Federal Register Vol. 81, No.32,

Federal Register Volume 81, Issue 32 (February 18, 2016)

Page Range8133-8387
FR Document

81_FR_32
Current View
Page and SubjectPDF
81 FR 8387 - Death of Antonin ScaliaPDF
81 FR 8379 - Establishment of the Sand to Snow National MonumentPDF
81 FR 8371 - Establishment of the Mojave Trails National MonumentPDF
81 FR 8363 - Establishment of the Castle Mountains National MonumentPDF
81 FR 8198 - Sunshine Act MeetingPDF
81 FR 8200 - Sunshine Act MeetingPDF
81 FR 8181 - Sunshine Act NoticePDF
81 FR 8214 - National Protection and Programs Directorate; Cybersecurity Information Sharing Act of 2015 Interim Guidance Documents-Notice of AvailabilityPDF
81 FR 8149 - Reporting of Original Issue Discount on Tax-Exempt Obligations; Basis and Transfer Reporting by Securities Brokers for Debt Instruments and OptionsPDF
81 FR 8252 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Request for Employment InformationPDF
81 FR 8357 - Art Advisory Panel of the Commissioner of Internal RevenuePDF
81 FR 8251 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Representative Fee RequestPDF
81 FR 8254 - National Science Board; Sunshine Act Meetings; NoticePDF
81 FR 8180 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
81 FR 8173 - Application for Additional Production Authority; The Coleman Company, Inc.; Subzone 119I; (Textile-Based Personal Flotation Devices); Change of Location for Public HearingPDF
81 FR 8179 - Agency Information Collection Activities: Comment Request; Emergency Processing RequestPDF
81 FR 8261 - Submission for OMB Review; Comments RequestPDF
81 FR 8256 - Mallinckrodt, LLCPDF
81 FR 8173 - Certain Cut-to-Length Carbon Steel Plate From the People's Republic of China: Initiation of Circumvention Inquiry on Antidumping Duty OrderPDF
81 FR 8258 - Independent Spent Fuel Storage Installation, Maine Yankee Atomic Power CompanyPDF
81 FR 8218 - Notice of Inventory Completion: Thomas Burke Memorial Washington State Museum, University of Washington, Seattle, WAPDF
81 FR 8216 - Notice of Intent To Repatriate Cultural Items: Mount Holyoke College Art Museum, South Hadley, MAPDF
81 FR 8217 - Notice of Inventory Completion: U.S. Department of Defense, Department of the Navy, Washington, DCPDF
81 FR 8219 - Native American Graves Protection and Repatriation Review Committee; Findings and Recommendations Regarding Human Remains and Associated Funerary Objects for The Osage NationPDF
81 FR 8197 - National Environmental Justice Advisory CouncilPDF
81 FR 8323 - Agency Information Collection Activities: Proposed Request and Comment RequestPDF
81 FR 8200 - Notice of Agreements FiledPDF
81 FR 8253 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)PDF
81 FR 8326 - Delegation of Authority 250-1: Further Assignment of Functions Under the Bipartisan Congressional Trade Priorities and Accountability Act of 2015 (the “Act”) to Other Departments and Agencies of the Executive BranchPDF
81 FR 8326 - U.S. Advisory Commission on Public Diplomacy; Notice of MeetingPDF
81 FR 8184 - Orders Granting Authority To Import and Export Natural Gas, To Import and Export Liquefied Natural Gas, and To Vacate Authorization During January 2016PDF
81 FR 8258 - Atomic Safety and Licensing Board; Before Administrative Judges: Ronald M. Spritzer, Chairman; Nicholas G. Trikouros; Dr. James F. Jackson; in the Matter of Southern Nuclear Operating Company, Inc.; (Vogtle Electric Generating Plant, Units 3 and 4)PDF
81 FR 8255 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Radiation Protection and Nuclear Materials; Notice of MeetingPDF
81 FR 8255 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on Plant License Renewal; Notice of MeetingPDF
81 FR 8256 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Reliability and PRAPDF
81 FR 8215 - 60-Day Notice of Proposed Information Collection: The Multifamily Project Application and Construction Prior to Initial EndorsementPDF
81 FR 8177 - Whaling Provisions; Aboriginal Subsistence Whaling QuotasPDF
81 FR 8199 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
81 FR 8197 - Pick-Sloan Missouri Basin Program-Eastern DivisionPDF
81 FR 8247 - Arvinder Singh, M.D.; Decision and OrderPDF
81 FR 8221 - Hatem M. Ataya, M.D.; Decision and Order; Introduction and Procedural HistoryPDF
81 FR 8246 - Importer of Controlled Substances Registration: Catalent Pharma Solutions, LLCPDF
81 FR 8245 - Manufacturer of Controlled Substances Registration: Mallinckrodt, LLCPDF
81 FR 8327 - CSX Transportation, Inc.-Discontinuance of Service Exemption-in Harlan County, KYPDF
81 FR 8246 - Manufacturer of Controlled Substances Registration: Euticals, Inc.PDF
81 FR 8247 - Importer of Controlled Substances Registration: Sigma Aldrich International GMBH-Sigma Aldrich Co. LLCPDF
81 FR 8246 - Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, Inc.PDF
81 FR 8213 - Merchant Mariner Medical Advisory CommitteePDF
81 FR 8326 - Railroad Cost Recovery Procedures-Productivity AdjustmentPDF
81 FR 8254 - Criteria and Design Features for Inspection of Water-Control Structures Associated With Nuclear Power PlantsPDF
81 FR 8171 - Television Broadcasting Services; Scottsbluff, Nebraska and Sidney, NebraskaPDF
81 FR 8220 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
81 FR 8182 - National Assessment Governing Board Quarterly Board MeetingPDF
81 FR 8177 - Gulf of Mexico Fishery Management Council; Public MeetingPDF
81 FR 8181 - Agency Information Collection Activities; Comment Request; Integrated Postsecondary Education Data System (IPEDS) 2016-2019PDF
81 FR 8178 - Gulf of Mexico Fishery Management Council; Public MeetingPDF
81 FR 8251 - Notice of Availability of Funds and Funding Opportunity Announcement for: Summer Jobs and Beyond: Career Pathways for Youth (CPY)PDF
81 FR 8193 - Clark Canyon Hydro, LLC; Notice of Application Ready for Environmental Analysis and Soliciting Comments, Recommendations, Terms and Conditions, and PrescriptionsPDF
81 FR 8194 - Comanche Solar PV, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 8188 - Idaho Power Company; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and ProtestsPDF
81 FR 8171 - Accelerating Reporting Requirements for Class I RailroadsPDF
81 FR 8146 - Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint SystemsPDF
81 FR 8206 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification ProcedurePDF
81 FR 8189 - Notice of Commission Staff AttendancePDF
81 FR 8262 - Agency Forms Submitted for OMB Review, Request for CommentsPDF
81 FR 8187 - Axpo U.S. LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 8186 - Smith Creek Hydro, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 8190 - Voyager Wind I, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 8196 - Notice of Schedule for Environmental Review of the Leach Xpress and Rayne Xpress Expansion ProjectsPDF
81 FR 8192 - Notice of Schedule for Environmental Review of the White Oak Mainline Expansion Project and System Reliability ProjectPDF
81 FR 8189 - Combined Notice of FilingsPDF
81 FR 8195 - Combined Notice of Filings #2PDF
81 FR 8193 - Combined Notice of Filings #1PDF
81 FR 8187 - 62SK 8ME LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 8191 - Summer Solar LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 8187 - Conway Corporation; Notice of FilingPDF
81 FR 8191 - City of West Memphis, Arkansas; Notice of FilingPDF
81 FR 8190 - Transcontinental Gas Pipe Line Company, LLC; Notice of Schedule for Environmental Review of the New York Bay Expansion ProjectPDF
81 FR 8185 - Combined Notice of FilingsPDF
81 FR 8143 - Airworthiness Directives; B-N Group Ltd. AirplanesPDF
81 FR 8327 - Notice of Final Federal Agency Actions on Proposed Highway in CaliforniaPDF
81 FR 8201 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
81 FR 8203 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 8215 - Endangered Species; Recovery Permit ApplicationsPDF
81 FR 8282 - PowerShares Exchange-Traded Self-Indexed Fund Trust, et al.; Notice of ApplicationPDF
81 FR 8157 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 8180 - Defense Personal Property Program (DP3)PDF
81 FR 8359 - Proposed Information Collection (Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA) Benefits-Application, Claim, Other Health Insurance & Potential Liability); Activity: Comment RequestPDF
81 FR 8358 - Agency Information Collection (Dependents' Request for Change of Program or Place of Training) Activity Under OMB ReviewPDF
81 FR 8359 - Proposed Information Collection-Request for a Certificate of Eligibility VA Form 26-1880PDF
81 FR 8358 - Proposed Information Collection (Report of Subcontracts to Small and Veteran-Owned Business-VA0896a); Activity: Comment RequestPDF
81 FR 8361 - Agency Information Collection (Loan Analysis) Activity Under OMB ReviewPDF
81 FR 8207 - Request for Nominations on Public Advisory Panels of the Medical Devices Advisory CommitteePDF
81 FR 8261 - New Postal ProductPDF
81 FR 8204 - Information Collection; New Funding Formula for the State Councils on Developmental Disabilities (SCDDs) and Protection and Advocacy Systems (P&As) Located in Each State and TerritoryPDF
81 FR 8264 - Joint Industry Plan; Notice of Filing of Amendment No. 3 to the National Market System Plan for the Selection and Reservation of Securities Symbols Submitted by Financial Industry Regulatory Authority, Inc., BATS Exchange, Inc., BOX Options Exchange, LLC, Chicago Board Options Exchange, Incorporated, Chicago Stock Exchange, Inc., EDGA Exchange, Inc., EDGX Exchange, Inc., International Securities Exchange, LLC, NASDAQ OMX BX, Inc., NASDAQ OMX PHLX, Inc., The Nasdaq Stock Market LLC, National Stock Exchange, Inc., New York Stock Exchange, LLC, NYSE MKT, LLC, and NYSE Arca, Inc.PDF
81 FR 8308 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Regarding Rule 505 and Rule 506PDF
81 FR 8178 - Atlantic Highly Migratory Species; Meeting of the Atlantic Highly Migratory Species Advisory PanelPDF
81 FR 8313 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to the Co-Location Services Offered by the Exchange To Include a Means for Co-Located Users To Receive the NASDAQ TotalView Ultra Market Data Feed Through a Wireless Connection and Reflect Changes to the Exchange Price ListPDF
81 FR 8265 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to the Co-Location Services Offered by the Exchange To Include a Means for Co-Located Users To Receive the NASDAQ TotalView Ultra Market Data Feed Through a Wireless Connection and Reflect Changes to the NYSE Arca Equities Schedule of Fees and Charges for Exchange Services and the Options Fee SchedulePDF
81 FR 8269 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change To Adopt NYSE Arca Equities Rule 8.900 To Permit Listing and Trading of Managed Portfolio Shares and To Permit Listing and Trading of Shares of Fifteen Issues of the Precidian ETFs TrustPDF
81 FR 8319 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend NOM Rules at Chapter XV, Section 2PDF
81 FR 8291 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Modifying the Arca Options Deep Market Data ProductPDF
81 FR 8310 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Modifying the Amex Options Deep Market Data ProductPDF
81 FR 8294 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Setting Aside Action by Delegated Authority, Approving Proposed Rule Change Concerning the Options Clearing Corporation's Capital Plan and Denying MotionsPDF
81 FR 8316 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to the Co-location Services Offered by the Exchange To Include a Means for Co-located Users To Receive the NASDAQ TotalView Ultra Market Data Feed Through a Wireless Connection and Reflect Changes to the NYSE MKT Equities Price List and the NYSE Amex Options Fee SchedulePDF
81 FR 8184 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Client Assistance Program (CAP)PDF
81 FR 8168 - Drawbridge Operation Regulation; Indian Creek, Miami Beach, FLPDF
81 FR 8208 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment RequestPDF
81 FR 8204 - Privacy Act of 1974; Report of a New Routine Use for a CMS System of RecordsPDF
81 FR 8209 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed MeetingPDF
81 FR 8210 - National Institute of Environmental Health Sciences; Notice of Closed MeetingsPDF
81 FR 8209 - National Institute of Mental Health; Notice of Closed MeetingsPDF
81 FR 8212 - National Institute on Aging, Notice of Closed MeetingPDF
81 FR 8210 - National Institute of Dental & Craniofacial Research; Notice of Closed MeetingPDF
81 FR 8210 - National Eye Institute; Notice of Closed MeetingPDF
81 FR 8212 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingsPDF
81 FR 8211 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 8133 - Unfair or Deceptive Acts or Practices (Regulation AA)PDF
81 FR 8342 - Native American CDFI Assistance Program (NACA Program) FY 2016 Funding RoundPDF
81 FR 8328 - Community Development Financial Institutions Program (CDFI Program) FY 2016 Funding RoundPDF
81 FR 8140 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 8138 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 8134 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 8164 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 8160 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 8166 - Airworthiness Directives; Fokker Services B.V. AirplanesPDF
81 FR 8155 - Airworthiness Directives; Airbus AirplanesPDF
81 FR 8357 - Notice of Open Public HearingPDF

Issue

81 32 Thursday, February 18, 2016 Contents Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 8180 2016-03424 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Emergency Processing Request, 8179-8180 2016-03422 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 8201-8204 2016-03304 2016-03305 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Privacy Act; Systems of Records, 8204 2016-03241 Coast Guard Coast Guard PROPOSED RULES Drawbridge Operations: Indian Creek, Miami Beach, FL, 8168-8170 2016-03262 NOTICES Meetings: Merchant Mariner Medical Advisory Committee, 8213-8214 2016-03348 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Community Development Community Development Financial Institutions Fund NOTICES Funds Availability: Community Development Financial Institutions Program FY 2016 Funding Round, 8328-8342 2016-03221 Native American CDFI Assistance Program FY 2016 Funding Round, 8342-8357 2016-03222 Community Living Administration Community Living Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: New Funding Formula for the State Councils on Developmental Disabilities and Protection and Advocacy Systems, 8204-8205 2016-03276 Defense Department Defense Department NOTICES Defense Personal Property Program (DP3), 8180-8181 2016-03290 Defense Nuclear Defense Nuclear Facilities Safety Board NOTICES Meetings; Sunshine Act, 8181 2016-03499 Drug Drug Enforcement Administration NOTICES Bulk Manufacturer of Controlled Substances; Applications: Cedarburg Pharmaceuticals, Inc., Grafton,WI, 8246 2016-03350 Decisions and Orders: Arvinder Singh, M.D., 8247-8251 2016-03361 Hatem M. Ataya, M.D., 8221-8245 2016-03359 Importer of Controlled Substances; Registration: Catalent Pharma Solutions, LLC, Philadelphia, PA, 8246-8247 2016-03358 Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC, 8247 2016-03353 Manufacturer of Controlled Substances; Registration: Euticals, Inc., Springfield, MO, 8246 2016-03355 Mallinckrodt, LLC, Saint Louis, MO, 8245 2016-03357 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Client Assistance Program, 8184 2016-03263 Integrated Postsecondary Education Data System 2016-2019, 8181-8182 2016-03338 Meetings: National Assessment Governing Board, 8182-8184 2016-03343 Employment and Training Employment and Training Administration NOTICES Availability of Funds and Funding Opportunity: Summer Jobs and Beyond -- Career Pathways for Youth, 8251 2016-03336 Energy Department Energy Department See

Federal Energy Regulatory Commission

See

Western Area Power Administration

NOTICES Authority to Import and Export Natural Gas, to Import and Export Liquefied Natural Gas, and to Vacate Authorization: Toyota Motor Engineering and Manufacturing North America, et al., 8184-8185 2016-03373
Environmental Protection Environmental Protection Agency NOTICES Requests for Nominations: National Environmental Justice Advisory Council, 8197-8198 2016-03405 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Airbus Airplanes, 8134-8138 2016-03215 B-N Group Ltd. Airplanes, 8143-8146 2016-03307 The Boeing Company Airplanes, 8138-8143 2016-03217 2016-03219 PROPOSED RULES Airworthiness Directives: Airbus Airplanes, 8155-8157, 8160-8164 2016-03135 2016-03137 Fokker Services B.V. Airplanes, 8166-8168 2016-03136 The Boeing Company Airplanes, 8157-8160, 8164-8166 2016-03138 2016-03297 Federal Communications Federal Communications Commission PROPOSED RULES Television Broadcasting Services: Scottsbluff, Nebraska and Sidney, NE, 8171 2016-03345 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 8199-8200 2016-03363 2016-03364 Meetings; Sunshine Act, 8198-8199 2016-03502 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 8200 2016-03501 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 8185-8186, 8189-8190, 8195-8196 2016-03309 2016-03310 2016-03320 2016-03321 2016-03322 Environmental Assessments; Availability, etc.: Eastern Shore Natural Gas Co.; Schedule for Environmental Review of the White Oak Mainline Expansion Project and System Reliability Project, 8192-8193 2016-03323 Filings: City of West Memphis, AR, 8191-8192 2016-03312 Conway Corporation, 8187 2016-03313 Hydroelectric Applications: Clark Canyon Hydro, LLC, 8193-8194 2016-03335 Idaho Power Co., 8188 2016-03333 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: 62SK 8ME, LLC, 8187 2016-03316 Axpo U.S. LLC, 8187-8188 2016-03327 Comanche Solar PV, LLC, 8194-8195 2016-03334 Smith Creek Hydro, LLC, 8186 2016-03326 Summer Solar, LLC, 8191 2016-03314 Voyager Wind I, LLC, 8190-8191 2016-03325 Schedule for Environmental Review of the Leach Xpress and Rayne Xpress Expansion Projects: Columbia Gas Transmission, LLC; Columbia Gulf Transmission. LLC, 8196-8197 2016-03324 Schedules for Environmental Review: Transcontinental Gas Pipe Line Company, LLC; The New York Bay Expansion Project, 8190 2016-03311 Staff Attendances, 8189 2016-03329 Federal Highway Federal Highway Administration NOTICES Final Federal Agency Actions on Proposed Highway in California, 8327-8328 2016-03306 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 8200-8201 2016-03378 Federal Reserve Federal Reserve System RULES Unfair or Deceptive Acts or Practices, 8133-8134 2016-03228 Fish Fish and Wildlife Service NOTICES Permit Applications: Endangered Species, 8215-8216 2016-03302 Food and Drug Food and Drug Administration RULES Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems, 8146-8149 2016-03331 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Substances Generally Recognized as Safe -- Notification Procedure, 8206-8207 2016-03330 Requests for Nominations: Public Advisory Panels of the Medical Devices Advisory Committee, 8207-8208 2016-03283 Foreign Trade Foreign-Trade Zones Board NOTICES Public Hearings: Application for Additional Production Authority, The Coleman Company, Inc., Subzone 119I; Location Change, 8173 2016-03423 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Community Living Administration

See

Food and Drug Administration

See

National Institutes of Health

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 8208-8209 2016-03249
Homeland Homeland Security Department See

Coast Guard

NOTICES Availabilities: Cybersecurity Information Sharing Act of 2015 Interim Guidance Documents, 8214 2016-03430
Housing Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 8215 2016-03367 Interior Interior Department See

Fish and Wildlife Service

See

National Park Service

Internal Revenue Internal Revenue Service RULES Reporting of Original Issue Discount on Tax-Exempt Obligations: Basis and Transfer Reporting by Securities Brokers for Debt Instruments and Options, 8149-8154 2016-03429 NOTICES Charter Renewals: Art Advisory Panel of the Commissioner of Internal Revenue, 8357 2016-03427 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Cut-to-Length Carbon Steel Plate from the People's Republic of China, 8173-8176 2016-03418 International Trade Com International Trade Commission NOTICES Complaints: Certain Mobile Electronic Devices Incorporating Haptics (Including Smartphones and Smartwatches) and Components Thereof, 8220-8221 2016-03344 Justice Department Justice Department See

Drug Enforcement Administration

Labor Department Labor Department See

Employment and Training Administration

See

Occupational Safety and Health Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Representative Fee Request, 8251-8252 2016-03426 Request for Employment Information, 8252-8253 2016-03428
National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 8211-8212 2016-03233 National Eye Institute, 8210 2016-03235 National Institute of Allergy and Infectious Diseases, 8212 2016-03234 National Institute of Dental and Craniofacial Research, 8210 2016-03236 National Institute of Environmental Health Sciences, 8210-8211 2016-03239 National Institute of Mental Health, 8209-8210 2016-03238 National Institute on Aging, 8212 2016-03237 National Institute on Alcohol Abuse and Alcoholism, 8209 2016-03240 National Oceanic National Oceanic and Atmospheric Administration NOTICES Meetings: Atlantic Highly Migratory Species, Atlantic Highly Migratory Species Advisory Panel, 8178-8179 2016-03272 Gulf of Mexico Fishery Management Council, 2016-03337 8177-8178 2016-03339 Whaling Provisions; Aboriginal Subsistence Whaling Quotas, 8177 2016-03366 National Park National Park Service NOTICES Inventory Completions: Thomas Burke Memorial Washington State Museum, University of Washington, Seattle, WA, 8218-8219 2016-03412 U.S. Department of Defense, Department of the Navy, Washington, DC, 8217-8218 2016-03408 Native American Graves Protection and Repatriation Review Committee: Findings and Recommendations Regarding Human Remains and Associated Funerary Objects for the Osage Nation, 8219-8220 2016-03407 Repatriation of Cultural Items: Mount Holyoke College Art Museum, South Hadley, MA, 8216-8217 2016-03411 National Science National Science Foundation NOTICES Meetings; Sunshine Act, 8254 2016-03425 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Atomic Safety and Licensing Board; Orders: Southern Nuclear Operating Co., Inc., Vogtle Electric Generating Plant, Units 3 and 4, 8258 2016-03372 Guidance: Criteria and Design Features for Inspection of Water-Control Structures Associated with Nuclear Power Plants, 8254-8255 2016-03346 Independent Spent Fuel Storage Installation: Maine Yankee Atomic Power Company, 8258-8261 2016-03413 License Terminations: Mallinckrodt, LLC., 8256-8258 2016-03419 Meetings: Advisory Committee on Reactor Safeguards Subcommittee on Plant License Renewal, 8255 2016-03370 Advisory Committee on Reactor Safeguards Subcommittee on Radiation Protection and Nuclear Materials, 8255-8256 2016-03371 Advisory Committee on Reactor Safeguards Subcommittee on Reliability and PRA, 8256 2016-03369 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Committee Membership: Maritime Advisory Committee for Occupational Safety and Health, 8253-8254 2016-03377 Overseas Overseas Private Investment Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 8261 2016-03420 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 8261-8262 2016-03281 Presidential Documents Presidential Documents PROCLAMATIONS Castle Mountains National Monument; Establishment (Proc. 9394), 8363-8369 2016-03540 Mojave Trails National Monument; Establishment (Proc. 9395), 8371-8377 2016-03544 Sand to Snow National Monument; Establishment (Proc. 9396), 8379-8385 2016-03548 Special Observances: Death of Antonin G. Scalia (Proc. 9397), 8387 2016-03550 Railroad Retirement Railroad Retirement Board NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 8262-8264 2016-03328 Securities Securities and Exchange Commission NOTICES Applications: PowerShares Exchange-Traded Self-Indexed Fund Trust, et al., 8282-8291 2016-03301 Joint Industry Plan; Filing of Amendment No. 3 to the National Market System Plan: Financial Industry Regulatory Authority, Inc., BATS Exchange, Inc., BOX Options Exchange, LLC, et al., 8264-8265 2016-03275 Self-Regulatory Organizations; Proposed Rule Changes: NASDAQ PHLX LLC, 8308-8310 2016-03274 New York Stock Exchange LLC, 8313-8316 2016-03271 NYSE Arca, Inc., 8265-8282, 8291-8294 2016-03267 2016-03269 2016-03270 NYSE MKT, LLC, 8310-8313, 8316-8319 2016-03264 2016-03266 The NASDAQ Stock Market LLC, 8319-8323 2016-03268 The Options Clearing Corporation, 8294-8308 2016-03265 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 8323-8326 2016-03380 State Department State Department NOTICES Delegations of Authority: Further Assignment of Functions under the Bipartisan Congressional Trade Priorities and Accountability Act to Other Departments and Agencies of the Executive Branch, 8326 2016-03376 Meetings: U.S. Advisory Commission on Public Diplomacy, 8326 2016-03374 Surface Transportation Surface Transportation Board PROPOSED RULES Accelerating Reporting Requirements for Class I Railroads, 8171-8172 2016-03332 NOTICES Discontinuance of Service Exemptions: CSX Transportation, Inc. in Harlan County, KY, 8327 2016-03356 Productivity Adjustments: Railroad Cost Recovery Procedures, 8326-8327 2016-03347 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

Treasury Treasury Department See

Community Development Financial Institutions Fund

See

Internal Revenue Service

U.S. China U.S.-China Economic and Security Review Commission NOTICES Meetings: U.S.-China Economic and Security Review Commission; Public Hearing, 8357-8358 2016-02999 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Civilian Health And Medical Program of the Department of Veterans Affairs Benefits -- Application, Claim, Other Health Insurance and Potential Liability, 8359-8360 2016-03288 Dependents' Request for Change of Program or Place of Training, 8358 2016-03287 Report of Subcontracts to Small and Veteran-Owned Business, 8358-8359 2016-03285 Request for a Certificate of Eligibility VA Form, 8359 2016-03286 Self-Regulatory Organizations; Proposed Rule Changes: Loan Analysis, 8361 2016-03284 Western Western Area Power Administration NOTICES Pick-Sloan Missouri Basin Program -- Eastern Division, 8197 2016-03362 Separate Parts In This Issue Part II Presidential Documents, 8363-8369, 8371-8377, 8379-8385, 8387 2016-03540 2016-03544 2016-03548 2016-03550 Reader Aids

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

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81 32 Thursday, February 18, 2016 Rules and Regulations FEDERAL RESERVE SYSTEM 12 CFR Part 227 [Docket No. R-1490; RIN 7100 AE-19] Unfair or Deceptive Acts or Practices (Regulation AA) AGENCY:

Board of Governors of the Federal Reserve System.

ACTION:

Final rule.

SUMMARY:

The Board of Governors of the Federal Reserve System (Board) is repealing its Regulation AA, which was issued pursuant to its rule writing authority under section 18(f)(1) of the Federal Trade Commission Act (FTC Act or Act). Section 1092(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) repealed section 18(f)(1) of the FTC Act, thus eliminating the Board's rule writing authority under the Act.

DATES:

The final rule is effective March 21, 2016.

FOR FURTHER INFORMATION CONTACT:

Mandie K. Aubrey, Counsel, Division of Consumer and Community Affairs, at (202) 452-3667, Board of Governors of the Federal Reserve System, 20th and C Streets NW., Washington, DC 20551. For users of Telecommunications Device for the Deaf (TDD) only, contact (202) 263-4869.

SUPPLEMENTARY INFORMATION:

I. Background

The FTC Act directs the Federal Trade Commission (FTC) to promulgate rules to define and prevent unfair or deceptive acts or practices for persons other than banks, savings and loans, and Federal credit unions.1 Pursuant to the Act, in 1984 the FTC issued its Credit Practices Rule, which applied to persons within the FTC's jurisdiction.2

1 15 U.S.C. 45 and 57a(a)(1).

2 16 CFR 444.1-.5.

Prior to amendments to the FTC Act made by the Dodd-Frank Act in 2010, section 18(f)(1) of the FTC Act required the Board to promulgate rules applicable to banks that were “substantially similar” to these FTC rules, with some exceptions.3 In addition, section 18(f)(1) of the Act provided the Board the authority to prescribe additional rules for banks addressing unfair or deceptive acts or practices—regardless of whether the FTC had promulgated rules about such acts or practices. The Act also required the Board to take appropriate action on complaints about unfair or deceptive acts or practices by banks.4

3 Section 18(f)(1) of the Act was previously codified at 15 U.S.C. 57a(f)(1). The Board was not required to impose substantially similar rules if it found that: (1) Such acts or practices of banks were not unfair or deceptive, or (2) implementation of similar regulations with respect to banks would seriously conflict with essential monetary and payments systems policies of the Board.

4 The same authority that was conferred to the Board by section 18(f)(1) of the Act also applied to the Federal Home Loan Bank Board (FHLBB) (predecessor to the Office of Thrift Supervision), with respect to savings associations, and to the National Credit Union Administration (NCUA), with respect to Federal credit unions.

Pursuant to its rule writing authority in section 18(f)(1) of the FTC Act, the Board issued Regulation AA, including the Board's credit practices rule, which was adopted in 1985.5 The Board's credit practices rule was substantially similar to the FTC's Credit Practices Rule; in adopting the rule, the Board relied on the extensive findings that had been made by the FTC that the prohibited practices were unfair or deceptive.

5 12 CFR part 227, subpart B.

The Board's credit practices rule in Regulation AA prohibited banks from using certain remedies to enforce consumer credit obligations and from including these remedies in their consumer credit contracts. The rule also prohibited banks from: (1) Obligating a co-signer on the debt unless the co-signer previously received a clear and conspicuous written notice explaining the nature of the co-signer's obligations and liabilities under the contract; and (2) imposing a late fee when a consumer makes a full loan payment on time or within the grace period, solely because the consumer did not pay a previous late fee imposed on an earlier installment (the “pyramiding” of late fees).

In addition, Regulation AA contained a provision that informed consumers how to file a complaint regarding a state member bank and explained the Board's procedure for responding to such complaints.6 Regulation AA also contained information regarding state exemptions from the credit practices rule.7 The Board published, separately from the regulation, Staff Guidelines to clarify how Regulation AA applied in particular circumstances.8

6 12 CFR 227.2. This provision listed an address to which consumers may send their complaint, and explained that consumers will receive, within 15 business days, either a substantive response or an acknowledgment setting a reasonable time for a substantive response.

7 12 CFR 227.16.

8http://www.federalreserve.gov/regulations/cg/crdtpracrul.htm.

The Dodd-Frank Act 9 repealed section 18(f)(1) of the FTC Act.10 This legislative repeal of the Board's rulemaking authority nullified the provisions in Regulation AA that were issued pursuant to that authority. Regulation AA did not transfer from the Board to the Consumer Financial Protection Bureau (Bureau) under the Dodd-Frank Act, as did other consumer protection laws and regulations.11 As a result, neither the Board nor the Bureau has authority to promulgate rules pursuant to the FTC Act. The Bureau, however, was given separate authority under the Dodd-Frank Act to promulgate rules to identify unfair, deceptive, or abusive acts or practices.12

9 Public Law 111-203, 124 Stat. 1376 (Jul. 21, 2010).

10See section 1092(2) of the Dodd-Frank Act. The repeal of section 18(f)(1) of the FTC Act also repealed the authorities of the former FHLBB and the NCUA. See supra note 4. Section 1092(2) of the Dodd-Frank Act did not repeal FTC Act rule writing authority for the FTC, so the FTC Credit Practices Rule remains in effect. See supra note 2.

11 The Dodd-Frank Act transferred rule writing authority only for “Federal consumer financial laws,” but did not include the FTC Act in the definition of “Federal consumer financial law.” Therefore, Regulation AA was excluded from the authority that transferred from the Board to the Bureau. See Dodd-Frank Act sections 1061(a)(1), (b)(1) (transferring authority of “Federal consumer financial laws” to the Bureau) and section 1002(14) (defining “Federal consumer financial laws”).

12 Section 1031 of the Dodd-Frank Act.

In August 2014, the Board published a proposal to repeal Regulation AA (Proposed Rule).13 Simultaneously with the proposed repeal of Regulation AA, the Board joined the Bureau, Federal Deposit Insurance Corporation, NCUA, and Office of the Comptroller of the Currency in issuing interagency guidance stating that, depending on the facts and circumstances, a depository institution might violate the prohibition against unfair or deceptive practices in the FTC Act and the Dodd-Frank Act if it engages in the practices prohibited by the former credit practices rules.14

13 79 FR 51115 (Aug. 27, 2014).

14 “Interagency Guidance Regarding Unfair or Deceptive Credit Practices” (Aug. 22, 2014). http://www.federalreserve.gov/newsevents/press/bcreg/bcreg20140822a2.pdf.

II. Discussion

Fourteen commenters responded to the proposed repeal of Regulation AA. Three individual commenters stated that Regulation AA was a necessary and helpful regulation; two of these commenters stated that the Board's reasons for repealing the regulation were unclear. A comment letter received from seven consumer advocate organizations acknowledged that the Board's repeal of Regulation AA was required by the Dodd-Frank Act. In their letter, these commenters also provided recommendations to the Bureau regarding acts or practices that the Bureau now has to authority to regulate if it finds they are unfair or deceptive.15

15 One state chartered bank commenter did not address the proposed repeal, but objected to examiners' citations of banks for unfair or deceptive practices in the supervisory process. Two individual commenters did not address the proposed repeal of Regulation AA.

Eight commenters addressed the interagency guidance that was issued simultaneously with the proposed repeal of Regulation AA. One individual commenter believed the guidance would discourage banks from engaging in unfair or deceptive acts or practices, but seven consumer advocate commenters recommended strengthening the guidance language. The consumer advocate commenters also recommended that the Board issue additional guidance regarding other acts or practices that the commenters believe should be declared unfair or deceptive acts or practices.

The Board is finalizing the repeal of Regulation AA as proposed. As the Board discussed in the Proposed Rule, the Dodd-Frank Act eliminated the Board's rule writing authority under the FTC Act, which nullified the regulation. The Board will continue to monitor developments with respect to unfair or deceptive acts or practices and assess whether to issue additional supervisory guidance.

The repeal of Regulation AA also eliminates Subpart A of the regulation, which generally describes the internal procedures used by the Board in handling consumer complaints. The Board did not receive comment on the removal of these internal procedures from the Code of Federal Regulations. Information about how the Board processes consumer complaints is provided on the Board's public Web site.16

16https://www.federalreserveconsumerhelp.gov/.

III. Final Regulatory Flexibility Analysis

The Regulatory Flexibility Act 17 (RFA) generally requires an agency to perform an assessment of the impact a rule is expected to have on small entities. Based on its analysis, and for the reasons stated below, the Board believes that this final rule will not have a significant economic impact on a substantial number of small entities.

17 5 U.S.C. 601 et seq.

1. Statement of the need for, and objectives of, the final rule. Regulation AA was issued pursuant to section 18(f)(1) of the FTC Act. As noted above, the Dodd-Frank Act repealed this provision of the FTC Act.18 Accordingly, the Board is repealing its Regulation AA.

18See section 1092(2) of the Dodd-Frank Act.

2. Summary of issues raised by comments in response to the initial regulatory flexibility analysis. The Board did not receive any comments on the initial regulatory flexibility analysis.

3. Small entities affected by the final rule. The final rule repeals Regulation AA, which was issued pursuant to section 18(f)(1) of the FTC. As a result of the FTC Act amendments made by the Dodd-Frank Act, the Board no longer has rule writing authority under section 18(f)(1). The legislative repeal of the Board's rulemaking authority nullified the provisions in Regulation AA that were issued pursuant to that authority. Consequently, the Board's repeal of the regulation, which no longer has legal effect, will not affect any entity, including any small entity. The repeal of Regulation AA will also remove information about how the Board processes consumer complaints from the Code of Federal Regulations. This is not expected to have an effect on small entities because that information is provided on the Board's public Web site.

4. Recordkeeping, reporting, and compliance requirements. The final rule repeals Regulation AA and therefore does not impose any recordkeeping, reporting, or compliance requirements on any entities.

5. Significant alternatives to the final revisions. Because the repeal of Regulation AA will have no impact, there are no alternatives that would further minimize the economic impact of the final rule on small entities.

IV. Paperwork Reduction Act

In accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3506; 5 CFR 1320 Appendix A.1), the Board reviewed the rule under the authority delegated to the Federal Reserve by the Office of Management and Budget (OMB). The final rule contains no requirements subject to the PRA.

List of Subjects in 12 CFR Part 227

Banks, Banking, Consumer protection, Credit, Federal Reserve System, Finance.

Authority and Issuance

For the reasons set forth in the preamble, and under the authority of section 1092(2) of Public Law 111-203, 124 Stat. 1376 (Jul. 21, 2010), the Board amends 12 CFR chapter II by removing part 227.

PART 227—[REMOVED] By order of the Board of Governors of the Federal Reserve System, February 11, 2016. Robert deV. Frierson, Secretary of the Board.
[FR Doc. 2016-03228 Filed 2-17-16; 8:45 am] BILLING CODE-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-0467; Directorate Identifier 2016-NM-008-AD; Amendment 39-18395; AD 2016-04-01] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

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

ACTION:

Final rule; request for comments.

SUMMARY:

We are superseding Airworthiness Directive (AD) 2015-26-02 for all Airbus Model A330-200, A330-200 Freighter, and A330-300 series airplanes; and Airbus Model A340-200, A340-300, A340-500, and A340-600 series airplanes. AD 2015-26-02 required, for certain airplanes, identification of the part number, serial number, and standard of the ram air turbine (RAT) pump, RAT module, RAT actuator, and RAT lower gearbox assembly; replacement of the balance weight screw, modification of the actuator coil spring, modification of the actuator, an inspection of the anti-stall valve for correct installation in the RAT pump housing; and corrective actions if necessary. For certain other airplanes, AD 2015-26-02 required re-identification or replacement of the RAT module. This new AD requires the same actions as AD 2015-26-02. This new AD was prompted by a report of a typographical error in the regulatory text of AD 2015-26-02. We are issuing this AD to prevent loss of the impeller function and RAT pump pressurization capability, which, if preceded by a total engine flame-out, could result in loss of control of the airplane.

DATES:

This AD becomes effective March 4, 2016.

The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of February 2, 2016 (80 FR 81174, December 29, 2015).

We must receive comments on this AD by April 4, 2016.

ADDRESSES:

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

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

Fax: 202-493-2251.

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

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

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

For Hamilton Sundstrand service information identified in this final rule, contact Hamilton Sundstrand, Technical Publications, Mail Stop 302-9, 4747 Harrison Avenue, P.O. Box 7002, Rockford, IL 61125-7002; telephone 860-654-3575; fax 860-998-4564; email [email protected]; Internet http://www.hamiltonsundstrand.com.

You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-0467.

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-2016-0467; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION: Discussion

On December 9, 2015, we issued AD 2015-26-02, Amendment 39-18350 (80 FR 81174, December 29, 2015) (“AD 2015-26-02”). AD 2015-26-02 applied to all Airbus Model A330-200, A330-200 Freighter, and A330-300 series airplanes; and Airbus Model A340-200, A340-300, A340-500, and A340-600 series airplanes. AD 2015-26-02 was prompted by a report indicating that, during a production flight test, the RAT did not pressurize the green hydraulic system. AD 2015-26-02 required for certain airplanes, identification of the part number, serial number, and standard of the RAT pump, RAT module, RAT actuator, and RAT lower gearbox assembly; replacement of the balance weight screw, modification of the actuator coil spring, modification of the actuator, an inspection of the anti-stall valve for correct installation in the RAT pump housing; and corrective actions if necessary. For certain other airplanes, AD 2015-26-02 required re-identification or replacement of the RAT module. We issued AD 2015-26-02 to prevent loss of the impeller function and RAT pump pressurization capability, which, if preceded by a total engine flame-out, could result in loss of control of the airplane.

Since we issued AD 2015-26-02, we received a report of a typographical error in the regulatory text of AD 2015-26-02. Paragraph (m) of AD 2015-26-02 inadvertently referred to paragraph (n) and should have referred to paragraph (o), “Parts Installation Prohibition.”

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2013-0274, dated November 15, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A330-200, A330-200 Freighter, and A330-300 series airplanes; and Airbus Model A340-200, A340-300, A340-500, and A340-600 series airplanes. The MCAI states:

During a production flight test of an A330-300 aeroplane, the Ram Air Turbine (RAT) did not pressurize the green hydraulic system. Investigation revealed that the impeller drive (hex) shaft had a reduced length of engagement with the pump drive shaft. This caused the impeller drive shaft to disengage from the pump and disconnect the impeller. It was determined that the disconnection was the result of internal hex dimensions on the pump impeller shaft, which had been changed in a manufacturing drawing. From the investigation analysis, it was possible to identify a list of affected parts.

This condition, if not detected and corrected, could lead to the loss of impeller function and RAT pump pressurization capability, possibly resulting, in case of total engine flame out, to the loss of control of the aeroplane.

To address this unsafe condition, a new design RAT pump shaft has been developed with a decreased hexagonal shaft housing depth, which increases the hexagonal drive shaft engagement in the impeller shaft to carry the impeller torque. Airbus issued Service Bulletin (SB) A330-29-3122, SB A340-29-4093 and SB A340-29-5021 to provide instructions for in-service replacement of the affected RAT hydraulic pumps, or re-identification of the RAT pump and complete RAT module, as applicable.

For the reasons described above, this [EASA] AD requires identification and replacement [modification] or re-identification of all affected RAT hydraulic pumps on A330 and A340-200/300 aeroplanes, and replacement [modification] of all affected RAT modules on A340-500/-600 aeroplanes.

For affected pumps, the required actions also include concurrent actions, as applicable, including replacement of the balance weight screw, modification of the actuator coil spring, modification of the actuator, an inspection of the anti-stall valve for correct installation in the RAT pump housing and re-installation if necessary. For affected pumps, corrective actions include replacement of the RAT hydraulic pump, and re-identification of the part number of the RAT module. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-0467.

Related Service Information Under 1 CFR Part 51

Airbus has issued the following service information:

• Airbus Service Bulletin A330-29-3122, dated October 25, 2012.

• Airbus Service Bulletin A340-29-4093, dated October 25, 2012.

This service information describes procedures for identifying the part number, serial number, and standard of the RAT pump, RAT module, RAT actuator, and RAT lower gearbox assembly; replacing the balance weight screw, modifying the actuator coil spring, modifying the actuator, and doing an inspection of the anti-stall valve for correct installation; and re-identifying the part numbers of the RAT hydraulic pump and RAT module.

Airbus also issued Service Bulletin A330-29-3126, dated June 12, 2014; and Service Bulletin A340-29-4097, dated June 12, 2014, which describe procedures for identifying the part number and serial number of the RAT actuator; modifying the RAT actuators; and re-identifying the part numbers of the RAT module.

In addition, Airbus issued Service Bulletin A340-29-5021, dated October 2, 2012; and Service Bulletin A340-29-5025, dated June 16, 2014, which describe procedures for replacing (modifying) the RAT module.

