) The meaning or explanatory text for the symbol as provided in the FDA recognition or, if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, the explanatory text as provided in the standard.

    7. Amend § 660.50 by revising paragraph (a) to read as follows:
    § 660.50 Anti-Human Globulin.

    (a) Proper name and definition. The proper name of this product shall be Anti-Human Globulin which shall consist of one or more antiglobulin antibodies identified in § 660.55(a)(4).

    8. Revise § 660.55 to read as follows:
    § 660.55 Labeling.

    (a) In addition to the applicable labeling requirements of §§ 610.62 through 610.65 and § 809.10 of this chapter, and in lieu of the requirements in §§ 610.60 and 610.61 of this chapter, the following requirements shall be met:

    (1) Final container label—(i) Color coding. The main panel of the final container label of all Anti-IgG, -C3d (polyspecific) reagents shall be white or colorless and printing shall be solid dark contrasting lettering. The main panel of the final container label of all other Anti-Human Globulin reagents shall be black with solid white lettering. A logo or company name may be placed on the final container label; however, the logo or company name shall be located along the bottom or end of the label, outside of the main panel.

    (ii) Required information. The proper name “Anti-Human Globulin” need not appear on the final container label provided the final container is distributed in a package and the package label bears the proper name. The final container label shall bear the following information:

    (A) Name of the antibody or antibodies present as set forth in paragraph (a)(4) of this section. Anti-Human Globulin may contain one or more antibodies to either immunoglobulins or complement components but the name of each significant antibody must appear on the final container label (e.g., anti-C3b, -C3d, -C4d). The final container labels of polyspecific Anti-Human Globulin are not required to identify antibody specificities other than anti-IgG and anti-C3d but the reactivity of the Anti-Human Globulin shall be accurately described in the package insert.

    (B) Name, address, and license number of the manufacturer.

    (C) Lot number, including any sublot designations.

    (D) Expiration date.

    (E) Source of the product.

    (F) Recommended storage temperature in degrees Celsius.

    (G) Volume of product.

    (H) Appropriate cautionary statement if the Anti-Human Globulin is not polyspecific. For example, “DOES NOT CONTAIN ANTIBODIES TO IMMUNOGLOBULINS” or “DOES NOT CONTAIN ANTIBODIES TO COMPLEMENT COMPONENTS.”

    (I) If the final container is not enclosed in a package, all items required for a package label shall appear on the container label.

    (iii) Lettering size. The type size for the designation of the specific antibody on the label of a final container shall be not less than 12 point, unless otherwise approved by the Director, Center for Biologics Evaluation and Research. The prefix anti- and other parts of the name such as polyspecific may appear in smaller type.

    (iv) Visual inspection. When the label has been affixed to the final container, a sufficient area of the container shall remain uncovered for its full length or for no less than 5 millimeters of the lower circumference to permit inspection of the contents.

    (2) Package label. The following items shall appear either on the package label or on the final container label if see-through packaging is used:

    (i) Proper name of the product, and the name of the antibody or antibodies as listed in paragraph (a)(4) of this section.

    (ii) Name, address (including ZIP code), and license number of the manufacturer.

    (iii) Lot number, including any sublot designations.

    (iv) Expiration date.

    (v) Preservative(s) used and its concentration.

    (vi) Number of containers, if more than one.

    (vii) Recommended storage temperature in degrees Celsius.

    (viii) Source of the product.

    (ix) Reference to enclosed package insert.

    (x) The statement: “For In Vitro Diagnostic Use.”

    (xi) The statement: “Meets FDA Potency Requirements.”

    (xii) A statement of an observable indication of an alteration of the product, e.g., turbidity, color change, precipitate, that may indicate possible deterioration of the product.

    (xiii) Appropriate cautions.

    (3) Package insert. Each final container of Anti-Human Globulin shall be accompanied by a package insert meeting the requirements of § 809.10 of this chapter. If two or more final containers requiring identical package inserts are placed in a single package, only one package insert per package is required.

    (4) Names of antibodies. Anti-Human Globulin preparations may contain one or more of the antibody specificities listed in this paragraph as described in paragraph (a)(1)(ii)(A) of this section.

    Antibody designation on
  • container label
  • Definition
    (1) Anti-IgG, -C3d; Polyspecific Contains anti-IgG and anti-C3d (may contain other anticomplement and anti-immunoglobulin antibodies). (2) Anti-IgG Contains anti-IgG with no anti-complement activity (not necessarily gamma chain specific). (3) Anti-IgG; heavy chains Contains only antibodies reactive against human gamma chains. (4) Anti-C3b Contains only C3b antibodies with no anti-immunoglobulin activity. Note: The antibody produced in response to immunization is usually directed against the antigenic determinant which is located in the C3c subunit; some persons have called this antibody “anti-C3c.” In product labeling, this antibody should be designated anti-C3b. (5) Anti-C3d Contains only C3d antibodies with no anti-immunoglobulin activity. (6) Anti-C4b Contains only C4b antibodies with no anti-immunoglobulin activity. (7) Anti-C4d Contains only C4d antibodies with no anti-immunoglobulin activity.

    (b) The applicant may provide the labeling information referenced in this section in the form of:

    (1) A symbol accompanied by explanatory text adjacent to the symbol;

    (2) A symbol not accompanied by adjacent explanatory text that:

    (i) Is contained in a standard that FDA recognizes under its authority in section 514(c) of the Federal Food, Drug, and Cosmetic Act;

    (ii) Is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition; and

    (iii) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used; or

    (3) A symbol not accompanied by adjacent explanatory text that:

    (i) Is established in a standard developed by a standards development organization (SDO);

    (ii) Is not contained in a standard that is recognized by FDA under its authority in section 514(c) or is contained in a standard that is recognized by FDA but is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition;

    (iii) Is determined by the manufacturer to be likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the Federal Food, Drug, and Cosmetic Act;

    (iv) Is used according to the specifications for use of the symbol set forth in the SDO-developed standard; and

    (v) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used.

    (c) The use of symbols in device labeling to provide the labeling information referenced in paragraph (a) of this section which do not meet the requirements of paragraph (b) of this section renders a device misbranded under section 502(c) of the Federal Food, Drug, and Cosmetic Act.

    (d) For purposes of paragraph (b) of this section:

    (1) An SDO is an organization that is nationally or internationally recognized and that follows a process for standard development that is transparent, (i.e., open to public scrutiny), where the participation is balanced, where an appeals process is included, where the standard is not in conflict with any statute, regulation, or policy under which FDA operates, and where the standard is national or international in scope.

    (2) The term “symbols glossary” means a compiled listing of:

    (i) Each SDO-established symbol used in the labeling for the device;

    (ii) The title and designation number of the SDO-developed standard containing the symbol;

    (iii) The title of the symbol and its reference number, if any, in the standard; and

    (iv) The meaning or explanatory text for the symbol as provided in the FDA recognition or, if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, the explanatory text as provided in the standard.

    PART 801—LABELING 9. The authority citation for part 801 is revised to read as follows: Authority:

    21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371, 374.

    10. Amend § 801.15 by revising the section heading and paragraph (c)(1) to read as follows:
    § 801.15 Medical devices; prominence of required label statements; use of symbols in labeling.

    (c)(1)(i) All words, statements, and other information required by or under authority of the act to appear on the label or labeling for a device shall appear thereon in one or more of the following formats:

    (A) The English language;

    (B) In the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English;

    (C) A symbol accompanied by adjacent explanatory English text, or text in the predominant language of the Territory, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English;

    (D) A symbol not accompanied by adjacent explanatory text that:

    (1) Is contained in a standard that FDA recognizes under its authority in section 514(c) of the act;

    (2) Is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition; and

    (3) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used;

    (E) A symbol not accompanied by adjacent explanatory text that:

    (1) Is established in a standard developed by a standards development organization (SDO);

    (2) Is not contained in a standard that is recognized by FDA under its authority in section 514(c) of the act or is contained in a standard that is recognized by FDA but is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition;

    (3) Is determined by the manufacturer to be likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the act;

    (4) Is used according to the specifications for use of the symbol set forth in the SDO-developed standard; and

    (5) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used;

    (F) The symbol statement “Rx only” or “℞ only” may be used as provided under § 801.109(b)(1).

    (ii) The use of symbols in device labeling which do not meet the requirements of paragraph (c)(1)(i) of this section renders a device misbranded under section 502(c) of the act.

    (iii) For purposes of paragraph (c)(1)(i) of this section:

    (A) An SDO is an organization that is nationally or internationally recognized and that follows a process for standard development that is transparent, (i.e., open to public scrutiny), where the participation is balanced, where an appeals process is included, where the standard is not in conflict with any statute, regulation, or policy under which FDA operates, and where the standard is national or international in scope.

    (B) The term “symbols glossary” means a compiled listing of:

    (1) Each SDO-established symbol used in the labeling for the device;

    (2) The title and designation number of the SDO-developed standard containing the symbol;

    (3) The title of the symbol and its reference number, if any, in the standard; and

    (4) The meaning or explanatory text for the symbol as provided in the FDA recognition or, if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, the explanatory text as provided in the standard.

    11. Amend § 801.109 by revising paragraph (b)(1) to read as follows:
    § 801.109 Prescription devices.

    (b) * * *

    (1) The symbol statement “Rx only” or “℞ only” or the statement “Caution: Federal law restricts this device to sale by or on the order of a ___”, the blank to be filled with the word “physician”, “dentist”, “veterinarian”, or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and

    PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE 12. The authority citation for part 809 continues to read as follows: Authority:

    21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 360i, 360j, 371, 372, 374, 381.

    13. In § 809.10: a. Add a last sentence to paragraph (a)(4), b. Add a last sentence to paragraph (b)(5)(ii), and c. Add paragraph (g).

    The additions read as follows:

    § 809.10 Labeling for in vitro diagnostic products.

    (a) * * *

    (4) * * * The limiting statement appropriate to the intended use of a prescription in vitro diagnostic product shall bear the symbol statement “Rx only” or “℞ only” or the statement “Caution: Federal law restricts this device to sale by or on the order of a ___”, the blank to be filled with the word “physician”, “dentist”, “veterinarian”, or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device.

    (b) * * *

    (5) * * *

    (ii) * * * The limiting statement appropriate to the intended use of a prescription in vitro diagnostic product shall bear the symbol statement “Rx only” or “℞ only” or the statement “Caution: Federal law restricts this device to sale by or on the order of a ___”, the blank to be filled with the word “physician”, “dentist”, “veterinarian”, or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device.

    (g)(1) The applicant may provide the labeling information referenced in this section in the form of:

    (i) A symbol accompanied by explanatory text adjacent to the symbol;

    (ii) A symbol not accompanied by adjacent explanatory text that:

    (A) Is contained in a standard that FDA recognizes under its authority in section 514(c) of the act;

    (B) Is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition; and

    (C) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used;

    (iii) A symbol not accompanied by adjacent explanatory text that:

    (A) Is established in a standard developed by a standards development organization (SDO);

    (B) Is not contained in a standard that is recognized by FDA under its authority in section 514(c) of the act or is contained in a standard that is recognized by FDA but is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition;

    (C) Is determined by the manufacturer to be likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the act;

    (D) Is used according to the specifications for use of the symbol set forth in the SDO-developed standard; and

    (E) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used; or

    (iv) The symbol statement “Rx only” or “℞ only” used as provided under paragraphs (a)(4) and (b)(5)(ii) of this section.

    (2) The use of symbols in device labeling which do not meet the requirements of paragraph (g)(1) of this section renders a device misbranded under section 502(c) of the act.

    (3) For purposes of paragraph (g)(1) of this section:

    (i) An SDO is an organization that is nationally or internationally recognized and that follows a process for standard development that is transparent, (i.e., open to public scrutiny), where the participation is balanced, where an appeals process is included, where the standard is not in conflict with any statute, regulation, or policy under which FDA operates, and where the standard is national or international in scope.

    (ii) The term “symbols glossary” means a compiled listing of:

    (A) Each SDO-established symbol used in the labeling for the device;

    (B) The title and designation number of the SDO-developed standard containing the symbol;

    (C) The title of the symbol and its reference number, if any, in the standard; and

    (D) The meaning or explanatory text for the symbol as provided in the FDA recognition or, if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, the explanatory text as provided in the standard.

    Dated: June 8, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-13989 Filed 6-14-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Parts 28, 30, 87, 180, and 3282 [Docket No. FR-5942-I-01] RIN 2501-AD79 Inflation Catch-Up Adjustment of Civil Monetary Penalty Amounts AGENCY:

    Office of the General Counsel, HUD.

    ACTION:

    Interim final rule.

    SUMMARY:

    This interim final rule amends HUD's civil monetary penalty regulations by making inflation adjustments as mandated by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. HUD also removes three obsolete civil monetary penalty regulations previously authorized under statutes for which either HUD no longer has enforcement authority or the program is no longer active. Lastly, HUD makes a technical change to the regulation language implementing the Program Fraud Civil Remedies Act which, due to a typographical error under the last civil money penalty adjustment, failed to include language assigning a penalty for causing a false claim or statement to be made.

    DATES:

    Effective date: August 16, 2016. Comment due date: August 15, 2016.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this interim final rule. Communications must refer to the above docket number and title. There are two methods for submitting public comments. All submissions must refer to the above docket number and title.

    1. Submission of Comments by Mail. Comments may be submitted by mail to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW., Room 10276, Washington, DC 20410-0500.

    2. Electronic Submission of Comments. Interested persons may submit comments electronically through the Federal eRulemaking Portal at www.regulations.gov. HUD strongly encourages commenters to submit comments electronically. Electronic submission of comments allows the commenter maximum time to prepare and submit a comment, ensures timely receipt by HUD, and enables HUD to make them immediately available to the public. Comments submitted electronically through the www.regulations.gov Web site can be viewed by other commenters and interested members of the public. Commenters should follow the instructions provided on that site to submit comments electronically.

    Note:

    To receive consideration as public comments, comments must be submitted through one of the two methods specified above. Again, all submissions must refer to the docket number and title of the rule.

    No Facsimile Comments. Facsimile (fax) comments are not acceptable.

    Public Inspection of Public Comments. All properly submitted comments and communications submitted to HUD will be available for public inspection and copying between 8 a.m. and 5 p.m., weekdays, at the above address. Due to security measures at the HUD Headquarters building, an advance appointment to review the public comments must be scheduled by calling the Regulations Division at 202-402-3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service, toll-free, at 800-877-8339. Copies of all comments submitted are available for inspection and downloading at www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Dane Narode, Associate General Counsel, Office of Program Enforcement, Department of Housing and Urban Development, 1250 Maryland Avenue SW., Suite 200, Washington, DC 20024; telephone number 202-245-4141 (this is not a toll-free number). Hearing- or speech-impaired individuals may access this number via TTY by calling the toll-free Federal Information Relay Service at 800-877-8339.

    SUPPLEMENTARY INFORMATION:

    I. Background

    On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), which further amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The 2015 Act requires agencies to: (1) Adjust the level of civil monetary penalties with an initial “catch-up” adjustment through an interim final rulemaking (IFR); and (2) make subsequent annual adjustments for inflation.

    Previously, the Inflation Adjustment Act required agencies to adjust CMP levels every four years based on the percentage by which the Consumer Price Index (CPI) for the month of June of the prior calendar year exceeded the CPI for the month of June of the calendar year during which the last adjustment was made. The Inflation Adjustment Act also capped the increase for each adjustment at 10 percent and rounded the adjustment based on the size of the penalty (e.g., multiple of $10 in the case of penalties less than or equal to $100). The rounding process meant that penalties would often not be increased at all if the inflation factor was not large enough. Furthermore, the cap on increases of 10 percent in tandem with the rounding meant that the formula over time caused penalties to lose value relative to total inflation. The 2015 Act updates these requirements by prescribing that agencies make annual adjustments for inflation based on the CPI for the month of October and round to the nearest dollar after an initial adjustment.

    In order to eliminate the inconsistent changes caused by the prior method, the 2015 Act resets the inflation adjustment by excluding prior inflationary adjustments under the Inflation Adjustment Act, which contributed to a decline in the real value of penalty levels. To do this, the 2015 Act provides that the initial adjustment shall be the percentage by which the CPI for the month of October, 2015 exceeds that of the month of October of the calendar year during which the amount of the CMP was originally established or otherwise adjusted under a provision of law other than the Inflation Adjustment Act. While the 2015 Act does not provide a cap on adjustments going forward, the initial adjustment under the 2015 Act does limit large CMP increases by providing that no initial adjustments may exceed 150 percent of the amount of the CMP as of the date the 2015 Act was enacted, November 2, 2015. Lastly, the 2015 Act requires that agencies publish an interim final rule with the initial adjustment by July 1, 2016, and have the adjustments take effect no later than August 1, 2016. The initial adjustment under the 2015 Act also provides that, following public comment, the head of an agency may reduce the required increase if the agency head determines that the increase will have a negative economic impact or the social costs of the increase outweigh the benefits; and the Director of the Office of Management and Budget concurs.

    II. This Interim Final Rule A. Inflation Adjustment of Civil Monetary Penalty Amounts

    For each component, HUD provides a table showing how the penalties are being increased pursuant to the 2015 Act. In the first column, HUD provides a description of the penalty. In the second column (“Citation,”) HUD provides the United States Code (U.S.C.) statutory citation providing for the penalty. In the third column (“Original Amount”), HUD provides the amount of the penalty as originally enacted by Congress or changed through a mechanism other than pursuant to the Inflation Adjustment Act. In the fourth column (“Regulatory Citation”), HUD lists the regulatory citation in the current Code of Federal Regulations (CFR) where the most recently amended penalty is codified. In the fifth column (“Current Amount”), HUD lists the existing penalty in the CFR. In the sixth column, (“New Amount”) HUD lists the penalty after disregarding adjustments under the Inflation Adjustment Act and applying the 2015 Act formula and cap for the first adjustment.

    Description Citation Original amount Regulatory
  • citation
  • Current amount New amount
    False Claims & Statements Omnibus Budget Reconciliation Act of 1986 (31 U.S.C. 3802(a)(1)) $5,000 § 28.10 $8,500 $10,781. Advance Disclosure of Funding Department of Housing and Urban Development Act (42 U.S.C. 3537a(c)) $10,000 § 30.20 $16,000 $18,936. Disclosure of Subsidy Layering Department of Housing and Urban Development Act (42 U.S.C. 3545(f)) $10,000 § 30.25 $16,000 $18,936. FHA Mortgagees and Lenders Violations HUD Reform Act of 1989 (12 U.S.C. 1735f-14(a)(2)) Per Violation: $5,000 Per Year: $1,000,000 § 30.35 Per Violation: $8,500 Per Year: $1,525,000 Per Violation: $9,468 Per Year: $1,893,610. Other FHA Participants Violations HUD Reform Act of 1989 (12 U.S.C. 1735f-14(a)(2)) Per Violation: $5,000 Per Year: $1,000,000 § 30.36 Per Violation: $7,050 Per Year: $1,335,000 Per Violation: $9,468 Per Year: $1,893,610. Indian Loan Mortgagees Violations Housing Community Development Act of 1992 1 (12 U.S.C. 1715z-13a(g)(2)) Per Violation: $5,000 Per Year: $1,000,000 § 30.40 Per Violation: $8,000 Per Year: $1,525,000 Per Violation: $9,468 Per Year: $1,893,610. Multifamily & Section 202 or 811 Owners Violations HUD Reform Act of 1989 (12 U.S.C. 1735f-15(c)(2)) $25,000 § 30.45 $42,500 $47,340. Ginnie Mae Issuers & Custodians Violations HUD Reform Act of 1989 (12 U.S.C. 1723i(b)) Per Violation: $5,000 Per Year: $1,000,000 § 30.50 Per Violation: $8,500 Per Year: $1,525,000 Per Violation: $9,468 Per Year: $1,893,610. Title I Broker & Dealers Violations HUD Reform Act of 1989 (12 U.S.C. 1703) Per Violation: $5,000 Per Year: $1,000,000 § 30.60 Per Violation: $8,500 Per Year: $1,525,000 Per Violation: $9,468 Per Year: $1,893,610. Lead Disclosure Violation Title X-Residential Lead-Based Paint Hazard Reduction Act of 1992 (42 U.S.C. 4852d(b)(1)) $10,000 § 30.65 $16,000 $16,773. Section 8 Owners Violations Multifamily Assisted Housing Reform and Affordability Act of 1997 (42 U.S.C. 1437z-1(b)(2)) $25,000 § 30.68 $27,500 $36,794. Lobbying Violation The Lobbying Disclosure Act of 1995 (31 U.S.C. 1352) Min: $10,000 Max: $100,000 § 87.400 Min: $10,000 Max: $100,000 Min: $18,936 Max: $189,361. Fair Housing Act Civil Penalties Fair Housing Amendments Act of 1988 (42 U.S.C. 3612(g)(3)) No Priors: $10,000 One Prior: $25,000 Two or More Priors: $50,000 § 180.671(a) No Priors: $16,000 One Prior: $42,500 Two or More Priors: $70,000 No Priors: $19,787 One Prior: $49,467 Two or More Priors: $98,935. Manufactured Housing Regulations Violation Housing Community Development Act of 1974 (42 U.S.C. 5410) Per Violation: $1,000 Per Year: $1,000,000 § 3282.10 Per Violation: $1,100 Per Year: $1,375,000 Per Violation: $2,750 Per Year: $3,437,500.
    B. Correction to 24 CFR 28.10

    In addition to applying the catch-up adjustment as required by the 2015 Act, HUD takes the opportunity to issue a technical correction to § 28.10. On January 18, 2013, HUD published a final rule (78 FR 4059) to apply a routine inflationary adjustment to CMPs under § 28.10, the regulation implementing the Program Fraud Civil Remedies Act, 31 U.S.C. 3802. Due to a typographical error, the final rule assigned a penalty for making a false claim or statement, but not for causing such claim or statement to be made. Liability is provided for both bases under 31 U.S.C. 3802, as well as under the version of § 28.10 that predated the 2013 rulemaking (See 73 FR 76831, Dec. 17, 2008), and the 2013 final rule was intended only to adjust the penalty amount, not to remove a basis for liability. As such, the bases for liability enumerated in § 28.10 are incomplete. Through this technical correction, HUD can ensure § 28.10 fully implements the statutory requirements of 31 U.S.C. 3802. Accordingly, HUD amends §§ 28.10(a), (b), and (c) to reflect statutory liability for causing a false claim or statement to be made, as originally intended.

    1 The Housing Community Development Act of 1992 (12 U.S.C. 1715z-13a(g)(2) incorporated the civil money penalties from section 536 of the HUD Reform Act of 1989 (12 U.S.C. 1715f-14), and thus the year applied for purposes of the 2015 Act adjustment is 1989.

    C. Removal of 24 CFR 30.30, 30.55, and 30.69

    HUD also takes the opportunity to remove from title 24 of the CFR two outdated regulations for which HUD no longer has statutory enforcement authority, and one regulation for which the HUD program was repealed.

    Section 30.30 implements CMPs for violations under the Urban Homesteading Program, which was administered by HUD's Office of Community Planning and Development and ceased operation due to repeal of 12 U.S.C. 1706e on October 1, 1991. Subsequently, HUD removed its Urban Homesteading regulation at 24 CFR part 590 (79 FR 51894, Sept. 2, 2014) but inadvertently retained § 30.30, which is now obsolete.

    Sections 30.55 and 30.69 implement CMPs for violations under the Secure and Fair Enforcement for Mortgage Licensing Act of 2008 (SAFE Act) (12 U.S.C. 5101 et seq.) and the Interstate Land Sales Full Disclosure Act (ILSFDA) (15 U.S.C. 1701 et seq.), respectively. In 2011, the Dodd-Frank Act 2 transferred from HUD to the Consumer Financial Protection Bureau (CFPB) all of its prior authority to administer, enforce, and otherwise implement the SAFE Act and ILSFDA. Accordingly, HUD issued regulations removing 24 CFR part 3400, its SAFE Act regulation (79 FR 34225, June 16, 2014), and removed 24 CFR parts 1710, 1715, and 1720, its ILSFDA regulations (79 FR 34225, June 16, 2014). Subsequently, CFPB issued its own regulations for these statutes.3 In the process of updating its regulations, HUD inadvertently retained §§ 30.55 and 30.69, which are now obsolete.

    2 Public Law 111-203, 124 Stat. 1376, approved July 21, 2010.

    3See 12 CFR parts 1007 and 1008 for the SAFE Act, and 12 CFR part 1024 for ILSFDA.

    HUD is now removing §§ 30.30, 30.55, and 30.69 from title 24 of the CFR, as originally intended. The removal of these regulations will streamline HUD's regulations and eliminate confusion regarding the status of these programs.

    II. Justification for Interim Final Rulemaking

    HUD generally publishes rules for advance public comment in accordance with its rule on rulemaking at 24 CFR part 10. However, under 24 CFR 10.1, HUD may omit prior public notice and comment if it is “impracticable, unnecessary, or contrary to the public interest.” In this instance, HUD has determined that it is unnecessary to delay the effectiveness of this rule for advance public comment.

    This interim final rule follows the statutory directive in the 2015 Act requiring a catch-up adjustment to HUD's CMPs by applying the adjustment formula established in the statute and publishing an interim final rule. Accordingly, because calculation of the adjustment is formula-driven, HUD has limited discretion in updating its regulations to reflect the new penalty levels derived from application of the formula. HUD emphasizes that this rule addresses only the matter of the calculation of the maximum civil monetary penalties for the respective violations described in the regulations. This rule does not address the issue of the Secretary's discretion to impose or not to impose a penalty, nor the procedures that HUD must follow in initiating a civil monetary penalty action, or in seeking a civil penalty in a Fair Housing Act case.

    III. Effective Date

    Section 7 of the Department of Housing and Urban Development Act, 42 U.S.C. 3535, paragraph (o), requires that “any regulation implementing any provision of the Department of Housing and Urban Development Reform Act of 1989 that authorizes the imposition of a civil money penalty may not become effective until after the expiration of a public comment period of not less than 60 days.” Therefore, HUD delays the effective date to August 16, 2016, which provides for the required 60 days of public comment and compliance with the 2015 Act's statutory deadline of August 1, 2016. These new penalties apply to violations occurring after August 16, 2016.

    IV. Findings and Certifications Regulatory Review—Executive Orders 12866 and 13563

    Under Executive Order 12866 (Regulatory Planning and Review), a determination must be made whether a regulatory action is significant and therefore, subject to review by the Office of Management and Budget (OMB) in accordance with the requirements of the order. Executive Order 13563 (Improving Regulations and Regulatory Review) directs executive agencies to analyze regulations that are “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.” Executive Order 13563 also directs that, where relevant, feasible, and consistent with regulatory objectives, and to the extent permitted by law, agencies are to identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public. As discussed above in this preamble, this interim final rule revises the civil monetary penalty regulations to make inflation adjustments required by the 2015 Act. It also provides a technical correction to 24 CFR part 28 to harmonize it with its authorizing statute and removes obsolete rules from the Code of Federal Regulations. This interim final rule is consistent with the goals of Executive Order 13563, to reduce regulatory burdens by modifying and removing ineffective or outmoded regulations.

    As a result of this review, OMB determined that this rule was not significant under Executive Order 12866 and Executive Order 13563.

    Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Because HUD has determined that good cause exists to issue this rule without prior public comment, this rule is not subject to the requirement to publish an initial or final regulatory flexibility analysis under the RFA as part of such action.

    Unfunded Mandates Reform

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 4 requires that an agency prepare a budgetary impact statement before promulgating a rule that includes a Federal mandate that may result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. If a budgetary impact statement is required, section 205 of UMRA also requires an agency to identity and consider a reasonable number of regulatory alternatives before promulgating a rule.5 However, the UMRA applies only to rules for which an agency publishes a general notice of proposed rulemaking. As discussed above, HUD has determined, for good cause, that prior notice and public comment is not required on this rule and, therefore, the UMRA does not apply to this interim final rule.

    4 2 U.S.C. 1532.

    5 2 U.S.C. 1534.

    Executive Order 13132, Federalism

    Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on state and local governments and is not required by statute, or the rule preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the Executive Order. This rule will not have federalism implications and would not impose substantial direct compliance costs on state and local governments or preempt state law within the meaning of the Executive Order.

    Environmental Review

    This interim final rule does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern, or regulate, real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction, or establish, revise or provide for standards for construction or construction materials, manufactured housing, or occupancy. Accordingly, under 24 CFR 50.19(c)(1), this final rule is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).

    List of Subjects 24 CFR Part 28

    Administrative practice and procedure, Claims, Fraud, Penalties.

    24 CFR Part 30

    Administrative practice and procedure, Grant programs—housing and community development, Loan programs—housing and community development, Mortgage insurance, Penalties.

    24 CFR Part 87

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

    24 CFR Part 180

    Administrative practice and procedure, Aged, Civil rights, Fair housing, Individuals with disabilities, Investigations, Mortgages, Penalties, Reporting and recordkeeping requirements.

    24 CFR Part 3282

    Administrative practice and procedure, Consumer protection, Intergovernmental relations, Manufactured homes, Reporting and recordkeeping requirements.

    Accordingly, for the reasons described in the preamble, HUD amends 24 CFR parts 28, 30, 87, 180, and 3282 as follows:

    PART 28—IMPLEMENTATION OF THE PROGRAM FRAUD CIVIL REMEDIES ACT OF 1986 1. The authority citation for part 28 is revised to read as follows: Authority:

    28 U.S.C. 2461 note; 31 U.S.C. 3801-3812; 42 U.S.C. 3535(d).

    2. In § 28.10, revise paragraphs (a)(1) introductory text and (b)(1) introductory text and the first sentence in paragraph (c) to read as follows:
    § 28.10 Basis for civil penalties and assessments.

    (a) * * *

    (1) A civil penalty of not more than $10,781 may be imposed upon any person who makes, presents, or submits, or causes to be made, presented, or submitted, a claim that the person knows or has reason to know:

    (b) * * *

    (1) A civil penalty of not more than $10,781 may be imposed upon any person who makes, presents, or submits, or causes to be made, presented, or submitted, a written statement that:

    (c) Limit on liability. If the claim or statement relates to low-income housing benefits or housing benefits for the elderly or handicapped, then a person may be held liable only if he or she has made or caused to be made the claim or statement in the course of applying for such benefits, with respect to his or her eligibility, or family's eligibility, to receive such benefits. * * *

    PART 30—CIVIL MONEY PENALTIES: CERTAIN PROHIBITED CONDUCT 3. The authority citation for part 30 is revised to read as follows: Authority:

    12 U.S.C. 1701q-1, 1703, 1723i, 1735f-14, and 1735f-15; 15 U.S.C. 1717a; 28 U.S.C. 1 note and 2461 note; 42 U.S.C. 1437z-1 and 3535(d).

    4. In § 30.20, revise paragraph (b) to read as follows:
    § 30.20 Ethical violations by HUD employees.

    (b) Maximum penalty. The maximum penalty is $18,936 for each violation.

    5. In § 30.25, revise paragraph (b) to read as follows:
    § 30.25 Violations by applicants for assistance.

    (b) Maximum penalty. The maximum penalty is $18,936 for each violation.

    § 30.30 [Removed]
    6. Remove § 30.30.
    7. In § 30.35, revise the first sentence in paragraph (c)(1) to read as follows:
    § 30.35 Mortgagees and lenders.

    (c)(1) Amount of penalty. The maximum penalty is $9,468 for each violation, up to a limit of $1,893,610 for all violations committed during any one-year period. * * *

    8. In § 30.36, revise the first sentence in paragraph (c) to read as follows:
    § 30.36 Other participants in FHA programs.

    (c) Amount of penalty. The maximum penalty is $9,468 for each violation, up to a limit of $1,893,610 for all violations committed during any one-year period. * * *

    9. In § 30.40, revise the first sentence in paragraph (c) to read as follows:
    § 30.40 Loan guarantees for Indian housing.

    (c) Amount of penalty. The maximum penalty is $9,468 for each violation, up to a limit of $1,893,610 for all violations committed during any one-year period. * * *

    10. In § 30.45, revise paragraph (g) to read as follows:
    § 30.45 Multifamily and section 202 or 811 mortgagors.

    (g) Maximum penalty. The maximum penalty for each violation under paragraphs (c) and (f) of this section is $47,340.

    11. In § 30.50, revise the first sentence in paragraph (c) to read as follows:
    § 30.50 GNMA issuers and custodians.

    (c) Amount of penalty. The maximum penalty is $9,468 for each violation, up to a limit of $1,893,610 during any one-year period. * * *

    § 30.55 [Removed]
    12. Remove § 30.55.
    13. In § 30.60, revise paragraph (c) to read as follows:
    § 30.60 Dealers or sponsored third-party originators.

    (c) Amount of penalty. The maximum penalty is $9,468 for each violation, up to a limit for any particular person of $1,893,610 during any one-year period.

    14. In § 30.65, revise paragraph (b) to read as follows:
    § 30.65 Failure to disclose lead-based paint hazards.

    (b) Amount of penalty. The maximum penalty is $16,773 for each violation.

    15. In § 30.68, revise paragraph (c) to read as follows:
    § 30.68 Section 8 owners.

    (c) Maximum penalty. The maximum penalty for each violation under this section is $36,794.

    § 30.69 [Removed]
    16. Remove § 30.69.
    PART 87—NEW RESTRICTIONS ON LOBBYING 17. The authority citation for part 87 is revised to read as follows: Authority:

    28 U.S.C. 1 note; 31 U.S.C. 1352; 42 U.S.C. 3535(d).

    18. In § 87.400, revise paragraphs (a), (b), and (e) to read as follows:
    § 87.400 Penalties.

    (a) Any person who makes an expenditure prohibited herein shall be subject to a civil penalty of not less than $18,936 and not more than $189,361 for each such expenditure.

    (b) Any person who fails to file or amend the disclosure form (see appendix B) to be filed or amended if required herein, shall be subject to a civil penalty of not less than $18,936 and not more than $189,361 for each such failure.

    (e) First offenders under paragraph (a) or (b) of this section shall be subject to a civil penalty of $18,936, absent aggravating circumstances. Second and subsequent offenses by persons shall be subject to an appropriate civil penalty between $18,936 and $189,361, as determined by the agency head or his or her designee.

    PART 180—CONSOLIDATED HUD HEARING PROCEDURES FOR CIVIL RIGHTS MATTERS 19. The authority citation for part 180 is revised to read as follows: Authority:

    28 U.S.C. 1 note; 29 U.S.C. 794; 42 U.S.C. 2000d-1, 3535(d), 3601-3619, 5301-5320, and 6103.

    20. In § 180.671, revise paragraphs (a)(1) through (3) to read as follows:
    § 180.671 Assessing civil penalties for Fair Housing Act cases.

    (a) * * *

    (1) $19,787, if the respondent has not been adjudged in any administrative hearing or civil action permitted under the Fair Housing Act or any state or local fair housing law, or in any licensing or regulatory proceeding conducted by a federal, state, or local governmental agency, to have committed any prior discriminatory housing practice.

    (2) $49,467, if the respondent has been adjudged in any administrative hearing or civil action permitted under the Fair Housing Act, or under any state or local fair housing law, or in any licensing or regulatory proceeding conducted by a federal, state, or local government agency, to have committed one other discriminatory housing practice and the adjudication was made during the 5-year period preceding the date of filing of the charge.

    (3) $98,935, if the respondent has been adjudged in any administrative hearings or civil actions permitted under the Fair Housing Act, or under any state or local fair housing law, or in any licensing or regulatory proceeding conducted by a federal, state, or local government agency, to have committed two or more discriminatory housing practices and the adjudications were made during the 7-year period preceding the date of filing of the charge.

    PART 3282—MANUFACTURED HOME PROCEDURAL AND ENFORCEMENT REGULATIONS 21. The authority citation for part 3282 is revised to read as follows: Authority:

    28 U.S.C. 1 note; 28 U.S.C. 2461 note; 42 U.S.C. 3535(d) and 5424.

    22. Revise § 3282.10 to read as follows:
    § 3282.10 Civil and criminal penalties.

    Failure to comply with these regulations may subject the party in question to the civil and criminal penalties provided for in section 611 of the Act, 42 U.S.C. 5410. The maximum amount of penalties imposed under section 611 of the Act shall be $2,750 for each violation, up to a maximum of $3,437,500 for any related series of violations occurring within one year from the date of the first violation.

    Dated: May 20, 2016. Helen R. Kanovsky, General Counsel.
    [FR Doc. 2016-14060 Filed 6-14-16; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF JUSTICE 28 CFR Part 104 [Docket No. CIV 151] RIN 1105-AB49 James Zadroga 9/11 Victim Compensation Fund Reauthorization Act AGENCY:

    Department of Justice.

    ACTION:

    Interim final rule.

    SUMMARY:

    On December 18, 2015, President Obama signed into law the James Zadroga 9/11 Victim Compensation Fund Reauthorization Act (the “Reauthorized Zadroga Act”). The Act extends the September 11th Victim Compensation Fund of 2001 which provides compensation to any individual (or a personal representative of a deceased individual) who suffered physical harm or was killed as a result of the terrorist-related aircraft crashes of September 11, 2001, or the rescue and recovery efforts during the immediate aftermath of such crashes or the debris removal efforts that took place in the immediate aftermath of those crashes. Special Master Sheila L. Birnbaum, appointed by the Attorney General to administer the Fund, is issuing this Interim Final Rule to address changes required by the Reauthorized Zadroga Act. Specifically, the statute extends the time period during which eligible claimants may submit claims for compensation until December 18, 2020, increases the Victim Compensation Fund's total funding available to pay claims, creates different categories of claims, directs the Victim Compensation Fund to issue full compensation to eligible claimants and imposes limitations on certain components of future loss calculations.

    DATES:

    Effective date: This rule is effective June 15, 2016. Comment date: Written comments must be submitted on or before July 15, 2016. Comments received by mail will be considered timely if they are postmarked on or before that date. The electronic Federal Docket Management System (FDMS) will accept comments until midnight Eastern Time at the end of that day.

    ADDRESSES:

    Please address all comments regarding this rule by U.S. mail to: Jordana Feldman, September 11th Victim Compensation Fund, Civil Division, U.S. Department of Justice, 290 Broadway, Suite 1300, New York, New York 10007. To ensure proper handling, please reference CIV Docket No. 151 on your correspondence. Comments may also be sent electronically through http://regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the http://regulations.gov Web site. The Civil Division will accept attachments to electronic comments in Microsoft Word, WordPerfect, or Adobe PDF formats only.

    FOR FURTHER INFORMATION CONTACT:

    Catherine V. Emerson, Director, Office of Management Programs, Civil Division, U.S. Department of Justice, Main Building, Room 3140, 950 Pennsylvania Avenue NW., Washington, DC 20530, telephone 855-885-1555 (TTY 855-885-1558).

    SUPPLEMENTARY INFORMATION:

    Public Comments

    The Department is publishing this interim final rule, effective on June 15, 2016, the statutory deadline for updating the existing regulations in light of the statutory changes made by the Reauthorized Zadroga Act.

    The Department is providing a 30-day period for public comment. The regulatory text of this rule is restating all of the provisions of 28 CFR part 104, as revised, for ease of reference and application for the filing of claims. Commenters should be aware, though, that only certain portions of the existing regulations are being revised at this time, and the Department is only soliciting public comments on the changes being made from the existing text of the regulations in 28 CFR part 104. These changes are clearly indicated in a redlined/strikeout version of the regulatory text that is included at www.regulations.gov and is available at www.vcf.gov or by calling 855-885-1555 (TTY 855-885-1558). Accordingly, public comments will be considered only with respect to the revisions made by the interim final rule and not as to provisions of the regulations that were already in effect prior to enactment of the Reauthorized Zadroga Act.

    Posting of Public Comments

    Please note that all comments received are considered part of the public record and made available for public inspection online at http://www.regulations.gov. Information made available for public inspection includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

    If you wish to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not wish it to be posted online, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also locate all the personal identifying information that you do not want posted online in the first paragraph of your comment and identify what information you want the agency to redact. Personal identifying information identified and located as set forth above will be placed in the agency's public docket file, but not posted online.

    If you wish to submit confidential business information as part of your comment but do not wish it to be posted online, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, the agency may choose not to post that comment (or to only partially post that comment) on http://www.regulations.gov. Confidential business information identified and located as set forth above will not be placed in the public docket file, nor will it be posted online.

    If you wish to inspect the agency's public docket file in person by appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.

    Background

    Pursuant to Title IV of Public Law 107-42 (“Air Transportation Safety and System Stabilization Act”) (2001 Act), the September 11th Victim Compensation Fund of 2001 was open for claims from December 21, 2001, through December 22, 2003. The Fund provided compensation to eligible individuals who were physically injured as a result of the terrorist-related aircraft crashes of September 11, 2001, and to personal representatives of those who died as a result of the crashes.

    Special Master Kenneth R. Feinberg was appointed by the Attorney General to administer the Fund. The Fund was governed by Interim Final Regulations issued on December 21, 2001, see 66 FR 66274, and by Final Regulations issued on March 13, 2002, see 67 FR 11233. During its two years of operation, the Fund distributed over $7.049 billion to survivors of 2,880 persons killed in the September 11th attacks and to 2,680 individuals who were injured in the attacks or in the rescue efforts conducted thereafter. In 2004, Special Master Feinberg issued a report describing how the fund was administered. See Final Report of the Special Master for the September 11th Victim Compensation Fund of 2001.

    On January 2, 2011, President Obama signed Public Law 111-347, the James Zadroga 9/11 Health and Compensation Act of 2010 (Zadroga Act) Public Law 114-113, Div. O, Title IV, into law. Title I of the Zadroga Act established a program within the Department of Health and Human Services to provide medical monitoring and treatment benefits to eligible individuals. Title II amended the 2001 Act and reopened the Fund. Among other changes, Title II added new categories of beneficiaries for the Fund and set new filing deadlines. It also imposed a cap on the total awards that can be paid by the Fund and limited the fees that an attorney may receive for awards made under the Fund.

    The Zadroga Act did not appropriate administrative funds for the Fund to begin taking and processing claims. On April 15, 2011, President Obama signed into law Public Law 112-10, the continuing budget resolution for 2011, which permits the Fund to draw on the money originally allocated in the Zadroga Act in order to pay for its administrative expenses, beginning on October 1, 2011.

    The Attorney General appointed Sheila L. Birnbaum to serve as Special Master and to administer the Fund. On June 21, 2011, the Special Master issued the Notice of Proposed Rulemaking, which provided for a 45-day public comment period. On August 26, 2011, after evaluating the comments received, the Special Master signed the Final Rule, and on August 31, 2011, the Final Rule was published in the Federal Register. See 76 FR 54112.

    On December 18, 2015, President Obama signed into law Public Law 114-113, providing for the reauthorization of the Zadroga Act. The Reauthorized Zadroga Act extends the time period during which eligible claimants may submit claims, increases the Victim Compensation Fund's total funding available to pay claims, creates different categories of claims, directs the Victim Compensation Fund to issue full compensation to eligible claimants and instructs the Victim Compensation Fund to implement certain changes to the policies and procedures used to evaluate and process claims.

    This Interim Final Rule addresses those changes mandated by the statute. In accordance with the rulemaking process, this Interim Final Rule is effective on June 15, 2016. Once the rule is published in the Federal Register, there will be a 30-day public comment period. After that period, the Special Master will review and evaluate any comments and will publish a final rule with any clarifications or amendments deemed appropriate.

    A. Summary of Key Statutory Changes

    The Reauthorized Zadroga Act makes several changes to the Zadroga Act, including the following: The statute extends the deadline for filing claims; adds or changes certain eligibility definitions; establishes different categories of claims based on timing of the issuance of a letter setting forth the total amount of compensation to which a claimant is entitled; changes certain policies and procedures for evaluating claims and computing losses; removes a category of losses previously compensable by the Fund; requires that the amount of compensation to which a claimant is entitled not exceed the collateral source compensation that the claimant has received or is entitled to receive; increases the amount of funding available to pay claims and administrative costs and accelerates of the availability of funding; and directs the Fund to perform an annual reassessment of policies and procedures.

    Specifically, the statute:

    • Extends the deadline for filing a claim from the original deadline of October 3, 2016 to the new deadline of December 18, 2020;

    • Codifies the definition of “9/11 crash site” to reflect the definition of the New York City exposure zone provided in the 2011 regulations;

    • Adds new definitions regarding the types of conditions covered by referencing WTC-related health conditions as defined by Section 3312(a) and 3322(b) of the Public Health Service Act (42 U.S.C. 300mm-22 and 300mm-32) and specifically excluding mental health conditions;

    • Establishes two categories of claims—Group A and Group B—based on the date the Special Master “postmarks and transmits” a final award determination to the claimant;

    • Imposes caps on the amount of non-economic loss that can be computed for different types of conditions (categorized as cancer and non-cancer);

    • Imposes a $200,000 cap on the annual gross income, as defined in Section 61 of the Internal Revenue Code, used to determine economic loss;

    • Directs the Victim Compensation Fund to prioritize the compensation of claims that present the most debilitating physical conditions;

    • Eliminates “future medical expense loss” as a compensable economic loss;

    • Eliminates any minimum award to the extent that collateral source offsets exceed the amount of compensation;

    • Makes the original $2,775,000,000 appropriation available immediately to pay claims. Previously, only $875,000,000 of this amount was available through October 3, 2016. It also provides an additional $4,600,000,000 in funding that becomes available in October 2016; and

    • Directs the Special Master to conduct an annual reassessment of policies and procedures.