Hamilton Sundstrand has issued Service Bulletin ERPS06M-29-19, dated August 6, 2012, which identifies the serial numbers of the suspect hydraulic pump.

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

FAA's Determination and Requirements of This AD

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

FAA's Determination of the Effective Date

We are superseding AD 2015-26-02 to correct a typographical error in the regulatory text. No other changes have been made to AD 2015-26-02. Therefore, we determined 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-2016-0467; Directorate Identifier 2016-NM-008-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 affects 66 airplanes of U.S. registry.

We also estimate that it will take about 14 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 $78,540, or $1,190 per product.

In addition, we estimate that any necessary follow-on actions will take about 18 work-hours and require parts costing up to $427,301, for a cost of $428,831 per product. We have no way of determining the number of aircraft that might need this action.

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) 2015-26-02, Amendment 39-18350 (80 FR 81174, December 29, 2015), and adding the following new AD: 2016-04-01 Airbus: Amendment 39-18395; Docket No. FAA-2016-0467; Directorate Identifier 2016-NM-008-AD. (a) Effective Date

This AD becomes effective March 4, 2016.

(b) Affected ADs

(1) This AD replaces AD 2015-26-02, Amendment 39-18350 (80 FR 81174, December 29, 2015).

(2) This AD affects AD 2012-21-19, Amendment 39-17235 (77 FR 65812, October 31, 2012); and AD 2012-21-20, Amendment 39-17236 (77 FR 65799, October 31, 2012).

(c) Applicability

This AD applies to all Airbus airplanes, certificated in any category, identified in paragraphs (c)(1) and (c)(2) of this AD, all manufacturer serial numbers.

(1) Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.

(2) Model A340-211, -212, -213, -311, -312, -313, -541, and -642 airplanes.

(d) Subject

Air Transport Association (ATA) of America Code 29, Hydraulic Power.

(e) Reason

This AD was prompted by a report indicating that, during a production flight test, the ram air turbine (RAT) did not pressurize the green hydraulic system. We are issuing this AD to prevent loss of the impeller function and RAT pump pressurization capability, which, if preceded by a total engine flame-out, could result in loss of control of the airplane.

(f) Compliance

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

(g) Identification of RAT Components

For Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and Model A340-211, -212, -213, -311, -312, and -313 airplanes: Except as provided by paragraph (i) of this AD, within 36 months after the effective date of this AD, identify the part number, serial number, and standard (through the mod-dots) of the RAT pump, RAT module, RAT actuator, and RAT lower gearbox assembly, in accordance with the Accomplishment Instructions of the applicable Airbus service information specified in paragraphs (g)(1) and (g)(2) of this AD. A review of airplane maintenance records is acceptable in lieu of this identification if the part number, serial number, and standard can be conclusively determined from that review.

(1) For Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes: Airbus Service Bulletin A330-29-3122, dated October 25, 2012.

(2) For Airbus Model A340-211, -212, -213, -311, -312, and -313 airplanes: Airbus Service Bulletin A340-29-4093, dated October 25, 2012.

(h) Corrective and Concurrent Actions

If the serial number of the RAT hydraulic pump is included in table 7, “Suspect Hydraulic Pump Serial Numbers,” of Hamilton Sundstrand Service Bulletin ERPS06M-29-19, dated August 6, 2012: Within 36 months after the effective date of this AD, do all applicable corrective actions, in accordance with the Accomplishment Instructions of the applicable Airbus service information specified in paragraphs (g)(1) and (g)(2) of this AD. Prior to or concurrently with doing the corrective actions required by this paragraph, do the actions specified in paragraphs (h)(1) through (h)(4) of this AD, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-29-3122, dated October 25, 2012 (for Model A330-200, -200 Freighter, and -300 series airplanes); or Airbus Service Bulletin A340-29-4093, dated October 25, 2012 (for Airbus Model A340-211, -212, -213, -311, -312, and -313 airplanes).

(1) Replace the balance weight screw.

(2) Modify the actuator coil spring.

(3) Modify the actuator.

(4) Do a general visual inspection of the anti-stall valve for correct installation in the RAT pump housing, and if any incorrect installation is found, before further flight, correctly install the anti-stall valve.

(i) Exception to Service Information Specifications

Airbus Service Bulletin A330-29-3122, dated October 25, 2012 (for Model A330-200, -200 Freighter, and -300 series airplanes), refers to Hamilton Sundstrand Service Bulletin “EPRPS06M-29-13” as an additional source of guidance for doing certain actions required by paragraph (h) of this AD. The first “P” in the citation should have been omitted; the correct reference is to Hamilton Sundstrand Service Bulletin “ERPS06M-29-13.”

(j) Re-Identification of Part Numbers

If the serial number of the RAT hydraulic pump is not included in table 7, “Suspect Hydraulic Pump Serial Numbers,” of Hamilton Sundstrand Service Bulletin ERPS06M-29-19, dated August 6, 2012: Within 36 months after the effective date of this AD, re-identify the part numbers of the RAT hydraulic pump and RAT module, in accordance with the Accomplishment Instructions of the applicable Airbus service information specified in paragraphs (g)(1) and (g)(2) of this AD.

(k) Service Information for Optional Actions

Accomplishment of the actions required by paragraphs (g), (h), and (j) of this AD, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-29-3126, dated June 12, 2014; or Airbus Service Bulletin A340-29-4097, dated June 12, 2014, as applicable, constitutes compliance with the requirements of paragraphs (g), (h), and (j) of this AD.

(l) RAT Module Replacement (Modification)

For Airbus Model A340-541 and -642 airplanes having RAT module part number (P/N) 772722D, 772722E, 772722F, or 772722G: Within 36 months after the effective date of this AD, replace (modify) the RAT module, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A340-29-5021, dated October 2, 2012. As an option, accomplishment of the RAT module replacement (modification), in accordance with the Accomplishment Instructions of Airbus Service Bulletin A340-29-5025, dated June 16, 2014, constitutes compliance with the requirement of this paragraph.

(m) Exception to Paragraphs (g), (h), and (j) of This AD

The actions required by paragraphs (g), (h), and (j) of this AD are not required for airplanes on which Airbus Modification 202537 was embodied in production, provided it can be determined that, since the airplane's first flight, no RAT hydraulic pump or RAT module having a part number identified in paragraph (o) of this AD is installed on that airplane.

(n) Terminating Action for Certain Requirements of Other ADs

(1) For Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and Model A340-211, -212, -213, -311, -312, and -313 airplanes: Accomplishment of the actions required by paragraphs (g), (h), and (j) of this AD constitutes compliance with the requirements of paragraphs (g)(1) and (g)(2) of AD 2012-21-19, Amendment 39-17235 (77 FR 65812, October 31, 2012); and paragraphs (g)(1) and (g)(2) of AD 2012-21-20, Amendment 39-17236 (77 FR 65799, October 31, 2012).

(2) For Airbus Model A340-541 and -642 airplanes: Accomplishment of the actions required by paragraph (l) of this AD constitutes compliance with the requirements of paragraphs (h)(1) and (h)(2) of AD 2012-21-20, Amendment 39-17236 (77 FR 65799, October 31, 2012).

(o) Parts Installation Prohibition

(1) For Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; and A340-211, -212, -213, -311, -312, and -313 airplanes: After modification of the RAT module as required by paragraph (h) of this AD, no person may install any complete RAT module having a part number identified in paragraph (o)(1)(i) of this AD, or any RAT hydraulic pump having the part number identified in paragraph (o)(1)(ii) of this AD, on any airplane.

(i) RAT module P/N 766351, 768084, 770379, 770952, 770952A, 770952B, 1702934, 1702934A, or 1702934B.

(ii) RAT hydraulic pump P/N 5909522 (Parker P/N 4207902).

(2) For Airbus Model A340-541 and -642 airplanes: After modification of the RAT module as required by paragraph (l) of this AD, no person may install any complete RAT module having P/N 772722D, 772722E, 772722F, or 772722G, on any airplane.

(p) Other FAA AD Provisions

The following provisions also apply to this AD:

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

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

(q) Related Information

Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2013-0274, dated November 15, 2013, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-0467.

(r) 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 February 2, 2016 (80 FR 81174, December 29, 2015).

(i) Airbus Service Bulletin A330-29-3122, dated October 25, 2012.

(ii) Airbus Service Bulletin A330-29-3126, dated June 12, 2014.

(iii) Airbus Service Bulletin A340-29-4093, dated October 25, 2012.

(iv) Airbus Service Bulletin A340-29-4097, dated June 12, 2014.

(v) Airbus Service Bulletin A340-29-5021, dated October 2, 2012.

(vi) Airbus Service Bulletin A340-29-5025, dated June 16, 2014.

(vii) Hamilton Sundstrand Service Bulletin ERPS06M-29-19, dated August 6, 2012.

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

(5) For Hamilton Sundstrand service information identified in this AD, contact Hamilton Sundstrand, Technical Publications, Mail Stop 302-9, 4747 Harrison Avenue, P.O. Box 7002, Rockford, IL 61125-7002; telephone 860-654-3575; fax 860-998-4564; email [email protected]; Internet http://www.hamiltonsundstrand.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 February 8, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-03215 Filed 2-17-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-3630; Directorate Identifier 2014-NM-253-AD; Amendment 39-18397; AD 2016-04-03] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 747-400F series airplanes. This AD was prompted by an analysis of the production methods used to increase fatigue resistance of the upper closure fittings at the nose cargo door portal's C-3 frame, which showed that cracking could start too early to be caught in a timely manner by the inspection or maintenance program. This AD requires inspections of the upper closure fitting and connected strap and doubler at the nose cargo door portal for cracking, and related investigative and corrective actions if necessary. We are issuing this AD to detect and correct such cracking, which could result in sudden decompression and loss of the airplane's structural integrity.

DATES:

This AD is effective March 24, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of March 24, 2016.

ADDRESSES:

For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-3630.

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-2015-3630; 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 (phone: 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Bill Ashforth, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6432; fax: 425-917-6590; email: [email protected]

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all The Boeing Company Model 747-400F series airplanes. The NPRM published in the Federal Register on September 15, 2015 (80 FR 55273) (“the NPRM”). The NPRM was prompted by a report indicating that an analysis of the production methods used to increase fatigue resistance of the upper closure fittings at the nose cargo door portal's C-3 frame showed that cracking could start too early to be caught in a timely manner by the inspection or maintenance program. The upper closure fittings used in the nose cargo door portal C-3 frame were shot peened to increase fatigue resistance. However, an analysis showed that the increase in fatigue resistance was still not enough to ensure that cracking would be caught by the inspection program specified in the Boeing 747-400 maintenance planning data (MPD) document. The NPRM proposed to require inspections of the upper closure fitting and connected strap and doubler at the nose cargo door portal for cracking, and related investigative and corrective actions if necessary. We are issuing this AD to detect and correct such cracking, which could result in sudden decompression and loss of the airplane's structural integrity.

Comments

We gave the public the opportunity to participate in developing this AD. We considered the comment received. Boeing supported the NPRM.

Conclusion

We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this 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 Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014. This service information describes procedures for a detailed inspection of the upper closure fitting and connected strap and doubler, a surface high frequency eddy current (HFEC) inspection of the upper closure fitting for cracking, and related investigative and corrective actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

We estimate that this AD affects 38 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

Estimated Costs Action Labor cost Parts cost Cost per product Cost on U.S. operators Inspections 9 work-hours × $85 per hour = $765 per inspection cycle $0 $765 per inspection cycle $29,070 per inspection cycle.

We estimate the following costs to do any necessary repairs or replacements that would be required based on the results of the inspection. Parts costs could be up to $42,930 per airplane. We have no way of determining the number of work hours (because the type of repair will vary depending on findings) or the number of aircraft that might need the repairs or replacements.

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

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

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

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

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

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

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2016-04-03 The Boeing Company: Amendment 39-18397; Docket No. FAA-2015-3630; Directorate Identifier 2014-NM-253-AD. (a) Effective Date

This AD is effective March 24, 2016.

(b) Affected ADs

None.

(c) Applicability

This AD applies to all The Boeing Company Model 747-400F series airplanes, certificated in any category, as identified in paragraph 1.A., “Effectivity,” of Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014.

(d) Subject

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

(e) Unsafe Condition

This AD was prompted by a report that an analysis of the production methods used to increase fatigue resistance of the upper closure fittings at the nose cargo door portal's C-3 frame showed that cracking could still start too early to be caught in a timely manner by the inspection or maintenance program. We are issuing this AD to detect and correct such cracking, which could result in sudden decompression and loss of the airplane's structural integrity.

(f) Compliance

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

(g) Inspections and Corrective Actions

Except as required by paragraph (h) of this AD: At the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014, do a detailed inspection of the upper closure fitting, strap, and doubler and a surface high frequency eddy current (HFEC) inspection of the upper closure fitting at the nose cargo door portal for cracking, and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014. Repeat the inspections at the time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014. Do the applicable related investigative and corrective actions at the times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014.

(h) Exceptions to the Service Information

(1) Where paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014, refers to a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specific compliance time after the effective date of this AD.

(2) If any crack is found during any inspection required by this AD, and Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014, specifies to contact Boeing for appropriate action: Before further flight, repair the cracking using a method approved in accordance with the procedures specified in paragraph (i) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

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

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

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

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

(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

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

(j) Related Information

For more information about this AD, contact Bill Ashforth, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6432; fax: 425-917-6590; email: [email protected].

(k) Material Incorporated by Reference

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

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

(i) Boeing Alert Service Bulletin 747-53A2880, dated December 3, 2014.

(ii) Reserved.

(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet https://www.myboeingfleet.com.

(4) You may view this service information 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 February 8, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-03217 Filed 2-17-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-2460; Directorate Identifier 2014-NM-163-AD; Amendment 39-18396; AD 2016-04-02] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

We are superseding Airworthiness Directive (AD) 2010-26-10, which applied to certain The Boeing Company Model 747-200C, -200F, -400, -400D, and -400F series airplanes. AD 2010-26-10 required repetitive inspections for cracking of the lap joints, modification of certain lap joints, and certain post-repair inspections of the lap joints. This new AD adds new repetitive post-modification inspections for cracking in the lap joints, and repair if necessary. This AD was prompted by an evaluation by the design approval holder (DAH) which indicated that certain lap joints are subject to widespread fatigue damage (WFD). We are issuing this AD to detect and correct fatigue cracking in certain lap joints, which could result in rapid depressurization and consequent reduced structural integrity of the airplane.

DATES:

This AD is effective March 24, 2016.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of March 24, 2016.

ADDRESSES:

For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-2460.

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-2015-2460; 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 (phone: 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Nathan Weigand, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6428; fax: 425-917-6590; email: [email protected]

SUPPLEMENTARY INFORMATION: Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2010-26-10, Amendment 39-16549 (75 FR 81427, December 28, 2010). AD 2010-26-10 applied to certain The Boeing Company Model 747-200C, -200F, -400, -400D, and -400F series airplanes. The NPRM published in the Federal Register on July 9, 2015 (80 FR 39394). The NPRM was prompted by an evaluation by the DAH that indicated that certain lap joints are subject to WFD. The NPRM proposed to continue to require repetitive inspections for cracking of the lap joints, modification of certain lap joints, and certain post-repair inspections of the lap joints. The NPRM also proposed to require new repetitive post-modification inspections for cracking in the lap joints, and repair if necessary. We are issuing this AD to detect and correct fatigue cracking in certain lap joints, which could result in rapid depressurization and consequent reduced structural integrity of the airplane.

Comments

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM (80 FR 39394, July 9, 2015) and the FAA's response to each comment. United Airlines concurred with the NPRM.

Request To Correct Typographical Error

Boeing asked that we correct the reference in the “Related Service Information under 1 CFR part 51” from “. . . sections 41, 42, and 43” to “. . . sections 41, 42, and 46.” Boeing stated that section 43 should be section 46, and noted that this is a typographical error.

We agree with the commenter's request for the reason provided. We have corrected this typographical error in “Related Service Information under 1 CFR part 51” accordingly.

Request To Clarify Certain Requirements

Boeing asked that we clarify paragraph (i)(1) of the proposed AD (80 FR 39394, July 9, 2015) by including “per Table 7” in that paragraph. Boeing also asked that we clarify paragraph (i)(3) of the proposed AD by including “per Table 10” in that paragraph.

We agree that clarification is necessary but we do not agree to change paragraphs (i)(1) and (i)(3) of this AD. Paragraph (i) of this AD specifies doing the applicable inspections in paragraphs (i)(1), (i)(2), or (i)(3) of this AD, in accordance with the Accomplishment Instructions of the referenced service information; and repeating the applicable inspections at the applicable times specified in Tables 7, 8, 9, and 10 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014. In each of these tables the applicable groups are identified and match the groups identified in paragraphs (i)(1), (i)(2), and (i)(3) of this AD. We refer to the tables in paragraph 1.E., “Compliance,” of service information for the applicable compliance times and not for how to accomplish the required actions. Therefore, we have not changed this AD in this regard.

Conclusion

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

• Are consistent with the intent that was proposed in the NPRM (80 FR 39394, July 9, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 39394, July 9, 2015).

Related Service Information Under 1 CFR Part 51

We reviewed Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014. The service information describes procedures for body skin lap joint inspections and modifications in sections 41, 42, and 46. 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 120 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

Estimated Costs Action Labor cost Parts cost Cost per product Cost on U.S.
  • operators
  • Pre-modification inspections [retained action from AD 2010-26-10, Amendment 39-16549 (75 FR 81427, December 28, 2010)] Up to 675 work-hours × $85 per hour = up to $57,375 $0 Up to $57,375 per inspection cycle Up to $6,885,000 per inspection cycle. Modification [retained action from AD 2010-26-10, Amendment 39-16549 (75 FR 81427, December 28, 2010)] Up to 5,819 work-hours × $85 per hour = up to $494,615 0 Up to $494,615 Up to $59,353,800. New proposed post-modification inspections Up to 105 work-hours × $85 per hour = up to $8,925 0 Up to $8,925 per inspection cycle Up to $1,071,000 per inspection cycle.

    We have received no definitive data that would enable us to provide a cost estimate 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 have 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 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) 2010-26-10, Amendment 39-16549 (75 FR 81427, December 28, 2010), and adding the following new AD: 2016-04-02 The Boeing Company: Amendment 39-18396; Docket No. FAA-2015-2460; Directorate Identifier 2014-NM-163-AD. (a) Effective Date

    This AD is effective March 24, 2016.

    (b) Affected ADs

    This AD replaces AD 2010-26-10, Amendment 39-16549 (75 FR 81427, December 28, 2010).

    (c) Applicability

    This AD applies to The Boeing Company Model 747-200C, -200F, -400, -400D, and -400F series airplanes; certificated in any category; as identified in Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014.

    (d) Subject

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

    (e) Unsafe Condition

    This AD was prompted by an evaluation by the design approval holder indicating that certain lap joints are subject to widespread fatigue damage. We are issuing this AD to detect and correct fatigue cracking in certain lap joints, which could result in rapid depressurization and consequent reduced structural integrity of the airplane.

    (f) Compliance

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

    (g) Repetitive Lap Joint Inspections

    At the applicable time specified in Table 1 and Table 3 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014, except as required by paragraph (j)(1) of this AD: Do eddy current inspections for cracks in the skin of the lap joints, and do all applicable repairs, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014, except as required by paragraph (j)(2) of this AD. Do all applicable repairs before further flight. Repeat the applicable inspections thereafter at intervals not to exceed those specified in Table 1 and Table 3 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014.

    (h) Lap Joint Modification

    At the applicable time specified in Tables 2, 4, 5, and 6 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014, except as required by paragraph (j)(1) of this AD: Modify the applicable lap joints, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014, except as required by paragraph (j)(2) of this AD. Accomplishment of the modification required by this paragraph terminates the repetitive inspections required by paragraph (g) of this AD for the length of the modified lap joint.

    (i) Lap Joint Post-Modification Inspections

    At the applicable time specified in Tables 7, 8, 9, and 10 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014, except as required by paragraph (j)(1) of this AD: Do the applicable inspections specified in paragraph (i)(1), (i)(2), or (i)(3) of this AD, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014. Repeat the applicable inspections thereafter at the applicable times specified in Tables 7, 8, 9, and 10 of paragraph 1.E, “Compliance,” of Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014. If any crack is found during any inspection, repair before further flight using a method approved in accordance with the procedures specified in paragraph (l) of this AD.

    (1) For airplanes identified as Groups 2 through 5 and 8 through 10 in Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014: Internal detailed and surface high frequency eddy current (HFEC) inspections for any crack in the skin or internal doubler.

    (2) For airplanes identified as Groups 6, 11, and 19 in Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014: External detailed and low frequency eddy current inspections of the upper and lower skin panels for cracking, external detailed and HFEC inspections of the doubler for cracking, and internal detailed and HFEC inspections of the upper and lower skin panels for cracking (for airplanes with a stringer 6 lap joint modification installed between STA 340 and STA 400 as specified in Boeing Service Bulletin 747-53-2272); or internal detailed and surface HFEC inspections for any crack in the skin or internal doubler (for airplanes with lap joints modified as specified in Boeing Alert Service Bulletin 747-53A2499.)

    (3) For airplanes identified as Groups 1, 7, and 12 through 18 in Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014: Internal detailed and surface HFEC inspections for any crack in the skin or internal doubler.

    (j) Exceptions to Service Bulletin Procedures

    (1) Where Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014, specifies a compliance time “after the Revision 3 date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.

    (2) Where Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014, specifies to contact Boeing for repair instructions: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (l) of this AD.

    (k) Credit for Previous Actions

    Actions done before the effective date of this AD using the service information identified in paragraph (k)(1) or (k)(2) of this AD are acceptable for compliance with the corresponding requirements of paragraphs (g) and (h) of this AD.

    (1) Boeing Alert Service Bulletin 747-53A2499, Revision 1, dated October 30, 2008, which is not incorporated by reference in this AD.

    (2) Boeing Alert Service Bulletin 747-53A2499, Revision 2, dated August 12, 2010, which was incorporated by reference in AD 2010-26-10, Amendment 39-16549 (75 FR 81427, December 28, 2010).

    (l) Alternative Methods of Compliance (AMOCs)

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

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

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

    (4) AMOCs approved for AD 2010-26-10, Amendment 39-16549 (75 FR 81427, December 28, 2010), are approved as AMOCs for the corresponding provisions of paragraphs (g) and (h) this AD.

    (m) Related Information

    (1) For more information about this AD, contact Nathan Weigand, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6428; fax: 425-917-6590; email: [email protected]

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

    (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 the AD specifies otherwise.

    (i) Boeing Alert Service Bulletin 747-53A2499, Revision 3, dated July 15, 2014.

    (ii) Reserved.

    (3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet https://www.myboeingfleet.com.

    (4) You may view this service information at 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 February 7, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-03219 Filed 2-17-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-4803; Directorate Identifier 2015-CE-034-AD; Amendment 39-18399; AD 2016-04-05] RIN 2120-AA64 Airworthiness Directives; B-N Group Ltd. Airplanes AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    We are superseding an airworthiness directive (AD) 2014-03-18 for B-N Group Ltd. Models BN-2, BN-2A, BN-2A-2, BN-2A-3, BN-2A-6, BN-2A-8, BN-2A-9, BN-2A-20, BN-2A-21, BN-2A-26, BN-2A-27, BN-2B-20, BN-2B-21, BN-2B-26, BN-2B-27, BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-3 airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued 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 damage of the cable sliding end assembly and installation of the incorrect end fitting on engine control cable assemblies. We are issuing this AD to require actions to address the unsafe condition on these products.

    DATES:

    This AD is effective March 24, 2016.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of March 24, 2016.

    The Director of the Federal Register approved the incorporation by reference of a certain other publication listed in this AD as of April 1, 2014 (79 FR 10340, February 25, 2014).

    ADDRESSES:

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-4803; or in person at the 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 service information identified in this final rule, contact Britten-Norman Aircraft Limited, Commodore House, Mountbatten Business Centre, Millbrook Road East, Southampton SO15 1HY, United Kingdom; telephone: +44 20 3371 4000; fax: +44 20 3371 4001; email: [email protected]; Internet: http://www.britten-norman.com/customer-support/. You may view this 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 Docket No. FAA-2015-4803.

    FOR FURTHER INFORMATION CONTACT:

    Raymond Johnston, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4159; fax: (816) 329-3047; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to B-N Group Ltd. Models BN-2, BN-2A, BN-2A-2, BN-2A-3, BN-2A-6, BN-2A-8, BN-2A-9, BN-2A-20, BN-2A-21, BN-2A-26, BN-2A-27, BN-2B-20, BN-2B-21, BN-2B-26, BN-2B-27, BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-3 airplanes. The NPRM was published in the Federal Register on October 29, 2015 (80 FR 66482), and proposed to supersede AD 2014-03-18, Amendment 39-17755 (79 FR 10340; February 25, 2014).

    The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states that:

    Britten-Norman Aircraft Limited was made aware of two occurrences where a failure of engine control cable assemblies has caused engine control difficulties. In both reported cases, the cable sliding end assemblies were in poor condition and in both cases, an incorrect end-fitting was installed, which may have contributed to the failures.

    This condition, if not detected and corrected, could result in reduced engine control, possibly resulting in reduced control of the aeroplane.

    To address this potential unsafe condition, Britten-Norman Aircraft issued Service Bulletin (SB) 334 to provide inspection instructions, and EASA issued AD 2013-0215 to require a one-time inspection and functional test of the engine control cables and, depending on findings, replacement of the cables.

    Subsequently, as it was found that BN2 “Islander” aeroplanes were mistakenly omitted from the AD applicability, EASA issued AD 2013-0263, retaining the requirements of EASA AD 2013-0215, which was superseded, and extending the applicability to BN2 aeroplanes.

    Since EASA AD 2013-0263 was issued, it was found that certain parts, specific to BN2A “Trislander” aeroplanes only, were inadvertently not included in SB 334 and, as a consequence, not required by AD 2013-0263 to be inspected.

    Prompted by these findings, Britten-Norman revised SB 334 (now at issue 2) to include the missing parts.

    For the reason described above, this AD retains the requirements of EASA AD 2013-0263, which is superseded, and adds inspection requirements for the additional parts.

    The MCAI can be found in the AD docket on the Internet at: http://www.regulations.gov/#!documentDetail;D=FAA-2015-4803-0001. 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 relevant data and determined that air safety and the public interest require adopting the 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 (80 FR 66482, October 29, 2015) for correcting the unsafe condition; and

    • Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 66482, October 29, 2015).

    Related Service Information Under 1 CFR Part 51

    We reviewed Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 1, dated August 30, 2013; and Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 2, dated July 17, 2015. The service information describes procedures for inspection and replacement if necessary of the engine control cable assemblies. 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 this final rule.

    Costs of Compliance

    We estimate that this AD will affect 96 products of U.S. registry. We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour.

    Based on these figures, we estimate the cost of this AD on U.S. operators to be $8,160 or $85 per product.

    In addition, we estimate that any necessary follow-on actions would take about 10 work-hours and require parts costing $6,000, for a cost of $6,850 per product. We have no way of determining the number of products that may need these actions.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

    For the reasons discussed above, I certify this AD:

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

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

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

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

    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-2015-4803; 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 NPRM, 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.

    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 Amendment 39-17755 (79 FR 10340; February 25, 2014) and adding the following new AD: 2016-04-05 B-N Group Ltd.: Amendment 39-18399; Docket No. FAA-2015-4803; Directorate Identifier 2015-CE-034-AD. (a) Effective Date

    This airworthiness directive (AD) becomes effective March 24, 2016.

    (b) Affected ADs

    This AD supersedes AD 2014-03-18, Amendment 39-17755 (79 FR 10340; February 25, 2014) (“AD 2014-03-18”).

    (c) Applicability

    This AD applies to B-N Group Ltd. Models BN-2, BN-2A, BN-2A-2, BN-2A-3, BN-2A-6, BN-2A-8, BN-2A-9, BN-2A-20, BN-2A-21, BN-2A-26, BN-2A-27, BN-2B-20, BN-2B-21, BN-2B-26, BN-2B-27, BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-3 airplanes, all serial numbers, certificated in any category.

    (d) Subject

    Air Transport Association of America (ATA) Code 76: Engine Controls.

    (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 possible damage of the cable sliding end assembly and installation of the incorrect end fitting on engine control cable assemblies. We are issuing this proposed AD to detect and correct damage of the cable sliding end assembly (cracking, distortion, corrosion) and incorrect end fittings on the engine control assemblies, which could lead to reduced engine control with consequent loss of control, and to incorporate revised service information with updated information on applicability and on the identity of parts to be inspected on some airplanes.

    (f) Actions and Compliance

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

    (1) For all airplanes except the Trislander Models BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-3: Within the next 6 months after April 1, 2014 (the effective date retained from AD 2014-03-18), do a one-time inspection of the engine control cable assemblies, part number (P/N) 137835, P/N 172449-1, P/N 172450, and P/N 172451, and surrounding areas for damage (cracking, distortion, corrosion); for the correct cable end-fitting; and to assure the wire locking is intact following Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 1, dated August 30, 2013; or Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 2, dated July 17, 2015.

    (2) For the Trislander Models BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-3 airplanes: Within the next 3 months after March 24, 2016 (the effective date of this AD), do a one-time inspection of the engine control cable assemblies, P/N 80468 and P/N NB-45-2883, and surrounding areas for damage (cracking, distortion, corrosion); for the correct cable end-fitting; and to assure the wire locking is intact following Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 2, dated July 17, 2015.

    (3) For all airplanes except the Trislander Models BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-3: If no discrepancies are found during the inspection required in paragraph (f)(1) of this AD, before further flight, inspect the control linkages for proper adjustment and make any necessary changes following Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 1, dated August 30, 2013; or Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 2, dated July 17, 2015.

    (4) For the Trislander Models BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-3 airplanes: If no discrepancies are found during the inspection required in paragraph (f)(2) of this AD, before further flight, inspect the control linkages for proper adjustment and make any necessary changes following Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 2, dated July 17, 2015.

    (5) For all airplanes except the Trislander Models BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-3: If any discrepancies are found during the inspection required in paragraph (f)(1) of this AD and/or the control linkages cannot be properly adjusted as specified in paragraph (f)(3) of this AD, before further flight, replace the engine control cable assembly with a serviceable unit following Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 1, dated August 30, 2013; or Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 2, dated July 17, 2015.

    (6) For the Trislander Models BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-3 airplanes: If any discrepancies are found during the inspection required in paragraph (f)(2) of this AD and/or the control linkages cannot be properly adjusted as specified in paragraph (f)(4) of this AD, before further flight, replace the engine control cable assembly with a serviceable unit following Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 2, dated July 17, 2015.

    (7) For all airplanes except the Trislander Models BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-3: After April 1, 2014 (the effective date retained from AD 2014-03-18), do not install on any airplane engine control cable assemblies, P/N 137835, P/N 172449-1, P/N 172450, and P/N 172451, unless they are new or have been inspected as required in paragraphs (f)(1) and (f)(3) of this AD and found free of any discrepancies and have proper adjustment.

    (8) For the Trislander Models BN2A MK. III, BN2A MK. III-2, and BN2A MK. III-3 airplanes: After March 24, 2016 (the effective date of this AD), do not install on any airplane engine control cable assemblies P/N 80468 and/or P/N NB-45-2883, unless they are new or have been inspected as required in paragraphs (f)(2) and (f)(4) of this AD and found free of any discrepancies and have proper adjustment.

    (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: Raymond Johnston, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4159; fax: (816) 329-3047; 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.: 2015-0184, dated September 1, 2015; for related information. The MCAI can be found in the AD docket on the Internet at: http://www.regulations.gov/#!documentDetail;D=FAA-2015-4803-0001.

    (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.

    (3) The following service information was approved for IBR on March 24, 2016 (the effective date of this AD).

    (i) Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 2, dated July 17, 2015.

    (ii) Reserved.

    (4) The following service information was approved for IBR on April 1, 2014 (79 FR 10340; February 25, 2014).

    (i) Britten-Norman Aircraft Limited Service Bulletin No. SB 334, Issue 1, dated August 30, 2013.

    (ii) Reserved.

    (5) For Britten-Norman service information identified in this AD, contact Britten-Norman Aircraft Limited, Commodore House, Mountbatten Business Centre, Millbrook Road East, Southampton SO15 1HY, United Kingdom; telephone: +44 20 3371 4000; fax: +44 20 3371 4001; email: [email protected]; Internet: http://www.britten-norman.com/customer-support/.

    (6) You may view this service information at 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. In addition, you can access this service information on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-4803.

    (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 Kansas City, Missouri, on February 10, 2016. Pat Mullen, Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-03307 Filed 2-17-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 888 [Docket No. FDA-2011-N-0661] Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final order.

    SUMMARY:

    The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

    DATES:

    This order is effective on February 18, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Sergio M. de del Castillo, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993, 301-796-6419.

    SUPPLEMENTARY INFORMATION:

    I. Background—Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments, established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

    Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as preamendments devices), are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

    Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices), are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 807.

    A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification (510(k)) procedures to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a PMA until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval. Section 515(b)(1) of the FD&C Act directs FDA to issue an order requiring premarket approval for a preamendments class III device.

    Although, under the FD&C Act, the manufacturer of a preamendments class III device may respond to the call for PMAs by filing a PMA or a notice of completion of a PDP. In practice, the option of filing a notice of completion of a PDP has rarely been used. For simplicity, although the PDP option remains available to manufacturers in response to a final order under section 515(b) of the FD&C Act, this document will refer only to the requirement for the filing of, and obtaining approval of, a PMA.

    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA amended section 513(e) of the FD&C Act, changing the process for reclassifying a device from rulemaking to an administrative order. Section 608(b) of FDASIA amended section 515(b) of the FD&C Act, changing the process for requiring premarket approval for a preamendments class III device from rulemaking to an administrative order.

    FDA is requiring PMAs for total metal-on-metal (MoM) semi-constrained hip joint systems (heretofore referenced as “MoM hips”), which include the following two specific preamendments class III devices: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

    Section 515(b)(1) of the FD&C Act sets forth the process for issuing a final order. Specifically, prior to the issuance of a final order requiring premarket approval for a preamendments class III device, the following must occur: (1) Publication of a proposed order in the Federal Register; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act; and (3) consideration of comments from all affected stakeholders, including patients, payors, and providers. FDA published a proposed order to require PMAs for MoM hips in the Federal Register of January 18, 2013 (78 FR 4094), and convened a meeting of a device classification panel for MoM hips as discussed in the proposed order and in this document.

    Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification panel described in section 513(b) of the FD&C Act, issue a final order to require premarket approval or publish a document terminating the proceeding together with the reasons for such termination.

    A preamendments class III device may be commercially distributed without a PMA until 90 days after FDA issues a final order (a final rule issued under section 515(b) of the FD&C Act prior to the enactment of FDASIA is considered to be a final order for purposes of section 501(f) of the FD&C Act (21 U.S.C. 351(f))) requiring premarket approval for the device, or 30 months after final classification of the device under section 513 of the FD&C Act, whichever is later. For MoM hips, the later of these two time periods is the 90-day period. Therefore, section 501(f)(2)(B) of the FD&C Act requires that a PMA for such devices be filed within 90 days of the date of issuance of this final order. If a PMA is not filed for such devices within 90 days after the issuance of this final order, the devices will be deemed adulterated under section 501(f) of the FD&C Act.

    Also, a preamendments device subject to the order process under section 515(b) of the FD&C Act is not required to have an approved investigational device exemption (IDE) (see part 812 (21 CFR part 812)) contemporaneous with its interstate distribution until the date identified by FDA in the final order, requiring the filing of a PMA for the device. At that time, an IDE is required only if a PMA has not been filed. If the manufacturer, importer, or other sponsor of the device submits an IDE application and FDA approves it, the device may be distributed for investigational use. If a PMA is not filed by the later of the two dates, and the device is not distributed for investigational use under an IDE, the device is deemed to be adulterated within the meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure and condemnation under section 304 of the FD&C Act (21 U.S.C. 334), if its distribution continues. Other enforcement actions include, but are not limited to, the following: Shipment of devices in interstate commerce may be subject to injunction under section 302 of the FD&C Act (21 U.S.C. 332), and the individuals responsible for such shipment may be subject to prosecution under section 303 of the FD&C Act (21 U.S.C. 333).

    FDA held a meeting of a device classification panel described in section 513(b) of the FD&C Act with respect to MoM hips on August 8, 2001, and therefore, has met this requirement under section 515(b)(1) of the FD&C Act. The panel recommended that the devices remain in class III because there was insufficient information to establish special controls; the panel also agreed unanimously that MoM hips are for a use which is of substantial importance in preventing impairment of human health (Ref. 1). FDA is not aware of new information that would provide a basis for a different recommendation or findings, and the recent reports and evaluations discussed in the proposed order further support that reclassification of MoM hips is not appropriate. Furthermore, the problems identified in the medical device reporting systems and recalls for MoM hips further indicate the need to review these devices under a PMA to provide reasonable assurance of their safety and effectiveness.

    FDA received and has considered several sets of comments from nine commenters on the proposed order, as discussed in section II.

    II. Public Comments in Response to the Proposed Order

    In response to the January 18, 2013 (78 FR 4094), proposed order to require premarket approval for MoM hips, FDA received several sets of comments from nine commenters. These comments, as well as the Agency's consideration of them, are summarized further in this section.

    Six commenters generally agreed with FDA's proposal to require PMAs for MoM hips. One commenter (the American Academy of Orthopaedic Surgeons, also referred to as AAOS) stated that the existing data is not adequate to support reclassification of MoM hips because special controls could not be established to provide a reasonable assurance of device safety and effectiveness. This comment echoes the findings and recommendations of the August 8, 2001, panel.

    Another commenter stated that MoM hip resurfacing devices should be classified as Class III; however, MoM hip resurfacing devices are not regulated under 21 CFR 888.3320 or 21 CFR 888.3330 and are not the subject of this order.

    Several commenters requested that all currently marketed MoM hips be removed from the market, either through a FDA-initiated recall or voluntary action by the device manufacturer.

    As explained in more detail in section III of this order, if a PMA for a currently marketed MoM hip is not filed on or before the 90th day past the effective date of this order, that device will be deemed adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial distribution of the device must cease immediately. FDA intends to take appropriate action to ensure compliance with the 90-day deadline for the submission of PMAs. The Agency believes this information adequately addresses the commenters' concern.

    One commenter recommended standardizing the modularity and other design features of MoM hips to mitigate adverse events attributed to the manufacturing process for these devices. The Agency does not believe sufficient information exists to establish any manufacturing standards or specific technical specifications for MoM hips that could potentially be generalized for this technology to mitigate adverse events.

    One commenter requested that the Agency set revision surgery standards. Revision surgery involves a complex clinical decision that falls within the practice of medicine, which FDA generally does not regulate. In addition, insufficient information exists to establish any standards for revision surgery. FDA notes, however, that the American Association of Hip and Knee Surgeons, the American Academy of Orthopaedic Surgeons, and the Hip Society issued a consensus statement regarding assessment of risks in patients implanted with MoM hips, including factors to consider for revision surgery, based on currently available information (Ref. 2). FDA's Web site for MoM hips also provides some general considerations regarding revision surgery (Ref. 3).

    One commenter requested that MoM hips not be used in women, including those of child-bearing age, and children who are still growing (i.e., skeletally immature). As noted in the proposed order and as presented during the June 27-28, 2012, panel meeting, labeling for MoM hips includes warnings or contraindications for skeletally immature patients and patients who are pregnant or who may become pregnant (Ref. 4). In addition, the Agency will review all data included in the required PMA for a MoM hip to determine what information needs to be included in the device labeling to assure its safe and effective use, including any warnings and contraindications. The removal of any current contraindications for these patient populations would need to be supported by valid scientific evidence, in accordance with 21 CFR 860.7.

    One commenter requested the adoption of standards for metal ion levels in the serum of patients implanted with a MoM hip. As discussed in detail during the June 28, 2012, panel meeting, there are challenges to implementing metal ion testing into clinical evaluations of patients treated with MoM hips, as well as challenges in the interpretation of metal ion testing results (Ref. 5). For example, the equipment and expertise required to conduct such testing are currently not widely available in health care facilities. In addition, there can be significant variability in test results, based on a number of factors, including the laboratory conducting the testing (inter-laboratory variability) and the specific MoM hip implanted in the patient. Further, insufficient information exists to establish a definitive correlation between metal ion levels and clinical outcomes. Therefore, the Agency does not believe such standards can be adequately developed at this time. Nonetheless, the Agency acknowledges the importance of using metal ion levels within the overall clinical assessment of patients implanted with MoM hips. On May 6, 2011, under section 522 of the FD&C Act (21 U.S.C. 360l), FDA ordered manufacturers of MoM hips to conduct postmarket surveillance studies of these devices. As part of these studies, manufacturers are required to study the effects of metal ion concentrations in the bloodstream. The Agency will use the data from these studies to determine if any additional recommendations can be developed with respect to metal ion levels.

    One commenter stated that FDA should affirmatively assert that common law liability claims relating to MoM hips that are included under this final order, which were cleared through the 510(k) process before the effective date of this final order, should not be preempted under section 521 of the FD&C Act (21 U.S.C. 360k). Section 521 of the FD&C Act includes an express preemption provision that preempts certain state requirements that are “different from, or in addition to” certain Federal requirements applicable to devices. Two Supreme Court cases: Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), address the scope of this provision. In Lohr, the Court held that design defect, manufacturing, and failure to warn claims relating to a 510(k)-cleared device were not preempted because there were no Federal “requirements” imposed by the 510(k) review where (1) the device could “take any particular form for any particular reason,” and (2) the general Federal manufacturing and labeling requirements were not specific to the device in question. Id. at 493, 497-502. In contrast, the Court determined in Riegel that the PMA review imposed Federal “requirements” under section 521 of the FD&C Act because FDA required that the PMA-approved device be made with almost no deviations from the specifications in the approved PMA. 552 U.S. at 323. The Riegel Court went on to hold that the Riegels' common law claims were preempted where New York law imposed requirements on the PMA-approved device that were “different from, or in addition to” the Federal requirements. Id. at 327-330. As seen in these cases, the preemption analysis under section 521 of the FD&C Act depends on whether “requirements” imposed by State law are different from or in addition to “requirements” imposed by Federal law. This determination involves resolution of a number of critical factual issues, including identifying the applicable State and Federal (if any) requirements that relate to the claims asserted, defining the scope of those requirements, and evaluating their relationship to one another. Although Lohr may be relevant to the situation described in the comment, FDA notes that the inquiry into preemption needs to consider the context and all relevant facts. The situation described in the comment is fairly generalized, and as such, FDA believes it would not be helpful to opine on this issue at this point in time.

    Finally, several comments recommended actions that address broader issues or programmatic areas, such as changes to the postmarket surveillance process for all class III medical devices, recommendations for research studies, and the establishment of a “trust fund” for healthcare reimbursement of failed MoM hips. These requests are outside the scope of the regulatory actions described in this order.

    III. The Final Order

    Under section 515(b)(3) of the FD&C Act, FDA is adopting its findings as published in the proposed order (78 FR 4094), and is issuing this final order to require the filing of a PMA for MoM hips, which specifically includes the following two device types: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. This final order will revise 21 CFR part 888.

    Under the final order, a PMA is required to be filed on or before May 18, 2016, for any of these preamendments class III devices that were in commercial distribution before May 28, 1976, or that has been found by FDA to be substantially equivalent to such a device on or before May 18, 2016. An applicant of a device subject to this order that was legally in commercial distribution before May 28, 1976, or that has been found to be substantially equivalent to a device that was legally in commercial distribution before May 28, 1976, may continue marketing such class III device during FDA's review of the PMA provided that the PMA is filed on or before May 18, 2016. However, if FDA denies approval of the PMA, then the device will be deemed adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial distribution of the device must cease immediately. Any other device subject to this order is required to have an approved PMA in effect before it may be marketed. FDA intends to review any PMA for the device within 180 days, and any notice of completion of a PDP for the device within 90 days of the date of filing. FDA cautions that under section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an agreement to extend the review period for a PMA beyond 180 days unless the Agency finds that “the continued availability of the device is necessary for the public health.”

    If a PMA for any of the preamendments class III devices subject to this order is not filed on or before May 18, 2016, that device will be deemed adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial distribution of the device must cease immediately. FDA requests that manufacturers take action to prevent the further use of MoM hips for which no PMA has been filed.

    The device may, however, be distributed for investigational use, if the applicable requirements of the IDE regulations (part 812), including obtaining IDE approval, are met on or before 90 days after the effective date of this order. There will be no extended period for filing an IDE or exemption from the IDE requirements (see § 812.2(d)), and clinical studies may not be initiated without appropriate IDE approvals, as required.

    IV. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) 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.

    V. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of information found in FDA regulations. These collections of information 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 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, subpart B, have been approved under OMB control number 0910-0231; and the collections of information under 21 CFR part 801 have been approved under OMB control number 0910-0485.

    VI. Codification of Orders

    Prior to the amendments by FDASIA, section 515(b) of the FD&C Act provided for FDA to issue regulations to require approval of an application for premarket approval for preamendments devices or devices found substantially equivalent to preamendments devices. Section 515(b) of the FD&C Act, as amended by FDASIA, provides for FDA to require approval of an application for premarket approval for such devices by issuing a final order following the issuance of a proposed order in the Federal Register. FDA will continue to codify the requirement for an application for premarket approval in the Code of Federal Regulations (CFR). Therefore, under section 515(b)(1) of the FD&C Act, as amended by FDASIA, in this final order, FDA is requiring approval of an application for premarket approval for total MoM semi-constrained hip joint systems, which include the following two specific preamendments class III devices: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis; and the Agency is making the language in 21 CFR 888.3320 and 888.3330 consistent with this final order.

    VII. 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. FDA, Orthopaedic and Rehabilitation Devices Panel transcript, August 8, 2001. Available at http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3780t1.rtf. 2. Kwon et al. “Risk Stratification Algorithm for Management of Patients with Metal-on-Metal Hip Arthroplasty.” Journal of Bone and Joint Surgery, American Volume, 96:e4, 2014. 3. FDA, Metal-on-Metal Hip Implants Web site, Information for Orthopaedic Surgeons. Available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241667.htm. 4. FDA, Orthopaedic and Rehabilitation Devices Panel, FDA Executive Summary, June 27-28, 2012. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309302.pdf. 5. FDA, Orthopaedic and Rehabilitation Devices Panel transcript, June 28, 2012. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM313605.pdf. List of Subjects in 21 CFR Part 888

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 888 is amended as follows:

    PART 888—ORTHOPEDIC DEVICES 1. The authority citation for 21 CFR part 888 continues to read as follows: Authority:

    21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 888.3320 is amended by revising paragraph (c) to read as follows:
    § 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.

    (c) Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with a cemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

    3. Section 888.3330 is amended by revising paragraph (c) to read as follows:
    § 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

    (c) Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

    Dated: February 11, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-03331 Filed 2-17-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9750] RIN 1545-BM59 Reporting of Original Issue Discount on Tax-Exempt Obligations; Basis and Transfer Reporting by Securities Brokers for Debt Instruments and Options AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Final regulations.

    SUMMARY:

    This document contains final regulations relating to information reporting by brokers for transactions involving debt instruments and options, including the reporting of original issue discount (OID) on tax-exempt obligations, the treatment of certain holder elections for reporting a taxpayer's adjusted basis in a debt instrument, and transfer reporting for section 1256 options and debt instruments. The regulations in this document provide guidance to brokers and payors and to their customers.

    DATES:

    Effective date: These regulations are effective on February 18, 2016.

    Applicability dates: For the dates of applicability, see §§ 1.6045-1(n)(11)(i)(A), 1.6045-1(n)(11)(i)(B), 1.6045-1(n)(12)(ii), 1.6045A-1(b)(3)(x), 1.6045A-1(b)(4)(iv), and 1.6049-10(c).

    FOR FURTHER INFORMATION CONTACT:

    Pamela Lew of the Office of the Associate Chief Counsel (Financial Institutions and Products) at (202) 317-7053 (not a toll-free number).

    SUPPLEMENTARY INFORMATION: Paperwork Reduction Act

    The collection of information contained in §§ 1.6045-1(n) and 1.6045A-1(b) of these final regulations has been reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) under control number 1545-2186. The collection of information is required to comply with the provisions of section 403 of the Energy Improvement and Extension Act of 2008, Division B of Public Law 110-343 (122 Stat. 3765, 3854 (2008)) (the Act). The information required under § 1.6045-1(n) minimizes the need for reconciliation between information reported by a broker to both a customer and the IRS and the amounts reported on the customer's tax return. The information required under § 1.6045A-1 is necessary to allow brokers that effect sales of transferred section 1256 options and debt instruments that are covered securities to determine and report the adjusted basis of these securities in compliance with section 6045(g) of the Internal Revenue Code (Code). The burden for the collection of information contained in § 1.6049-10 of these final regulations will be reflected in the burden for Form 1099-OID, Original Issue Discount (OMB control number 1545-0117), when it is revised to request the additional information in the regulations. This information is required to enable the IRS to verify that a taxpayer is reporting the correct amount of tax-exempt interest each year for alternative minimum tax and other purposes. In addition, because this information is used to determine a taxpayer's adjusted basis in a debt instrument for purposes of section 6045(g), this information is required to enable the IRS to verify that a taxpayer is reporting the correct amount of gain or loss upon the sale of a tax-exempt obligation.

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the Office of Management and Budget.

    Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by section 6103.

    Background

    Section 6045 generally requires a broker to report gross proceeds upon the sale of a security. Section 6045 was amended by section 403 of the Act to require the reporting of adjusted basis for a covered security and whether any gain or loss upon the sale of the security is long-term or short-term. In addition, the Act added section 6045A of the Code, which requires certain information to be reported in connection with a transfer of a covered security to another broker, and section 6045B of the Code, which requires an issuer of a specified security to file a return relating to certain actions that affect the basis of the security. Section 6049 requires the reporting of interest payments (including accruals of OID treated as payments).

    On November 25, 2011, the Treasury Department and the IRS published in the Federal Register proposed regulations relating to information reporting by brokers, transferors, and issuers of securities under sections 6045, 6045A, and 6045B for debt instruments, options, and securities futures contracts (REG-102988-11 at 76 FR 72652) (the 2011 proposed basis reporting regulations). On April 18, 2013, the Treasury Department and the IRS published in the Federal Register final regulations under sections 6045, 6045A, and 6045B (the 2013 final basis reporting regulations) and temporary regulations relating to information reporting for bond premium and acquisition premium under section 6049 (TD 9616 at 78 FR 23116) (the 2013 temporary interest reporting regulations). A notice of proposed rulemaking cross-referencing the 2013 temporary interest reporting regulations also was published in the Federal Register on April 18, 2013 (REG-154563-12 at 78 FR 23183) (the 2013 proposed interest reporting regulations).

    On March 13, 2015, the Treasury Department and the IRS published in the Federal Register final regulations under sections 6045, 6045A, and 6049 (TD 9713 at 80 FR 13233) (the 2015 final basis reporting regulations, and, together with the 2013 final basis reporting regulations, the final basis reporting regulations). A number of commenters on the 2013 final basis reporting regulations requested changes to the basis reporting rules relating to certain debt elections. In addition, for purposes of section 6045A, several commenters requested that a transferring broker provide additional information on the transfer statement for a debt instrument and that a transferring broker provide a transfer statement for a section 1256 option contract. Several commenters also suggested that the rules for reporting OID associated with a tax-exempt obligation be conformed to the rules regarding basis reporting for those debt instruments. Accordingly, TD 9713 also included temporary regulations relating to information reporting for debt instruments under sections 6045, 6045A, and 6049 (the 2015 temporary reporting regulations). A notice of proposed rulemaking cross-referencing the 2015 temporary reporting regulations was published in the Federal Register on March 13, 2015 (REG-143040-14 at 80 FR 13292) (the 2015 proposed reporting regulations). A correction to § 1.6045A-1T(f) was published on June 5, 2015 (TD 9713 at 80 FR 31995), delaying the effective date of § 1.6045A-1T(f) from June 30, 2015, to January 1, 2016.

    Written comments were received on the 2015 proposed reporting regulations and are summarized below. No public hearing was requested or held. In general, these final regulations adopt the provisions of the 2015 proposed reporting regulations. These final regulations also remove the corresponding 2015 temporary reporting regulations.

    After the publication of the 2015 final basis reporting regulations, the Treasury Department and the IRS received written comments on certain provisions of the final basis reporting regulations. In response to these comments, this document contains final regulations under section 6045 relating to the treatment of certain debt instruments as non-covered securities.

    The written comments on the 2015 proposed reporting regulations and the 2015 final basis reporting regulations are available for public inspection at http://www.regulations.gov or upon request.

    Explanation of Provisions A. Constant Yield Election for Accruals of Market Discount

    Under section 1276(b)(2), a customer may elect to accrue market discount on a constant yield method rather than a ratable method. The election may be made on a debt instrument by debt instrument basis and must be made for the earliest taxable year for which the customer is required to determine accrued market discount. The election may not be revoked once it has been made. In most cases, the use of a constant yield method backloads market discount and is therefore more taxpayer favorable than the use of a ratable method.

    In response to comments on the 2013 final basis reporting regulations (which required the broker to assume that the customer had not made a constant yield election), § 1.6045-1T(n)(11)(i)(B) of the 2015 temporary reporting regulations provided that for a debt instrument acquired on or after January 1, 2015, brokers are required to assume that a customer has elected to determine accrued market discount using a constant yield method unless the customer notifies the broker otherwise. A customer that does not want to use a constant yield method to determine accrued market discount must, by the end of the calendar year in which the customer acquired the debt instrument in an account with the broker, notify the broker in writing that the customer wants the broker to use the ratable method to determine accrued market discount.

    No comments were received on the substantive rules in § 1.6045-1T(n)(11)(i)(B). Accordingly, the rules in the final regulations in this document are the same as the rules in § 1.6045-1T(n)(11)(i)(B). Several commenters requested permission to apply the default constant yield method to debt instruments acquired on or after January 1, 2014, which was the first date for which a broker was required to report accrued market discount under section 6045, provided that the broker had not reported accrued market discount to a customer for the 2014 calendar year using the ratable method. According to the commenters, the use of a single method to compute market discount accruals for all covered securities with market discount would simplify the calculation of accrued market discount and the reporting of this information to their customers.

    The final regulations in this document permit, but do not require, a broker to apply the default constant yield method to a debt instrument acquired on or after January 1, 2014, and before January 1, 2015, provided the broker was not informed that the customer had made a section 1278(b) election (the election to include market discount in income as it accrues rather than upon a disposition or receipt of a partial principal payment), there were no principal payments on the debt instrument during the 2014 calendar year, and the broker therefore had not reported accrued market discount to the customer for the 2014 calendar year using the ratable method.

    B. Transfer Statements

    Under § 1.6045A-1T(e) of the 2015 temporary reporting regulations, a transferring broker is required to provide a transfer statement upon the transfer of a section 1256 option to ensure that the receiving broker has all of the information required for purposes of section 6045. The temporary regulations provide that a transfer statement is required for the transfer of a section 1256 option that occurs on or after January 1, 2016. The temporary regulations also list the data specific to section 1256 options that must be provided.

    One commenter asserted that including the fair market value information on a transfer statement for a section 1256 option is unnecessary because the receiving broker can look up the information if it is needed and suggested saving space on the transfer statement by eliminating this data item. After considering the suggestion, the Treasury Department and IRS decline to adopt this suggestion. Providing fair market value information on a transfer statement will help ensure that the receiving broker is reporting an amount of realized but unrecognized gain or loss from the prior year that is consistent with the amount reported in the prior year by the transferring broker, which will minimize the possibility of double counting or omission of gain or loss.

    No other comments were received on § 1.6045A-1T of the 2015 temporary reporting regulations. The rules in the final regulations in this document are substantively the same as the rules in the 2015 temporary regulations. However, the rules in § 1.6045A-1T(e) are in § 1.6045A-1(b)(4)(iv) of the final regulations in this document and the rules in § 1.6045A-1T(f) are in § 1.6045A-1(b)(3)(x) of the final regulations in this document.

    C. Reporting of OID on a Tax-Exempt Obligation

    To coordinate the reporting of OID under section 6049 with the reporting of basis for tax-exempt obligations under section 6045, § 1.6049-10T of the 2015 temporary reporting regulations provides that a payor must report under section 6049 the daily portions of OID on a tax-exempt obligation. The daily portions of OID are determined as if section 1272 and § 1.1272-1 applied to a tax-exempt obligation. A payor must determine whether a tax-exempt obligation was issued with OID and the amount that accrues for each relevant period. In addition, OID on a tax-exempt obligation is determined without regard to the de minimis rule in section 1273(a)(3) and § 1.1273-1(d). Because the temporary regulations require the reporting of OID, payors also must report amortized acquisition premium (which offsets OID) on a tax-exempt obligation. A broker may report either a gross amount for both OID and amortized acquisition premium, or a net amount of OID that reflects the offset of the OID by the amount of amortized acquisition premium allocable to the OID. Section 1.6049-10T of the 2015 temporary reporting regulations applies to a tax-exempt obligation acquired on or after January 1, 2017.

    No comments were received on the substantive rules in § 1.6049-10T. Accordingly, the rules in the final regulations in this document are the same as the rules in § 1.6049-10T. However, several commenters requested that, for taxable years beginning after December 31, 2016, a broker be permitted to report on Form 1099-OID the OID and acquisition premium on a tax-exempt obligation that is a covered security acquired before January 1, 2017. According to the commenters, customers might be confused because of the difference between the date that a tax-exempt obligation generally became a covered security (that is, an obligation acquired on or after January 1, 2014), and the date after which a tax-exempt obligation that is a covered security becomes subject to mandatory reporting of OID and acquisition premium (that is, an obligation acquired on or after January 1, 2017). Because a broker is required to track basis for a tax-exempt obligation that is a covered security for purposes of section 6045, the broker is responsible for calculating OID on a tax-exempt obligation acquired on or after January 1, 2014, even if the broker has no obligation to report the obligation's OID to the customer for purposes of section 6049. To simplify the reporting of OID and acquisition premium and to minimize any customer confusion, the commenters requested that the final regulations permit a broker to report OID and acquisition discount on all tax-exempt bonds that are covered securities.

    After considering the requests, for taxable years beginning after December 31, 2016, the final regulations in this document permit, but do not require, a broker to report OID and acquisition discount for a tax-exempt obligation that is a covered security acquired before January 1, 2017.

    D. Treatment of Certain Debt Instruments Subject to January 1, 2016, Reporting

    Under § 1.6045-1(n)(3) of the 2013 final basis reporting regulations, certain debt instruments are subject to basis reporting only if the debt instrument is acquired by a customer on or after January 1, 2016. For example, § 1.6045-1(n)(3) applies to a contingent payment debt instrument, a debt instrument that is not issued by a U.S. issuer, and a debt instrument the terms of which are not reasonably available to a broker within 90 days of acquisition of the debt instrument by the customer.

    Several commenters on the 2013 final basis reporting regulations requested guidance for a debt instrument the terms of which are not reasonably available to the broker. The commenters stated that they would not have the information necessary to comply with the information reporting rules for these instruments. Several commenters stated that information for a debt instrument issued by a non-U.S. issuer and for a tax-exempt obligation is particularly difficult to obtain. One commenter noted that under SEC Release 34-67908, issued on September 21, 2012 (77 FR 59427), issuers of municipal securities are required to provide certain data to the Electronic Municipal Market Access system set up by the Municipal Securities Rulemaking Board for new issuances, but there is no requirement to file similar information for issuances already outstanding as of the November 1, 2012, effective date of the release.

    The Treasury Department and the IRS agree that a broker may not always be able to obtain information for a debt instrument issued by a non-U.S. issuer or for a tax-exempt obligation issued before January 1, 2014. The final regulations in this document therefore provide that a debt instrument issued by a non-U.S. issuer or a tax-exempt obligation issued before January 1, 2014, is treated as a noncovered security (and, therefore, is not subject to basis reporting under section 6045) if the terms of the debt instrument are not reasonably available to the broker within 90 days of the date the debt instrument was acquired by the customer. The Treasury Department and the IRS believe that the information necessary for section 6045 compliance should be available for other debt instruments.

    Applicability Dates

    The final regulations under section 6045 in this document (other than § 1.6045-1(n)(12)) apply to a debt instrument acquired on or after January 1, 2015. Section 1.6045-1(n)(12) applies to a debt instrument acquired on or after February 18, 2016. The final regulations under section 6049 in this document apply to a tax-exempt obligation that is a covered security acquired on or after January 1, 2017. The final regulations under section 6045A in this document apply to a transfer of a section 1256 option that occurs on or after January 1, 2016, and to a transfer of a debt instrument that occurs on or after January 1, 2016.

    Special Analyses

    Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations.

    It is hereby certified that the final regulations in this document will not have a significant economic impact on a substantial number of small entities. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. It is anticipated that the requirements in the final regulations in this document, except in the case of the notification by a customer discussed in the next paragraph, will fall only on financial services firms with annual receipts greater than the $38.5 million threshold and, therefore, on no small entities.

    Section 403(a) of the Act requires a broker to report the adjusted basis of a debt instrument that is a covered security. Although a holder of a debt instrument (customer) is permitted to make a number of elections that affect how basis is computed, a broker only is required to take into account specified elections in reporting the adjusted basis of a debt instrument, including the election under section 1276(b)(2) to determine accruals of market discount on a constant yield method. Under the 2013 final basis reporting regulations, a customer was required to notify the broker that the customer had made the section 1276(b)(2) election. However, § 1.6045-1(n)(11)(i)(B) requires a broker to take into account the election under section 1276(b)(2) in reporting a debt instrument's adjusted basis unless the customer timely notifies the broker that the customer has not made the election. The notification must be in writing, which includes a writing in electronic format. In most cases, this election results in a more taxpayer-favorable result than the default ratable method. It is anticipated that this collection of information in the regulations will not fall on a substantial number of small entities, especially because fewer customers will need to notify brokers about the election. Further, the regulations implement the statutory requirements for reporting adjusted basis under section 403 of the Act. Moreover, any economic impact is expected to be minimal because it should take a customer no more than seven minutes to satisfy the information-sharing requirement in these regulations.

    Section 403(c) of the Act added section 6045A, which requires applicable persons to provide a transfer statement in connection with the transfer of custody of a covered security. Section 1.6045A-1 effectuates the Act by giving the broker who receives the transfer statement the information necessary to determine and report adjusted basis and whether any gain or loss with respect to a debt instrument or section 1256 option is long-term or short-term as required by section 6045 when the security is subsequently sold. Consequently, § 1.6045A-1 does not add to the impact on small entities imposed by the statutory provisions. Instead, the regulations limit the information to be reported to only those items necessary to effectuate the statutory scheme.

    The information required under § 1.6049-10 will enable the IRS to verify that a taxpayer is reporting the correct amount of tax-exempt interest each year for alternative minimum tax and other purposes. In addition, because this information is used to determine a taxpayer's adjusted basis in a debt instrument for purposes of section 6045(g), this information is required to enable the IRS to verify that a taxpayer is reporting the correct amount of gain or loss upon the sale of a tax-exempt obligation. Any economic impact on small entities is expected to be minimal because a broker already is required to determine the accruals of OID and acquisition premium for purposes of determining and reporting a customer's adjusted basis on Form 1099-B under section 6045. Moreover, any effect on small entities of the rules in the final regulations flows from section 6049 and section 403 of the Act.

    Therefore, because the final regulations in this document will not have a significant economic impact on a substantial number of small entities, a regulatory flexibility analysis is not required.

    Pursuant to section 7805(f) of the Internal Revenue Code, the proposed regulations preceding the final regulations in this document were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small businesses. No comments were received.

    Drafting Information

    The principal author of these regulations is Pamela Lew, Office of Associate Chief Counsel (Financial Institutions and Products). However, other personnel from the Treasury Department and the IRS participated in their development.

    List of Subjects in 26 CFR Part 1

    Income taxes, Reporting and recordkeeping requirements.

    Adoption of Amendments to the Regulations

    Accordingly, 26 CFR part 1 is amended as follows:

    PART 1—INCOME TAXES Paragraph 1. The authority citation for part 1 is amended by removing the entries for §§ 1.6045A-1T and 1.6049-10T and adding an entry for § 1.6049-10 to read in part as follows: Authority:

    26 U.S.C. 7805 * * *

    Section 1.6049-10 also issued under 26 U.S.C. 6049(a). * * *

    Par. 2. Section 1.6045-1 is amended by: 1. Adding a sentence at the end of paragraph (n)(4) introductory text. 2. Revising the last sentence in paragraph (n)(4)(iv). 3. Revising the last sentence in paragraph (n)(5)(i). 4. Revising the second sentence in paragraph (n)(6)(i). 5. Adding a sentence at the end of paragraph (n)(6)(ii). 6. Revising the last sentence in paragraph (n)(7)(iii). 7. Revising “§ 1.6049-9T” to read “§ 1.6049-9” in two places in paragraph (n)(9). 8. Revising paragraph (n)(11). 9. Adding paragraph (n)(12).

    The revisions and additions read as follows:

    § 1.6045-1 Returns of information of brokers and barter exchanges.

    (n) * * *

    (4) * * * However, see paragraph (n)(11) of this section for the treatment of an election described in paragraph (n)(4)(iii) of this section (election to accrue market discount based on a constant yield) and an election described in paragraph (n)(4)(iv) of this section (election to treat all interest as OID).

    (iv) * * * However, see paragraph (n)(11)(i)(A) of this section for a debt instrument acquired on or after January 1, 2014.

    (5) * * *

    (i) * * * However, see paragraph (n)(11) of this section for the treatment of an election described in paragraph (n)(4)(iii) of this section (election to accrue market discount based on a constant yield) and an election described in paragraph (n)(4)(iv) of this section (election to treat all interest as OID).

    (6) * * *

    (i) * * * See paragraphs (n)(5) and (n)(11)(i)(B) of this section to determine whether the amount reported should take into account a customer election under section 1276(b)(2). * * *

    (ii) * * * See paragraphs (n)(5) and (n)(11)(i)(B) of this section to determine whether the amount reported should take into account a customer election under section 1276(b)(2).

    (7) * * *

    (iii) * * * However, if a broker took into account a customer election under § 1.1272-3 in 2014, the broker must decrease the customer's basis in the debt instrument by the amount of acquisition premium that is taken into account each year to reduce the amount of the original issue discount that is otherwise includible in the customer's income for that year in accordance with §§ 1.1272-2(b)(5) and 1.1272-3.

    (11) Additional rules for certain holder elections—(i) In general. For purposes of this section, the rules in this paragraph (n)(11) apply notwithstanding any other rule in paragraph (n) of this section.

    (A) Election to treat all interest as OID. A broker must report the information required under paragraph (d) of this section without taking into account any election described in paragraph (n)(4)(iv) of this section (the election to treat all interest as OID in § 1.1272-3). As a result, for example, a broker must determine the amount of any acquisition premium taken into account each year for purposes of this section in accordance with § 1.1272-2(b)(4). This paragraph (n)(11)(i)(A) applies to a debt instrument acquired on or after January 1, 2015. A broker, however, may rely on this paragraph (n)(11)(i)(A) for a debt instrument acquired on or after January 1, 2014, and before January 1, 2015.

    (B) Election to accrue market discount based on a constant yield. A broker must report the information required under paragraph (d) of this section by assuming that a customer has made the election described in paragraph (n)(4)(iii) of this section (the election to accrue market discount based on a constant yield). However, if a customer notifies a broker in writing that the customer does not want the broker to take into account this election, the broker must report the information required under paragraph (d) of this section without taking into account this election. The customer must provide this notification to the broker by the end of the calendar year in which the customer acquired the debt instrument in an account with the broker. This paragraph (n)(11)(i)(B) applies to a debt instrument acquired on or after January 1, 2015. A broker, however, may rely on this paragraph (n)(11)(i)(B) to report accrued market discount for a debt instrument that is a covered security acquired on or after January 1, 2014, and before January 1, 2015, if the customer had not informed the broker that the customer had made a section 1278(b) election and there were no principal payments on the debt instrument during this period.

    (ii) [Reserved].

    (12) Certain debt instruments treated as noncovered securities—(i) In general. Notwithstanding paragraph (a)(15) of this section, a debt instrument is treated as a noncovered security for purposes of this section if the terms of the debt instrument are not reasonably available to the broker within 90 days of the date the debt instrument was acquired by the customer and the debt instrument is either—

    (A) A debt instrument issued by a non-U.S. issuer; or

    (B) A tax-exempt obligation issued before January 1, 2014.

    (ii) Effective/applicability date. Paragraph (n)(12)(i) of this section applies to a debt instrument described in paragraph (n)(12)(i)(A) or (B) of this section that is acquired on or after February 18, 2016. However, a broker may rely on paragraph (n)(12)(i) of this section for a debt instrument described in paragraph (n)(12)(i)(A) or (B) of this section acquired before February 18, 2016.

    Par. 3. Section 1.6045-1T is amended by revising paragraphs (h) through (p) to read as follows:
    § 1.6045-1T Returns of information of brokers and barter exchanges (temporary).

    (h) through (p) [Reserved]. For further guidance, see § 1.6045-1(h) through (p).

    Par. 4. Section 1.6045A-1 is amended by: 1. Removing “and” at the end of paragraph (b)(3)(viii), removing the period at the end of paragraph (b)(3)(ix) and adding “and;” in its place, and adding paragraph (b)(3)(x). 2. Removing “and” at the end of paragraph (b)(4)(ii), removing the period at the end of paragraph (b)(4)(iii) and adding “and;” in its place, and adding paragraph (b)(4)(iv). 3. Removing paragraphs (e) and (f).

    The additions read as follows:

    § 1.6045A-1 Statements of information required in connection with transfers of securities.

    (b) * * *

    (3) * * *

    (x) For a transfer that occurs on or after January 1, 2016, the last date on or before the transfer date that the transferor made an adjustment for a particular item (for example, the last date on or before the transfer date that bond premium was amortized). A broker, however, may rely on this paragraph (b)(3)(x) for a transfer of a covered security that occurs on or after June 30, 2015, and before January 1, 2016.

    (4) * * *

    (iv) For a transfer of an option described in § 1.6045-1(m)(3) (section 1256 option) that occurs on or after January 1, 2016, the original basis of the option and the fair market value of the option as of the end of the prior calendar year.

    § 1.6045A-1T [Removed]
    Par. 5. Section 1.6045A-1T is removed.
    Par. 6. Section 1.6049-10 is added to read as follows:
    § 1.6049-10 Reporting of original issue discount on a tax-exempt obligation.

    (a) In general. For purposes of section 6049, a payor (as defined in § 1.6049-4(a)(2)) of original issue discount (OID) on a tax-exempt obligation (as defined in section 1288(b)(2)) is required to report the daily portions of OID on the obligation as if the daily portions of OID that accrued during a calendar year were paid to the holder (or holders) of the obligation in the calendar year. The amount of the daily portions of OID that accrues during a calendar year is determined as if section 1272 and § 1.1272-1 applied to a tax-exempt obligation. Notwithstanding any other rule in section 6049 and the regulations thereunder, a payor must determine whether a tax-exempt obligation was issued with OID and the amount of OID that accrues for each relevant period. As prescribed by section 1288(b)(1), OID on a tax-exempt obligation is determined without regard to the de minimis rules in section 1273(a)(3) and § 1.1273-1(d).

    (b) Acquisition premium. A payor is required to report acquisition premium amortization on a tax-exempt obligation in accordance with the rules in § 1.6049-9(c) as if section 1272 applied to a tax-exempt obligation. See paragraph (a) of this section to determine the amount of OID allocable to an accrual period.

    (c) Effective/applicability date. This section applies to a tax-exempt obligation that is a covered security (within the meaning of § 1.6045-1(a)(15) and (n)(12)) acquired on or after January 1, 2017. For a taxable year beginning after December 31, 2016, a broker, however, may rely on this section to report OID and acquisition premium for a tax-exempt obligation that is a covered security acquired before January 1, 2017.

    § 1.6049-10T [Removed]
    Par. 7. Section 1.6049-10T is removed.
    John Dalrymple, Deputy Commissioner for Services and Enforcement. Approved: January 13, 2016. Mark J. Mazur, Assistant Secretary of the Treasury (Tax Policy).
    [FR Doc. 2016-03429 Filed 2-17-16; 8:45 am] BILLING CODE 4830-01-P
    81 32 Thursday, February 18, 2016 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-0466; Directorate Identifier 2014-NM-188-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Airbus Model A300 B4-603, B4-605R, and B4-622R airplanes; and Model A310-304, -324, and -325 airplanes. This proposed AD was prompted by a report of a crack found on door frame (FR) 73A between stringers 24 and 25. This proposed AD would require inspections around the rivet heads of the seal retainer run-out holes at certain frames and corrective actions if necessary. We are proposing this AD to detect and correct cracking of the door frame, which could result in reduced structural integrity of the airplane.

    DATES:

    We must receive comments on this proposed AD by April 4, 2016.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Airbus SAS, Airworthiness Office—EAW, 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.

    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-2016-0466; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    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 proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-0466; Directorate Identifier 2014-NM-188-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

    Discussion

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2014-0202R1, dated September 19, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A300 B4-603, B4-605R, and B4-622R airplanes; and Model A310-304, -324, and -325 airplanes The MCAI states:

    During the preparation phase for conversion of an A300-600 aeroplane from passenger to freighter configuration, a crack was detected on door frame (FR) 73A, between stringer (STRG) 24 and STRG 25.

    DGAC France had issued AD 1999-013-276R1 [http://ad.easa.europa.eu/ad/F-1999-013-276R1] to require inspections at FR 73A in accordance with the instructions of Airbus Service Bulletin (SB) A310-53-2107 or SB A300-53-6116, as applicable. However, the new crack was found in an area not covered by the existing inspection and is therefore addressed by this new [EASA] AD. (DGAC France AD 1999-013-276R1 remains in place).

    Further investigations identified that, on A300-600 aeroplanes, the areas at FR 56A and FR 57A have the same design and material as at FR 73A.

    This condition, if not detected and corrected, could affect the structural integrity of the airframe.

    For the reasons described above, this [EASA] AD requires repetitive [high frequency eddy current (HFEC)] inspections of the rivet heads of the seal retainer run out holes to detect cracks and, depending on findings, accomplishment of corrective actions [repair].

    Even though no crack has been identified at FR 56A and FR 57A, as a preventive measure, the inspection is extended to these areas. On A310 aeroplanes, only the area at FR 73A needs to be inspected.

    This [EASA] AD is revised to reduce the applicability to aeroplanes in post-MOD 06924 configuration.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-0466.

    Related Service Information Under 1 CFR Part 51

    Airbus has issued Service Bulletins A300-53-6175, and A310-53-2138, both dated May 28, 2014. The service information describes procedures to do HFEC inspections around the rivet heads of the seal retainer run-out holes at certain frame locations on the left-hand and right-hand sides. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

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

    Costs of Compliance

    We estimate that this proposed AD affects 24 airplanes of U.S. registry.

    We also estimate that it would take about 11 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $22,440, or $935 per product.

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

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Airbus: Docket No. FAA-2016-0466; Directorate Identifier 2014-NM-188-AD. (a) Comments Due Date

    We must receive comments by April 4, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Airbus Model A300B4-603, A300B4-605R, A300B4-622R, A310-304, A310-324, and A310-325 airplanes; certificated in any category; all manufacturer serial numbers (MSNs) in post-modification (MOD) 06924 configuration, except MSN 464, 477, 479, 481, 482, 483, 484, and 488.

    Note 1 to paragraph (c) of this AD:

    MSNs 464, 477, 479, 481, 482, 483, 484 and 488 partially embodied MOD 06924 by means of modification proposal D05902.

    (d) Subject

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

    (e) Reason

    This AD was prompted by a report of a crack found on door frame (FR) 73A between stringers 24 and 25. We are issuing this AD to detect and correct cracking, which could reduce the structural integrity of the airplane.

    (f) Compliance

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

    (g) Inspection

    At the later of the compliance times specified in paragraphs (g)(1) and (g)(2) of this AD: Do a high frequency eddy current (HFEC) inspection for any crack around the rivet heads of the seal retainer run-out holes at FR 56A, FR 57A, and FR 73A, left-hand (LH) and right-hand (RH) sides on Model A300-600 airplanes; and at FR 73A, LH and RH sides on Model A310 airplanes; in accordance with the Accomplishment Instructions of Airbus Service Bulletin A310-53-2138, dated May 28, 2014; or Airbus Service Bulletin A300-53-6175, dated May 28, 2014; as applicable. Repeat the HFEC inspection thereafter at intervals not to exceed 7,500 flight cycles.

    (1) Before the accumulation of 32,000 total flight cycles.

    (2) Within 36 months after the effective date of this AD, or before the accumulation of 36,000 total flight cycles, whichever occurs first.

    (h) Corrective Actions

    If any crack is found during any inspection required by paragraph (g) of this AD, repair before further flight 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).

    (i) 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: 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. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

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

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

    (j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2014-0202R1, dated September 19, 2014, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-0466.

    (2) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 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 service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on February 6, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-03135 Filed 2-17-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-3697; Directorate Identifier 2015-NM-143-AD] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to supersede Airworthiness Directive (AD) 2011-01-15, which applies to certain The Boeing Company Model 757-200, -200CB, and -300 series airplanes. AD 2011-01-15 currently requires repetitive inspections for cracking of the fuselage skin of the crown skin panel along the chem-milled step at stringers S-4L (left) and S-4R (right), from stations (STA) 297 through STA 439, and repair, if necessary. AD 2011-01-15 also includes terminating action for the repetitive inspections of the repaired areas only. Since we issued AD 2011-01-15, we received reports of the initiation of new fatigue cracking in the fuselage skin of the crown skin panel along locally thinned channels adjacent to the chem-milled steps. This proposed AD would add repetitive inspections for cracking in additional areas and repair if necessary. This proposed AD would also remove airplanes from the applicability in AD 2011-01-15. This proposed AD would also add an optional skin panel replacement which would terminate all inspections and an optional preventative modification that would terminate certain inspections. We are proposing this AD to detect and correct fatigue cracking of the fuselage skin of the crown skin panel, which could result in pressure venting and consequent rapid decompression of the airplane.

    DATES:

    We must receive comments on this proposed AD by April 4, 2016.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Data & Services Management, 3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001; telephone: 206-544-5000, extension 2; fax: 206-766-5683; Internet https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-3697.

    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-2016-3697; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Eric Schrieber, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5348; fax: 562-627-5210; email: [email protected]

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-3697; Directorate Identifier 2015-NM-143-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

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

    Discussion

    On December 28, 2010, we issued AD 2011-01-15, Amendment 39-16572 (76 FR 1351, January 10, 2011), for certain The Boeing Company Model 757-200, -200CB, and -300 series airplanes. AD 2011-01-15 requires repetitive inspections for cracking of the fuselage skin of the crown skin panel along the chem-milled step at stringers S-4L and S-4R, from stations (STA) 297 through STA 439, and repair if necessary. AD 2011-01-15 also includes terminating action for the repetitive inspections of the repaired areas only. AD 2011-01-15 resulted from reports of cracking in the fuselage skin of the crown skin panel. We issued AD 2011-01-15 to detect and correct fatigue cracking of the fuselage skin of the crown skin panel, which could result in pressure venting and consequent rapid decompression of the airplane.

    Actions Since AD 2011-01-15, Amendment 39-16572 (76 FR 1351, January 10, 2011), Was Issued

    The preamble to AD 2011-01-15, Amendment 39-16572 (76 FR 1351, January 10, 2011), specifies that we consider the requirements “interim action.” AD 2011-01-15 explains that we might consider further rulemaking if final action is later identified. We now have determined that it is necessary to initiate further rulemaking to add repetitive inspections for cracking in additional areas for certain airplanes, and repair if necessary.

    We have removed Model 757-200 CB series airplanes from the applicability because the crown skins on those airplanes are manufactured differently and therefore are not affected by the identified unsafe condition.

    We have also determined that the external detailed inspection that is allowed as an option in AD 2011-01-15, Amendment 39-16572 (76 FR 1351, January 12, 2011), does not adequately address the identified unsafe condition. Only eddy current inspections are adequate to address the identified unsafe condition.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. The service information describes procedures for repetitive external sliding probe eddy current (EC) and external spot-probe-medium-frequency EC inspections for cracking of the crown skin panel, repair, a preventive modification, and replacement of the crown skin panel. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination

    We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

    Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified in the service information described previously. For information on the procedures and compliance times, see this service information at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-3697.

    Explanation of “RC” Steps in Service Information

    The FAA worked in conjunction with industry, under the Airworthiness Directive Implementation Aviation Rulemaking Committee (ARC), to enhance the AD system. One enhancement was a new process for annotating which steps in the service information are required for compliance with an AD. Differentiating these steps from other tasks in the service information is expected to improve an owner's/operator's understanding of crucial AD requirements and help provide consistent judgment in AD compliance. The steps identified as RC (required for compliance) in any service information identified previously have a direct effect on detecting, preventing, resolving, or eliminating an identified unsafe condition.

    Costs of Compliance

    We estimate that this proposed AD affects 652 airplanes of U.S. registry.

    We estimate the following costs to comply with this proposed AD:

    Estimated Costs Action Labor cost Parts cost Cost per product Cost on U.S.
  • operators
  • Inspections (Zone 1) [Retained actions from AD 2011-01-15, Amendment 39-16572 (76 FR 1351, January 10, 2011)] 2 work-hour × $85 per hour = $170 per inspection cycle $0 $170 per inspection cycle $110,840 per inspection cycle. Inspections (Zones 2 and 3) [new proposed action] Up to 4 work-hours × $85 per hour = Up to $340 per inspection cycle $0 Up to $340 per inspection cycle $221,680 per inspection cycle. Optional modification Up to 615 work-hours × $85 per hour = Up to $52,275 Up to $26,496 Up to $78,771 Up to $51,358,692.

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

    We have received no definitive data that would enable us to provide a cost estimate for the optional replacement specified in this proposed AD.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by removing Airworthiness Directive (AD) 2011-01-15, Amendment 39-16572 (76 FR 1351, January 10, 2011), and adding the following new AD: The Boeing Company: Docket No. FAA-2016-3697; Directorate Identifier 2015-NM-143-AD. (a) Comments Due Date

    The FAA must receive comments on this AD action by April 4, 2016.

    (b) Affected ADs

    This AD replaces AD 2011-01-15, Amendment 39-16572 (76 FR 1351, January 10, 2011).

    (c) Applicability

    (c) This AD applies to The Boeing Company Model 757-200 and -300 series airplanes, certificated in any category, as identified in Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015.

    (d) Subject

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

    (e) Unsafe Condition

    This AD was prompted by reports of the initiation of fatigue cracking in the fuselage skin of the crown skin panel along locally thinned channels adjacent to the chem-milled steps. We are issuing this AD to detect and correct fatigue cracking of the fuselage skin of the crown skin panel, which could result in pressure venting and consequent rapid decompression of the airplane.

    (f) Compliance

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

    (g) Repetitive Inspections

    Do the applicable inspections required by paragraphs (g)(1), (g)(2), and (g)(3) of this AD.

    (1) For all airplanes: At the applicable time specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015: Do the inspection specified in paragraph (g)(1)(i) or (g)(1)(ii) of this AD in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. Repeat the inspection thereafter at the applicable times specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. Accomplishing the preventative modification specified in paragraph (j)(1) of this AD or the replacement specified in paragraph (j)(2) of this AD terminates the inspections required by this paragraph.

    (i) Do an external sliding probe eddy current (EC) inspection for cracking of the crown skin panel at stringers S-4L (left) and S-4R (right).

    (ii) Do an external spot-probe-medium-frequency EC inspection for cracking of the crown skin panel at stringers S-4L and S-4R.

    (2) For airplanes on which any crack is found during any inspection required by paragraph (g)(1) of this AD; or any repair is installed that covers the Zone 1 inspection area specified in Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015; or any preventive modification is installed as specified in Part 3 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015: At the applicable time specified in table 2 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015, except as required by paragraph (k)(1) of this AD: Do the inspection specified in paragraph (g)(2)(i) or (g)(2)(ii) of this AD, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. Repeat the inspection thereafter at the applicable times specified in table 2 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. Accomplishing the replacement specified in paragraph (j)(2) of this AD terminates the inspections required by this paragraph.

    (i) Do an external sliding probe EC inspection for cracking of the crown skin panel at stringers S-2L, S-3L, and S-3R, as applicable.

    (ii) Do an external spot-probe-medium-frequency EC inspection for cracking of the crown skin panel at stringers S-2L, S-3L, and S-3R, as applicable.

    (3) For airplanes on which any crack is found during any inspection required by paragraph (g)(1) of this AD; or any repair is installed that covers the Zone 1 inspection area specified in Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015; or any preventive modification is installed as specified in Part 3 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015: At the applicable time specified in table 3 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015, except as required by paragraph (k)(1) of this AD: Do the inspection specified in paragraph (g)(3)(i) or (g)(3)(ii) of this AD, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. Repeat the inspection thereafter at the applicable times specified in table 3 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. Accomplishing the replacement specified in paragraph (j)(2) of this AD terminates the inspections required by this paragraph.