    B. Revisions to the Rule Conforming to Statutory Changes

    These interim final regulations amend the Department of Justice's August 2011 final regulations in order to reflect changes required by the Reauthorized Zadroga Act. Specifically:

    • Section 104.2 Eligibility definitions and requirements is revised to include the definition of “Group A claims” and “Group B claims.” It also includes the definition of a “WTC-Related Physical Health Condition”, and makes clear that mental health conditions are not covered. This section also reflects the codification of the prior regulations in terms of one of the definitions of the “9/11 crash site”—the definition of the New York City exposure zone.

    • Section 104.41 Amount of compensation is revised to reflect the statutory mandate that no Group B claim shall receive compensation greater than the amount of loss determined less the amount of any collateral source compensation that the claimant has received or is entitled to receive, thus eliminating the $10,000 minimum award that the Fund issued for Group A claims in the event that collateral offsets exceeded losses.

    • Section 104.43 Determination of presumed economic loss for decedents is revised to account for the $200,000 annual gross income cap and the elimination of future medical expenses loss as a compensable loss.

    • Section 104.44 Determination of presumed economic loss for injured claimants is revised to account for the $200,000 annual gross income cap and the elimination of future medical expenses loss as a compensable loss.

    • Section 104.46 Determination of presumed noneconomic losses for injured claimants is revised to reflect the noneconomic loss cap of $250,000 for any single type of cancer and a noneconomic loss cap of $90,000 for any single type of non-cancer condition

    • Section 104.51 Payments to eligible individuals is revised to reflect the amount and timing of availability of funding to pay claims and administrative costs: The $2,755,000,000 previously appropriated over time to be made immediately available and paid as soon as practicable and an additional $4,600,000,000 to be available in October 2016. The section also reflects the directive to the Special Master to prioritize the compensation of claims that present the most debilitating physical conditions. The section further addresses the statutory mandate to conduct an annual reassessment of policies and procedures and make adjustments as necessary to ensure that total expenditures do not exceed available funds.

    • Section 104.62 Time limit on filing claims is revised to reflect the extended statutory deadline for filing claims, from October 3, 2016 to December 18, 2020.

    C. Additional Regulatory Changes To Reduce Burdens for Claimants

    This rule includes four additional regulatory changes, not required by the statute. All of these changes are designed to benefit claimants or reduce claimant burden.

    First, in section 104.3(c)(3), the definition of “spouse” has been expanded. Under the previous definition, the Special Master was required to identify the spouse of the deceased victim as the person who was reported or who legally could have been identified as the spouse on the victim's Federal tax return for the year prior to the year of the victim's death. The previous definition included two exceptions: (1) If the victim was married or divorced in accordance with applicable state law on or after January 1 of the year of the victim's death; or (2) If the victim was not required by law to file a Federal tax return for the year prior to the year of the victim's death. The updated regulations expand this definition to include a third exception: If the victim had a same-sex spouse who was lawfully married to the victim under applicable state law. The 2011 regulations were published when Section 3 of the Defense of Marriage Act was in effect, prohibiting the Federal government from recognizing same-sex marriages. As such, same-sex married couples could not identify themselves as married on their tax returns. Since that time, that section was held to be unconstitutional. These updated regulations reflect the changed law. They also reflect the Fund's policy to treat a same-sex spouse who was legally married to the victim under applicable state law as a spouse for purposes of this program.

    Second, section 104.22(c)(1) has been revised to remove the requirement that all claimants shall, at a minimum, submit all tax returns that were filed for the period beginning three years prior to the year of death or discovery of the injury and ending with the year the claim was filed or the year of death. Over the course of the program, the Special Master has found that this requirement can be burdensome in some cases where the tax returns are not necessary for determination. The Special Master retains the discretion to require the submission of tax returns where necessary for evaluation of the claim. For example, the Special Master may require the submission of tax returns where a claimant is seeking loss of self-employment income or loss of partnership income, or in order to evaluate whether an individual was identified on a deceased victim's Federal tax return for the year prior to the year of the victim's death. Accordingly, the updated regulations allow the Special Master discretion to determine whether and to what extent tax returns should be submitted for a particular claimant.

    Third, section 104.45(e) has been added as a new paragraph to address the determination of noneconomic losses for claimants who have a WTC-Related Physical Condition and who are found eligible for economic loss. The Reauthorized Zadroga Act imposes caps on the amount of noneconomic loss for an eligible cancer ($250,000) and an eligible non-cancer condition ($90,000). The revised regulations clarify that the Special Master shall determine the appropriate noneconomic loss for economic loss claims in the same manner that she determines noneconomic loss only claims, see section 104.46, taking into account the extent of disability and the fact that different eligible conditions may contribute to the disability.

    The regulations further make clear in section 104.46 that the Reauthorized Zadroga Act does not place an aggregate cap on noneconomic loss but merely states that the loss for any type of cancer shall not exceed $250,000 and the loss for any type of non-cancer shall not exceed $90,000. A noneconomic loss may result from both a cancer and non-cancer condition and/or may result from more than one type of cancer. The revised regulations provide that the Special Master has discretion to consider the effect of multiple cancer conditions or multiple cancer and non-cancer conditions in computing the total noneconomic loss in such claims.

    Fourth, section 104.52 has been revised to remove the requirement that, for a claim filed by a Personal Representative on behalf of a deceased victim, the Personal Representative shall submit a plan of distribution for any award received from the Fund before the payment is authorized. Because the Personal Representative has an independent fiduciary obligation to distribute the award in accordance with applicable state law or court order, this documentation may not be needed in every case. Therefore, the revised regulations allow the Special Master discretion to determine whether a distribution plan is required prior to authorizing the payment authorization on a particular claim.

    Regulatory Certifications Administrative Procedure Act

    The Department's implementation of this rule as an interim final rule, with provision for post-promulgation public comment, is based on Sections 553(b)(A), 553(b)(B) and 553(d) of the Administrative Procedure Act. 5 U.S.C. 553. Under Section 553(b), an agency may issue a rule without notice of proposed rulemaking and the pre-promulgation opportunity for public comment where “good cause” exists or for “interpretive rules, general statements of policy, or rules of agency organization, procedure, or practice.”

    The revisions made by this interim final rule fit within the exceptions to the requirement for pre-promulgation opportunity for notice and comment set out in Section 553. See 5 U.S.C. 553(b)(A). All of the revisions identified in Part B above, “Revisions to the Rule Conforming to Statutory Changes” are interpretive rules issued by the Department to advise the public of the Department's construction of the new statute. These revisions to the rule merely explain or clarify the application of the substantive law set forth in the Reauthorized Zadroga Act; they do not create new rights or impose obligations independent of the statute. As noted, the Reauthorized Zadroga Act requires revisions to the implementing regulations including extending the deadline for filing claims, defining different categories of claims (Group A and Group B), changing certain policies and procedures for evaluating claims and computing compensable losses and increasing the funding available to pay claims, among other things. The interim final rule merely incorporates those changes and explains certain provisions in more detail, such as those relating to the filing and evaluation of claims and computation of losses for claims defined as Group B under the statute.

    The four additional changes, described in Part C, “Additional Regulatory Changes to Reduce Burdens for Claimants,” similarly are not subject to formal notice-and-comment requirements. The first change, to section 104.3(c)(3) is interpretive and clarifies the meaning of the term “spouse” consistent with law and pre-existing Department policy. The second and fourth changes, which eliminate certain documentation requirements, see sections 104.22(c)(1) and 104.52, are procedural in nature; they eliminate a required component of the documentation submitted with a claim and instead advise that the Special Master retains the discretion to ask for these documents if needed. Finally, the addition of section 104.45(e) and the revisions of section 104.46 reflect general statements of policy; they serve only to advise the public that the Special Master may exercise her discretionary power in certain ways. For these reasons, the interim final rule is not subject to the formal notice-and-comment requirements under Section 553 of the APA.

    Furthermore, an agency may find good cause to exempt a rule from provisions of the APA if it is determined that those procedures are impracticable, unnecessary, or contrary to the public interest. (5 U.S.C. 553(b)(B)). The Department finds that it is unnecessary and contrary to the public interest to seek public comment prior to promulgating this interim final rule for several reasons. First, delaying the implementation of the rule would delay the determination and payment of appropriate compensation for eligible Group B claims. Compensation determinations and corresponding payments will not be issued until the rule is effective. Thus, eligible claimants, particularly those suffering from terminal illness or extreme financial hardship, would be harmed by any delay. Second, the regulations that the interim final rule modifies were enacted pursuant to notice and comment rulemaking and to a large extent reflect changes recently mandated by statute. As previously discussed, the changes made by this interim final rule that are not mandated by the Reauthorized Zadroga Act reduce certain regulatory burdens on claimants or otherwise benefit the claimant by alleviating unnecessary document submission requirements and asserting the Special Master's discretion to prioritize the compensation of claims based on indicators that demonstrate severity of the claimant's eligible conditions. Third, the interim rule will be subject to public comment before its final implementation. The Department will consider any public comments made following publication of this interim final rule and make any appropriate adjustments or clarifications in the final rule. Finally, the deadline imposed by Congress to implement the regulations is exceedingly strict and therefore the Department has a limited period of time within which to update the regulations.

    The APA also permits an agency to make a rule effective upon date of publication in the Federal Register where “good cause” exists or for “interpretive rules and statements of policy.” 5 U.S.C. 553(d). As stated, the Department has determined that it would be unnecessary and contrary to the public interest to engage in full notice and comment rulemaking before putting these interim final regulations into effect, and that it is in the public interest to promulgate interim final regulations. For the same reasons, the Department has determined that there is good cause to make these interim final regulations effective immediately upon publication in the Federal Register, in accordance with Section 553(d) of the APA (5 U.S.C. 553(d)). Therefore, waiver of the 30-day period prior to the rule's effective date is appropriate here. The Department welcomes public comments on the changes being made by this interim final rule, and will carefully review any comments to ensure that any substantive concerns or issues regarding these changes are addressed in the final rule.

    Paperwork Reduction Act of 1995

    This rule implements Public Law 114-113 which reauthorizes the September 11th Victim Compensation Fund of 2001. In order to be able to evaluate claims and provide compensation, the Fund will need to collect information from an individual (or a personal representatives of a deceased individual) who suffered physical harm or was killed as a result of the terrorist-related aircraft crashes of September 11, 2001 or the debris removal efforts that took place in the immediate aftermath of those crashes. Accordingly, the Department of Justice, Civil Division will submit an information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the emergency review procedures of the Paperwork Reduction Act of 1995. This request will seek reinstatement of the prior information collection authorized under Public Law 111-347. The Department has also published a Notice in the Federal Register soliciting public comment on the information collection associated with this rulemaking. 81 FR 20674 (April 8, 2016).

    Regulatory Flexibility Act

    These regulations set forth procedures by which the Federal government will award compensation benefits to eligible victims of the September 11, 2001 terrorist attacks. Under 5 U.S.C. 601(6), the term “small entity” does not include the Federal government, the party charged with incurring the costs attendant to the implementation and administration of the Victim Compensation Fund. Because this rule is being adopted as an interim final rule, a Regulatory Flexibility analysis is not required. This rule provides compensation to individuals, not to entities.

    Executive Orders 12866 and 13563—Regulatory Review

    This regulation has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review” section 1(b), Principles of Regulation and in accordance with Executive Order 13563 “Improving Regulation and Regulatory Review” section 1(b) General Principles of Regulation. The Department of Justice has determined that this rule is an “economically significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review, and accordingly this rule has been reviewed by the Office of Management and Budget. Further, both Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Department has assessed the costs and benefits of this regulation and believes that the regulatory approach selected maximizes net benefits. As is described more fully in the next paragraph, the economic impact of the rule is a transfer of the funds that are being allocated by the Federal government to any individual (or a personal representative of a deceased individual) who suffered physical harm or was killed as a result of the terrorist-related aircraft crashes of September 11, 2001, or the rescue and recovery efforts during the immediate aftermath of such crashes or the debris removal efforts that took place in the immediate aftermath of those crashes.

    Assessment of Benefits, Costs, and Alternatives

    As required by Executive Order 13563 and Executive Order 12866 for economically significant regulatory actions, the Department has assessed the benefits and costs anticipated from this rulemaking and considered whether there are reasonably feasible alternatives to this rulemaking, including considering whether there are reasonably viable non-regulatory actions that could be taken in lieu of this rulemaking. The purpose of this rulemaking is to provide the legal and administrative framework necessary to provide compensation to any individual (or a personal representative of a deceased individual) who suffered physical harm or was killed as a result of the terrorist-related aircraft crashes of September 11, 2001 or the debris removal efforts that took place in the immediate aftermath of those crashes, as provided by Title II of the Zadroga Act and the Reauthorized Zadroga Act. The primary benefits and costs of this rulemaking are both set by statute as Congress has appropriated a capped amount for this program—an initial $2.775 billion payable under the Zadroga Act and an additional $4.6 billion under the Reauthorized Zadroga Act. Because the $7.375 billion appropriated by Congress for the Fund must pay for claimant awards as well as the Fund's administrative expenses, it is important for the Fund to establish procedures to screen out ineligible or inappropriate claims while keeping administrative expenses as low as possible consistent with the goal of ensuring that funds are not diverted to processing ineligible claims in order to maximize the amount of funds available for claimants. Finally, based on past practice with the operation of the original Fund and the reopened Fund and the necessity to establish the legal and administrative framework for the reauthorized Fund, the Department concludes that there are no viable non-regulatory actions that it could take to implement the Reauthorized Zadroga Act in a fair and efficient manner.

    Time Period for Public Comment

    This interim final rule provides for a 30-day public comment period after publication. The rule is an interpretive rule that merely clarifies or explains the statute or that sets out procedural rules or general statements of policy. Therefore, an extended period of public comment is not necessary. A 30-day comment period will afford the public a meaningful opportunity to comment on the interim final rule.

    Executive Order 13132—Federalism

    This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. However, the Department of Justice has worked cooperatively with state and local officials in the affected communities in the preparation of this rule. Also, the Department individually notified national associations representing elected officials regarding this rulemaking.

    Executive Order 12988—Civil Justice Reform

    This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

    Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

    Small Business Regulatory Enforcement Fairness Act of 1996

    This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign- based companies in domestic and export markets.

    List of Subjects in 28 CFR Part 104

    Disaster assistance, Disability benefits, Terrorism.

    Accordingly, for the reasons set forth in the preamble, chapter I of Title 28 of the Code of Federal Regulations is amended by revising part 104 to read as follows: PART 104—SEPTEMBER 11TH VICTIM COMPENSATION FUND Subpart A—General; Eligibility Sec. 104.1 Purpose. 104.2 Eligibility definitions and requirements. 104.3 Other definitions. 104.4 Personal Representative. 104.5 Foreign claims. 104.6 Amendments to this part. Subpart B—Filing for Compensation 104.21 Presumptively covered conditions. 104.22 Filing for compensation. Subpart C—Claim Intake, Assistance, and Review Procedures 104.31 Procedure for claims evaluation. 104.32 Eligibility review. 104.33 Hearing. 104.34 Publication of awards. 104.35 Claims deemed abandoned by claimants. Subpart D—Amount of Compensation for Eligible Claimants 104.41 Amount of compensation. 104.42 Applicable state law. 104.43 Determination of presumed economic loss for decedents. 104.44 Determination of presumed noneconomic losses for claims on behalf of decedents. 104.45 Determination of presumed economic loss for injured claimants. 104.46 Determination of presumed noneconomic losses for injured claimants. 104.47 Collateral sources. Subpart E—Payment of Claims 104.51 Payments to eligible individuals. 104.52 Distribution of award to decedent's beneficiaries. Subpart F—Limitations 104.61 Limitation on civil actions. 104.62 Time limit on filing claims. 104.63 Subrogation. Subpart G—Measures To Protect the Integrity of the Compensation Program 104.71 Procedures to prevent and detect fraud. Subpart H—Attorney Fees 104.81 Limitation on attorney fees. Authority:

    Title IV of Pub. L. 107-42, 115 Stat. 230, 49 U.S.C. 40101 note; Title II of Pub. L. 111-347, 124 Stat. 3623; Title IV of Pub. L. 114-113, 129 Stat. 2242.

    Subpart A—General; Eligibility
    § 104.1 Purpose.

    This part implements the provisions of the September 11th Victim Compensation Fund of 2001, Title IV of Public Law 107-42, 115 Stat. 230 (Air Transportation Safety and System Stabilization Act), as amended by the James Zadroga 9/11 Health and Compensation Act of 2010, Title II of Public Law 111-347, and as amended by the James Zadroga 9/11 Victim Compensation Fund Reauthorization Act, Division O, Title IV of Public Law 114-113 (the “Act”) to provide full compensation to eligible individuals who were physically injured (as defined herein) as a result of the terrorist-related aircraft crashes of September 11, 2001, or the rescue and recovery efforts during the immediate aftermath of such crashes or debris removal during the immediate aftermath of those crashes, and to the “personal representatives” of those who were killed as a result of the crashes or the rescue and recovery efforts during the immediate aftermath of such crashes or debris removal during the immediate aftermath of such crashes. All compensation provided through the Victim Compensation Fund will be on account of personal physical conditions, physical injuries or death. The provisions of these regulations that relate to filing and evaluation of claims, determination of eligibility, and determination of compensable loss shall apply to all claims that are defined as Group B claims in the Act and in these regulations. Eligibility and compensation for Group A claims has been determined prior to the effective date of these regulations, pursuant to the regulations previously in effect.

    § 104.2 Eligibility definitions and requirements.

    (a) Categories of claims—(1) Group A claims. A claim is a Group A claim if the Special Master has transmitted a final award determination by sending a letter postmarked and transmitted on or before December 17, 2015 indicating the total amount of compensation to which the claimant is entitled for that claim, pursuant to the regulations and methodology in effect on December 17, 2015.

    (2) Group B claims. A claim is a Group B claim if it is not a Group A claim. An individual can have both Group A claims and Group B claims.

    (b) Eligible claimants. The term eligible claimants means:

    (1) Individuals present at a 9/11 crash site at the time of or in the immediate aftermath of the terrorist-related aircraft crashes and who suffered physical harm, as defined herein, as a direct result of the crashes or the rescue and recovery efforts or debris removal;

    (2) The Personal Representatives of deceased individuals aboard American Airlines flights 11 or 77 and United Airlines flights 93 or 175; and

    (3) The Personal Representatives of individuals who were present at a 9/11 crash site at the time of or in the immediate aftermath of the crashes and who died as a direct result of the terrorist-related aircraft crash or the rescue and recovery efforts during the immediate aftermath of such crashes or the debris removal during the immediate aftermath of such crashes.

    (4) The term eligible claimants does not include any individual or representative of an individual who is identified to have been a participant or conspirator in the terrorist-related crashes of September 11.

    (c) Immediate aftermath. The term immediate aftermath means any period beginning with the terrorist-related aircraft crashes of September 11, 2001, and ending on May 30, 2002.

    (d) Physical harm. The term physical harm shall mean:

    (1) A WTC-Related Physical Health Condition; or

    (2) A physical injury to the body resulting from the 9/11 attacks that was treated by a medical professional within a reasonable time from the date of discovering such harm and is verifiable by medical records created by or at the direction of the medical professional who provided the medical care contemporaneously with the care; but

    (3) Not including any Mental Health Condition.

    (e) Mental Health Condition. The term Mental Health Condition shall mean a mental health condition described in paragraph (1)(A)(ii) or (3)(B) of section 3312(a) of the Public Health Service Act (42 U.S.C. 300 mm-22(a)), or any mental health condition certified under section 3312(b)(2)(B)(iii) of such Act (including such certification as applied under section 3322(a) (42 U.S.C. 300mm-32(a) of such Act), or a mental health condition described in section 3322(b)(2) (42 U.S.C. 300mm-32(b)(2)) of such Act, or any other mental health condition.

    (f) Personal Representative. The term Personal Representative shall mean the person determined to be the Personal Representative under § 104.4 of this part.

    (g) WTC Health Program. The term WTC Health Program means the World Trade Center Health Program established by Title I of Public Law 111-347 (codified at Title XXXIII of the Public Health Service Act, 42 U.S.C. 300mm through 300mm-61).

    (h) WTC Program Administrator. The WTC Program Administrator shall mean the WTC Program Administrator as defined in section 3306 of the Public Health Service Act (42 U.S.C. 300mm-5).

    (i) WTC-Related Physical Health Condition. The term WTC-Related Physical Health Condition means a WTC-related health condition listed in Section 3312(a) of the Public Health Service Act (42 U.S.C. 300mm-22(a)), including the conditions listed in section 3322(b) of such Act (42 U.S.C. 300mm-32(b)), and including those health conditions added by the WTC Program Administrator through rulemaking pursuant to the Public Health Service Act, 42 CFR part 88, except that such term shall not include any Mental Health Condition.

    (j) 9/11 crash site. The term 9/11 crash site means:

    (1) The World Trade Center site, Pentagon site, and Shanksville, Pennsylvania site; or

    (2) The buildings or portions of buildings that were destroyed as a result of the terrorist-related airplane crashes of September 11, 2001; or

    (3) The area in Manhattan that is south of the line that runs along Canal Street from the Hudson River to the intersection of Canal Street and East Broadway, north on East Broadway to Clinton Street, and east on Clinton Street to the East River; and

    (4) Any area related to, or along, routes of debris removal, such as barges and Fresh Kills.

    § 104.3 Other definitions.

    (a) Beneficiary. The term beneficiary shall mean a person to whom the Personal Representative shall distribute all or part of the award under § 104.52 of this part.

    (b) Dependents. The Special Master shall identify as dependents those persons so identified by the victim on his or her Federal tax return for the year prior to the year of the victim's death (or those persons who legally could have been identified by the victim on his or her Federal tax return for the year prior to the year of the victim's death) unless:

    (1) The claimant demonstrates that a minor child of the victim was born or adopted on or after January 1 of the year of the victim's death;

    (2) Another person became a dependent in accordance with then- applicable law on or after January 1 of the year of the victim's death; or

    (3) The victim was not required by law to file a Federal income tax return for the year prior to the year of the victim's death.

    (c) Spouse. The Special Master shall identify as the spouse of a victim the person reported as spouse on the victim's Federal tax return for the year prior to the year of the victim's death (or the person who legally could have been identified by the victim on his or her Federal tax return for the year prior to the year of the victim's death) unless:

    (1) The victim was married or divorced in accordance with applicable state law on or after January 1 of the year of the victim's death; or

    (2) The victim was not required by law to file a Federal income tax return for the year prior to the year of the victim's death.

    (3) The Special Master shall identify as the spouse of a victim any same-sex spouse who was lawfully married to the victim under applicable state law.

    (d) The Act. The Act, as used in this part, shall mean Public Law 107-42, 115 Stat. 230 (“Air Transportation Safety and System Stabilization Act”), 49 U.S.C. 40101 note, as amended by the James Zadroga 9/11 Health and Compensation Act of 2010, Title II of Public Law 111-347 and as further amended by the James Zadroga 9/11 Victim Compensation Fund Reauthorization Act, Division O, Title IV of Public Law 114-113.

    (e) Victim. The term victim shall mean an eligible injured claimant or a decedent on whose behalf a claim is brought by an eligible Personal Representative.

    (f) Substantially Complete. A claim becomes substantially complete when, in the opinion of the Special Master or her designee, the claim contains sufficient information and documentation to determine both the claimant's eligibility and, if the claimant is eligible, an appropriate award.

    § 104.4 Personal Representative.

    (a) In general. The Personal Representative shall be:

    (1) An individual appointed by a court of competent jurisdiction as the Personal Representative of the decedent or as the executor or administrator of the decedent's will or estate.

    (2) In the event that no Personal Representative or executor or administrator has been appointed by any court of competent jurisdiction, and such issue is not the subject of pending litigation or other dispute, the Special Master may, in her discretion, determine that the Personal Representative for purposes of compensation by the Fund is the person named by the decedent in the decedent's will as the executor or administrator of the decedent's estate. In the event no will exists, the Special Master may, in her discretion, determine that the Personal Representative for purposes of compensation by the Fund is the first person in the line of succession established by the laws of the decedent's domicile governing intestacy.

    (b) Notice to beneficiaries. (1) Any purported Personal Representative must, before filing an Eligibility Form, provide written notice of the claim (including a designated portion of the Eligibility Form) to the immediate family of the decedent (including, but not limited to, the decedent's spouse, former spouses, children, other dependents, and parents), to the executor, administrator, and beneficiaries of the decedent's will, and to any other persons who may reasonably be expected to assert an interest in an award or to have a cause of action to recover damages relating to the wrongful death of the decedent.

    (2) Personal delivery or transmission by certified mail, return receipt requested, shall be deemed sufficient notice under this provision. The claim forms shall require that the purported Personal Representative certify that such notice (or other notice that the Special Master deems appropriate) has been given. In addition, as provided in § 104.21(b)(5) of this part, the Special Master may publish a list of individuals who have filed Eligibility Forms and the names of the victims for whom compensation is sought, but shall not publish the content of any such form.

    (c) Objections to Personal Representatives. Objections to the authority of an individual to file as the Personal Representative of a decedent may be filed with the Special Master by parties who assert a financial interest in the award up to 30 days following the filing by the Personal Representative. If timely filed, such objections shall be treated as evidence of a “dispute” pursuant to paragraph (d) of this section.

    (d) Disputes as to identity. The Special Master shall not be required to arbitrate, litigate, or otherwise resolve any dispute as to the identity of the Personal Representative. In the event of a dispute over the appropriate Personal Representative, the Special Master may suspend adjudication of the claim or, if sufficient information is provided, calculate the appropriate award and authorize payment, but place in escrow any payment until the dispute is resolved either by agreement of the disputing parties or by a court of competent jurisdiction. Alternatively, the disputing parties may agree in writing to the identity of a Personal Representative to act on their behalf, who may seek and accept payment from the Fund while the disputing parties work to settle their dispute.

    § 104.5 Foreign claims.

    In the case of claims brought by or on behalf of foreign citizens, the Special Master may alter the requirements for documentation set forth herein to the extent such materials are unavailable to such foreign claimants.

    § 104.6 Amendments to this part.

    All claims will be processed in accordance with the current provisions of this part.

    Subpart B—Filing for Compensation
    § 104.21 Presumptively covered conditions.

    (a) In general. The Special Master shall maintain and publish on the Fund's Web site a list of presumptively covered conditions that resulted from the terrorist-related air crashes of September 11, 2001, or rescue and recovery or debris removal efforts during the immediate aftermath of such crashes. The list shall consist of the WTC-Related Physical Health Conditions that resulted from the terrorist-related air crashes of September 11, 2001 or rescue and recovery or debris removal efforts during the immediate aftermath of such crashes. Group B claims shall be eligible for compensation only if the Special Master determines based on the evidence presented that a claimant who seeks compensation for physical harm has at least one WTC-Related Physical Health Condition, with respect to a deceased individual, the cause of such individual's death is determined at least in part to be attributable to a WTC-Related Physical Health Condition.

    (b) Updates. The Special Master shall update the list of presumptively covered conditions to conform to any changes in the WTC-Related Physical Health Conditions. Claims may then be amended pursuant to § 104.22(e)(ii).

    (c) Conditions other than presumptively covered conditions. A claimant may also be eligible for payment under § 104.51 where the claimant has at least one WTC-Related Physical Health Condition and the Special Master determines that the claimant—

    (1) Has a physical injury to the body that resulted from the terrorist-related air crashes of September 11, 2001 or rescue and recovery or debris removal efforts during the immediate aftermath of such crashes or presents extraordinary circumstances; and

    (2) Is otherwise eligible for payment.

    § 104.22 Filing for compensation.

    (a) Compensation form; “filing.” A compensation claim shall be deemed “filed” for purposes of section 405(b)(3) of the Act (providing that the Special Master shall issue a determination regarding the matters that were the subject of the claim not later than 120 calendar days after the date on which a claim is filed), and for any time periods in this part, when it is substantially complete.

    (b) Eligibility Form. The Special Master shall develop an Eligibility Form, which may be a portion of a complete claim form, that will require the claimant to provide information necessary for determining the claimant's eligibility to recover from the Fund.

    (1) The Eligibility Form may require that the claimant certify that he or she has dismissed any pending lawsuit seeking damages as a result of the terrorist-related airplane crashes of September 11, 2001, or for damages arising from or related to debris removal (except for actions seeking collateral source benefits) no later than January 2, 2011 and that there is no pending lawsuit brought by a dependent, spouse, or beneficiary of the victim.

    (2) The Special Master may require as part of the notice requirement pursuant to § 104.4(b) that the Personal Representative of the deceased individual provide copies of a designated portion of the Eligibility Form to the immediate family of the decedent (including, but not limited to, the spouse, former spouses, children, other dependents, and parents), to the executor, administrator, and beneficiaries of the decedent's will, and to any other persons who may reasonably be expected to assert an interest in an award or to have a cause of action to recover damages relating to the wrongful death of the decedent.

    (3) The Eligibility Form may require claimants to provide the following proof:

    (i) Proof of death: Death certificate or similar official documentation;

    (ii) Proof of presence at site: Documentation sufficient to establish presence at a 9/11 crash site, which may include, without limitation, a death certificate, proof of residence, such as a lease or utility bill, records of employment or school attendance, contemporaneous medical records, contemporaneous records of federal, state, city or local government, a pay stub, official personnel roster, site credentials, an affidavit or declaration of the decedent's or injured claimant's employer, or other sworn statement (or unsworn statement complying with 28 U.S.C. 1746) regarding the presence of the victim;

    (iii) Proof of physical harm: Certification of a conclusion by the WTC Health Program that the claimant suffers from a WTC-Related Physical Health Condition and is eligible for treatment under the WTC Health Program, or verification by the WTC Program Administrator that the claimant suffers from a WTC-Related Physical Health Condition, or other credible medical records from a licensed medical professional.

    (iv) Personal Representative: Copies of relevant legal documentation, including court orders; letters testamentary or similar documentation; proof of the purported Personal Representative's relationship to the decedent; copies of wills, trusts, or other testamentary documents; and information regarding other possible beneficiaries as requested by the Eligibility Form;

    (v) Any other information that the Special Master deems necessary to determine the claimant's eligibility.

    (vi) The Special Master may also require waivers, consents, or authorizations from claimants to obtain directly from third parties tax returns, medical information, employment information, or other information that the Special Master deems relevant in determining the claimant's eligibility or award, and may request an opportunity to review originals of documents submitted in connection with the Fund.

    (vii) The Special Master may publish a list of individuals who have filed Eligibility Forms on behalf of a deceased victim and the names of the deceased victims for whom compensation is sought, but shall not publish the content of any such form.

    (c) Personal Injury Compensation Form and Death Compensation Form. The Special Master shall develop a Personal Injury Compensation Form, which may be a portion of a complete claim form, that each injured claimant must submit. The Special Master shall also develop a Death Compensation Form, which may be a portion of a complete claim form, that each Personal Representative must submit. These forms shall require the claimant to provide certain information that the Special Master deems necessary to determining the amount of any award, including information concerning income, collateral sources, benefits, settlements and attorneys' fees relating to civil actions described in section 405(c)(3)(C)(iii) of the Act, and other financial information, and shall require the claimant to state the factual basis for the amount of compensation sought. It shall also allow the claimant to submit certain other information that may be relevant, but not necessary, to the determination of the amount of any award.

    (1) The Special Master may ask claimants to submit certain tax returns or tax transcripts for returns that the Special Master deems appropriate for determination of an award. The Special Master may also require waivers, consents, or authorizations from claimants to obtain directly from third parties medical information, employment information, or other information that the Special Master deems relevant to determining the amount of any award.

    (2) Claimants may attach to the `Personal Injury Compensation Form” or “Death Compensation Form” any additional statements, documents or analyses by physicians, experts, advisors, or any other person or entity that the claimant believes may be relevant to a determination of compensation.

    (d) Submission of a claim. Section 405(c)(3)(C) of the Act provides that upon the submission of a claim under the Fund, the claimant waives the right to file a civil action (or to be a party to an action) in any Federal or State court for damages sustained as a result of the terrorist-related aircraft crashes of September 11, 2001, or debris removal, except for civil actions to recover collateral source obligations and civil actions against any person who is a knowing participant in any conspiracy to hijack any aircraft or commit any terrorist act. A claim shall be deemed submitted for purposes of section 405(c)(3)(C) of the Act when the Eligibility Form is deemed filed, regardless of whether any time limits are stayed or tolled.

    (e) Amendment of claims. A claimant who has previously submitted a claim may amend such claim to include:

    (1) An injury or loss that the claimant had not suffered (or did not reasonably know the claimant suffered) at the time the claimant filed the previous claim;

    (2) A condition that the Special Master has identified and published in accordance with 104.21(a), since the time the claimant filed the previous claim, as a presumptively covered condition;

    (3) An injury for which the claimant was previously compensated by the Fund, but only if that injury has substantially worsened, resulting in damages or loss that was not previously compensated.

    (f) Provisions of information by third parties. Any third party having an interest in a claim brought by a Personal Representative may provide written statements or information regarding the Personal Representative's claim. The Claims Evaluator or the Special Master or the Special Master's designee may, at his or her discretion, include the written statements or information as part of the claim.

    Subpart C—Claim Intake, Assistance, and Review Procedures
    § 104.31 Procedure for claims evaluation.

    (a) Initial review. Claims Evaluators shall review the forms filed by the claimant and either deem the claim “filed” or notify the claimant of any deficiency in the forms or any required documents.

    (b) Procedure. The Claims Evaluator shall determine eligibility and the claimant's presumed award pursuant to §§ 104.43 to 104.46 of this part and notify the claimant in writing of the eligibility determination, or the amount of the presumed award as applicable, and the right to request a hearing before the Special Master or her designee under § 104.33 of this part. After an eligible claimant has been notified of the presumed award, within 30 days the claimant may either accept the presumed compensation determination as the final determination and request payment, or may instead request a review before the Special Master or her designee pursuant to § 104.33. Claimants found to be ineligible may appeal pursuant to § 104.32.

    (c) Multiple claims from the same family. The Special Master may treat claims brought by or on behalf of two or more members of the same immediate family as related or consolidated claims for purposes of determining the amount of any award.

    § 104.32 Eligibility review.

    Any claimant deemed ineligible by the Claims Evaluator may appeal that decision to the Special Master or her designee by filing an eligibility appeal within 30 days on forms created by the office of the Special Master.

    § 104.33 Hearing.

    (a) Conduct of hearings. Hearings shall be before the Special Master or her designee. The objective of hearings shall be to permit the claimant to present information or evidence that the claimant believes is necessary to a full understanding of the claim. The claimant may request that the Special Master or her designee review any evidence relevant to the determination of the award, including without limitation: The nature and extent of the claimant's injury; evidence of the claimant's presence at a 9/11 crash site; factors and variables used in calculating economic loss; the identity of the victim's spouse and dependents; the financial needs of the claimant, facts affecting noneconomic loss; and any factual or legal arguments that the claimant contends should affect the award. Claimants shall be entitled to submit any statements or reports in writing. The Special Master or her designee may require authentication of documents, including medical records and reports, and may request and consider information regarding the financial resources and expenses of the victim's family or other material that the Special Master or her designee deems relevant.

    (b) Location and duration of hearings. The hearings shall, to the extent practicable, be scheduled at times and in locations convenient to the claimant or his or her representative. The hearings shall be limited in length to a time period determined by the Special Master or her designee.

    (c) Witnesses, counsel, and experts. Claimants shall be permitted, but not required, to present witnesses, including expert witnesses. The Special Master or her designee shall be permitted to question witnesses and examine the credentials of experts. The claimant shall be entitled to be represented by an attorney in good standing, but it is not necessary that the claimant be represented by an attorney. All testimony shall be taken under oath.

    (d) Waivers. The Special Master shall have authority and discretion to require any waivers necessary to obtain more individualized information on specific claimants.

    (e) Award Appeals. For award appeals, the Special Master or her designee shall make a determination whether:

    (1) There was an error in determining the presumptive award, either because the claimant's individual criteria were misapplied or for another reason; or

    (2) The claimant presents extraordinary circumstances not adequately addressed by the presumptive award.

    (f) Determination. The Special Master shall notify the claimant in writing of the final amount of the award, but need not create or provide any written record of the deliberations that resulted in that determination. There shall be no further review or appeal of the Special Master's determination. In notifying the claimant of the final amount of the award, the Special Master may designate the portions or percentages of the final award that are attributable to economic loss and non-economic loss, respectively, and may provide such other information as appropriate to provide adequate guidance for a court of competent jurisdiction and a personal representative.

    § 104.34 Publication of awards.

    The Special Master reserves the right to publicize the amounts of some or all of the awards, but shall not publish the name of the claimants or victims that received each award. If published, these decisions would be intended by the Special Master as general guides for potential claimants and should not be viewed as precedent binding on the Special Master or her staff.

    § 104.35 Claims deemed abandoned by claimants.

    The Special Master and her staff will endeavor to evaluate promptly any information submitted by claimants. Nonetheless, it is the responsibility of the claimant to keep the Special Master informed of his or her current address and to respond within the duration of this program to requests for additional information. Claims outstanding because of a claimant's failure to complete his or her filings shall be deemed abandoned.

    Subpart D—Amount of Compensation for Eligible Claimants
    § 104.41 Amount of compensation.

    As provided in section 405(b)(1)(B)(ii) of the Act, in determining the amount of compensation to which a claimant is entitled, the Special Master shall take into consideration the harm to the claimant, the facts of the claim, and the individual circumstances of the claimant. The individual circumstances of the claimant may include the financial needs or financial resources of the claimant or the victim's dependents and beneficiaries. As provided in section 405(b)(6) of the Act, the Special Master shall reduce the amount of compensation by the amount of collateral source compensation the claimant (or, in the case of a Personal Representative, the victim's beneficiaries) has received or is entitled to receive as a result of the terrorist- related aircraft crashes of September 11, 2001. In no event shall a Group B claim receive an amount of compensation that is greater than the amount of loss determined pursuant to these regulations less the amount of any collateral source compensation that the claimant has received or is entitled to receive for such claim as a result of the terrorist related aircraft crashes of September 11, 2001 for the Group B claim.

    § 104.42 Applicable state law.

    The phrase “to the extent recovery for such loss is allowed under applicable state law,” as used in the statute's definition of economic loss in section 402(5) of the Act, is interpreted to mean that the Special Master is not permitted to compensate claimants for those categories or types of economic losses that would not be compensable under the law of the state that would be applicable to any tort claims brought by or on behalf of the victim.

    § 104.43 Determination of presumed economic loss for decedents.

    In reaching presumed determinations for economic loss for Personal Representatives bringing claims on behalf of eligible decedents, the Special Master shall consider sums corresponding to the following:

    (a) Loss of earnings or other benefits related to employment. The Special Master, as part of the process of reaching a “determination” pursuant to section 405(b) of the Act, has developed a methodology and may publish updated schedules, tables, or charts that will permit prospective claimants to estimate determinations of loss of earnings or other benefits related to employment based upon individual circumstances of the deceased victim, including: The age of the decedent as of the date of death; the number of dependents who survive the decedent; whether the decedent is survived by a spouse; and the amount and nature of the decedent's income for recent years. The decedent's salary/income in the three years preceding the year of death (or for other years the Special Master deems relevant) shall be evaluated in a manner that the Special Master deems appropriate. The Special Master may, if she deems appropriate, take an average of income figures for the three years preceding the year of death, and may also consider income for other periods that she deems appropriate, including published pay scales for victims who were government or military employees. In computing any loss of earnings due to physical harm as defined herein the Special Master shall, for each year for which any loss of earnings or other benefits related to employment is computed, limit the annual past or projected future gross income of the decedent to an amount that is not greater than $200,000. For purposes of the computation of loss of earnings, annual gross income shall have the meaning given such term in section 61 of the Internal Revenue Code of 1986. In cases where the victim was a minor child, the Special Master may assume an average income for the child commensurate with the average income of all wage earners in the United States. For victims who were members of the armed services or government employees such as firefighters or police officers, the Special Master may consider all forms of compensation (or pay) to which the victim was entitled. For example, military service members' and uniformed service members' compensation includes all of the various components of compensation, including, but not limited to, basic pay (BPY), basic allowance for housing (BAH), basic allowance for subsistence (BAS), federal income tax advantage (TAD), overtime bonuses, differential pay, and longevity pay.

    (b) Medical expense loss. This loss equals the documented past out-of-pocket medical expenses that were incurred as a result of the eligible physical harm suffered by the decedent (i.e., those medical expenses that were not paid for or reimbursed through health insurance or other programs). This loss shall be calculated on a case-by-case basis, using documentation and other information submitted by the Personal Representative. The Special Master shall not consider any future medical expense loss.

    (c) Replacement services loss. For decedents who did not have any prior earned income, or who worked only part-time outside the home, economic loss may be determined with reference to replacement services and similar measures.

    (d) Loss due to death/burial costs. This loss shall be calculated on a case- by-case basis, using documentation and other information submitted by the personal representative and includes the out-of-pocket burial costs that were incurred.

    (e) Loss of business or employment opportunities. Such losses shall be addressed through the procedure outlined above in paragraph (a) of this section.

    § 104.44 Determination of presumed noneconomic losses for death for claims on behalf of decedents.

    The presumed non-economic losses for an eligible death shall be $250,000 plus an additional $100,000 for the spouse and each dependent of the deceased victim. Such presumed losses include a noneconomic component of replacement services loss.

    § 104.45 Determination of presumed economic loss for injured claimants.

    In reaching presumed determinations for economic loss for claimants who suffered an eligible physical harm (but did not die), the Special Master shall consider sums corresponding to the following:

    (a) Loss of earnings or other benefits related to employment. The Special Master may determine the loss of earnings or other benefits related to employment on a case-by-case basis, using documentation and other information submitted by the claimant, regarding the actual amount of work that the claimant has missed or will miss without compensation. Alternatively, the Special Master may determine the loss of earnings or other benefits related to employment by relying upon the methodology created pursuant to § 104.43(a) and adjusting the loss based upon the extent of the victim's physical harm. In determining or computing any loss of earnings due to eligible physical harm, the Special Master shall, for each year of any past or projected future loss of earnings or other benefits related to employment, limit the annual gross income of the claimant to an amount that is not greater than $200,000. For purposes of the computation of loss of earnings, annual gross income shall have the meaning given such term in section 61 of the Internal Revenue Code of 1986.

    (1) Disability; in general. In evaluating claims of disability, the Special Master will, in general, make a determination regarding whether the claimant is capable of performing his or her usual profession in light of the eligible physical conditions. The Special Master may require that the claimant submit an evaluation of the claimant's disability and ability to perform his or her occupation prepared by medical experts.

    (2) Total permanent disability. With respect to claims of total permanent disability, the Special Master may accept a determination of disability made by the Social Security Administration as evidence of disability without any further medical evidence or review. The Special Master may also consider determinations of permanent total disability made by other governmental agencies or private insurers in evaluating the claim.

    (3) Partial disability. With respect to claims of partial disability, the Special Master may consider evidence of the effect of the partial disability on the claimant's ability to perform his or her usual occupation as well as the effect of the partial disability on the claimant's ability to participate in usual daily activities.

    (b) Medical Expense Loss. This loss equals the documented past out-of-pocket medical expenses that were incurred as a result of the physical harm suffered by the victim (i.e., those medical expenses that were not paid for or reimbursed through health insurance or other programs). The Special Master shall not consider any future medical expense loss.

    (c) Replacement Services. For claimants who suffer physical harm and did not have any prior earned income or who worked only part time outside the home, economic loss may be determined with reference to replacement services and similar measures.

    (d) Loss of business or employment opportunities. Such losses shall be addressed through the procedure outlined above in paragraph (a) of this section.

    (e) Determination of Noneconomic Loss for Claimants Who Have a WTC-Related Physical Condition and Who Are Found Eligible for Economic Loss. The Special Master shall determine the appropriate noneconomic loss for such claimants in accordance with the provisions of § 104.46, taking into account the extent of disability, and may consider whether the claimant has multiple WTC-Related Physical Health Conditions that contribute to the disability.

    § 104.46 Determination of presumed noneconomic losses for injured claimants

    The Special Master may determine the presumed noneconomic losses for claimants who suffered physical harm (but did not die) by relying upon the noneconomic losses described in § 104.44 and adjusting the losses based upon the extent of the victim's physical harm. The presumed noneconomic loss for a claim based on any single type of cancer shall not exceed $250,000 and the presumed noneconomic loss for a claim based on any single type of non-cancer condition shall not exceed $90,000. Such presumed losses include any noneconomic component of replacement services loss. The Special Master has discretion to consider the effect of multiple cancer conditions or multiple cancer and non-cancer conditions in computing the total noneconomic loss.

    § 104.47 Collateral sources.

    (a) Payments that constitute collateral source compensation. The amount of compensation shall be reduced by all collateral source compensation the claimant has received or is entitled to receive as a result of the terrorist-related aircraft crashes of September 11, 2001, or debris removal in the immediate aftermath, including life insurance, pension funds, death benefits programs, payments by Federal, State, or local governments related to the terrorist- related aircraft crashes of September 11, 2001, or debris removal and payments made pursuant to the settlement of a civil action as described in section 405(c)(3)(C)(iii) of the Act. In determining the appropriate collateral source offset for future benefit payments, the Special Master may employ an appropriate methodology for determining the present value of such future benefits. In determining the appropriate value of offsets for pension funds, life insurance and similar collateral sources, the Special Master may, as appropriate, reduce the amount of offsets to take account of self- contributions made or premiums paid by the victim during his or her lifetime. In determining the appropriate collateral source offset for future benefit payments that are contingent upon one or more future event(s), the Special Master may reduce such offsets to account for the possibility that the future contingencies may or may not occur. In cases where the recipients of collateral source compensation are not beneficiaries of the awards from the Fund, the Special Master shall have discretion to exclude such compensation from the collateral source offset where necessary to prevent beneficiaries from having their awards reduced by collateral source compensation that they will not receive.