    (i) Do an external sliding probe EC inspection for cracking of the crown skin panel at stringers S-3L and S-3R.

    (ii) Do an external spot-probe-medium-frequency EC inspection for cracking of the crown skin panel at stringers S-3L and S-3R.

    (h) Post-Preventive Modification Supplemental Inspections

    For airplanes on which a preventive modification has been installed as specified in Part 3 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015: At the applicable time specified in table 4 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015; do eddy current and detailed inspections for cracking of the applicable areas of the fuselage skin of the doublers, triplers, and fillers of the preventive modification, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015. Repeat the inspection thereafter at the applicable times specified in table 4 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015.

    (i) Repair

    If any cracking is found during any inspection required by paragraph (g)(1), (g)(2), (g)(3), or (h) of this AD, repair before further flight using a method approved in accordance with the procedures specified in paragraph (m) of this AD. Doing the repair ends the repetitive inspections for the repaired area only.

    (j) Optional Terminating Actions

    (1) Accomplishing the preventative modification, including doing high frequency EC inspections for cracking around existing fastener holes, in accordance with Part 3 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015, except as required by paragraphs (k)(2) and (k)(3) of this AD, terminates the inspections required by paragraph (g)(1) of this AD, provided the preventative modification is done before further flight after accomplishing an inspection required by paragraph (g) of this AD.

    (2) Replacing the crown skin panel between STA 297 and STA 439, S-4L to S-4R, using a method approved in accordance with the procedures specified in paragraph (m) of this AD, terminates the inspections required by paragraphs (g)(1), (g)(2), and (g)(3) of this AD.

    (k) Exceptions to Service Information Specifications and Preventative Modification

    (1) Where Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015, specifies a compliance time “after the Revision 2 date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.

    (2) Where Boeing Special Attention Service Bulletin 757-53-0097, Revision 2, dated July 28, 2015, specifies to contact Boeing for repair instructions: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (m) of this AD.

    (3) If any cracking is found during any inspection specified in paragraph (j)(1) of this AD, before further flight, repair using a method approved in accordance with the procedures specified in paragraph (m) of this AD.

    (l) Credit for Previous Actions

    (1) This paragraph provides credit for Zone 1 inspections required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Boeing Special Attention Service Bulletin 757-53-0097, dated November 22, 2010, which was incorporated by reference in AD 2011-01-15, Amendment 39-16572 (76 FR 1351, January 10, 2011).

    (2) This paragraph provides credit for the Zone 1 inspection required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD, using Boeing Special Attention Service Bulletin 757-53-0097, Revision 1, dated January 6, 2011, which is not incorporated by reference in this AD.

    (m) Alternative Methods of Compliance (AMOCs)

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

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

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

    (4) AMOCs approved for AD 2011-01-15, Amendment 39-16572 (76 FR 1351, January 10, 2011), are not approved as AMOCs for the corresponding provisions of paragraph (g) of this AD.

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

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

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

    (n) Related Information

    (1) For more information about this AD, contact Eric Schrieber, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5348; fax: 562-627-5210; email: [email protected]

    (2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, 3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001; telephone: 206-544-5000, extension 2; fax: 206-766-5683; Internet https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on February 8, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-03297 Filed 2-17-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-0465; Directorate Identifier 2015-NM-096-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for certain Airbus Model A330-200 and -300 series airplanes; and Model A340-200 and -300 series airplanes. This proposed AD was prompted by a determination that the compliance times for certain post-repair inspections and certain allowable damage limits (ADLs) must be reduced in order to address fatigue. This proposed AD would require identifying any repairs and ADLs used to assess or control any structural damage on certain structural areas, and corrective action if necessary. We are proposing this AD to prevent fatigue damage on primary structure and structural repairs, which could result in reduced structural integrity of the airplane.

    DATES:

    We must receive comments on this proposed AD by April 4, 2016.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

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

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-0465; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-0465; Directorate Identifier 2015-NM-096-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

    Discussion

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2015-0101R1, dated June 12, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A330-200 and -300 series airplanes; and Model A340-200 and -300 series airplanes. The MCAI states:

    Result of a fleet survey accomplished in 2008 identified that the nature of flight missions of A330 and A340-200/300 fleets had significantly changed in comparison with assumed usage during the type certification. Consequently, it was decided to recalculate the Structural Repair Manual (SRM) fatigue values to ensure that the given threshold and intervals remain valid.

    The results of this recalculation identified reduced thresholds and intervals applicable for repairs and Allowable Damage Limits (ADL) affecting the following areas:

    —Door cut-out corners of door surrounding panels (forward cargo door, forward passenger (PAX) door, mid PAX door, emergency exit door/PAX door 3, aft cargo door, bulk cargo door, aft PAX door), on both Left Hand (LH) and Right Hand (RH) sides, —Stringer (STGR) 9 junction between Frame (FR) 10 and FR13 on both LH and RH sides, and —Fuselage skin doubler repairs on both LH and RH sides.

    Failing to apply the reduced thresholds and intervals, could adversely affect the structural integrity of the aeroplane.

    To address this unsafe condition, Airbus issued SRM revision dated April 2013 and temporary revision (TR) 53-001 for the STGR9 junction between FR10 and FR13 area (and subsequent revisions) to introduce reduced thresholds and intervals for the affected ADLs and repairs and issued a set of Service Bulletins (SB) to identify the ADLs used and repairs made, as well as to enable operators to update aeroplane repair records.

    Consequently EASA issued AD * * *, to require identification of any repairs and/or ADL used to assess or control any structural damage on certain structural areas and, depending on findings, accomplishment of corrective action(s) [including revising the maintenance or inspection program as applicable to incorporate revised thresholds and intervals and repair].

    Since that [EASA] AD was issued, data review confirmed that A330 freighter versions are not affected by the unsafe condition.

    This [EASA] AD is revised to remove A330-223F and A330-243F from the Applicability.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-0465.

    Related Service Information Under 1 CFR Part 51

    Airbus has issued the following service information. The service information describes procedures for updating the airplane repair records with revised thresholds and intervals.

    • Airbus Service Bulletin A330-53-3232, dated November 4, 2014.

    • Airbus Service Bulletin A330-53-3233, dated September 26, 2014.

    • Airbus Service Bulletin A330-53-3234, dated December 8, 2014.

    • Airbus Service Bulletin A330-53-3235, Revision 01, dated January 14, 2015.

    • Airbus Service Bulletin A340-53-4222, dated November 25, 2014.

    • Airbus Service Bulletin A340-53-4223, dated September 26, 2014.

    • Airbus Service Bulletin A340-53-4224, dated December 15, 2014.

    • Airbus Service Bulletin A340-53-4225, Revision 01, dated January 14, 2015.

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

    FAA's Determination and Requirements of This Proposed AD

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

    Costs of Compliance

    We estimate that this proposed AD affects 95 airplanes of U.S. registry. We also estimate that it would take about 2 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $16,150, 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 proposed AD.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Airbus: Docket No. FAA-2016-0465; Directorate Identifier 2015-NM-096-AD. (a) Comments Due Date

    We must receive comments by April 4, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to the airplanes, certificated in any category, identified in paragraphs (c)(1) and (c)(2) of this AD; manufacturer serial numbers (MSNs) 1 through 1,600 inclusive.

    (1) Airbus Model A330-201, -202, -203, -223, -243, -301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.

    (2) Airbus Model A340-211, -212, -213, -311, -312, and -313 airplanes.

    (d) Subject

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

    (e) Reason

    This AD was prompted by a determination that the compliance times for certain post-repair inspections and certain allowable damage limits (ADLs) must be reduced in order to address fatigue. We are issuing this AD to prevent fatigue damage on primary structure and structural repairs, 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) Records Review

    At the applicable times in table 1 to paragraph (g) of this AD, review the airplane maintenance records to identify any structural repair manual (SRM) ADLs used to assess or control any structural damage or any structural repair accomplished as specified in an SRM, as applicable, that have been applied on the areas as specified in table 2 to paragraph (g) of this AD.

    Table 1 to Paragraph (g) of This AD—Compliance Times Affected airplanes ADL location/repair Compliance time Related Service Bulletin A330-200 Pre-mod 49144 Mid passenger (PAX) door surround panels Within 12 months after the effective date of this AD Airbus Service Bulletin A330-53-3232, dated November 4, 2014. A330-200 Pre-mod 49144 Forward cargo door, emergency exit door/PAX door 3, aft cargo door, bulk cargo door, and aft PAX door surround panels Within 24 months after the effective date of this AD Airbus Service Bulletin A330-53-3232, dated November 4, 2014. A330-300 Pre-mod 49144 and A340-200/-300 pre-mod 49144 Mid PAX door surround panels, forward cargo door, emergency exit door/PAX door 3, aft cargo door, bulk cargo door, and aft PAX door surround panels Within 24 months after the effective date of this AD Airbus Service Bulletin A330-53-3232, dated November 4, 2014 or Airbus Service Bulletin A340-53-4222, dated November 25, 2014. All, Post-mod 40347 Forward PAX door surround panels with an ADL with a Temporary Life Limit Within 12 months after the effective date of this AD Airbus Service Bulletin A330-53-3233, dated September 26, 2014 or Airbus Service Bulletin A340-53-4223, dated September 26, 2014. All, Post-mod 40347 Forward PAX door surround panels with an ADL with a Permanent Acceptance Within 24 months after the effective date of this AD Airbus Service Bulletin A330-53-3233, dated September 26, 2014 or Airbus Service Bulletin A340-53-4223, dated September 26, 2014. All STGR9 junction between frame (FR) 10 and FR13 Within 12 months after the effective date of this AD Airbus Service Bulletin A330-53-3235, Revision 01, dated January 14, 2015 or Airbus Service Bulletin A340-53-4225, Revision 01, dated January 14, 2015. A340-200/-300 Weight Variant (WV)00s Forward and rear fuselage Within 12 months after the effective date of this AD Airbus Service Bulletin A340-53-4224, dated December 15, 2014. A340-200/-300 WV00s Nose forward and center fuselage Within 24 months after the effective date of this AD Airbus Service Bulletin A340-53-4224, dated December 15, 2014. A330-200/-300 pre-MOD 49144 and A340-200/-300 WV20s Forward and rear fuselage, nose forward and center fuselage Within 24 months after the effective date of this AD Airbus Service Bulletin A330-53-3234, dated December 8, 2014 or Airbus Service Bulletin A340-53-4224, dated December 15, 2014. A330-200/-300 post-MOD 49144 and A340-200/-300 post-MOD 49144 Nose forward and center fuselage Within 24 months after the effective date of this AD Airbus Service Bulletin A330-53-3234, dated December 8, 2014 or Airbus Service Bulletin A340-53-4224, dated December 15, 2014. Table 2 to Paragraph (g) of This AD—Affected Areas Affected areas (on both left-hand and right-hand sides) As specified in Airbus Service Bulletin— Door cut-out corners of door surrounding panels (forward cargo door, mid PAX door, emergency exit door/PAX door 3, aft cargo door, bulk cargo door, aft PAX door) A330-53-3232, dated November 4, 2014 (for Model A330 series airplanes) or A340-53-4222, dated November 25, 2014 (for Model A340 series airplanes). Forward PAX door surround panels A330-53-3233, dated September 26, 2014 (for Model A330 series airplanes) or A340-53-4223, dated September 26, 2014 (for Model A340 series airplanes). Fuselage skin doubler repairs A330-53-3234, dated December 8, 2014 (for Model A330 series airplanes) or A340-53-4224, dated December 15, 2014 (for Model A340 series airplanes). STGR9 junction between FR10 and FR13 A330-53-3235, Revision 01, dated January 14, 2015 (for Model A330 series airplanes) or A340-53-4225, Revision 01, dated January 14, 2015 (for Model A340 series airplanes). (h) Corrective Actions

    If, during any review required by paragraph (g) of this AD, it is determined that an SRM ADL was used on an area specified in table 2 to paragraph (g) of this AD to assess or control any structural damage, or any structural repair of an area specified in table 2 to paragraph (g) of this AD was accomplished as specified in the instructions of the applicable SRM revision, dated before April 2013 or SRM temporary revision (TR) dated before November 28, 2014: Within the applicable compliance time specified in table 1 to paragraph (g) of this AD, do the actions specified in paragraph (h)(1) or (h)(2) of this AD, as applicable.

    (1) Revise the maintenance or inspection program, as applicable, with the applicable revised thresholds and intervals for the identified structural repairs embodied on the airplane, and accomplish all updated inspections, in accordance with the Accomplishment Instructions of the applicable service information identified in table 2 to paragraph (g) of this AD, except as required by paragraphs (h)(1)(i) and (h)(1)(ii) of this AD.

    (i) Where the applicable Airbus service information identified in table 2 to paragraph (g) of this AD specifies to contact Airbus for specific assessment, revise the maintenance or inspection program and accomplish all updated inspections, as applicable, 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).

    (ii) Where the Airbus applicable service information identified in table 2 to paragraph (g) of this AD specifies “current SRM,” no SRM revision dated before April 2013 or SRM TR dated before November 28, 2014, is considered a “current SRM.”

    (2) For any repair that was previously allowed in any revision of the Airbus A330 or A340 SRM, as applicable, dated before April 2013; or in any SRM TR dated before November 28, 2014, to the applicable SRM: Make an assessment using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA; or Airbus's EASA DOA and perform necessary corrective actions at the applicable times identified therein.

    (i) Limitation on Repair/Replacement

    As of the effective date of this AD, for any structural damage in the areas identified in table 2 to paragraph (g) of this AD that has exceeded the ADL, no repair or replacement may be done using an Airbus A330 or A340 SRM dated before April 2013, or any SRM TR dated before November 28, 2014.

    (j) Other FAA AD Provisions

    The following provisions also apply to this AD:

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

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

    (3) Required for Compliance (RC): Except as required by paragraphs (h)(1)(i), (h)(1)(ii), and (h)(2) of this AD: If any service information contains procedures or tests that are identified as RC, those procedures and tests must be done to comply with this AD; any procedures or tests that are not identified as RC are recommended. Those procedures and tests that are not identified as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the procedures and tests identified as RC can be done and the airplane can be put back in an airworthy condition. Any substitutions or changes to procedures or tests identified as RC require approval of an AMOC.

    (k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2015-0101R1, dated June 12, 2015, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-0465.

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

    Issued in Renton, Washington, on February 6, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-03137 Filed 2-17-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-0463; Directorate Identifier 2015-NM-155-AD] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model 777 airplanes. This proposed AD was prompted by a report of an incident involving a landing in which the pilots needed to input corrections due to airplane yaw and roll to the right; the main landing gear (MLG) aft trunnion pin was later found to be fractured. This proposed AD would require identification and replacement of certain MLG aft trunnion pins. We are proposing this AD to prevent a fractured MLG aft trunnion pin, which could result in collapse of the MLG and consequent loss of control of the airplane during landing.

    DATES:

    We must receive comments on this proposed AD by April 4, 2016.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-0463.

    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-2016-0463; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Narinder Luthra, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6513; fax: 415-917-6590; 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-2016-0463; Directorate Identifier 2015-NM-155-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 have received a report of an incident involving a landing in which the pilots needed to input corrections due to airplane yaw and roll to the right; the MLG aft trunnion pin was later found to be fractured. Other damage included minor damage to the gear beam and trunnion door panel and a broken tie rod. Analysis of the fractured pin showed that the crack started from an area of heat damage introduced during manufacturing. A review of gear overhaul records indicated that other pins manufactured by the same supplier had similar signs of heat damage, suspected to have been caused by abusive chrome grinding. This evidence suggests that the heat damage occurred during manufacturing, so it is possible that other airplanes have aft trunnion pins with similar heat damage. This condition, if not corrected, could result in collapse of the MLG and consequent loss of control of the airplane during landing.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 777-32A0103, Revision 1, dated December 10, 2015. The service information describes procedures for identifying and replacing certain MLG aft trunnion pins. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination

    We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

    Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified in the service information described previously.

    Differences Between This Proposed AD and the Service Information

    Boeing Alert Service Bulletin 777-32A0103, Revision 1, dated December 10, 2015, limits the effectivity to Model 777 airplanes, line numbers 1 through 1330 inclusive. However, this proposed AD does not propose to limit the applicability to those line numbers. The applicability of this proposed AD includes all The Boeing Company Model 777-200, 777-200LR, 777-300, 777-300ER, and 777F series airplanes. Because the affected trunnion pins are rotable parts, we have determined that these parts could later be installed on airplanes that were initially delivered with acceptable pins, thereby subjecting those airplanes to the unsafe condition. This difference has been coordinated with Boeing.

    Explanation of “RC” Steps in Service Information

    The FAA worked in conjunction with industry, under the Airworthiness Directive Implementation Aviation Rulemaking Committee (ARC), to enhance the AD system. One enhancement was a new process for annotating which steps in the service information are required for compliance with an AD. Differentiating these steps from other tasks in the service information is expected to improve an owner's/operator's understanding of crucial AD requirements and help provide consistent judgment in AD compliance. The steps identified as Required for Compliance (RC) in any service information identified previously have a direct effect on detecting, preventing, resolving, or eliminating an identified unsafe condition.

    For service information that contains steps that are labeled as RC, the following provisions apply: (1) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD, and an AMOC is required for any deviations to RC steps, including substeps and identified figures; and (2) steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

    Costs of Compliance

    We estimate that this proposed AD affects 123 airplanes of U.S. registry.

    We estimate the following costs to comply with this proposed AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S.
  • operators
  • Inspection 2 work-hours × $85 per hour = $170 $0 $170 $20,910

    We estimate the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need this repair:

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Replacement of aft trunnion pin 34 work-hours × $85 per hour = $2,890 $5,291 $8,181
    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    (3) Will not affect intrastate aviation in Alaska and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): The Boeing Company: Docket No. FAA-2016-0463; Directorate Identifier 2015-NM-155-AD. (a) Comments Due Date

    We must receive comments by April 4, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all The Boeing Company Model 777-200, 777-200LR, 777-300, 777-300ER, and 777F series airplanes, certificated in any category.

    (d) Subject

    Air Transport Association (ATA) of America Code 32, Landing gear.

    (e) Unsafe Condition

    This AD was prompted by a report of an incident involving a landing in which the pilots needed to input corrections due to airplane yaw and roll to the right; the main landing gear (MLG) aft trunnion pin was later found to be fractured. We are issuing this AD to prevent a fractured MLG aft trunnion pin, which could result in collapse of the MLG and consequent loss of control of the airplane during landing.

    (f) Compliance

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

    (g) Aft Trunnion Pin Identification

    Within 36 months after the effective date of this AD, identify the serial number and marking of the MLG aft trunnion pins, in accordance with Part 1 of the Accomplishment Instructions of Boeing Alert Service Bulletin 777-32A0103, Revision 1, dated December 10, 2015.

    (h) MLG Aft Trunnion Pin Replacement

    For any MLG aft trunnion pin that begins with serial number “EGL” or “MAL,” on which no “BASE METAL INSPECTED” marking is found, replace with a new or serviceable MLG aft trunnion pin within 36 months after the effective date of this AD, in accordance with Part 2 of the Accomplishment Instructions of Boeing Alert Service Bulletin 777-32A0103, Revision 1, dated December 10, 2015.

    (i) Part Installation Prohibition

    As of the effective date of this AD, no person may install, on any airplane, any MLG aft trunnion pin that begins with serial number “EGL” or “MAL” and is not marked “BASE METAL INSPECTED.”

    (j) Credit for Previous Actions

    (1) This paragraph provides credit for the actions specified in paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Boeing Multi-Operator Message (MOM) MOM-MOM15-0303-01B, dated May 13, 2015, which is not incorporated by reference in this AD.

    (2) This paragraph provides credit for the actions specified in paragraphs (g) and (h) of this AD, if those actions were performed before the effective date of this AD using Boeing Alert Service Bulletin 777-32A0103, dated September 11, 2015, which is not incorporated by reference in this AD.

    (k) Alternative Methods of Compliance (AMOCs)

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

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

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

    (4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (k)(4)(i) and (k)(4)(ii) of this AD apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

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

    (l) Related Information

    (1) For more information about this AD, contact Narinder Luthra, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6513; fax: 415-917-6590; email: [email protected].

    (2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet https://www.myboeingfleet.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on February 6, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate Aircraft Certification Service.
    [FR Doc. 2016-03138 Filed 2-17-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-0464; Directorate Identifier 2015-NM-046-AD] RIN 2120-AA64 Airworthiness Directives; Fokker Services B.V. Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for all Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes. This proposed AD was prompted by the need for more restrictive airworthiness limitations. This proposed AD would require revising the maintenance program or inspection program, as applicable, to incorporate certain maintenance requirement tasks, thresholds, and intervals. We are proposing this AD to reduce the potential for significant failure conditions and consequent loss of controllability of the airplane.

    DATES:

    We must receive comments on this proposed AD by April 4, 2016.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email [email protected]; Internet http://www.myfokkerfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-0464; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1149.

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-0464; Directorate Identifier 2015-NM-046-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

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

    Discussion

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0027, dated February 20, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes. The MCAI states:

    Fokker Services published issue 11 of Engineering Report SE-473, containing Certification Maintenance Requirements (CMRs). This report is Part 1 of the Airworthiness Limitations Section (ALS Part 1) of the Instructions for Continued Airworthiness, referred to in Section 06, Appendix 1, of the Fokker 70/100 Maintenance Review Board (MRB) document.

    The complete ALS currently consists of:

    Part 1—Report SE-473 (CMRs), Part 2—Report SE-623, Airworthiness Limitation Items (ALIs) and Safe Life Items (SLIs), and Part 3—Report SE-672, Fuel ALIs and Critical Design Configuration Control Limitations (CDCCLs).

    The instructions contained in those reports have been identified as mandatory actions for continued airworthiness.

    For the reasons described above, this [EASA] AD requires implementation of the maintenance actions as specified in ALS Part 1 of the Instructions for Continued Airworthiness, Fokker Services Engineering Report SE-473 at issue 11.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-0464.

    Related Service Information Under 1 CFR Part 51

    Fokker Services B.V. has issued Engineering Report, Airworthiness Limitations Section (ALS), “Fokker 70/100 Certification Maintenance Requirements,” of Fokker Services B.V. Engineering Report SE-473, Issue 11, released January 19, 2015. This service information describes certification maintenance requirements. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination and Requirements of This Proposed AD

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

    This proposed AD would require revisions to certain operator maintenance documents to include new actions (e.g., inspections). Compliance with these actions is required by 14 CFR 91.403(c). For airplanes that have been previously modified, altered, or repaired in the areas addressed by this proposed AD, the operator may not be able to accomplish the actions described in the revisions. In this situation, to comply with 14 CFR 91.403(c), the operator must request approval for an alternative method of compliance according to paragraph (i)(1) of this proposed AD. The request should include a description of changes to the required actions that will ensure the continued operational safety of the airplane.

    Differences Between This Proposed AD and the MCAI or Service Information

    The MCAI specifies that if there are findings from the ALS inspection tasks, corrective actions must be accomplished in accordance with Fokker Services B.V. maintenance documentation or by contacting Fokker Services B.V. for repair instructions, and provides for varying compliance times for the corrective actions depending on the inspection findings. However, this proposed AD does not include that requirement. Operators of U.S.-registered airplanes are required by general airworthiness and operational regulations to perform all maintenance before further flight using methods that are acceptable to the FAA. We consider those methods to be adequate to address any corrective actions necessitated by the findings of ALS inspections required by this proposed AD.

    Costs of Compliance

    We estimate that this proposed AD affects 8 airplanes of U.S. registry.

    We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $680, or $85 per product.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Fokker Services B.V.: Docket No. FAA-2016-0464; Directorate Identifier 2015-NM-046-AD. (a) Comments Due Date

    We must receive comments by April 4, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Fokker Services B.V. Model F.28 Mark 0070 and 0100 airplanes, certificated in any category, all serial numbers.

    (d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/Maintenance Checks.

    (e) Reason

    This AD was prompted by the need for more restrictive airworthiness limitations. We are issuing this AD to reduce the potential for significant failure conditions and consequent loss of controllability of the airplane.

    (f) Compliance

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

    (g) Maintenance Program Revision

    (1) Within 12 months after the effective date of this AD, revise the maintenance or inspection program, as applicable, to incorporate the certification maintenance requirements (CMR) specified in Fokker Services B.V. Engineering Report, Airworthiness Limitations Section (ALS), “Fokker 70/100 Certification Maintenance Requirements,” of Fokker Services B.V. Engineering Report SE-473, Issue 11, released January 19, 2015.

    (2) Do the applicable initial CMR inspection at the time specified in paragraph (g)(2)(i) or (g)(2)(ii) of this AD, as applicable, as specified in Fokker Services B.V. Engineering ALS, “Fokker 70/100 Certification Maintenance Requirements,” Fokker Services B.V. Engineering Report SE-473, Issue 11, released January 19, 2015. If any discrepancy is found during any inspection, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency; or Fokker B.V. Service's EASA Design Organization Approval (DOA). Repair any discrepancy before further flight.

    (i) For CMR inspection 783100-CM-01: Within 1 year or 3,000 flight hours after the effective date of this AD, whichever occurs first, but not later than 12,000 flight hours after accomplishing MRB task 783100-00-04.

    (ii) For CMR inspection 783500-CM-01: Within 1 year or 3,000 flight hours after the effective date of this AD, whichever occurs first, but not later than 10,000 flight hours after accomplishing MRB task 783100-01-01.

    (h) No Alternative Inspections or Inspection Intervals

    After accomplishment of the actions specified in paragraph (g)(2) of this AD, no alternative actions (e.g., inspections) and intervals, may be used, unless the actions or intervals are approved as an alternative method of compliance (AMOC) in accordance with the procedures specified in paragraph (i)(1) of this AD.

    (i) 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: Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1149. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

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

    (j) Related Information

    (1) Refer to MCAI EASA Airworthiness Directive 2015-0027, dated February 20, 2015, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-0464.

    (2) For service information identified in this AD, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email [email protected]; Internet http://www.myfokkerfleet.com. You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on February 6, 2016. Michael Kaszycki, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-03136 Filed 2-17-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2015-0940] RIN 1625-AA09 Drawbridge Operation Regulation; Indian Creek, Miami Beach, FL AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to modify the operating schedule that governs the 63rd Street Bridge across Indian Creek, mile 4.0, at Miami Beach, FL. This proposed rule implements restrictions that allow the bridge to not open for vessels during peak vehicle traffic times. Bridge openings during peak vehicle traffic times cause major traffic jams that may be avoided without negatively impacting vessel traffic on the Indian Creek. Modifying the bridge operating schedule will reduce major vehicle traffic issues during rush hour times.

    DATES:

    Comments and related material must reach the Coast Guard on or before April 18, 2016.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2015-0940 using Federal eRulemaking Portal at http://www.regulations.gov.

    See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section below for instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this proposed rule, call or email Mr. Rod Elkins with the Coast Guard; telephone 305-415-6989, email [email protected]

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security E.O. Executive Order FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background, Purpose and Legal Basis

    On March 11th, 2015 the Miami Beach City Commission held a public meeting to discuss appropriate action for modifying the bridge operations. Additionally, the City conducted traffic studies and reviewed the bridge logs which showed a 45% increase in vehicular traffic from 7 a.m. to 10 a.m. and 4 p.m. to 7 p.m. with no corresponding increase in vessel traffic during those time periods. Input from the public meeting and the traffic data was used to develop the proposed rule. That data will be included in the electronic docket for this proposed rulemaking.

    63rd Street Bridge across Indian Creek, mile 4.0, at Miami Beach, FL is a single leaf bascule bridge. It has a vertical clearance of 11 feet at mean high water in the closed position and a horizontal clearance of 50 feet.

    Presently, in accordance with 33 CFR 117.5, the 63rd Street Bridge is required to open on signal for the passage of vessels. The City of Miami Beach and Miami Dade County determined that restricting bridge openings during peak traffic hours will significantly reduce traffic congestion. Based on this determination, the City of Miami Beach requested this action to alleviate additional traffic congestion created by bridge openings during peak hours.

    In addition to proposing a schedule that will allow for limited openings during the regular work week, the Coast Guard is proposing a regulation change that will apply during the annual boat show. Every year in mid-February the City of Miami Beach hosts the Yacht and Brokerage Show which creates unusually high vehicle and vessel traffic during the weeks before and after the show. The Coast Guard typically issues temporary deviations to the 63rd Street Bridge operations that help balance vessel and vehicle needs during those times. The Coast Guard proposes adopting the annual temporary deviation as part of this bridge regulation.

    III. Discussion of Proposed Rule

    The Coast Guard proposes to add a new regulation for the operations of the 63rd Street Bridge, Indian Creek mile 4.0, at Miami Beach. The proposed regulation would implement three closure periods, which would allow the bridge to not open for vessels during morning and afternoon peak vehicle traffic times. The following schedule is proposed: (1) From Monday through Friday from 7 a.m. to 7 p.m. the bridge would only open on the hour and half hour; (2) from 7:10 a.m. to 9:55 a.m. and 4:05 p.m. to 6:59 p.m. Monday through Friday, the bridge would remain closed; and (3) from 10 a.m. to 4 p.m. the seven days before and the four days following the City of Miami Beach Yacht and Brokerage Show the second week of February, the bridge would only open for ten minutes at the top of the hour. For federal holidays, weekends, and other times the bridge would continue to open for vessels on signal.

    These proposed changes will still allow vessels to pass through the bridge while taking into account the reasonable needs of other modes of transportation.

    IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on these statutes and E.O.s and we also discuss First Amendment rights of protestors.

    A. Regulatory Planning and Review

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

    This regulatory action determination is based on the limited impact that it is anticipated to have on vessel traffic on the Indian Creek while taking into account the needs of vehicular traffic. Vessels that can transit under the bridge without an opening may do so. Other vessels can transit during non closure period times, and emergency vessels and tugs with tows can still request openings at any time.

    B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section IV.A above this proposed rule would not have a significant economic impact on any vessel owner or operator.

    If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

    C. Collection of Information

    This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

    D. Federalism and Indian Tribal Government

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This proposed rule promulgates the operating regulations or procedures for drawbridges. Normally such actions are categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction.

    Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

    G. Protest Activities

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

    V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

    We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

    We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

    Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

    List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:

    PART 117—DRAWBRIDGE OPERATION REGULATIONS 1. The authority citation for part 117 continues to read as follows: Authority:

    33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.

    2. Add § 117.293 to read as follows:
    § 117.293 Indian Creek.

    The draw of the 63rd Street Bridge, Indian Creek mile 4.0, at Miami Beach, shall open on signal except as follows:

    (a) From 7 a.m. to 7 p.m., Monday through Friday except Federal holidays, the draw need open only on the hour and half-hour.

    (b) From 7:10 a.m. to 9:55 a.m. and 4:05 p.m. to 6:59 p.m., Monday through Friday except Federal holidays, the draw need not open for the passage of vessels.

    (c) In February of each year during the period seven days prior to the City of Miami Beach Yacht and Brokerage Show and the four days following the show, from 10:00 a.m. to 4:00 p.m., the bridge need not open except for 10 minutes at the top of the hour. At all other times the bridge shall operate on its normal schedule.

    Dated: February 11, 2016. S.A. Buschman, Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard District.
    [FR Doc. 2016-03262 Filed 2-17-16; 8:45 am] BILLING CODE 9110-04-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [MB Docket No. 16-29, RM-11758; DA 16-139] Television Broadcasting Services; Scottsbluff, Nebraska and Sidney, Nebraska AGENCY:

    Federal Communications Commission.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Commission has before it a petition for rulemaking filed by Gray Television License, LLC, proposed assignee of KDUH-TV, Scottsbluff, Nebraska and New Rushmore Radio, Inc., the licensee of station KDUH-TV, channel 7, Scottsbluff, Nebraska (collectively “Petitioners”), requesting an amendment of the DTV Table of Allotments to delete channel 7 at Scottsbluff and substitute channel 7 at Sidney, Nebraska. While the Commission instituted a freeze on the acceptance of full power television rulemaking petitions requesting channel substitutions in May 2011, Petitioners are seeking a waiver asserting that because the proposed change in community of license does not involve any proposed change in technical facilities, grant of the petition would not impact on the Post-Transition Table of DTV Allotments. Petitioners believe that a waiver here would serve the public interest and that community in Sidney would remain well-served after reallotment.

    DATES:

    Comments must be filed on or before March 21, 2016, and reply comments on or before April 4, 2016.

    ADDRESSES:

    Federal Communications Commission, Office of the Secretary, 445 12th Street SW., Washington, DC 20554. In addition to filing comments with the FCC, interested parties should serve counsel for petitioner as follows: Gray Television Licensee, LLC, c/o Cooley LLP, John R. Feore, Jr. Esq. and Derek Teslik, Esq., 1299 Pennsylvania Avenue NW., Suite 700, Washington, DC 20004; New Rushmore Radio Inc., c/o Law Office of Jack N. Goodman, Jack N. Goodman, Esq., 1200 New Hampshire Ave. NW., Suite 600, Washington, DC 20036.

    FOR FURTHER INFORMATION CONTACT:

    Adrienne Y. Denysyk, [email protected], Media Bureau, (202) 418-2561.

    SUPPLEMENTARY INFORMATION:

    This is a synopsis of the Commission's Notice of Proposed Rule Making, MB Docket No. 16-29, adopted February 8, 2016, and released February 8, 2016. The full text of this document is available for public inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, CY-A257, 445 12th Street SW., Washington, DC 20554. This document will also be available via ECFS (http://www.fcc.gov/cgb/ecfs/). (Documents will be available electronically in ASCII, Word 97, and/or Adobe Acrobat.). To request this document in accessible formats (computer diskettes, large print, audio recording, and Braille), send an email to [email protected] or call the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY). This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

    Provisions of the Regulatory Flexibility Act of 1980 do not apply to this proceeding.

    Members of the public should note that from the time a Notice of Proposed Rule Making is issued until the matter is no longer subject to Commission consideration or court review, all ex parte contacts (other than ex parte presentations exempt under 47 CFR 1.1204(a)) are prohibited in Commission proceedings, such as this one, which involve channel allotments. See 47 CFR 1.1208 for rules governing restricted proceedings.

    For information regarding proper filing procedures for comments, see 47 CFR 1.415 and 1.420.

    List of Subjects in 47 CFR Part 73

    Television.

    Federal Communications Commission. Thomas Horan, Chief of Staff, Media Bureau. Proposed Rules

    For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 73 as follows:

    PART 73—RADIO BROADCAST SERVICES 1. The authority citation for Part 73 continues to read as follows: Authority:

    47 U.S.C. 154, 303, 334, 336, and 339.

    § 73.622 [Amended]
    2. Section 73.622(i), the Post-Transition Table of DTV Allotments under Nebraska is amended by removing channel 7 at Scottsbluff. 3. Section 73.622(i), the Post-Transition Table of DTV Allotments under Nebraska is amended by adding Sidney. 4. Section 73.622(i), the Post-Transition Table of DTV allotments under Nebraska is amended by adding channel 7 at Sidney.
    [FR Doc. 2016-03345 Filed 2-17-16; 8:45 am] BILLING CODE 6712-01-P
    SURFACE TRANSPORTATION BOARD 49 CFR Parts 1241, 1242, 1243, 1244, 1245, 1246, 1247, and 1248 [Docket No. EP 701] Accelerating Reporting Requirements for Class I Railroads AGENCY:

    Surface Transportation Board.

    ACTION:

    Proposed rule, withdrawn.

    SUMMARY:

    The Board is withdrawing the proposed rules and discontinuing the EP 701 rulemaking proceeding which proposed to accelerate the filing deadlines for certain financial, employee, and traffic reports submitted by Class I railroads.

    DATES:

    The proposed rule is withdrawn and the rulemaking proceeding is discontinued on February 18, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Pedro Ramirez, (202) 245-0333. Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at (800) 877-8339.

    SUPPLEMENTARY INFORMATION:

    On July 8, 2015, the Board issued a Notice of Proposed Rulemaking (NPRM) seeking public comment on a proposal to accelerate the filing deadlines for certain financial, employee, and traffic reports submitted by Class I railroads.1 The Board has authority to collect financial and statistical data from railroads as necessary for the economic oversight of the industry. 49 U.S.C. 1321(b),2 11145. To this end, the Board's regulations require Class I railroads to submit annual, quarterly, and monthly reports containing financial and operating statistics, including employment and traffic data. 49 U.S.C. 11145; 49 CFR 1241-1248. The data collected is used by the Board in various proceedings, as well as by other governmental agencies and interested parties in evaluating the railroad industry.

    1 The NPRM was published in the Federal Register on July 8, 2015 (80 FR 39045).

    2 The recently enacted Surface Transportation Board Reauthorization Act of 2015, Public Law 114-110, recodifies provisions of title 49, United States Code, redesignating 49 U.S.C. 721, as § 1321.

    In the NPRM, the Board proposed changing the filing deadlines for a number of these reports. Specifically, the NPRM proposed the following deadlines: Schedule 250 would be filed by March 31 each year, at the same time as the Annual Report Form R-1; Quarterly Report Form RE&I, Form CBS, Quarterly Wage Forms A & B, and Reports of Fuel Cost, Consumption, and Surcharge Revenue would be filed within 15 days after the end of each quarter; Annual Wage Forms A & B and Annual Form QCS would be filed 30 days after the end of each year; Quarterly Form QCS would be filed 30 days after the end of each quarter; Form STB-54 would be filed within 60 days after the end of each year; and Form C would be filed 10 days after the end of each month.

    The NPRM also proposed to: Update several form titles; clarify the method by which carriers arrive at the number of employees reported on Form C, pursuant to part 1246; replace references to the “Interstate Commerce Act” with “pt. A of subtitle IV of tit. 49, United States Code” between 49 CFR parts 1241 and 1248 to accurately describe the current controlling statute; and eliminate the requirement of railroads to file duplicate copies of reports, with the exception of the Annual Report Form R-1, which requires hard copies to be filed.

    On August 21, 2015, the AAR filed comments on the proposed rules. AAR expresses concern that the proposed accelerated deadlines would impose significant burdens while not conferring a public benefit. (AAR Comment 7.) AAR states that the proposed deadlines for the STB reports would be incompatible with and would create additional reporting obligations for the railroads under Securities and Exchange Commission (SEC) regulations. (Id. at 10-12.) AAR also states that accelerated deadlines could cause investor confusion because the information in Board filings is based on a different corporate entity than information in the SEC filings, and there are also differences in accounting between Board reports and SEC reports. (Id. at 13.)

    Based on AAR's comments, the proposed rules could impose a significant burden on the railroads and conflict with SEC reporting requirements. No other comments were submitted. Therefore, we will not adopt the proposed accelerated deadlines and will discontinue this proceeding.

    However, some of the nonsubstantive updates that the Board proposed will be adopted in Improving Regulation and Regulatory Review, EP 712. These updates include changing the following form titles: “Form MRRE” to “Form C” (49 CFR 1246.1) and; “Form QRSC” and “Form ARSC” to “Quarterly Wage Forms A & B” and “Annual Wage Forms A & B” respectively (49 CFR 1245.2). In that proceeding, we will also eliminate the requirement for railroads to file duplicate copies of reports, with the exception of the Annual Report Form R-1, which requires hard copies to be filed.

    This action will not significantly affect either the quality of the human environment or the conservation of energy resources.

    Decided: February 11, 2016.

    By the Board, Chairman Elliott, Vice Chairman Miller, and Commissioner Begeman.

    Brendetta S. Jones, Clearance Clerk.
    [FR Doc. 2016-03332 Filed 2-17-16; 8:45 am] BILLING CODE 4915-01-P
    81 32 Thursday, February 18, 2016 Notices DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-53-2015] Application for Additional Production Authority; The Coleman Company, Inc.; Subzone 119I; (Textile-Based Personal Flotation Devices); Change of Location for Public Hearing

    A public hearing has been scheduled for February 24, 2016, at 9:30 a.m., on the application for additional production authority submitted by The Coleman Company, Inc., for activity within Subzone 119I in Sauk Rapids, Minnesota (see 80 FR 79820, December 23, 2015). The location for the hearing has been changed to Room 48019, U.S. Department of Commerce, Hoover Building, 1401 Constitution Avenue NW., Washington, DC 20230.

    For further information, contact Pierre Duy at [email protected] or (202) 482-1378.

    Dated: February 12, 2016. Pierre V. Duy, Acting Executive Secretary.
    [FR Doc. 2016-03423 Filed 2-17-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-849] Certain Cut-to-Length Carbon Steel Plate From the People's Republic of China: Initiation of Circumvention Inquiry on Antidumping Duty Order AGENCY:

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

    DATES:

    Effective Date: February 18, 2016.

    SUMMARY:

    In response to a request from Nucor Corporation and SSAB Enterprises LLC (collectively “Domestic Producers”), the Department of Commerce (“Department”) is initiating a circumvention inquiry, pursuant to section 781(c) of the Tariff Act of 1930, as amended (the “Act”), to determine whether certain imports of certain cut-to-length carbon steel plate (“CTL plate”) are circumventing the antidumping duty order on CTL plate from the People's Republic of China (“PRC”).1

    1See Suspension Agreement on Certain Cut-to-Length Carbon Steel Plate From the People's Republic of China; Termination of Suspension Agreement and Notice of Antidumping Duty Order, 68 FR 60081 (October 21, 2003) (“Order”).

    FOR FURTHER INFORMATION CONTACT:

    Patrick O'Connor or Thomas Martin, AD/CVD Operations, Office IV, Enforcement & Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0989, and (202) 482-3936, respectively.

    SUPPLEMENTARY INFORMATION:

    On June 17, 2015, Domestic Producers requested that the Department make a final circumvention ruling within 45 days pursuant to 19 CFR 351.225(c)(2) and (d) with respect to CTL plate from the PRC with small amounts of any alloying elements added so as to classify the steel as alloy steel under the Harmonized Tariff Schedule of the United States (“HTSUS”), regardless of exporter or importer.2 As a result of further clarification and comments regarding Domestic Producers' allegation, we extended the deadline to make a final ruling or initiate a circumvention inquiry until February 10, 2016.3

    2 Domestic Producers initially filed versions of their request on April 30, 2015 (Business Proprietary) and May 1, 2015 (Public Version), but these submissions were rejected by the Department due to filing deficiencies. See Letter from Robert Bolling to Domestic Producers, “Re: Rejection of Submission- Certain Cut-To-Length Carbon Steel Plate from the People's Republic of China,” dated June 9, 2015 letter.