    (b) Payments that do not constitute collateral source compensation. The following payments received by claimants do not constitute collateral source compensation:

    (1) The value of services or in-kind charitable gifts such as provision of emergency housing, food, or clothing; and

    (2) Charitable donations distributed to the beneficiaries of the decedent, to the injured claimant, or to the beneficiaries of the injured claimant by privately funded charitable entities; provided however, that the Special Master may determine that funds provided to victims or their families through a privately funded charitable entity constitute, in substance, a payment described in paragraph (a) of this section.

    (3) Tax benefits received from the Federal government as a result of the enactment of the Victims of Terrorism Tax Relief Act.

    Subpart E—Payment of Claims
    § 104.51 Payments to eligible individuals.

    (a) Payment date. Subject to paragraph (c) of this section, the Special Master shall authorize payment of an award to a claimant not later than 20 days after the date on which:

    (1) The claimant accepts the presumed award; or

    (2) A final award for the claimant is determined after a hearing on appeal.

    (b) Failure to accept or appeal presumed award. If a claimant fails to accept or appeal the presumed award determined for that claimant within 30 days, the presumed award shall be deemed to have been accepted and all rights to appeal the award shall have been waived.

    (c) Payment of Group A claims. Group A claims shall be paid as soon as practicable from the capped amount appropriated for such claims of $2,775,000,000.

    (d) Payment of Group B claims. Group B claims may be paid after the date on which new Group B claims may be filed under these regulations from the amount appropriated for Group A claims if and to the extent that there are funds remaining after all Group A claims have been paid and, thereafter, from the $4,600,000,000 amount appropriated specifically for Group B claims once it becomes available in fiscal year 2017 until expended.

    (e) Prioritization. The Special Master shall identify claims that present the most debilitating physical conditions and shall prioritize the compensation of such claims so that claimants with such debilitating conditions are not unduly burdened.

    (f) Reassessment. Commencing on December 18, 2017, and continuing at least annually thereafter until the closure of the Victim Compensation Fund, the Special Master shall review and reassess policies and procedures and make such adjustments as may be necessary to ensure that the total expenditures including administrative costs in providing compensation for claims in Group B do not exceed the funds deposited into the Victim Compensation Fund and to ensure that the compensation of those claimants who suffer from the most debilitating physical conditions is prioritized to avoid undue burden on such claimants.

    § 104.52 Distribution of award to decedent's beneficiaries.

    The Personal Representative shall distribute the award in a manner consistent with the law of the decedent's domicile or any applicable rulings made by a court of competent jurisdiction. The Special Master may require the Personal Representative to provide to the Special Master a plan for distribution of any award received from the Fund before payment is authorized. Notwithstanding any other provision of these regulations or any other provision of state law, in the event that the Special Master concludes that the Personal Representative's plan for distribution does not appropriately compensate the victim's spouse, children, or other relatives, the Special Master may direct the Personal Representative to distribute all or part of the award to such spouse, children, or other relatives.

    Subpart F—Limitations
    § 104.61 Limitation on civil actions.

    (a) General. Section 405(c)(3)(C) of the Act provides that upon the submission of a claim under the Fund, the claimant waives the right to file a civil action (or be a party to an action) in any Federal or State court for damages sustained as a result of the terrorist-related aircraft crashes of September 11, 2001, or for damages arising from or related to debris removal, except that this limitation does not apply to recover collateral source obligations, or to a civil action against any person who is a knowing participant in any conspiracy to hijack any aircraft or commit any terrorist act. The Special Master shall take appropriate steps to inform potential claimants of section 405(c)(3)(C) of the Act.

    (b) Pending actions. Claimants who have filed a civil action or who are a party to such an action as described in paragraph (a) of this section may not file a claim with the Special Master unless they withdraw from such action not later than January 2, 2012.

    (c) Settled actions. In the case of an individual who settled a civil action described in Section 405(c)(3)(C) of the Act, such individual may not submit a claim under this title unless such action was commenced after December 22, 2003, and a release of all claims in such action was tendered prior to January 2, 2011.

    § 104.62 Time limit on filing claims.

    (a) In general. Group B claims. Group B claims that were not submitted to the Victim Compensation Fund on or before December 17, 2015 may be filed by an individual (or by a personal representative on behalf of a deceased individual) during the period beginning on June 15, 2016, and ending on December 18, 2020. Notwithstanding the above, an individual who intends to file a Group B claim must register with the Victim Compensation Fund in accordance with the following:

    (1) In the case that the individual knew (or reasonably should have known) before October 3, 2011, that the individual suffered a physical harm or died as a result of the terrorist-related aircraft crashes of September 11, 2001, or as a result of debris removal, and is eligible to file a claim under this part as of October 3, 2011, the individual or representative of such individual as appropriate may file a claim not later than October 3, 2013.

    (2) In the case that the individual first knew (or reasonably should have known) on or after October 3, 2011, that the individual suffered a physical harm or died or in the case that the individual became eligible to file a claim under this part on or after that date, the individual or representative of such individual as appropriate may file a claim not later than the last day of the 2-year period beginning on the date that the individual or representative first knew (or should have known) that the individual both suffered from such harm and was eligible to file a claim under this title, but in no event beyond December 18, 2020.

    (b) Determination by Special Master. The Special Master or the Special Master's designee should determine the timeliness of all claims under paragraph of this section.

    § 104.63 Subrogation.

    Compensation under this Fund does not constitute the recovery of tort damages against a third party nor the settlement of a third party action, and the United States shall be subrogated to all potential claims against third party tortfeasors of any victim receiving compensation from the Fund. For that reason, no person or entity having paid other benefits or compensation to or on behalf of a victim shall have any right of recovery, whether through subrogation or otherwise, against the compensation paid by the Fund.

    Subpart G—Measures To Protect the Integrity of the Compensation Program
    § 104.71 Procedures to prevent and detect fraud.

    (a) Review of claims. For the purpose of detecting and preventing the payment of fraudulent claims and for the purpose of assuring accurate and appropriate payments to eligible claimants, the Special Master shall implement procedures to:

    (1) Verify, authenticate, and audit claims;

    (2) Analyze claim submissions to detect inconsistencies, irregularities, duplication, and multiple claimants; and

    (3) Ensure the quality control of claims review procedures.

    (b) Quality control. The Special Master shall institute periodic quality control audits designed to evaluate the accuracy of submissions and the accuracy of payments, subject to the oversight of the Inspector General of the Department of Justice.

    (c) False or fraudulent claims. The Special Master shall refer all evidence of false or fraudulent claims to appropriate law enforcement authorities.

    Subpart H—Attorney Fees
    § 104.81 Limitation on attorney fees.

    (a) In general—(1) In general. Notwithstanding any contract, the representative of an individual may not charge, for services rendered in connection with the claim of an individual under this title, including expenses routinely incurred in the course of providing legal services, more than 10 percent of an award paid under this title on such claim. Expenses incurred in connection with the claim of an individual in this title other than those that are routinely incurred in the course of providing legal services may be charged to a claimant only if they have been approved by the Special Master.

    (2) Certification. In the case of any claim in connection with which services covered by this section were rendered, the representative shall certify his or her compliance with this section and shall provide such information as the Special Master requires to ensure such compliance.

    (b) Limitation—(1) In general. Except as provided in paragraph (b)(2) of this section, in the case of an individual who was charged a legal fee in connection with the settlement of a civil action described in section 405(c)(3)(C)(iii) of the Act, the representative who charged such legal fee may not charge any amount for compensation for services rendered in connection with a claim filed by or on behalf of that individual under this title.

    (2) Exception. If the legal fee charged in connection with the settlement of a civil action described in section 405(c)(3)(C)(iii) of the Act of an individual is less than 10 percent of the aggregate amount of compensation awarded to such individual through such settlement, the representative who charged such legal fee to that individual may charge an amount for compensation for services rendered to the extent that such amount charged is not more than Ten (10) percent of such aggregate amount through the settlement, minus the total amount of all legal fees charged for services rendered in connection with such settlement.

    (c) Discretion to lower fee. In the event that the Special Master finds that the fee limit set by paragraph (a) or (b) of this section provides excessive compensation for services rendered in connection with such claim, the Special Master may, in the discretion of the Special Master, award as reasonable compensation for services rendered an amount lesser than that permitted for in paragraph (a) of this section.

    Dated: June 13, 2016. Sheila L. Birnbaum, Special Master.
    [FR Doc. 2016-14259 Filed 6-13-16; 4:15 pm] BILLING CODE 4410-12-P
    PENSION BENEFIT GUARANTY CORPORATION 29 CFR Parts 4022 and 4044 Allocation of Assets in Single-Employer Plans; Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Valuing and Paying Benefits AGENCY:

    Pension Benefit Guaranty Corporation.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule amends the Pension Benefit Guaranty Corporation's regulations on Benefits Payable in Terminated Single-Employer Plans and Allocation of Assets in Single-Employer Plans to prescribe interest assumptions under the benefit payments regulation for valuation dates in July 2016 and interest assumptions under the asset allocation regulation for valuation dates in the third quarter of 2016. The interest assumptions are used for valuing and paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC.

    DATES:

    Effective July 1, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Deborah C. Murphy ([email protected]), Deputy Assistant General Counsel for Regulatory Affairs, Pension Benefit Guaranty Corporation, 1200 K Street NW., Washington, DC 20005, 202-326-4024. (TTY/TDD users may call the Federal relay service toll free at 1-800-877-8339 and ask to be connected to 202-326-4024.)

    SUPPLEMENTARY INFORMATION:

    PBGC's regulations on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) and Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribe actuarial assumptions—including interest assumptions — for valuing and paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulations are also published on PBGC's Web site (http://www.pbgc.gov).

    The interest assumptions in Appendix B to Part 4044 are used to value benefits for allocation purposes under ERISA section 4044. PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.

    The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the asset allocation regulation are updated quarterly; assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for July 2016 and updates the asset allocation interest assumptions for the third quarter (July through September) of 2016.

    The third quarter 2016 interest assumptions under the allocation regulation will be 2.50 percent for the first 20 years following the valuation date and 2.85 percent thereafter. In comparison with the interest assumptions in effect for the second quarter of 2016, these interest assumptions represent no change in the select period (the period during which the select rate (the initial rate) applies), a decrease of 0.27 percent in the select rate, and a decrease of 0.01 percent in the ultimate rate (the final rate).

    The July 2016 interest assumptions under the benefit payments regulation will be 0.75 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for June 2016, these interest assumptions are unchanged.

    PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

    Because of the need to provide immediate guidance for the valuation and payment of benefits under plans with valuation dates during July 2016, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

    PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

    Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

    List of Subjects 29 CFR Part 4022

    Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements.

    29 CFR Part 4044

    Employee benefit plans, Pension insurance, Pensions.

    In consideration of the foregoing, 29 CFR parts 4022 and 4044 are amended as follows:

    PART 4022—BENEFITS PAYABLE IN TERMINATED SINGLE-EMPLOYER PLANS 1. The authority citation for part 4022 continues to read as follows: Authority:

    29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344.

    2. In appendix B to part 4022, Rate Set 273, as set forth below, is added to the table. Appendix B to Part 4022—Lump Sum Interest Rates for PBGC Payments Rate set For plans with a valuation date On or after Before Immediate annuity rate
  • (percent)
  • Deferred annuities
  • (percent)
  • i 1 i 2 i 3 n 1 n 2
    *         *         *         *         *         *         * 273 7-1-16 8-1-16 0.75 4.00 4.00 4.00 7 8
    3. In appendix C to part 4022, Rate Set 273, as set forth below, is added to the table. Appendix C to Part 4022—Lump Sum Interest Rates for Private-Sector Payments Rate set For plans with a valuation date On or after Before Immediate annuity rate
  • (percent)
  • Deferred annuities
  • (percent)
  • i 1 i 2 i 3 n 1 n 2
    *         *         *         *         *         *         * 273 7-1-16 8-1-16 0.75 4.00 4.00 4.00 7 8
    PART 4044—ALLOCATION OF ASSETS IN SINGLE-EMPLOYER PLANS 4. The authority citation for part 4044 continues to read as follows: Authority:

    29 U.S.C. 1301(a), 1302(b)(3), 1341, 1344, 1362.

    5. In appendix B to part 4044, a new entry for July-September 2016, as set forth below, is added to the table. Appendix B to Part 4044—Interest Rates Used To Value Benefits For valuation dates occurring in the month— The values of i t are: i t for t = i t for t = i t for t = *         *         *         *         *         *         * July-September 2016 0.0250 1-20 0.0285 >20 N/A N/A
    Issued in Washington, DC, on this 9th day of June 2016. Judith Starr, General Counsel, Pension Benefit Guaranty Corporation.
    [FR Doc. 2016-14076 Filed 6-14-16; 8:45 am] BILLING CODE 7709-02-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2016-OS-0063] 32 CFR Part 311 Privacy Act of 1974; Implementation AGENCY:

    Office of the Secretary, DoD.

    ACTION:

    Direct final rule.

    SUMMARY:

    The Office of the Secretary of Defense is exempting those records contained in DMDC 24 DoD, entitled “Defense Information System for Security (DISS),” when investigatory material is compiled solely for the purpose of determining suitability, eligibility, or qualifications for Federal civilian employment, military service, Federal contracts, or access to classified information, but only to the extent that such material would reveal the identity of a confidential source.

    This direct final rule establishes a new exemption to the Office of the Secretary Privacy Program. The Defense Information System for Security is the new DoD enterprise-wide information system for personnel security; it provides a common, comprehensive medium to request, record, document, and identify personnel security actions within the Department including: Determinations of eligibility and access to classified information, national security, suitability and/or fitness for employment, and HSPD-12 determination for Personal Identity Verification (PIV) to access government facilities and systems, submitting adverse information, verification of investigation and or adjudicative status, support of continuous evaluation and insider threat detection, prevention, and mitigation activities. DISS consists of two applications, the Case Adjudication Tracking system (CATS) and the Joint Verification System (JVS). CATS is used by the DoD Adjudicative Community for the purpose of recording eligibility determinations. JVS is used by DoD Security Managers and Industry Facility Security Officers for the purpose of verifying eligibility, recording access determinations, submitting incidents for subsequent adjudication, and visit requests from the field (worldwide). The records may also be used as a management tool for statistical analyses, tracking, reporting, evaluating program effectiveness, and conducting research. This direct final rule is consistent with the rule currently published regarding DMDC 11, Investigative Records Repository.

    DATES:

    The rule is effective on September 13, 2016 unless adverse comments are received by August 15, 2016. If adverse comment is received, the Department of Defense will publish a timely withdrawal of the rule in the Federal Register.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

    Federal Rulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name and docket number for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    Mrs. Luz D. Ortiz, 571-372-0478.

    SUPPLEMENTARY INFORMATION:

    This rule is being published as a direct final rule as the Department of Defense does not expect to receive any adverse comments, and so a proposed rule is unnecessary.

    Direct Final Rule and Significant Adverse Comments

    DoD has determined this rulemaking meets the criteria for a direct final rule because it involves non-substantive changes dealing with DoD's management of its Privacy Programs. DoD expects no opposition to the changes and no significant adverse comments. However, if DoD receives a significant adverse comment, the Department will withdraw this direct final rule by publishing a notice in the Federal Register. A significant adverse comment is one that explains: (1) Why the direct final rule is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the direct final rule will be ineffective or unacceptable without a change. In determining whether a comment necessitates withdrawal of this direct final rule, DoD will consider whether it warrants a substantive response in a notice and comment process.

    Executive Order 12866, “Regulatory Planning and Review” and Executive Order 13563, “Improving Regulation and Regulatory Review”

    It has been determined that Privacy Act rules for the Department of Defense are not significant rules. The rules do not (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 these Executive orders.

    Public Law 96-354, “Regulatory Flexibility Act” (5 U.S.C. Chapter 6)

    It has been determined that this Privacy Act rule for the Department of Defense does not have significant economic impact on a substantial number of small entities because it is concerned only with the administration of Privacy Act systems of records within the Department of Defense. A Regulatory Flexibility Analysis is not required.

    Public Law 95-511, “Paperwork Reduction Act” (44 U.S.C. Chapter 35)

    It has been determined that this Privacy Act rule for the Department of Defense imposes no additional information requirements beyond the Department of Defense and that the information collected within the Department of Defense is necessary and consistent with 5 U.S.C. 552a, known as the Privacy Act of 1074.

    Section 202, Public Law 104-4, “Unfunded Mandates Reform Act”

    It has been determined that this Privacy Act rule for the Department of Defense does not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that this rulemaking will not significantly or uniquely affect small governments.

    Executive Order 13132, “Federalism”

    It has been determined that this Privacy Act rule for the Department of Defense does not have federalism implications. This rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, no Federalism assessment is required.

    List of Subjects in 32 CFR Part 311

    Privacy.

    Accordingly, 32 CFR part 311 is amended as follows:

    PART 311—OFFICE OF THE SECRETARY OF DEFENSE AND JOINT STAFF PRIVACY PROGRAM 1. The authority citation for 32 CFR part 311 continues to read as follows: Authority:

    5 U.S.C. 552a.

    2. Section 311.8 is amended by adding paragraph (c)(27) to read as follows:
    § 311.8 Procedures for exemptions.

    (c) * * *

    (27) System identifier and name: DMDC 24 DoD, Defense Information System for Security (DISS).

    (i) Exemption: Investigatory material compiled solely for the purpose of determining suitability, eligibility, or qualifications for Federal civilian employment, military service, Federal contracts, or access to classified information may be exempt pursuant to 5 U.S.C. 552a(k)(5), but only to the extent that such material would reveal the identity of a confidential source.

    (ii) Authority: 5 U.S.C. 552a(k)(5).

    (iii) Reasons: (A) from subsections (c)(3) and (d) when access to accounting disclosure and access to or amendment of records would cause the identity of a confidential source to be revealed. Disclosure of the source's identity not only will result in the Department breaching the promise of confidentiality made to the source but it will impair the Department's future ability to compile investigatory material for the purpose of determining suitability, eligibility, or qualifications for Federal civilian employment, Federal contracts, or access to classified information. Unless sources can be assured that a promise of confidentiality will be honored, they will be less likely to provide information considered essential to the Department in making the required determinations.

    (B) From subsection (e)(1) because in the collection of information for investigatory purposes, it is not always possible to determine the relevance and necessity of particular information in the early stages of the investigation. It is only after the information is evaluated in light of other information that its relevance and necessity becomes clear. Such information permits more informed decision-making by the Department when making required suitability, eligibility, and qualification determinations.

    Dated: May 24, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-14183 Filed 6-14-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket No. USCG-2016-0358] Special Local Regulation; Annual Kennewick, Washington, Columbia Unlimited Hydroplane Races AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of enforcement of regulation.

    SUMMARY:

    The Coast Guard will enforce the special local regulation for the Annual Kennewick, Washington, Columbia Unlimited Hydroplane Races from 7 a.m. to 5:30 p.m. each day, from July 29, 2016, through July 31, 2016. This enforcement action is necessary to assist in minimizing the inherent dangers associated with hydroplane races. Our regulation for Recurring Marine Events in Captain of the Port Sector Columbia River Zone identifies the regulated area for this regatta. During the enforcement period, no vessel may transit this regulated area without approval from the Captain of the Port or a designated representative.

    DATES:

    The regulation in 33 CFR 100.1303 will be enforced from 7 a.m. until 5:30 p.m. on July 29, 2016 through July 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this notice of enforcement, call or email Mr. Ken Lawrenson, Waterways Management Division, MSU Portland, Oregon, Coast Guard; telephone 503-240-9319, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Coast Guard will enforce special local regulations in 33 CFR 100.1303 from 7 a.m. until 5:30 p.m. on July 29, 2016, through July 31, 2016, for the Annual Kennewick, Washington, Columbia Unlimited Hydroplane Races. This enforcement action is being taken to provide for the safety of life on navigable waterways during the regatta. Our regulation for Annual Kennewick, Washington, Columbia Unlimited Hydroplane, § 100.1303, specifies the location of the regulated area for all waters of the Columbia river bounded by two lines drawn from between position latitude 46°14′07″ N., longitude 119°10′42″ W. and position latitude 46°13′42″ N., longitude 119°10′51″ W.; and the second line running between position latitude 46°13′35″ N., longitude 119°07′34″ W. and position latitude 46°13′10″ N., longitude 119°07′47″ W. As specified in § 100.1303, during the enforcement period, no vessel may transit this regulated area without approval from the Captain of the Port Sector Columbia River (COTP) or a COTP designated representative.

    This notice of enforcement is issued under authority of 33 CFR 100.1303 and 5 U.S.C. 552(a). In addition to this notice of enforcement in the Federal Register, the Coast Guard plans to provide notification of this enforcement period via the Local Notice to Mariners and marine information broadcasts.

    Dated: June 7, 2016. D.F. Berliner, Captain, U.S. Coast Guard, Alternate Captain of the Port, Sector Columbia River.
    [FR Doc. 2016-14067 Filed 6-14-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0497] Drawbridge Operation Regulation; Mullica River, Green Bank, NJ 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 Green Bank Bridge (Green Bank Road/CR563) across the Mullica River, mile 18.0, at Green Bank, NJ. The deviation is necessary to perform bridge repairs. This deviation allows the bridge to remain in the closed-to-navigation position.

    DATES:

    This deviation is effective from 7:30 a.m. on June 20, 2016, through 3:30 p.m. on June 23, 2016.

    ADDRESSES:

    The docket for this deviation, [USCG-2016-0497] is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Mr. Hal R. Pitts, Bridge Administration Branch Fifth District, Coast Guard, telephone 757-398-6222, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Atlantic County, NJ, that owns and operates the Green Bank Bridge (Green Bank Road/CR563), has requested a temporary deviation from the current operating regulations to perform urgent repairs to the bridge operating machinery. The bridge is a bascule draw bridge and has a vertical clearance in the closed position of 5 feet above mean high water.

    The current operating schedule is set out in 33 CFR 117.731(b). Under this temporary deviation, the bridge will remain in the closed-to-navigation position from 7:30 a.m. on June 20, 2016, through 3:30 p.m. on June 23, 2016. At all other times the bridge will operate per 33 CFR 117.731(b).

    The Mullica River is used by a variety of vessels including small U.S. government vessels, small commercial vessels, and recreational vessels. The Coast Guard has carefully considered the nature and volume of vessel traffic on the waterway in publishing this temporary deviation.

    Vessels able to pass through the bridge in the closed position may do so. 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 also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transit 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: June 9, 2016. Hal R. Pitts, Bridge Program Manager, Fifth Coast Guard District.
    [FR Doc. 2016-14064 Filed 6-14-16; 8:45 am] BILLING CODE 9110-04-P
    POSTAL REGULATORY COMMISSION 39 CFR Part 3020 [Docket No. RM2016-8; Order No. 3360] Mail Classification Schedule AGENCY:

    Postal Regulatory Commission.

    ACTION:

    Final rule.

    SUMMARY:

    The Commission is issuing a set of final rules amending existing rules related to the Mail Classification Schedule and its associated product lists. The final rules revise some existing rules in order to better conform with current Commission practices related to the Mail Classification Schedule. Relative to the proposed rules, one change was made for clarification purposes. No other proposed rules were changed.

    DATES:

    Effective July 15, 2016.

    FOR FURTHER INFORMATION CONTACT:

    David A. Trissell, General Counsel, at 202-789-6820.

    SUPPLEMENTARY INFORMATION: Regulatory History

    81 FR 21506, April 12, 2016

    Table of Contents I. Introduction II. Comments and Discussion III. Ordering Paragraphs I. Introduction

    On April 6, 2016, the Postal Regulatory Commission (Commission) issued a Notice of Proposed Rulemaking Concerning Product Lists and the Mail Classification Schedule, April 6, 2016.1 The Commission proposed rules to fulfill its responsibilities under the Postal Accountability and Enhancement Act (PAEA), Public Law 109-435, 120 Stat. 3198 (2006). The rulemaking proposes to replace existing 39 CFR part 3020, subpart A in its entirety, and make conforming changes to 39 CFR part 3020, subparts B, C, and D.

    1 Notice of Proposed Rulemaking Concerning Product Lists and the Mail Classification Schedule, April 6, 2016 (Order No. 3213); see also 81 FR 21506 (April 12, 2016).

    The rulemaking proposes to amend existing rules concerning the Mail Classification Schedule (MCS) and the associated market dominant and competitive product lists 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 Public Representative and the Postal Service filed comments in response to Order No. 3213.2 The commenters were generally supportive of the proposed rules. The commenters also included suggestions for improvements and sought minor clarification on various aspects of the proposed rules.

    2 Public Representative Comments on Proposed Rulemaking Concerning Product Lists and the Mail Classification Schedule, May 12, 2016 (PR Comments); United Stated Postal Service Comments on Proposed Rules Concerning Product Lists and the Mail Classification Schedule, May 12, 2016 (Postal Service Comments).

    The Commission adopts the proposed rules as final rules with one minor clarification added to proposed § 3020.5(a).

    II. Comments and Discussion A. Public Representative Comments

    The Public Representative generally supports adoption of the proposed rules and presents several suggestions for improvement.

    The Public Representative states it appears that the Commission's intent is to publish updates to the product lists in the CFR on a quarterly basis. PR Comments at 2. He bases this assumption on the following:

    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.

    Order No. 3213 at 7. Regardless, he notes that proposed § 3020.3(b) does not expressly state that updates will occur on a quarterly basis. He suggests the addition of the word “quarterly” to the proposed rule such that it reads: “Notice shall be submitted `quarterly' to the Federal Register for publication within 6 months of the issue date of the applicable final order that affects the change.” PR Comments at 2.

    The Commission intends to publish updates to the product lists appearing in the CFR on a quarterly basis. A further goal is to publish updates within one week of the close of each fiscal quarter. However, the Commission chooses not to make quarterly publication a rigid requirement, as would be the case if the word “quarterly” was added to the rule. Experience has shown that the press of more important business occasionally takes precedence over producing the quarterly updates. Although the quarterly updates are an important recordkeeping function that provides visibility into current Postal Service product offerings, publication does not directly affect the substantive rights of any interested persons and may be delayed when necessary.3

    3 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. Order No. 3213 at 7. The quarterly updates merely represent the effect of previously issued Commission orders.

    The Public Representative states that proposed § 3020.5(a) may be interpreted to require the Commission to “immediately” update the MCS whenever the Commission issues a final order to update the MCS. PR Comments at 2. However, proposed § 3020.5(a) states that “Modification to the Mail Classification Schedule shall be incorporated within 3 months of the issue date of the final order.” The Public Representative suggests clarifying proposed § 3020.5(a) by adding the phrase “in accordance with section (b)” such that it reads: “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 `in accordance with section (b).' ” Id.

    The Commission will modify § 3020.5(a) to read: “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 in accordance with paragraph (b) of this section.”

    The Public Representative reminds the Commission that appendices A and B, containing the market dominant and competitive product lists appearing in the proposed rules, may not be up to date as of the time the final rule is issued. He suggests that product lists, current as of the time the final order is issued in this docket, appear in the final order. Id.

    The Commission has established a quarterly update schedule for product lists. Administratively, it is most efficient for the Commission to adhere to that schedule.4 Thus, the product lists that appear in the final rule will be equivalent to the product lists that appear in the CFR at the time the final rule is issued. The next comprehensive update is scheduled for July of 2016.

    4 A significant amount of tracking information indicating the source of product list changes appears in the quarterly update notices. Including the tracking information in this Order would be confusing and therefore not appropriate at this time.

    B. Postal Service Comments

    The Postal Service supports the Commission's general approach of including the product lists, but not the MCS, in the CFR. Postal Service Comments at 2. Additionally, the Postal Service seeks further clarification of two aspects of the proposals.

    The Postal Service observes that proposed § 3020.1(b) includes new references to 39 U.S.C. 404(e) (nonpostal services) and 39 U.S.C. 3641 (market tests). Postal Service Comments at 3. Furthermore, it states that the MCS currently requires identification of products that are either nonpostal services or market tests. Id. at 3-4. The Postal Service is concerned by the description appearing in Order No. 3213, in regard to these new statutory references. Specifically, it expresses concern with the use of “expands upon” in the description, as it could create unnecessary confusion. Id. at 4.

    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)).

    Order No. 3213 at 5-6 [emphasis added, footnote omitted].

    The Commission's intent of including citations to the statutory authority for nonpostal services or market tests is not to expand upon or otherwise affect the substantive requirements, or the scope of Commission review, relating to these types of products. The inclusion only expands upon the description appearing in existing § 3020.1(a) of the types of products that are intended to appear on product lists and in the MCS.5 There is no change to current practice.

    5 Existing § 3020.13 already includes nonpostal services and market tests in product lists and the MCS.

    The Postal Service contends that it is duplicative to require the inclusion of size and weight limitations in the MCS in both proposed § 3020.4(b) and in existing § 3020.110. Postal Service Comments at 4. It suggests either deleting existing § 3020.11, or cross-referencing § 3020.110 in § 3020.4(b). Id. at 4-5.

    Proposed § 3020.4(b)(2)(ii)(A) and § 3020.4(b)(3)(ii)(A) read:

    Where applicable, the general characteristics, size and weight limitations, minimum volume requirements, price categories, and available optional features of each market dominant product.

    Order No. 3213 at 12-13.

    Existing § 3020.110 reads:

    Applicable size and weight limitations for mail matter shall appear in the Mail Classification Schedule as part of the description of each product.

    39 CFR 3020.110, subpart F.

    The Commission concurs that the requirements appear duplicative, but will not make any changes at this time. The requirements are consistent with each other. However, as explained below, the underlying source for each requirement is different. Any potential confusion should be minimal.

    The requirements of proposed § 3020.4(b)(2)(ii)(A) and § 3020.4(b)(3)(ii)(A) reflect useful information that historically has been included in mail classification schedules. It is appropriate to include a general synopsis of all material that will appear in the MCS in one section of the regulations.

    The requirements of § 3020.110 et seq. were written in direct response to the new requirements of 39 U.S.C. 3682. This statutory provision requires, among other things, the Commission to prescribe rules for Postal Service requests to establish size and weight limitations for mail matter in the market dominant category of mail. Section 3020.110 points to the source of the material (the MCS) that all of § 3020.110 et seq. addresses. Deleting § 3020.110 would potentially make the remainder of that subpart unclear.6

    6 While adding a cross-reference to proposed § 3020.4(b)(2)(ii)(A) and § 3020.4(b)(3)(ii)(A) may not be technically incorrect, it may diminish the distinction that the Commission is attempting to preserve, which is that 39 U.S.C. 3682 is the source for the regulations appearing in § 3020.110 et seq.

    III. Ordering Paragraphs

    It is ordered:

    1. Part 3020 of title 39, Code of Federal Regulations, is amended as set forth below the signature of this Order, effective 30 days after publication in the Federal Register.

    2. The Secretary shall arrange for publication of this Order in the Federal Register.

    3. Docket No. RM2016-8 is hereby closed.

    List of Subjects in 39 CFR Part 3020

    Administrative practice and procedure.

    For the reasons discussed in the preamble, the Commission amends 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 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 document shall:

    (1) Identify modifications to the current list of market dominant products and the current list of competitive products; and

    (2) 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 in accordance with paragraph (b) of this section.

    (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 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 Contract 201 Priority Mail Contract 202 Priority Mail Contract 203 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 Priority Mail & Parcel Select Contract 1 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 to read 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 to read 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.

    By the Commission.

    Stacy L. Ruble, Secretary.
    [FR Doc. 2016-14171 Filed 6-14-16; 8:45 am] BILLING CODE 7710-FW-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2011-0969; FRL-9947-71-Region 5] Indiana; Ohio; Disapproval of Interstate Transport Requirements for the 2008 Ozone NAAQS AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is disapproving elements of State Implementation Plan (SIP) submissions from Indiana and Ohio regarding the infrastructure requirements of section 110 of the Clean Air Act (CAA) for the 2008 ozone National Ambient Air Quality Standards (NAAQS). The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program is adequate to meet the state's responsibilities under the CAA. This action pertains specifically to infrastructure requirements concerning interstate transport provisions, for which Ohio and Indiana made SIP submissions that, among other things, certified that their existing SIPs were sufficient to meet the interstate transport infrastructure SIP requirements for the 2008 ozone NAAQS.

    DATES:

    This final rule is effective on July 15, 2016.

    ADDRESSES:

    EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2011-0969. All documents in the docket are listed on the www.regulations.gov Web site. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either through www.regulations.gov or please contact the person identified in the “For Further Information Contact” section for additional availability information.

    FOR FURTHER INFORMATION CONTACT:

    Sarah Arra, Environmental Scientist, Attainment Planning and Maintenance Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-9401, [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

    I. What is the background of these SIP submissions? II. What action did EPA propose on the SIP submissions? III. What is our response to comments received on the proposed rulemaking? IV. What action is EPA taking? V. Statutory and Executive Order Reviews. I. What is the background of these SIP submissions?

    This rulemaking addresses CAA section 110(a)(2)(D)(i) requirements in two infrastructure SIP submissions addressing the applicable infrastructure requirements with respect to the 2008 ozone NAAQS: A December 12, 2011, submission from the Indiana Department of Environmental Management (IDEM), clarified in a May 24, 2012, letter; and a December 27, 2012, submission from the Ohio Environmental Protection Agency (Ohio EPA).

    The requirement for states to make a SIP submission of this type arises out of CAA section 110(a)(1). Pursuant to section 110(a)(1), states must make SIP submissions “within 3 years (or such shorter period as the Administrator may prescribe) after the promulgation of a national primary ambient air quality standard (or any revision thereof),” and these SIP submissions are to provide for the “implementation, maintenance, and enforcement” of such NAAQS. The statute directly imposes on states the duty to make these SIP submissions, and the requirement to make the submissions is not conditioned upon EPA's taking any action other than promulgating a new or revised NAAQS. Section 110(a)(2) includes a list of specific elements that “[e]ach such plan” submission must address. EPA commonly refers to such state plans as “infrastructure SIPs.”

    This rulemaking takes action on three CAA section 110(a)(2)(D)(i) requirements of these submissions. In particular, section 110(a)(2)(D)(i)(I) requires SIPs to include provisions prohibiting any source or other type of emissions activity in one state from contributing significantly to nonattainment of the NAAQS (“prong one”), or interfering with maintenance of the NAAQS (“prong two”), by any another state. Section 110(a)(2)(D)(i)(II) requires that infrastructure SIPs include provisions prohibiting any source or other type of emissions activity in one state from interfering with measures required to prevent significant deterioration (PSD) of air quality (“prong three”) and to protect visibility (“prong four”) in another state. This rulemaking addresses prongs one, two, and four of this CAA section. The majority of the other infrastructure elements were approved in rulemakings on April 29, 2015 (80 FR 23713) for Indiana; and October 16, 2014 (79 FR 62019) for Ohio.

    II. What action did EPA propose on the SIP submissions?

    The proposed rulemaking associated with today's final action was published on March 16, 2016 (81 FR 14025).

    In that action, EPA proposed to disapprove the portions of Ohio's December 27, 2012 SIP submission addressing prongs one, two, and four of CAA section 110(a)(2)(D)(i). In proposing to disapprove the SIP submission as to prongs one and two, EPA noted several deficiencies in Ohio's submission: (1) Ohio's SIP submission lacks any technical analysis evaluating or demonstrating whether emissions in each state impact air quality in other states with respect to the 2008 ozone NAAQS; (2) Ohio's SIP does not demonstrate how certain state programs and rules provide sufficient controls on emissions to address interstate transport for the 2008 ozone NAAQS; (3) Ohio's submission relied on the state's implementation of the Clean Air Interstate Rule (CAIR), which was not designed to address interstate transport with respect to the 2008 ozone standard and which is no longer being implemented; and (4) EPA recently released technical data which contradicts the state's conclusion that its SIP contained adequate provisions to address interstate transport with respect to the 2008 ozone NAAQS.

    In proposing to disapprove the Ohio SIP submission as to prong four, EPA explained that there are two ways in which a state may satisfy its visibility transport obligations: (1) A fully approved regional haze SIP, or (2) a demonstration that emissions within its jurisdiction do not interfere with other air agencies' plans to protect visibility. Ohio's SIP submission relied on the State's regional haze SIP to satisfy its visibility transport requirements under CAA section 110(a)(2)(i)(II). However, Ohio does not have a fully approved regional haze SIP in place because its obligations are satisfied in part by EPA's Cross-State Air Pollution Rule (CSAPR) based regional haze Federal Implementation Plan (FIP). Ohio also did not provide an alternate demonstration that its emissions would not interfere with plans to protect visibility in other states.

    EPA also proposed to disapprove the portions of Indiana's December 12, 2011 SIP submission addressing prongs one, two, and four of CAA section 110(a)(2)(D)(i). In proposing to disapprove the SIP submission as to prongs one and two, EPA noted several deficiencies in Ohio's submission: (1) Indiana's SIP submission lacks any technical analysis evaluating or demonstrating whether emissions in each state impact air quality in other states with respect to the 2008 ozone NAAQS; (2) Indiana's SIP submission relied on the state's participation on the CSAPR trading program, which was not designed to address interstate transport with respect to the 2008 ozone standard; (3) the state failed to cite any other rules currently being implemented by the state that are part of Indiana's approved SIP or that are being submitted as part of the state's SIP submission to address interstate transport for the 2008 ozone NAAQS; and (4) EPA recently released technical data which contradicts the state's conclusion that its SIP contained adequate provisions to address interstate transport with respect to the 2008 ozone NAAQS.

    In proposing to disapprove the Indiana SIP submission as to prong four, EPA noted that Indiana's SIP submission relies on its regional haze SIP to satisfy the state's visibility transport obligations. However, Indiana does not have a fully approved regional haze SIP in place because its obligations are satisfied in part by EPA's CSAPR-based regional haze FIP. Indiana also did not provide an alternate demonstration that its emissions would not interfere with plans to protect visibility in other states.

    III. What is our response to comments received on the proposed rulemaking?

    EPA received four comments during the comment period, which ended on April 15, 2016. A synopsis of the comments contained in these letters and EPA's responses, are provided below.

    A. Comments on the Ohio Disapproval for Prongs One and Two

    Comment 1: Ohio EPA commented that the proposed disapproval focuses on the state's duty to make a SIP submission addressing CAA section 110(a)(2)(D), but contends that EPA has historically taken the lead in addressing transported emissions, citing several prior EPA rulemakings including the Oxides of Nitrogen (NOX) SIP Call, CAIR, and CSAPR. The state noted that meeting the bar that EPA has set with these rulemakings would be “extremely resource intensive and require unprecedented multi-state collaboration,” and is therefore best suited for EPA. Ohio EPA alleged that EPA's actions to develop these regulations are too late for the states to incorporate into their SIPs.

    The state further commented that EPA has provided insufficient guidance to states addressing the requirements of section 110(a)(2)(D) in their SIPs, and guidance that is provided is often ill-timed. Ohio EPA gave the example of guidance for the 2006 fine particulate matter (PM2.5) NAAQS that was released on September 25, 2009, four days after SIPs addressing this standard were due, which stated that the states could not rely on the CAIR. The state also noted that for the 2008 ozone standard, SIP submissions were due on March 12, 2011, and EPA guidance issued two years later on September 13, 2013 did not address section 110(a)(2)(D)(i)(I). The state also commented that under cooperative federalism, EPA should not only set standards, but provided the necessary information and technical assistance for the state to fulfil their CAA obligations. Ohio EPA commented that the proposal did not acknowledge the continued efforts to meet EPA requirements on a timely basis and alleged that they were being punished with a disapproval because of a consent decree in which they were not a party. The state contends that EPA engages in secretive “sue and settle” arrangements where EPA agrees to issue disapprovals that commit the states to actions or timeframes that are unreasonable. The state also contends that EPA must disapprove Ohio's SIP submission in order to impose a FIP. The state proposed that a better course of action under cooperative federalism would have been for EPA to have provided the necessary information and allowed the state the necessary time to submit an approvable SIP.

    Response 1: While EPA issued several previous Federal rulemakings addressing interstate transport obligations in eastern states with respect to ozone and fine particulate matter, the Supreme Court confirmed that the states have the first obligation to prepare and submit state plans that prohibit the appropriate levels of emissions that significantly contribute to nonattainment or interfere with maintenance of the NAAQS in other states. In EPA v. EME Homer City Generation, L.P., the Supreme Court clearly held that “nothing in the statute places EPA under an obligation to provide specific metrics to States before they undertake to fulfill their good neighbor obligations.” 134 S. Ct. 1584, 1601 (2014).1 While EPA has taken a different approach in some prior rulemakings by providing states with an opportunity to submit a SIP after EPA quantified the states' budgets (e.g., the NOX SIP Call and CAIR), the statute does not require such an approach.

    1 “Nothing in the Act differentiates the Good Neighbor Provision from the several other matters a State must address in its SIP. Rather, the statute speaks without reservation: Once a NAAQS has been issued, a State ‘shall’ propose a SIP within three years, § 7410(a)(1), and that SIP ‘shall’ include, among other components, provisions adequate to satisfy the Good Neighbor Provision, § 7410(a)(2).” EPA v. EME Homer City Generation, L.P., 134 S. Ct. at 1600.

    While EPA did not provide specific guidance regarding how states could satisfy their statutory obligation with respect to CAA section 110(a)(2)(D)(i)(I) with respect to the 2008 ozone NAAQS, EPA did provide information to assist states with developing or supplementing their SIP submissions. On January 22, 2015, EPA issued a memorandum providing preliminary modeling information regarding potential downwind air quality problems and levels of upwind state contributions. See Memorandum from Stephen D. Page to Regional Air Division Directors, Regions 1-10, “Information on the Interstate Transport ‘Good Neighbor’ Provision for the 2008 Ozone [NAAQS] under [CAA] Section 110(a)(2)(D)(i)(I)” (Jan. 22, 2015). As noted at proposal, EPA also provided updated modeling and contribution information in its August 4, 2015 Notice of Data Availability. 80 FR 46271. While Ohio's December 27, 2012 SIP was submitted prior to this information being provided, the state did not attempt to revise or supplement its SIP submission to address this information.

    Moreover, EPA does not agree that the states needed formal guidance to understand that it was inappropriate to rely on CAIR for purposes of satisfying the state's interstate transport obligations with respect to the 2008 ozone NAAQS. As noted earlier, CAIR was designed to address interstate transport with respect to the 1997 ozone NAAQS, not the more stringent 2008 ozone NAAQS, and in any event the rule is no longer being implemented by the states or EPA. More importantly, in North Carolina v. EPA, the D.C. Circuit held that CAIR was “fundamentally flawed,” 531 F.3d 896, 929 (D.C. Cir. 2008), in part because CAIR did not satisfy the statutory requirement to “achieve[] something measurable towards the goal of prohibiting sources ‘within the State’ from contributing to nonattainment or interfering with maintenance in ‘any other State.’ ” Id. at 908. Accordingly, the D.C. Circuit held in EME Homer City Generation, L.P. v. EPA, “when our decision in North Carolina deemed CAIR to be an invalid effort to implement the requirements of the good neighbor provision, that ruling meant that the initial approval of the CAIR SIPs was in error at the time it was done.” 795 F.3d 118, 133 (2015). For these reasons, EPA cannot now approve an interstate transport SIP addressing any NAAQS based on the state's participation in CAIR.

    Finally, EPA disagrees that either the litigation regarding EPA's deadline to act on Ohio's SIP submission or EPA's proposed action to update CSAPR to address the 2008 ozone standard (CSAPR Update) have dictated the substance of EPA's action on Ohio's SIP with respect to prongs one and two. CAA section 110(k)(2) requires EPA to act on a state's SIP submission within one year after the submission is determined to be complete. Therefore, EPA's statutory obligation to act on Ohio's December 27, 2012 SIP submission was overdue. While EPA did enter into a consent decree with litigants in Sierra Club v. McCarthy, No. 4:14-cv-5091-YGR (N.D. Cal.), which raised claims regarding EPA's alleged failure to fulfill its mandatory duty to take action on Ohio's SIP under CAA section 110(k)(2), that agreement governs only the timetable on which EPA must act on the state's SIP submissions under CAA section 110(k)(2) and not the substance of EPA's action. As described earlier, EPA has evaluated Ohio's SIP submission on its merits and found that it is deficient for purposes of addressing the state's obligation pursuant to CAA section 110(a)(2)(D)(i)(I).

    Comment 2: A commenter cited comments that were submitted on the docket for the CSAPR Update rulemaking because the modeling used to support that rule is also being used in the disapproval Ohio's interstate transport SIP. The commenter stated that “the comments detail legal problems and technical flaws with the modeling” and asserted that EPA should not have acted on Ohio's SIP submission until the CSAPR Update was finalized and EPA had responded to the comments. The commenter disagreed with the need for EPA to take action on the submission at this time and stated that EPA should have issued a SIP call or asked the state for a supplemental submission instead of disapproving the December 27, 2012 SIP submission which was “in accordance with what was required at the time”. The commenter noted that EPA's analysis was completed three years after the state's submission.

    Response 2: EPA disagrees with the commenter's conclusion that EPA is disapproving Ohio's SIP submission addressing prongs one and two based primarily on the modeling conducted to support the proposed CSAPR Update rulemaking. As noted earlier, states bear the primary responsibility to demonstrate that their plans contain adequate provisions to address the statutory interstate transport provisions, specifically to demonstrate that the plan properly prohibits emissions that will significantly contribute to nonattainment or interfere with maintenance of the NAAQS in downwind states. As described in the proposal and earlier in this notice, EPA has identified several ways in which Ohio's SIP submission fails to fulfill this obligation. In particular, EPA is disapproving Ohio's submission for its reliance on CAIR, which is legally invalid, and the lack of state rules identified in its submission that are sufficient to prohibit emissions that significantly contribute to nonattainment or interfere with maintenance of the standard in other states.

    While EPA cited the modeling conducted for the CSAPR Update as additional evidence that Ohio may significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS in downwind states, we did not propose to make a specific finding of contribution or to quantify any specific emissions reduction obligation. Rather, the evaluation of whether emissions from Ohio significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS downwind, and if so what reductions are necessary to address that contribution, is being conducted in the context of the CSAPR Update rulemaking. Accordingly, EPA will consider timely-submitted comments regarding EPA's air quality modeling and various associated legal and policy decisions in finalizing that rulemaking. Moreover, it is inappropriate for the commenter to merely cite to or attach comments prepared for another rulemaking without identifying which portions of those comments are pertinent to this action. Without further explanation, EPA has no obligation to address comments prepared for the purpose of the CSAPR Update in the context of this rulemaking.

    EPA notes that the technical data discussed at proposal with respect to Ohio's potential contribution to downwind air quality problems is consistent with modeling previously conducted for trading programs addressing interstate ozone transport such as CAIR (70 FR 25162), CSAPR (76 FR 48208), and the NOx SIP Call (63 FR 57356) showing that Ohio is frequently linked to downwind receptors. The modeling conducted to support the proposed CSAPR Update is the most recent technical information available to the Agency which still shows such linkages. Even absent this modeling data, Ohio's SIP submission is inadequate to address prongs one and two of CAA section 110(a)(2)(D)(i)(I) with respect to the 2008 ozone NAAQS.

    Comment 3: Ohio EPA also attached comments that were submitted for the proposal to update CSAPR to address the 2008 ozone NAAQS because, the state explained, the modeling is also being used to disapprove Ohio's SIP as to prongs one and two. The state commented that the attached comments point out “significant errors and concerns in U.S. EPA's analyses regarding the [Notice of Data Availability] and transport updates” and that “it is ill-timed and erroneous for U.S. EPA to use these analyses as evidence that Ohio has not addressed its transport obligations.”

    Response 3: While EPA cited the modeling conducted for the CSAPR Update as additional evidence that Ohio may significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS in downwind states, we did not propose to make a specific finding of contribution or to quantify any specific emissions reduction obligation. Rather, the evaluation of whether emissions from Ohio significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS downwind, and if so what reductions are necessary to address that contribution, is being conducted in the context of the CSAPR Update rulemaking. Accordingly, EPA will consider timely-submitted comments regarding EPA's air quality modeling and various associated legal and policy decisions in finalizing that rulemaking. Moreover, it is inappropriate for the commenter to merely cite to or attach comments prepared for another rulemaking without identifying which portions of those comments are pertinent to this action. Without further explanation, EPA has no obligation to address comments prepared for the purpose of the CSAPR Update in the context of this rulemaking.

    B. Comments on the Indiana Disapproval for Prongs One and Two

    Comment 4: The commenter gave a summary of the regulatory history of CSAPR and the overlapping timeline of the IDEM submission. The commenter alleged that “EPA was uncertain about the scope of the air transport law, and therefore cannot be certain about its proposed disapproval of the Indiana infrastructure SIP.”

    Response 4: In evaluating Indiana's SIP submission with respect to prongs one and two of the interstate transport provisions of the statute, EPA has identified several clear deficiencies in the state's analysis. In particular, EPA noted that the state relied on participation in CSAPR, which does not address interstate transport with respect to the 2008 ozone NAAQS, and failed to otherwise provide any technical analysis to support its conclusion that the state had satisfied its statutory obligation. The commenter has identified no legal uncertainty underlying these bases for EPA's disapproval of Indiana's SIP.

    Comment 5: The commenter cites to a comment from Connecticut on an older rulemaking in which Connecticut requests further reductions of upwind emissions to address nonattainment concerns in Connecticut. The commenter gave an overview of the Reasonably Available Control Technology (RACT) plan developed by Connecticut looking at feasible local controls to address air quality in the nonattainment area including Connecticut. The commenter concluded that because there are further local controls available to address the nonattainment area, and any attempt to impose reduction obligations on upwind states such as Indiana without addressing these controls first would result in over-control by the upwind states.

    Response 5: This action is not determining what, if any, emission reductions sources in Indiana may need to achieve in order to address the state's interstate transport obligation with respect to the 2008 ozone NAAQS. Instead, EPA is evaluating the state's interstate transport SIP to determine whether the current submission satisfies the statutory obligations at CAA section 110(a)(2)(D)(i)(I). As noted earlier, Indiana's SIP contains several deficiencies that justify EPA's decision to finalize disapproval as to prongs one and two transport, as Indiana has failed to provide an adequate technical analysis demonstrating that the state's current SIP contains sufficient provisions to properly address interstate transport with respect to the 2008 ozone NAAQS. Moreover, besides Connecticut, EPA's most recent technical analysis shows that emissions from Indiana contribute to projected air quality problems in Wisconsin, Kentucky, Maryland, Michigan, New Jersey, New York, Ohio, and Pennsylvania.

    Comment 6: A commenter alleged that “EPA propose[d] disapproval, and its disagreement with IDEM's submission, rests in great part on the modeling and technical data that was used to support the CSAPR Update” and that a contrary view suggests “that there is no basis to conclude that Indiana would be expected to significantly contribute to the nonattainment of or interfere with the maintenance of the 2008 ozone NAAQS in 2017.”

    The following comments pertain to modeling conducted to support the proposed CSAPR Update and EPA's application of the modeling data in the proposed rule. The commenter first noted that a study prepared by Alpine Geophysics looked at ozone concentrations during a more recent time period. The comment alleged that the concentrations from this study were more appropriate because they reflected recent controls, economic factors, recent regulatory programs, and more consistent precipitation and temperature ranges. The commenter stated that using this data set resulted in all projected air quality problems (both nonattainment and maintenance receptors) being resolved in 2017 with the exception of those in Fairfield, Connecticut. The commenter notes that the proposed rulemaking does not find Indiana to be a significant contributor to the Fairfield, Connecticut monitor.

    The commenter also cited what they believe are legal and policy issues with the proposed CSAPR Update. The commenter alleged that EPA's reliance on modeled maximum design value for determining whether a state interferes with maintenance of the NAAQS downwind is inconsistent with the Supreme Court's 2014 decision, the D.C. Circuit's 2015 decision in the EME Homer City litigation, the CAA. The commenter contends that this interpretation of that statutory obligation would result in unnecessary over-control. The commenter also alleged that EPA's approach to addressing maintenance concerns is applied differently in transport than it is in the context of redesignations.

    The commenter contends, based on the Alpine Geophysics report, that EPA inappropriately used grids in its modeling platform that include overwater receptors as well as land receptors, and further inappropriately selected to represent the monitor the highest concentration in the grid from an over the water location.

    The commenter further alleged that EPA using the latest version of the Integrated Planning Model would show great emissions reductions already in place therefore lowering projected concentrations in downwind states. The commenter also commented that that model did not include controls such as a Pennsylvania RACT rule and mobile source controls in the New England area that are needed to reduce concentrations at the Connecticut monitor. The commenter contended that EPA did not properly account for international emissions, and doing so would lead to the conclusion that Indiana is not contributing to the Connecticut monitor. The commenter concluded that using the alternate analysis by Alpine Geophysical eliminates attainment and maintenance issues at all the monitors except Connecticut and for the reasons summarized above, Indiana does not significantly contribute to that monitor.

    Response 6: EPA disagrees with the commenter's conclusion that EPA is disapproving Indiana's SIP submission addressing prongs one and two based primarily on the modeling conducted to support the proposed CSAPR Update rulemaking. As noted earlier, states bear the primary responsibility to demonstrate that their plans contain adequate provisions to address the statutory interstate transport provisions, specifically to demonstrate that the plan properly prohibits emissions that will significantly contribute to nonattainment or interfere with maintenance of the NAAQS in downwind states. As described in the proposal and earlier in this notice, EPA has identified several ways in which Indiana's SIP submission fails to fulfill this obligation. In particular, EPA is disapproving Indiana's submission for its reliance on CSAPR, which does not currently address the 2008 ozone standard, and the submission's lack of identified state rules that are sufficient to prohibit emissions that significantly contribute to nonattainment or interfere with maintenance of the standard in other states.

    While EPA cited the modeling conducted for the CSAPR Update as additional evidence that Indiana may significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS in downwind states, we did not propose to make a specific finding of contribution or to quantify any specific emissions reduction obligation. Rather, the evaluation of whether emissions from Indiana significantly contribute to nonattainment or interfere with maintenance of the 2008 ozone NAAQS downwind, and if so what reductions are necessary to address that contribution, is being conducted in the context of the CSAPR Update rulemaking. Accordingly, EPA will consider comments timely submitted to the Agency regarding EPA's air quality modeling and various associated legal and policy decisions in finalizing that rulemaking. While EPA appreciates the information provided by the commenter regarding EPA's identification of downwind air quality problems and Indiana's potential contribution to those areas, these data do not undermine EPA's primary bases for disapproving Indiana's SIP with respect to prongs one and two of CAA section 110(a)(2)(D)(i)(I).

    EPA notes that the technical data discussed at proposal with respect to Indiana's potential contribution to downwind air quality problems is consistent with modeling previously conducted for trading programs addressing interstate ozone transport such as CAIR (70 FR 25162), CSAPR (76 FR 48208), and the NOX SIP Call (63 FR 57356) showing that Indiana is frequently linked to downwind receptors. The modeling conducted to support the proposed CSAPR Update is the most recent technical information available to the Agency which still shows such linkages. Even absent these modeling data, Indiana's SIP submission is inadequate to address prongs one and two of CAA section 110(a)(2)(D)(i)(I) with respect to the 2008 ozone NAAQS.

    C. Comments on Both the Indiana and Ohio Disapprovals for Prongs One and Two

    Comment 7: The Connecticut Department of Energy and Environmental Protection (DEEP) is supportive of the proposed disapprovals of Indiana and Ohio's SIP submissions addressing the prongs one and two transport obligations. DEEP encouraged EPA to finalize the disapproval quickly and propose and finalize a full transport remedy rather than waiting to couple the action with the 2015 ozone NAAQS. DEEP also encourages EPA to “describe the implications of the disapproval with respect to each state's good neighbor SIP obligations and the proposed partial remedy provided by the [CSAPR] Update,” and DEEP supports action by Indiana and Ohio towards resolving outstanding SIP obligations.

    Response 7: EPA is supportive of any actions taken by the states to resolve transport obligations. EPA will address further obligations for Ohio and Indiana in the final CSAPR Update rule.

    D. Comments on Both the Indiana and Ohio Disapprovals for Prong Four

    Comment 8: Both commenters on Indiana's submission and Ohio's submission stated that the visibility portion should be approved, because reliance on CAIR as better than Best Available Retrofit Technology (BART) for electric generating units (EGUs) was consistent with CAA requirements at the time of both submissions. One commenter also stated that since CAIR is better than BART has been replaced with CSAPR is better than BART in the form a FIP, the requirements have been fully addressed, and this transport prong should be fully approved. The other commenter asserts that if EPA decides to finalize the disapproval, EPA should clarify that no further action is needed because of the FIP in place showing that for Ohio EGUs, CSAPR meets the BART requirements for regional haze. Ohio EPA also disagreed with EPA's proposed disapproval of prong four, because there is a FIP in place that satisfies Ohio's obligations.

    Response 8: Indiana and Ohio cannot rely on CAIR to satisfy their regional haze obligations, and by extension their prong four obligations, because neither the states nor EPA are currently implementing this program. Neither state has submitted an approvable regional haze SIP to replace its current reliance on CAIR; thus, both States have regional haze FIPs in place. However, as stated above, states cannot rely on FIPs to satisfy their prong four obligations. This is consistent with our approach for transport provisions and federally implemented PSD programs. EPA is not promulgating FIPs to address the states' prong four deficiencies in this action.

    IV. What action is EPA taking?

    EPA is disapproving a portion of Indiana's December 12, 2011 submission and Ohio's December 27, 2012 submission seeking to address the required infrastructure element under CAA section 110(a)(2)(D)(i) for the 2008 ozone NAAQS, specifically prongs one, two, and four. This disapproval triggers an obligation under CAA section 110(c) for EPA to promulgate a FIP no later than two years from the effective date of this disapproval, if EPA has not approved a SIP revision or revisions addressing the deficiencies identified in this action. This action is not tied to attainment planning requirements and therefore does not start any sanction clocks.

    V. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

    B. Paperwork Reduction Act (PRA)

    This rule does not impose an information collection burden under the provisions of the PRA.

    C. Regulatory Flexibility Act (RFA)

    The Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This action merely proposes to disapprove state law as not meeting Federal requirements and imposes no additional requirements beyond those imposed by state law.

    D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

    E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

    F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

    This action does not have tribal implications as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments. Thus, Executive Order 13175 does not apply to this rule.

    G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children because it proposes to disapprove a state rule.

    H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

    I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

    J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

    EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations.

    Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this 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. 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 August 15, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone.

    Dated: June 3, 2016. Robert A. Kaplan, Acting Regional Administrator, Region 5.

    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.

    2. In § 52.770 the table in paragraph (e) is amended by revising the entry for “Section 110(a)(2) Infrastructure Requirements for the 2008 Ozone NAAQS”. The amended text reads as follows:
    § 52.770 Identification of plan.

    (e) * * *

    EPA-Approved Indiana Nonregulatory and Quasi-Regulatory Provisions Title Indiana date EPA approval Explanation *         *         *         *         *         *         * Section 110(a)(2) Infrastructure Requirements for the 2008 ozone NAAQS 12/12/2011 6/15/2016, [insert Federal Register citation] This action addresses the following CAA elements: 110(a)(2)(A), (B), (C), (D), (E), (F), (G), (H), (J), (K), (L), and (M). *         *         *         *         *         *         *
    3. In § 52.1870 the table in paragraph (e) is amended by revising the entry for “Section 110(a)(2) infrastructure requirements for the 2008 Ozone NAAQS”. The amended text reads as follows:
    § 52.1870 Identification of plan.

    (e) * * *

    EPA-Approved Ohio Nonregulatory and Quasi-Regulatory Provisions Title Applicable geographical or non-attainment area State date EPA approval Comments *         *         *         *         *         *         * Section 110(a)(2) infrastructure requirements for the 2008 ozone NAAQS Statewide 12/27/2012 6/15/2016, [insert Federal Register citation] Addresses the following CAA elements: 110(a)(2) (A) to (H) and (J) to (M). *         *         *         *         *         *         *
    [FR Doc. 2016-14103 Filed 6-14-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR PART 52 [EPA-R02-OAR-2016-0316; FRL-9947-77-Region 2] Finding of Failure To Submit a State Implementation Plan; New Jersey; Interstate Transport Requirements for 2008 8-Hour National Ambient Air Quality Standards for Ozone AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking final action finding that New Jersey has failed to submit an infrastructure State Implementation Plan (SIP) revision to satisfy certain interstate transport requirements of the Clean Air Act (CAA) with respect to the 2008 8-hour ozone national ambient air quality standard (NAAQS). Specifically, these requirements pertain to the obligation to prohibit emissions which significantly contribute to nonattainment, or interfere with maintenance, of the 2008 8-hour ozone NAAQS in other states. This finding of failure to submit establishes a 2-year deadline for the EPA to promulgate a Federal Implementation Plan (FIP) to address the interstate transport SIP requirements pertaining to the state's significant contribution to nonattainment and interference with maintenance of the 2008 ozone NAAQS in other states unless, prior to the EPA promulgating a FIP, the state submits, and the EPA approves, a SIP that meets these requirements.

    DATES:

    This rule is effective on July 15, 2016.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R02-OAR-2016-0316. All documents in the docket are listed on the www.regulations.gov Web site.

    FOR FURTHER INFORMATION CONTACT:

    Kenneth Fradkin, Environmental Protection Agency, 290 Broadway, 25th Floor, New York, NY 10007-1866, (212) 637-3702, or by email at [email protected].

    SUPPLEMENTARY INFORMATION:

    Section 553 of the Administrative Procedures Act, 5 United States Code (U.S.C.) 553(b)(3)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. The EPA has determined that there is good cause for making this rule final without prior proposal and opportunity for comment because no significant EPA judgment is involved in making a finding of failure to submit SIPs, or elements of SIPs, required by the CAA, where states have made no submittals, or incomplete submittals, to meet the requirement by the statutory date. Thus, notice and public procedure are unnecessary. The EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(3)(B).

    Table of Contents I. Background II. Final Action III. Statutory and Executive Order Reviews I. Background

    Section 110(a) of the CAA imposes an obligation upon states to submit SIPs that provide for the implementation, maintenance and enforcement of a new or revised NAAQS within 3 years following the promulgation of that NAAQS. Section 110(a)(2) lists specific requirements that states must meet in these SIP submissions, as applicable. The EPA refers to this type of SIP submission as the “infrastructure” SIP because the SIP ensures that states can implement, maintain and enforce the air standards. Within these requirements, section 110(a)(2)(D)(i) contains requirements to address interstate transport of NAAQS pollutants. A SIP revision submitted for this sub-section is referred to as an “interstate transport SIP.” In turn, section 110(a)(2)(D)(i)(I) requires that such a plan contain adequate provisions to prohibit emissions from the state that will contribute significantly to nonattainment of the NAAQS in any other state (“prong 1”) or interfere with maintenance of the NAAQS in any other state (“prong 2”). Interstate transport prongs 1 and 2, also called the “good neighbor” provisions, are the requirements relevant to this findings notice.

    Pursuant to CAA section 110(k)(1)(B), the EPA must determine no later than 6 months after the date by which a state is required to submit a SIP whether a state has made a submission that meets the minimum completeness criteria established in CAA section 110(k)(1)(A). The EPA refers to the determination that a state has not submitted a SIP submission that meets the minimum completeness criteria as a “finding of failure to submit.” If the EPA finds a state has failed to submit a SIP to meet its statutory obligation to address 110(a)(2)(D)(i)(I), pursuant to section 110(c)(1) the EPA has not only the authority, but the obligation, to promulgate a FIP within 2 years to address the CAA requirement. This finding therefore starts a 2-year clock for promulgation by the EPA of a FIP, in accordance with CAA section 110(c)(1), unless prior to such promulgation the state submits, and the EPA approves, a submittal from the state to meet the requirements of CAA section 110(a)(2)(D)(i)(I). The EPA notes this action does not start a mandatory sanctions clock pursuant to CAA section 179 because this finding of failure to submit does not pertain to a part D plan for nonattainment areas required under CAA section 110(a)(2)(I) or a SIP call pursuant to CAA section 110(k)(5).

    On March 12, 2008, the EPA strengthened the NAAQS for ozone. The EPA revised the 8-hour primary ozone standard from 0.08 parts per millions (ppm) to 0.075 ppm. The EPA also revised the secondary 8-hour standard to the level of 0.075 ppm making it identical to the revised primary standard. Infrastructure SIPs addressing the revised standard, including the interstate transport requirements, were due March 12, 2011.

    On October 17, 2014, New Jersey submitted a multi-pollutant infrastructure SIP revision for 2008 Ozone, 2010 Sulfur Dioxide, 2010 Nitrogen Dioxide, 2008 Lead, 2011 Carbon Monoxide, and the 2012 PM2.5 (Fine Particles) NAAQS. New Jersey addressed the “good neighbor” provision for the 2008 Ozone NAAQS in their submission.

    On July 13, 2015, the EPA published a rule 1 finding that 24 states failed to submit complete SIPs that addressed the “good neighbor” provision for the 2008 Ozone NAAQS. See 80 FR 39961, (July 13, 2015). The finding action triggered a 2-year clock for the EPA to issue FIPs to address the “good neighbor” requirements for those states by August 12, 2017. Prior to issuance of the finding action, New Jersey made a submission addressing the “good neighbor” provision for the 2008 Ozone NAAQS on October 17, 2014; therefore, the state was not included in the EPA's July 2015 finding notice. Following New Jersey's submittal of their infrastructure SIP and the EPA's July 2015 finding notice, the EPA proposed a rule on November 16, 2015 2 to address the “good neighbor” requirements for the 2008 Ozone NAAQS. The rule proposed to promulgate FIPs in 23 eastern states, including New Jersey, to reduce interstate ozone transport as to the 2008 ozone NAAQS. The EPA proposed to issue final FIPs only for those states that either failed to submit a SIP or for which the EPA disapproved a state's SIP addressing the “good neighbor” provision by the date the rule was finalized. The EPA expects to finalize the rule and respective FIPs, as applicable, later this year.

    1 80 FR 39961 (July 13, 2015) (effective August 12, 2015).

    2 See “Cross-State Air Pollution Rule Update for the 2008 Ozone NAAQS; Proposed Rules,” 80 FR 75706 (December 3, 2015).

    In a letter to the EPA dated March 30, 2016, New Jersey withdrew from EPA's consideration the “good neighbor” portion of its multi-pollutant infrastructure SIP as it relates to the 2008 ozone NAAQS. New Jersey stated that it was withdrawing that portion of its submission “in order not to delay the EPA's ability to implement the FIP on those upwind states that are significantly contributing to ozone levels in New Jersey and the other states within [New Jersey's] shared ozone nonattainment area.” New Jersey stated that its decision to withdraw was based on a desire that EPA would “fully implement the FIP” proposed in 2016, and that it “reserve[d] the right to resubmit” the language of its original submission. The full letter can be found in the docket for this rulemaking.3

    3 Letter from Bob Martin, Commissioner, New Jersey Department of Environmental Protection to Judith Enck, Regional Administrator, U.S. EPA Region II, March 30, 2016.

    On the basis of New Jersey's March 30, 2016 withdrawal letter, New Jersey does not have a complete pending submittal addressing the “good neighbor” provision for the 2008 ozone NAAQS. The EPA is therefore making a finding that New Jersey has failed to submit a SIP revision to address the requirements of CAA sections 110(a)(2)(D)(i)(I) as to the 2008 ozone NAAQS.

    II. Final Action

    This action reflects the EPA's determination with respect to the requirements of CAA section 110(a)(2)(D)(i)(I) for the 2008 8-hour ozone NAAQS for New Jersey, as discussed in section I of this findings notice. The EPA is making a finding of failure to submit for New Jersey for the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for the 2008 8-hour ozone NAAQS. This finding starts a 2-year clock for promulgation by the EPA of a FIP after the effective date of this final rule, in accordance with section 110(c)(1), unless prior to such promulgation that New Jersey submits, and the EPA approves, a submittal that meets the requirements of CAA section 110(a)(2)(D)(i)(I) as to the 2008 ozone NAAQS. This finding of failure to submit does not impose sanctions, and does not set deadlines for imposing sanctions as described in section 179, because it does not pertain to the elements of a CAA title I, part D plan for nonattainment areas as required under section 110(a)(2)(I), and because this action is not a SIP call pursuant to section 110(k)(5).

    III. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

    B. Paperwork Reduction Act

    This action does not impose an information collection burden under the Paperwork Reduction Act. This final rule does not establish any new information collection requirement apart from that already required by law.

    C. Regulatory Flexibility Act (RFA)

    This action is not subject to the RFA. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. This rule is not subject to notice and comment requirements because the agency has invoked the APA “good cause” exemption under 5 U.S.C. 553(b).

    D. Unfunded Mandates Reform Act of 1995 (UMRA)

    This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action implements mandates specifically and explicitly set forth in the CAA under section 110(a) without the exercise of any policy discretion by the EPA.

    E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

    F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

    This action does not have tribal implications as specified in Executive Order 13175. This rule responds to the requirement in the CAA for states to submit SIPs under section 110(a) to address CAA section 110(a)(2)(D)(i)(I) for the 2008 ozone NAAQS. No tribe is subject to the requirement to submit an implementation plan under section 110(a) within 3 years of promulgation of a new or revised NAAQS. Thus, Executive Order 13175 does not apply to this action.

    G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

    H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

    I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

    J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

    The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations because it does not affect the level of protection provided to human health or the environment.

    This notice is making a procedural finding that New Jersey has failed to submit a SIP to address CAA section 110(a)(2)(D)(i)(I) for the 2008 ozone NAAQS. The EPA did not conduct an environmental analysis for this rule because this rule would not directly affect the air emissions of particular sources. Because this rule will not directly affect the air emissions of particular sources, it does not affect the level of protection provided to human health or the environment. Therefore, this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations.

    K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. The CRA allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and comment rulemaking procedures are impracticable, unnecessary or contrary to the public interest (5 U.S.C. 808(2)). The EPA has made a good cause finding for this rule as discussed in the Supplementary Information section of this final rule, including the basis for that finding.

    L. Judicial Review

    Under Section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 15, 2016.

    Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, and Reporting and recordkeeping requirements.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: June 2, 2016. Judith A. Enck, Regional Administrator, Region 2.
    [FR Doc. 2016-14180 Filed 6-14-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 15 and 27 [ET Docket No. 14-165; FCC 15-99] Unlicensed Use of TV Band and 600 MHz Band Spectrum AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule; announcement of effective date.

    SUMMARY:

    In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection associated with the rule changes for white space devices and wireless microphones in the Commission's August 11, 2015 Part 15 Report and Order, FCC 15-99. This document is consistent with the Report and Order which stated that the Commission would publish a document in the Federal Register announcing OMB approval and the effective date of the requirements.

    DATES:

    The amendments to 47 CFR 15.713(b)(2)(iv) through (v), (j)(4), (j)(10) and (j)(11), 15.715(n) through (q) and 27.1320 published at 80 FR 73043, November 23, 2015, are effective on June 15, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Cathy Williams on (202) 418-2918 or via email to: [email protected]

    SUPPLEMENTARY INFORMATION:

    This document announces that, on May 11, 2016, OMB approved, for a period of three years, the information collection requirements contained in 47 CFR 15.713(b)(2)(iv) through (v), (j)(4), (j)(10) and (j)(11), 15.715(n) through (q) and 27.1320. The Commission publishes this document to announce the effective date of these rule sections. See In the Matter of Amendment of Part 15 of the Commission's Rules for Unlicensed Operations in the Television Bands, Repurposed 600 MHz Band, 600 MHz Guard Bands and Duplex Gap, and Channel 37, and Amendment of Part 74 of the Commission's Rules for Low Power Auxiliary Stations in the Repurposed 600 MHz Band and 600 MHz Duplex Gap and Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions, ET Docket No. 14-165 and GN Docket No. 12-268, FCC 15-99, 80 FR 73043, November 23, 2015.

    Synopsis

    As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on May 11, 2016, for the information collection requirements contained in the modifications to the Commission's rules in 47 CFR 15.713(b)(2)(iv) through (v), (j)(4), (j)(10) and (j)(11), 15.715(n) through (q) and 27.1320. Under 5 CFR 1320.5(b), an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

    No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number.

    The OMB Control Number is 3060-1155. The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

    The total annual reporting burdens and costs for the respondents are as follows:

    OMB Approval Date: May 11, 2016.

    OMB Expiration Date: May 31, 2019.

    Title: Sections 15.713, 15.714, 15.715, 15.717 and 27.1320, TV White Space Broadcast Bands.

    Form Number: Not applicable.

    Respondents: Business or other for-profit entities.

    Number of Respondents and Responses: 2,010 respondents; 4,000 responses.

    Estimated Time per Response: 2 hours.

    Frequency of Response: On-occasion reporting requirements; recordkeeping requirements; and third party disclosure.

    Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this information collection is contained in 47 U.S.C. Sections 154(i), 302, 303(c), 303(f), and 307.

    Total Annual Burden: 8,000 hours.

    Total Annual Cost: $200,000.

    Nature and Extent of Confidentiality: The Commission is not requesting respondents to submit confidential information to the Commission. Respondents may request confidential treatment of such information under 47 CFR 0.459 of the Commission's rules.

    Privacy Impact Assessment: No impact(s).

    Needs and Uses: On August 11, 2015, the Federal Communications Commission adopted a Report and Order (R&O), ET Docket No. 14-165 and GN Docket No. 12-268, FCC 15-99. This R&O made certain changes to the rules for unlicensed device operations in the frequency bands that are now and will continue to be allocated and assigned to broadcast television services (TV bands), including fixed and personal/portable white space devices and unlicensed wireless microphones. It also adopted rules for fixed and personal/portable white space devices and wireless microphones in the 600 MHz guard bands, including the duplex gap, and the 600 MHz band that will be repurposed for new wireless services, and for fixed and personal/portable white space devices on channel 37.

    Federal Communications Commission. Marlene H. Dortch, Secretary. Office of the Secretary.
    [FR Doc. 2016-14178 Filed 6-14-16; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 635 [Docket No. 120627194-3657-02] RIN 0648-XE567 Atlantic Highly Migratory Species; North Atlantic Swordfish Fishery AGENCY:

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

    ACTION:

    Temporary rule; Swordfish General Commercial permit retention limit inseason adjustment for the Northwest Atlantic, Gulf of Mexico, and U.S. Caribbean regions.

    SUMMARY:

    NMFS is adjusting the Swordfish (SWO) General Commercial permit retention limits for the Northwest Atlantic, Gulf of Mexico, and U.S. Caribbean regions for July through December of the 2016 fishing year, unless otherwise later noticed. The SWO General Commercial permit retention limit in each of these regions is increased from the regulatory default limits to six swordfish per vessel per trip. The SWO General Commercial permit retention limit in the Florida SWO Management Area will remain unchanged at the default limit of zero swordfish per vessel per trip. This adjustment applies to SWO General Commercial permitted vessels and Highly Migratory Species (HMS) Charter/Headboat permitted vessels when on a non-for-hire trip. This action is based upon consideration of the applicable inseason regional retention limit adjustment criteria.

    DATES:

    The adjusted SWO General Commercial permit retention limits in the Northwest Atlantic, Gulf of Mexico, and U.S. Caribbean regions are effective July 1, 2016, through December 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Rick Pearson or Randy Blankinship, 727-824-5399.

    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 North Atlantic swordfish by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. Section 635.27 subdivides the U.S. North Atlantic swordfish quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) into two equal semi-annual directed fishery quotas, an annual incidental catch quota for fishermen targeting other species or taking swordfish recreationally, and a reserve category, according to the allocations established in the 2006 Consolidated Highly Migratory Species Fishery Management Plan (2006 Consolidated HMS FMP) (71 FR 58058, October 2, 2006), as amended, and in accordance with implementing regulations. NMFS is required under ATCA and the Magnuson-Stevens Act to provide U.S. fishing vessels with a reasonable opportunity to harvest the ICCAT-recommended quota.

    The 2016 adjusted North Atlantic swordfish quota is expected to be 3,359.4 mt dw (equivalent to the 2015 adjusted quota). From the adjusted quota, 50 mt dw would be allocated to the reserve category for inseason adjustments and research, and 300 mt dw would be allocated to the incidental category, which includes recreational landings and landings by incidental swordfish permit holders, per § 635.27(c)(1)(i). This would result in an allocation of 3,009.4 mt dw for the directed fishery, which would be split equally (1,504.7 mt dw) between two seasons in 2016 (January through June, and July through December).

    Adjustment of SWO General Commercial Permit Vessel Retention Limits

    The 2016 North Atlantic swordfish fishing year, which is managed on a calendar-year basis and divided into two equal semi-annual quotas, began on January 1, 2016. Landings attributable to the SWO General Commercial permit are counted against the applicable semi-annual directed fishery quota. Regional default retention limits for this permit have been established and are automatically effective from January 1 through December 31 each year, unless changed based on the inseason regional retention limit adjustment criteria at § 635.24(b)(4)(iv). The default retention limits established for the SWO General Commercial permit are: (1) Northwest Atlantic region—three swordfish per vessel per trip; (2) Gulf of Mexico region—three swordfish per vessel per trip; (3) U.S. Caribbean region—two swordfish per vessel per trip; and, (4) Florida SWO Management Area—zero swordfish per vessel per trip. The default retention limits apply to SWO General Commercial permitted vessels and to HMS Charter/Headboat permitted vessels when fishing on non for-hire trips. As a condition of these permits, vessels may not possess, retain, or land any more swordfish than is specified for the region in which the vessel is located.

    Under § 635.24(b)(4)(iii), NMFS may increase or decrease the SWO General Commercial permit vessel retention limit in any region within a range from zero to a maximum of six swordfish per vessel per trip. Any adjustments to the retention limits must be based upon a consideration of the relevant criteria provided in § 635.24(b)(4)(iv), which include: The usefulness of information obtained from biological sampling and monitoring of the North Atlantic swordfish stock; the estimated ability of vessels participating in the fishery to land the amount of swordfish quota available before the end of the fishing year; the estimated amounts by which quotas for other categories of the fishery might be exceeded; effects of the adjustment on accomplishing the objectives of the fishery management plan and its amendments; variations in seasonal distribution, abundance, or migration patterns of swordfish; effects of catch rates in one region precluding vessels in another region from having a reasonable opportunity to harvest a portion of the overall swordfish quota; and, review of dealer reports, landing trends, and the availability of swordfish on the fishing grounds.

    NMFS has considered these criteria as discussed below and their applicability to the SWO General Commercial permit retention limit in all regions for July through December of the 2016 North Atlantic swordfish fishing year. Last year, through June 30, 2015, with application of the default retention limits, directed swordfish landings were 493 mt dw (32.8 percent of the 1,505 mt dw January to June semi-annual adjusted directed sub-quota). On July 28, 2015, NMFS adjusted SWO General Commercial permit retention limits in the Northwest Atlantic, Gulf of Mexico, and U.S. Caribbean regions from default levels to six swordfish per vessel per trip (80 FR 44884). Through December 31, 2015, directed swordfish landings for the July through December semi-annual period were approximately 659.9 mt dw (43.9 percent of the adjusted directed sub-quota). Preliminary total annual directed swordfish landings, through December 31, 2015, were approximately 1,152.9 mt dw, or 38.3 percent of the 3,010 mt dw annual adjusted directed swordfish quota. A six swordfish per vessel trip limit for SWO General Commercial permit holders was maintained for the period January 1, 2016, through June 30, 2016, in the Northwest Atlantic, Gulf of Mexico, and U.S. Caribbean regions (80 FR 81770). As of April 30, 2016, directed swordfish landings were 268.2 mt dw (or 17.8% of the anticipated 1,504.7 mt dw adjusted directed sub-quota).

    Given that directed swordfish landings in 2015 fell well below the adjusted 2015 annual quota, and that 2016 directed landings continue to be below the anticipated 2016 annual swordfish quota, and considering the regulatory criteria, NMFS has determined that the SWO General Commercial permit vessel retention limits in the Northwest Atlantic, Gulf of Mexico, and U.S. Caribbean regions applicable to persons issued a SWO General Commercial permit or HMS Charter/Headboat permit (when on a non for-hire trip) should be increased from the default levels that would otherwise automatically become effective on July 1, 2016.

    A principal consideration is the objective of providing opportunities to harvest the full North Atlantic directed swordfish quota without exceeding it based upon the 2006 Consolidated HMS FMP goal to, consistent with other objectives of this FMP, “manage Atlantic HMS fisheries for continuing optimum yield so as to provide the greatest overall benefit to the Nation, particularly with respect to food production, providing recreational opportunities, preserving traditional fisheries, and taking into account the protection of marine ecosystems.” At the same time, it is also important for NMFS to continue to provide protection to important swordfish juvenile areas and migratory corridors.

    After considering all of the relevant criteria, NMFS has determined that increases from the default limits are warranted. With respect to the regulatory criteria, NMFS has examined dealer reports and landing trends and determined that the information obtained from biological sampling and monitoring of the North Atlantic swordfish stock is useful. Recently implemented electronic dealer reporting provides accurate and timely monitoring of landings. This information indicates that sufficient directed swordfish quota will be available from July 1 through December 31, 2016, at the higher retention levels, if recent swordfish landing trends continue. Regarding the regulatory criterion that NMFS consider “the estimated ability of vessels participating in the fishery to land the amount of swordfish quota available before the end of the fishing year,” the directed swordfish quota has not been harvested for several years and, based upon current landing trends, is not likely to be harvested or exceeded during the remainder of 2016. Based upon recent landings rates from dealer reports, an increase in the vessel retention limit for SWO General Commercial permit holders is not likely to cause quotas for other categories of the fishery to be exceeded. Similarly, regarding the criteria that NMFS consider the estimated amounts by which quotas for other categories of the fishery might be exceeded and the effects of catch rates in one region precluding vessels in another region from having a reasonable opportunity to harvest a portion of the overall swordfish quota, NMFS expects there to be sufficient swordfish quota for 2016, and thus increased catch rates in these three regions are not expected to preclude vessels in any of the other regions from having a reasonable opportunity to harvest a portion of the overall swordfish quota. Landings by vessels issued this permit (and Charter/Headboat permitted vessels on a non for-hire trip) are counted against the adjusted directed swordfish quota. As indicated above, this quota has not been exceeded for several years and, based upon current landing trends, is not likely to be exceeded during the remainder of 2016.

    With regard to swordfish abundance, the 2015 report by ICCAT's Standing Committee on Research and Statistics indicated that the North Atlantic swordfish stock is not overfished (B2011/Bmsy = 1.14), and overfishing is not occurring (F2011/Fmsy = 0.82). Increasing the retention limits for this U.S. handgear fishery is not expected to affect the swordfish stock status determination because any additional landings would be in compliance with the ICCAT recommended U.S. North Atlantic swordfish quota allocation.

    Based upon landings over the last several years, including 2016, it is highly unlikely that either of the two semi-annual directed swordfish subquotas would be harvested with the default retention limits of three swordfish per vessel per trip (Northwest Atlantic and Gulf of Mexico), and two swordfish per vessel per trip (U.S. Caribbean). For the entire 2015 fishing year, 38.3 percent of the total adjusted directed swordfish quota was harvested. Thus far, swordfish landings in 2016 have been less than landings during the same period in 2015.

    Increasing the swordfish General Commercial permit retention limits to six fish per vessel per trip will increase the likelihood that directed swordfish landings will approach, but not exceed, the total annual directed swordfish quota. Increasing opportunity beginning on July 1, 2016, is also important because of the migratory nature and seasonal distribution of swordfish, one of the regulatory criteria to be considered when changing the retention limit inseason (variations in seasonal distribution, abundance, or migration patterns of swordfish). In a particular geographic region, or waters accessible from a particular port, the amount of fishing opportunity for swordfish may be constrained by the short amount of time the swordfish are present as they migrate. Dealer reports for Swordfish General Commercial permitted vessels indicate that swordfish are available from July through December in the Northwest Atlantic, Gulf of Mexico, and U.S. Caribbean regions.

    Based upon these considerations, NMFS has determined that a six-fish per vessel per trip swordfish General Commercial permit retention limit is warranted in the Northwest Atlantic, Gulf of Mexico, and U.S. Caribbean regions from July 1, 2016 through December 31, 2016, for swordfish General Commercial permitted vessels and HMS Charter/Headboat permitted vessels when on a non for-hire trip. This will provide a reasonable opportunity to harvest the U.S. quota of swordfish without exceeding it, while maintaining an equitable distribution of fishing opportunities; help achieve optimum yield in the swordfish fishery; allow for the collection of data for stock monitoring purposes; and be consistent with the objectives of the 2006 Consolidated HMS FMP, as amended. With regard to the objectives of the FMP, this adjustment provides the greatest overall benefit to the Nation, particularly with respect to food production, by increasing commercial swordfish fishing opportunities without exceeding the available quota. It helps to preserve a traditional swordfish handgear fishery (rod and reel, handline, harpoon, bandit gear, and greenstick) which, in New England, dates back to the 1880s. Although this action does not specifically provide recreational fishing opportunities, it will have a minimal impact on this sector because recreational landings are counted against a separate incidental swordfish quota. Finally, as discussed in the next paragraph, this action takes into account the protection of marine ecosystems by maintaining a zero-fish retention limit in the Florida Swordfish Management Area. Therefore, NMFS increases the swordfish General Commercial permit retention limits from the default levels to six swordfish per vessel per trip in these three regions, effective from July 1, 2016 through December 31, 2016, unless otherwise noticed.

    NMFS has determined that the retention limit will remain at zero swordfish per vessel per trip in the Florida SWO Management Area at this time. As described in Amendment 8 to the 2006 Consolidated HMS FMP, the area off the southeastern coast of Florida, particularly the Florida Straits, contains oceanographic features that make the area biologically unique. It provides important juvenile swordfish habitat, and is essentially a narrow migratory corridor containing high concentrations of swordfish located in close proximity to high concentrations of people who may fish for them. Public comment on Amendment 8, including from the Florida Fish and Wildlife Conservation Commission, indicated concern about the resultant high potential for the improper rapid growth of a commercial fishery, increased catches of undersized swordfish, the potential for larger numbers of fishermen in the area, and the potential for crowding of fishermen, which could lead to gear and user conflicts. These concerns remain valid. NMFS will continue to collect information to evaluate the appropriateness of the retention limit in the Florida SWO Management Area and other regional retention limits.

    These adjustments are consistent with the 2006 Consolidated HMS FMP as amended, ATCA, and the Magnuson-Stevens Act, and are not expected to negatively impact stock health.

    Monitoring and Reporting

    NMFS will continue to monitor the swordfish fishery closely during 2016 through mandatory landings and catch reports. Dealers are required to submit landing reports and negative reports (if no swordfish were purchased) on a weekly basis.

    Depending upon the level of fishing effort and catch rates of swordfish, NMFS may determine that additional retention limit adjustments or closures are necessary to ensure that available quota is not exceeded or to enhance fishing opportunities. Subsequent actions, if any, will be published in the Federal Register. In addition, fishermen may access http://www.nmfs.noaa.gov/sfa/hms/species/swordfish/landings/index.html for updates on quota monitoring.

    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 to respond to changes in swordfish landings, the availability of swordfish on the fishing grounds, the migratory nature of this species, and regional variations in the fishery. Based on available swordfish quota, stock abundance, fishery performance in recent years, and the availability of swordfish on the fishing grounds, among other considerations, adjustment to the swordfish General Commercial permit retention limits from the default levels is warranted. Analysis of available data shows that adjustment to the swordfish daily retention limit from the default levels would result in minimal risks of exceeding the ICCAT-allocated quota. NMFS provides notification of retention limit adjustments 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 HMS Breaking News” Web site at http://www.nmfs.noaa.gov/sfa/hms/news/breaking_news.html.

    Delays in temporarily increasing these retention limits caused by the time required to publish a proposed rule and accept public comment would adversely affect those SWO General Commercial permit holders and HMS Charter/Headboat permit holders that would otherwise have an opportunity to harvest more than the default retention limits of three swordfish per vessel per trip in the Northwest Atlantic and Gulf of Mexico regions, and two swordfish per vessel per trip in the U.S. Caribbean region. Further, any delay beyond July 1, 2016, the start of the second semi-annual directed fishing period, could exacerbate the problem of low swordfish landings and subsequent quota rollovers. Limited opportunities to harvest the directed swordfish quota may have negative social and economic impacts for U.S. fishermen. Adjustment of the retention limits needs to be effective on July 1, 2016, to allow all of the affected sectors to benefit from the adjustment during the relevant time period, which could pass by for some fishermen if the action is delayed for notice and public comment, and to not preclude fishing opportunities for fishermen who have access to the fishery during a short time period because of seasonal fish migration. 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 also 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 635.24(b)(4) and is exempt from review under Executive Order 12866.

    Authority:

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

    Dated: June 9, 2016. Alan D. Risenhoover, Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-14068 Filed 6-14-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 150902808-6451-02] RIN 0648-BF04 Fisheries of the Northeastern United States; Amendment 17 to the Atlantic Surfclam and Ocean Quahog Fishery Management Plan AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    This final rule approves and implements management measures contained in Amendment 17 to the Atlantic Surfclam and Ocean Quahog Fishery Management Plan. Amendment 17 management measures were developed by the Mid-Atlantic Fishery Management Council to: Add cost recovery provisions for the Individual Transferable Quota component of the fishery; modify how biological reference points are incorporated into the fishery management plan; and remove the plan's optimum yield range. These changes are intended to make the management plan consistent with requirements of the Magnuson-Stevens Act, and to improve the management of these fisheries.

    DATES:

    This rule is effective July 15, 2016.

    ADDRESSES:

    Copies of Amendment 17 and the Environmental Assessment (EA), with its associated Finding of No Significant Impact (FONSI) and the Regulatory Impact Review (RIR), are available from the Mid-Atlantic Fishery Management Council, 800 North State Street, Suite 201, Dover, DE 19901. The Amendment 17 EA/FONSI/RIR is also accessible online at: www.greateratlantic.fisheries.noaa.gov.

    FOR FURTHER INFORMATION CONTACT:

    Douglas Potts, Fishery Policy Analyst, 978-281-9341.