    3See Letter from Abdelali Elouaradia to Petitioners, “Re: Certain Cut-to-Length Carbon Steel Plate from the People's Republic of China: Request for Circumvention Ruling,” dated January 13, 2016. The Department tolled this deadline by four business days. See Memorandum from Ron Lorentzen to The Record, “Tolling of Administrative Deadlines as a Result of the Government Closure during Snowstorm “Jonas”,” dated January 27, 2016.

    Domestic Producers alleged that producers, exporters and importers are circumventing the Order by adding alloying elements (i.e., making minor alterations) to CTL plate that is otherwise ASTM A36 and A572 commodity-grade steel plate.4 Domestic Producers provided business proprietary evidence which they believe supports their allegation.5

    4See 781(c) of the Act; see also Letter from Domestic Producers regarding, “Certain Cut-to-Length Carbon Steel Plate From the People's Republic of China: Re-submission of Request for Circumvention Ruling,” dated June 17, 2015 (“Domestic Producers' Request”).

    5See Memorandum from Thomas Martin to the File, regarding “Anti-Circumvention Inquiry on Certain Cut-To Length Carbon Steel Plate (“CTL plate”), from the People's Republic of China: Initiation of Antidumping Circumvention Inquiry” with the subject “Memorandum of Business Proprietary Information Accompanying the Notice of Initiation of Antidumping Circumvention Inquiry,” dated concurrently with this notice (“Alloying Elements Circumvention BPI Memorandum”) at Note 1.

    Domestic Producers noted that there is a history of evading the Order, and that the Department has made two separate circumvention determinations with regard to CTL plate from the PRC. In the first determination, the Department found that merchandise produced by Tianjin Iron and Steel Co., Ltd. and merchandise imported by Toyota Tsusho America Inc., regardless of producer or exporter, containing 0.0008 percent or more boron, by weight, and otherwise meeting the description of in-scope merchandise is subject to the Order unless the merchandise meets all of the following requirements: (1) An aluminum level of 0.02 percent or greater, by weight; (2) a ratio of 3.4 to 1 or greater, by weight, of titanium to nitrogen; and (3) a hardenability test (i.e., Jominy test) result indicating a boron factor of 1.8 or greater.6 In the second determination, the Department found “that it is appropriate to consider all plate with at least 0.0008 percent boron content and otherwise meeting the description of the scope to be covered by the order, unless the merchandise also possesses the three distinguishing characteristics referenced above.” 7 The Department also found it appropriate to apply its second determination “on a countrywide basis, given that multiple parties have been found to be circumventing the order using the same general approach (i.e., inclusion of small inconsequential amounts of an alloying element in order to change the tariff classification from non-alloy to alloy steel).” 8

    6See Affirmative Final Determination of Circumvention of the Antidumping Duty Order on Certain Cut-to-Length Carbon Steel Plate From the People's Republic of China, 74 FR 40565 (August 12, 2009) (“Toyota Tsusho Circumvention Final Determination”).

    7See Affirmative Final Determination of Circumvention of the Antidumping Duty Order on Certain Cut-to-Length Carbon Steel Plate From the People's Republic of China, 76 FR 50996 (August 17, 2011) (“Wuyang Circumvention Final Determination”).

    8Id. at 50997.

    Domestic Producers contended that PRC producers are now adding other alloying elements, in addition to boron, to otherwise subject CTL plate in order to circumvent the Order. 9 According to Domestic Producers, PRC manufacturers have an incentive to produce the CTL plate at issue to circumvent antidumping duties, and only began adding certain alloying elements in response to the Order and the Department's prior circumvention findings.10 Domestic Producers stated that another possible motivation for PRC CTL plate producers to add other alloying elements to their plate, such as chromium, is the PRC government's cancellation of the Value Added Tax (“VAT”) export rebate for steel with boron added. CTL plate with other alloys continues to receive the VAT rebate.11 Domestic Producers submitted news articles to support this contention.12

    9See Domestic Producers' Request at 12-15.

    10Id. at 21-23.

    11Id. at 10-11.

    12Id. at Exhibits 6-7.

    On July 6, 2015, the Department identified various areas of the Domestic Producers' Request that required clarification and therefore issued questions to them.13 On July 22, 2015, Domestic Producers submitted their responses to those questions.14 In their responses, Domestic Producers clarified the names and addresses of the exporters and importers of the product that they believe is being produced to circumvent the Order. 15 Regarding the PRC government's cancellation of VAT rebates for steel with boron added, Domestic Producers submitted an official announcement from the PRC government's Ministry of Finance, cancelling the rebate program.16 Domestic Producers also clarified that 80 percent of the market for commodity-grade carbon steel plate meets ASTM specifications A36 and A572, and that there is no overlap between these specifications and alloy steel specifications that require heat treatment, have a higher tensile strength, and require minimum levels of nickel, chromium, and molybdenum.17

    13See Letter from Howard Smith, “Re: Certain Cut-To-Length Carbon Steel Plate (“CTL Carbon Plate”) from the People's Republic of China (“PRC”): Anti-circumvention Ruling Request,” dated July 6, 2015.

    14See Letter from Domestic Producers' regarding, “Certain Cut-to-Length Carbon Steel Plate From the People's Republic of China: Supplemental Response to Questions Regarding Petitioners' Request for an Anti-Circumvention Ruling,” dated July 22, 2015 (“First Supplemental Submission”).

    15See First Supplemental Submission at 5.

    16Id. at Exhibit 9.

    17Id. at 6-8.

    Domestic Producers also stated that the exclusion criteria in Toyota Tsusho Circumvention Final Determination is specific to boron's intended purpose of increasing hardenability in steel that has been heat treated, and is not relevant to other alloying elements such as chromium and titanium.18 They contended that the addition of alloying elements to steel plate is only useful when steel plate is heat treated, which has a substantial cost, and PRC producers are not heat treating the steel plate at issue.19 Domestic Producers claimed that commodity-grade carbon steel plate of ASTM specifications A36 and A572 is not heat-treated.20 Thus, Domestic Producers contended that there is no reason to produce CTL plate which meets the exclusion criteria in Toyota Tsusho Circumvention Final Determination, but that is not heat treated, other than to circumvent the Order. According to Domestic Producers, it is possible to determine from mill test certificates whether CTL steel plate has been heat treated.21 Domestic Producers provided relevant business proprietary evidence in their supplemental submission.22

    18Id. at 5-6.

    19Id. at 12-13, 14, 17, 23-24.

    20Id. at 14, 17, 23-24.

    21Id. at 12-13.

    22See Alloying Elements Circumvention BPI Memorandum at Note 2.

    On August 5, 2015, Wuyang Iron and Steel Co., Ltd. (“Wuyang”) commented on Domestic Producers' First Supplemental Submission.23 Wuyang contended that although Domestic Producers requested the Department to initiate a circumvention inquiry regarding all alloys, Domestic Producers failed to identify any alloy, other than boron, chromium and titanium, which they claim PRC producers add to steel plate, and failed to claim whether adding any of the other alloys can actually have a beneficial effect on steel.24 Further, Wuyang stated that Domestic Producers should not be permitted to add heat treatment to the three-part test to exclude CTL plate with at least 0.0008 percent boron content from the Order, (the exception established in Toyota Tsusho Circumvention Final Determination), without specifying whether the heat treatment must occur before or after importation, how U.S. Customs and Border Protection (“CBP”) can administer such a proposed rule, and what alloy ASTM specifications are at issue.25

    23See Letter from Wuyang regarding “Circumvention Inquiry of the Antidumping Duty Order on Certain Cut-to-Length Carbon Steel Plate From China: Comments on Petitioners' Response to Supplemental Questionnaire regarding Ant-Circumvention Ruling Request” dated August 5, 2015 (“Wuyang Comments”).

    24See Wuyang Comments at 4, 6.

    25Id. at 5.

    On August 28, 2015, the Department issued another request for information to Domestic Producers,26 to which they responded on September 11, 2015.27 In their response, Domestic Producers clarified that their request covers steel plate with any alloy listed in note (f) of Chapter 72 of the HTSUS at levels that would allow the plate to be classified as alloy steel under the HTSUS, that is marketed, priced or sold in the United States as commodity-grade carbon steel plate or made to specifications considered to be carbon steel specifications in the market (e.g., ASTM specifications A36 and A572).28 For further support of their claim that PRC producers are adding alloying elements other than boron, chromium and titanium to CTL plate to circumvent the Order, Domestic Producers submitted news articles regarding PRC steel overproduction, as well as information regarding a circumvention inquiry in Australia.29 Domestic Producers claimed that adding any alloys to commodity-grade steel plate has no commercial or metallurgical purpose other than to change the tariff classification of the plate in the HTSUS.30 Domestic Producers also explicitly stated that the three-part exclusion established in Toyota Tsusho Circumvention Final Determination is no longer a legitimate or reliable exclusion for the Order, and that the Department should analyze boron in the same manner as any other alloy.31 Domestic Producers also stated that ASTM specification A36 steel would not be classifiable as alloy steel in the HTSUS due to its manganese or silicon content because this ASTM specification has a maximum range for manganese and silicon below the thresholds in note (f) of Chapter 72 of the HTSUS.32 According to Domestic Producers, the application of the circumvention inquiry to ASTM specifications A36 and A572 would be easily enforced by CBP since these specifications are identified in mill test certificates and also marked on the steel itself.33 However, Domestic Producers also requested that all “commodity-grade” steel plate be covered by the circumvention inquiry in case any ASTM specifications are eliminated, changed or developed in the future.34

    26See Letter from Howard Smith, “Re: Certain Cut-To-Length Carbon Steel Plate (“CTL Carbon Plate”) from the People's Republic of China (“PRC”): Anti-circumvention Ruling Request,” dated August 28, 2015.

    27See Letter from Domestic Producers regarding, “Certain Cut-to-Length Carbon Steel Plate From the People's Republic of China: Second Supplemental Response to Questions Regarding Petitioners' Request for an Anti-Circumvention Ruling,” dated September 11, 2015 (“Second Supplemental Submission”)

    28See Second Supplemental Submission at 3.

    29Id. at 5-6.

    30Id. at 7-8.

    31Id. at 11.

    32Id. at 12-14; see also Alloying Elements Circumvention BPI Memorandum at Note 3.

    33See Second Supplemental Submission at 15.

    34Id. at 15.

    On November 18, 2015, the Department again issued a request for information to the Domestic Producers requesting clarification of certain previously submitted evidence and additional evidence relating to their allegation.35 On November 24, 2015, Domestic Producers submitted their response to the request for information.36 In their response, Domestic Producers provided evidence that is business proprietary.37

    35See Letter from Howard Smith, “Re: Certain Cut-To-Length Carbon Steel Plate (“CTL Carbon Plate”) from the People's Republic of China (“PRC”): Anti-circumvention Ruling Request,” dated November 18, 2015.

    36See Letter from Domestic Producers regarding, “Certain Cut-to-Length Carbon Steel Plate From the People's Republic of China: Third Supplemental Response to Questions Regarding Petitioners' Request for an Anti-Circumvention Ruling,” dated November 24, 2015 (“Third Supplemental Submission”)

    37See Alloying Elements Circumvention BPI Memorandum at Note 4.

    On January 20, 2016, Domestic Producers submitted additional business proprietary factual support for their request for a circumvention inquiry.38

    38See Letter from Domestic Producers, “Re: Certain Cut-To-Length Carbon Steel Plate (“CTL Carbon Plate”) from the People's Republic of China (“PRC”): Request to Issue Final Ruling Or Initiate Anti-Circumvention Inquiry,” dated January 20, 2016 and Alloying Elements Circumvention BPI Memorandum at Note 5.

    Scope of the Order

    The product covered by the order is certain cut-to-length carbon steel plate from the PRC. Included in this description is hot-rolled iron and non-alloy steel universal mill plates (i.e., flat-rolled products rolled on four faces or in a closed box pass, of a width exceeding 150 mm but not exceeding 1250 mm and of a thickness of not less than 4 mm, not in coils and without patterns in relief), of rectangular shape, neither clad, plated nor coated with metal, whether or not painted, varnished, or coated with plastics or other nonmetallic substances; and certain iron and non-alloy steel flat-rolled products not in coils, of rectangular shape, hot-rolled, neither clad, plated, nor coated with metal, whether or not painted, varnished, or coated with plastics or other nonmetallic substances, 4.75 mm or more in thickness and of a width which exceeds 150 mm and measures at least twice the thickness. Included as subject merchandise in the order are flat-rolled products of nonrectangular cross-section where such cross-section is achieved subsequent to the rolling process (i.e., products which have been “worked after rolling”)—for example, products which have been bevelled or rounded at the edges. This merchandise is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under item numbers 7208.40.3030, 7208.40.3060, 7208.51.0030, 7208.51.0045, 7208.51.0060, 7208.52.0000, 7208.53.0000, 7208.90.0000, 7210.70.3000, 7210.90.9000, 7211.13.0000, 7211.14.0030, 7211.14.0045, 7211.90.0000, 7212.40.1000, 7212.40.5000, 7212.50.0000. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the order is dispositive. Specifically excluded from subject merchandise within the scope of the order is grade X-70 steel plate.

    Merchandise Subject to the Minor Alterations Antidumping Duty Circumvention Inquiry

    For the reasons explained below in the “Conclusion” section of this notice, we have not initiated this circumvention inquiry on all of the products described in Domestic Producers' Request. Rather, this circumvention inquiry covers all CTL plate from the PRC made to ASTM A36 or A572 specifications with levels of chromium or titanium above the levels identified in note (f), “Other alloy steel”, of Chapter 72 of the HTSUS. This inquiry also covers all CTL plate from the PRC made to ASTM A36 or A572 specifications which contains levels of boron above the levels identified in note (f) of Chapter 72 of the HTSUS and which has not been heat treated to meet tensile and hardness requirements beyond commodity-grade ASTM specifications. This inquiry will cover U.S. imports of all CTL plate from the PRC.

    Initiation of Minor Alterations Antidumping Duty Circumvention Proceeding

    Section 781(c)(1) of the Act provides that the class or kind of merchandise subject to an antidumping duty order shall include articles “altered in form or appearance in minor respects . . . whether or not included in the same tariff classification.” The Department notes that, while the statute is silent as to what factors to consider in determining whether alterations are properly considered “minor,” the legislative history of this provision indicates there are certain factors which should be considered before reaching a circumvention determination. In conducting a circumvention inquiry under section 781(c) of the Act, the Department has generally relied upon “such criteria as the overall physical characteristics of the merchandise, the expectations of the ultimate users, the use of the merchandise, the channels of marketing and the cost of any modification relative to the total value of the imported products.” 39

    39See S. Rep. No.71, 100th Cong., 1st Sess. 100 (1987) (“In applying this provision, the Commerce Department should apply practical measurements regarding minor alterations, so that circumvention can be dealt with effectively, even where such alterations to an article technically transform it into a differently designated article.”)

    Overall Physical Characteristics

    According to Domestic Producers, the CTL plate at issue is made in nearly the same manner, made to the same specifications, and has the same physical characteristics as carbon steel plate. Domestic Producers claimed that the effect of the added alloying elements is negligible.40 Specifically, Domestic Producers claimed that commodity-grade carbon steel plate of ASTM specifications A36 and A572 is not heat-treated, and thus cannot achieve the hardenability of alloy steel by adding alloys.41 Thus, Domestic Producers maintained that CTL plate with small amounts of alloying elements that is considered commodity-grade steel plate has the same physical characteristics as subject CTL plate.42

    40See Domestic Producers' Request at 16-17.

    41See First Supplemental Submission at 14, 17, 23-24.

    42See Alloying Elements Circumvention BPI Memorandum at Note 6.

    Expectations of the Ultimate Users

    Domestic Producers contended that the ultimate users purchasing the CTL plate at issue with elevated levels of alloys expect a commodity-grade, rather than a specialty alloy, product because of the way the product is represented to purchasers, and because of its price.43 Also, according to Domestic Producers, information in recent administrative reviews of the Order indicating that no importers entered steel plate from the PRC into the United States as subject merchandise, supports the belief that the ultimate users of CTL plate are consuming plates with elevated levels of boron, chromium and titanium, in place of steel plate without elevated levels of boron, chromium and titanium.44

    43See Domestic Producers' Request at 17-19 and the Alloying Elements Circumvention BPI Memorandum at Note 7.

    44See Third Supplemental Submission at 7-8.

    Use of the Merchandise

    Domestic Producers argued that the product at issue is used for the same purposes as subject merchandise.45 Domestic Producers claimed that adding alloys to commodity-grade steel plate has no commercial or metallurgical purpose other than to change the tariff classification in the HTSUS.46 Domestic Producers stated that the CTL plate at issue with elevated alloy levels is still classified as ASTM A36 and A572 plate, and thus is not suitable for additional uses beyond those of commodity-grade plate with these specifications.47 Domestic Producers also contended that the addition of elevated levels of alloying elements are only useful when steel plate is heat treated, which has a substantial cost, and PRC producers are not heat treating the steel plates at issue.48 Specifically, Domestic Producers claim that commodity-grade carbon steel plate of ASTM specifications A36 and A572 is generally not heat-treated.49

    45See Domestic Producers' Request at 19-20.

    46See Second Supplemental Submission at 7-8.

    47See Domestic Producers' Request at 19-20.

    48See First Supplemental Submission at 10-12, 15-17.

    49Id. at 14, 17, 23-24; see also Alloying Elements Circumvention BPI Memorandum at Note 8.

    Channels of Marketing

    Domestic Producers stated that PRC producers market the CTL plate at issue in the same manner as the CTL plate without the alloying elements.50 According to Domestic Producers, the CTL plate at issue and subject plate appeal to the same end users and are used for the same end uses.51

    50See Domestic Producers' Request at 20.

    51Id. and Alloying Elements Circumvention BPI Memorandum at Note 9.

    Cost of Modification

    Domestic Producers claimed that the cost of adding only small amounts of alloying elements is small when compared to the total cost of production and total value of CTL plate.52 In particular, Domestic Producers noted that the Department determined in CTL Plate from Canada that the cost of adding alloying elements is minor relative to the total value of the merchandise.53 Also, as noted above, Domestic Producers contended that alloying elements are only useful when steel plate is heat treated, which has a substantial cost; however, PRC producers are not heat treating the steel plate at issue.54

    52See Domestic Producers' Request at 20.

    53Id. at 20-21.

    54See First Supplemental Submission at 10-12, 15-17.

    Conclusion

    Based on the information provided by Domestic Producers, the Department finds there is sufficient basis to initiate an antidumping duty circumvention inquiry, pursuant to section 781(c) of the Act, to determine whether CTL plate from the PRC made to ASTM A36 or A572 specifications with levels of chromium or titanium above the levels identified in note (f), “Other alloy steel”, of Chapter 72 of the HTSUS involves a minor alteration to subject merchandise that is so insignificant as to render the resulting merchandise (classified as “alloy” steel under the HTSUS) subject to the Order. We also find sufficient basis to initiate an antidumping duty circumvention inquiry, pursuant to section 781(c) of the Act, to determine whether CTL plate from the PRC made to ASTM A36 or A572 specifications which contains levels of boron above the levels identified in note (f) of Chapter 72 of the HTSUS and which has not been heat treated to meet tensile and hardness requirements beyond commodity-grade ASTM specifications involves a minor alteration to subject merchandise that is so insignificant as to render the resulting merchandise (classified as “alloy” steel under the HTSUS) subject to the Order.

    Although Domestic Producers requested a circumvention inquiry with respect to all of the alloying elements identified in note (f), “Other alloy steel”, of Chapter 72 of the HTSUS, we limited initiation to the alloys noted above (chromium, titanium, and boron where there was no heat treatment) based on the evidence of alleged circumvention provided. Moreover, we have not described the merchandise subject to this inquiry as steel plate marketed, priced or sold in the United States as commodity-grade carbon steel plate or made to specifications considered to be carbon steel specifications in the market because of concerns over the administrability of that language (e.g., difficulties determining whether certain prices are commodity-grade carbon steel plate prices, the lack of clarity with respect to which specifications should be considered to be carbon steel specifications). Based on the evidence of alleged circumvention provided, and Domestic Producers' statement that 80 percent of the market for commodity-grade carbon steel plate meets ASTM specifications A36 and A572, we have described the merchandise subject to this inquiry as CTL plate from the PRC made to ASTM A36 or A572 specifications. Lastly, as noted above, the Department intends to apply its circumvention ruling to all U.S. imports of CTL plate from the PRC, consistent with the recent history of this proceeding.55

    55See Wuyang Circumvention Final Determination, 76 FR at 50997.

    Although Domestic Producers requested that the Department make a final ruling within 45 days, additional time is needed for further inquiry into Domestic Producers' allegations. The Department intends to issue its final determination within 300 days of the date of the initiation of this antidumping duty circumvention inquiry.

    The Department will not order the suspension of liquidation of entries of any of the merchandise at issue at this time. However, in accordance with 19 CFR 351.225(l)(2), if the Department issues a preliminary affirmative determination, we will then instruct CBP to suspend liquidation and require a cash deposit of estimated duties, at the applicable rate, for each unliquidated entry of the merchandise at issue, entered, or withdrawn from warehouse for consumption, on or after the date of initiation of the inquiry.

    The Department will establish a schedule for questionnaires and comments on the issues.

    This notice is published in accordance with section 781(c) of the Act and 19 CFR 351.225(i).

    Dated: February 10, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-03418 Filed 2-17-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE408 Whaling Provisions; Aboriginal Subsistence Whaling Quotas AGENCY:

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

    ACTION:

    Notice; notification of quota for bowhead whales.

    SUMMARY:

    NMFS notifies the public of the aboriginal subsistence whaling quota for bowhead whales that it has assigned to the Alaska Eskimo Whaling Commission (AEWC), and of limitations on the use of the quota deriving from regulations of the International Whaling Commission (IWC). For 2016, the quota is 75 bowhead whales struck. This quota and other applicable limitations govern the harvest of bowhead whales by members of the AEWC.

    DATES:

    Effective February 18, 2016.

    ADDRESSES:

    Office for International Affairs and Seafood Inspection, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910.

    FOR FURTHER INFORMATION CONTACT:

    Melissa Andersen Garcia, (301) 427-8385.

    SUPPLEMENTARY INFORMATION:

    Aboriginal subsistence whaling in the United States is governed by the Whaling Convention Act (WCA) (16 U.S.C. 916 et seq.). Under the WCA, IWC regulations shall generally become effective with respect to all persons and vessels subject to the jurisdiction of the United States, within 90 days of notification from the IWC Secretariat of an amendment to the IWC Schedule (16 U.S.C. 916k). Regulations that implement the WCA, found at 50 CFR 230.6, require the Secretary of Commerce (Secretary) to publish, at least annually, aboriginal subsistence whaling quotas and any other limitations on aboriginal subsistence whaling deriving from regulations of the IWC.

    At the 64th Annual Meeting of the IWC, the Commission set catch limits for aboriginal subsistence use of bowhead whales from the Bering-Chukchi-Beaufort Seas stock. The bowhead catch limits were based on a joint request by the United States and the Russian Federation, accompanied by documentation concerning the needs of two Native groups: Alaska Eskimos and Chukotka Natives in the Russian Far East.

    The IWC set a 6-year block catch limit of 336 bowhead whales landed. For each of the years 2013 through 2018, the number of bowhead whales struck may not exceed 67, except that any unused portion of a strike quota from any prior year may be carried forward. No more than 15 strikes may be added to the strike quota for any one year. At the end of the 2015 harvest, there were 15 unused strikes available for carry-forward, so the combined strike quota set by the IWC for 2016 is 82 (67 + 15).

    An arrangement between the United States and the Russian Federation ensures that the total quota of bowhead whales landed and struck in 2016 will not exceed the limits set by the IWC. Under this arrangement, the Russian natives may use no more than seven strikes, and the Alaska Eskimos may use no more than 75 strikes.

    Through its cooperative agreement with the AEWC, NOAA has assigned 75 strikes to the Alaska Eskimos. The AEWC will in turn allocate these strikes among the 11 villages whose cultural and subsistence needs have been documented, and will ensure that its hunters use no more than 75 strikes.

    Other Limitations

    The IWC regulations, as well as the NOAA regulation at 50 CFR 230.4(c), forbid the taking of calves or any whale accompanied by a calf.

    NOAA regulations (at 50 CFR 230.4) contain a number of other prohibitions relating to aboriginal subsistence whaling, some of which are summarized here:

    • Only licensed whaling captains or crew under the control of those captains may engage in whaling.

    • Captains and crew must follow the provisions of the relevant cooperative agreement between NOAA and a Native American whaling organization.

    • The aboriginal hunters must have adequate crew, supplies, and equipment to engage in an efficient operation.

    • Crew may not receive money for participating in the hunt.

    • No person may sell or offer for sale whale products from whales taken in the hunt, except for authentic articles of Native American handicrafts.

    • Captains may not continue to whale after the relevant quota is taken, after the season has been closed, or if their licenses have been suspended. They may not engage in whaling in a wasteful manner.

    Dated: February 11, 2016. John Henderschedt, Director, Office for International Affairs and Seafood Inspection, National Marine Fisheries Service.
    [FR Doc. 2016-03366 Filed 2-17-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0649-XE447 Gulf of Mexico Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The Gulf of Mexico Fishery Management Council will hold a meeting of its Standing and Special Shrimp Scientific and Statistical Committee (SSC).

    DATES:

    The meeting will convene via WEBINAR on Tuesday, March 8, 2016 from 1 p.m. to 3 p.m. EST; you may register for the webinar at: https://attendee.gotowebinar.com/register/1004643937909180674.

    After registering, you will receive a confirmation email containing information about joining the webinar.

    ADDRESSES:

    Council address: Gulf of Mexico Fishery Management Council, 2203 N. Lois Avenue, Suite 1100, Tampa, FL 33607; telephone: (813) 348-1630.

    FOR FURTHER INFORMATION CONTACT:

    Morgan Kilgour, Fishery Biologist, [email protected]; Gulf of Mexico Fishery Management Council telephone: (813) 348-1630.

    SUPPLEMENTARY INFORMATION: Agenda

    The Chairman will start the meeting with introductions and adoption of agenda, approval of minutes from the March 10-12, 2015 Standing, Special Reef Fish, Special Shrimp, and Special Spiny Lobster Scientific and Statistical Committee (SSC) meeting, and selection of an SSC representative to attend the April, 2016 Council Meeting. The SSC will review updated Penaeid Shrimp Stock Assessments and review an update on the Aggregate Maximum Sustainable Yield (MSY) and Optimum Yield (OY) Working Group. Lastly, the SSC will discuss other business, if any.

    —Meeting Adjourns—

    The Agenda is subject to change, and the latest version along with other meeting materials will be posted on the Council's file server. To access the file server, the URL is https://public.gulfcouncil.org:5001/webman/index.cgi, or go to the Council's Web site and click on the FTP link in the lower left of the Council Web site (http://www.gulfcouncil.org). The username and password are both “gulfguest.” Click on the “Library Folder,” then scroll down to “SSC meeting-2016-03.”

    The meeting will be webcast over the internet. A link to register for the webcast is available on the Council's Web site, http://www.gulfcouncil.org.

    Although other non-emergency issues not on the agenda may come before the Scientific and Statistical Committee for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Scientific and Statistical Committee will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Gulf Council Office (see ADDRESSES), at least 5 working days prior to the meeting.

    Dated: February 12, 2016. Tracy Thompson, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-03339 Filed 2-17-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE446 Gulf of Mexico Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The Gulf of Mexico Fishery Management Council will hold a meeting of its Ad Hoc Red Snapper Charter Advisory Panel (AP).

    DATES:

    The meeting will convene Tuesday, March 8, 2016 from 8:30 a.m. to 5 p.m., and Wednesday, March 9, 2016 from 8:30 a.m. to 12 p.m.

    ADDRESSES:

    The meeting will take place at the Gulf of Mexico Fishery Management Council, 2203 N. Lois Avenue, Suite 1100, Tampa, FL 33607; telephone: (813) 348-1630.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Ava Lasseter, Anthropologist, Gulf of Mexico Fishery Management Council; [email protected]; telephone: (813) 348-1630.

    SUPPLEMENTARY INFORMATION: Agenda

    The items of discussion on the agenda are as follows:

    Ad Hoc Red Snapper Charter Advisory Panel Agenda, Tuesday, March 8, 2016 from 8:30 a.m. to 5 p.m., and Wednesday, March 9, 2016 from 8:30 a.m. to 12 p.m.

    I. Adoption of Agenda II. Approval of May 2015 Ad Hoc Red Snapper Charter AP meeting summary III. Overview of Draft Amendment 41 IV. Program Goals and Objectives V. Recommendations to the Council on the design of a Red Snapper Management Program for Charter Vessels VI. Other Business —Meeting Adjourns—

    The Agenda is subject to change, and the latest version along with other meeting materials will be posted on the Council's file server. To access the file server, the URL is https://public.gulfcouncil.org:5001/webman/index.cgi, or go to the Council's Web site and click on the File Server link in the lower left of the Council Web site (http://www.gulfcouncil.org). The username and password are both “gulfguest.” Click on the “Library Folder,” then scroll down to “Ad Hoc Red Snapper Charter AP.”

    The meeting will be webcast over the Internet. A link to the ebcast will be available on the Council's Web site, http://www.gulfcouncil.org.

    Although other non-emergency issues not on the agenda may come before the Advisory Panel for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Advisory Panel will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Gulf Council Office (see ADDRESSES), at least 5 working days prior to the meeting.

    Dated: February 12, 2016. Tracy Thompson, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-03337 Filed 2-17-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE421 Atlantic Highly Migratory Species; Meeting of the Atlantic Highly Migratory Species Advisory Panel AGENCY:

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

    ACTION:

    Notice of public meeting and webinar/conference call.

    SUMMARY:

    NMFS will hold a 3-day Atlantic Highly Migratory Species (HMS) Advisory Panel (AP) meeting in March 2016. The intent of the meeting is to consider options for the conservation and management of Atlantic HMS. The meeting is open to the public.

    DATES:

    The AP meeting and webinar will be held from 10:30 a.m. to 6 p.m. on Tuesday, March 29, 2016; from 8:30 a.m. to 6 p.m. on Wednesday, March 30, 2016; and from 8:30 a.m. to 12 p.m. on Thursday, March 31, 2016. There will be an introduction for new AP members at 9 a.m. on Tuesday, March 29, 2016.

    ADDRESSES:

    The meeting will be held at the DoubleTree by Hilton Hotel, 8120 Wisconsin Avenue, Bethesda, MD 20814. The meeting presentations will also be available via WebEx webinar/conference call.

    On Tuesday, March 29, 2016, the conference call information is phone number 1-888-566-6157; Participant Code: 5998985; and the webinar event address is: https://noaaevents2.webex.com/noaaevents2/onstage/g.php?MTID=ee08141a7a0cf50251a257df9d3b931fa; event password: NOAA.

    On Wednesday, March 30, 2016, the conference call information is phone number 1-888-282-0431; Participant Code: 9825698; and the webinar event address is: https://noaaevents2.webex.com/noaaevents2/onstage/g.php?MTID=ee29585c757454c5e48b292d7dc2fc95f; event password: NOAA.

    On Thursday, March 31, 2016, the conference call information is phone number 1-800-593-9960; Participant Code: 5039500; and the webinar event address is: https://noaaevents2.webex.com/noaaevents2/onstage/g.php?MTID=e9dc5e094b476fc2b3621dfbe73e9cd6c; event password: NOAA.

    Participants are strongly encouraged to log/dial in fifteen minutes prior to the meeting. NMFS will show the presentations via webinar and allow public comment during identified times on the agenda.

    FOR FURTHER INFORMATION CONTACT:

    Guy DuBeck or Margo Schulze-Haugen at (301) 427-8503.

    SUPPLEMENTARY INFORMATION:

    The Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1801 et seq., as amended by the Sustainable Fisheries Act, Public Law 104-297, provided for the establishment of an AP to assist in the collection and evaluation of information relevant to the development of any Fishery Management Plan (FMP) or FMP amendment for Atlantic HMS. NMFS consults with and considers the comments and views of AP members when preparing and implementing FMPs or FMP amendments for Atlantic tunas, swordfish, billfish, and sharks.

    The AP has previously consulted with NMFS on: Amendment 1 to the Billfish FMP (April 1999); the HMS FMP (April 1999); Amendment 1 to the HMS FMP (December 2003); the Consolidated HMS FMP (October 2006); and Amendments 1, 2, 3, 4, 5a, 5b, 6, 7, 8, and 9 to the 2006 Consolidated HMS FMP (April and October 2008, February and September 2009, May and September 2010, April and September 2011, March and September 2012, January and September 2013, April and September 2014, March and September 2015), among other things.

    The intent of this meeting is to consider alternatives for the conservation and management of all Atlantic tunas, swordfish, billfish, and shark fisheries. We anticipate discussing the upcoming Amendments 5b on dusky sharks and 10 on Essential Fish Habitat, including lemon shark aggregations off southeast Florida; reviewing implementation of Final Amendment 9 on smoothhound sharks and Final Amendment 7 on bluefin tuna management; and progress updates on the final rule to implement the electronic bluefin tuna documentation system and the various other rulemakings. We also anticipate discussing a survey of Atlantic HMS tournaments that is in development, a request from the South Atlantic Fishery Management Council to consider management changes regarding blacknose sharks, and domestic implementation of recommendations from the 2015 meeting of the International Commission for the Conservation of Atlantic Tunas. We also intend to invite other NMFS offices to provide updates on their activities relevant to HMS fisheries such as the IUU Task Force implementation and international trade, and DeepWater Horizon Pelagic Longline Project.

    Additional information on the meeting and a copy of the draft agenda will be posted prior to the meeting at: http://www.nmfs.noaa.gov/sfa/hms/advisory_panels/hms_ap/meetings/ap_meetings.html.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Guy DuBeck at (301) 427-8503 at least 7 days prior to the meeting.

    Dated: February 11, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-03272 Filed 2-17-16; 8:45 am] BILLING CODE 3510-22-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION [Docket No: CFPB-2016-0007] Agency Information Collection Activities: Comment Request; Emergency Processing Request AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice and request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is proposing a new information collection titled, “Application Process for Designation of Rural Area under Federal Consumer Financial Law.”

    DATES:

    An emergency review has been requested in accordance with the PRA (44 U.S.C. Chapter 3507(j)). Approval by the Office of Management and Budget (OMB) has been requested by February 29, 2016. A standard PRA clearance process is also beginning. Interested persons are invited to submit comments on or before April 18, 2016.

    ADDRESSES:

    You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:

    Electronic: http://www.regulations.gov. Follow the instructions for submitting comments.

    Mail: Consumer Financial Protection Bureau (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552.

    Hand Delivery/Courier: Consumer Financial Protection Bureau (Attention: PRA Office), 1275 First Street NE., Washington, DC 20002.

    Please note that comments submitted after the comment period will not be accepted. In general, all comments will become public records, including any personal information provided. Sensitive personal information, such as account numbers or social security numbers, should not be included.

    FOR FURTHER INFORMATION CONTACT:

    Documentation prepared in support of this information collection request is available at www.regulations.gov. Requests for additional information should be directed to the Consumer Financial Protection Bureau, (Attention: PRA Office), 1700 G Street, NW., Washington, DC 20552, (202) 435-9575, or email: [email protected] Please do not submit comments to this mailbox.

    SUPPLEMENTARY INFORMATION:

    Title of Collection: Application Process for Designation of Rural Area under Federal Consumer Financial Law.

    OMB Control Number: 3170-XXXX.

    Type of Review: New collection (Request for a new OMB control number).

    Affected Public: Private sector (banks and credit unions).

    Estimated Number of Respondents: 1.

    Estimated Total Annual Burden Hours: 5.

    Abstract: On December 4, 2015, Congress passed the Helping Expand Lending Practices in Rural Communities Act of 2015 (HELP Rural Communities Act or the Act) Public Law 114-94, Title LXXXIX (2015). Section 89002 requires the Bureau to establish, within 90 days of its passage, a procedure by which persons and businesses may apply to have a geographic area designated as “rural” for the purposes of applying federal consumer protection law and certain exceptions related to areas so designated.

    Due to the 90-day deadline, contained in the Act, if following standard PRA clearance procedures, the Bureau would be unable to meet this statutory deadline. In order to meet the statutory deadline, the Bureau plans to issue the enabling procedural rule by March 3, 2016. Therefore, the Bureau is requesting emergency processing and approval of the following information collection request.

    The Bureau requests OMB approval of this request by February 29, 2016. Contemporaneously with this request for emergency processing, the Bureau is also initiating standard clearance procedures by publishing a notice in the Federal Register allowing the public 60 days to comment on this collection of information. Accordingly, this request will also be resubmitted to OMB under standard clearance procedures.

    Request for Comments: Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record.

    Dated: February 12, 2016. Darrin A. King, Paperwork Reduction Act Officer, Bureau of Consumer Financial Protection.
    [FR Doc. 2016-03422 Filed 2-17-16; 8:45 am] BILLING CODE 4810-AM-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION [Docket No: CFPB-2016-0006] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice and request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is requesting to renew the Office of Management and Budget (OMB) approval for an existing information collection, titled, “Loan Originator Compensation Amendment (Regulation Z).”

    DATES:

    Written comments are encouraged and must be received on or before March 21, 2016 to be assured of consideration.

    ADDRESSES:

    You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:

    Electronic: http://www.regulations.gov. Follow the instructions for submitting comments.

    OMB: Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503 or fax to (202) 395-5806. Mailed or faxed comments to OMB should be to the attention of the OMB Desk Officer for the Bureau of Consumer Financial Protection.

    Please note that comments submitted after the comment period will not be accepted. In general, all comments received will become public records, including any personal information provided. Sensitive personal information, such as account numbers or social security numbers, should not be included.

    FOR FURTHER INFORMATION CONTACT:

    Documentation prepared in support of this information collection request is available at www.reginfo.gov (this link active on the day following publication of this notice). Select “Information Collection Review,” under “Currently under review, use the dropdown menu “Select Agency” and select “Consumer Financial Protection Bureau” (recent submissions to OMB will be at the top of the list). The same documentation is also available at http://www.regulations.gov. Requests for additional information should be directed to the Consumer Financial Protection Bureau, (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552, (202) 435-9575, or email: [email protected] Please do not submit comments to this email box.

    SUPPLEMENTARY INFORMATION:

    Title of Collection: Loan Originator Compensation Amendment (Regulation Z).

    OMB Control Number: 3170-0031.

    Type of Review: Extension without change of a currently approved collection.

    Affected Public: Private sector.

    Estimated Number of Respondents: 8,254.

    Estimated Total Annual Burden Hours: 94,635.

    Abstract: The Truth in Lending Act (TILA), 15 U.S.C. 1601 et seq., was enacted to foster comparison credit shopping and informed credit decision making by requiring accurate disclosure of the costs and terms of credit to consumers. The Dodd-Frank Act then amended TILA to include, among other things, provisions about the qualifications and compensation of mortgage loan officers, in order to ensure consumers are getting a fair deal on their loans.

    Request for Comments: The Bureau issued a 60-day Federal Register notice on December 9, 2015 (80 FR 76459). Comments were solicited and continue to be invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record.

    Dated: February 11, 2016. Darrin A. King, Paperwork Reduction Act Officer, Bureau of Consumer Financial Protection.
    [FR Doc. 2016-03424 Filed 2-17-16; 8:45 am] BILLING CODE 4810-AM-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DoD-2015-OS-0090] Defense Personal Property Program (DP3) AGENCY:

    United States Transportation Command (USTRANSCOM), DoD.

    ACTION:

    Notice.

    SUMMARY:

    The DoD is not proceeding with the proposed Defense Personal Property Program (DP3) Household Goods Channeling Pilot Test, as set forth in the September 8, 2015 notice (80 FR 53786). We appreciate all inputs made toward providing the information necessary to reach this conclusion.

    Dated: February 11, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-03290 Filed 2-17-16; 8:45 am] BILLING CODE 5001-06-P
    DEFENSE NUCLEAR FACILITIES SAFETY BOARD Sunshine Act Notice AGENCY:

    Defense Nuclear Facilities Safety Board.

    ACTION:

    Notice of closed meeting.

    SUMMARY:

    Pursuant to the provisions of the Government in the Sunshine Act (5 U.S.C. 552b), and the Defense Nuclear Facilities Safety Board's (Board) regulations implementing the Government in the Sunshine Act, notice is hereby given of the Board's closed meeting described below.

    DATES:

    3:00 p.m.-4:00 p.m., February 25, 2016.

    ADDRESSES:

    Defense Nuclear Facilities Safety Board, 625 Indiana Avenue NW., Washington, DC 20004.

    FOR FURTHER INFORMATION CONTACT:

    Mark Welch, General Manager, Defense Nuclear Facilities Safety Board, 625 Indiana Avenue NW., Suite 700, Washington, DC 20004-2901, (800) 788-4016. This is a toll-free number.

    SUPPLEMENTARY INFORMATION:

    The meeting will be closed to the public. No participation from the public will be considered during the meeting.

    Status

    Closed. During the closed meeting, the Board Members will discuss issues dealing with potential Recommendations to the Secretary of Energy. The Board is invoking the exemption to close a meeting described in 5 U.S.C. 552b(c)(3) and (9)(B) and 10 CFR 1704.4(c) and (h). The Board has determined that it is necessary to close the meeting since conducting an open meeting is likely to disclose matters that are specifically exempted from disclosure by statute, and/or be likely to significantly frustrate implementation of a proposed agency action. In this case, the deliberations will pertain to potential Board Recommendations which, under 42 U.S.C. 2286d(b) and (h)(3), may not be made publicly available until after they have been received by the Secretary of Energy or the President, respectively.

    Matters To Be Considered: The meeting will proceed in accordance with the closed meeting agenda which is posted on the Board's public Web site at www.dnfsb.gov. Technical staff may present information to the Board. The Board Members are expected to conduct deliberations regarding potential Recommendations to the Secretary of Energy.

    Dated: February 12, 2016. Joyce L. Connery, Chairman.
    [FR Doc. 2016-03499 Filed 2-16-16; 4:15 pm] BILLING CODE 3670-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0020] Agency Information Collection Activities; Comment Request; Integrated Postsecondary Education Data System (IPEDS) 2016-2019 AGENCY:

    National Center for Education Statistics (NCES), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before April 18, 2016.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2016-ICCD-0020. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 2E-103, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Kashka Kubzdela at [email protected]

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Integrated Postsecondary Education Data System (IPEDS) 2016-2019.

    OMB Control Number: 1850-0582.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 77,600.

    Total Estimated Number of Annual Burden Hours: 999,060.

    Abstract: The National Center for Education Statistics (NCES) seeks authorization from OMB to continue the Integrated Postsecondary Education Data System (IPEDS) data collection. Current authorization expires 12/31/2016 (OMB No. 1850-0582). We are requesting a new clearance for the 2016-17, 2017-18, and 2018-19 data collections to enable us to provide consistency in our collection of postsecondary data over the next 3 years. IPEDS is a Web-based data collection system designed to collect basic data from all postsecondary institutions in the United States and the other jurisdictions. IPEDS enables NCES to report on key dimensions of postsecondary education such as enrollments, degrees and other awards earned, tuition and fees, average net price, student financial aid, graduation rates, student outcomes, revenues and expenditures, faculty salaries, and staff employed. The IPEDS Web-based data collection system was implemented in 2000-01, and it collects basic data from approximately 7,500 postsecondary institutions in the United States and the other jurisdictions that are eligible to participate in Title IV Federal financial aid programs. All Title IV institutions are required to respond to IPEDS (Section 490 of the Higher Education Amendments of 1992 [Pub. L. 102-325]). IPEDS allows other (non-title IV) institutions to participate on a voluntary basis. About 200 elect to respond. IPEDS data are available to the public through the College Navigator and IPEDS Data Center Web sites. This clearance package includes a number of proposed changes to the data collection.

    Dated: February 12, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management.
    [FR Doc. 2016-03338 Filed 2-17-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION National Assessment Governing Board Quarterly Board Meeting AGENCY:

    National Assessment Governing Board, U.S. Department of Education.

    ACTION:

    Announcement of open and closed meetings.

    SUMMARY:

    This notice sets forth the agenda for the March 3-5, 2016 Quarterly Meeting of the National Assessment Governing Board (hereafter referred to as Governing Board). This notice provides information to members of the public who may be interested in attending the meeting or providing written comments on the meeting. The notice of this meeting is required under section 10(a)(2) of the Federal Advisory Committee Act (FACA).

    DATES:

    The Quarterly Board meeting will be held on the following dates:

    • March 3, 2016 from 2:30 p.m. to 6:00 p.m.

    • March 4, 2016 from 8:30 a.m. to 5:00 p.m.

    • March 5, 2016 from 7:30 a.m. to 12:00 p.m.

    ADDRESSES:

    Hilton Arlington, 950 Stafford Street, Arlington, VA 22203.

    FOR FURTHER INFORMATION CONTACT:

    Munira Mwalimu, Executive Officer/Designated Federal Official, 800 North Capitol Street NW., Suite 825, Washington, DC 20002, telephone: (202) 357-6938, fax: (202) 357-6945.

    SUPPLEMENTARY INFORMATION:

    Statutory Authority and Function: The National Assessment Governing Board is established under title III—National Assessment of Educational Progress Authorization Act, Public Law 107-279. Information on the Board and its work can be found at www.nagb.gov.

    The Board is established to formulate policy for the National Assessment of Educational Progress (NAEP). The Board's responsibilities include the following: selecting subject areas to be assessed, developing assessment frameworks and specifications, developing appropriate student achievement levels for each grade and subject tested, developing standards and procedures for interstate and national comparisons, improving the form and use of NAEP, developing guidelines for reporting and disseminating results, and releasing initial NAEP results to the public.

    March 3-5, 2016 Committee Meetings

    The Board's standing committees will meet to conduct regularly scheduled work, based on agenda items planned for this quarterly Board meeting, and follow-up items as reported in the Board's committee meeting minutes available at http://nagb.gov/what-we-do/board-committee-reports-and-agendas.html.

    Detailed Meeting Agenda: March 3-5, 2016

    March 3: Inside NAEP: Taking the NAEP Technology and Engineering Literacy Assessment: Closed Session: 2:30 p.m.-4:00 p.m.

    March 3: Executive Committee: Closed Session: 4:30 p.m.-5:20 p.m.; Open Session: 5:20 p.m.-6:00 p.m.

    March 4: Full Board Meeting

    Full Board: Open Session: 8:30 a.m.-10:00 a.m.; Closed Session: 1:00 p.m.-2:30 p.m.; Open Session 3:00 p.m.-5:00 p.m.

    March 4: Committee Meetings

    Reporting and Dissemination Committee (R&D): Open Session 10:15 a.m.-12:00 p.m.; Closed Session 12:05 p.m.-12:35 p.m.; Open Session 12:35 p.m. -12:45 p.m.

    Assessment Development Committee (ADC): Open Session: 10:15 a.m.-10:50 a.m.; Closed Session: 10:50 a.m.-12:45 p.m.

    Committee on Standards, Design and Methodology (COSDAM): Open Session: 10:15 a.m.-11:20 a.m.; Closed Session: 11:20 a.m.-12:25 p.m.; Open Session: 12:25 p.m.-12:45 p.m.

    March 5: Full Board and Committee Meetings

    Nominations Committee: Closed Session: 7:30 a.m.-8:15 a.m.

    Full Board: Closed Session: 8:30 a.m.-8:50 a.m.; Open Session: 8:50 a.m.-10:45 a.m.; Closed Session: 11:00 a.m.-12:00 p.m.

    On March 3, 2016, the Board will meet in closed session from 2:30 p.m.-4:00 p.m. to take the 2014 NAEP Technology and Engineering Literacy (TEL) assessment for grade 8. Board members will access secure NAEP TEL items used in the 2014 TEL assessment. This part of the meeting must be conducted in closed session because the test items are secure and have not been released to the public. Public disclosure of the secure TEL items would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.

    Thereafter, the Executive Committee will convene in closed session from 4:30 p.m. to 5:20 p.m., and in open session to conduct regularly scheduled work from 5:20 p.m. to 6:00 p.m. During the closed session, the Executive Committee will receive and discuss cost estimates and implications for implementing NAEP's Assessment Schedule through 2024. This meeting must be conducted in closed session because public disclosure of this information would likely have an adverse financial effect on the NAEP program by providing confidential cost details and proprietary contract costs of current contractors to the public. Discussion of this information would be likely to significantly impede implementation of a proposed agency action if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.

    On March 4, 2016, the Full Board will meet in open session from 8:30 a.m. to 10:00 a.m. The Board will review and approve the March 3-5, 2016 Board meeting agenda and meeting minutes from the November 2015 Quarterly Board meeting. This session will be followed by new Board member introductions and administration of the Oath of Office for new members. The Chairman will then deliver remarks on the Salzburg Global Seminar. Thereafter the Executive Director of the Governing Board, William Bushaw, will provide his report, followed by an update on the work of IES provided by Ruth Neild, Deputy Director for Policy and Research, IES. The NCES update will be provided by the Acting Commissioner of NCES, Peggy Carr. The Board will recess for committee meetings at 10:00 a.m. which are scheduled to take place from 10:15 a.m. to 12:45 p.m.

    The Reporting and Dissemination (R&D) Committee will meet in open session from 10:15 a.m. to 12:00 p.m. and in closed session from 12:05 p.m. to 12:35 p.m. and thereafter in open session from 12:35 p.m. to 12:45 p.m. During the closed session, the Committee will preview and discuss a prototype of the Web site that will host results of the 12th grade NAEP reading and mathematics assessments. The data from these assessments have not been released and will not be released until a month after the Board meeting. This session must be closed because the Web site will display secure data that have not been released to the public and members will discuss the secure data. Disclosure of the secure data would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.

    The Assessment Development Committee (ADC) will meet open session from 10:15 a.m. to 10:50 a.m., and in two closed sessions from 10:50 a.m. to 12:45 p.m. During the first closed session, scheduled from 10:50 a.m. to 12:00 p.m., the ADC will review secure NAEP test questions in grades 4 and 8 for the 2019 Mathematics pilot assessment. These test questions have not been released to the public. Disclosure of the secure data would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.

    During the second closed session scheduled from 12:00 p.m. to 12:45 p.m. ADC will receive an embargoed briefing on NAEP's transition to digital-based assessment (DBA). The briefing will include secure data from the 2015 DBA pilot in Reading and Mathematics, which have not been publicly released. The briefing will also include secure NAEP test questions in Reading and Mathematics at grades 4 and 8. This meeting is being conducted in closed session because the data have not been released to the public. Public disclosure of the secure data would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.

    On Friday March 4, 2016, the Committee on Standards, Design and Methodology (COSDAM) will meet in open session from 10:15 a.m. to 11:20 a.m. in closed session from 11:20 a.m. to 12:25 p.m. and in open session from 12:25 p.m. to 12:45 p.m. During the first part of the closed session (11:20 a.m. to 12:05 p.m.), COSDAM will discuss information regarding analyses of the 2015 bridge studies for paper-and-pencil and digital-based assessments, and discuss secure NAEP Reading and Mathematics data. This part of the meeting must be conducted in closed session because the analysis involves the use of secure data for the NAEP Reading and Mathematics assessments on digital-based platforms. Public disclosure of secure data would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.

    During the second part of the closed session from 12:05 p.m. to 12:25 p.m., COSDAM will discuss requirements for an upcoming procurement to set achievement levels on the 2017 grade 4 Writing assessment. Public disclosure of procurement sensitive data would provide an unfair advantage to potential offerors, and significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.

    Following the committee meetings, on March 4, the full Board will meet in closed session from 1:00 p.m. to 2:30 p.m. to receive a briefing and discuss the 2014 NAEP Technology and Engineering Literacy (TEL) Report Card for Grade 8. Results of the TEL assessment have not been released to the public. Premature disclosure of the results would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of 552b of title 5 U.S.C.

    On March 4, 2016, from 3:00 p.m. to 4:00 p.m., the Board will meet in open session to receive a briefing on STEM perspectives from the Frameworks Institute. This session will then be followed by a briefing and discussion with Hill staff on legislative matters as they pertain to education policy issues and NAEP. The March 4, 2016 session of the Board meeting will adjourn at 5:00 p.m.

    On March 5, 2016, the Nominations Committee will meet in closed session from 7:30 a.m. to 8:15 a.m. to discuss the final slate of candidates for Board vacancies for terms beginning on October 1, 2016. The Nominations Committee's discussions pertain solely to internal personnel rules and practices of an agency and information of a personal nature where disclosure would constitute an unwarranted invasion of personal privacy. As such, the discussions are protected by exemptions 2 and 6 of section 552b(c) of title 5 of the United States Code.

    On March 5, 2016, the full Board will meet in closed session from 8:30 a.m. to 8:50 a.m. to discuss the final slate of candidates for Board vacancies for terms beginning October 1, 2016. The Board's discussions pertain solely to internal personnel rules and practices of an agency and information of a personal nature where disclosure would constitute an unwarranted invasion of personal privacy. As such, the discussions are protected by exemptions 2 and 6 of section 552b(c) of title 5 of the United States Code.

    Following this closed session, the full Board will meet in open session from 8:50 a.m. to 9:00 a.m. to take action on the slate of candidates for the 2016 Board vacancies. From 9:15 a.m. to 9:45 a.m. the Board will receive committee reports and take action on the New Trial Urban Districts for 2017 and on the TEL Release Plan for Grade 8. Thereafter, from 9:45 a.m. to 10:45 a.m. the Board will receive an update and discuss the Governing Board's Strategic Planning Initiative.

    The Board will meet in closed session on March 5, 2016 from 11:00 a.m. to 12:00 p.m. to receive a briefing and discuss the 2015 NAEP Reading and Mathematics Report Cards for Grade 12. This meeting must be conducted in closed session because results of this assessment have not been released to the public. Public disclosure of test results would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of section 552b of title 5 U.S.C.

    The March 5, 2016 meeting is scheduled to adjourn at 12:00 p.m.

    Access to Records of the Meeting: Pursuant to FACA requirements, the public may also inspect the meeting materials at www.nagb.gov on Thursday, March 4, 2016 by 7:00 a.m. ET. The official verbatim transcripts of the public meeting sessions will be available for public inspection no later than 30 calendar days following the meeting.

    Reasonable Accommodations: The meeting site is accessible to individuals with disabilities. If you will need an auxiliary aid or service to participate in the meeting (e.g., interpreting service, assistive listening device, or materials in an alternate format), notify the contact person listed in this notice at least two weeks before the scheduled meeting date. Although we will attempt to meet a request received after that date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.

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

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

    Authority:

    Pub. L. 107-279, Title III—National Assessment of Educational Progress section 301.

    Dated: February 11, 2016. William J. Bushaw, Executive Director, National Assessment Governing Board, U.S. Department of Education.
    [FR Doc. 2016-03343 Filed 2-17-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2015-ICCD-0136] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Client Assistance Program (CAP) AGENCY:

    Office of Special Education and Rehabilitative Services (OSERS), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before March 21, 2016.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2015-ICCD-0136. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 2E115, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Jim Doyle, (202) 245-6630.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Client Assistance Program (CAP).

    OMB Control Number: 1820-0520.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 56.

    Total Estimated Number of Annual Burden Hours: 9.

    Abstract: This form is used by states to request funds to establish and carry out Client Assistance Programs (CAP). CAP is mandated by the Rehabilitation Act of 1973, as amended (Rehabilitation Act), to assist consumers and applicants in their relationships with projects, programs and services provided under the Rehabilitation Act including the Vocational Rehabilitation program.

    Dated: February 11, 2016. Tomakie Washington, Acting Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management.
    [FR Doc. 2016-03263 Filed 2-17-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Orders Granting Authority To Import and Export Natural Gas, To Import and Export Liquefied Natural Gas, and To Vacate Authorization During January 2016 FE Docket Nos. TOYOTA MOTOR ENGINEERING & MANUFACTURING NORTH AMERICA 15-109-NG SABINE PASS LIQUEFACTION, LLC 15-171-LNG APPLIED LNG TECHNOLOGIES, LLC 16-05-NG COAHUILA ENERGY 15-189-NG WHITE EAGLE TRADING, LLC 16-04-NG CANNAT ENERGY, INC. 15-184-NG BNP PARIBAS ENERGY CANADA CORP 15-176-NG FREEPORT LNG DEVELOPMENT, L.P 16-02-LNG BNP PARIBAS ENERGY TRADING GP 15-177-NG MERCURIA COMMODITIES CANADA CORPORATION 15-162-NG AGENCY:

    Office of Fossil Energy, Department of Energy.

    ACTION:

    Notice of orders.

    SUMMARY:

    The Office of Fossil Energy (FE) of the Department of Energy gives notice that during January 2016, it issued orders granting authority to import and export natural gas, to import and export liquefied natural gas (LNG), and to vacate authority. These orders are summarized in the attached appendix and may be found on the FE Web site at http://energy.gov/fe/listing-doefe-authorizationsorders-issued-2016. They are also available for inspection and copying in the U.S. Department of Energy (FE-34), Division of Natural Gas Regulation, Office of Regulation and International Engagement, Office of Fossil Energy, Docket Room 3E-033, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-9478. The Docket Room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.

    Issued in Washington, DC, on February 10, 2016. John A. Anderson, Director, Office of Regulation and International Engagement, Office of Oil and Natural Gas. APPENDIX DOE/FE Orders Granting Import/Export Authorizations 3695-A 01/19/16 15-109-NG Toyota Motor Engineering & Manufacturing North America Order vacating blanket authority to export natural gas to Mexico. 3767 01/13/16 15-171-LNG Sabine Pass Liquefaction, LLC Order granting blanket authority to export LNG by vessel from the Sabine Pass LNG Terminal located in Cameron Parish, Louisiana. 3771 01/19/16 16-05-NG Applied LNG Technologies, LLC Order granting blanket authority to export natural gas to Canada/Mexico. 3772 01/19/16 15-189-NG Coahuila Energy Order granting blanket authority to export natural gas to Mexico. 3773 01/19/16 16-04-NG White Eagle Trading, LLC Order granting blanket authority to export natural gas to Mexico. 3775 01/19/16 15-184-NG Cannat Energy, Inc Order granting blanket authority to import natural gas from Canada. 3776 01/19/16 15-176-NG BNP Paribas Energy Canada Corp Order granting blanket authority to import/export natural gas from/to Canada. 3777 01/19/16 16-02-LNG Freeport LNG Development, L.P. Order granting blanket authority to import LNG from various international sources by vessel. 3778 01/19/16 15-177-NG BNP Paribas Energy Trading GP Order granting blanket authority to import natural gas from Canada. 3779 01/28/16 15-162-LNG Mercuria Commodities Canada Corporation Order granting long-term authority to export natural gas to Canada.
    [FR Doc. 2016-03373 Filed 2-17-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: PR16-14-000.

    Applicants: NorthWestern Corporation.

    Description: Tariff filing per 284.123(b)(1),: Revised Rate Schedules for Transportation and Storage Service to be effective 1/1/2016; Filing Type: 1000.

    Filed Date: 1/27/16.

    Accession Number: 201601275251.

    Comments/Protests Due: 5 p.m. ET 2/17/16.

    Docket Numbers: PR16-15-000.

    Applicants: Columbia Gas of Maryland, Inc.

    Description: Tariff filing per 284.123(b)(1)/.: CMD SOC 1-28-2016 to be effective 1/1/2016; Filing Type: 980.

    Filed Date: 1/28/16.

    Accession Number: 201601285120.

    Comments/Protests Due: 5 p.m. ET 2/18/16.

    Docket Numbers: PR16-16-000.

    Applicants: Public Service Company of Colorado.

    Description: Tariff filing per 284.123(b)(1)/.: 20160128_PSCo SOR Eff 1-1-16 to be effective 1/1/2016; Filing Type: 980.

    Filed Date: 1/28/16.

    Accession Number: 201601285136.

    Comments/Protests Due: 5 p.m. ET 2/18/16.

    Docket Number: PR16-17-000.

    Applicants: Acadian Gas Pipeline System.

    Description: Tariff filing per 284.123(e) + (g): SOC Update per NAESB Nomination Timeline Language Requirement/FERC Order 809 to be effective 4/1/2016; Filing Type: 1280.

    Filed Date: 1/28/2016.

    Accession Number: 201601285248.

    Comments Due: 5 p.m. ET 2/18/16.

    284.123(g) Protests Due: 5 p.m. ET 3/28/16.

    Docket Number: PR16-18-000.

    Applicants: Cypress Gas Pipeline, LLC.

    Description: Tariff filing per 284.123(e) + (g): SOC Update per NAESB Nomination Timeline Language Requirement/FERC Order 809 to be effective 4/1/2016; Filing Type: 1280.

    Filed Date: 1/28/2016.

    Accession Number: 201601285251.

    Comments Due: 5 p.m. ET 2/18/16.

    284.123(g) Protests Due: 5 p.m. ET 3/28/16.

    Docket Numbers: PR16-19-000.

    Applicants: Southern California Gas Company.

    Description: Tariff filing per 284.123(b)(1)/.: Revision of Statement of Rates to be effective 1/28/2016; Filing Type: 980.

    Filed Date: 1/29/16.

    Accession Number: 201601295026.

    Comments/Protests Due: 5 p.m. ET 2/19/16.

    Docket Number: PR16-20-000.

    Applicants: Enterprise Texas Pipeline LLC.

    Description: Tariff filing per 284.123(e) + (g): SOC Update per NAESB Nomination Timeline Language Requirement/FERC Order 809 to be effective 4/1/2016; Filing Type: 1280.

    Filed Date: 1/29/2016.

    Accession Number: 201601295047.

    Comments Due: 5 p.m. ET 2/19/16.

    284.123(g) Protests Due: 5 p.m. ET 3/29/16.

    Docket Numbers: PR16-21-000.

    Applicants: Jefferson Island Storage & Hub, L.L.C.

    Description: Tariff filing per 284.123(e)/.224: JISH Revised Statement of Operating Terms and Conditions, Version 3.0.0 to be effective 4/1/2016; Filing Type: 770.

    Filed Date: 1/29/16.

    Accession Number: 201601295067.

    Comments/Protests Due: 5 p.m. ET 2/19/16.

    Docket Numbers: PR16-22-000.

    Applicants: Columbia Gas of Ohio, Inc.

    Description: Tariff filing per 284.123(b)(1)/.: COH SOC 1-29-2016 to be effective 12/31/2015; Filing Type: 980.

    Filed Date: 1/29/16.

    Accession Number: 201601295078.

    Comments/Protests Due: 5 p.m. ET 2/19/16.

    Docket Number: PR16-23-000.

    Applicants: Enterprise Intrastate LLC.

    Description: Tariff filing per 284.123(e) + (g): SOC Update per NAESB Nomination Timeline Language Requirement/FERC Order 809 to be effective 4/1/2016; Filing Type: 1280.

    Filed Date: 1/29/2016.

    Accession Number: 201601295146.

    Comments Due: 5 p.m. ET 2/19/16.

    284.123(g) Protests Due: 5 p.m. ET 3/29/16.

    Docket Numbers: PR16-24-000.

    Applicants: Bay Gas Storage Company, Ltd.

    Description: Tariff filing per 284.123/.224: Bay Gas Storage Company, Ltd. FERC Order No. 809 Compliance Filing to be effective 4/1/2016; Filing Type: 790.

    Filed Date: 1/29/16.

    Accession Number: 201601295185.

    Comments/Protests Due: 5 p.m. ET 2/19/16.

    Docket Numbers: RP16-587-000.

    Applicants: Vector Pipeline L.P.

    Description: Section 4(d) Rate Filing: Negotiated Rate Filing—Union Gas Limited to be effective 4/1/2016.

    Filed Date: 2/5/16.

    Accession Number: 20160205-5021.

    Comments Due: 5 p.m. ET 2/17/16.

    Docket Numbers: RP16-588-000.

    Applicants: Midcontinent Express Pipeline LLC.

    Description: Section 4(d) Rate Filing: Clean Up Filing to be effective 3/7/2016.

    Filed Date: 2/5/16.

    Accession Number: 20160205-5056.

    Comments Due: 5 p.m. ET 2/17/16.

    Docket Numbers: RP16-589-000.

    Applicants: Kinder Morgan Louisiana Pipeline LLC.

    Description: Section 4(d) Rate Filing: Clean Up Filing to be effective 3/7/2016.

    Filed Date: 2/5/16.

    Accession Number: 20160205-5063.

    Comments Due: 5 p.m. ET 2/17/16.

    Docket Numbers: RP16-590-000.

    Applicants: National Fuel Gas Supply Corporation.

    Description: Section 4(d) Rate Filing: GT&C Section 15 Correction to be effective 10/1/2015.

    Filed Date: 2/5/16.

    Accession Number: 20160205-5151.

    Comments Due: 5 p.m. ET 2/17/16.

    Docket Numbers: RP16-591-000.

    Applicants: Monroe Gas Storage Company, LLC.

    Description: Petition for Declaratory Order of Monroe Gas Storage Company, LLC under RP16-591.Filed Date: 2/5/16.

    Accession Number: 20160205-5245.

    Comments Due: 5 p.m. ET 2/17/16.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified date(s). Protests may be considered, but intervention is necessary to become a party to the proceeding.

    Filings in Existing Proceedings

    Docket Numbers: RP16-505-001.

    Applicants: Portland General Electric Company.

    Description: Compliance filing NAESB V3 Standards Compliance Filing Correction to be effective 4/1/2016.

    Filed Date: 2/5/16.

    Accession Number: 20160205-5150.

    Comments Due: 5 p.m. ET 2/17/16.

    Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 8, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03310 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-904-000] Smith Creek Hydro, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Smith Creek Hydro, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 1, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 10, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03326 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL16-18-000] Conway Corporation; Notice of Filing

    Take notice that on February 10, 2016, Conway Corporation submitted a supplement to its November 19, 2015 application for proposed rate for Reactive Supply and Voltage Control.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant and all the parties in this proceeding.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern Time on February 17, 2016.

    Dated: February 10, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03313 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-893-000] 62SK 8ME LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of 62SK 8ME LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 1, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 10, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03316 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-914-000] Axpo U.S. LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Axpo U.S. LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 1, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 10, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03327 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2055-099] Idaho Power Company; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:

    a. Application Type: Amendment to Land Management Plan.

    b. Project No: 2055-099.

    c. Date Filed: December 29, 2015.

    d. Applicant: Idaho Power Company.

    e. Name of Project: C.J. Strike Hydroelectric Project.

    f. Location: The project is located on the Snake and Bruneau Rivers, in Elmore and Owyhee counties, Idaho.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.

    h. Applicant Contact: L. Lewis Wardle, Senior Biologist—Licensing Program; [email protected]; (208) 388-2964.

    i. FERC Contact: Krista Sakallaris, (202) 502-6302, [email protected]

    j. Deadline for filing comments, motions to intervene, and protests: March 10, 2015.

    The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, or recommendations using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-2055-099.

    The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.

    k. Description of Request: Idaho Power Company (IPC) filed a five-year compliance report for the C.J. Strike Project's approved land management plan as well as proposed updates to the existing plan. Updates include new land-use classification maps based off previously approved changes and modifications to the use classification of private boat docks on conservation and agriculture/grazing land. IPC proposes to change the use classification of private boat docks to “conditional” in conservation and agriculture/grazing land-use areas, which are currently listed as prohibited uses. To remain consistent across projects, IPC proposes the modification due to changes in land ownership and land use patterns from open-range grazing to private/rural-residential uses in the project area, as well as at several other IPC projects. IPC states that by listing private boat docks as conditional it would review all applications to ensure the proposal does not have adverse resource effects. Additionally, all dock applications would be required to meet the IPC's existing boat dock standards and applicants would be required to obtain the required state and federal permits and consult with specified resource agencies.

    l. Locations of the Application: A copy of the application is available for inspection and reproduction at the Commission's Public Reference Room, located at 888 First Street NE., Room 2A, Washington, DC 20426, or by calling (202) 502-8371. This filing may also be viewed on the Commission's Web site at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, call 1-866-208-3676 or email [email protected], for TTY, call (202) 502-8659. A copy is also available for inspection and reproduction at the address in item (h) above. Agencies may obtain copies of the application directly from the applicant.

    m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.

    n. Comments, Protests, or Motions to Intervene: Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214, respectively. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.

    o. Filing and Service of Documents: Any filing must (1) bear in all capital letters the title “COMMENTS”, “PROTEST”, or “MOTION TO INTERVENE” as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person commenting, protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis. Any filing made by an intervenor must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 385.2010.

    Dated: February 10, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03333 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff will attend the following meeting related to the Midcontinent Independent System Operator, Inc. (MISO)—PJM Interconnection, L.L.C. (PJM) Joint and Common Market Initiative (Docket No. AD14-3-000):

    MISO/PJM Joint Stakeholder Meeting—February 18, 2016

    The above-referenced meeting will be held at: PJM Conference & Training Center, 2750 Monroe Boulevard, Audubon, PA 19403.

    The above-referenced meeting is open to the public.

    Further information may be found at www.pjm.com.

    The discussions at the meeting described above may address matters at issue in the following proceedings:

    Docket Nos. ER16-533, ER16-534, Midcontinent Independent System Operator, Inc. Docket Nos. ER16-535, ER16-536, PJM Interconnection, L.L.C. Docket No. ER16-488, PJM Interconnection, L.L.C. Docket No. ER16-490, Midcontinent Independent System Operator, Inc. Docket No. EL13-88, Northern Indiana Public Service Company v. Midcontinent Independent System Operator, Inc. and PJM Interconnection, L.L.C. Docket No. EL11-34, Midcontinent Independent System Operator, Inc. Docket No. EL14-21, Southwest Power Pool, Inc. v. Midcontinent Independent System Operator, Inc. Docket No. EL14-30, Midcontinent Independent System Operator, Inc. v. Southwest Power Pool, Inc. Docket No. ER11-1844, Midwest Independent Transmission System Operator, Inc. Docket No. ER10-1791, Midwest Independent Transmission System Operator, Inc. Docket Nos. ER13-1923, ER13-1938, ER13-1943, ER13-1945, Midcontinent Independent System Operator, Inc. Docket Nos. ER13-1924, ER13-1926, ER13-1936, ER13-1944, ER13-1947, ER15-2200, PJM Interconnection, L.L.C. Docket Nos. ER13-1937, ER13-1939, Southwest Power Pool, Inc. Docket No. ER14-1174, Southwest Power Pool, Inc. Docket No. ER14-1736, Midcontinent Independent System Operator, Inc. Docket No. ER14-2022, Midcontinent Independent System Operator, Inc. Docket No. ER14-2445, Midcontinent Independent System Operator, Inc. Docket No. ER16-56, Midcontinent Independent System Operator, Inc. Docket No. ER15-2613, PJM Interconnection, L.L.C. Docket No. ER15-2616, Midcontinent Independent System Operator, Inc. Docket No. EL15-99, Internal MISO Generation v. Midcontinent Independent System Operator, Inc.

    For more information, contact John Taber, Office of Energy Policy and Innovation, Federal Energy Regulatory Commission at (202) 502-8394 or [email protected]

    Dated: February 10, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03329 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP16-592-000.

    Applicants: Columbia Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: OTRA Mechanism Extension to be effective 3/1/2016.

    Filed Date: 2/8/16.

    Accession Number: 20160208-5042.

    Comments Due: 5 p.m. ET 2/22/16.

    Docket Numbers: RP16-593-000.

    Applicants: Equitrans, L.P.

    Description: Compliance filing Notice Regarding Non-Jurisdictional Gathering Facilities (W-4088).

    Filed Date: 2/8/16.

    Accession Number: 20160208-5044.

    Comments Due: 5 p.m. ET 2/22/16.

    Docket Numbers: RP16-594-000.

    Applicants: Guardian Pipeline, L.L.C.

    Description: § 4(d) Rate Filing: Negotiated Rate PAL Agreement—Koch Energy Serv., LLC to be effective 2/6/2016.

    Filed Date: 2/8/16.

    Accession Number: 20160208-5146.

    Comments Due: 5 p.m. ET 2/22/16.

    Docket Numbers: RP16-595-000.

    Applicants: Texas Eastern Transmission, LP.

    Description: § 4(d) Rate Filing: Negotiated Rate eff 4-1-2016 for Macquarie 911328 to be effective 4/1/2016.

    Filed Date: 2/9/16.

    Accession Number: 20160209-5055.

    Comments Due: 5 p.m. ET 2/22/16.

    Docket Numbers: RP16-596-000.

    Applicants: Texas Eastern Transmission, LP.

    Description: § 4(d) Rate Filing: Feb2016 Deletion of Expired Statements of Negotiated Rates to be effective 3/11/2016.

    Filed Date: 2/9/16.

    Accession Number: 20160209-5075.

    Comments Due: 5 p.m. ET 2/22/16.

    Docket Numbers: RP16-597-000.

    Applicants: Tallgrass Interstate Gas Transmission, L.

    Description: Compliance filing Compliance with Order 587-W to be effective 4/1/2016.

    Filed Date: 2/9/16.

    Accession Number: 20160209-5158.

    Comments Due: 5 p.m. ET 2/22/16.

    Docket Numbers: RP16-598-000.

    Applicants: Rockies Express Pipeline LLC.

    Description: Compliance filing Compliance with Order No. 587-W to be effective 4/1/2016.

    Filed Date: 2/9/16.

    Accession Number: 20160209-5161.

    Comments Due: 5 p.m. ET 2/22/16.

    Docket Numbers: RP16-599-000.

    Applicants: Trailblazer Pipeline Company LLC.

    Description: Compliance filing Order No. 587-W to be effective 4/1/2016.

    Filed Date: 2/9/16.

    Accession Number: 20160209-5199.

    Comments Due: 5 p.m. ET 2/22/16.

    Docket Numbers: RP16-600-000.

    Applicants: Guardian Pipeline, L.L.C.

    Description: § 4(d) Rate Filing: Negotiated Rate PAL Agreements—NJR Energy & Exelon to be effective 3/1/2016.

    Filed Date: 2/9/16.

    Accession Number: 20160209-5237.

    Comments Due: 5 p.m. ET 2/22/16.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    Filings in Existing Proceedings

    Docket Numbers: RP16-323-001.

    Applicants: Kern River Gas Transmission Company.

    Description: Compliance filing 2016 Meter Modification Compliance to be effective 2/1/2016.

    Filed Date: 2/9/16.

    Accession Number: 20160209-5035.

    Comments Due: 5 p.m. ET 2/22/16.

    Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 10, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03322 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP15-527-000] Transcontinental Gas Pipe Line Company, LLC; Notice of Schedule for Environmental Review of the New York Bay Expansion Project

    On July 8, 2015, Transcontinental Gas Pipe Line Company, LLC (Transco) filed an application in Docket No. CP15-527-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) of the Natural Gas Act to construct and operate certain natural gas pipeline facilities. The proposed project is known as the New York Bay Expansion Project (Project), and would modify existing facilities and replace existing pipeline to provide an additional 115,000 dekatherms per day of firm transportation service to National Grid New York to meet 2017-2018 winter heating season needs.

    On July 21, 2015, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the Project. Among other things, that notice alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization within 90 days of the date of issuance of the Commission staff's Environmental Assessment (EA) for the Project. This instant notice identifies the FERC staff's planned schedule for the completion of the EA for the Project.

    Schedule for Environmental Review Issuance of EA April 4, 2016. 90-day Federal Authorization Decision Deadline July 3, 2016.

    If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.

    Project Description

    The Project would involve the following activities at existing aboveground facilities in the specified towns and municipalities:

    • Uprate Compressor Station 200 from 30,860 horsepower (hp) to 33,000 hp (East Whiteland Township, Chester, Pennsylvania);

    • uprate a unit of Compressor Station 303 from 25,000 hp to 27,500 hp (Roseland Borough, Essex, New Jersey);

    • add 11,000 hp of electric-driven compression to Compressor Station 207 (Old Bridge Township, Middlesex, New Jersey); and

    • install various appurtenances and modifications at three meter and regulation stations in East Brandywine Township (Chester, Pennsylvania), Sayreville Borough (Middlesex, New Jersey), and Staten Island Borough (Richmond, New York).

    In addition, Transco proposes to replace three segments of its 42-inch-diameter Lower New York Bay Lateral pipeline, totaling 0.25 mile, and uprate the lateral pipeline's operating pressure from 960 to 1000 pounds per square inch in Middlesex County, New Jersey.

    Background

    On October 8, 2015, the Commission issued a Notice of Intent to Prepare an Environmental Assessment for the Proposed New York Bay Expansion Project and Request for Comments on Environmental Issues (NOI). The NOI was sent to affected landowners; federal, state, and local government agencies; elected officials; environmental and public interest groups; Native American tribes; other interested parties; and local libraries and newspapers. In response to the NOI, the Commission received comments from the New Jersey Department of Environmental Protection, the New Jersey State Historic Preservation Office, the Pennsylvania Department of Environmental Protection, and two citizens. The primary issues raised by the commentors are general comments for natural gas transmission projects in each state, specific questions for Transco regarding the operation of the facilities, and concerns about possible system alternatives.

    Additional Information

    In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC Web site (www.ferc.gov). Using the “eLibrary” link, select “General Search” from the eLibrary menu, enter the selected date range and “Docket Number” excluding the last three digits (i.e., CP15-527), and follow the instructions. For assistance with access to eLibrary, the helpline can be reached at (866) 208-3676, TTY (202) 502-8659, or at [email protected] The eLibrary link on the FERC Web site also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rule makings.

    Dated: February 10, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03311 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-902-000] Voyager Wind I, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Voyager Wind I, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 1, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 10, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03325 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-890-000] Summer Solar LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Summer Solar LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 1, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 10, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03314 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL16-17-000] City of West Memphis, Arkansas; Notice of Filing

    Take notice that on February 10, 2016, the City of West Memphis, Arkansas submitted a supplement to its November 19, 2015 application for proposed rate for Reactive Supply and Voltage Control.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant and all the parties in this proceeding.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern Time on February 17, 2016.

    Dated: February 10, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03312 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Schedule for Environmental Review of the White Oak Mainline Expansion Project and System Reliability Project Docket Nos. Eastern Shore Natural Gas Company CP15-18-000
  • CP15-18-001
  • CP15-498-000
  • On November 21, 2014, Eastern Shore Natural Gas Company (Eastern Shore) filed an application in Docket No. CP15-18-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) of the Natural Gas Act to construct and operate certain natural gas pipeline facilities as part of the White Oak Mainline Expansion Project (White Oak Project) in Chester County, Pennsylvania, and New Castle County, Delaware. On November 18, 2015, Eastern Shore filed an amendment to its application in Docket No. CP15-18-001 to construct the Kemblesville Loop Alternative 2 along Eastern Shore's existing right-of-way. Also, on May 22, 2015, Eastern Shore filed an application in Docket No. CP15-498-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) of the Natural Gas Act to construct and operate certain natural gas pipeline facilities as part of the System Reliability Project in Kent, New Castle, and Sussex Counties, Delaware.

    On December 8, 2014 and June 8, 2015, the Federal Energy Regulatory Commission (Commission or FERC) issued its respective Notice of Application for the White Oak Project and the System Reliability Project. On November 25, 2015, the Commission issued its Notice of Amendment to Application for the White Oak Project. Among other things, these notices alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization within 90 days of the date of issuance of the Commission staff's Environmental Assessment (EA) for the projects. This instant notice identifies the FERC staff's planned schedule for the completion of the EA for the White Oak and System Reliability Projects. Staff is preparing a single EA for the two projects because of the proximity of the projects to each other and because the System Reliability Project assumes the prior completion of the White Oak Project, as stated in Eastern Shore's amended application.

    Schedule for Environmental Review Issuance of EA April 12, 2016. 90-day Federal Authorization Decision Deadline July 11, 2016.

    If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the projects' progress.

    Project Descriptions

    The White Oak Project consists of 3.3 miles of 16-inch-diameter looping pipeline (the Daleville Loop) and 2.1 miles of 16-inch-diameter looping pipeline (Kemblesville Loop) in Chester County, Pennsylvania, and 3,550 horsepower of additional compression at Eastern Shore's existing Delaware City Compressor Station in New Castle County, Delaware. The White Oak Project would result in incremental expansion capacity sufficient to support Eastern Shore's agreement to provide 45,000 dekatherms per day of firm transportation service to Calpine Energy Services, L.P.'s Garrison Energy Center.

    The System Reliability Project consists of 2.5 miles of 16-inch-diameter looping pipeline in New Castle County; about 7.6 miles of 16-inch-diameter looping pipeline in Kent County; installation of various appurtenant underground and aboveground facilities; and an additional 1,775 horsepower of compression at Eastern Shore's existing Bridgeville Compressor Station in Sussex County, all in Delaware. According to Eastern Shore, the System Reliability Project would increase the reliability of natural gas to Eastern Shore's existing customers during high demand winter months.

    Background

    On January 22, 2015, the Commission issued a Notice of Intent to Prepare an Environmental Assessment for the Proposed White Oak Mainline Expansion Project and Request for Comments on Environmental Issues (White Oak NOI). On July 9, 2015, the Commission issued a Supplemental White Oak NOI and opened a supplemental scoping period for the Kemblesville Loop Alternative 2 route. On September 4, 2015, the Commission issued a Notice of Intent to Prepare an Environmental Assessment for the Proposed System Reliability Project and Request for Comments on Environmental Issues (System Reliability NOI). The notices were sent to affected landowners; federal, state, and local government agencies; elected officials; environmental and public interest groups; other interested parties; and local libraries and newspapers. In response to the White Oak NOI, the Commission received environmental comments from the U.S. Fish and Wildlife Service, the Delaware Nation, the Franklin Township Historical Commission, the National Oceanic and Atmospheric Administration, the National Park Service, the Franklin Township, the Pennsylvania Department of Conservation and Natural Resources, the Chester County Water Resources Authority, and private landowners. The primary concerns raised were regarding wetland and waterbody impacts; impacts due to forest clearing; impacts on the White Clay Creek National Wild and Scenic River; impacts on watersheds within the project area; impacts on the Kemblesville Village Historic District; impacts on bog turtle habitat; cultural resources; alternative routes, including the Kemblesville Loop Alternative Route 2; old growth forested areas along the pipeline routes; pipeline safety; and pipeline installation within proximity to residences. In response to the System Reliability NOI, the Commission received comments from the National Park Service and landowners. The National Park Service noted potential impacts on the Bridgeville Playground, which was funded through a Land and Water Conservation Fund Grant. Landowners submitted comments about public safety; effects on private property; wetlands; the 100-year floodplain; noise; vibration from trains; property values; less expensive alternatives to the project; and whether the Porter Road Loop would be necessary for system reliability.

    Additional Information

    In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC Web site (www.ferc.gov). Using the “eLibrary” link, select “General Search” from the eLibrary menu, enter the selected date range and “Docket Number” excluding the last three digits (i.e., CP15-18 or CP15-498), and follow the instructions. For assistance with access to eLibrary, the helpline can be reached at (866) 208-3676, TTY (202) 502-8659, or at [email protected] The eLibrary link on the FERC Web site also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rule makings.

    Additional information about the White Oak and System Reliability Projects can be obtained by contacting the environmental project manager, Gertrude Johnson, by telephone at (202) 502-6692 or by electronic mail at [email protected]

    Dated: February 10, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03323 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-1484-012.

    Applicants: Shell Energy North America (US), L.P.

    Description: Supplement to November 11, 2015 Notice of Non-Material Change in Status of Shell Energy North America (US), L.P.

    Filed Date: 2/10/16.

    Accession Number: 20160210-5204.

    Comments Due: 5 p.m. ET 3/2/16.

    Docket Numbers: ER15-1332-004; ER10-2397-003; ER10-2403-005; ER10-2425-005; ER15-1020-002; ER15-1333-004.

    Applicants: Arbuckle Mountain Wind Farm LLC, Arlington Wind Power Project LLC, Cloud County Wind Farm, LLC, Pioneer Prairie Wind Farm I, LLC, Rising Tree Wind Farm III LLC, Waverly Wind Farm LLC.

    Description: Notice of Non-Material Change in Status of Arbuckle Mountain Wind Farm LLC, et al.

    Filed Date: 2/10/16.

    Accession Number: 20160210-5212.

    Comments Due: 5 p.m. ET 3/2/16.

    Docket Numbers: ER16-711-001.

    Applicants: Pio Pico Energy Center, LLC.

    Description: Tariff Amendment: Amendment to MBR to be effective 3/1/2016.

    Filed Date: 2/11/16.

    Accession Number: 20160211-5093.

    Comments Due: 5 p.m. ET 3/3/16.

    Docket Numbers: ER16-922-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) Rate Filing: Amendment of LGIA, Service Agreement No. 157 to be effective 4/11/2016.

    Filed Date: 2/10/16.

    Accession Number: 20160210-5168.

    Comments Due: 5 p.m. ET 3/2/16.

    Docket Numbers: ER16-923-000.

    Applicants: Puget Sound Energy, Inc.