    SUPPLEMENTARY INFORMATION:

    Background

    This final rule concurrently approves Amendment 17 to the Atlantic Surfclam and Ocean Quahog Fishery Management Plan (FMP) on behalf of the Secretary of Commerce and finalizes implementing regulations. The Mid-Atlantic Fishery Management Council developed this amendment to establish a program to recover the costs of managing the surfclam and ocean quahog individual transferable quota (ITQ) fisheries, as required by the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), and to make administrative changes to improve the efficiency of the FMP. We published a notice of availability on February 24, 2016 (81 FR 9159), announcing a 60-day period for the public to review and provide written comments on whether we, acting on behalf of the Secretary of Commerce, should approve Amendment 17. This comment period ended on April 25, 2016. On March 16, 2016, we published a proposed rule (81 FR 14072) to implement the amendment, and solicited written comments on the proposed rule for a 30-day period, which ended on April 15, 2016.

    We reviewed all comments received during these comment periods, whether directed at our approval decision or the proposed regulations. See Comments and Responses section for more information. Now, on behalf of the Secretary of Commerce, we are approving and implementing Amendment 17, consistent with the review and approval process outlined in section 304 of the Magnuson-Stevens Act (16 U.S.C. 1854).

    Cost Recovery Program

    The Magnuson-Stevens Act requires each limited access privilege program (LAPP), such as the surfclam/ocean quahog ITQ program, to include measures to recover the costs of management, data collection and analysis, and enforcement activities involved with the program. This action implements a cost recovery program for the surfclam and ocean quahog ITQ fisheries modeled on the Council's existing cost recovery program for the Tilefish Individual Fishing Quota (IFQ) Program.

    Under the program, any surfclam or ocean quahog ITQ permit holder who has quota share (i.e., receives an initial allocation of cage tags each year) will be responsible for paying a fee at the end of the year. The fee will be based on the number of the ITQ permit holder's cage tags that were used to land clams that year. In the first quarter of each year, the Greater Atlantic Regional Fisheries Office (GARFO) will announce the fee percentage and the associated per-tag fee for that year, and distribute this announcement widely, and distribution will include posting the announcement online and sending it to each ITQ permit holder. Annual fee information will not be published in the Federal Register. The fee percentage will be based on the total recoverable costs from the prior fiscal year, adjusted for any prior over- or under-collection, divided by the total ex-vessel value of the fishery. The resulting percentage cannot exceed the 3-percent statutory maximum. Then NMFS will calculate a per-tag fee based on the total number of cage tags used to land surfclams or ocean quahogs in the previous year. This tag fee will be separate from, and in addition to, the price ITQ permit holders currently pay to the tag vendor to obtain the physical cage tags each year. If an ITQ permit holder transfers some or all of his or her cage tags or quota share after the start of the fishing year, they will still be liable for any cost recovery fee based on landings of the initial allocation of cage tags.

    This process includes an inherent assumption that a similar number of cage tags will be used each year. While the fishery has been largely stable over time, many factors (e.g., weather events, market demand, etc.) may result in the use of more or fewer tags in any given year. As a result, we fully anticipate that, in some years, we will collect more or less money than is necessary to recover our costs. Refunding over-collections and issuing supplemental bills to make up for shortfalls would increase the cost of administering the fishery, which would increase the amount charged in bills the following year. To avoid these additional costs, we will apply any over- or under-collection to our calculation of recoverable costs and per-tag fees for the following year. Our communications with ITQ permit holders each year will make clear that any prior over- or under-collection adjustments will be incorporated into the following year's cost-recovery billing.

    Under the cost recovery program established by this final rule, at the start of the 2017 calendar year, we will use the total recoverable costs from the 2016 fiscal year (October 1, 2015, through September 30, 2016) and the total value of the fisheries in the 2016 calendar year to calculate fee percentages for both surfclam and ocean quahogs. We will then use the total number of tags used during the 2016 calendar year to determine a per-tag fee for the 2017 calendar year.

    In early 2018 (most likely February or March) we will issue the first cost recovery bills based on the previously announced per-tag fee and the number of cage tags that were used to land surfclams or ocean quahogs in 2017. At the same time, we will announce the fee percentage and per-tag fees for the 2018 fishing year. This anticipated timeline is detailed in Table 1.

    Table 1—Surfclam and Ocean Quahog Cost Recovery Implementation Timeline Date Anticipated action October 2015 We began tracking recoverable costs for surfclam and ocean quahog ITQ fisheries during fiscal year 2016. March 2017 We will announce the 2017 cost recovery per-tag fee, based on recoverable costs in fiscal year 2016 and the total number of cage tags used in calendar year 2016. March 2018 We will issue a 2017 bill to each ITQ permit holder based on the previously announced per-tag fee and how many of the ITQ permit holder's 2017 cage tags were used to land clams. March 2018 Concurrent with issuing bills for 2017, we will announce the 2018 cost recovery per-tag fee, based on costs in fiscal year 2017 (adjusted for any anticipated over- or under-collection) and the total number of cage tags used in calendar year 2017. Subsequent years Each year, we will issue bills for the previous fishing year and announce the cost recovery per-tag fee for the current fishing year.

    Cost recovery bills will be due within 30 days of the date of the bill, and must be paid using the GARFO fishing industry Web site: Fish Online (www.greateratlantic.fisheries.noaa.gov/apps/login/login). Fish Online is a secure Web site and we provide a username and password for individuals to access their accounts. Members of the fishing industry may use the site to check details about their fishing permit and landings. The Web page has been used since 2010 to collect cost recovery payments for the Tilefish IFQ and Limited Access General Category Scallop IFQ fisheries. Cost recovery bills may be paid with a credit card or with an account number and routing number from a bank account, often referred to as an Automated Clearing House or ACH payment. Once bills are issued, ITQ permit holders will be able to log onto Fish Online and access the Cost Recovery section. Payments made through Fish Online are processed using the U.S. Treasury Department's Pay.gov tool, and no bank account or credit card information is retained by NMFS. We will not be able to accept partial payments or advance payments before bills are issued. We do not anticipate that other payment methods will be accepted, as the current payment system has been effective for other cost recovery programs. However, other payment methods may be authorized if the Regional Administrator determines that electronic payment is not practicable.

    The cost recovery program implemented by this final rule includes procedures in case an ITQ permit holder should fail to pay their cost recovery bill. If a bill is not paid by the due date, NMFS would issue a demand letter, formally referred to as an initial administrative determination. This letter would describe the past-due fee, describe any applicable interest or penalties that may apply, stipulate a 30-day deadline to either pay the amount due or submit a formal appeal to the Regional Administrator, and provide instructions for submitting such an appeal. If no appeal is submitted by the deadline, the Regional Administrator would issue a final determination based on the information already on file. An appeal must be submitted in writing, allege credible facts or circumstances, and include any relevant information or documentation to support the appeal. If an appeal is submitted, the Regional Administrator would appoint an appeals officer to determine if there is sufficient information to support the appeal and that all procedural requirements have been met. The appeals officer would then review the record and issue a recommendation to the Regional Administrator. The Regional Administrator, acting on behalf of the Secretary of Commerce, would then review the appeal and issue a written decision. If the Regional Administrator's final determination (whether or not there was an appeal) finds that ITQ permit holder is out of compliance, full payment would be required within 30 days. Following a final determination, we may also prohibit any transfer of cage tags or quota share, or renewal of the ITQ permit until full payment, including any interest or penalties, is received. If full payment is not received within this final 30-day period as required, we may then refer the matter to the Department of Treasury for collection.

    Each year NMFS will issue a report on the status of the ITQ cost recovery program. This report will provide details of the recoverable costs to be collected, the success of previous collection efforts, and other relevant information.

    Biological Reference Points

    Under National Standard 1, the Magnuson-Stevens Act requires that each Council FMP define overfishing as a rate or level of fishing mortality (F) that jeopardizes a fishery's capacity to produce maximum sustainable yield (MSY) on a continuing basis, and defines an overfished stock as a stock size that is less than a minimum biomass threshold (see 50 CFR 600.310(e)(2)). The Magnuson-Stevens Act also requires that each FMP specify objective and measurable status determination criteria (i.e., biological reference points (BRPs)) for identifying when stocks covered by the FMP are overfished or subject to overfishing (see section 303(a)(10), 16 U.S.C. 1853). To fulfill these requirements, status determination criteria are comprised of two components: (1) A maximum fishing mortality threshold; and (2) a minimum stock size threshold.

    This action modifies how these BRPs are incorporated in the FMP. Rather than using specific definitions, the FMP will now include broad criteria to allow for greater flexibility in incorporating changes to the definitions of the maximum fishing mortality threshold and/or minimum stock size threshold as the best scientific information becomes available, consistent with National Standards 1 and 2. The Council has already adopted this approach in several of its other FMPs, and this change will make the Surfclam and Ocean Quahog FMP consistent with these other FMPs. Further details of this change were provided in the preamble to the proposed rule and are not repeated here.

    Optimum Yield

    This action removes the optimum yield ranges (1.85-3.40 million bushels (98.5 to 181.0 million L) for surfclam, and 4.00-6.00 million bushels (213.0 to 319.4 million L) for ocean quahog) from the FMP, as explained in detail in the preamble to the proposed rule. As part of the normal specifications process, the Council's Scientific and Statistical Committee will recommend Acceptable Biological Catch limits, and the Surfclam and Ocean Quahog Advisory Panel will develop recommendations for commercial quotas, including optimum yield recommendations. This information will be provided to the Council to inform its decisions regarding annual catch limits, catch targets, and commercial harvest quotas.

    Corrections and Clarifications

    Apart from the management measures in Amendment 17, this action modifies the Atlantic surfclam and ocean quahog regulations pursuant to the Secretary's authority under section 305(d) of the Magnuson-Stevens Act (16 U.S.C. 1855(d)) to ensure that FMPs are implemented as intended and consistent with the requirements of the Magnuson-Stevens Act. This action modifies the regulations at 50 CFR 648.11(a) so that vessels holding a Federal permit for Atlantic surfclam or ocean quahog are included on the list of vessels required to carry a NMFS-certified fisheries observer if requested by the Regional Administrator. A detailed explanation for this change was provided in the preamble of the proposed rule and is not repeated here.

    In addition, this final rule includes corrections for two minor errors in the existing regulations that were not addressed in the proposed rule. These corrections (for an error in a cross-reference and a conversion error) are described below in more detail.

    Changes From the Proposed Rule

    As mentioned above, this final rule corrects two minor errors in the regulations that were not mentioned in the proposed rule. After publication of the proposed rule, two minor errors were discovered in the current surfclam and ocean quahog regulations. A cross reference in § 648.75(a)(2)(iii) refers to the wrong sub-paragraph, and § 648.76(a) contains an erroneous conversion from nautical miles to kilometers. Both errors, which were inadvertently introduced by a September 29, 2011, final rule (76 FR 60606), are corrected in this final rule.

    We also have modified a portion of the proposed rule language that would add a new paragraph (c) to the existing regulations at § 648.74, pertaining to the consequences for failing to pay a cost recovery fee. The proposed rule language at § 648.74(c)(6)(iii)(C)(1) would have authorized NMFS to suspend an ITQ permit for non-payment until the outstanding fee is paid in full. As a result of suspension of an ITQ permit for non-payment, the ITQ permit holder would have been prohibited from transferring quota share or cage tags and from using any previously issued cage tags. In addition, renewal of the permit could be prohibited in subsequent years until payment is received. The resulting prohibition on using previously issued cage tags for the current fishing year was potentially more punitive than necessary, and was inconsistent with other catch share programs that we administer around the country. Therefore, the language of this final rule at § 648.74(c)(6)(iii)(C)(1) does not authorize suspension of the current ITQ permit, but instead authorizes the Regional Administrator to disapprove any application to transfer quota share or cage tags to or from the ITQ permit holder and to deny issuance of an ITQ permit in subsequent years, until full payment is received. Thus, the current ITQ permit would remain valid and any previously issued cage tags could continue to be used to land clams for the remainder of that fishing year.

    Comments and Responses

    A total of five comments were received on the proposed rule and notice of availability. One commenter did not address the proposed action, but was generally opposed to commercial fishing and our management of the resource. The four other comments were submitted by members and representatives of the commercial surfclam and ocean quahog industry. All four letters made similar points, which are discussed by topic.

    Comment 1: Commenters from the clam industry assert that the Magnuson-Stevens Act only requires collection of the incremental costs of a LAPP, and that if those costs are negative then no cost recovery program is necessary. To support this position, they cite the 2010 NOAA Catch Share Policy document. The commenters state that the costs of managing the clam fishery are significantly lower now, under the ITQ, than they were in the 1980s. As a result, they assert that cost recovery is not necessary and should not be imposed on the surfclam and ocean quahog ITQ program.

    Response: The 2010 NOAA Catch Share Policy document represents a series of guiding principles for consideration when developing a catch share program. It does not, however, have the force of law or represent binding requirements for all catch share programs. In discussions of cost recovery, the document does state that the relevant costs for cost recovery would be the incremental costs of the catch share program, and describes how those costs may be determined using a before and after comparison, effectively describing the net costs of the program. This language was taken from the 2007 report “The Design and Use of Limited Access Privilege Programs,” by editors Lee Anderson and Mark Holliday (NOAA Technical Memorandum NMFS-F/SPO-86). Since the publication of the 2007 report, it has become common to use the terms “recoverable costs” and “incremental costs” interchangeably. However, there are several problems with using this approach to determining recoverable costs in a LAPP.

    The Magnuson-Stevens Act does not use the term “incremental costs” when addressing cost recovery in LAPPs. Section 304(d)(2)(A) of the Act requires the Secretary to “collect a fee to recover the actual costs directly related to the management, data collection, and enforcement” (emphasis added) of any LAPP. The GARFO has consistently advised the Council that this requirement is best interpreted to refer to costs that are specific to the LAPP, and that would not have been incurred if the fishery was not managed as a LAPP. This approach is consistently applied across other LAPPs in the Greater Atlantic Region. For the surfclam and ocean quahog ITQ program, these costs would include the costs of issuing and renewing ITQ permits, processing cage tag transfers, and tracking cage tag usage. There are always some new tasks associated with a new LAPP, so while these costs could be low they could not be negative.

    Comment 2: One commenter claims that the cost recovery program will require the industry to pay for at-sea observers.

    Response: As described in the previous response, we have determined that the recoverable costs are for tasks that would not be conducted if not for the ITQ program. Current observer coverage in the surfclam and ocean quahog fisheries is based on the standardized bycatch reporting methodology (SBRM). Coverage specified under the SBRM is paid for by the Federal Government through NMFS. The SBRM is a requirement for all fisheries managed by the Council and is not specific to the ITQ. Therefore, the cost of SBRM observer coverage would not be considered recoverable under this program.

    Comment 3: The four members of the clam industry that provided comments express opposition to the proposed change to how BRPs are incorporated into the FMP. The commenters maintain that this change is discretionary on the part of the Council, that the proposed criteria for acceptable peer review is not rigorous enough, and that any change could lead to instability in the management of these fisheries.

    Response: As mentioned above, National Standard 1 guidelines direct all FMPs to specify BRPs, and National Standard 2 requires all conservation and management measures to be based on the best scientific information available. Under the current specifications process, when new BRPs are identified through an approved scientific review, they are used in setting management measures consistent with National Standard 2, even though they may differ from the BRPs in the FMP. This can lead to inconsistencies between the information in the FMP and what is used for management, and such inconsistencies can linger and cause confusion for years before an appropriate FMP amendment is developed and implemented. The Council has elected to use a broad and standardized list of potential peer review processes for establishing new BRPs. This allows the Council to maintain some consistency between FMPs, while ensuring that the best available scientific information is readily available for use in decision making, but does not mean that all potential peer review processes are equally applicable to every stock the Council manages. Consistent with the process now used by the Council and its SSC, each stock assessment is evaluated based on the information available and how well it performs relative to previous assessments. This change to the FMP does not reduce the scientific rigor needed to establish BRPs for the surfclam and ocean quahog stocks. We acknowledge that this change to the Council's FMP is discretionary, as it is not specifically mandated by any statute. However, the Council is free to determine how best to manage its fisheries and to make such modifications to its FMPs, if those changes are consistent with applicable law. Because updated BRPs are already used in setting management measures for surfclam and ocean quahog, regardless of the BRPs that are formally stated in the FMP, the modification will have no practical impact on the specification-setting process. The change implemented by this final rule will make the plan consistent with other Council FMPs and established practice.

    Comment 4: The four members of the clam industry that provided comment express opposition to the proposed removal of the optimum yield ranges for surfclams and ocean quahogs and support for the no-action alternative. The commenters state that the change is unnecessary and that they are concerned that removing the optimum yield ranges from the FMP could result in significant and rapid changes in harvest quotas.

    Response: As stated in the previous response, the Council has the flexibility to determine how best to manage its fisheries and to make such modifications to its FMPs, if those changes are consistent with applicable law. As discussed in the preamble of this rule, the current optimum yield ranges specified in the FMP have been in place for many years and no longer reflect our understanding of the biology of the stocks. Because the optimum yield ranges in the FMP are not connected to the maximum sustainable yield, the use of the term is inconsistent with how the term “optimum yield” is used in the current National Standard 1 guidance. For these reasons, the Council has opted to remove the ranges from the FMP. The industry's preference for a constant harvest strategy is well known, and the Council is free to factor that preference into its specifications-setting process and support consistent harvest quotas for surfclams and ocean quahogs. The surfclam and ocean quahog industry has consistently been an invaluable partner in the successful management of these species. We are confident that this partnership will continue in the future, and that the Council will give full consideration to the preferences of the industry when considering harvest quotas.

    Classification

    Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the Administrator, Greater Atlantic Region, NMFS, has determined that this final rule is consistent with Amendment 17, other provisions of the Magnuson-Stevens Act, and other applicable law.

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

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

    List of Subjects in 50 CFR Part 648

    Fisheries, Fishing, Reporting and recordkeeping requirements.

    Dated: June 9, 2016. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 648 is amended as follows:

    PART 648—FISHERIES OF THE NORTHEASTERN UNITED STATES 1. The authority citation for part 648 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq.

    2. In § 648.11, revise paragraph (a) to read as follows:
    § 648.11 At-sea sea sampler/observer coverage.

    (a) The Regional Administrator may request any vessel holding a permit for Atlantic sea scallops, NE multispecies, monkfish, skates, Atlantic mackerel, squid, butterfish, scup, black sea bass, bluefish, spiny dogfish, Atlantic herring, tilefish, Atlantic surfclam, ocean quahog, or Atlantic deep-sea red crab; or a moratorium permit for summer flounder; to carry a NMFS-certified fisheries observer. A vessel holding a permit for Atlantic sea scallops is subject to the additional requirements specific in paragraph (g) of this section. Also, any vessel or vessel owner/operator that fishes for, catches or lands hagfish, or intends to fish for, catch, or land hagfish in or from the exclusive economic zone must carry a NMFS-certified fisheries observer when requested by the Regional Administrator in accordance with the requirements of this section.

    3. In § 648.72, revise paragraph (a) introductory text and paragraph (a)(1) to read as follows:
    § 648.72 Surfclam and ocean quahog specifications.

    (a) Establishing catch quotas. The amount of surfclams or ocean quahogs that may be caught annually by fishing vessels subject to these regulations will be specified for up to a 3-year period by the Regional Administrator. Specifications of the annual quotas will be accomplished in the final year of the quota period, unless the quotas are modified in the interim pursuant to paragraph (b) of this section.

    (1) Quota reports. On an annual basis, MAFMC staff will produce and provide to the MAFMC an Atlantic surfclam and ocean quahog annual quota recommendation paper based on the ABC recommendation of the SSC, the latest available stock assessment report prepared by NMFS, data reported by harvesters and processors, and other relevant data, as well as the information contained in paragraphs (a)(1)(i) through (vi) of this section. Based on that report, and at least once prior to August 15 of the year in which a multi-year annual quota specification expires, the MAFMC, following an opportunity for public comment, will recommend to the Regional Administrator annual quotas and estimates of DAH and DAP for up to a 3-year period. In selecting the annual quotas, the MAFMC shall consider the current stock assessments, catch reports, and other relevant information concerning:

    (i) Exploitable and spawning biomass relative to the quotas.

    (ii) Fishing mortality rates relative to the quotas.

    (iii) Magnitude of incoming recruitment.

    (iv) Projected effort and corresponding catches.

    (v) Geographical distribution of the catch relative to the geographical distribution of the resource.

    (vi) Status of areas previously closed to surfclam fishing that are to be opened during the year and areas likely to be closed to fishing during the year.

    4. In § 648.74, add paragraph (c) to read as follows:
    § 648.74 Individual Transferable Quota (ITQ) Program.

    (c) ITQ cost recovery—(1) General. The cost recovery program collects fees of up to three percent of the ex-vessel value of surfclams or ocean quahogs harvested under the ITQ program in accordance with the Magnuson-Stevens Act. NMFS collects these fees to recover the actual costs directly related to the management, data collection, and enforcement of the surfclam and ocean quahog ITQ program.

    (2) Fee responsibility. If you are an ITQ permit holder who holds ITQ quota share and receives an annual allocation pursuant to paragraph (a) of this section, you shall incur a cost recovery fee, based on all landings of surfclams or ocean quahogs authorized under your initial annual allocation of cage tags. You are responsible for paying the fee assessed by NMFS, even if the landings are made by another ITQ permit holder (i.e., if you transfer cage tags to another individual who subsequently uses those tags to land clams). If you permanently transfer your quota share, you are still responsible for any fee that results from your initial annual allocation of cage tags even if the landings are made after the quota share is permanently transferred.

    (3) Fee basis. NMFS will establish the fee percentages and corresponding per-tag fees for both the surfclam and ocean quahog ITQ fisheries each year. The fee percentages cannot exceed three percent of the ex-vessel value of surfclams and ocean quahogs harvested under the ITQ fisheries pursuant to section 304(d)(2)(B) of the Magnuson-Stevens Act.

    (i) Calculating fee percentage. In the first quarter of each calendar year, NMFS will calculate the fee percentages for both the surfclam and ocean quahog ITQ fisheries based on information from the previous year. NMFS will use the following equation to annually determine the fee percentages: Fee percentage = the lower of 3 percent or (DPC/V) × 100, where:

    (A) “DPC,” or direct program costs, are the actual incremental costs for the previous fiscal year directly related to the management, data collection, and enforcement of the ITQ program. “Actual incremental costs” mean those costs that would not have been incurred but for the existence of the ITQ program. If the amount of fees collected by NMFS is greater or lesser than the actual incremental costs incurred, the DPC will be adjusted accordingly for calculation of the fee percentage in the following year.

    (B) “V” is the total ex-vessel value from the previous calendar year attributable to the ITQ fishery.

    (ii) Calculating per-tag fee. To facilitate fee collection, NMFS will convert the annual fee percentages into per-tag fees for both the surfclam and ocean quahog ITQ fisheries. NMFS will use the following equation to determine each per-tag fee: Per-Tag Fee = (Fee Percentage × V)/T, where:

    (A) “T” is the number of cage tags used, pursuant to § 648.77, to land shellfish in the ITQ fishery in the previous calendar year.

    (B) “Fee percentage” and “V” are defined in paragraph (c)(3)(i) of this section.

    (C) The per-tag fee is rounded down so that it is expressed in whole cents.

    (iii) Publication. During the first quarter of each calendar year, NMFS will announce the fee percentage and per-tag fee for the surfclam and ocean quahog ITQ fisheries, and publish this information on the Regional Office Web site (www.greateratlantic.fisheries.noaa.gov).

    (4) Calculating individual fees. If you are responsible for a cost recovery fee under paragraph (c)(2) of this section, the fee amount is the number of ITQ cage tags you were initially allocated at the start of the fishing year that were subsequently used to land shellfish multiplied by the relevant per-tag fee, as described in paragraph (c)(3)(ii) of this section. If no tags from your initial allocation are used to land clams you will not incur a fee.

    (5) Fee payment and collection. NMFS will send you a bill each year for any applicable ITQ cost recovery fee.

    (i) Payment due date. You must submit payment within 30 days of the date of the bill.

    (ii) Payment method. You may pay your bill electronically using a credit card or direct Automated Clearing House withdrawal from a designated checking account through the Federal web portal, www.pay.gov, or another internet site designated by the Regional Administrator. Instructions for electronic payment will be included with your bill and are available on the payment Web site. Alternatively, payment by check may be authorized by the Regional Administrator if he/she determines that electronic payment is not practicable.

    (6) Payment compliance. If you do not submit full payment by the due date, NMFS will notify you in writing via an initial administrative determination (IAD) letter.

    (i) IAD. In the IAD, NMFS will:

    (A) Describe the past-due fee;

    (B) Describe any applicable interest charges that may apply;

    (C) Provide you 30 days to either pay the specified amount or submit an appeal; and

    (D) Include instructions for submitting an appeal.

    (ii) Appeals. If you wish to appeal the IAD, your appeal must:

    (A) Be in writing;

    (B) Allege credible facts or circumstances;

    (C) Include any relevant information or documentation to support your appeal; and

    (D) Be received by NMFS no later than 30 calendar days after the date on the IAD. If the last day of the time period is a Saturday, Sunday, or Federal holiday, the time period will extend to the close of the business on the next business day. Your appeal must be mailed or hand delivered to the address specified in the IAD.

    (iii) Final decision—(A) Final decision on your appeal. If you appeal an IAD, the Regional Administrator shall appoint an appeals officer. After determining there is sufficient information and that all procedural requirements have been met, the appeals officer will review the record and issue a recommendation on your appeal to the Regional Administrator, which shall be advisory only. The recommendation must be based solely on the record. Upon receiving the findings and recommendation, the Regional Administrator, acting on behalf of the Secretary of Commerce, will issue a written decision on your appeal which is the final decision of the Department of Commerce.

    (B) Final decision if you do not appeal. If you do not appeal the IAD within 30 calendar days, NMFS will notify you via a final decision letter. The final decision will be from the Regional Administrator and is the final decision of the Department of Commerce.

    (C) If the final decision determines that you are out of compliance. (1) The Regional Administrator may, at any time thereafter, disapprove any application to transfer quota share or cage tags under § 648.74(b), and prohibit issuance of the surfclam or ocean quahog ITQ permit for subsequent years, until the outstanding balance is paid in full.

    (2) The final decision will require full payment within 30 calendar days.

    (3) If full payment is not received within 30 calendar days of issuance of the final decision, NMFS may refer the matter to the appropriate authorities for the purposes of collection or enforcement.

    (7) Annual report. NMFS will publish annually a report on the status of the ITQ cost recovery program. The report will provide details of the costs incurred by NMFS for the management, data collection, and enforcement of the surfclam and ocean quahog ITQ program, and other relevant information at the discretion of the Regional Administrator.

    5. In § 648.75, revise paragraph (a)(2)(iii) to read as follows:
    § 648.75 Shucking at sea and minimum surfclam size.

    (a) * * *

    (2) * * *

    (iii) If the Regional Administrator makes the determination specified in paragraph (a)(2)(i) of this section, he/she may authorize the vessel owner to shuck surfclams or ocean quahogs at sea. Such authorization shall be in writing and be carried aboard the vessel.

    6. In § 648.76, revise paragraph (a)(1) to read as follows:
    § 648.76 Closed areas.

    (a) * * *

    (1) Boston Foul Ground. The waste disposal site known as the “Boston Foul Ground” and located at 42°25′36″ N. lat., 70°35′00″ W. long., with a radius of 1 nm (1.852 km) in every direction from that point.

    7. In § 648.79, revise paragraph (a)(1) to read as follows:
    § 648.79 Surfclam and ocean quahog framework adjustments to management measures.

    (a) * * *

    (1) Adjustment process. The MAFMC shall develop and analyze appropriate management actions over the span of at least two MAFMC meetings. The MAFMC must provide the public with advance notice of the availability of the recommendation(s), appropriate justification(s) and economic and biological analyses, and the opportunity to comment on the proposed adjustment(s) at the first meeting, and prior to and at the second MAFMC meeting. The MAFMC's recommendations on adjustments or additions to management measures must come from one or more of the following categories: Adjustments within existing ABC control rule levels; adjustments to the existing MAFMC risk policy; introduction of new AMs, including sub-ACTs; description and identification of EFH (and fishing gear management measures that impact EFH); habitat areas of particular concern; set-aside quota for scientific research; VMS; and suspension or adjustment of the surfclam minimum size limit. Issues that require significant departures from previously contemplated measures or that are otherwise introducing new concepts may require an amendment of the FMP instead of a framework adjustment.

    [FR Doc. 2016-14087 Filed 6-14-16; 8:45 am] BILLING CODE 3510-22-P
    81 115 Wednesday, June 15, 2016 Proposed Rules DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 930 [Doc. No. AMS-FV-15-0047; FV15-930-2 PR] Tart Cherries Grown in the States of Michigan, et al.; Revision of Optimum Supply Requirements and Establishment of Inventory Release Procedures AGENCY:

    Agricultural Marketing Service, USDA.

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule would implement recommendations from the Cherry Industry Administrative Board (Board) to add inventory release procedures and revise optimum supply provisions under the marketing order for tart cherries grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin (order). The Board locally administers the order and is comprised of growers and handlers operating within the production area. This rule would establish procedures for releasing inventory from reserves and increase the maximum carry-out volume available when calculating optimum supply from 20 million pounds to 100 million pounds. These changes would provide clear procedures should an inventory release be necessary and would provide more flexibility when calculating optimum supply.

    DATES:

    Comments must be received by July 15, 2016.

    ADDRESSES:

    Interested persons are invited to submit written comments concerning this proposal. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet: http://www.regulations.gov. All comments should reference the document number and the date and page number of this issue of the Federal Register and will be made available for public inspection in the Office of the Docket Clerk during regular business hours, or can be viewed at: http://www.regulations.gov. All comments submitted in response to this proposal will be included in the record and will be made available to the public. Please be advised that the identity of the individuals or entities submitting the comments will be made public on the internet at the address provided above.

    FOR FURTHER INFORMATION CONTACT:

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

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

    SUPPLEMENTARY INFORMATION:

    This proposal is issued under Marketing Order No. 930, as amended (7 CFR part 930), regulating the handling of tart cherries grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

    The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 12866, 13563, and 13175.

    This proposal has been reviewed under Executive Order 12988, Civil Justice Reform. This proposed rule is not intended to have retroactive effect.

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

    This proposal invites comments on changes that would add inventory release procedures and would revise the optimum supply and exemption provisions under the order. This proposal would establish procedures for releasing inventory from reserves and increase the maximum carry-out volume available when calculating optimum supply from 20 million pounds to 100 million pounds. These changes would provide clear procedures should an inventory release be necessary and would provide more flexibility when calculating optimum supply. The Board voted to recommend these proposed changes to the Secretary at its meeting on June 25, 2015.

    Section 930.50 prescribes procedures for calculating an optimum supply based on sales history to determine free and restricted percentages under volume regulation. As part of the process, the Board is required to determine the volume of fruit they anticipate would be necessary to have on hand at the end of the crop year. The order refers to this volume as carry-out inventory. This section currently specifies, in part, that the Board can consider a carry-out inventory of up to 20 million pounds, or another amount with the approval of the Secretary. This proposal would amend Section 930.151 to increase the maximum carry-out volume available when calculating optimum supply from 20 million pounds to 100 million pounds.

    Section 930.54 of the order governs the use or disposition of inventory reserve cherries. Under this authority, the Board can recommend to the Secretary that a portion or all of inventory reserve cherries be released if there is not sufficient fruit on the market to meet commercial demand. Sections 930.55 and 930.57 outline the provisions and requirements of the primary and secondary reserves, respectively. Further, no cherries in the secondary reserve may be released until all cherries in the primary reserve have been released. This proposal would create Section 930.154 to establish procedures for releasing inventory from reserves.

    When volume regulation is in place, the restricted portion of the crop is either held in reserve by handlers or can be sold for exempt uses as authorized in the rules and regulations of the order. Reserves can be held over multiple crop years and are released when there is a shortfall in supply. While the Board maintains record of the volume in reserve, handlers maintain ownership of the reserve fruit.

    All inventory reserves were released to meet demand following a crop disaster in 2012. The following year, the industry was still recovering and the Board did not recommend a volume regulation. When the Board recommended a volume regulation for the 2014-15 season to the Secretary, and cherries were again being added to the reserve, the Board established a committee to review the procedures for releasing restricted inventory from reserves. The committee recommended to the Board that the procedures as previously developed by the Board be maintained, and that any releases should first come from inventory currently in the primary reserve and then from any cherries designated for reserve from the current season if necessary.

    Under these procedures, once the additional volume needed for release is established, the release should be apportioned among handlers based on each handler's prior three-year average of volume handled as a percentage of the industry's three-year average. For example, if a handler handled five percent of the previous three years' production, and the Board recommended a release of 20 million pounds, that handler would potentially be authorized to release one million pounds of established reserves (.05 × 20 million). If a handler receives a release larger than what they have in the primary reserve, the excess amount would be reapportioned to those handlers with remaining primary reserve. If the handler in the scenario above had only 750,000 pounds in the primary reserve, the remaining 250,000 pounds would be reallocated to those handlers who still had inventory in the primary reserve.

    The committee that reviewed the procedures for releasing restricted inventory from the reserves recognized that inventory reserves can be accumulated over a period of years. Therefore, the committee agreed releases should be based on the average amount handled during the three previous crop years, rather than using a year-to-year basis. The existing release procedures were crafted by the Board through a series of actions in past years and meetings. However, the procedures were not codified in the rules and regulations under the order. This proposal would add the inventory release procedures to the regulations.

    This recommendation was also thought to be the most equitable way to conduct releases. One Board member believed the releases should come from the current year's reserves prior to releasing from existing reserves, and did not support the recommendation. However, the Board recognized that during the crop year, complete information on reserves and shipment data would not be available. Thus, the Board recommended codifying inventory release procedures as recommended by the committee. The Board supported the recommendation by a vote of 17-1. This proposal would add a new Section 930.154 to the regulations to establish procedures for releasing inventory from reserves.

    In addition to reviewing inventory release procedures, the Board discussed changes to some of its practices regarding calculation of optimum supply. Optimum supply is defined as the average free sales of the prior three years plus desirable carry-out inventory. Desirable carry-out is the amount of fruit needed by the industry to be carried into the succeeding crop year to meet marketing demand until the new crop is available. Desirable carry-out is set each year by the Board after considering market circumstances and needs. Section 930.50(a) currently specifies that desirable carry-out can range from 0 to a maximum of 20 million pounds, but also authorizes the Board to establish an alternative carry-out figure with the approval of the Secretary.

    Since the promulgation of the order, the industry has seen new products and new segments emerge, such as dried tart cherries. As a result, at the end of a season there are multiple product lines that need to be supplied with tart cherries before the next harvest, which has impacted desirable carry-out. Desirable carry-out is the amount of fruit needed by the industry to be carried into the succeeding crop year to meet marketing demand until the new crop is available.

    In 2014, the Board used its authority to recommend to the Secretary a carry-out volume above the order-prescribed 20 million pound maximum for the 2014-2015 crop year. At that time, the Board estimated it was necessary to have 50 million pounds available at the end of the crop year to fulfill the needs of the industry. In discussing volume regulation for the 2015-2016 crop year, the Board agreed an increased carry-out was again necessary and recommended to the Secretary a 55 million pound carry-out when calculating the optimum supply.

    In order to facilitate future carry-out needs without engaging with annual rulemaking, the Board recommended permanently increasing the maximum carry-out to 100 million pounds. Some members considered the 100 million pound upper limit to be too high, and voted against the recommendation. However, this proposed change would only increase the available range for the carry-out value from 0 to 20 million pounds to 0 to 100 million. This proposed amendment would provide the Board with additional flexibility when considering the carry-out, but in itself does not establish a carry-out amount. The Board would still have to discuss and recommend a desirable carry-out value that represents current industry needs each crop year. Consequently, the Board supported the recommendation by a vote of 12-5. This proposal would amend Section 930.151 of the regulations to increase the maximum carry-out volume possible when calculating optimum supply from 20 million pounds to 100 million pounds.

    The Board made several other recommendations for changes to the rules and regulations under the order at its June 25, 2015 meeting. These changes are being considered under a separate action.

    Initial Regulatory Flexibility Analysis

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

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

    There are approximately 600 producers of tart cherries in the regulated area and approximately 40 handlers of tart cherries who are subject to regulation under the order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000 and small agricultural service firms have been defined as those having annual receipts of less than $7,500,000 (13 CFR 121.201).

    According to the National Agricultural Statistics Service and Board data, the average annual grower price for tart cherries during the 2014-15 crop year was $0.35 per pound, and total utilization was around 300 million pounds. Therefore, average receipts for tart cherry producers were around $175,800, well below the SBA threshold for small producers. In 2014, The Food Institute estimated an f.o.b. price of $0.96 per pound for frozen tart cherries, which make up the majority of processed tart cherries. Using this data, average annual handler receipts were about $6.9 million, which is also below the SBA threshold for small agricultural service firms. Assuming a normal distribution, the majority of producers and handlers of tart cherries may be classified as small entities.

    This proposed action would create § 930.154 of the rules and regulations, establishing procedures for release of inventory reserves. This proposed rule would also revise § 930.151 to allow the Board to consider a carry-out of up to 100 million pounds when calculating optimum supply. These changes are intended to provide clear direction in the event an inventory release becomes necessary and allow the Board to be more responsive to tart cherry market demand. The authority for these actions is provided in §§ 930.50 and 930.54 of the order. The Board voted to recommend these proposed changes to the Secretary at its meeting on June 25, 2015.

    It is not anticipated that this action would impose additional costs on handlers or growers, regardless of size. The proposed changes are administrative in nature and intended to align the provisions of the order with current industry practices. The addition of rules and regulations regarding inventory releases is a codification of administrative procedures the Board has had in place for many years. The expanded carry-out upper limit would allow the Board additional flexibility in meeting market needs without additional rulemaking.

    The benefits of this rule are not expected to be disproportionately greater or less for small handlers or producers than for larger entities.

    The Board discussed alternatives to these proposed changes to the order, including releasing reserves from the current crop year or releasing cherries in the order in which the fruit was put into reserve. A committee was established to review the reserve procedures, and it proposed using a three-year average percentage for each handler and releasing the previous crop years' reserves. The Board agreed that the committee's recommendation would be the most equitable solution. Regarding the carry-out limit, the Board considered not recommending a permanent change. However, the Board anticipates needing more than 20 million pounds of carry-out for the foreseeable future. A member suggested changing the motion to 80 million pounds, but that suggestion did not receive support. Thus, the suggested alternatives were rejected.

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0177, (Tart Cherries Grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin). No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.

    Accordingly, this proposal would not impose any additional reporting or recordkeeping requirements on either small or large tart cherry handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

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

    USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule.

    The Board's meeting was widely publicized throughout the tart cherry industry and all interested persons were invited to attend and participate in Board deliberations on all issues. Like all Board meetings, the June 25, 2015, meeting was a public meeting and all entities, both large and small, were able to express views on these issues. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and informational impacts of this action on small businesses.

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

    A 30-day comment period is provided to allow interested persons to respond to this proposal. A 30-day period is deemed appropriate because this action would need to be in place as soon as possible since handlers are already putting cherries into reserve from the 2015-2016 crop. The action would also need to be in place before the Board meets in June to have preliminary discussions on volume control, including determining an appropriate carry-out figure. All written comments received during the comment period will be considered before a final determination is made on this matter.

    List of Subjects in 7 CFR Part 930

    Marketing agreements, Reporting and recordkeeping requirements, Tart cherries.

    For the reasons set forth in the preamble, 7 CFR part 930 is proposed to be amended as follows:

    PART 930—TART CHERRIES GROWN IN THE STATES OF MICHIGAN, NEW YORK, PENNSYLVANIA, OREGON, UTAH, WASHINGTON, AND WISCONSIN 1. The authority citation for 7 CFR part 930 continues to read as follows: Authority:

    7 U.S.C. 601-674.

    2. In § 930.151: a. Designate the current paragraph as paragraph (a); and b. Add a new paragraph (b) to read as follows:
    § 930.151 Desirable carry-out inventory.

    (b) Beginning with the crop year starting July 1, 2016, for the purposes of determining an optimum supply volume, the Board may recommend a desirable carry-out inventory not to exceed 100 million pounds.

    3. Section 930.154 is added to read as follows:
    § 930.154 Release of inventory reserve cherries.

    As provided in § 930.54, the Board may recommend a release of a portion or all of the primary and/or secondary reserve cherries. The total available reserves will be determined at the beginning of the crop year. The primary reserve as defined in §§ 930.55 and 930.150 must be depleted before the secondary reserve can be released. If a release is recommended, the recommended volume shall be apportioned to handlers on the basis of each handler's proportion of the total volume handled in the preceding three crop years. If a handler has less volume in reserve than is apportioned, the excess volume shall be reapportioned to those who still have volume in reserve until the total release is complete.

    Dated: June 10, 2016. Elanor Starmer, Administrator, Agricultural Marketing Service.
    [FR Doc. 2016-14173 Filed 6-14-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-6140; Directorate Identifier 2015-NM-059-AD] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM); extension of comment period.

    SUMMARY:

    This document announces an extension of the comment period for the above-referenced NPRM, which proposed the adoption of a new airworthiness directive (AD) for certain The Boeing Company Model 777 airplanes. That NPRM invited comments concerning the proposed requirement to modify the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions. This extension of the comment period is necessary to provide all interested persons an opportunity to present their views on the proposed requirements of that NPRM.

    DATES:

    We must receive comments on the NPRM by September 19, 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.

    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-2016-6140; 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 the 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:

    Jon Regimbal, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6506; 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-2016-6140; Directorate Identifier 2015-NM-059-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 issued an NPRM to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Model 777 airplanes. The NPRM published in the Federal Register on May 4, 2016 (81 FR 26750) (“the NPRM”). The NPRM proposed to require modifying the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions.

    The NPRM invited comments on regulatory, economic, environmental, and energy aspects of the proposal.

    The NPRM was prompted by fuel system reviews conducted by the manufacturer. The actions specified by the NPRM are intended to prevent ignition sources inside the center fuel tank, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.

    Related Rulemaking

    At the time we issued the NPRM, we issued five other NPRMs that also proposed to require modification of the FQIS:

    • Docket No. FAA-2016-6139, Directorate Identifier 2015-NM-061-AD, for certain The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes.

    • Docket No. FAA-2016-6141, Directorate Identifier 2015-NM-048-AD, for certain The Boeing Company Model 767 airplanes.

    • Docket No. FAA-2016-6143, Directorate Identifier 2015-NM-028-AD, for all Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes), and Model A310 series airplanes.

    • Docket No. FAA-2016-6144, Directorate Identifier 2015-NM-088-AD, for certain Airbus Model A318, A319, A320, and A321 airplanes.

    • Docket No. FAA-2016-6145, Directorate Identifier 2015-NM-056-AD, for certain The Boeing Company Model 747 airplanes.

    Actions Since Previous NPRM Was Issued

    Since we issued the NPRM, we have received a request from Airlines for America (A4A) to extend the comment period. A4A stated that the NPRMs are controversial and could drive substantial costs, especially for cargo airlines. To be able to prepare informed and meaningful comments with coordinated consensus among its members, A4A requested a longer comment period to understand a number of factors, including related service information, data and safety analysis of the unsafe condition, and potential costs.

    We agree with the request, and have determined that it is appropriate to extend the comment period for the NPRM to give all interested persons additional time to examine the proposed requirements and submit comments. We have determined that extending the comment period until September 19, 2016, will not compromise the safety of the affected airplanes.

    The comment period for Docket No. FAA-2016-6140 closes September 19, 2016.

    Because no other portion of the proposal or other regulatory information has been changed, the entire proposal is not being republished.

    Issued in Renton, Washington, on June 8, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-14113 Filed 6-14-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-6143; Directorate Identifier 2015-NM-028-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM); extension of comment period.

    SUMMARY:

    This document announces an extension of the comment period for the above-referenced NPRM, which proposed the adoption of a new airworthiness directive (AD) for all Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes), and Model A310 series airplanes. That NPRM invited comments concerning the proposed requirement to modify the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions. This extension of the comment period is necessary to provide all interested persons an opportunity to present their views on the proposed requirements of that NPRM.

    DATES:

    We must receive comments on the NPRM by September 19, 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.

    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-2016-6143; 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 the 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:

    Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-2125; fax 425-227-1149.

    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-2016-6143; Directorate Identifier 2015-NM-028-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 issued an NPRM to amend 14 CFR part 39 by adding an AD that would apply to all Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes), and Model A310 series airplanes. The NPRM published in the Federal Register on May 3, 2016 (81 FR 26493) (“the NPRM”). The NPRM proposed to require modifying the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions.

    The NPRM invited comments on regulatory, economic, environmental, and energy aspects of the proposal.

    The NPRM was prompted by fuel system reviews conducted by the manufacturer. The actions specified by the NPRM are intended to prevent ignition sources inside the center fuel tank, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.

    Related Rulemaking

    At the time we issued the NPRM, we issued five other NPRMs that also proposed to require modification of the FQIS:

    • Docket No. FAA-2016-6139, Directorate Identifier 2015-NM-061-AD, for certain The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes.

    • Docket No. FAA-2016-6140, Directorate Identifier 2015-NM-059-AD, for certain The Boeing Company Model 777 airplanes.

    • Docket No. FAA-2016-6141, Directorate Identifier 2015-NM-048-AD, for certain The Boeing Company Model 767 airplanes.

    • Docket No. FAA-2016-6144, Directorate Identifier 2015-NM-088-AD, for certain Airbus Model A318, A319, A320, and A321 airplanes.

    • Docket No. FAA-2016-6145, Directorate Identifier 2015-NM-056-AD, for The Boeing Company Model 747 airplanes.

    Actions Since Previous NPRM Was Issued

    Since we issued the NPRM, we have received a request from Airlines for America (A4A) to extend the comment period for some of the NPRMs referenced above. A4A stated that the NPRMs are controversial and could drive substantial costs, especially for cargo airlines. To be able to prepare informed and meaningful comments with coordinated consensus among its members, A4A requested a longer comment period to understand a number of factors, including related service information, data and safety analysis of the unsafe condition, and potential costs.

    We agree with the request, and have determined that it is appropriate to extend the comment period for all of the NPRMs to give all interested persons additional time to examine the proposed requirements and submit comments. We have determined that extending the comment period until September 19, 2016, will not compromise the safety of the affected airplanes.

    The comment period for Docket No. FAA-2016-6143 closes September 19, 2016.

    Because no other portion of the proposal or other regulatory information has been changed, the entire proposal is not being republished.

    Issued in Renton, Washington, on June 8, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-14116 Filed 6-14-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-6144; Directorate Identifier 2015-NM-088-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM); extension of comment period.

    SUMMARY:

    This document announces an extension of the comment period for the above-referenced NPRM, which proposed the adoption of a new airworthiness directive (AD) for certain Airbus Model A318, A319, and A320 series airplanes; Model A330-200, -200 Freighter, and -300 series airplanes; and Model A340-200, -300, -500, and -600 series airplanes. That NPRM invited comments concerning the proposed requirement to modify the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions. This extension of the comment period is necessary to provide all interested persons an opportunity to present their views on the proposed requirements of that NPRM.

    DATES:

    We must receive comments on the NPRM by September 19, 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.

    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-2016-6144; 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 the 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:

    Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-2125; fax 425-227-1149.

    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-2016-6144; Directorate Identifier 2015-NM-028-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 issued an NPRM to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Model A318, A319, and A320 series airplanes; Model A330-200, -200 Freighter, and -300 series airplanes; and Model A340-200, -300, -500, and -600 series airplanes. The NPRM published in the Federal Register on May 3, 2016 (81 FR 26487) (“the NPRM”). The NPRM proposed to require modifying the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions.

    The NPRM invited comments on regulatory, economic, environmental, and energy aspects of the proposal.

    The NPRM was prompted by fuel system reviews conducted by the manufacturer. The actions specified by the NPRM are intended to prevent ignition sources inside the center fuel tank, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.

    Related Rulemaking

    At the time we issued the NPRM, we issued five other NPRMs that also proposed to require modification of the FQIS:

    • Docket No. FAA-2016-6139, Directorate Identifier 2015-NM-061-AD, for certain The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes.

    • Docket No. FAA-2016-6140, Directorate Identifier 2015-NM-059-AD, for certain The Boeing Company Model 777 airplanes.

    • Docket No. FAA-2016-6141, Directorate Identifier 2015-NM-048-AD, for certain The Boeing Company Model 767 airplanes.

    • Docket No. FAA-2016-6143, Directorate Identifier 2015-NM-028-AD, for all Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes), and Model A310 series airplanes.

    • Docket No. FAA-2016-6145, Directorate Identifier 2015-NM-056-AD, for certain The Boeing Company Model 747 airplanes.

    Actions Since Previous NPRM Was Issued

    Since we issued the NPRM, we have received a request from Airlines for America (A4A) to extend the comment period. A4A stated that the NPRMs are controversial and could drive substantial costs, especially for cargo airlines. To be able to prepare informed and meaningful comments with coordinated consensus among its members, A4A requested a longer comment period to understand a number of factors, including related service information, data and safety analysis of the unsafe condition, and potential costs.

    We agree with the request, and have determined that it is appropriate to extend the comment period for the NPRM to give all interested persons additional time to examine the proposed requirements and submit comments. We have determined that extending the comment period until September 19, 2016, will not compromise the safety of the affected airplanes.

    The comment period for Docket No. FAA-2016-6144 closes September 19, 2016.

    Because no other portion of the proposal or other regulatory information has been changed, the entire proposal is not being republished.

    Issued in Renton, Washington, on June 8, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-14115 Filed 6-14-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-6145; Directorate Identifier 2015-NM-056-AD] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM); extension of comment period.

    SUMMARY:

    This document announces an extension of the comment period for the above-referenced NPRM, which proposed the adoption of a new airworthiness directive (AD) for certain The Boeing Company Model 747-400, 747-400D, and 747-400F series airplanes. That NPRM invited comments concerning the proposed requirement to modify the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions. This extension of the comment period is necessary to provide all interested persons an opportunity to present their views on the proposed requirements of that NPRM.

    DATES:

    We must receive comments on the NPRM by September 19, 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.

    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-2016-6145; 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 the 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:

    Jon Regimbal, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6506; 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-2016-6145; Directorate Identifier 2015-NM-056-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 issued an NPRM to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 747-400, 747-400D, and 747-400F series airplanes. The NPRM published in the Federal Register on May 3, 2016 (81 FR 26490) (“the NPRM”). The NPRM proposed to require modifying the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions.

    The NPRM invited comments on regulatory, economic, environmental, and energy aspects of the proposal.

    The NPRM was prompted by fuel system reviews conducted by the manufacturer. The actions specified by the NPRM are intended to prevent ignition sources inside the center fuel tank, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.

    Related Rulemaking

    At the time we issued the NPRM, we issued five other NPRMs that also proposed to require modification of the FQIS:

    • Docket No. FAA-2016-6139, Directorate Identifier 2015-NM-061-AD, for certain The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes.

    • Docket No. FAA-2016-6140, Directorate Identifier 2015-NM-059-AD, for certain The Boeing Company Model 777 airplanes.

    • Docket No. FAA-2016-6141, Directorate Identifier 2015-NM-048-AD, for certain The Boeing Company Model 767 airplanes.

    • Docket No. FAA-2016-6143, Directorate Identifier 2015-NM-028-AD, for all Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes), and Model A310 series airplanes.

    • Docket No. FAA-2016-6144, Directorate Identifier 2015-NM-088-AD, for Airbus Model A318, A319, A320, and A321 airplanes.

    Actions Since Previous NPRM Was Issued

    Since we issued the NPRM, we have received a request from Airlines for America (A4A) to extend the comment period. A4A stated that the NPRMs are controversial and could drive substantial costs, especially for cargo airlines. To be able to prepare informed and meaningful comments with coordinated consensus among its members, A4A requested a longer comment period to understand a number of factors, including related service information, data and safety analysis of the unsafe condition, and potential costs.

    We agree with the request, and have determined that it is appropriate to extend the comment period for the NPRM to give all interested persons additional time to examine the proposed requirements and submit comments. We have determined that extending the comment period until September 19, 2016, will not compromise the safety of the affected airplanes.

    The comment period for Docket No. FAA-2016-6145 closes September 19, 2016.

    Because no other portion of the proposal or other regulatory information has been changed, the entire proposal is not being republished.

    Issued in Renton, Washington, on June 8, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-14112 Filed 6-14-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-6141; Directorate Identifier 2015-NM-048-AD] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM); extension of comment period.

    SUMMARY:

    This document announces an extension of the comment period for the above-referenced NPRM, which proposed the adoption of a new airworthiness directive (AD) for certain The Boeing Company Model 767 airplanes. That NPRM invited comments concerning the proposed requirement to modify the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions. This extension of the comment period is necessary to provide all interested persons an opportunity to present their views on the proposed requirements of that NPRM.

    DATES:

    We must receive comments on the NPRM by September 19, 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.

    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-2016-6141; 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 the 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:

    Jon Regimbal, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6506; 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-2016-6141; Directorate Identifier 2015-NM-048-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 issued an NPRM to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 767 airplanes. The NPRM published in the Federal Register on May 4, 2016 (81 FR 26747) (“the NPRM”). The NPRM proposed to require modifying the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions.

    The NPRM invited comments on regulatory, economic, environmental, and energy aspects of the proposal.

    The NPRM was prompted by fuel system reviews conducted by the manufacturer. The actions specified by the NPRM are intended to prevent ignition sources inside the center fuel tank, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.

    Related Rulemaking

    At the time we issued the NPRM, we issued five other NPRMs that also proposed to require modification of the FQIS:

    • Docket No. FAA-2016-6139, Directorate Identifier 2015-NM-061-AD, for certain The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes.

    • Docket No. FAA-2016-6140, Directorate Identifier 2015-NM-059-AD, for certain The Boeing Company Model 777 airplanes.

    • Docket No. FAA-2016-6143, Directorate Identifier 2015-NM-028-AD, for all Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes), and Model A310 series airplanes.

    • Docket No. FAA-2016-6144, Directorate Identifier 2015-NM-088-AD, for Airbus Model A318, A319, A320, and A321 airplanes.

    • Docket No. FAA-2016-6145, Directorate Identifier 2015-NM-056-AD, for certain The Boeing Company Model 747 airplanes.

    Actions Since Previous NPRM Was Issued

    Since we issued the NPRM, we have received a request from Airlines for America (A4A) to withdraw the NPRM because of a specific concern regarding a yet-unpublished service bulletin. A4A stated that this service bulletin, which would add measures regarding removal of Kapton insulated wiring near the FQIS bundles, has been rejected by the FAA. A4A stated that there may be substantial changes to the proposed cost estimates that would influence the comments. A4A accordingly requested withdrawal of the NPRM until Boeing satisfies the FAA's concerns, and the costs of compliance can be estimated. A4A asserted that any delay will not substantially affect safety given the previously instituted flammability reduction measures that are already in place.

    We disagree with the request to withdraw the NPRM. The FAA is currently reviewing service information related to Kapton wiring that may be installed near FQIS wires. The cost to remove existing Kapton wiring was not included in the NPRM for Model 767 airplanes; we do not anticipate that this cost will be significant.

    While we do not agree to withdraw the NPRM, we have determined that it is appropriate to extend the comment period for the NPRM to give all interested persons additional time to examine the proposed requirements and submit comments. We have determined that extending the comment period until September 19, 2016, will not compromise the safety of the affected airplanes.

    The comment period for Docket No. FAA-2016-6141 closes September 19, 2016.

    Because no other portion of the proposal or other regulatory information has been changed, the entire proposal is not being republished.

    Issued in Renton, Washington, on June 8, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-14111 Filed 6-14-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-6139; Directorate Identifier 2015-NM-061-AD] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM); extension of comment period.

    SUMMARY:

    This document announces an extension of the comment period for the above-referenced NPRM, which proposed the adoption of a new airworthiness directive (AD) for certain The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes. That NPRM invited comments concerning the proposed requirement to modify the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions. This extension of the comment period is necessary to provide all interested persons an opportunity to present their views on the proposed requirements of that NPRM.

    DATES:

    We must receive comments on the NPRM by September 19, 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.

    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-2016-6139; 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 the 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:

    Jon Regimbal, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6506; 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-2016-6139; Directorate Identifier 2015-NM-061-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 issued an NPRM to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 737-600, -700, -700C, -800, -900, and -900ER series airplanes. The NPRM published in the Federal Register on May 3, 2016 (81 FR 26485) (“the NPRM”). The NPRM proposed to require modifying the fuel quantity indicating system (FQIS) to prevent development of an ignition source inside the center fuel tank due to electrical fault conditions.

    The NPRM invited comments on regulatory, economic, environmental, and energy aspects of the proposal.

    The NPRM was prompted by fuel system reviews conducted by the manufacturer. The actions specified by the NPRM are intended to prevent ignition sources inside the center fuel tank, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.

    Related Rulemaking

    At the time we issued the NPRM, we issued five other NPRMs that also proposed to require modification of the FQIS:

    • Docket No. FAA-2016-6140, Directorate Identifier 2015-NM-059-AD, for certain The Boeing Company Model 777 airplanes.

    • Docket No. FAA-2016-6141, Directorate Identifier 2015-NM-048-AD, for certain The Boeing Company Model 767 airplanes.

    • Docket No. FAA-2016-6143, Directorate Identifier 2015-NM-028-AD, for certain all Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes), and Model A310 series airplanes.

    • Docket No. FAA-2016-6144, Directorate Identifier 2015-NM-088-AD, for certain Airbus Model A318, A319, A320, and A321 airplanes.

    • Docket No. FAA-2016-6145, Directorate Identifier 2015-NM-056-AD, for certain The Boeing Company Model 747 airplanes.

    Actions Since Previous NPRM Was Issued

    Since we issued the NPRM, we have received a request from Airlines for America (A4A) to extend the comment period for some of the NPRMs referenced above. A4A stated that the NPRMs are controversial and could drive substantial costs, especially for cargo airlines. To be able to prepare informed and meaningful comments with coordinated consensus among its members, A4A requested a longer comment period to understand a number of factors, including related service information, data and safety analysis of the unsafe condition, and potential costs.

    We agree with the request, and have determined that it is appropriate to extend the comment period for all the NPRMs referenced above to give all interested persons additional time to examine the proposed requirements and submit comments. We have determined that extending the comment period until September 19, 2016, will not compromise the safety of the affected airplanes.

    The comment period for Docket No. FAA-2016-6139 closes September 19, 2016.

    Because no other portion of the proposal or other regulatory information has been changed, the entire proposal is not being republished.

    Issued in Renton, Washington, on June 8, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-14114 Filed 6-14-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 172 [Docket No. FDA-2016-F-1444] Styrene Information and Research Center; Filing of Food Additive Petition AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of petition.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by the Styrene Information and Research Center (SIRC), requesting that we amend our food additive regulations to no longer provide for the use of styrene as a synthetic flavoring substance and adjuvant in food because these uses of styrene have been abandoned.

    DATES:

    The food additive petition was filed on May 16, 2016. Submit either electronic or written comments by August 15, 2016.

    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-2016-F-1444 for “Styrene Information and Research Center; Filing of Food Additive Petition.” 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:

    Judith Kidwell, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1071.

    SUPPLEMENTARY INFORMATION: I. Background

    Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(b)(5)), we are giving notice that we have filed a food additive petition (FAP 6A4817), submitted by SIRC, c/o Keller and Heckman LLP, 1001 G Street NW., Suite 500 West, Washington, DC 20001. The petition proposes to amend § 172.515 (21 CFR 172.515) to no longer provide for the use of styrene (CAS Reg. No. 100-42-5) as a synthetic flavoring substance and adjuvant in food because these uses of styrene have been permanently abandoned.

    II. Abandonment

    Under section 409(i) of the FD&C Act, we “shall by regulation prescribe the procedure by which regulations under the foregoing provisions of this section may be amended or repealed, and such procedure shall conform to the procedure provided in this section for the promulgation of such regulations.” Our regulations specific to administrative actions for food additives provide that the Commissioner of Food and Drugs, on his own initiative or on the petition of any interested person, under 21 CFR part 10, may propose the issuance of a regulation amending or repealing a regulation pertaining to a food additive or granting or repealing an exception for such additive (§ 171.130(a) (21 CFR 171.130(a))). These regulations further provide that any such petition shall include an assertion of facts, supported by data, showing that new information exists with respect to the food additive or that new uses have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the existing regulation or exemption may justify its amendment or appeal. New data must be furnished in the form specified in 21 CFR 171.1 and 171.100 for submitting petitions (§ 171.130(b)). Under these regulations, a petitioner may propose that we amend a food additive regulation if the petitioner can demonstrate that there are “old uses abandoned” for the relevant food additive. Such abandonment must be complete for any intended uses in the U.S. market. While section 409 of the FD&C Act and § 171.130 also provide for amending or revoking a food additive regulation based on safety, an amendment or revocation based on abandonment is not based on safety, but is based on the fact that regulatory authorization is no longer necessary because the use of that food additive has been abandoned.

    Abandonment may be based on the abandonment of certain authorized food additive uses for a substance (e.g., if a substance is no longer used in certain product categories), or on the abandonment of all authorized food additive uses of a substance (e.g., if a substance is no longer being manufactured). If a petition seeks an amendment to a food additive regulation based on the abandonment of certain uses of the food additive, such uses must be adequately defined so that both the scope of the abandonment and any amendment to the food additive regulation are clear.

    The petition submitted on behalf of SIRC contains public information and information collected from companies that produce styrene to support the petitioner's claim that styrene is no longer being manufactured, imported, or otherwise marketed for use as a synthetic flavoring substance and adjuvant in food in the U.S. market and that the manufacturers have abandoned the use of styrene for these uses. SIRC surveyed its membership, which contains over 95 percent of the current North American styrene industry, to verify that their members do not:

    • Currently manufacture styrene for use as a synthetic flavoring substance and adjuvant in food in the United States;

    • currently import styrene for use as a synthetic flavoring substance and adjuvant in food into the United States;

    • intend to manufacture or import styrene for use as a synthetic flavoring substance and adjuvant in food in the United States in the future; and

    • currently maintain any inventory of styrene for sale or distribution into commerce that is intended to be marketed for use as a synthetic flavoring substance and adjuvant in food in the United States.

    SIRC also has confirmed that no foreign manufacturers appear to be using or marketing styrene for use as a synthetic flavoring agent or adjuvant in food.

    We expressly request comments on SIRC's request to amend § 172.515 of the food additive regulations to no longer permit the use of styrene as a synthetic flavoring substance and adjuvant in food. As noted, the basis for the proposed amendment is that the uses of styrene as a synthetic flavoring substance and adjuvant in food have been permanently abandoned. Accordingly, we request comments that address whether these uses of styrene have been completely abandoned, such as information on whether food containing styrene used as a synthetic flavoring substance and adjuvant are currently being introduced or delivered for introduction into the U.S. market. We are not currently aware of information that suggests continued use of styrene as a synthetic flavoring substance and adjuvant in food. We are providing the public with 60 days to submit comments. We anticipate that some interested persons may wish to provide us with certain information they consider to be trade secret or confidential commercial information (CCI) that would be exempt under Exemption 4 of the Freedom of Information Act (5 U.S.C. 552). Interested persons may claim information that is submitted to us as CCI or trade secret by clearly marking both the document and the specific information as “confidential.” Information so marked will not be disclosed except in accordance with the Freedom of Information Act and our disclosure regulations (21 CFR part 20). For electronic submissions to http://www.regulations.gov, indicate in the “comments” box of the appropriate docket that your submission contains confidential information. Interested persons must also submit a copy of the comment that does not contain the information claimed as confidential for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice.

    We are not requesting comments on the safety of these uses of styrene because such information is not relevant to abandonment, which is the basis of the proposed action. We will not consider any comments addressing the safety of styrene or containing safety information on styrene in our evaluation of this petition.

    We have determined under 21 CFR 25.32(m) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

    Dated: June 9, 2016. Dennis M. Keefe, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition.
    [FR Doc. 2016-14107 Filed 6-14-16; 8:45 am] BILLING CODE 4164-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2015-0449; FRL-9947-62-Region 4] Air Plan Approval; North Carolina; Regional Haze Progress Report AGENCY:

    Environmental Protection Agency.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of North Carolina through the North Carolina Division of Air Quality (NC DAQ) on May 31, 2013. North Carolina's May 31, 2013, SIP revision (Progress Report) addresses requirements of the Clean Air Act (CAA or Act) and EPA's rules that require each state to submit periodic reports describing progress towards reasonable progress goals (RPGs) established for regional haze and a determination of the adequacy of the state's existing SIP addressing regional haze (regional haze plan). EPA is proposing to approve North Carolina's Progress Report on the basis that it addresses the progress report and adequacy determination requirements for the first implementation period for regional haze.

    DATES:

    Comments must be received on or before July 15, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R04-OAR-2015-0449 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Sean Lakeman, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr. Lakeman can be reached by phone at (404) 562-9043 and via electronic mail at [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    Under the Regional Haze Rule,1 each state was required to submit its first implementation plan addressing regional haze visibility impairment to EPA no later than December 17, 2007. See 40 CFR 51.308(b). North Carolina submitted its regional haze plan on that date, and like many other states subject to the Clean Air Interstate Rule (CAIR), relied on CAIR to satisfy best available retrofit technology (BART) requirements for emissions of sulfur dioxide (SO2) and nitrogen oxides (NOX) from electric generating units (EGUs) in the State. On June 7, 2012, EPA finalized a limited disapproval of North Carolina's December 17, 2007 regional haze plan submission because of deficiencies arising from the State's reliance on CAIR to satisfy certain regional haze requirements. See 77 FR 33642. In a separate action taken on June 27, 2012, EPA finalized a limited approval of North Carolina's December 17, 2007, regional haze plan submission, as meeting some of the applicable regional haze requirements as set forth in sections 169A and 169B of the CAA and in 40 CFR 51.300-51.308. See 77 FR 38185. On October 31, 2014, the State submitted a regional haze plan revision to correct the deficiencies identified in the June 27, 2012, limited disapproval by replacing reliance on CAIR with reliance on the State's Clean Smokestacks Act (CSA) as an alternative to NOX and SO2 BART for BART-eligible EGUs formerly subject to CAIR. EPA approved that SIP revision on May 13, 2016, resulting in a full approval of North Carolina's regional haze plan.

    1 40 CFR part 51, subpart P.

    Each state is also required to submit a progress report in the form of a SIP revision every five years that evaluates progress towards the RPGs for each mandatory Class I Federal area within the state and for each mandatory Class I Federal area outside the state which may be affected by emissions from within the state. See 40 CFR 51.308(g). Each state is also required to submit, at the same time as the progress report, a determination of the adequacy of its existing regional haze plan. See 40 CFR 51.308(h). The first progress report is due five years after submittal of the initial regional haze plan.

    On May 31, 2013, as required by 40 CFR 51.308(g), NC DAQ submitted to EPA, in the form of a revision to North Carolina's SIP, a report on progress made towards the RPGs for Class I areas in the State and for Class I areas outside the State that are affected by emissions from sources within the State. This submission also includes a negative declaration pursuant to 40 CFR 51.308(h)(1) that the State's regional haze plan is sufficient in meeting the requirements of the Regional Haze Rule (40 CFR 51.300 et seq.). EPA is proposing to approve North Carolina's Progress Report on the basis that it satisfies the requirements of 40 CFR 51.308(g) and (h) now that EPA has fully approved the State's regional haze plan.

    II. Requirements for the Regional Haze Progress Report and Adequacy Determinations A. Regional Haze Progress Report

    Under 40 CFR 51.308(g), states must submit a regional haze progress report as a SIP revision every five years and must address, at a minimum, the seven elements found in 40 CFR 51.308(g). As described in further detail in section III below, 40 CFR 51.308(g) requires: (1) A description of the status of measures in the approved regional haze plan; (2) a summary of emissions reductions achieved; (3) an assessment of visibility conditions for each Class I area in the state; (4) an analysis of changes in emissions from sources and activities within the state; (5) an assessment of any significant changes in anthropogenic emissions within or outside the state that have limited or impeded progress in Class I areas impacted by the state's sources, (6) an assessment of the sufficiency of the approved regional haze plan; and (7) a review of the state's visibility monitoring strategy.

    B. Adequacy Determinations of the Current Regional Haze Plan

    Under 40 CFR 51.308(h), states are required to submit, at the same time as the progress report, a determination of the adequacy of their existing regional haze plan and to take one of four possible actions based on information in the progress report. As described in further detail in section III below, 40 CFR 51.308(h) requires states to: (1) Submit a negative declaration to EPA that no further substantive revision to the state's existing regional haze plan is needed; (2) provide notification to EPA (and to other state(s) that participated in the regional planning process) if the state determines that its existing regional haze plan is or may be inadequate to ensure reasonable progress at one or more Class I areas due to emissions from sources in other state(s) that participated in the regional planning process, and collaborate with these other state(s) to develop additional strategies to address deficiencies; (3) provide notification with supporting information to EPA if the state determines that its existing regional haze plan is or may be inadequate to ensure reasonable progress at one or more Class I areas due to emissions from sources in another country; or (4) revise its regional haze plan to address deficiencies within one year if the state determines that its existing regional haze plan is or may be inadequate to ensure reasonable progress in one or more Class I areas due to emissions from sources within the state.

    III. What is EPA's analysis of North Carolina's regional haze progress report and adequacy determination?

    On May 31, 2013, NC DAQ submitted a revision to North Carolina's regional haze plan to address progress made towards the RPGs for Class I areas in the State and for Class I areas outside the State that are affected by emissions from sources within North Carolina. This submittal also includes a determination of the adequacy of the State's existing regional haze plan. North Carolina has five Class I areas within its borders: Great Smoky Mountains National Park (GSMNP), Joyce Kilmer-Slickrock Wilderness Area (JOKI), Linville Gorge Wilderness Area (LIGO), Shining Rock Wilderness Area (SHRO), and Swanquarter Wildlife Refuge (SWAN). Both the Great Smoky Mountains and Joyce Kilmer-Slickrock Areas are located in North Carolina and Tennessee. In its regional haze plan, the State also identified, through an area of influence modeling analysis based on back trajectories, one Class I area in one neighboring state potentially impacted by North Carolina sources: James River Face Wilderness Area in Virginia. See 77 FR 11858, 11869 (February 28, 2012).

    A. Regional Haze Progress Report

    The following sections summarize: (1) Each of the seven elements that must be addressed by a progress report under 40 CFR 51.308(g); (2) how North Carolina's Progress Report addressed each element; and (3) EPA's analysis and proposed determination as to whether the State satisfied each element.

    1. Status of Control Measures

    40 CFR 51.308(g)(1) requires a description of the status of implementation of all measures included in the regional haze plan for achieving RPGs for Class I areas both within and outside the state.

    The State evaluated the status of measures included in its 2007 regional haze plan in accordance with 40 CFR 51.308(g)(1). Specifically, in its Progress Report, North Carolina summarizes the status of the emissions reduction measures that were included in the final iteration of the Visibility Improvement State and Tribal Association of the Southeast (VISTAS) regional haze emissions inventory and RPG modeling used by the State in developing its regional haze plan. The measures include, among other things, applicable Federal programs (e.g., mobile source rules, Maximum Achievable Control Technology standards), Federal consent agreements, and Federal and state control strategies for EGUs.2 The State also discusses the status of several measures that were not included in the final VISTAS emissions inventory and were not relied upon in the initial regional haze plan to meet RPGs. The State notes that the emissions reductions from these measures will help ensure Class I areas impacted by North Carolina sources achieve their RPGs. In aggregate, as noted in sections III.A.2 and III.A.6 of this document, the emissions reductions from the identified measures are expected to exceed the emissions reductions projected in North Carolina's regional haze plan.

    2 North Carolina's progress report discusses the status of CAIR, CSAPR, and the CSA as of the date of submission. As noted above, North Carolina subsequently submitted a SIP revision to replace its reliance on CAIR as NOX and SO2 BART for BART-eligible units formerly subject to CAIR with reliance on the CSA as a BART Alternative, and EPA approved that SIP revision on May 13, 2016.

    EPA proposes to find that North Carolina's analysis adequately addresses 40 CFR 51.308(g)(1) for the reasons discussed below. The State documents the implementation status of measures from its regional haze plan in addition to describing additional measures not originally accounted for in the final VISTAS emissions inventory that came into effect since the VISTAS analyses for the regional haze plan were completed. The State's Progress Report also provides detailed information on EGU control strategies in its regional haze plan and the status of existing and future expected controls for North Carolina's EGUs because, in its regional haze plan, North Carolina identified SO2 emissions from coal-fired EGUs as the key contributor to regional haze in the VISTAS region. North Carolina discusses the status of the CSA, which the State identified as the primary state control strategy in its regional haze plan, and the resulting emissions reductions.3 Under the CSA, power plants were required to reduce their NOX emissions by 77 percent in 2009 and their SO2 emissions by 73 percent in 2013. The State notes that all of the CSA subject units are controlled with a scrubber for SO2 control and a selective catalytic reduction unit or a selective non-catalytic reduction for NOX control, or have retired, which will result in more SO2 and NOX emissions reductions than those projected in the regional haze plan.

    3 According to the State, in 2011, regulated sources under the CSA emitted 73,454 tons per year (tpy) of SO2 and 39,284 tpy of NOX, well below the CSA's annual emissions caps for SO2 and NOX. The State also notes that the 2018 current emissions projection of SO2 from the sources subject to CSA is 18,420 tpy, which is approximately 80 percent lower than the original 2018 projections used in the North Carolina regional haze plan.

    2. Emissions Reductions and Progress

    40 CFR 51.308(g)(2) requires a summary of the emissions reductions achieved in the state through the measures subject to 40 CFR 51.308(g)(1).

    In its regional haze plan and Progress Report, North Carolina focuses its assessment on SO2 emissions from EGUs because of VISTAS' findings that ammonium sulfate accounted for more than 70 percent of the visibility-impairing pollution in the VISTAS states and that SO2 point source emissions in 2018 represent more than 95 percent of the total SO2 emissions in the State.4 As discussed in section III.A.5, below, North Carolina determined that sulfates continue to be the largest contributor to regional haze for Class I areas in the State.

    4 For additional information, see North Carolina's December 17, 2007, regional haze plan at page 24.

    In its Progress Report, North Carolina presents SO2 emissions data for EGUs in the State and notes that North Carolina's EGU sector represents over 50 percent of statewide SO2 emissions from stationary sources. SO2 emissions reductions from 2002 to 2011 for North Carolina EGUs (387,373 tpy) are greater than the SO2 emissions reductions from 2002 to 2018 estimated in North Carolina's regional haze plan for these EGUs (367,528 tpy). Additionally, the State updated the 2018 SO2 emissions projections for North Carolina EGUs in its regional haze plan. These updated 2018 SO2 EGU emissions projections are approximately 80 percent lower than the projected 2018 SO2 emissions in the regional haze plan.5

    5 See page 32 of the May 31, 2013, submission.

    North Carolina states that coal-fired EGUs in North Carolina emitted a total of 370,000 tpy of SO2 in 2007, whereas in 2011, these same EGUs emitted a total of 73,000 tpy of SO2, a reduction of 297,000 tpy, due largely to the installation and operation of scrubbers. The State expects that future SO2 emissions will decline further from more natural gas use and the continued retirement of older, smaller coal-fired EGUs without scrubbers. NOX emissions from these EGUs dropped from a total of approximately 57,400 tpy in 2007 to approximately 39,300 tpy of NOX in 2011, an 18,100 tpy reduction.

    North Carolina identified the retirement of over 100 EGUs at 35 facilities located in eight nearby states that VISTAS modeling indicates potentially impact visibility in North Carolina's Class I areas. These units emitted more than 550,000 tpy of SO2 in 2011. The State believes that this is another indicator that the Class I areas in North Carolina are on track to meet their RPGs. North Carolina also discussed the SO2 emissions reductions that occurred at non-EGU facilities identified in its regional haze plan as contributing one percent or more to visibility impairment at any Class I area.

    EPA proposes to conclude that North Carolina has adequately addressed 40 CFR 51.308(g)(2). As discussed above, the State provides estimates, and where available, actual emissions reductions of visibility-impairing pollutants resulting from the measures relied upon in its regional haze plan. The State appropriately focused on SO2 emissions from its EGUs in its Progress Report because the State had previously identified these emissions as the most significant contributors to visibility impairment at North Carolina's Class I areas and those areas that North Carolina sources impact.

    3. Visibility Progress

    40 CFR 51.308(g)(3) requires that states with Class I areas provide the following information for the most impaired and least impaired days for each area, with values expressed in terms of five-year averages of these annual values: 6 (i) Current visibility conditions; (ii) the difference between current visibility conditions and baseline visibility conditions; and (iii) the change in visibility impairment over the past five years.

    North Carolina provides figures with visibility monitoring data that address the three requirements of 40 CFR 51.308(g)(3) for the State's five Class I areas. North Carolina reported current conditions as the 2006-2010 five-year time period and used the 2000-2004 baseline period for its Class I areas.7 Table 1, below, shows the current visibility conditions and the difference between current visibility conditions and baseline visibility conditions.

    6 The “most impaired days” and “least impaired days” in the regional haze refers to the average visibility impairment (measured in deciviews) for the 20 percent of monitored days in a calendar year with the highest and lowest amount of visibility impairment, respectively, averaged over a five-year period. 40 CFR 51.301.

    7 For the first regional haze plans, “baseline” conditions were represented by the 2000-2004 time period. See 64 FR 35730 (July 1, 1999).

    Table 1—Baseline Visibility, Current Visibility, and Visibility Changes in Class I Areas in North Carolina Class I area Baseline
  • (2000-2004)
  • Current
  • (2009-2013)
  • Difference
    20% Worst Days Great Smoky Mountain National Park 30.3 26.6 −3.7 Joyce Kilmer-Slickrock 30.3 26.6 −3.7 Linville Gorge 28.6 25.1 −3.5 Shining Rock 28.5 25.8 −2.7 Swanquarter 24.7 24.2 −0.5 20% Best Days Great Smoky Mountain National Park 13.6 12.3 −1.3 Joyce Kilmer-Slickrock 13.6 12.3 −1.3 Linville Gorge 11.1 11 −0.1 Shining Rock 8.2 7.25 −0.95 Swanquarter 12 12.9 0.9

    All North Carolina Class I areas saw an improvement in visibility on the 20 percent worst days from 2006-2010 and between baseline and 2006-2010 conditions. All North Carolina Class I areas except for Swanquarter Wildlife Refuge saw an improvement in visibility on the 20 percent best days from 2006-2010 and between baseline and 2006-2010 conditions.

    At Swanquarter, a 0.9 dv increase was recorded in the 20 percent best-day average between 2006-2010 conditions (12.9 dv) and the 2000-2004 baseline (12.0 dv). This could be due, in part, to the fact that the visibility data for 2008 at Swanquarter did not meet EPA's data completeness criteria and was therefore removed from the 2006-2010 average, resulting in a four-year average during this review period.8 Regardless, North Carolina believes that planned changes to operating status and emission controls on large sources within the Swanquarter area of influence provide sufficient evidence that by 2018, the 20 percent best days will be protected.9 Furthermore, the 20 percent best-day average at Swanquarter has continued to improve, dropping to 12.2 dv for 2007-2011.10 Based on the visibility data reported in the Western Regional Air Partnership Technical Support System, the 20 percent best-day five year averages have continued to improve through 2014 and have dropped below the baseline beginning with the 2008-2012 average.11

    8See USEPA (2003) “Guidance for Tracking Progress Under the Regional Haze Rule,” http://www.epa.gov/ttn/oarpg/t1/memoranda/rh_tpurhr_gd.pdf, pp. 2-8.

    9See pp. 43-49 of the May 31, 2013, submission.

    10See pp. 41-42 of the May 31, 2013, submission.

    11See http://vista.cira.colostate.edu/tss/Results/HazePlanning.aspx Web site for dv between 2011-2014.

    North Carolina's Progress Report includes revised RPGs for the five Class I areas within the State. North Carolina's original RPGs were based on the VISTAS modeling run available at the time of the 2007 SIP revision. In 2008, VISTAS provided updated modeling results that changed the modeled progress for North Carolina's Class I areas. North Carolina seeks to include revised RPGs that reflect this modeled progress. Table 2 identifies the RPGs for North Carolina's Class I areas in the State's regional haze plan and the updated RPGs proposed in its Progress Report.

    Table 2—Updated RPGs for North Carolina's Class 1 Areas [Deciviews] Class I areas RPG 20%
  • worst days
  • (2007 regional
  • haze plan)
  • RPG 20%
  • worst days
  • (2013 progress
  • report)
  • RPG 20%
  • best days
  • (2007 regional
  • haze plan)
  • RPG 20%
  • best days
  • (2013 progress
  • report)
  • GSMNP 23.7 23.5 12.2 12.1 JOKI 23.7 23.5 12.2 12.1 LIGO 22.0 21.7 9.6 9.5 SHRO 22.1 21.9 6.9 6.9 SWAN 20.4 20.3 11.0 10.9

    EPA proposes to approve the updated RPGs for North Carolina's Class I areas because they reflect more recent modeling. Also, EPA proposes to conclude that North Carolina has adequately addressed 40 CFR 51.308(g)(3) because the State provides the information regarding visibility conditions and visibility changes necessary to meet the requirements of the regulation. The Progress Report includes current conditions based on the Interagency Monitoring of Protected Visual Environments (IMPROVE) monitoring data for the years 2006-2010, the difference between current visibility conditions and baseline visibility conditions, and the change in visibility impairment over the five-year period 2006-2010.

    4. Emissions Tracking

    40 CFR 51.308(g)(4) requires an analysis tracking emission changes of visibility-impairing pollutants from the state's sources by type or category over the past five years based on the most recent updated emissions inventory.

    In its Progress Report, North Carolina presents data from statewide actual emissions inventories for 2008 and projected emissions inventories developed for the years 2009 and 2010. The State compares these data to the baseline emissions inventory for 2002. The pollutants inventoried include volatile organic compounds (VOC), NOX, fine particulate matter (PM2.5), and SO2. The emissions inventories include the following source classifications: Point, area, non-road mobile, and on-road mobile sources.

    North Carolina includes the emissions inventories from the regional haze plan for 2002 and 2009, and summarizes emissions data from EPA's 2008 National Emissions Inventory. North Carolina's analysis shows that 2008 emissions are lower than 2002 emissions. North Carolina estimates on-road mobile source emissions in the 2008 and 2010 inventories using the MOVES2010a model. This model tends to estimate higher emissions than its previous counterpart, the MOBILE6 model used by the State to estimate on-road mobile source emissions for the 2002 and 2009 inventories, especially for NOX emissions. North Carolina has concluded that MOVES model predictions for NOX can be 1.7 to 2.1 times higher than MOBILE6. Despite the change in methodology, a declining trend in all pollutants can be seen between 2002 and 2008 as seen in Table 4.

    North Carolina also includes an emission inventory for 2010 in its Progress Report. The State estimates 2010 point source emissions by taking the emissions reported by sources for 2010 and adding the latest emissions for the small sources that only report emissions every five years. This procedure differs from the procedure used by the State in its regional haze plan that included only those sources that reported emissions in 2002. In its 2010 inventory, North Carolina estimated that small sources that did not report contribute one percent of total NOX emissions, seven percent of total VOC emissions, one percent of total SO2 emissions, and seven percent of total PM2.5 emissions. North Carolina estimates area source emissions by growing the existing 2007 emissions inventory to 2010 and estimates non-road mobile source emissions using the EPA's NONROAD2008 model for those sources covered by the model and growing the 2007 airport, locomotive, and commercial marine emissions to 2010.

    North Carolina estimates on-road mobile source emissions for 2010 using MOVES2010a with the latest vehicle miles traveled (VMT) and speed data. If 2010 speeds and VMT were not available for a particular county, interpolated or projected 2010 data was used. Using MOVES2010a, the on-road mobile emissions are higher than those that would be predicted using the older model. As seen in Tables 3 and 5, the 2010 emissions inventory is significantly lower than the 2002 emissions inventory despite including additional stationary point sources and the use of MOVES, which predicts higher NOX emissions than its predecessor MOBILE6.2.

    Table 3—2002 Emissions Inventory Summary for North Carolina [tpy] Source category VOC NOX SO2 PM2.5 Point 61,484 196,731 522,093 26,953 Area 250,044 41,517 5,815 83,520 On-road Mobile 263,766 327,329 12,420 4,623 Non-road Mobile 94,480 84,284 7,693 7,348 Total 669,774 649,861 548,021 122,444 Table 4—Actual 2008 Annual Emission Summary for North Carolina [tpy] Source category VOC NOX SO2 PM2.5 Point 39,053 97,879 274,541 27,987 Area 149,264 43,672 13,937 48,807 On-road Mobile 122,503 253,849 1,190 7,895 Non-road Mobile 72,754 52,469 980 4,924 Total 383,573 447,869 290,648 89,613 Table 5—2010 Emissions Inventory Summary for North Carolina [tpy] Source category VOC NOX SO2 PM2.5 Point 42,504 90,155 151,210 13,966 Area 83,274 11,353 5,105 23,114 On-road Mobile 101,731 256,381 1,205 8,905 Non-road Mobile 66,773 65,353 2,829 5,455 Total 294,281 423,242 160,350 51,441

    When comparing the 2010 emissions (Table 5) with the projected 2009 emissions (Table 6), the total emissions of each pollutant are lower in 2010 with the exception of NOX. The slight increase in 2010 NOX emissions is likely due to the use of MOBILE6 to estimate on-road mobile source NOX emissions for 2009 and the use of MOVES to estimate on-road mobile source NOX emissions for 2010. As noted above, MOVES predicts higher NOX emissions than MOBILE6.

    Table 6—2009 Emissions Inventory Summary for North Carolina [tpy] Source category VOC NOX SO2 PM2.5 Point 62,161 101,236 284,802 26,360 Non-road Mobile 74,056 70,997 1,892 5,760 Area 200,873 45,382 6,281 90,729 On-road Mobile 168,676 201,609 1,503 3,493 Total 505,766 419,224 294,478 126,342

    EPA proposes to conclude that North Carolina has adequately addressed 40 CFR 51.308(g)(4). North Carolina tracked changes in emissions of visibility-impairing pollutants from 2002-2010 for all source categories and analyzed trends in emissions from 2002-2010, the most current quality-assured data available for these units at the time of progress report development. The 2010 emissions were also compared to the projected 2009 emissions, which were with the exception of NOX, as discussed above. While ideally the five-year period to be analyzed for emissions inventory changes is the time period since the current regional haze plan was submitted, there is an inevitable time lag in developing and reporting complete emissions inventories once quality-assured emissions data becomes available. Therefore, EPA believes that there is some flexibility in the five-year time period that states can select.

    5. Assessment of Changes Impeding Visibility Progress

    40 CFR 51.308(g)(5) requires an assessment of any significant changes in anthropogenic emissions within or outside the state that have occurred over the past five years that have limited or impeded progress in reducing pollutant emissions and improving visibility in Class I areas impacted by the state's sources.

    In its Progress Report, North Carolina documented that sulfates, which are formed from SO2 emissions, continue to be the biggest single contributor to regional haze for Class I areas in the State and therefore focused its analysis on large SO2 emissions from point sources. In addressing the requirements at 40 CFR 51.308(g)(5), North Carolina references its analyses that SO2 emissions from point sources show an overall downward trend over the period 2006 to 2010 and examines other potential pollutants of concern affecting visibility in Class I areas in North Carolina. After ammonium sulfate, primary organic matter is the next largest contributor to visibility impairment at Class I areas in North Carolina. The State demonstrates that there are no significant changes in emissions of SO2, PM2.5, or NOX that have impeded progress in reducing emissions and improving visibility in Class I areas impacted by North Carolina sources. Furthermore, the Progress Report shows that the State is on track to meeting its 2018 RPGs for Class I areas in North Carolina. For these reasons, EPA proposes to conclude that North Carolina's Progress Report has adequately addressed 40 CFR 51.308(g)(5).

    6. Assessment of Current Strategy

    40 CFR 51.308(g)(6) requires an assessment of whether the current regional haze plan is sufficient to enable the state, or other states, to meet the RPGs for Class I areas affected by emissions from the state.

    The State believes that it is on track to meet the 2018 RPGs for the North Carolina Class I areas and will not impede Class I areas outside of North Carolina from meeting their RPGs based on the trends in visibility and emissions presented in its Progress Report. In its Progress Report, North Carolina provided reconstructed light extinction figures for the 20 percent worst days for all Class I areas in the Southeast for 2006 through 2010. The 20 percent worst days extinction clearly demonstrates that sulfates continue to be the major concern, with EGUs being the largest contributor. As identified in Table 3-1 of the Progress Report, the State estimates that SO2 emissions from EGUs in North Carolina have decreased by approximately 387,400 tons per year from 2002 to 2011 and expects that these emissions will continue to decrease through the first regional haze planning period.

    The only coal-fired EGU in North Carolina which is in the area of influence (as defined by North Carolina's methodology) of the James River Face Class I area in Virginia was retired in April 2012. The SO2 emission reductions resulting from this retirement are expected to contribute to achieving the RPGs for the James River Face Class I area.

    EPA proposes to conclude that North Carolina has adequately addressed 40 CFR 51.308(g)(6). EPA views this requirement as a qualitative assessment that should evaluate emissions and visibility trends and other readily available information, including expected emissions reductions associated with measures with compliance dates that have not yet become effective. In its assessment, the State references the improving visibility trends and the downward emissions trends in the State, with a focus on SO2 emissions from North Carolina EGUs. These trends support the State's determination that the State's regional haze plan is sufficient to meet RPGs for Class I areas within and outside the State impacted by North Carolina sources.

    7. Review of Current Monitoring Strategy

    40 CFR 51.308(g)(7) requires a review of the state's visibility monitoring strategy and an assessment of whether any modifications to the monitoring strategy are necessary.

    In its Progress Report, North Carolina summarizes the existing monitoring network in North Carolina and in Tennessee to monitor visibility in North Carolina's Class I areas in North Carolina and concludes that no modifications to the existing visibility monitoring strategy are necessary. The primary monitoring network for regional haze, both nationwide and in North Carolina, is the IMPROVE network. There are currently three IMPROVE sites in North Carolina (LIGO, SHRO, and SWAN). In addition, an IMPROVE site just across the border in Tennessee serves as the monitoring site for both the Great Smoky Mountains National Park and Joyce Kilmer-Slickrock Wilderness Area, both of which lie partly in Tennessee and partly in North Carolina.