    Description: § 205(d) Rate Filing: OATT EIM Changes to be effective 4/1/2012.

    Filed Date: 2/10/16.

    Accession Number: 20160210-5196.

    Comments Due: 5 p.m. ET 3/2/16.

    Docket Numbers: ER16-924-000.

    Applicants: Portland General Electric Company.

    Description: Initial rate filing: Service Agreement Under Portland General Electric Companys OATT to be effective 3/1/2016.

    Filed Date: 2/11/16.

    Accession Number: 20160211-5000.

    Comments Due: 5 p.m. ET 3/3/16.

    Docket Numbers: ER16-925-000.

    Applicants: New York Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: LGIA (SA No. 2260) between NMPC and Indeck-Corinth to be effective 11/19/2015.

    Filed Date: 2/11/16.

    Accession Number: 20160211-5001.

    Comments Due: 5 p.m. ET 3/3/16.

    Docket Numbers: ER16-926-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 3164 Aksamit Resource Management, LLC GIA to be effective 1/19/2016.

    Filed Date: 2/11/16.

    Accession Number: 20160211-5038.

    Comments Due: 5 p.m. ET 3/3/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 11, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03320 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14677-001] Clark Canyon Hydro, LLC; Notice of Application Ready for Environmental Analysis and Soliciting Comments, Recommendations, Terms and Conditions, and Prescriptions

    Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.

    a. Type of Application: Original License for a Major Water Power Project at an Existing Dam, 5 Megawatts or Less.

    b. Project No.: 14677-001.

    c. Date filed: November 23, 2015.

    d. Applicant: Clark Canyon Hydro, LLC.

    e. Name of Project: Clark Canyon Dam Hydroelectric Project.

    f. Location: On the Beaverhead River, in the Town of Dillon, Beaverhead County, Montana. The project would occupy 62.1 acres of land owned by the U.S. Bureau of Reclamation and 0.2 acres of land owned by the U.S. Bureau of Land Management.

    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).

    h. Applicant Contact: John Gangemi, (406) 249-3972, email at [email protected]

    i. FERC Contact: Kelly Wolcott, (202) 502-6480, email at [email protected]

    j. Deadline for filing comments, recommendations, terms and conditions, and prescriptions: 30 days from the issuance date of this notice; reply comments are due 75 days from the issuance date of this notice.

    The Commission strongly encourages electronic filing. Please file comments, recommendations, terms and conditions, and prescriptions using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-14677-001.

    The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.

    k. This application has been accepted and is now ready for environmental analysis.

    l. The Clark Canyon Dam Hydroelectric Project would utilize the U.S. Bureau of Reclamation's Clark Canyon Dam and outlet works including an intake structure and concrete conduit in the reservoir. The project would consist of the following new facilities: (1) A 360-foot-long, 8-foot-diameter steel penstock within the existing concrete conduit, ending in a trifurcation; (2) two 35-foot-long, 8-foot-diameter penstocks extending from the trifurcation to the powerhouse, transitioning to 6-foot-diameter before entering the powerhouse; (3) a 10-foot-long, 8-foot-diameter steel penstock leaving the trifurcation and ending in a 7-foot-diameter cone valve and reducer to control discharge into the existing outlet stilling basin; (4) a 65-foot-long, 46-foot-wide reinforced concrete powerhouse containing two vertical Francis-type turbine/generator units with a total capacity of 4.7 megawatts; (5) two 25-foot-long steel draft tubes transitioning to concrete draft tube/tailrace section; (6) a 17-foot-long, 15-foot-diameter tailrace channel connecting with the existing spillway stilling basin; (7) a 45-foot-long, 10-foot-wide aeration basin downstream of the powerhouse with three frames containing 330 diffusers; (8) a 1,100-foot-long, 4.16-kilovolt (kV) buried transmission line from the powerhouse to a substation; (9) a substation containing step-up transformers and switchgear; (10) a 7.9-mile-long, 69-kV transmission line extending from the project substation to the Peterson Flat substation (the point of interconnection); and (11) appurtenant facilities. The estimated annual generation of the Clark Canyon Dam Project would be 15.4 gigawatt-hours. All project facilities would be located on federal lands owned by the U.S. Bureau of Reclamation and the U.S. Bureau of Land Management. The applicant proposes to operate the project as run-of-release.

    m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support. A copy is also available for inspection and reproduction at the address in item h above.

    All filings must (1) bear in all capital letters the title “COMMENTS”, “REPLY COMMENTS”, “RECOMMENDATIONS,” “TERMS AND CONDITIONS,” or “PRESCRIPTIONS;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person submitting the filing; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. Each filing must be accompanied by proof of service on all persons listed on the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b), and 385.2010.

    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    n. Public notice of the filing of the initial development application, which has already been given, established the due date for filing competing applications or notices of intent. Under the Commission's regulations, any competing development application must be filed in response to and in compliance with public notice of the initial development application. No competing applications or notices of intent may be filed in response to this notice.

    o. A license applicant must file no later than 60 days following the date of issuance of this notice: (1) A copy of the water quality certification; (2) A copy of the request for certification, including proof of the date on which the certifying agency received the request; or (3) evidence of waiver of water quality certification.

    Dated: February 11, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03335 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-915-000 ] Comanche Solar PV, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Comanche Solar PV, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is March 2, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 11, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03334 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #2

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC16-69-000.

    Applicants: Duke Energy Florida, LLC.

    Description: Application for Authorization to Transfer Assets under Section 203 of the Federal Power Act of Duke Energy Florida, LLC.

    Filed Date: 2/10/16.

    Accession Number: 20160210-5089.

    Comments Due: 5 p.m. ET 3/2/16.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER16-524-001.

    Applicants: Wolverine Holdings, L.P.

    Description: Tariff Amendment: Amendment to Notice of Succession to be effective 1/1/2016.

    Filed Date: 2/10/16.

    Accession Number: 20160210-5045.

    Comments Due: 5 p.m. ET 3/2/16.

    Docket Numbers: ER16-526-001.

    Applicants: Sempra Generation, LLC.

    Description: Tariff Amendment: Sempra Generation, LLC Amended Market-Based Rate Tariff Feb. 10, 2016 to be effective 12/31/2024.

    Filed Date: 2/10/16.

    Accession Number: 20160210-5068.

    Comments Due: 5 p.m. ET 3/2/16.

    Docket Numbers: ER16-921-000.

    Applicants: ISO New England Inc., New England Power Pool Participants Committee.

    Description: § 205(d) Rate Filing: Revisions to Forward Reserve Market Offer Cap and Elimination of Price Netting to be effective 6/1/2016.

    Filed Date: 2/10/16.

    Accession Number: 20160210-5075.

    Comments Due: 5 p.m. ET 3/2/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 10, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03309 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #2

    Take notice that the Commission received the following exempt wholesale generator filings:

    Docket Numbers: EG16-55-000.

    Applicants: Grant County Interconnect, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of Grant County Interconnect, LLC.

    Filed Date: 2/11/16.

    Accession Number: 20160211-5149.

    Comments Due: 5 p.m. ET 3/3/16.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER15-13-005.

    Applicants: Transource Wisconsin, LLC.

    Description: Compliance filing: Transource Wisconsin Compliance Filing Revision to be effective 12/1/2014.

    Filed Date: 2/11/16.

    Accession Number: 20160211-5139.

    Comments Due: 5 p.m. ET 3/3/16.

    Docket Numbers: ER16-842-001.

    Applicants: Kay Wind, LLC.

    Description: Tariff Amendment: Kay Wind Amemdment Filing to be effective 2/2/2016.

    Filed Date: 2/11/16.

    Accession Number: 20160211-5190.

    Comments Due: 5 p.m. ET 3/3/16.

    Docket Numbers: ER16-927-000.

    Applicants: International Transmission Company.

    Description: § 205(d) Rate Filing: CIAC Agreement with Fortistar LLC to be effective 4/11/2016.

    Filed Date: 2/11/16.

    Accession Number: 20160211-5129.

    Comments Due: 5 p.m. ET 3/3/16.

    Docket Numbers: ER16-928-000.

    Applicants: ISO New England Inc.

    Description: ISO New England Inc. submits Foruth Quarter 2015 Capital Budget Report under ER16-928.

    Filed Date: 2/11/16.

    Accession Number: 20160211-5131.

    Comments Due: 5 p.m. ET 3/3/16.

    Docket Numbers: ER16-929-000.

    Applicants: AES Ohio Generation, LLC.

    Description: § 205(d) Rate Filing: Rate Schedule No. 3 to be effective 2/12/2016.

    Filed Date: 2/11/16.

    Accession Number: 20160211-5163.

    Comments Due: 5 p.m. ET 3/3/16.

    Docket Numbers: ER16-930-000.

    Applicants: AES Ohio Generation, LLC.

    Description: § 205(d) Rate Filing: FERC Rate Schedule No. 1 to be effective 2/12/2016.

    Filed Date: 2/11/16.

    Accession Number: 20160211-5165.

    Comments Due: 5 p.m. ET 3/3/16.

    Docket Numbers: ER16-931-000.

    Applicants: AES Ohio Generation, LLC.

    Description: § 205(d) Rate Filing: FERC Electric Tariff, Vol. No. 2 to be effective 2/12/2016.

    Filed Date: 2/11/16.

    Accession Number: 20160211-5166.

    Comments Due: 5 p.m. ET 3/3/16.

    Docket Numbers: ER16-932-000.

    Applicants: Grant County Interconnect, LLC.

    Description: Baseline eTariff Filing: Grant County Interconnect LLC Filing of Coordination Services Agreement to be effective 2/11/2016.

    Filed Date: 2/11/16.

    Accession Number: 20160211-5191.

    Comments Due: 5 p.m. ET 3/3/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: February 11, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03321 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Schedule for Environmental Review of the Leach Xpress and Rayne Xpress Expansion Projects Docket No. Columbia Gas Transmission, LLC CP15-514-000 Columbia Gulf Transmission, LLC CP15-539-000

    On June 8, 2015, Columbia Gas Transmission, LLC (Columbia Gas) filed an application in Docket No. CP15-514-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) and 7(b) of the Natural Gas Act to construct, operate, abandon in-place, and maintain certain natural gas pipeline facilities. The proposed Leach XPress Project, located in West Virginia, Ohio, and Pennsylvania, would provide about 1.5 million dekatherms of natural gas per day of firm transportation service to natural gas consumers served by the Columbia Gas pipeline systems.

    Additionally, on July 29, 2015, Columbia Gulf Transmission, LLC (Columbia Gulf) filed an application in Docket No. CP15-539-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) of the Natural Gas Act to construct, own, and operate the proposed Rayne XPress Expansion Project. The Rayne Express Expansion Project, located in Kentucky, would add new compression and provide about 621,000 dekatherms per day of firm transportation on Columbia Gulf's system. Together, these proposals are referred to in this notice as “the Projects.”

    On June 22 and August 11, 2015, respectively, the Federal Energy Regulatory Commission (FERC or Commission) issued its Notice of Application for the Leach XPress Project and Rayne XPress Expansion Project. Among other things, these notices alerted other agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on the request for a federal authorization within 90 days of the date of issuance of the Commission staff's final Environmental Impact Statement (EIS) for the Projects. This instant notice identifies the FERC staff's planned schedule for completion of the final EIS for the Projects.

    Schedule for Environmental Review Issuance of Notice of Availability of the final EIS September 1, 2016. 90-day Federal Authorization Decision Deadline November 30, 2016.

    If a schedule change becomes necessary, an additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.

    Project Description

    Columbia Gas plans to construct approximately 160 miles of new natural gas pipeline in West Virginia (Marshall County), Ohio (Fairfield, Hocking, Monroe, Morgan, Muskingum, Noble, Perry and Vinton Counties) and Pennsylvania (Greene County), two new compressor stations in Ohio (Noble and Jackson Counties), one new compressor station in West Virginia (Marshall County), and modify two existing compressor stations in West Virginia and Ohio.

    Columbia Gulf plans to construct and operate 51,800 horsepower of new compression in two new compressor stations located in Carter, Menifee and Montgomery Counties, Kentucky, and modify the existing Means Measurement and Regulation Station in Means and Montgomery County, Kentucky.

    Background

    On October 9, 2014, the Commission staff granted Columbia Gas's request to use the FERC's Pre-filing environmental review process and assigned the Leach XPress Project Docket No. PF14-23-000. On January 13, 2015, the Commission issued a Notice of Intent to Prepare an Environmental Impact Statement for the Planned Leach XPress Project, Request for Comments on Environmental Issues, and Notice of Public Scoping Meetings (NOI). Additionally, on September 4, 2015, the Commission issued a Notice of Intent to Prepare an Environmental Impact Statement for the Rayne XPress Expansion Project and Request for Comments on Environmental Issues.

    Both NOIs were sent to federal, state, and local government agencies; elected officials; affected landowners; environmental and public interest groups; Native American tribes and regional organizations; commentors and other interested parties; and local libraries and newspapers. The primary issues raised by the commentors included federally listed bats, forested plant and animal habitat, freshwater mussel habitat, salamander habitat, potential future subsidence of mining land, and effects on public health and safety.

    The U.S. Environmental Protection Agency, U.S. Army Corps of Engineers, U.S. Fish and Wildlife Service, Ohio Environmental Protection Agency, the West Virginia Department of Environmental Protection, the West Virginia Department of Natural Resources, and the Kentucky Department for Environmental Protection are cooperating agencies in the preparation of the EIS.

    Additional Information

    In order to receive notification of the issuance of the EIS and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Additional information about the Projects is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC Web site (www.ferc.gov). Using the “eLibrary” link, select “General Search” from the eLibrary menu, enter the selected date range and “Docket Number” for the project you wish to access excluding the last three digits (i.e., CP15-514, CP15-539), and follow the instructions. For assistance with access to eLibrary, the helpline can be reached at (866) 208-3676, TTY (202) 502-8659, or at [email protected] The eLibrary link on the FERC Web site also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rule makings.

    Dated: February 10, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-03324 Filed 2-17-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Western Area Power Administration Pick-Sloan Missouri Basin Program—Eastern Division AGENCY:

    Western Area Power Administration, DOE.

    ACTION:

    Notice of transfer of functional control of eligible Western-Upper Great Plains Region transmission facilities to Southwest Power Pool, Inc. on October 1, 2015, and Rate Schedules WAUGP-ATRR, WAUGP-AS1, WAUW-AS3, WAUW-AS4, WAUW-AS5, WAUW-AS6 and WAUW-AS7 made effective on that date.

    SUMMARY:

    Western Area Power Administration (Western) transferred functional control of eligible Western-Upper Great Plains Region (Western-UGP) transmission facilities to Southwest Power Pool, Inc. (SPP) on October 1, 2015. Transmission service is being provided over Western-UGP's eligible facilities under SPP's Open Access Transmission Tariff. Western-UGP costs are included in Western-UGP Formula rates for Transmission and Ancillary Services under Rate Schedules WAUGP-ATRR, WAUGP-AS1, WAUW-AS3, WAUW-AS4, WAUW-AS5, WAUW-AS6 and WAUW-AS7, which became effective on October 1, 2015.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Lloyd Linke, Vice President of Operations for Upper Great Plains Region, Upper Great Plains Region, Western Area Power Administration, 1330 41st Street, Watertown, SD, 57201; telephone: (605) 882-7500; email: [email protected]; or Ms. Linda Cady-Hoffman, Rates Manager, Upper Great Plains Region, Western Area Power Administration, 2900 4th Avenue North, Billings, MT 59101-1266; telephone: (406) 255-2920; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    On July 27, 2015, Western published a Federal Register Notice (80 FR 44339) providing a Notice of Final Transmission and Ancillary Services Formula Rates for Western's Pick-Sloan Missouri Basin Program-Eastern Division (P-SMBP—ED). Western explained that Western-UGP intended to transfer functional control of Western-UGP's P-SMBP—ED eligible transmission facilities located in the Upper Missouri Zone (UMZ or Zone 19) to SPP on October 1, 2015. Western announced the final transmission and ancillary services formula rates and the P-SMBP—ED transmission and ancillary services formula rates would go into effect when functional control was transferred to SPP.

    The purpose of this notice is to announce that Western-UGP successfully transferred functional control of eligible transmission facilities on October 1, 2015, and Rate Schedules WAUGP-ATRR, WAUGP-AS1, WAUW-AS3, WAUW-AS4, WAUW-AS5, WAUW-AS6 and WAUW-AS7 were made effective on that date.

    Availability of Information

    Information regarding the public process for Western-UGP's formula rate adjustment process and annual recalculation is available on Western's Web site and Western-UGP's Open Access Same-Time Information System (OASIS) home page, which are located respectively at the following locations:

    https://www.wapa.gov/regions/UGP/rates/Pages/rates.aspx http://www.oatioasis.com/wapa/index.html Dated: February 8, 2016. Mark A. Gabriel, Administrator.
    [FR Doc. 2016-03362 Filed 2-17-16; 8:45 am] BILLING CODE 6450-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9942-51-OECA] National Environmental Justice Advisory Council AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Request for Nominations to the National Environmental Justice Advisory Council (NEJAC).

    SUMMARY:

    The U.S. Environmental Protection Agency (EPA) invites nominations from a diverse range of qualified candidates to be considered for appointment to its National Environmental Justice Advisory Council (NEJAC). The NEJAC was chartered to provide advice regarding broad, cross-cutting issues related to environmental justice. This notice solicits nominations to fill approximately six (6) new vacancies for terms through September 2019. To maintain the representation outlined by the charter, nominees will be selected to represent: grassroots community-based organizations (2 vacancies); non-governmental/environmental organizations (2 vacancies); State government agencies (1 vacancy); and business and industry (1 vacancy). Vacancies are anticipated to be filled by July 2016. Sources in addition to this Federal Register Notice also may be utilized in the solicitation of nominees.

    DATES:

    Nominations should be submitted in time to arrive no later than Friday, April 15, 2016.

    ADDRESSES:

    Submit nominations electronically with the subject line NEJAC Membership 2016 to [email protected]. You also may submit nominations by mail to: Karen L. Martin, NEJAC Project Manager, Office of Environmental Justice, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., (MC 2201A), Washington, DC 20460. Non-electronic submissions must follow the same format and contain the same information. The Office of Environmental Justice will acknowledge receipt of nominations.

    FOR FURTHER INFORMATION CONTACT:

    Matthew Tejada, Designated Federal Officer for the NEJAC, U.S. EPA; telephone (202) 564-8047; fax: (202) 564-1624.

    SUPPLEMENTARY INFORMATION:

    The NEJAC is a federal advisory committee chartered under the Federal Advisory Committee Act (FACA), Public Law 92-463. EPA established the NEJAC in 1993 to provide independent consensus advice to the EPA Administrator about a broad range of environmental issues related to environmental justice. The NEJAC conducts business in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and related regulations.

    The Council consists of 28 members (including a Chairperson) appointed by EPA's Administrator. Members serve as non-federal stakeholders representing: six (6) from academia, two (2) from business and industry; six (6) from community based organizations; seven (7) from non-governmental/environmental organizations; four (4) from state and local governments; and three (3) from tribal governments and indigenous organizations, of which one member serves as a liaison to the National Tribal Caucus. Members are appointed for three (3)-year terms with the possibility of reappointment to a second term.

    The NEJAC usually meets face-to-face twice a year, generally in the Spring and the Fall. Additionally, members may be asked to participate in teleconference meetings or serve on work groups to develop recommendations, advice letters, and reports to address specific policy issues. The average workload for members is approximately 5 to 8 hours per month. EPA provides reimbursement for travel and other incidental expenses associated with official government business.

    Nominations: Any interested person and/or organization may nominate qualified individuals for membership. The EPA values and welcomes diversity. In an effort to obtain nominations of diverse candidates, the agency encourages nominations of women and men of all racial and ethnic groups. All nominations will be fully considered, but applicants need to be aware of the specific representation sought as outlined in the Summary above. In addition, EPA is seeking nominees with knowledge in community sustainability, public health and health disparities, climate change adaptation, land use and equitable development, environmental sociology and social science, and environmental financing.

    Other criteria used to evaluate nominees will include:

    • The background and experience that would help members contribute to the diversity of perspectives on the committee (e.g., geographic, economic, social, cultural, educational background, professional affiliations, and other considerations;

    • demonstrated experience with environmental justice and community sustainability issues at the national, state, or local level;

    • excellent interpersonal and consensus-building skills;

    • ability to volunteer time to attend meetings 2-3 times a year, participate in teleconference meetings, attend listening sessions with the Administrator or other senior-level officials, develop policy recommendations to the Administrator, and prepare reports and advice letters; and

    • willingness to commit time to the committee and demonstrated ability to work constructively and effectively on committees.

    How To Submit Nominations: Any interested person or organization may nominate qualified persons to be considered for appointment to this advisory committee. Individuals are encouraged to self-nominate. Nominations can be submitted in electronic format (preferred) following the template available at http://www3.epa.gov/environmentaljustice/nejac/index.html#membership. To be considered, all nominations should include:

    • Current contact information for the nominee, including the nominee's name, organization (and position within that organization), current business address, email address, and daytime telephone number.

    • Brief Statement describing the nominees interest in serving on the NEJAC

    • Résumé and a short biography (no more than 2 paragraphs) describing the professional and educational qualifications of the nominee, including a list of relevant activities, and any current or previous service on advisory committees

    • Letter[s] of recommendation from a third party supporting the nomination. Letter[s] should describe how the nominee's experience and knowledge will bring value to the work of the NEJAC.

    Other sources, in addition to this Federal Register notice, may also be utilized in the solicitation of nominees. To help the EPA in evaluating the effectiveness of its outreach efforts, please tell us how you learned of this opportunity.

    Dated: February 5, 2016. Matthew Tejada, Designated Federal Officer, National Environmental Justice Advisory Council.
    [FR Doc. 2016-03405 Filed 2-17-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION Sunshine Act Meeting February 17, 2016.

    The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Thursday, February 18, 2016, which is scheduled to commence at 10:30 a.m. in Room TW-C305, at 445 12th Street SW., Washington, DC.

    The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Thursday, February 18, 2016, which is scheduled to commence at 10:30 a.m. in Room TW-C305, at 445 12th Street SW., Washington, DC.

    Item No. Bureau Subject 1 MEDIA TITLE: Promoting the Availability of Diverse and Independent Sources of Video Programming. SUMMARY: The Commission will consider a Notice of Inquiry that seeks comment on the current state of programming diversity and the principal obstacles that independent programmers face in obtaining carriage on video distribution platforms. 2 MEDIA TITLE: Expanding Consumers' Video Navigation Choices; Commercial Availability of Navigation Devices (CS Docket No. 97-80). SUMMARY: The Commission plans to discuss a document that seeks comment on a framework for providing innovators, device manufacturers and app developers the information they need to develop new technologies to access video content. 3 CONSUMER & GOVERNMENTAL AFFAIRS TITLE: Closed Captioning of Video Programming (CG Docket No. 05-231); Telecommunications for the Deaf and Hard of Hearing, Inc. Petition for Rulemaking. SUMMARY: The Commission will consider a Second Report and Order that allocates responsibilities for the delivery of closed captions on video programming and the handling of captioning complaints. Consent Agenda

    The Commission will consider the following subjects listed below as a consent agenda and these items will not be presented individually:

    1 ENFORCEMENT TITLE: Enforcement Bureau Action. SUMMARY: The Commission will consider whether to take an enforcement action. 2 ENFORCEMENT TITLE: Enforcement Bureau Action. SUMMARY: The Commission will consider whether to take an enforcement action. 3 ENFORCEMENT TITLE: Enforcement Bureau Action. SUMMARY: The Commission will consider whether to take an enforcement action.

    The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an email to: [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

    Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the Internet from the FCC Live Web page at www.fcc.gov/live.

    For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the Internet. To purchase these services, call (703) 993-3100 or go to www.capitolconnection.gmu.edu.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2016-03502 Filed 2-16-16; 4:15 pm] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1177] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written PRA comments should be submitted on or before April 18, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control No.: 3060-1177.

    Title: 47 CFR 74.800, Channel Sharing Agreement.

    Form Numbers: Not applicable.

    Type of Review: Revision of a currently approved collection.

    Respondents: Business or other for profit entities; Not for profit institutions; State, local or Tribal government.

    Number of Respondents/Responses: 100 respondents; 100 responses.

    Estimated Hours per Response: 1 hr.

    Frequency of Response: One time reporting requirement.

    Total Annual Burden: 100 hours.

    Total Annual Cost: $54,000.

    Obligation To Respond: Required to obtain benefits. The statutory authority for this information collection is contained in sections 1, 4(i) and (j), 7, 154(i), 301, 302, 303, 307, 308, 309, 312, 316, 318, 319, 324, 325, 336 and 337 of the Communications Act of 1934, as amended.

    Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

    Privacy Act Assessment: No impact(s).

    Needs and Uses: On December 18, 2015, the Commission released a Third Report and Order and Fourth Notice of Proposed Rulemaking, In the Matter of Amendment of Parts 73 and 74 of the Commission's Rules to Establish Rules for Digital Low Power Television and Television Translator Stations, MB Docket No. 03-185, FCC 15-175. Low power television and television translator stations (collectively “LPTV stations”) will be required to include certain terms in their channel sharing agreements (CSAs) and to file their CSAs with the Commission. This new requirement is provided in 47 CFR 74.800.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2016-03363 Filed 2-17-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1138] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before April 18, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-1138.

    Title: Sections 1.49 and 1.54, Forbearance Petition Filing Requirements.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities.

    Number of Respondents: 11 respondents; 11 responses.

    Estimated Time per Response: 640 hours.

    Frequency of Response: On occasion reporting requirement, recordkeeping requirement and third party disclosure requirement.

    Obligation To Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 10, 151, 154(i), 154(j),155(c), 160, 201 and 303(r) of the Communications Act of 1934.

    Total Annual Burden: 7,040 hours.

    Total Annual Cost: No cost.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: The Commission is not requesting respondents to submit or disclose confidential information. Respondents may, however, request confidential treatment for information they believe to be confidential under 47 CFR 0.459 of the Commission's rules.

    Needs and Uses: Under section 10 of the Communications Act of 1934, as amended, telecommunications carriers may petition the Commission to forbear from applying to a telecommunications carrier any statutory provision or Commission regulation. When a carrier petitions the Commission for forbearance, section 10 requires the Commission to make three determinations with regard to the need for the challenged provision or regulation. If the Commission fails to act within one year (extended by three additional months, if necessary) the petition is “deemed granted” by operation of law. These determinations require complex, fact-intensive analysis, e.g., “whether forbearance from enforcing the provision or regulation will promote competitive market conditions.” Under the new filing procedures, the Commission requires that petitions for forbearance must be “complete as filed” and explain in detail what must be included in the forbearance petition. The Commission also incorporates by reference its rule, 47 CFR 1.49, which states the Commission's standard “specifications as to pleadings and documents.” Precise filing requirements are necessary because of section 10's strict time limit for Commission action. Also, commenters must be able to understand clearly the scope of the petition in order to comment on it. Finally, standard filing procedures inform petitioners precisely what the Commission expects from them in order to make the statutory determinations that the statute requires.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2016-03364 Filed 2-17-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meeting AGENCY:

    Federal Election Commission.

    DATE & TIME:

    Tuesday, February 23, 2016 at 10:00 a.m. and its continuation at the conclusion of the open meeting on February 25, 2016.

    PLACE:

    999 E Street NW., Washington, DC.

    STATUS:

    This meeting will be closed to the public.

    ITEMS TO BE DISCUSSED:

    Compliance matters pursuant to 52 U.S.C. 30109.

    Matters concerning participation in civil actions or proceeding, or arbitration.

    Information the premature disclosure of which would be likely to have a considerable adverse effect on the implementation of a proposed Commission action.

    PERSON TO CONTACT FOR INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Shawn Woodhead Werth, Secretary and Clerk.
    [FR Doc. 2016-03501 Filed 2-16-16; 4:15 pm] BILLING CODE 6715-01-P
    FEDERAL MARITIME COMMISSION Notice of Agreements Filed

    The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties may submit comments on the agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the Federal Register. Copies of the agreement are available through the Commission's Web site (www.fmc.gov) or by contacting the Office of Agreements at (202)-523-5793 or [email protected]

    Agreement No.: 012390.

    Title: Siem Car Carriers AS/Liberty Global Logistics LLC Space Charter Agreement.

    Parties: Siem Car Carriers AS and Liberty Global Logistics LLC.

    Filing Party: Ashley W. Craig Esq.; Venable LLP; 575 Seventh Street NW.; Washington, DC 20004.

    Synopsis: The agreement authorizes the parties to charter space to/from each other in the trade between the U.S. on the one hand, and China, Japan, South Korea, Mexico and Germany on the other hand.

    Agreement No.: 012391.

    Title: Hanjin/UASC/CMA CGM/COSCON Vessel Sharing Agreement.

    Parties: Hanjin Shipping Co., Ltd.; United Arab Shipping Co, S.A.G.; CMA CGM S.A.; and COSCO Container Lines Company, Limited.

    Filing Party: Joshua Stein, Esq.; Cozen O'Connor; 1200 Nineteenth St, N.W; Washington, DC 20006.

    Synopsis: The agreement would authorize the parties to cooperate through a combination of vessel sharing and slot charter arrangements on routes between ports in Italy, France, Spain and Malta on the one hand, and the U.S. East Coast on the other hand.

    By Order of the Federal Maritime Commission.

    Dated: February 12, 2016. Rachel E. Dickon, Assistant Secretary.
    [FR Doc. 2016-03378 Filed 2-17-16; 8:45 am] BILLING CODE 6731-AA-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-16PJ; Docket No. ATSDR-2016-0002] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on “Collections Related to Synthetic Turf Fields with Crumb Rubber Infill.” The purpose of the proposed studies is to evaluate and characterize the chemical composition and use of synthetic turf with crumb rubber infill and exposure potential to constituents in crumb rubber infill.

    DATES:

    Written comments must be received on or before April 18, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. ATSDR-2016-0002 by any of the following methods:

    Federal eRulemaking Portal: Regulation.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov. For this docket, ATSDR is only accepting comments on the proposed studies' data collections referenced in this notice.

    Please note:

    All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    Proposed Project

    Collections Related to Synthetic Turf Fields with Crumb Rubber Infill—New—Agency for Toxic Substances and Disease Registry (ATSDR).

    Background and Brief Description

    Currently in the United States, there are more than 12,000 synthetic turf fields in use. While the Synthetic Turf Council has set guidelines for the content of crumb rubber used as infill in synthetic turf fields, manufacturing processes result in differences among types of crumb rubber. Additionally, the chemical composition may vary highly between different processes and source materials and may vary even within granules from the same origin.

    Due to the limited information, the Agency for Toxic Substances and Disease Registry (ATSDR) and the United States Environmental Protection Agency (USEPA) propose to conduct two studies to investigate the chemical composition and use of crumb rubber infill in synthetic turf and the potential for exposure to environmental constituents that may result from contact with crumb rubber infill.

    Prior to study initiation, outreach and engagement efforts may be undertaken among stakeholders, including but not limited to industry representatives, state or local partners, and sports coaches. These efforts will inform the design and implementation of the proposed studies and will involve less than ten respondents per stakeholder groups. The outreach and engagement efforts will allow us to better understand the manufacturing process for synthetic turf and crumb rubber infill and allow us to obtain first-hand perspectives on activities conducted on synthetic turf leading to potential exposures. Additionally, outreach efforts will involve discussions and coordination with state partners to identify their current and future research studies on synthetic turf.

    The first study, titled “Determination of Field Operating Procedures, Use Conditions, and Chemical Composition of Crumb Rubber Infill in Synthetic Turf Fields,” will characterize field use procedures and conditions. The respondents will include facility representatives who are knowledgeable about the standard operating procedures for synthetic turf fields with crumb rubber infill. We aim to enroll an estimate of ten facilities in each of the four US census regions. The questionnaire will focus on key questions to characterize activity use patterns, field maintenance (e.g., redistribution of crumb rubber material), and other procedures and facility characteristics potentially affecting exposure to any chemicals of potential concern. Also, these facilities may be asked to supply samples from their synthetic turf fields with crumb rubber infill. The samples will be used to characterize the chemical constituents of the crumb rubber infill, including semi-volatile organic compounds (SVOC), metal content, and measurements of volatile organic compounds (VOC) and SVOC emission levels.

    The second study, titled “Characterization of Exposure Potential during Activities Conducted on Synthetic Turf with Crumb Rubber Infill,” will be the first assessment of activities conducted on synthetic turf for the purpose of characterizing potential exposure patterns. The study will include persons who use synthetic turf with crumb rubber infill (e.g., facility users) and who routinely perform activities that would result in a high level of contact to crumb rubber. This will allow for evaluation of potential high-end exposures to constituents in synthetic turf among this group of users. The respondents will be administered a detailed questionnaire on activity patterns on synthetic turf with crumb rubber infill. This instrument, along with extant videography of persons engaged in activities of interest, will be used to characterize exposure scenarios, including the nature and duration of potential exposures.

    Furthermore, if time and resources allow, we will conduct a full exposure characterization sub-study among a subset of the respondents. If possible, we will use the facilities sampled in the first study to conduct activities for the full exposure characterization of facility users. The exposure characterization sub-study will likely include but is not limited to field environment and material sampling, personal air monitoring, dermal sampling, and urine collection. It is likely that some of the collection items will not be analyzed in the current project time frame but will be archived for future analysis.

    The burden hours for the research study of crumb rubber infill composition and field operating procedures is 76 hours among 40 respondents; the burden hours requested for the research study of activity levels in persons playing on synthetic turf with crumb rubber infill is 216 hours among 60 respondents. The total estimated annual time burden requested for these studies equals 292 hours. There is no cost to the respondents other than their time in the study.

    Estimated Annualized Burden Hours

    “Determination of Field Operating Procedures, Use Conditions, and Chemical Composition of Crumb Rubber Infill in Synthetic Turf Fields”

    Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hrs.)
  • Total burden
  • (in hrs.)
  • Facilities Facility Eligibility Screening 70 1 5/60 6 Synthetic Turf Fields Questionnaire 40 1 45/60 30 Field Sampling Collection Form 40 1 1 40 Total 76
    “Characterization of Exposure Potential during Activities Conducted on Synthetic Turf with Crumb Rubber Infill” Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hrs.)
  • Total burden
  • (in hrs.)
  • Facility Users Facility User Eligibility Screening 75 1 5/60 6 Facility User Questionnaire 60 1 30/60 30 Full Exposure Characterization Form 45 1 4 180 Total 216
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-03305 Filed 2-17-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-16-1019] Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

    Proposed Project

    Integrating Community Pharmacists and Clinical Sites for Patient-Centered HIV Care (OMB 0920-1019, expires 8/31/2018)—Revision—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Medication Therapy Management (MTM) is a group of pharmacist provided services that is independent of, but can occur in conjunction with, provision of medication. Medication Therapy Management encompasses a broad range of professional activities and cognitive services within the licensed pharmacists' scope of practice and can include monitoring prescription filling patterns and timing of refills, checking for medication interactions, patient education, and monitoring of patient response to drug therapy.

    HIV specific MTM programs have demonstrated success in improving HIV medication therapy adherence and persistence. While MTM programs have be shown to be effective in increasing medication adherence for HIV-infected persons, no MTM programs have been expanded to incorporate primary medical providers in an effort to establish patient-centered HIV care. To address this problem, CDC has entered into a public-private partnership with Walgreen Company (a.k.a. Walgreens pharmacies, a national retail pharmacy chain) to develop and implement a model of HIV care that integrates community pharmacists with primary medical providers for patient-centered HIV care. The model program will be implemented in ten sites and will provide patient-centered HIV care for approximately 1,000 persons.

    The patient-centered HIV care model will include the core elements of MTM as well as additional services such as individualized medication adherence counseling, active monitoring of prescription refills and active collaboration between pharmacists and medical clinic providers to identify and resolve medication related treatment problems such as treatment effectiveness, adverse events and poor adherence. The expected outcomes of the model program are increased retention in HIV care, adherence to HIV medication therapy and viral load suppression.

    On May 16, 2014 OMB approved the collection of standardized information from ten project sites over the three-year project period and one retrospective data collection during the first year of the three-year project period. The retrospective data collection will provide information about clients' baseline characteristics prior to participation in the model program which is needed to compare outcomes before and after program implementation. On August 17, 2015, OMB approved the conduct of key informant interviews with program clinic and pharmacy staff in order to evaluate the program processes, administration of a staff communication questionnaire, and OMB approved the collection of time and cost data to be used to estimate the cost of the model program.

    CDC newly requests approval to administer a staff communication questionnaire for medical providers in order to determine how and if the model program improves patient outcomes through improved communication and collaboration between patients' clinical providers and pharmacists. The staff communication questionnaire for medical providers will be administered twice to program clinic staff. The staff communication questionnaire for medical providers is different from the previously improved staff communication questionnaire; the staff communication questionnaire for medical providers will be administered to program clinic staff whereas the staff communication questionnaire will be administered to program pharmacy staff.

    Pharmacy, laboratory, and medical data will be collected through abstraction of all participant clients' pharmacy and medical records. Pharmacy, laboratory and medical data are needed to monitor retention in care, adherence to therapy, viral load suppression and other health outcomes. Program specific data, such as the number of MTM elements completed per project site and time spent on program activities, will be collected by program. Qualitative data will be gathered from program staff through in-person or telephone interviews and through a questionnaire to program pharmacy staff and a separate questionnaire to program clinic staff.

    The data collection will allow CDC to conduct continuous program performance monitoring which includes identification of barriers to program implementation, solutions to those barriers, and documentation of client health outcomes. Performance monitoring will allow the model program to be adjusted, as needed, in order to develop a final implementation model that is self-sustaining and which can be used to establish similar collaborations in a variety of clinical settings. Collection of cost data will allow for the cost of the program to be estimated.

    There is no cost to participants other than their time. The total estimated annualized burden hours are 6,043.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Clinic Data Manager Project clinic characteristics form 10 3 30/60 Pharmacist Project pharmacy characteristics form 10 3 30/60 Clinic Data Manager *Patient Demographic Information form 10 100 5/60 Clinic Data Manager *Initial patient information form 10 100 1 Clinic Data Manager Quarterly patient information form 10 400 30/60 Pharmacist Pharmacy record abstraction form 10 400 30/60 Key informants Interviewer data collection worksheet 60 2 30/60 Project staff (pharmacists) Staff communication questionnaire 30 2 30/60 Project staff (medical providers) Staff communication questionnaire for medical providers 40 2 30/60 Clinic staff Clinic cost form 20 2 10 Pharmacy staff Pharmacy cost form 20 2 10
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-03304 Filed 2-17-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a New Routine Use for a CMS System of Records AGENCY:

    Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).

    ACTION:

    Altered System Notice, Adding a New Routine Use for a CMS System of Records.

    SUMMARY:

    In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), CMS is adding a new routine use to the existing system of records titled Enrollment Data Base (EDB), System No. 09-70-0502, last modified 73 Federal Register 10249 (February 26, 2008), to assist with transmitting data to the Internal Revenue Service (IRS) for 10958 processing.

    The new routine use will authorize CMS to disclose information maintained in the system “to the IRS for the purposes of reporting Medicare Part A enrollment information and to provide statements to the individual enrollees with respect to whom information is reported to the IRS. Disclosures made pursuant to the routine use will be coordinated through CMS' Division of Medicare Enrollment Coordination, Medicare Enrollment and Appeals Group, Center for Medicare.

    DATES:

    Effective Dates: The new routine use described in this notice will become effective without further notice 30 days after publication of this notice in the Federal Register, unless comments are received that warrant revisions to this Notice. Written comments should be submitted within 30 days.

    ADDRESSES:

    The public should address comments to: CMS Privacy Officer, Division of Security, Privacy Policy and Governance, Information Security and Privacy Group, Office of Enterprise Information, CMS, 7500 Security Boulevard, Baltimore, MD 21244-1870, Mailstop: N 1-24-08, Office: (410) 786-5357 or via email: [email protected]. Comments received will be available for review at this location, by appointment, during regular business hours, Monday through Friday from 9:00 a.m.-3:00 p.m., Eastern Time zone.

    FOR FURTHER INFORMATION CONTACT:

    Roland Herrera, Health Insurance Specialist, Division of Medicare Enrollment Coordination, Medicare Enrollment and Appeals Group, CMS Center for Medicare, 7500 Security Boulevard, Mail Stop C2-12-16, Baltimore, MD 21244, Office phone: 410.786.0668, Facsimile: 443.380.5418, Email: [email protected].

    SUPPLEMENTARY INFORMATION:

    CMS is required to produce reports and statements of enrollment in Medicare Part A to confirm enrollment in minimum essential coverage under Section 6055 of the Affordable Care Act. The enrollment information must be provided to the IRS for tax administration purposes to enable the IRS to properly assess tax returns filed to ensure that Medicare Part A Enrollees are not assessed a tax penalty for not beenrolled in health care coverage.

    For the reason explained above, the following routine use is added to Enrollment Data Base (EDB), System No. 09-70-0502:

    11. To the IRS for the purposes of reporting Medicare Part A enrollment information and to provide statements to the individual enrollees with respect to whom information is reported to the IRS.

    Celeste Dade-Vinson, Health Insurance Specialist, Centers for Medicare & Medicaid Services.
    [FR Doc. 2016-03241 Filed 2-17-16; 8:45 am] BILLING CODE 4120-03-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Information Collection; New Funding Formula for the State Councils on Developmental Disabilities (SCDDs) and Protection and Advocacy Systems (P&As) Located in Each State and Territory AGENCY:

    Administration on Intellectual and Developmental Disabilities (AIDD), Administration on Disabilities (AoD), Administration for Community Living (ACL), Department of Health and Human Services (HHS), HHS.

    ACTION:

    Notice of guidance.

    SUMMARY:

    The Administration on Intellectual and Developmental Disabilities (AIDD) within the Administration on Disabilities (AoD), located within the Administration for Community Living (ACL) at the United States Department of Health and Human Services (HHS), is soliciting comments from the public on the New Funding Formula for the State Councils on Developmental Disabilities (SCDDs) and Protection and Advocacy Systems (P&As) located in each State and Territory.

    DATES:

    To ensure consideration comments must be received no later than March 21, 2016.

    ADDRESSES:

    The revised formula is described below and a table demonstrating the effects of the revised formula on allocations to States based on the FY 2016 appropriations can be found at the Web site: http://www.acl.gov/About_ACL/Allocations/DD-Act.aspx. Please email comments to [email protected] Emailed comments are preferred, but comments may be submitted via mail to: Andrew Morris, Office of the Commissioner, Administration on Disabilities, U.S. Department of Health and Human Services, 330 C St. SW., Washington, DC 20201. Please note comments sent through the mail must be received by the close of business on the date the comment period closes or they will not be considered. Also, please note that we are only accepting comments related to the new formula and will not respond to comments on other subjects submitted through this process.