    The State also explains the importance of the IMPROVE monitoring network for tracking visibility trends at Class I areas in North Carolina. North Carolina states that data produced by the IMPROVE monitoring network will be used nearly continuously for preparing the 5-year progress reports and the 10-year SIP revisions, each of which relies on analysis of the preceding five years of data, and thus, the monitoring data from the IMPROVE sites needs to be readily accessible and to be kept up to date. The VIEWS Web site has been maintained by VISTAS and the other Regional Planning Organizations to provide ready access to the IMPROVE data and data analysis tools.

    In addition to the IMPROVE measurements, some ongoing long-term limited monitoring supported by Federal Land Managers provides additional insight into progress toward regional haze goals. North Carolina benefits from the data from these measurements, but is not responsible for associated funding decisions to maintain these measurements into the future.

    A continuous nitrate monitor operates at the Millbrook site in Raleigh and a second continuous nitrate monitor operates at the Rockwell monitoring site in Rowan County. The State plans to operate these monitors as long as funding and supplies allow. North Carolina began operating a continuous sulfate monitor at the Millbrook in August 2007 and is currently operating aethalometers at the Millbrook and Rockwell sites.

    In addition, the NC DAQ and the local air agencies in the State operate a comprehensive PM2.5 network of the filter based Federal reference method monitors, continuous mass monitors, filter-based speciated monitors, and continuous speciated monitors. These PM2.5 measurements help the NC DAQ characterize air pollution levels in areas across the State, and therefore aid in the analysis of visibility improvement in and near the Class I areas in North Carolina.

    EPA proposes to conclude that North Carolina has adequately addressed the sufficiency of its monitoring strategy as required by 40 CFR 51.308(g)(7). The State reaffirmed its continued reliance upon the IMPROVE monitoring network; assessed its entire visibility monitoring network, including additional continuous sulfate and PM2.5 monitors, used to further understand visibility trends in the State; and determined that no changes to its monitoring strategy are necessary.

    B. Determination of Adequacy of Existing Regional Haze Plan

    Under 40 CFR 51.308(h), states are required to take one of four possible actions based on the information gathered and conclusions made in the progress report. The following section summarizes: (1) The action taken by North Carolina under 40 CFR 51.308(h); (2) North Carolina's rationale for the selected action; and (3) EPA's analysis and proposed determination regarding the State's action.

    In its Progress Report, North Carolina took the action provided for by 40 CFR 51.308(h)(1), which allows a state to submit a negative declaration to EPA if the state determines that the existing regional haze plan requires no further substantive revision at this time to achieve the RPGs for Class I areas affected by the state's sources. The basis for the State's negative declaration is the findings from the Progress Report, including the findings that: Visibility has improved at Class I areas (with the exception of the best-days visibility at SWAN as discussed above) in North Carolina; SO2 emissions from the State's sources have decreased beyond the 2018 projections in the regional haze plan; additional EGU control measures not relied upon in the State's regional haze plan have occurred or will occur in the implementation period; and the EGU SO2 emissions in North Carolina are already below the levels projected for 2018 in the regional haze plan and are expected to continue to trend downward. EPA proposes to conclude that North Carolina has adequately addressed 40 CFR 51.308(h) because the visibility trends at the Class I areas impacted by the State's sources and the emissions trends of the State's largest emitters of visibility-impairing pollutants indicate that the RPGs for Class I areas impacted by source in North Carolina will be met.

    IV. Proposed Action

    EPA is proposing to approve North Carolina's Regional Haze Progress Report, SIP revision, submitted by the State on May 31, 2013, as meeting the applicable regional haze requirements set forth in 40 CFR 51.308(g) and (h). EPA also proposes to approve the updated RPGs for North Carolina's Class I areas.

    V. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

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

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: June 1, 2016. Heather McTeer Toney, Regional Administrator, Region 4.
    [FR Doc. 2016-14036 Filed 6-14-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2008-0603; FRL-9947-67-Region 3] Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Philadelphia County Reasonably Available Control Technology Under the 1997 8-Hour Ozone National Ambient Air Quality Standards AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve state implementation plan (SIP) revisions submitted by the Commonwealth of Pennsylvania. These revisions pertain to a demonstration that Philadelphia County (Philadelphia) meets the requirements for reasonably available control technology (RACT) of the Clean Air Act (CAA) for nitrogen oxides (NOX) and volatile organic compounds (VOC) as ozone precursors for the 1997 8-hour ozone national ambient air quality standards (NAAQS). In this rulemaking action, EPA is proposing to approve three separate SIP revisions addressing RACT under the 1997 8-hour ozone NAAQS for Philadelphia, including new or revised source-specific RACT determinations for fifteen major sources of NOX and/or VOC and certifications that certain previous source-specific RACT determinations for major sources of NOX and/or VOC continue to adequately represent RACT under the 1997 8-hour ozone NAAQS. EPA also proposes to convert the prior conditional approval of the Philadelphia RACT demonstration for the 1997 8-hour ozone NAAQS to full approval, as Pennsylvania has met the obligations associated with the conditional approval. EPA therefore proposes to find that Pennsylvania has met all applicable RACT requirements under the CAA for the 1997 8-hour ozone NAAQS for Philadelphia. This action is being taken under the CAA.

    DATES:

    Written comments must be received on or before July 15, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R03-OAR-2008-0603 at http://www.regulations.gov, or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be confidential business information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Emlyn Vélez-Rosa, (215) 814-2038, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    On June 27, 2014, February 18, 2015, and April 26, 2016, the Pennsylvania Department of Environmental Protection (PADEP) submitted on behalf of Philadelphia Air Management Services (AMS) three separate revisions to its SIP to satisfy the RACT requirements for the 19978-hour ozone NAAQS for Philadelphia. Altogether, the Philadelphia RACT SIP revisions are intended to fulfill the conditions in EPA's December 13, 2013 conditional approval. 78 FR 75902.

    I. Background A. General

    Ground level ozone pollution (commonly referred to as smog) is formed when VOC react with NOX in the presence of sunlight. In order to reduce ozone concentrations in the ambient air, the CAA requires all nonattainment areas to apply controls on VOC and NOX emission sources to achieve emission reductions. Among effective control measures, RACT controls are a major group for reducing VOC and NOX emissions from stationary sources.

    Since the 1970's, EPA has consistently interpreted RACT to mean the lowest emission limit that a particular source is capable of meeting by the application of the control technology that is reasonably available considering technological and economic feasibility.1 Section 172(c)(1) of the CAA provides that SIPs for nonattainment areas must include reasonably available control measures (RACM) for attainment of the NAAQS, including emissions reductions from existing sources through adoption of RACT. Sections 182(b)(2) and (f)(1) of the CAA require states with moderate, or worse, ozone nonattainment areas to implement RACT controls on each category of stationary sources covered by a control technique guideline (CTG) document issued by EPA and on all major stationary sources of VOC and NOX emissions located in the area.2 Pursuant to section 184(b) of the CAA, the same requirements for sources of NOX and VOC apply to any areas in an ozone transport region (OTR) established under section 184(a), therefore including marginal and moderate nonattainment areas as well attainment areas within an OTR. A single OTR has been established, comprised of 12 eastern states, or portions thereof, and the District of Columbia (hereafter, “the OTR”). The entire Commonwealth of Pennsylvania is part of the OTR.

    1See 44 FR 53782 (September 17, 1979); EPA's 1976 memorandum from Roger Strelow, Assistant Administrator for Air and Waste Management to Regional Administrators, “Guidance for Determining Acceptability of SIP Regulations in Non-attainment Areas” (December 9, 1976); and also, 72 FR 20586, 20610 (April 25, 2007).

    2 A major source in an ozone nonattainment area is defined as any stationary source that emits or has the potential to emit NOX and VOC emissions above a certain applicability threshold that is based on the classification of the ozone nonattainment area. See “major stationary source” in 40 CFR 51.165.

    On July 18, 1997 (62 FR 38856), EPA revised the NAAQS for ground-level ozone, setting at 0.08 parts per million (ppm) averaged over an 8-hour time frame. On April 15, 2004, EPA issued final designations for the 1997 8-hour ozone NAAQS, which included Philadelphia County as part of the Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE moderate ozone nonattainment area. 69 FR 23858, at 23931 (April 30, 2004). At the same time, EPA published the first phase of its final rule to implement the 1997 8-hour ozone NAAQS (Phase I Ozone Implementation Rule), in which EPA revoked the previous 1-hour ozone NAAQS for most areas of the country, effective on June 15, 2005, and established anti-backsliding principles to transition from implementing the revoked 1-hour ozone NAAQS to the more protective 1997 8-hour ozone NAAQS, as codified in 40 CFR 51.905.3 The nonattainment designation for Philadelphia under the 1997 8-hour ozone NAAQS, and its location in the OTR, triggered the Commonwealth's obligation to submit a SIP revision addressing how it meets the CAA RACT requirements in Philadelphia under the standard.

    3 “Final Rule to Implement the 8-Hour Ozone National Ambient Air Quality Standard—Phase 1,” 69 FR 23951 (April 30, 2001).

    On March 12, 2008 (73 FR 16436), EPA significantly strengthened the 8-hour ozone NAAQS by revising the primary 8-hour ozone standard to a level of 0.075 ppm. On March 6, 2015 (80 FR 12264), EPA published a final rule for the implementation of the 2008 8-hour ozone NAAQS, while at the same time revoking the 1997 8-hour ozone NAAQS, effective on April 6, 2015.4 Consistent with EPA's previous approach, the 2008 8-Hour Ozone Implementation Rule established anti-backsliding principles to transition from implementing the revoked 1997 8-hour ozone NAAQS to the 2008 8-hour ozone NAAQS, as codified in 40 CFR 51.1100. In this rule, EPA clarified that RACT under the 1997 8-hour ozone NAAQS, among other requirements, continues to apply to a nonattainment area, in accordance with its designation and classification for the 1997 8-hour ozone NAAQS at the time of the revocation of the standard. Therefore, 1997 8-hour ozone RACT continues to be an applicable requirement for Philadelphia.

    4 “Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements” Final Rule, 80 FR 12264 (March 6, 2015).

    The implementation of RACT controls under the 1997 8-hour ozone NAAQS is required in Philadelphia for each category of VOC sources covered by a CTG document issued by EPA (i.e., CTG RACT) and all other major stationary sources of NOX and VOC (major source RACT or non-CTG RACT), as defined for a moderate nonattainment area. Philadelphia was also subject to the CAA RACT requirements under the1-hour ozone NAAQS, as it was designated as part of the Philadelphia-Wilmington-Trenton, PA-NJ-DE-MD severe ozone nonattainment area under the 1-hour ozone NAAQS. See 56 FR 56694, 56822 (November 6, 1991). As a result, PADEP and AMS implemented numerous RACT controls in Philadelphia to meet the statutory RACT requirements under this previous standard.

    B. EPA's Requirements Under the 1997 8-Hour Ozone RACT

    On November 29, 2005, EPA published the second phase to its implementation rule to address nonattainment SIP requirements for the 1997 8-hour ozone NAAQS (the Phase 2 Ozone Implementation Rule).5 This rule addressed, among other things, control and planning obligations as they apply to nonattainment areas under the 1997 8-hour ozone NAAQS, including RACT and RACM. In this rule, EPA specifically required that states meet the RACT requirements under the 1997 8-hour ozone NAAQS, either through a certification that previously adopted RACT controls in their SIP revisions approved by EPA under the 1-hour ozone NAAQS continue to represent adequate RACT control levels for 1997 8-hour ozone NAAQS attainment purposes, or through the adoption of new or more stringent regulations that represent RACT control levels.6 A certification must be accompanied by appropriate supporting information such as consideration of information received during the public comment period and consideration of new data. Adoption of new RACT regulations should occur when states have new stationary sources not covered by existing RACT regulations, or when new data or technical information indicates that a previously adopted RACT measure does not represent a newly available RACT control level. EPA also requires states to submit a negative declaration if there are no CTG major sources of VOC and NOX emissions within the nonattainment area in lieu of or in addition to a certification.

    5 “Final Rule to Implement the 8-Hour Ozone National Ambient Air Quality Standard—Phase 2,” 70 FR 71612-71705 (November 29, 2005).

    6 For more information, see the preamble of the final Phase 2 Ozone Implementation Rule for a discussion of EPA's interpretation of the CAA RACT requirements for the 1997 8-hour ozone NAAQS, in 70 FR 71652-71659 (November 29, 2005).

    EPA particularly addressed controls for NOX emissions from electric generating units (EGUs) in the Phase 2 Ozone Implementation Rule. EPA determined that the regional NOX emissions reductions that result from either the NOX SIP Call or the Clean Air Interstate Rule (CAIR) for addressing interstate transport of ozone pollution, would meet the NOX RACT requirement for EGUs located in states included within the respective geographic regions. Thus, EPA concluded that the states did not need to perform a NOX RACT analysis for sources subject to the state's emission cap-and-trade program where such program has been adopted by the state and approved by EPA as meeting the NOX SIP Call requirements or, in states achieving the CAIR reductions solely from EGUs, the CAIR NOX requirements.

    In November 2008, several parties challenged the Phase 2 Ozone Implementation Rule, particularly, EPA's determination that compliance by EGUs with the requirements of the NOX SIP and/or CAIR could also be construed as compliance with RACT under the 1997 8-hour ozone NAAQS. As a result of this litigation, the United States Court of Appeals for the District of Columbia Circuit (D.C. Circuit) decided that such presumptions and determinations by EPA in the Phase 2 Ozone Implementation Rule were inconsistent with the statutory requirements of section 172(c)(1) of the CAA. Because region-wide RACT-level emissions reductions do not meet the statutory requirement that the reductions be from sources in the nonattainment area, the D.C. Circuit found that EPA had not shown that compliance with NOX SIP Call would result in at least RACT-level reductions in emissions from sources within each nonattainment area. See NRDC v. EPA, 571 F.3d 1245 (D.C. Cir. 2009).7

    7 The D.C. Circuit addressed whether reductions from the NOX SIP call could address NOX RACT. The issue as to whether CAIR satisfies NOX RACT for EGUs was not addressed by the D.C. Circuit because the D.C. Circuit had already remanded CAIR to EPA for further analysis at that time. See North Carolina v. EPA, 531 F.3d 896; modified by 550 F.3d 1176 (D.C. Cir. 2008). In subsequent litigation, the rule that EPA promulgated to replace CAIR (i.e., the Cross State Air Pollution Rule or CSAPR) was initially vacated by the D.C. Circuit but upheld by the U.S. Supreme Court. EPA v. EME Homer City Generation, L.P., 134 S. Ct. 1584 (2014). EPA began implementing CSAPR in January 2015. See 79 FR 71663 (December 3, 2014) (interim final rulemaking issued after D.C. Circuit lifted stay on CSAPR). Thus, EPA decided it would be appropriate to reconsider its prior determination that CAIR could satisfy NOX RACT in light of the earlier decision in NRDC v. EPA. See 79 FR 32892 (June 9, 2014) (proposing removal of prior determination that CAIR could be NOX RACT).

    C. EPA's Conditional Approval for Philadelphia's 1997 8-Hour Ozone RACT Demonstration

    On September 29, 2006, PADEP submitted, on behalf of AMS, a SIP revision purporting to address the RACT requirements for Philadelphia under the 1997 8-hour ozone NAAQS. The 2006 SIP revision consisted of a RACT demonstration for Philadelphia, including (1) a certification that previously adopted RACT regulations that were approved by EPA in Pennsylvania's SIP for Philadelphia under the 1-hour ozone NAAQS continue to represent RACT for the 1997 8-hour ozone NAAQS implementation purposes; (2) the adoption of federally enforceable permits that represent CTG RACT control for four major VOC sources; and (3) a negative declaration that certain VOC source categories that would be covered by CTG documents do not exist in Philadelphia.

    EPA identified two deficiencies in the 2006 SIP revision which precluded EPA's approval. First, the 2006 SIP revision included as RACT certain provisions that relied on the NOX SIP Call, which in light of the 2009 D.C. Circuit decision in NRDC v. EPA regarding the inappropriateness of the NOX SIP Call as RACT, precluded EPA from approving the 2006 SIP revision. Specifically, the 2006 SIP submittal certified as RACT the following PADEP regulations: 25 Pa Code sections 145.1-145.100 (“NOX Budget Trading Program”), 25 Pa Code sections 145.111-145.113 (“Emissions of NOX from Stationary Internal Combustion Engines”), and 25 Pa Code sections 145.141-144 (“Emissions of NOX from Cement Manufacturing”). Second, EPA also determined that the Philadelphia 2006 SIP revision did not sufficiently address the source-specific RACT requirements for 46 major sources of NOX and/or VOC that were previously approved under the 1-hour ozone NAAQS, per the SIP approved regulation in 25 Pa Code sections 129.91-92, which AMS certified as RACT under the 1997 8-hour ozone NAAQS.

    On June 22, 2010, PADEP submitted another RACT SIP revision addressing certain CTG RACT requirements that superseded portions of the RACT demonstration in the 2006 SIP revision. The 2010 SIP revision consisted of two new CTG regulations, Air Management Regulation (AMR) V section XV (“Control of Volatile Organic Compounds (VOC) from Marine Vessel Coating Operations”) and AMR V section XVI (“Synthetic Organic Manufacturing Industry (SOCMI) Air Oxidation, Distillation, and Reactor Processes”), and related amendments to AMR V Section I (“Definitions”), as adopted by AMS on April 26, 2010, effective upon adoption. The 2010 SIP revision also included a negative declaration demonstrating that there are no sources in Philadelphia for the CTG source category of natural gas and gasoline processing plants. The CTG regulations adopted in 2010 superseded source-specific RACT determinations provided in the 2006 SIP revision, because the new provisions are as, if not more, stringent than those RACT requirements previously submitted in 2006.8 Additionally, the 2010 SIP revision clarified that in the 2006 SIP submission, AMS had erroneously defined two sources in Philadelphia under the CTG category for natural gas and gasoline processing plants, and for which AMS submitted source-specific RACT determinations in the 2006 SIP revision. For these reasons, EPA determined that the provisions in the 2006 and 2010 SIP revisions were related in addressing Philadelphia's 1997 8-hour ozone NAAQS RACT obligation and were not separable for approval purposes as each SIP submittal contained provisions addressing RACT obligations.

    8 AMR V section XV and AMR V section XVI address EPA's RACT requirements as specified in the following CTGs: (1) “Control Techniques Guidelines for Shipbuilding and Ship Repair Operations (Surface Coating)” (61 FR 44050, August 27, 1996), (2) “Control of Volatile Organic Compound Emissions from Air Oxidation Processes in Synthetic Organic Chemical Manufacturing Industry” (EPA-450/3-84-015, December 1984), and (3) “Control of Volatile Organic Compound Emissions from Reactor Processes and Distillation Operations in Synthetic Organic Chemical Manufacturing Industry” (EPA-450/4-91-031, August 1993).

    Pursuant to section 110(k)(4) of the CAA, on April 26, 2013, PADEP submitted, on behalf of AMS, a letter in which AMS committed to submit SIP revisions addressing the source-specific RACT requirements for major sources of NOX and/or VOC in Philadelphia under the 1997 8-hour ozone NAAQS, including EGUs that were presumed to rely on the NOX SIP Call provisions to meet RACT. In the April 26, 2013 letter, AMS identified five sources that since the approval of the 1-hour ozone source-specific RACT determinations have adopted or will adopt additional controls that it believed represent RACT under the 1997 8-hour ozone NAAQS, and for which it would submit new source-specific RACT determinations: (1) Philadelphia Energy Solutions Refining and Marketing, LLC (formerly Sunoco Inc. (R&M)—Philadelphia), (2) Kraft Nabisco (formerly Nabisco Biscuit Co, and presently Mondelez), (3) Temple University—Health Sciences Campus, (4) GATX Terminals Corporation (presently, Kinder Morgan Liquids terminals, LLC), and (5) Honeywell International—Frankford Plant (formerly Sunoco Chemicals—Frankford Plant). Additionally, AMS indicated it would submit source-specific RACT determinations for five EGU sources in Philadelphia that relied on emissions reductions under the NOX SIP Call as RACT including: (1) Exelon Generating Company—Delaware Station, (2) Exelon Generating Company—Richmond Station, (3) Exelon Generating Company— Schuylkill Station, (4) Veolia Energy—Edison Station (formerly TRIGEN—Edison Station), and (5) Veolia Energy—Schuylkill Station (formerly TRIGEN- Schuylkill Station). AMS needed to submit source-specific RACT determinations or alternative certifications to address RACT for any major NOX sources, such as EGUs, for which AMS relied in prior SIP submissions on the NOX SIP Call to address RACT for the 1997 8-hour ozone NAAQS, because EPA cannot approve as RACT provisions relying on the NOX SIP Call. See NRDC v. EPA, 571 F.3d 1245.

    On June 19, 2013 (78 FR 36716), EPA proposed conditional approval of the Philadelphia 1997 8-hour ozone RACT demonstration included in both the 2006 and 2010 RACT SIP revisions, based upon AMS's commitment to submit additional SIP revisions to correct the deficiencies previously identified by EPA.9 In the June 19, 2013 proposed conditional approval, EPA proposed that in order to correct the deficiencies in the Philadelphia 1997 8-hour ozone RACT demonstration, AMS needed to provide a source-specific RACT analysis for each major NOX/VOC source subject to 25 Pa Code 129.91-92 for which current controls do not currently and adequately represent RACT for the 1997 8-hour ozone NAAQS, including each of the 10 major NOX and/or VOC sources identified by AMS in the April 26, 2013 letter, or alternatively provide a certification that source-specific RACT controls for all other major sources of NOX and VOC in Philadelphia previously approved by EPA in Pennsylvania's SIP for the 1-hour ozone NAAQS continue to adequately represent RACT for the 1997 8-hour ozone NAAQS.

    9 In this action, EPA also withdrew its previous proposed rule published on August 26, 2008 (73 FR 50270), proposing to fully approve the 2006 SIP revision addressing 1997 8-hour ozone RACT for Philadelphia.

    On December 13, 2013 (78 FR 75902), EPA finalized its conditional approval of the Philadelphia 1997 8-hour ozone RACT demonstration, as provided in the 2006 and 2010 SIP revisions, with the condition that Pennsylvania, on behalf of AMS, submits additional SIP revisions addressing source-specific RACT to address the deficiencies in the previously submitted 1997 8-hour ozone RACT demonstration. As stated in the December 13, 2013 final action, once EPA determines that AMS has satisfied this condition, EPA shall remove the conditional nature of such approval and the Philadelphia 1997 8-hour ozone RACT demonstration will receive at that time full approval status. For a detailed discussion of EPA's conditional approval of Philadelphia's 1997 8-hour ozone RACT demonstration and the identified deficiencies of the 2006 SIP revision, see 78 FR 75902 (December 13, 2013) (final action) and 78 FR 36716 (June 19, 2013) (proposed action).

    II. Summary of SIP Revisions

    To satisfy the requirements from EPA's December 13, 2013 conditional approval, PADEP has submitted to EPA, on behalf of AMS, subsequent SIP revisions addressing the source-specific RACT requirements for major sources in Philadelphia subject to 25 Pa Code 129.91-92. On June 27, 2014, February 18, 2015, and April 26, 2016, PADEP submitted to EPA, on behalf of AMS, three separate SIP revisions pertaining to the Philadelphia 1997 8-hour ozone RACT demonstration (hereafter collectively referred to as “the Philadelphia RACT SIP revisions”). AMS provided documentation in the Philadelphia RACT SIP revisions to support that RACT has been met for all major sources of NOX and/or VOC in Philadelphia, including source-specific RACT determinations for affected emission units at each major source subject to 25 Pa Code 129.91-92.10 Specifically, AMS evaluated a total of 25 major NOX and/or VOC sources in Philadelphia for RACT.

    10 The applicable “major source” thresholds for 1997 8-hour ozone RACT purposes are 50 tons per year (TPY) of VOC and 100 TPY of NOX or greater of potential emissions for each respective pollutant, in light of the moderate ozone classification of Philadelphia for the 1997 8-hour ozone NAAQS, as well as its location in the OTR.

    On April 26, 2016, PADEP also submitted a letter, on behalf of AMS, withdrawing from the 2006 SIP revision the certification of the Pennsylvania rules related to the NOX SIP Call as 1997 8-hour ozone RACT, specifically 25 Pa Code sections 145.1-145.100, 25 Pa Code sections 145.111-145.113, and 25 Pa Code sections 145.141-144. In the letter, PADEP reaffirms that AMS is no longer relying on the SIP approved provisions related to the NOX SIP Call as 1997 8-hour ozone RACT for any sources in Philadelphia. On May 4, 2016, EPA submitted a letter accepting PADEP's request for withdrawal of these provisions from the 2006 SIP revision, and acknowledging that this portion of the submittal is no longer pending before EPA for a final action.

    The June 27, 2014 SIP revision consists of a source-specific RACT determination for certain emissions units (6 process heaters) at Philadelphia Energy Solutions Refining and Marketing, LLC (PES). The February 19, 2015 SIP revision addresses RACT requirements for the 25 major sources of NOX and/or VOC in Philadelphia, including the remaining emissions units at PES that were not addressed in the June 27, 2014 SIP revision. The April 26, 2016 SIP revision amends the RACT determinations for 15 sources that were previously addressed in the February 19, 2015 SIP revision.

    In the Philadelphia RACT SIP revisions, AMS includes a RACT evaluation for each major source of NOX and/or VOC in Philadelphia. AMS identifies applicable RACT requirements for the existing emissions units at each major source located in Philadelphia, including CTG RACT, presumptive RACT requirements, and source-specific RACT requirements.11 AMS identified 16 major sources of NOX and/or VOC in Philadelphia subject to Pennsylvania's source-specific RACT requirements, as summarized in Table 1, including 14 major sources subject to previous source-specific RACT determinations and 2 major sources newly subject to source-specific RACT.

    11 The CTG RACT requirements are those specified in regulations in the Pennsylvania SIP and are consistent with EPA's CTGs for the affected source categories. Presumptive RACT requirements are those specified in 25 Pa Code section 129.93, which are alternative compliance option for sources subject to source-specific RACT.

    Table 1—Major NOX and/or VOC Sources in Philadelphia Subject to Source-Specific RACT Under the 1997 8-Hour Ozone NAAQS Major source Plant ID No. 1-Hr
  • ozone
  • RACT
  • source?
  • Major source
  • pollutant
  • New or revised source-specific determination?
  • (“Yes” or “No”)
  • New or revised RACT permit
  • (effective date)
  • Exelon Generating Company—Delaware Station 04901 X NOX No Exelon Generating Company—Richmond Station 04903 X NOX Yes PA-51-4903 (02/09/16). Exelon Generating Company—Schuylkill Station 04904 X NOX No Honeywell—Frankford Plant [formerly, Sunoco Chemical—Frankford Plant] 01551 X NOX and VOC Yes PA-51-1151 (02/09/16). Kinder Morgan Liquids Terminals, LLC [formerly, GATX Terminals Corp.] 05003 X VOC Yes PA-51-5003 (02/09/16). Naval Surface Warfare Center, Carderock Division (NSWCCD) 09724 X NOX Yes PA-51-9724 (02/09/16). Newman & Company, Inc. 03489 X NOX No PaperWorks Industries Inc. [formerly, Jefferson Smurfit, Corp./Container Corp. of America] 01566 X NOX Yes PA-51-1566 (01/09/15). Philadelphia Energy Solutions—Refining and Marketing, LLC [formerly, Sunoco Inc. (R&M)—Philadelphia] 01501/01517 X NOX and VOC Yes PA-51-01501 and PA-51-01517 (02/09/16). Philadelphia Gas Works—Richmond Plant 04922 X NOX Yes PA-51-4922 (01/09/15). Philadelphia Prison System 09519 NOX Yes PA-51-9519 (02/09/16). Plain Products Terminals, LLC [formerly, Maritank Philadelphia, Inc. and Exxon Company, USA] 05013 X VOC Yes PA-51-05013 (02/09/16). Temple—Health Sciences Campus 08906 X NOX Yes PA-51-8906 (01/09/15). Temple—Main Campus 08905 NOX Yes PA-51-8905 (01/09/15). Veolia Energy—Edison Station [formerly TRIGEN- Edison Station] 04902 X NOX Yes PA-51-4902 (01/09/15). Veolia Energy—Schuylkill Station [TRIGEN—Schuylkill Station]/Grays Ferry Cogeneration Partnership/Veolia Energy Efficiency, LLC a 04942/04944/10459 X NOX Yes PA-51-4942 (02/09/16)/PA-51-4944 (01/09/15)/PA-51-10459 (01/09/15). a Grays Ferry Cogeneration Plant, Veolia Schuylkill, and Veolia Energy Efficiency have been aggregated as a single major source after the 1-hour RACT determination. AMS submitted RACT documentation for each facility separately, although considering RACT applicability as a single major source of NOX.

    The source-specific RACT determinations submitted by AMS consist of an evaluation of all reasonably available controls at this time for each affected emissions unit, resulting in an AMS determination of what specific control requirements, if any, satisfy RACT for that particular unit. The adoption of new or additional controls or the revisions to existing controls as RACT were specified as requirements in new or revised federally enforceable permits (hereafter RACT permits) issued by AMS for the source. The new or revised RACT permits have been submitted as part of the Philadelphia RACT SIP revisions for EPA's approval in the Pennsylvania SIP under 40 CFR 52.2020(d)(1). For sources subject to previous RACT determinations specified in RACT permits under 40 CFR 52.2020(d)(1) for which AMS is revising or adopting additional source-specific controls, the revised RACT permits, once approved by EPA, will supersede those permits currently in the SIP. All new or revised RACT permits submitted by AMS are listed in the last column of Table 1.

    As part of the source-specific RACT determinations, AMS is also certifying for certain emissions units at major sources subject to source-specific RACT determinations under the 1-hour ozone NAAQS, which are part of the Pennsylvania SIP at 40 CFR 52.2020(d)(1), that the existing RACT controls continue to represent RACT for the 1997 8-hour ozone NAAQS. For these units, AMS did not propose additional revisions.

    AMS submitted source-specific RACT determinations for nine of the ten major sources identified in EPA's conditional approval. AMS did not submit the required source-specific RACT determination for Kraft Nabisco (formerly Nabisco Biscuit Co, and presently Mondelez), because it concluded that this source is no longer considered a major source of NOX and VOC for 1997 8-hour ozone RACT. As clarified in the Philadelphia RACT SIP revisions, in 2012, Mondelez took federally enforceable facility-wide limits of 25 tons per year for both NOX and VOC emissions, restricting the facility's potential emissions under the applicable thresholds for 1997 8-hour ozone RACT. EPA concurs with AMS's conclusion regarding the operational status of Mondelez and thus determines that the condition in the December 13, 2013 conditional approval to submit a source-specific RACT determination under the 1997 8-hour ozone NAAQS for this source is no longer applicable.

    AMS is further certifying that there are 27 additional NOX and/or VOC sources in Philadelphia subject to source-specific RACT determinations for the 1-hour ozone NAAQS in the Pennsylvania SIP at 40 CFR 52.2020(d)(1) that are no longer subject to RACT for purposes of the 1997 8-hour ozone NAAQS. AMS clarifies that 18 of these sources have permanently shut down, while the remaining nine are no longer considered major sources of NOX/VOC emissions for RACT under the 1997 8-hour ozone NAAQS (less than 100 or 50 TPY, respectively). Sources that remain in operation must still comply with the SIP approved 1-hour ozone RACT determinations, although not subject to 1997 8-hour ozone RACT. AMS is formally requesting EPA to remove from the SIP the 18 source-specific RACT determinations approved under the 1-hour ozone NAAQS, as codified in 40 CFR 52.2020(d)(1). The shutdown sources and their respective SIP approved RACT Permits are listed in Table 2. AMS certifies that none of these shutdown facilities have active operating permits or air pollution licenses for any equipment, and that under Pennsylvania and Philadelphia regulations, they cannot operate until further notification and issuance of applicable permits.

    Table 2—Shutdown Major Sources of NOX and/or VOC in Philadelphia Subject to Previous Source-Specific RACT Determinations Source SIP approved RACT
  • permit
  • (effective date)
  • EPA's SIP approval date
    Aldan Rubber Company PA-51-1561 (07/21/00) 10/30/01, 66 FR 54691. Amoco Oil Company PA-51-5011 (05/29/15) 10/31/01, 66 FR 54936. Arbill Industries, Inc PA-51-3811 (07/27/99) 10/30/01, 66 FR 54691. Braceland Brothers, Inc PA-51-3679 (07/14/00) 10/30/01, 66 FR 54691. Budd Company PA-51-1564 (12/28/95) 12/15/00, 65 FR 78418. Eastman Chemical [formerly, McWhorter Technologies, Inc.] PA-51-3542 (07/27/99) 10/30/01, 66 FR 54691. Graphic Arts, Incorporated PA-51-2260 (07/14/00) 10/30/01, 66 FR 54691. Interstate Brands Corporation PA-51-5811 (04/10/95) 12/15/00, 65 FR 78418. Kurz Hastings, Inc. PA-51-1585 (05/29/95) 10/31/01, 66 FR 54936. Lawrence McFadden, Inc PA-51-2074 (06/11/97) 10/31/01, 66 FR 54936. O'Brien (Philadelphia) Cogeneration, Inc.—Northeast Water Pollution Control Plant PA-51-1533 (07/21/00) 10/30/01, 66 FR 54691. O'Brien (Philadelphia) Cogeneration, Inc.—Southwest Water Pollution Control Plant PA-51-1534 (07/21/00) 10/30/01, 66 FR 54691. Pearl Pressman Liberty PA-51-7721 (07/24/00) 10/30/01, 66 FR 54691. Philadelphia Baking Company PA-51-3048 (04/10/95) 10/31/01, 66 FR 54936. Rohm and Haas Company—Philadelphia PA-51-1531 (07/27/99) 10/31/01, 66 FR 54942. Tasty Baking Co PA-51-2054 (04/04/95) 10/31/01, 66 FR 54942. Transit America, Inc PA-51-1563 (06/11/97) 11/5/01, 66 FR 55880. SBF Communications PA-51-2197 (07/21/00) 10/31/01, 66 FR 54942.
    III. EPA's Evaluation of SIP Revisions

    After thorough review and evaluation of the information provided by AMS in the Philadelphia RACT SIP revisions for major sources of NOX and/or VOC in Philadelphia, EPA finds that the AMS source-specific RACT determinations and conclusions provided are reasonable and address RACT requirements for Philadelphia for the 1997 8-hour ozone NAAQS in accordance with the Phase 2 Ozone Implementation Rule and latest available information. EPA finds that the proposed source-specific RACT controls and emissions limits in the Philadelphia RACT SIP revisions adequately meet the CAA RACT requirements for the 1997 8-hour ozone NAAQS for each major source of NOX and VOC in Philadelphia not covered by Pennsylvania RACT regulations.

    EPA also finds that the all proposed revisions to previously SIP approved RACT requirements, as discussed in the Philadelphia RACT SIP revisions will result in equivalent or additional reductions of NOX and/or VOC emissions and should not interfere with any applicable requirement concerning attainment or reasonable further progress with the NAAQS or interfere with other applicable CAA requirement in section 110(l) of the CAA. In the case of AMS removal of RACT requirements from the SIP that are no longer applicable, as the sources have been permanently removed, EPA finds these SIP revisions to be adequate and will not have any adverse impact to air quality. EPA's complete analysis of the Philadelphia RACT SIP revisions is included in the technical support document (TSD) available in the docket for this rulemaking action and available on line at http://www.regulations.gov.

    As discussed earlier, EPA determined in the December 15, 2013 conditional approval that the Philadelphia 1997 8-hour ozone RACT demonstration as provided in the 2006 and 2010 SIP revisions adequately met RACT under the CAA, with exception of the source-specific RACT requirements in 25 PA Code sections 129.91-92 and the NOX SIP Call related provisions in the Pennsylvania SIP in 25 Pa Code sections 145.1-145.100, 25 Pa Code sections 145.111-145.113, and 25 Pa Code sections 145.141-144. In this proposed rulemaking action, EPA finds that the subsequent Philadelphia RACT SIP revisions adequately correct the two deficiencies identified by EPA on the Philadelphia RACT demonstration, as provided in the 2006 and 2010 SIP revisions, and thus satisfy the December 15, 2013 conditional approval. Based on PADEP's withdrawal of the certified provisions relying on NOX SIP Call as RACT from the 2006 SIP revision, EPA finds that the remaining certified NOX and/or VOC regulations, the CTG negative declarations, and the recently adopted regulatory provisions in AMR V sections XV and XVI, submitted as part of the 2006 and 2010 SIP revisions, are consistent with the latest available information and EPA's guidance and therefore adequately meet RACT for the 1997 8-hour ozone NAAQS.12

    12 EPA's evaluation of the 2006 and 2010 SIP revisions is provided in the June 19, 2013 proposed conditional approval and related technical support document dated May 22, 2013, and will not be restated here. See 78 FR 36716.

    Consequently, EPA finds that the Philadelphia 1997 8-hour ozone RACT demonstration, as provided within the SIP revisions submitted to EPA from 2006 to 2016, address RACT under the 1997 8-hour ozone NAAQS for all NOX and/or VOC major sources in Philadelphia through: (1) Compliance with previously approved RACT regulations in the Pennsylvania SIP, including but not limited to CTG regulations (in the 2006 and 2010 SIP revisions); (2) submission of negative declarations (in the 2006 and 2010 SIP revisions) for CTG source categories; (3) the adoption of additional source-specific controls and/or limits in major sources, included in federally enforceable permits and submitted as part of the SIP revisions; and/or (4) certifications for major sources subject to source-specific RACT controls previously approved into the SIP, which controls continue to represent RACT under the 1997 8-hour ozone NAAQS. Additional details regarding Philadelphia's source-specific RACT determinations, full background on the Philadelphia RACT SIP revisions, and EPA's detailed evaluation of the Philadelphia RACT SIP revisions can be found in the TSD prepared for this rulemaking action and available in the docket for this rulemaking at http://www.regulations.gov.

    IV. Proposed Action

    EPA proposes to approve the Philadelphia RACT SIP revisions submitted on June 27, 2014, February 18, 2015, and April 26, 2016 for all major sources of NOX and/or VOC in Philadelphia subject to 25 Pa Code 129.91-92, as adequately meeting the CAA RACT requirements for the 1997 8-hour ozone NAAQS. EPA is proposing to incorporate by reference in the Pennsylvania SIP, via RACT permits, source-specific RACT determinations under the 1997 8-hour ozone NAAQS for certain major sources of NOX and VOC emissions.

    EPA also proposes to find that the Philadelphia RACT SIP revisions satisfy the conditions established by EPA in its December 13, 2013 conditional approval to correct the deficiencies of the previously submitted Philadelphia 1997 8-hour ozone NAAQS RACT demonstration. For this reason, EPA also proposes to remove the conditional nature of the December 13, 2013 conditional approval and grant full approval to the Philadelphia 1997 8-hour ozone NAAQS RACT demonstration, as submitted on September 29, 2006 and June 22, 2010 as SIP revisions.

    EPA also proposes in this rulemaking action that the certified and recently adopted NOX and VOC regulations and the negative declarations, included in the September 29, 2006 and June 22, 2010 SIP revisions, meet RACT under the 1997 8-hour ozone NAAQS. Therefore, EPA also proposes to incorporate by reference into the Pennsylvania SIP the regulatory provisions in AMR V sections I, XV, and XVI, as amended or adopted in April 26, 2010 and effective upon adoption. Finally, EPA proposes that the Philadelphia 1997 8-hour ozone NAAQS RACT demonstration, included within the September 29, 2006, June 22, 2010, June 27, 2014, February 18, 2015, and April 26, 2016 SIP revisions, satisfies the RACT requirements under the CAA for the 1997 8-hour ozone NAAQS, in accordance with the Phase 2 Ozone Implementation Rule. EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before taking final action.

    V. Incorporation by Reference

    In this proposed rulemaking action, EPA is proposing to include in a final EPA rule, regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference source-specific RACT determinations under the 1997 8-hour ozone NAAQS for certain major sources of NOX and VOC emissions, and Philadelphia CTG RACT regulations of AMR V sections I, XV, and XVI, as amended or adopted in April 26, 2010 and effective upon adoption. EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or may be viewed at the appropriate EPA office (see the ADDRESSES section of this preamble for more information). In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference the regulatory provisions under 40 CFR 52.2020(c) and the source-specific RACT requirements under 40 CFR 52.2020(d)(1).

    VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. 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 proposed action:

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

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

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

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

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

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

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

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

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

    In addition, this proposed rule, regarding the Philadelphia RACT requirements under the 1997 8-hour ozone NAAQS, does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: June 3, 2016. Shawn M. Garvin, Regional Administrator, Region III.
    [FR Doc. 2016-14102 Filed 6-14-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R01-OAR-2015-0238, FRL-9947-68-Region 1] Air Plan Approval; CT; NOX Emission Trading Orders as Single Source SIP Revisions AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Connecticut. This revision continues to allow facilities to create and/or use emission credits using NOX Emission Trading and Agreement Orders (TAOs) to comply with the NOX emission limits required by Regulations of Connecticut State Agencies (RCSA) section 22a-174-22 (Control of Nitrogen Oxides). The intended effect of this action is to propose approval of the individual trading orders to allow facilities to determine the most cost-effective way to comply with the state regulation. This action is being taken in accordance with the Clean Air Act (CAA).

    DATES:

    Written comments must be received on or before July 15, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID Number EPA-R01-OAR-2015-0238 at http://www.regulations.gov, or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the For Further Information Contact section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Donald Dahl, Air Permits, Toxics, and Indoor Programs Unit, Office of Ecosystem Protection, U.S. Environmental Protection Agency, EPA New England Regional Office, 5 Post Office Square, Suite 100, (OEP05-2), Boston, MA 02109-3912, phone number (617) 918-1657, fax number (617) 918-0657, email [email protected]

    SUPPLEMENTARY INFORMATION:

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

    Table of Contents I. Background and Purpose. II. Analysis of State Submission III. Proposed Action IV. Statutory and Executive Order Reviews I. Background and Purpose

    On November 15, 2011, the Connecticut Department of Energy and Environmental Protection (CT DEEP) submitted a formal revision to its State Implementation Plan (SIP). This SIP revision consists of eighty-nine source-specific Trading Agreement and Orders (TAOs) that allow twenty-four individual stationary sources of nitrogen oxide (NOX) emissions to create and/or trade NOX emission credits in order to ensure more effective compliance with EPA SIP-approved state regulations for reducing NOX emissions. We previously approved source-specific TAOs of the same kind issued by CT DEEP under this program for these same sources on September 28, 1999 (64 FR 52233), March 23, 2001 (66 FR 16135), and September 9, 2013 (78 FR 54962). The SIP submittal also includes Consent Order 8029A issued to Hamilton Sundstrand which addresses Volatile Organic Compound (VOC) emissions.

    In our September 9, 2013 approval, EPA acted on most of the TAOs contained in CT DEEP's July 1, 2004 SIP revision submission to EPA. At that time, EPA did not act on (1) TAO 8021 issued to Pfizer; (2) TAO 8246 issued to Sikorsky Aircraft; (3) TAO 8110A issued to Yale University; and (4) Consent Order 7019A issued to Hamilton Sundstrand Corporation. On May 29, 2015, CT DEEP revised its July 1, 2004 SIP revision submittal to EPA by modifying TAO 8110A. Today we are acting on the modified version of TAO 8110A. EPA will take action on TAOs 8246 and 8021 at a future date. Lastly, on April 22, 2014 the CT DEEP withdrew Consent Order 7019A from the 2004 SIP submittal.

    The CAA requires states to develop Reasonably Available Control Technology (RACT) regulations for all major stationary sources of NOX in areas which have been classified as “moderate,” “serious,” “severe,” and “extreme” as well as in all areas of the Ozone Transport Region (OTR). EPA has defined RACT as the lowest emission limitation that a particular source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility (44 FR 53762; September 17, 1979). This requirement is established by sections 182(b)(2), 182(f), and 184(b) of the CAA.

    Connecticut, as part of the OTR as well as being designated nonattainment for ozone, established NOX emission limits for existing major sources in order to meet the RACT requirement. The NOX emission limits are codified in Regulations of Connecticut State Agencies (RCSA) section 22a-174-22 (Control of Nitrogen Oxides). These state regulations were last approved by EPA into the Connecticut SIP on October 6, 1997. (See 62 FR 52016).

    As stated above, when determining what constitutes RACT for a source, a state and EPA need to consider both technology and economic feasibility. For example, it is technically possible for a source to install pollution control devices in series to further reduce emissions. However, if a state and EPA determined that such an installation would be economically infeasible in relation to the additional emissions reductions achieved, then the RACT emission limit under Connecticut's regulations could legitimately be established at a higher rate than would be achieved by installing control devices in series.

    RCSA 22a-174-22 establishes NOX emission limits for several types of fossil-fuel firing emission units. RCSA 22a-174-38 establishes NOX emission limits for municipal waste combustors. Since RACT is determined on a source-by-source basis, a fossil-fuel firing source may under Connecticut's regulations request a higher emission limit by making a demonstration to the CT DEEP that it is either technologically or economically infeasible, or both, to meet the NOX RACT limit in RCSA 22a-174-22. CT DEEP's use of the NOX TAOs has rendered the need for higher source-specific emission rates, based on demonstrations of technological and/or economic feasibility, less frequent, thus having the effect of reducing overall NOX emissions to a greater degree than would be the case without the TAO trading mechanism. For example, in its RACT Analysis for the 2008 ozone national ambient air quality standard (NAAQS) submitted to EPA on July 18, 2014 (2014 RACT Analysis), CT DEEP stated that “[t]he traditional cost effectiveness ($/ton of NOX emitted) evaluation of controlling NOX emissions from the load-following boilers and uncontrolled turbines will not address high electric demand day (HEDD) emissions because the addition of controls on existing units that operate infrequently will nearly always result in a cost of control that is not reasonable.”

    Accordingly, as an alternative to these potential single source SIP determinations, which can lead to higher levels of NOX emissions, Connecticut established an emission trading program in RCSA 22a-174-22(j) for fossil-fuel firing emission units and RSCA 22a-174-38(d) for municipal waste combustors. These two SIP-approved regulations allow a source to participate in Connecticut's NOX emission trading program using two different mechanisms. RSCA 22a-174-22(j) requires a source that wants to participate in the program to enter into a TAO with the CT DEEP. RSCA 22a-174-38(d) does not require a municipal waste combustor (MWC) to enter into a TAO and instead contains specific requirements that an MWC must meet in order to create a NOX emission reduction credit that can be used in Connecticut's trading program. These emission trading programs provide incentives for some facilities subject to the NOX emission limits in either RSCA 22a-174-22 or RSCA 22a-174-38 to reduce their NOX emissions beyond what is required to meet RACT by allowing them to create discrete emission reduction credits (DERCs).1 The DERCs may then be purchased by other sources which otherwise may have needed a higher source-specific NOX emission limit due to technological and/or economic infeasibility. DERCs are created when a facility installs and operates a control device which reduces emissions beyond what is required to meet the NOX emission limitations in RSCA 22a-174-22 or in RSCA 22a-174-38(d). Once a DERC is created, it can then be sold to another source that is unable to meet the NOX limit in RSCA 22a-174-22 .2 The incentive to over control leads to a greater NOX emission reduction than the reduction that would have occurred if Connecticut had to establish a higher NOX emission limit for those sources which demonstrated that they would be unable to meet the NOX limits in RSCA 22a-174-22 due to cost or technological infeasibility, or both.

    1 The NOX emission credits created pursuant to RSCA 22a-174-38(d) are referred to as emission reduction credits.

    2 RSCA 22a-174-38(d)(1) also allows a municipal waste combustor that commenced construction prior to December 20, 1989 to use emission credits created under RSCA 22a-174-38 to comply with the NOX emission limits contained in RSCA 22a-174-38(c)(8).

    At the time Connecticut instituted the NOX emission trading program in 1995, the sources generating NOX emission credits in Connecticut were reducing their emissions to levels below those required by Connecticut's RACT regulations. Since that time, in more recent years, other states have established NOX RACT emission limits for emission units similar to those in Connecticut, at levels lower than the emission limits in RSCA 22a-174-22 which are currently approved in the Connecticut SIP as meeting RACT for the 1997 ozone standard. CT DEEP is now required by the CAA to recertify that its regulations meet RACT for the 2008 ozone standard. During this recertification process, CT DEEP recognized the fact the NOX emission limits contained in RSCA 22a-174-22 may not be stringent enough for the 2008 ozone standard by stating in its 2014 RACT Analysis that “[w]hile the combination of emissions limits and trading initially led (sic) to significant system-wide emission reductions throughout Connecticut in 1995, the efforts to “over-control” to generate credits are now merely RACT in many other states. DEEP must therefore consider elimination of the single source emissions trading program, as well as more stringent emission limits, to meet current RACT levels and realize additional reductions in Connecticut emissions.” In other words, CT DEEP's NOX emission trading program, as presently structured in RSCA 22a-174-22, may no longer be viable in the future to meet today's standards for RACT, as emission limits in RSCA 22a-174-22 may need to be revised in order for CT DEEP to demonstrate attainment with the 2008 ozone standard. In fact, CT DEEP's July 1, 2014 RACT submittal states, “DEEP commits to perform further evaluation of Connecticut's municipal waste combustor and fuel-burning source NOX requirements and to seek any regulatory revisions necessary to revise the control requirements to a RACT level for the 2008 ozone NAAQS,” and also states, “DEEP commits to begin a review of NOX emissions and emissions controls for the sources now subject to RCSA section 22a-174-22 with the goal of developing changes to RCSA section 22a-174-22 sufficient to satisfy RACT under the 2008 ozone NAAQS.” 3 Therefore, EPA is not deciding if the NOX trading program allowed by RSCA 22a-174-22 is sufficient to meet RACT for the 2008 ozone standard and is not taking any action on Connecticut's July 1, 2014 RACT SIP revision in this action. Rather, EPA will address those issues in a future rulemaking.

    3 Furthermore, CT DEEP is currently working with a RACT stakeholder workgroup on draft regulations. See www.ct.gov/deep/cwp/view.asp?a=2684&q=546804&deepNav_GID=1619.

    Banked emission reduction credits must be correctly accounted for in attainment plans in order to prevent unplanned future emissions. On February 1, 2008, Connecticut submitted its 2002 to 2008 reasonable further progress (RFP) plan and 2002 base year inventory to EPA as part of its attainment demonstration SIP submittal for the 1997 8-hr ozone standard. On October 14, 2009, Connecticut submitted a revision to the RFP plan. EPA approved Connecticut's RFP plan, as revised, on August 22, 2012 (77 FR 50595). In the October 14, 2009 revision, Connecticut explained that any DERCs that existed in the base year 2002 will have expired by the end of the RFP period in 2008. This is based on the fact that under Connecticut's NOX emission trading program, DERCs expire within five years of creation. Since any DERCs existing in 2002 would not be available for use in 2008, banked DERCs need not be accounted for in a state's RFP analysis, and Connecticut has properly done that. Therefore, EPA is concluding the TAO's that we are proposing to approve into the SIP today have been properly accounted for in Connecticut's attainment plan.

    With respect to the 2008 ozone standard, both Connecticut nonattainment areas were initially designated “marginal” nonattainment for this standard on May 21, 2012. (See 77 FR 30088). However, on May 4, 2016, EPA re-classified or “bumped-up” these areas to moderate nonattainment. (See 81 FR 26697). Connecticut will need to account for DERCs in its new RFP and attainment plans for this standard which must be submitted as expeditiously as practicable, but no later than January 1, 2017.

    II. Analysis of State Submission

    EPA issued a guidance document “Improving Air Quality with Economic Incentive Programs” (EIP Guidance) .4 This guidance applies to discretionary economic incentive programs (EIPs). EPA's final action on these discretionary economic incentive programs occurs when EPA acts on a state's request to revise the SIP. EPA reviewed the source-specific TAOs with respect to the expectations of the EIP Guidance. EPA has concluded, after review and analysis of the source-specific TAOs, that they are consistent with the EIP Guidance. See the Technical Support Document in the docket for this action for EPA's analysis of why the TAO's are consistent with the EIP.

    4 See EPA-452/R-01-001, January 2001 at https://www3.epa.gov/ttn/caaa/t1/memoranda/eipfin.pdf.

    When EPA designated areas for the 2008 ozone standard, Connecticut was divided into two separate areas, the Greater Connecticut Area and the New York-N. New Jersey-Long Island NY-NJ-CT area. CT DEEP and EPA analyzed emission trading data for the period of time the TAOs were in effect to determine if more emission reduction credits were being used for compliance than were generated or created in any of Connecticut's two nonattainment areas. EPA has determined the TAOs have resulted in RACT equivalent emission reductions in each of the two nonattainment areas. See the Technical Support Document in the docket for this action for an explicit accounting of the emissions from each facility in each nonattainment area.

    The TAOs being approved into Connecticut's SIP today are limited to facilities which have already been authorized in the past by the State to operate under a TAO and those TAOs continue to authorize the sources until May 31, 2014 to create and/or use NOX emission credits and allow for unused NOX allowances to be converted into NOX emission credits. The TAOs previously issued by Connecticut to these facilities were approved by EPA into the Connecticut SIP on September 28, 1999 (64 FR 52233), March 23, 2001 (66 FR 16135), and September 9, 2013 (78 FR 54962). The reason the TAOs must be approved at this time for these same facilities is that the TAOs previously approved had all expired by May 1, 2007.

    III. Proposed Action

    EPA is proposing to approve Connecticut's submitted SIP revision for the NOX TAOs submitted on November 15, 2011. EPA is not taking action on Consent Order 8029A issued to Hamilton Sundstrand Corporation. EPA will take action on this Consent Order at a later date. EPA is also proposing to approve TAO 8110A, submitted on July 1, 2004 and amended on May 29, 2015. EPA is soliciting public comments on the issues discussed in this document or on other relevant matters. These comments will be considered before taking final action. Interested parties may participate in the Federal rulemaking procedure by submitting written comments to the EPA New England Regional Office listed in the ADDRESSES section of this Federal Register.

    IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed 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 proposed action:

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

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

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

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

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

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

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

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

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

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

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Reporting and recordkeeping requirements.

    Dated: May 31, 2016. H. Curtis Spalding, Regional Administrator, EPA New England.
    [FR Doc. 2016-14100 Filed 6-14-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2015-0675; FRL-9947-61-Region 4] Air Plan Approval; Kentucky; Source Specific Revision for Louisville Gas and Electric AGENCY:

    Environmental Protection Agency.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the Commonwealth of Kentucky through its Energy and Environment Cabinet, Department of Environmental Protection, Division for Air Quality (KY DAQ) on February 13, 2013, for the purpose of establishing emission requirements for the changeover from coal-fired units U4, U5 and U6 to a new natural gas-fired combined cycle (NGCC) generating unit U15 and auxiliary boiler U16 at the Louisville Gas and Electric Company, Cane Run Generating Station (LG & E Cane Run Facility).

    DATES:

    Comments must be received on or before July 15, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R04-OAR-2015-0675 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the Web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Jane Spann of the Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Ms. Spann may be reached by telephone at (404) 562-9029 or via electronic mail at [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    Ozone is created when chemical reactions between volatile organic compounds (VOC) and nitrogen oxides (NOX) occur in the presence of sunlight. Ozone is reduced by reducing VOC and NOX emissions. The Louisville Metro Air Pollution Control District (LMAPCD) adopted regulation 6.42 Reasonably Available Control Technology Requirements for Major Volatile Organic Compound and Nitrogen Oxides Emitting Facilities on February 2, 1994. LMAPCD's regulation 6.42 was submitted to EPA, through the Commonwealth of Kentucky, on May 21, 1999. On October 23, 2001, EPA approved LMAPCD's regulation 6.42, section 4.4 of which requires LMAPCD to submit each source-specific reasonably available control technology (RACT) determination to EPA for approval into the Kentucky SIP. See 66 FR 53658. On the same date, EPA approved the NOX RACT plan for LG & E's Cane Run Facility into the SIP. See 66 FR 53684.

    On June 13, 2011, LG & E submitted to the Air Pollution Control Board of Jefferson County (Board) an application for a permit to construct a new NGCC generating unit U15 and auxiliary boiler U16 and retire coal-fired units U4, U5 and U6 at LG & E's Cane Run Facility to comply with other federal requirements, including the Mercury & Air Toxics Standards and the Cross-State Air Pollution Rule.1 In response, on July 18, 2012, the Board adopted Amendment 2 establishing NOX emission rates for the new units. On February 13, 2013, KY DAQ, on behalf of LMAPCD, submitted a SIP revision for EPA to approve the LG & E Cane Run Generating Station NOX RACT Plan Amendment 2 into the Kentucky SIP. The LG & E Cane Run Generating Station NOX RACT Plan Amendment 2 includes two parts: Part 1, the existing NOX RACT Plan for the coal-fired units, which will remain in effect until those units are retired; and Part 2, the plan that will become effective upon the start of operation of the NGCC facility and the shut-down of the coal-fired units.

    1 Amendment 2 of the February 13, 2013, submittal includes a Dew Point Heater (U17). In 2014, LG&E notified LMAPCD that LG&E is not installing U17 after all.

    II. Analysis of State Submittal

    CAA section 110(l) does not allow approval of a SIP revision if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress or any other applicable requirement of the CAA. On May 19, 2015, LMAPCD submitted supplemental information regarding the February 13, 2013, submittal to address CAA section 110(l). The May 19, 2015, supplemental document compares the NOX and VOC emissions from the coal-fired electric generation units (EGUs) (U4, U5 and U6) to those from the new NGCC generating unit U15 and auxiliary boiler U16. The comparison shows that substitution of NGCC units for the coal-fired EGUs will cause a reduction of 11,660 tons per year (tpy) of NOX allowable emissions.2 It also indicates a possible increase of 25.2 tpy of VOC allowable emissions.3

    2 Permitted, maximum, allowable NOX emissions for any consecutive 12 month period.

    3 Permitted, maximum, allowable VOC emissions for any consecutive 12 month period.

    The Louisville area is currently in compliance with the ozone national ambient air quality standards (NAAQS). To demonstrate that the potential VOC increase of 25.2 tpy would not interfere with the area's ongoing attainment of the ozone NAAQS, LMAPCD conducted an analysis of ozone sensitivity based on data from monitors in the Louisville Metropolitan Statistical Area and a region-wide modeling project known as the “Southeastern Modeling, Analysis, and Planning” (SEMAP).4 The analysis compared the tons per day of ozone reduced based on NOX reductions and based on VOC reductions and determined that NOX emission reductions in the Louisville region are 2 to 16 times more effective than VOC emission reductions at reducing ozone concentrations. Based on this analysis, LMAPCD determined that a 25-ton increase in VOC emissions can be offset with a reduction in NOX emissions of as much as 400 tons to as little as 50 tons. Therefore, LMAPCD concluded that the potential increase in VOC of 25.2 tpy from the Cane Run facility is offset by the concurrent 11,660 tpy reduction in NOX. EPA has preliminarily determined that the new NOX RACT plan associated with Cane Run's change from coal-fired to natural gas-fired units meets the requirements of CAA section 110(l). Thus, EPA is proposing to approve the February 13, 2013, SIP submittal into the federally-approved SIP. This area is, as noted above, in compliance with the ozone NAAQS and there is no indication that this proposed action will cause interference with compliance with the fine particulate matter or nitrogen dioxide NAAQS.

    4 Odam, Talat, and Zac Adelman. Emissions and Air Quality Modeling for SEMAP. Georgia Institute of Technology Environmental Engineering Department, the University of North Carolina Institute for the Environment and the Colorado State University Cooperative Institute for Research in the Atmosphere. October 15, 2014.

    III. Incorporation by Reference

    In this rule, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference the KY DAQ source-specific provision entitled “Air Pollution Control Board of Jefferson County Board Order—Amendment 2,” approved by LMAPCD on July 18, 2012. EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the EPA Region 4 office (see the ADDRESSES section of this preamble for more information).

    IV. Proposed Action

    EPA is proposing to approve the February 13, 2013, Kentucky SIP revision which adds LG & E Cane Run Generating Station NOX RACT Plan Amendment 2 to the federally-approved Kentucky SIP. This SIP includes emission requirements for the changeover from coal-fired units to natural gas-fired combined cycle EGUs and associated equipment.

    V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this proposed 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 proposed action:

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

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

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

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

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

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

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

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

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

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

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: June 1, 2016. Heather McTeer Toney, Regional Administrator, Region 4.
    [FR Doc. 2016-14032 Filed 6-14-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 45 CFR Part 5 RIN 0991-AC04 Freedom of Information Regulations AGENCY:

    Office of the Secretary, Department of Health and Human Services (HHS).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Department of Health and Human Services (HHS) is proposing to revise and republish its regulations implementing the Freedom of Information Act (FOIA). The regulations are being revised in order to incorporate changes made to the FOIA by the Openness Promotes Effectiveness in our National Government Act of 2007 (OPEN Government Act) and the Electronic FOIA Act of 1996 (E-FOIA Act). Additionally, the regulations are being updated to reflect changes to the organization, to make the FOIA process easier for the public to navigate, to update HHS's fee schedule, and to make provisions clearer. Because of the numerous changes to the organization and to the headings, the regulations are being republished in their entirety.

    DATES:

    Submit comments on or before August 15, 2016.

    ADDRESSES:

    You may submit comments via the Federal eRulemaking Portal at www.regulations.gov. In addition, please include the Docket ID at the top of your comments.

    FOR FURTHER INFORMATION CONTACT:

    Michael Marquis, Michael Bell, Deborah Peters, and/or Brandon Lancey by email to: [email protected]. These individuals also can be reached by telephone at 202-690-7453.

    SUPPLEMENTARY INFORMATION:

    This rule proposes revisions to the Department's regulations implementing the Freedom of Information Act (FOIA), 5 U.S.C. 552. The Department's FOIA regulations were last revised on November 23, 1988. Since that time, there have been major changes to the FOIA through the passage of the Openness Promotes Effectiveness in our National Government Act of 2007 (OPEN Government Act) (Pub. L. 110-175, 121 Stat. 2524) and the Electronic Freedom of Information Act Amendments of 1996 (E-FOIA Act) (Pub. L. 104-231, 110 Stat. 3048). This revision proposes to update the regulations to make them consistent with the OPEN Government Act and the E-FOIA Act. In addition, these regulations are being updated to reflect changes to the organization, to make the FOIA process easier for the public to navigate, to update HHS's fee schedule, and to make provisions clearer.

    The OPEN Government Act

    The OPEN Government Act was enacted into law on December 31, 2007. Changes resulting from the enactment of the OPEN Government Act are found throughout this proposed rule. New provisions implementing the OPEN Government Act have been included in the following sections addressing the following subjects: § 5.3 (Chief FOIA Officer); § 5.3, § 5.23(c), and § 5.29(a) (FOIA Public Liaisons); § 5.3 (definition of “representative of the news media”); § 5.3, § 5.25(c), and § 5.41(f) (tolling of time limits); § 5.23(b) (receipt of requests); § 5.25(a) (tracking numbers for all requests); § 5.28(c) (indicate exemption under which redaction is made); § 5.29(b) and § 5.54(b) (references to the Office of Government Information Services (OGIS)); and § 5.44(d) (ability to charge fees when a time limit is missed).

    The E-FOIA ACT

    This revision proposes to update the regulations to make them consistent with the E-FOIA Act. New provisions implementing the E-FOIA Act have been included in the following sections addressing the following subjects: § 5.1(b)(3)(iv) and § 5.1(b)(3)(v) (additional category of reading room records and indexing of this category); § 5.3 and § 5.22(e) (electronic posting of reading room records); § 5.3 (definition of “record” to include material stored electronically); § 5.3 (definition of “search” to include electronic form or format); § 5.25(e) (number of days to make disclosure decision increased from 10 working days to 20); § 5.25(e) and (f) (adoption of multi-track system for processing FOIA requests); § 5.25(e), (f), (g), and (h) (FOIA requests involving “unusual circumstances”); § 5.27 (expedited processing); § 5.28(b) (informing requesters about the amount of information redacted); and § 5.28(f) (form and format of response).

    Additional Changes

    The proposed rule revises the FOIA regulations in order to reflect the current organizational structure of the Department. Since the regulations were last revised, the following Operating Divisions and Staff Divisions were created: The Administration for Children and Families in 1991, the Administration for Community Living in 2012, the Agency for Healthcare Research & Quality in 1989, the Program Support Center in 1995, and the Substance Abuse and Mental Health Services Administration in 1992. In addition, the Health Care Financing Administration was renamed the Centers for Medicare & Medicaid Services in 2001 and the Social Security Administration became an independent agency, leaving the organization in 1995. Sections 5.3 and 5.23 have been updated to reflect these changes.

    The proposed rule establishes and defines the role of the Deputy Chief FOIA Officer at § 5.3. The proposed rule also more clearly defines the role of the HHS Freedom of Information Officer in the Office of the Secretary and details this individual's responsibility for Department-wide administration and coordination of the Freedom of Information Act at § 5.3. Finally, in § 5.3, the departmental regulations have been amended to specify that each HHS Freedom of Information Officer has the authority to task agency organizational components to search for records in response to a FOIA request and provide records located to the cognizant FOIA office.

    The proposed rule makes a number of changes to assist the public in navigating the FOIA process. The new § 5.2 asserts the Department's commitment to provide access to public records and increase openness and transparency. Section 5.22 has been further clarified to better inform requesters of the type of information they should include in a FOIA request. Sections 5.23 and 5.24 provide requesters with the information needed to submit a FOIA request electronically. Section 5.25(a) creates procedures for acknowledging FOIA requests. Section 5.25(c) describes how the FOIA Service Centers will attempt to seek clarification from requesters before closing ambiguous requests. Section 5.28(e) establishes a policy that encourages interim responses for requests that involve a voluminous amount of material or searches in multiple locations. Section 5.31(d)(4)(ii) increases the number of days to respond to a submitter notice from 5 working days to 10 working days and gives the Department and its Operating Divisions and Staff Divisions the option to extend this timeframe as necessary; this will allow submitters the opportunity to make more clearly articulated disclosure objections rather than seeking to broadly designate information as exempt. Section 5.52(a) provides the contact information for submitting an appeal and increases the number of calendar days within which an appeal must be received from 30 to 45. Finally, § 5.61 informs requesters of how long the Department retains records created in administering the Department's Freedom of Information Program.

    The proposed rule includes changes to the HHS fee schedule and other fee-related items. Revisions to the HHS fee schedule can be found at § 5.43. The proposed rule also provides updated procedures for handling of advanced payments (§ 5.41(b)); negotiating fees (§ 5.41(e)); and costs for reproducing electronic records (§ 5.43(c)(2) and (3)), using special delivery (§ 5.43(d)), and certifying records (§ 5.43(e)). The proposed rule provides the Department the ability to waive fees as a matter of administrative discretion in § 5.45(e). Finally, § 5.42(b) increases the minimum threshold for fee charges.

    Regulatory Analysis Executive Order 12866

    The proposed rule has been drafted and reviewed in accordance with Executive Order 12866, 58 FR 51735 (Sept. 30, 1993), section 1(b), Principles of Regulation, and Executive Order 13563, 76 FR 3821 (January 18, 2011), Improving Regulation and Regulatory Review. The proposed rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the rulemaking has not been reviewed by the Office of Management and Budget.

    Regulatory Flexibility Act

    The Department certifies under 5 U.S.C. 605(b) that the proposed rule will not have a significant economic impact on a substantial number of small entities because the proposed revisions do not impose any burdens upon FOIA requesters, including those that might be small entities. Therefore, a regulatory flexibility analysis is not required by the Regulatory Flexibility Act.

    Unfunded Mandates Reform Act of 1995

    The proposed rule will not result in the expenditure by State, local, or tribal governments in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions are deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

    Executive Order 12612

    This proposal has been reviewed under Executive Order 12612, Federalism, and it has been determined that it does not have sufficient implications for federalism to warrant preparation of a Federalism Assessment.

    Paperwork Reduction Act

    The proposed rule contains no new information collection requirements subject to review by the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

    List of Subjects in 45 CFR Part 5

    Freedom of information.

    In consideration of the foregoing, HHS proposes to revise part 5 of title 45, Code of Federal Regulations, to read as follows:

    PART 5—FREEDOM OF INFORMATION REGULATIONS Subpart A—General Information About Freedom of Information Act Requests Sec. 5.1 Purpose. 5.2 Presumption of openness and proactive disclosures. 5.3 Definitions. 5.4 Regulatory scope. 5.5 Interrelationship between the FOIA and the Privacy Act of 1974. Subpart B—How To Request Records Under FOIA 5.21 Who can file a FOIA request? 5.22 What do I include in my FOIA request? 5.23 Where do I send my FOIA request? 5.24 Does HHS accept electronic FOIA requests? 5.25 How does HHS process my FOIA request? 5.26 How does HHS determine estimated completion dates for FOIA requests? 5.27 How do I request expedited processing? 5.28 How does HHS respond to my request? 5.29 How may I request assistance with the FOIA process? Subpart C—Exemptions to Disclosure 5.31 What are the reasons records may be withheld? 5.32 Records not subject to the requirements of the FOIA—law enforcement exclusions. Subpart D—Fees 5.41 General information on fees for all FOIA requests. 5.42 What fee policies apply to HHS records? 5.43 What is the FOIA fee schedule for obtaining records? 5.44 How does HHS calculate FOIA fees for different categories of requesters? 5.45 How may I request a fee waiver? Subpart E—Appeals 5.51 When may I appeal HHS's FOIA determination? 5.52 How do I file an appeal? 5.53 How does HHS process appeals? 5.54 What avenues are available to me if I disagree with HHS's appeal decision? Subpart F—Records Retention 5.61 How does HHS retain FOIA records? Authority:

    5 U.S.C. 552, 18 U.S.C. 1905, 31 U.S.C. 9701, 42 U.S.C. 1306(c), E.O. 12600, E.O. 13392.

    Subpart A—General Information About Freedom of Information Act Requests
    § 5.1 Purpose.

    This part implements the provisions of the Freedom of Information Act (FOIA), 5 U.S.C. 552, as amended, for Department of Health and Human Services (HHS) records that are subject to the FOIA. This part contains the rules that we follow to process FOIA requests, such as the amount of time we have to make a determination regarding the release of records, who can decide to release records and who can decide not to release them, the fees we may charge, if applicable, the reasons why some records are exempt from disclosure under the FOIA, and the administrative and legal remedies available should a requester disagree with our initial disclosure determination.

    (a) The FOIA provides a right of access to agency records, except to the extent that any portions of the records are protected from public disclosure by an exemption or exclusion in the statute. The FOIA does not require us to perform research for you or to answer your questions. The FOIA does not require agencies to create new records or to perform analysis of existing records; for example, by extrapolating information from existing agency records, reformatting publicly available information, preparing new electronic programs or databases, or creating data through calculations of ratios, proportions, percentages, trends, frequency distributions, correlations, or comparisons. However, at our discretion and if it would conserve government resources, we may decide to supply requested information by consolidating information from various records.

    (b) This part does not apply to:

    (1) Records that are currently available, either from HHS or from another Federal government agency, under a statute that provides for charging fees for those records;

    (2) Records that have been made publicly available by an HHS Staff Division or Operating Division or other Federal agency, as part of its regular program activity;

    (3) Records that have been affirmatively and continuously posted online as required by subsection (a)(2) of the FOIA, which includes the following categories of records:

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

    (ii) Those statements of policy and interpretations which have been adopted by the agency and are not published in the Federal Register;

    (iii) Administrative staff manuals and instructions to staff that affect a member of the public;

    (iv) Frequently requested records; and

    (v) A general index of the records referred to under paragraph (b)(3)(iv) of this section;

    (4) Data generated by an agency grant recipient under the provisions of 45 CFR part 75 to the extent the requirements of 45 CFR 75.322(e) do not apply to the data. We will not process your request under the FOIA or these regulations if that data is already available to the public through an archive or other source. In that situation, we will refer you to that other source; and

    (5) Records requested from the System Manager of a Privacy Act system of records, pursuant to access provisions contained in the system's System of Records Notice (as described in 5 U.S.C. 552a(e)(4)), if the access request is fully granted by the System Manager under the Privacy Act, so that it is unnecessary to process the request under the FOIA. For information pertaining to the Privacy Act, please refer to 5 U.S.C. 552a, and the Department's Privacy Act regulations at 45 CFR part 5b. Privacy Act exemptions are not addressed in this regulation; they are addressed at 45 CFR 5b.11, and in the Privacy Act at 5 U.S.C. 552a(d)(5), (j), and (k).

    § 5.2 Presumption of openness and proactive disclosures.

    In administering the FOIA, we are committed to providing access to public records as part of the Department's efforts to increase openness and transparency, but with due regard for protecting the legitimate interests of entities that have submitted records to the Department, the privacy interests of individuals who would be affected by release of records, and the interests of the agency in creating policy, making operating decisions and carrying out its mission.

    (a) It is our policy to respond to all requests for records, irrespective of whether those requests conform to the requirements of these regulations. However, in order to preserve rights given to you by the FOIA and by this regulation (for example, the right to appeal if we deny your request and the right to have our appeal decision reviewed by a court), your request must be in writing and make reference to the FOIA. In certain exceptional circumstances, a Freedom of Information Office may, at its discretion, accept an oral request from you and reduce it to writing for you.

    (b) [Reserved]

    § 5.3 Definitions.

    The following definitions apply to this part:

    Agency is defined at 5 U.S.C. 551(1). HHS is an agency. Private entities performing work under a contractual agreement with the government are not agencies for the purpose of this definition. However, information maintained for an agency under Government contract, for the purposes of records management, is considered an agency record.

    Chief FOIA Officer means a senior official of HHS, at the Assistant Secretary or equivalent level, who has agency-wide responsibility for ensuring efficient and appropriate compliance with the FOIA, monitoring implementation of the FOIA throughout the agency, and making recommendations to the head of the agency to improve the agency's implementation of the FOIA. The Secretary of HHS has designated the Assistant Secretary, Office of the Assistant Secretary for Public Affairs (ASPA), as the Agency Chief FOIA Officer (ACFO); that official may be contacted at [email protected]

    Commercial use means a use or purpose that furthers a commercial, trade, or profit interest of the requester or the person or entity on whose behalf the request is made.

    Department or HHS means the U.S. Department of Health and Human Services.

    Deputy Agency Chief FOIA Officer (DACFO) means a designated official within the Office of the Assistant Secretary for Public Affairs, who has been authorized by the Chief FOIA Officer to act upon their behalf to implement compliance with the FOIA, as described above. This official is also the approving review authority for FOIA administrative appeals.

    Direct costs mean those expenses that an agency incurs in searching for and duplicating (and, in the case of commercial use requests, reviewing) records in order to respond to a FOIA request. For example, direct costs include the salary of the employee performing the work (i.e., the basic rate of pay for the employee, plus 16 percent of that rate to cover benefits) and the cost of operating computers and other electronic equipment, such as photocopiers and scanners. Direct costs do not include overhead expenses such as the costs of space, and of heating or lighting a facility.

    Duplication means the process of making a copy of a record and sending it to the requester, to the extent necessary to respond to the request. Such copies include both paper copies and electronic records. Fees for duplication are further explained within § 5.43.

    Educational institution means a school, university, or other entity of learning that operates a program of scholarly research. To qualify for this category, a requester must show that the request is authorized by, and is made under the auspices of, a qualifying institution and that the records are sought to further a scholarly research goal of the institution, and not for a commercial use or purpose, or for individual use or benefit.

    Expedited processing means the process set forth in the FOIA that allows requesters to request faster processing of their FOIA request, if they can demonstrate a specific compelling need.

    Fee category means one of the four categories established by the FOIA to determine whether a requester will be charged fees for search, review, and duplication. The categories are: Commercial use requests; non-commercial scientific or educational institutions requests; news media requests; and all other requests. Fee categories are further explained within § 5.44.

    Fee waiver means the waiver or reduction of fees if a requester is able to demonstrate that certain standards set forth in the FOIA and this part are satisfied, including that disclosure of the records is in the public interest and that the records are not requested to further a commercial interest.

    First-party request means a request by an individual for records pertaining to that individual, or an authorized representative acting upon an individual's behalf.

    FOIA Public Liaison means an agency official who reports to the agency Chief FOIA Officer and serves as a supervisory official to whom a requester can raise concerns about the service the requester has received from the FOIA Service Center. This individual is responsible for assisting in reducing delays, increasing transparency, and understanding of the status of requests, and assisting in the resolution of disputes.

    FOIA request means a written request, which reasonably describes the records sought. We may contact a requester to clarify the records that are sought or to discuss the scope of the request.

    Freedom of Information Act (FOIA) means the law codified at 5 U.S.C. 552 that provides the public with the right to request agency records from Federal executive branch agencies. A link to the text of the FOIA is at http://www.justice.gov/sites/default/files/oip/legacy/2014/07/23/amended-foia-redlined-2010.pdf.

    Freedom of Information Officer means an HHS official who has been delegated the authority to release or withhold records; to assess, waive, or reduce fees in response to FOIA requests; and to determine whether to grant expedited processing. In that capacity, the Freedom of Information Officer has the authority to task agency organizational components to search for records in response to a FOIA request, and to provide records located in their office. Apart from records subject to proactive disclosure pursuant to subsection (a)(2) of the FOIA, only Freedom of Information Officers have the authority to release or withhold records or to waive fees in response to a FOIA request. Our FOIA operations are decentralized, and each FOIA Service Center listed in § 5.23 has a designated official with this authority; the contact information for each FOIA Service Center is also listed in § 5.23.

    (1) The HHS Freedom of Information Officer in the Office of the Secretary means the HHS official who in addition to overseeing the daily operations of the FOIA program in that office and having the authority of a Freedom of Information Officer, is also responsible for the Department-wide administration and coordination of the FOIA and its implementing regulations and policies as they pertain to the programs and activities of the Department. This individual serves as the principal resource with respect to the articulation of procedures designed to implement and ensure compliance with the FOIA and its implementing regulations and policies as they pertain to the Department. This individual reports through the DACFO to the ACFO to support oversight and compliance with the OPEN Government Act.

    (2) Operating Division and Staff Division Freedom of Information Officers means the officials who are responsible for overseeing the daily operations of their FOIA programs in their respective Operating Divisions or Staff Divisions of the Department, with the full authority as described in the definition of Freedom of Information Officer in this section. These individuals serve as the principal resource and authority for FOIA operations and implementation within their respective Operating Divisions or Staff Divisions.

    Frequently requested records means records, regardless of form or format, that have been released to any person under the FOIA and that, because of the nature of their subject matter, the agency determines have become or are likely to become the subject of subsequent requests for substantially the same records.

    Immediate Office of the Secretary (IOS) means the Office of the Secretary, responsible for operations and work of the Secretary. It includes the Office of the Deputy Secretary, Office of the Chief of Staff, Secretary's Counselors, the Executive Secretariat, the Office of Health Reform, and the Office of Intergovernmental and External Affairs.

    Non-commercial scientific institution means an institution that is operated for the purpose of conducting scientific research and not at all on a basis that furthers the commercial, trade, or profit interests of any person or organization. We decide whether to grant a requester non-commercial status on a case-by-case basis, based on the requester's intended use of the requested records.

    Office of the Inspector General (OIG) means the Staff Division within the Office of the Secretary (OS), which is responsible for protecting the integrity of HHS programs and the health and welfare of the beneficiaries of those programs. OIG is responsible for processing FOIA requests sent to its Office.

    Office of the Secretary (OS) means the HHS's chief policy officer and general manager, who administers and oversees the organization, its programs and activities. The Deputy Secretary and a number of Assistant Secretaries and Staff Divisions support OS. The HHS FOIA Office within ASPA processes FOIA requests for records maintained by OS Staff Divisions other than the OIG and the Program Support Center (PSC). In certain circumstances and at the HHS FOIA Office's discretion, the HHS FOIA office may also process FOIA requests involving other HHS OpDivs, as further described in § 5.28(a).

    Operating Divisions (OpDivs) means any of the following divisions within HHS which are subject to this regulation:

    Office of the Secretary (OS) Administration for Children and Families (ACF) Administration for Community Living (ACL) Agency for Healthcare Research and Quality (AHRQ) Agency for Toxic Substances and Disease Registry (ATSDR) Centers for Disease Control and Prevention (CDC) Centers for Medicare & Medicaid Services (CMS) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Indian Health Service (IHS) National Institutes of Health (NIH) Substance Abuse and Mental Health Services Administration (SAMHSA).

    Other requester means any individual or organization whose request does not qualify as a commercial-use request, representative of the news media request (including a request made by a freelance journalist), or an educational or non-commercial scientific institution request.

    Program Support Center (PSC) means the Program Support Center. The PSC FOIA Office is located within the Office of Assistant Secretary for Administration (ASA) (i.e., within an OS Staff Division) and processes FOIA requests for certain OS records and FOIA requests and FOIA appeals for certain HHS OpDivs, as further described in § 5.23.

    Reading room records are records that are required to be made available to the public without a specific request under 5 U.S.C. 552(a)(2). As referenced in § 5.1(b)(3), we make reading room records available to the public electronically through our Web pages (http://www.hhs.gov/foia/reading/index.html) and at the physical locations identified in § 5.23. Other records may also be made available at our discretion through our Web pages (http://www.hhs.gov).

    Record means any information that would be an agency record when maintained by an agency in any format, including an electronic format; and any information that is maintained for an agency by an entity under Government contract, for the purposes of records management. This definition does not include materials available from the agency's libraries and reading rooms.

    Redact means delete or mark over.

    Representative of the news media means any person or entity that actively gathers information of potential interest to a segment of the public, uses its editorial skills to turn raw materials into a distinct work, and distributes that work to an audience. The term “news” means information that is about current events or that would be of current interest to the public. Examples of news media entities include television or radio stations that broadcast news to the public at large and publishers of periodicals, including print and online publications that disseminate news and make their products available through a variety of means to the general public. We do not consider requests for records that support the news-dissemination function of the requester to be a commercial use. We consider “freelance” journalists who demonstrate a solid basis for expecting publication through a news media entity as working for that entity. A publishing contract provides the clearest evidence that a journalist expects publication; however, we also consider a requester's past publication record. We decide whether to grant a requester media status on a case-by-case basis, based on the requester's intended use of the requested records.

    Review means examining records responsive to a request to determine whether any portions are exempt from disclosure. Review time includes processing a record for disclosure (i.e., doing all that is necessary to prepare the record for disclosure), including redacting the record and marking the appropriate FOIA exemptions.

    Search means the process of identifying, locating, and retrieving records to find records responsive to a request, whether in hard copy or in electronic form or format.

    Staff Divisions (StaffDivs) means an organization component that provides leadership, direction, and policy and management guidance to the Office of the Secretary and the Department. The following StaffDivs are subject to the regulations in this part:

    Immediate Office of the Secretary (IOS) Assistant Secretary for Administration (ASA) Assistant Secretary for Financial Resources (ASFR) Assistant Secretary for Health (OASH) Assistant Secretary for Legislation (ASL) Assistant Secretary for Planning and Evaluation (ASPE) Assistant Secretary for Public Affairs (ASPA) Assistant Secretary for Preparedness and Response (ASPR) Departmental Appeals Board (DAB) Office of Civil Rights (OCR) Office of the General Counsel (OGC) Office of Global Affairs (OGA) Office of the Inspector General (OIG) Office of Medicare Hearings and Appeals (OMHA) Office of the National Coordinator for Health Information Technology (ONC)

    Submitter means any person or entity that provides commercial information to the agency, and includes individuals, corporations, other organizational entities, and state and foreign governments.

    Tolling means temporarily stopping the running of a time limit. We may toll a request to seek clarification or to address fee issues, as further described in § 5.25.

    § 5.4 Regulatory scope.

    The requirements in this part apply to all OpDivs and StaffDivs of HHS. Some OpDivs and StaffDivs may establish or continue to maintain additional rules because of unique program requirements, but such rules must be consistent with this part, the FOIA and the precedential case law which interprets it. If additional rules are issued, they must be published in the Federal Register and you may get copies online at https://www.federalregister.gov/, http://www.regulations.gov/ or by contacting one of our FOIA Service Centers.

    § 5.5 Interrelationship between the FOIA and the Privacy Act of 1974.

    The FOIA allows any person (whether an individual or entity) to request access to any Federal agency record. The Privacy Act, at 5 U.S.C. 552a(d), provides an additional right of access, allowing individuals to request records about themselves, if the records are maintained in a system of records (defined in 5 U.S.C. 552a(a)(5)).

    (a) Requesting your own records: If you request records about yourself that are maintained within a system of records as defined by the Privacy Act, you should make your request in accordance with the Privacy Act and the Department's implementing regulations at 45 CFR part 5b. This includes requirements to verify your identity. If you request records about someone other than yourself, you may receive greater access if you submit appropriate documentation signed by the other person that certifies their identity and confirms that they have given their consent for you to have access to their records. If any of the FOIA Service Centers receive a Privacy Act request, they will forward it to the appropriate Privacy Act Officer. If you are an individual requesting your own records as described in this section, your request will be processed under the Privacy Act in coordination with the appropriate Privacy Act Officer. If an exemption under the Privacy Act applies, you may still be able to access your records, or a portion thereof, under the FOIA.

    (b) Requesting another individual's record. If you request records that are about an individual other than yourself and do not have that individual's written consent (including authentication of that individual's identity), we will process your request under the FOIA.

    Subpart B—How To Request Records Under FOIA
    § 5.21 Who can file a FOIA request?

    Any individual, partnership, corporation, association, or public or private organization other than a Federal agency, regardless of nationality, may submit a FOIA request to us. The FOIA excludes Federal agencies from filing FOIA requests. However, state and local governments may file FOIA requests.

    § 5.22 What do I include in my FOIA request?

    In your FOIA request:

    (a) Describe the records you seek in sufficient detail to enable our staff to locate them with a reasonable amount of effort. The more information you provide, the better possibility we have of finding the records you are seeking. Information that will help us find the records would include:

    (1) The agencies, offices, or individuals involved;

    (2) The approximate date(s) when the records were created;

    (3) The subject, title, or description of the records sought; and

    (4) Author, recipient, case number, file designation, or other reference number, if available.

    (b) Include your name, full mailing address, and phone number and if available, your email address. This information allows us to reach you faster if we have any questions about your request. It is your responsibility to keep your current mailing address up to date with the office where you have filed the FOIA request.

    (c) If you are requesting the medical records of an individual other than yourself and you are not that individual's legally authorized representative, you should submit a Health Insurance Portability and Accountability Act (HIPAA) compliant release authorization form signed by the subject of records or the individual's legally authorized representative. The HIPAA Privacy Rule requires that an authorization form contain certain core elements and statements which are described in the Privacy Rule's requirements at 45 CFR 164.508. If you are submitting a request for Medicare records to CMS, CMS has a release authorization form at the following link: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS10106.pdf.

    (d) Mark both your letter and envelope, or the subject line of your email, with the words “FOIA Request.”

    (e) Before filing your request, you may find it helpful to consult the HHS FOIA Service Centers online at http://www.hhs.gov/foia/contacts/index.html, which provides additional guidance to assist in submitting a FOIA request to a specific HHS OpDiv or StaffDiv or to regional offices or divisions within an OpDiv or StaffDiv. You may also wish to check in the agency's electronic reading rooms available online at http://www.hhs.gov/foia/reading/index.html, to see if the information you wish to obtain is already available.

    § 5.23 Where do I send my FOIA request?

    We have several FOIA Service Centers (FOIA offices) that process FOIA requests. You should send your FOIA request to the appropriate FOIA Service Center that you believe would have the records you seek. An up-to-date listing is maintained online at http://www.hhs.gov/foia/contacts/index.html.

    (a) If you are requesting research data made available under the provisions of 45 CFR 75.322(e), requests for such data should be addressed to the HHS OpDiv that made the award under which the data were first produced. That OpDiv will process your request in accordance with established procedures consistent with the FOIA and 45 CFR 75.322(e).

    (b) We officially receive your request when it reaches the FOIA Service Center with responsibility for the HHS OpDiv or StaffDiv where requested records are likely to be located, but no later than 10 working days after the request first arrives at any of our FOIA Service Centers.

    (c) If you have questions concerning the processing of your FOIA request, you may contact the FOIA Service Center processing your request. If that initial contact does not resolve your concerns, you may wish to contact the designated FOIA Public Liaison for the OpDiv or StaffDiv processing your request. You can find a list of our FOIA Service Centers and Public Liaisons at http://www.hhs.gov/foia/contacts/index.html.

    § 5.24 Does HHS accept electronic FOIA requests?

    Yes. The body of the message should contain all of the information listed in § 5.22. You also may file a FOIA request by emailing your request to the appropriate FOIA Service Center, as listed in the table provided in § 5.23. If an OpDiv or StaffDiv does not have a separate email or electronic link to submit a FOIA request, you may submit a FOIA request at the Department's main link at https://requests.publiclink.hhs.gov/palMain.aspx.

    § 5.25 How does HHS process my FOIA request?

    (a) Acknowledgement. We acknowledge all FOIA requests in writing within 10 working days after receipt by the appropriate office. The acknowledgement letter or email informs you of your request tracking number, provides contact information, and informs you of any complexity we are aware of in processing that may lengthen the time required to reach a final decision on the release of the records. The acknowledgement letter or email or a subsequent communication may also seek additional information to clarify your request or to ask you to narrow the scope of a very large or broad request. Should we ascertain at any time while processing your request that another agency may possess the requested records, we will either refer your request to that agency and notify you of that referral, or advise you how to contact that agency.

    (b) Perfected requests. (1) A request is considered to be perfected (i.e., the 20 working day statutory response time begins to run) when—

    (i) The request is received by the responsible FOIA office;

    (ii) The requested records are reasonably described;

    (iii) The request contains sufficient information to enable the FOIA office to contact the requestor and transmit records to the requestor; and

    (iv) The requester has agreed to pay all or an established amount of applicable fees or requested a fee waiver.

    (2) We provide at least 10 working days for you to respond to a request to perfect your request, after notification. Should you not answer any correspondence, or should the correspondence be returned as undeliverable, we reserve the right to administratively close the FOIA request.

    (c) Stops in processing time (tolling). We may stop the processing of your request one time if we require additional information regarding the specifics of the request. Requests must reasonably describe the records sought and not be overly broad. If we determine that a request does not reasonably describe the records sought, we will attempt to contact you using the contact information you have provided. The processing time resumes upon our receipt of your response. We also may stop the processing of your request if we require clarification regarding fee assessments. If additional information or clarification is required, we will attempt to contact you using the cont