    FOR FURTHER INFORMATION CONTACT:

    Andrew Morris, Office of the Commissioner, Administration on Disabilities, 330 C St. SW., Washington, DC 20201. Telephone (202) 795-7408. Email [email protected] Please note the telephone number is not toll free. This document will be made available in alternative formats upon request. Written correspondence can be sent to Administration for Community Living, U.S. Department of Health and Human Services, 330 C St. SW., Washington, DC 20201.

    SUPPLEMENTARY INFORMATION: Background

    The Developmental Disabilities Assistance and Bill of Rights Act of 2000 (P.L. 106-402) (DD Act) provides, among other things, formula grants to States for the purpose of operating State Councils on Developmental Disabilities and Protection & Advocacy Systems for People with Developmental Disabilities. The DD Act provides authority and flexibility in Section 122 to AIDD to determine the formula for allocating annual grant awards using three statutory factors for determining each state's funding amount. These factors are:

    1. Total population of the state/territory 2. Need for services for people with DD in the state/territory 3. Financial need of the state/territory

    The current formula is out of date. For example, the current formula uses the best data points available in the 1970s/1980s for determining need for services and financial need. These data are now outdated and severely undercount the population of individuals with developmental disabilities. The updated formula is believed to be more clear, concise, transparent, and consistent with Congress' intent to provide funds to states based on greatest need.

    In addition to the formula, the DD Act prescribes minimum allotments for states with small populations and territories (Puerto Rico is not considered a territory under the DD Act). About half of the states receive a minimum allotment. The DD Act also requires adjusting (increasing) the minimum allotment amounts if certain criteria are met. After minimum allotments are met, the remaining appropriations are allocated using the formula.

    Finally, the Act requires a hold-harmless for the State DD Councils that was passed as an amendment to the DD Act in 2003, P.L. 108-154. Through this hold-harmless clause, SCDD awards are based on the award amount from the previous year, FY 2000, FY 2001, or FY 2002, whichever is highest. If there are not enough funds available to fully fund all of the awards, the SCDDs then receive an equal percent reduction. It is important to note that a new formula may not immediately impact the SCDDs due to the hold harmless clause. The new formula would impact the SCDDs only when appropriations rise to such a level that all SCDDs would receive an increase in allotments above the previous fiscal year's award level.

    Methodology

    AIDD convened a workgroup of researchers, retired SCDD and P&A directors, national associations, and AIDD staff in the spring of 2015 and held four meetings over a two month period. The workgroup reviewed the three elements required for the formula and discussed each, identifying potential data sources for each element in cooperation with the HHS Assistant Secretary for Policy and Evaluation (ASPE). The workgroup discussed the strengths and challenges of the different data and based on these discussions provided recommendations to AIDD. In addition, the workgroup worked with the Grants Management Office at ACL to test the impact of different scenarios.

    Revised Formula

    Beginning in FY 2017, AIDD's State DD Councils and P&A grants will use a new formula to distribute funds after meeting statutory minimums and hold-harmless requirements:

    1. State/Territory Population (30%): Based on July Census figures released in August of each year.

    2. Need for services (30%): Based on a 1.58 percent prevalence rate for developmental disabilities in each State and Territory from the HHS National Health Interview Survey on Disability (NHIS-D).

    In determining the need for services, the workgroup discussed using data sources such as Medicaid and the Individuals with Disabilities Education Act; concluding that these data are unreliable because each State determines program eligibility and reporting requirements differently. The prevalence rate for developmental disabilities of 1.58 percent was established by the Federal government in the early 1990s through the NHIS-D and is still the most current prevalence rate available that meets the definition of Developmental Disabilities per the DD Act.

    3. Financial need (40%): Use a combination of poverty (20%) and unemployment rates (20%) from July of each calendar year.

    The workgroup thought it was best to use a combination of a State/Territory's poverty and unemployment rates because it best reflects the economic status of a State/Territory and, thus, their financial need.

    Request for Comments

    This notice invites public comment on the new formula for the SCDD and P&A annual awards. We seek diverse perspectives including, but not limited to, that of grantees, technical assistance providers, and advocates, as well as federal agencies and for-profit and not-for-profit stakeholders. The comments will be important factors in finalizing the formula.

    Privacy Act Notification Statement: Responses to this guidance notice are voluntary. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response.

    Dated: February 11, 2016. Aaron Bishop, Commissioner, Administration on Disabilities.
    [FR Doc. 2016-03276 Filed 2-17-16; 8:45 am] BILLING CODE 4154-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0021] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by March 21, 2016.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-0495. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Substances Generally Recognized as Safe: Notification Procedure—21 CFR 170.36 and 570.36 (OMB Control Number 0910-0342)—Extension

    Section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348) establishes a premarket approval requirement for “food additives”; section 201(s) of the FD&C Act (21 U.S.C. 321(s)) provides an exclusion to the definition of “food additive” and thus from the premarket approval requirement, for uses of substances that are generally recognized as safe (GRAS) by qualified experts. In the Federal Register of April 17, 1997 (62 FR 18938) (the 1997 proposed rule), we published a proposed rule that would establish a voluntary procedure whereby manufacturers would notify us about a view of a particular use (or uses) of a substance that is not subject to the statutory premarket approval requirements based on a determination that such use is GRAS. Under an interim policy announced in the proposed rule, we invited manufacturers to submit notices of their independent determinations for review under the framework of the proposed rule during the period between issuance of the proposal and any final rule based on the proposal. The proposed regulations (proposed 21 CFR 170.36 and 21 CFR 570.36) provide a standard format for the voluntary submission of a notice.

    To assist respondents in submissions to our Center for Food Safety and Applied Nutrition (CFSAN), we developed Form FDA 3667 entitled “Generally Recognized as Safe (GRAS) Notice.” The form, and elements prepared as attachments to the form, may be submitted in electronic format via the Electronic Submission Gateway (ESG), or may be submitted in paper format, or as electronic files on physical media with paper signature page. While we do not expect Form FDA 3667 to reduce reporting time for respondents, use of the form helps to expedite our review of the information being submitted. For submissions to our Center for Veterinary Medicine (CVM), respondents may continue to send GRAS notices in letter format to the Agency, as instructed in our Federal Register notice of June 4, 2010 (75 FR 31800).

    Presently, we have committed to issuing a final rule regarding “Substances Generally Recognized as Safe” in 2016, as part of a settlement agreement with the Center for Food Safety, which filed a lawsuit in 2014 seeking to vacate our 1997 proposed rule.

    Description of Respondents: The respondents to this collection of information are manufacturers of substances used in food and feed.

    In the Federal Register of September 17, 2015 (80 FR 55857), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received a number of comments in support of the information collection generally. We also received one comment suggesting that the names, credentials, and affiliations of “qualified experts” associated with GRAS determinations be included on the form. We received a second comment suggesting that information submitted by manufacturers be reviewed by independent scientists. We appreciate this input. As discussed previously, rulemaking is underway that will necessitate a revision to the information collection provisions associated with our GRAS program and we continue to consider all comments.

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

    Table 1—Estimated Annual Reporting Burden 1 21 CFR Section Form No.2 Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total
  • annual
  • responses
  • Average
  • burden
  • per response
  • Total hours
    170.36 (CFSAN) 3667 3 40 1 40 150 6,000 570.36 (CVM) N/A 20 1 20 150 3,000 Total 9,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Only CFSAN uses Form FDA 3667. 3 Form FDA 3667 may be submitted electronically via the ESG.
    Table 2—Estimated Annual Recordkeeping Burden 1 21 CFR Section Number of
  • recordkeepers
  • Number of
  • records per
  • recordkeeper
  • Total
  • annual records
  • Average
  • burden per
  • recordkeeping
  • Total hours
    170.36(c)(v) (CFSAN) 40 1 40 15 600 570.36(c)(v) (CVM) 20 1 20 15 300 Total 900 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    For purposes of this extension request, we are retaining our 2012 estimates. The PRA analysis for the GRAS final rule will take into account any changes to the GRAS notification procedure as set forth in the final rule and we will revise the collection accordingly.

    Dated: February 12, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-03330 Filed 2-17-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device Panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice. FDA seeks to include the views of women, and men, members of all racial and ethnic groups and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.

    DATES:

    Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to FDA by March 21, 2016, (see sections I and II for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by March 21, 2016.

    ADDRESSES:

    All statements of interest from industry organizations interested in participating in the selection process of nonvoting industry representative nomination should be sent to Margaret Ames (see FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting industry representatives may be submitted electronically by accessing the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002. Information about becoming a member of an FDA advisory committee can also be obtained by visiting FDA's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm.

    FOR FURTHER INFORMATION CONTACT:

    Margaret Ames, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5215, Silver Spring, MD 20993, 301-796-5960, Fax: 301-847-8505, [email protected].

    SUPPLEMENTARY INFORMATION:

    The Agency is requesting nominations for nonvoting industry representatives to certain panels identified in the following paragraphs:

    I. Medical Devices Advisory Committee

    The Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. The panels engage in a number of activities to fulfill the functions the Federal Food, Drug, and Cosmetic Act envisions for device advisory panels. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, advises the Commissioner of Food and Drugs regarding recommended classification or reclassification of devices into one of three regulatory categories; advises on any possible risks to health associated with the use of devices; advises on formulation of product development protocols; reviews premarket approval applications for medical devices; reviews guidelines and guidance documents; recommends exemption of certain devices from the application of portions of the Act; advises on the necessity to ban a device; and responds to requests from the agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner of Food and Drugs on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. The Committee also provides recommendations to the Commissioner or designee on complexity categorization of in vitro diagnostics under the Clinical Laboratory Improvement Amendments of 1988.

    A. Anesthesiology and Respiratory Therapy Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in anesthesiology and respiratory therapy and makes appropriate recommendations to the Commissioner of Food and Drugs.

    B. Ear, Nose and Throat Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational ear, nose and throat devices and makes appropriate recommendations to the Commissioner of Food and Drugs.

    C. Gastroenterology and Urology Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational gastroenterology, urology and nephrology devices and makes appropriate recommendations to the Commissioner of Food and Drugs.

    D. General and Plastic Surgery Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational general and plastic surgery devices and makes appropriate recommendations to the Commissioner of Food and Drugs.

    E. Hematology and Pathology Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including pathology, hematology, histopathology, cytotechnology and molecular biology and makes appropriate recommendations to the Commissioner of Food and Drugs.

    F. Medical Devices Dispute Resolution

    Provides advice to the Center Director on complex or contested scientific issues between the FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by FDA, and Agency guidance and policies. The Panel makes recommendations on issues that are lacking resolution, are highly complex in nature, or result from challenges to Agency decisions or actions.

    G. Microbiology Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including microbiology, virology, and infectious disease and makes appropriate recommendations to the Commissioner of Food and Drugs.

    H. Molecular and Clinical Genetics Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including clinical and molecular genetics and makes appropriate recommendations to the Commissioner of Food and Drugs.

    I. Neurological Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in the neurological system and makes appropriate recommendations to the Commissioner of Food and Drugs.

    J. Orthopaedic and Rehabilitation Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational orthopedic and rehabilitation devices and makes appropriate recommendations to the Commissioner of Food and Drugs.

    K. Radiological Devices Panel

    Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational diagnostics or therapeutic radiological and nuclear medicine devices and makes appropriate recommendations to the Commissioner of Food and Drugs.

    II. Qualifications

    Persons nominated for the device panels should be full-time employees of firms that manufacture products that would come before the panel, or consulting firms that represent manufacturers, or have similar appropriate ties to industry.

    III. Selection Procedure

    Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations; and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for a particular device panel. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests.

    IV. Application Procedure

    Individuals may self nominate and/or an organization may nominate one or more individuals to serve as a nonvoting industry representative. Contact information, a current curriculum vitae, and the name of the Committee of interest may be submitted to the FDA Advisory Committee Membership Nomination Portal (see ADDRESSES) within 30 days of publication of this document (see DATES). FDA will forward all nominations to the organizations expressing interest in participating in the selection process for the particular device panel. (Persons who nominate themselves as nonvoting industry representatives will not participate in the selection process).

    This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: February 11, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs.
    [FR Doc. 2016-03283 Filed 2-17-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier OS-4040-0005 60D] Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request AGENCY:

    Electronic Government Office, HHS.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a 3-year extension for OMB Control Number 4040-0005. The ICR will expire on July 31, 2016. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

    DATES:

    Comments on the ICR must be received on or before April 18, 2016.

    ADDRESSES:

    Submit your comments to [email protected] or (202) 690-7569.

    FOR FURTHER INFORMATION CONTACT:

    Information Collection Clearance staff, [email protected] or (202) 690-6162.

    SUPPLEMENTARY INFORMATION:

    When submitting comments or requesting information, please include the OMB control number 4040-0005. Form is available http://www.grants.gov or upon request.

    Information Collection Request Title: SF-424 Application for Federal Assistance—Individual.

    OMB No.: 4040-0005.

    Abstract: The SF-424 Application for Federal Assistance—Individual is a common form used by Federal grant-making agencies for individual applicants without DUNS numbers to apply for Federal financial assistance.

    Need and Proposed Use of the Information: The SF-424 Application for Federal Assistance—The Individual common form is used by individuals not associated with organizations to apply for Federal financial assistance in the form of grants. These forms are submitted to the Federal grant-making agencies for evaluation and review.

    Likely Respondents: Organizations and institutions seeking grants.

    Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

    HHS does not use the form; however, HHS estimates that the SF-424 Application for Federal Assistance—Individual's will take 1 hour to complete.

    Once OMB approves the use of this common form, federal agencies may request OMB approval to use this common form without having to publish notices and request public comments for 60 and 30 days. Each agency must account for the burden associated with their use of the common form.

    EGOV specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    Total Estimated Annualized Burden Hours Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total
  • burden hours
  • SF-424 Application for Federal Assistance—Individual 0 1 1 0 Total 0 0
    Terry S. Clark, Asst Information Collection Clearance Officer.
    [FR Doc. 2016-03249 Filed 2-17-16; 8:45 am] BILLING CODE 4150-57-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Alcohol Abuse and Alcoholism Special Emphasis Panel; Multi-Site Randomized Controlled Clinical Trial Research Center on Alcohol's Health Effects (U10).

    Date: March 29, 2016.

    Time: 11:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health—NIAAA, 5635 Fishers Lane, Conference Room 2098, Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: Ranga Srinivas, Ph.D., Chief, Extramural Project Review Branch, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 5365 Fishers Lane, Room 2085, Rockville, MD 20852, (301) 451-2067, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards, National Institutes of Health, HHS)
    Dated: February 11, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-03240 Filed 2-17-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Mental Health; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Mental Health Special Emphasis Panel; Clinical Trials to Test the Effectiveness of Treatment, Preventive and Services Interventions.

    Date: March 4, 2016.

    Time: 11:30 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: Karen Gavin-Evans, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH Neuroscience Center, 6001 Executive Boulevard, Room 6153, MSC 9606, Bethesda, MD 20892, 301-451-2356, [email protected].

    Name of Committee: National Institute of Mental Health Special Emphasis Panel; Mental Health Services Conflicts.

    Date: March 9, 2016.

    Time: 11:30 a.m. to 12:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call).

    Contact Person: Karen Gavin-Evans, Ph.D., Scientific Review Officer, Division of Extramural Activities, National Institute of Mental Health, NIH Neuroscience Center, 6001 Executive Boulevard, Room 6153, MSC 9606, Bethesda, MD 20892, 301-451-2356, [email protected].

    (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS)
    Dated: February 11, 2016. Carolyn A. Baum, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-03238 Filed 2-17-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Dental & Craniofacial Research; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Dental and Craniofacial Research Special Emphasis Panel; Review of Applications for NIDCR Clinical Trial or Biomarker Clinical Validation Study Planning Grant (R34).

    Date: March 11, 2016.

    Time: 12:00 p.m. to 1:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892.

    Contact Person: Victor Henriquez, Ph.D., Scientific Review Officer, DEA/SRB/NIDCR, 6701 Democracy Blvd., Room 668, Bethesda, MD 20892-4878, 301-451-2405, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS)
    Dated: February 11, 2016. David Clary, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-03236 Filed 2-17-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Eye Institute Special Emphasis Panel; NEI Research Project Grant Applications.

    Date: March 10, 2016.

    Time: 12:00 p.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Brian Hoshaw, Ph.D., Scientific Review Officer, National Eye Institute, National Institutes of Health, Division of Extramural Research, 5635 Fishers Lane, Suite 1300, Rockville, MD 20892, 301-451-2020, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS)
    Dated: February 11, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-03235 Filed 2-17-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Time Sensitive Exploratory/Developmental Research Award.

    Date: February 29, 2016.

    Time: 2:30 p.m. to 3:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: NIEHS/National Institutes of Health, Keystone Building, 530 Davis Drive, Research Triangle Park, NC 27709 (Telephone Conference Call).

    Contact Person: Janice B. Allen, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute of Environmental Health Science, P.O. Box 12233, MD EC-30/Room 3170B, Research Triangle Park, NC 27709, 919/541-7556.

    Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; R13 Superfund Associated Conference Grant Applications.

    Date: March 1, 2016.

    Time: 11:30 a.m. to 3:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: NIEHS, Keystone Building, Room 2128, 530 Davis Drive, Research Triangle Park, NC 27709 (Telephone Conference Call).

    Contact Person: Janice B Allen, Ph.D., Scientific Review Officer Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute of Environmental Health Science, P.O. Box 12233, MD EC-30/Room 3170 B Research Triangle Park, NC 27709, 919/541-7556.

    Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; SRP Research Careers in Emerging Technologies.

    Date: March 7, 2016.

    Time: 11:00 a.m. to 2:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: NIEHS/National Institutes of Health, Key Stone Building, 530 Davis Drive, Research Triangle Park, NC 27709 (Telephone Conference Call).

    Contact Person: Linda K Bass, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute Environmental Health Sciences, P.O. Box 12233, MD EC-30 Research Triangle Park, NC 27709, (919) 541-1307 [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS)
    Dated: February 11, 2016. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-03239 Filed 2-17-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR 13-080: Accelerating the Pace of Drug Abuse Research Using Existing Data.

    Date: March 2, 2016.

    Time: 11:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Kate Fothergill, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive Room 3142, Bethesda, MD 20892, 301-435-2309, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR 13-080: Accelerating the Pace of Drug Abuse Research Using Existing Data: Additional Applications.

    Date: March 2, 2016.

    Time: 11:30 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: George Vogler, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3140, MSC 7770, Bethesda, MD 20892, (301) 237-2693, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Medical Imaging.

    Date: March 10-11, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Dana on Mission Bay, 1710 West Mission Bay Drive, San Diego, CA 92109.

    Contact Person: Leonid V. Tsap, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5128, MSC 7854, Bethesda, MD 20892, (301) 435-2507, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Brain Disorders and Related Neurosciences.

    Date: March 10-11, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Courtyard by Marriott Chevy Chase, 5520 Wisconsin Ave., Chevy Chase, MD 20815.

    Contact Person: Vilen A. Movsesyan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4040M, MSC 7806, Bethesda, MD 20892, 301-402-7278, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Biomedical Sensing, Measurement and Instrumentation.

    Date: March 10, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Dana on Mission Bay, 1710 West Mission Bay Drive, San Diego, CA 92109.

    Contact Person: Inna Gorshkova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301-435-1784, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Non-HIV Microbial Vaccines.

    Date: March 10, 2016.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Sheraton Tampa East, 10221 Princess Palm Avenue, Tampa, FL 33610.

    Contact Person: Andrea Keane-Myers, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4218, Bethesda, MD 20892, 301-435-1221, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Aging and Development, Auditory, Vision and Low Vision Technologies.

    Date: March 10-11, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015.

    Contact Person: Paek-Gyu Lee, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4201, MSC 7812, Bethesda, MD 20892, (301) 613-2064, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Bioanalytical Chemistry, Biophysics, and Assay Development.

    Date: March 10, 2016.

    Time: 9:30 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Vonda K Smith, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6188, MSC 7892, Bethesda, MD 20892, 301-435-1789, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cellular and Molecular Immunology.

    Date: March 10, 2016.

    Time: 3:00 p.m. to 5:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Tina McIntyre, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4202, MSC 7812, Bethesda, MD 20892, 301-594-6375, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Cardiovascular and Surgical Devices.

    Date: March 11, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Dana on Mission Bay, 1710 West Mission Bay Drive, San Diego, CA 92109.

    Contact Person: Jan Li, MD, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5106, Bethesda, MD 20892, 301.435.1049, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; RFA Panel: Molecular and Cellular Substrates of Complex Brain Disorders.

    Date: March 11, 2016.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814.

    Contact Person: Deborah L Lewis, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4183, MSC 7850, Bethesda, MD 20892, 301-408-9129, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; New R21 Applications for Microbial Diseases.

    Date: March 11, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Sheraton Tampa East, 10221 Princess Palm Avenue, Tampa, FL 33610.

    Contact Person: Andrea Keane-Myers, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4218, Bethesda, MD 20892, 301-435-1221, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Movement and Cognitive Impairments.

    Date: March 11, 2016.

    Time: 11:00 a.m. to 1:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Serena Chu, Ph.D., Scientific Review Officer, BBBP IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3178, MSC 7848, Bethesda, MD 20892, 301-500-5829, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: February 11, 2016. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-03233 Filed 2-17-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging, Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Aging Special Emphasis Panel; Sensory Deficits in Osteoporotic Study.

    Date: March 15, 2016.

    Time: 2:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute on Aging, Gateway Building, Suite 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Isis S. Mikhail, DRPH, MD, MPH, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301-402-7704, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
    Dated: February 11, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-03237 Filed 2-17-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Asthma and Allergic Diseases Cooperative Research Centers (U19).

    Date: March 15-17, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The William F. Bolger Center, Stain Glass Hall Room, 9600 Newbridge Drive, Potomac, MD 20854.

    Contact Person: Louis A. Rosenthal, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, Rm 3G42B, National Institutes of Health/NIAID, 5601 Fishers Lane, MSC-79823, Bethesda, MD 20892-9823, (240) 669-5070, [email protected]

    Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; NIAID Clinical Trial Planning Grant (R34), Implementation Grant (R01) and Cooperative Agreement (U01).

    Date: March 15, 2016.

    Time: 11:00 a.m. to 4:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Room 4H100, 5601 Fishers Lane, Rockville, MD 20892, (Telephone Conference Call).

    Contact Person: Maryam Feili-Hariri, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health/NIAID, 5601 Fishers Lane, Rockville, MD 20852, 240-669-5026, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS)
    Dated: February 11, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-03234 Filed 2-17-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2016-0122] Merchant Mariner Medical Advisory Committee AGENCY:

    Coast Guard, Department of Homeland Security.

    ACTION:

    Notice of Federal Advisory Committee meeting.

    SUMMARY:

    The Merchant Mariner Medical Advisory Committee and its working groups will meet to discuss matters relating to medical certification determinations for issuance of licenses, certificates of registry, merchant mariners' documents, medical standards and guidelines for the physical qualifications of operators of commercial vessels, medical examiner education, and medical research. The meetings will be open to the public. DATES: The Merchant Mariner Medical Advisory Committee and its working groups are scheduled to meet on Monday, March 14 and Tuesday, March 15, 2016, from 8 a.m. to 5:15 p.m. and 8 a.m. to 5 p.m. Please note that these meetings may adjourn early if the committee has completed its business.

    ADDRESSES:

    The meetings will be held at the Crowley Maritime Corporation, 1st Floor Conference Room, 9487 Regency Square Blvd., Jacksonville, FL 32225 (http://www.crowley.com). For further information about the meeting facilities, please contact Ms. Becky Kelly at (904)727-4213.

    Please be advised that all attendees are required to check-in to the visitor's booth located to the right of the main building entrance. All attendees will be required to provide a government-issued picture identification card in order to gain admittance to the building. For planning purposes, please notify the Merchant Mariner Medical Advisory Committee Alternate Designated Federal Officer of your attendance as soon as possible using the contact information provided in the FOR FURTHER INFORMATION CONTACT section of this notice.

    For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact the Alternate Designated Federal Officer as soon as possible.

    To facilitate public participation, we are inviting public comment on the issues to be considered by the committee as listed in the “Agenda” section below. Written comments for distribution to committee members must be submitted no later than March 7, 2016, if you want the committee members to be able to review your comments before the meeting, and must be identified by docket number USCG-2016-0122. Written comments may be submitted using the Federal eRulemaking Portal: http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the Alternate Designated Federal Officer for alternate instructions.

    Instructions: All submissions must include the words “Department of Homeland Security” and the docket number for this action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided. You may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005 issue of the Federal Register (70 FR 15086).

    Docket: For access to the docket to read documents or comments related to this Notice, go to http://www.regulations.gov, insert USCG-2016-0122 in the “SEARCH” box, press Enter and then click on the item you wish to view.

    A public comment period will be held on March 14, 2016, from approximately 11:30 a.m.-12 p.m. and March 15, 2016 from approximately 2:15 p.m.-2:45 p.m. Speakers are requested to limit their comments to 5 minutes. Please note that the public comment period may end before the time indicated, following the last call for comments. Additionally, public comment will be sought throughout the meeting as specific issues are discussed by the committee. Contact Lieutenant Ashley Holm as indicated below to register as a speaker.

    FOR FURTHER INFORMATION CONTACT:

    Lieutenant Ashley Holm, Alternate Designated Federal Officer for the Merchant Mariner Medical Advisory Committee, 2703 Martin Luther King Jr. Ave SE., Stop (7501), telephone 202-372-1128, fax 202-372-4908 or [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice of this meeting is given under the Federal Advisory Committee Act, Title 5 United States Code Appendix. The Merchant Mariner Medical Advisory Committee Meeting is authorized by 46 United States Code 7115 and advises the Secretary on matters related to (a) medical certification determinations for issuance of licenses, certificates of registry, and merchant mariners' documents; (b) medical standards and guidelines for the physical qualifications of operators of commercial vessels; (c) medical examiner education; and (d) medical research.

    Agenda Day 1

    The agenda for the March 14, 2016 meeting is as follows:

    (1) Opening remarks from Crowley Maritime leadership.

    (2) Opening remarks from Coast Guard leadership.

    (3) Opening remarks from the Designated Federal Officer.

    (4) Roll call of committee members and determination of a quorum.

    (5) Review of last full committee meeting's minutes.

    (6) Introduction of new task(s).

    (7) Presentation and discussion on marine casualty investigations and data analysis (could lead to future tasking for the committee).

    (8) Public comment period.

    (9) Presentation on mariner wellness.

    (10) Working Groups addressing the following task statements may meet to deliberate-

    (a) Task statement 13, Mariner Occupational Health Risk Analysis. This is a joint task statement with the Merchant Marine Personnel Advisory Committee.

    (b) Task statement(s) requesting recommendations on training content for a Designated Medical Examiner program.

    (c) Task statement requesting recommendations on guidance to mariners on over the counter medications, energy drinks/pills, diet aids, and dietary supplements.

    (d) The Committee may receive new task statements from the Coast Guard, review the information presented on each issue, deliberate and formulate recommendations for the Department's consideration.

    (10) Adjournment of meeting.

    Day 2

    The agenda for the March 15, 2016 meeting is as follows:

    (1) Continue work on Task Statements.

    (2) Presentation from the Council on Chiropractic Education.

    (3) Public comment period.

    (4) By mid-afternoon, the Working Groups will report, and if applicable, make recommendations for the full committee to consider for presentation to the Coast Guard. The committee may vote on the working group's recommendations on this date. The public will have an opportunity to speak after each Working Group's Report before the full committee takes any action on each report.

    (5) Closing remarks/plans for next meeting.

    (6) Adjournment of Meeting.

    Dated: February 11, 2016. V.B. Gifford, Captain, U.S. Coast Guard, Director of Inspections and Compliance.
    [FR Doc. 2016-03348 Filed 2-17-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY National Protection and Programs Directorate; Cybersecurity Information Sharing Act of 2015 Interim Guidance Documents—Notice of Availability AGENCY:

    National Protection and Programs Directorate, DHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    DHS is announcing the availability of Cybersecurity Information Sharing Act of 2015 Interim Guidance Documents jointly issued with the Department of Justice (DOJ) in compliance with the Act (CISA), which authorizes the voluntary sharing and receiving of cyber threat indicators and defensive measures for cybersecurity purposes, consistent with certain protections, including privacy and civil liberty protections.

    ADDRESSES:

    The CISA guidance documents may be found on www.us-cert.gov/ais.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this notice, email Matthew Shabat at [email protected] or telephone on (703) 235-5338. Questions may also be directed by mail to Matthew Shabat, 245 Murray Lane SW., Mail Stop 0610, Washington, DC 20528-0610.

    SUPPLEMENTARY INFORMATION:

    The CISA requires the Secretary of DHS and the Attorney General to jointly develop and make publicly available—

    • guidance to assist non-Federal entities and promote sharing of cyber threat indicators with the Federal Government;

    • interim and final guidelines for the protection of privacy and civil liberties; and

    • interim and final procedures related to the receipt of cyber threat indicators and defensive measures by the Government, which happen principally through the real-time DHS process, the existing DHS-operated Automated Indicator Sharing (AIS) initiative and may also occur through direct submissions to Federal agencies.

    The CISA also requires the Secretary of DHS, the Attorney General, the Director of National Intelligence, and the Secretary of Defense, to jointly develop interim procedures to facilitate and promote the sharing of cyber threat indicators and defensive measures by the Federal Government.

    Authority and Background

    On December 18, 2015, the President signed into law the Consolidated Appropriations Act, 2016, Public Law 114-113, which included at Division N, Title I the Cybersecurity Information Sharing Act of 2015 (CISA). Congress designed CISA to establish a voluntary cybersecurity information sharing process that encourages public and private sector entities to share cyber threat indicators and defensive measures while protecting privacy and civil liberties. The CISA requires various Executive Branch agencies to coordinate and create, within 60 days of enactment (i.e., not later than February 16, 2016), four guidance documents to facilitate this voluntary cybersecurity information sharing process. The CISA requires two of these interim documents to be made publicly available. See generally Public Law 114-113, Div. N, Title I secs. 103, 105).

    Overview of the 60 Day Guidance Required Under CISA

    The CISA sec. 103 requires the Director of National Intelligence, the Secretary of Homeland Security, the Secretary of Defense, and the Attorney General, in consultation with the heads of designated Federal entities,1 to jointly develop and issue procedures to facilitate and promote the sharing by the Federal Government of classified and unclassified cyber threat indicators, defensive measures, and other information and best practices related to mitigating cyber threats. The CISA sec. 103(b) requires these procedures to include a real-time sharing capability (namely the DHS Automated Indicator Sharing (AIS) initiative); incorporate existing Federal information sharing processes, procedures, roles, and responsibilities to the greatest extent possible; account for sharing done in error; and protect against unauthorized access to cyber threat information. Further, the procedures must account for the review of cyber threat indicators to identify personal information not related to the threat, a technical capability to remove such personal information, and a notification process to alert any U.S. person whose personal information is improperly shared by a Federal entity.

    1 The CISA defines Appropriate Federal Entities as the Departments of Commerce, Defense, Energy, Homeland Security, Justice, Treasury, and the Office of the Director of National Intelligence. See CISA sec. 102(3).

    The CISA sec. 105(a)(1) requires the Secretary of Homeland Security and the Attorney General, in consultation with the heads of designated Federal entities, to jointly develop and issue interim policies and procedures relating to the receipt of cyber threat indicators and defensive measures by the Federal Government. These internal operational procedures describe general rules applicable to DHS and other Federal agencies and the operative processes of the DHS AIS system, including the statutory requirement for Federal agencies that receive cyber threat indicators and defensive measures to share them with other appropriate agencies.

    The CISA sec. 105(a)(4) requires the Secretary of Homeland Security and the Attorney General to jointly develop and make publicly available guidance to assist non-Federal entities with sharing cyber threat indicators with Federal entities. This guidance includes explanations of how non-Federal entities can identify and share cyber threat indicators and defensive measures with the Federal Government in accordance with CISA and describes the protections non-Federal entities receive under CISA for sharing cyber threat indicators and defensive measures, including targeted liability protection and other statutory protections.

    Finally, CISA sec. 105(b) requires the Secretary of Homeland Security and the Attorney General, in consultation with the Department Heads and Chief Privacy and Civil Liberties Officers of the designated Federal entities, to jointly develop and make publicly available interim guidelines relating to privacy and civil liberties that govern the receipt, retention, use, and dissemination of cyber threat indicators by a Federal entity. These privacy and civil liberties guidelines are consistent with the Fair Information Practice Principles (FIPPs) set forth in Appendix A of the “National Strategy for Trusted Identities in Cyberspace,” published by the President in April 2011.

    Issuance of Agency Guidance Required Under CISA

    The CISA guidance documents may be found on www.us-cert.gov/ais.

    Dated: February 11, 2016. Andy Ozment, Assistant Secretary, Department of Homeland Security.
    [FR Doc. 2016-03430 Filed 2-17-16; 8:45 am] BILLING CODE 9110-9P-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5913-N-05] 60-Day Notice of Proposed Information Collection: The Multifamily Project Application and Construction Prior to Initial Endorsement AGENCY:

    Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.

    ACTION:

    Notice.

    SUMMARY:

    HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

    DATES:

    Comments Due Date: April 18, 2016.

    ADDRESSES:

    Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at [email protected] for a copy of the proposed forms or other available information. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.

    FOR FURTHER INFORMATION CONTACT:

    Theodore K. Toon, Director, Office of Multifamily Production, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email [email protected] or telephone 202-402-1142. This is not a toll-free number. Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Relay Service at (800) 877-8339.

    Copies of available documents submitted to OMB may be obtained from Ms. Pollard.

    SUPPLEMENTARY INFORMATION:

    This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.

    A. Overview of Information Collection

    Title of Information Collection: Multifamily Project Application and Construction Prior to Initial Endorsement.

    OMB Approval Number: 2502-0029.

    Type of Request: Revision.

    Form Number: HUD-92013, HUD-92013 Supp, HUD-92013-A, HUD-92013-B, HUD-92013-C, HUD-92013-D, HUD-92013-E, HUD-92264, HUD-92264-A, HUD-92273, HUD-92274, HUD-92326, HUD-92329, HUD-92331, HUD-92485, HUD-92415, HUD-92447, HUD-92452, HUD-92010, HUD-91708, HUD-2880, HUD-92466-R1, R2, R3, R4, HUD-92466 R5, HUD-92408, HUD-92466M, FM-1006, HUD-95379 and HUD-2.

    Description of the need for the information and proposed use: The Multifamily Project Applications and Construction Prior to Initial Endorsement is being revised to include two (2) supplemental forms that outline requirements of owners that elect to benefit from the simplified rate categories. These forms will be used during the processing of an application for a FHA insured mortgage to determine the appropriate mortgage insurance premium.

    Respondents (i.e. affected public): 1,002.

    Estimated Number of Respondents: 1,002.

    Estimated Number of Responses: 34,112.

    Frequency of Response: 1.

    Average Hours per Response: 34,112.

    Total Estimated Burden: 351,182.

    B. Solicitation of Public Comment

    This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:

    (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    (2) The accuracy of the agency's estimate of the burden of the proposed collection of information;

    (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and

    (4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    HUD encourages interested parties to submit comment in response to these questions.

    Authority:

    Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.

    Dated: February 4, 2016. Genger Charles, Senior Policy Advisory for Housing.
    [FR Doc. 2016-03367 Filed 2-17-16; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R1-ES-2016-N022; FXES11130100000-167-FF01E00000] Endangered Species; Recovery Permit Applications AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of availability; request for comments.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications for recovery permits to conduct activities with the purpose of enhancing the survival of endangered species. The Endangered Species Act of 1973, as amended (Act), prohibits certain activities with endangered species unless a Federal permit allows such activity. The Act also requires that we invite public comment before issuing such permits.

    DATES:

    To ensure consideration, please send your written comments by March 21, 2016.

    ADDRESSES:

    Program Manager, Restoration and Endangered Species Classification, Ecological Services, U.S. Fish and Wildlife Service, Pacific Regional Office, 911 NE 11th Avenue, Portland, OR 97232-4181. Please refer to the permit number for the application when submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    Colleen Henson, Fish and Wildlife Biologist, at the above address, or by telephone (503-231-6131) or fax (503-231-6243).

    SUPPLEMENTARY INFORMATION: Background

    The Act (16 U.S.C. 1531 et seq.) prohibits certain activities with respect to endangered and threatened species unless a Federal permit allows such activity. Along with our implementing regulations in the Code of Federal Regulations (CFR) at 50 CFR 17, the Act provides for certain permits, and requires that we invite public comment before issuing these permits for endangered species.

    A permit granted by us under section 10(a)(1)(A) of the Act authorizes the permittee to conduct activities (including take or interstate commerce) with respect to U.S. endangered or threatened species for scientific purposes or enhancement of propagation or survival. Our regulations implementing section 10(a)(1)(A) of the Act for these permits are found at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.

    Applications Available for Review and Comment

    We invite local, State, and Federal agencies and the public to comment on the following applications. Please refer to the permit number for the application when submitting comments.

    Documents and other information submitted with these applications are available for review by request from the Program Manager for Restoration and Endangered Species Classification at the address listed in the ADDRESSES section of this notice, subject to the requirements of the Privacy Act (5 U.S.C. 552a) and the Freedom of Information Act (5 U.S.C. 552).

    Permit Number: TE-003483 Applicant: U.S. Geological Survey, Pacific Island Ecosystems Research Center, Hawaii National Park, Hawaii.

    The applicant requests a permit amendment to take (capture, band, mark, measure, weigh, collect blood samples, radio-tag, release, recapture, and search for and monitor nests) Hawaiian gallinule (Gallinula galeata sandvicensis) on the island of Oahu, and to increase the number of radio-tagged Hawai`i `ākepa (Loxops coccineus) and Hawai`i creeper (Oreomystis mana) on the island of Hawaii, in conjunction with scientific research, for the purpose of enhancing the species' survival. The permit currently covers the Laysan duck (Anas laysanensis), `akiapōlā`au (Hemignathus munroi), `akeke'e (Loxops caeruleirostris), `akikiki (Oreomystis bairdi), puaiohi (Myadestes palmeri), `alae ke`oke`o or Hawaiian Coot (Fulica alai), ae`o or Hawaiian Stilt (Himantopus mexicanus knudseni), and the `ōpe`ape`a or Hawaiian hoary bat (Lasiurus cinereus semotus).

    Permit Number: TE-012136 Applicant: Oregon Department of Environmental Quality, Hillsboro, Oregon.

    The applicant requests a permit renewal with changes to take (capture, handle, and release) Borax Lake chub (Gila boraxobius) in conjunction with surveys throughout the species' range in Oregon for the purpose of enhancing its survival. The permit currently covers the Lost River sucker (Deltistes luxatus) and the shortnose sucker (Chasmistes brevirostris).

    Permit Number: TE-101141 Applicant: Washington State University, Vancouver, Washington.

    The applicant requests a permit amendment to take (survey, capture, mark, and release) Fender's blue butterfly (Icaricia icarioides fenderi) in conjunction with scientific research in Benton, Lane, Polk, Washington, and Yamhill Counties, Oregon, for the purpose of enhancing its survival.

    Permit Number: TE-27877B Applicant: Nathan L. Haan, Seattle, Washington.

    The applicant requests a permit amendment to take (captive rear adults) Taylor's checkerspot butterflies (Euphydryas editha taylori), in conjunction with scientific research in Thurston County, Washington, for the purpose of enhancing its survival.

    Public Availability of Comments

    All comments and materials we receive in response to this request will be available for public inspection, by appointment, during normal business hours at the address listed in the ADDRESSES section.

    Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Authority

    We provide this notice under section 10 of the Act (16 U.S.C. 1531 et seq.).

    Dated: February 10, 2016. Stephen J. Zylstra, Acting, Regional Director, Pacific Region, U.S. Fish and Wildlife Service.
    [FR Doc. 2016-03302 Filed 2-17-16; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-20233; PPWOCRADN0-PCU00RP14.R50000] Notice of Intent To Repatriate Cultural Items: Mount Holyoke College Art Museum, South Hadley, MA AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The Mount Holyoke College Art Museum, in consultation with the appropriate Indian tribes or Native Hawaiian organizations, has determined that the cultural item listed in this notice meets the definition of a sacred object and object of cultural patrimony. Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim this cultural item should submit a written request to the Mount Holyoke College Art Museum. If no additional claimants come forward, transfer of control of the cultural item to the lineal descendants, Indian tribes, or Native Hawaiian organizations stated in this notice may proceed.

    DATES:

    Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim this cultural item should submit a written request with information in support of the claim to the Mount Holyoke College Art Museum at the address in this notice by March 21, 2016.

    ADDRESSES:

    Aaron F. Miller, NAGPRA Coordinator, Mount Holyoke College Art Museum, 50 College Street, South Hadley, MA 01075, telephone (413) 538-3394, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3005, of the intent to repatriate a cultural item under the control of the Mount Holyoke College Art Museum that meets the definition of a sacred object and an object of cultural patrimony under 25 U.S.C. 3001.

    This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American cultural item. The National Park Service is not responsible for the determinations in this notice.

    History and Description of the Cultural Item

    In 2014, one cultural item was donated to the Mount Holyoke College Art Museum by the children of J. Donald Detenber, from Westborough, MA. Detenber was a collector and dealer in Native American objects, and it is unclear when and where he acquired the object. Detenber was most active in the 1980s and 1990s and purchased from various dealers and auction houses across the country. The sacred object/object of cultural patrimony is a woven cotton sash.

    This type of textile was used primarily by the bride in the traditional Hopi wedding ceremony and can be seen in various photographs from the early 20th century. As part of the ceremony, cotton was collected from various members of the community and woven by a specific group of relatives. Another known use of these sashes is the Powamu Festival, centered on the seasonal planting of beans. One aspect of the ceremonies is the imitation of Katchinas (ancestral spirits). In some cases, men would don the sash to dress as female Katchina spirits or women in general. One such female Katchina is Angwusnasomtaka (Crow Mother), who is often represented with this type of sash. Based on the above definitions and a general knowledge of these objects being used in various types of ceremonies, there is a relationship of shared group identity that can be reasonably traced between the cultural item and the Hopi Tribe of Arizona.

    Determinations Made by the Mount Holyoke College Art Museum

    Officials of the Mount Holyoke College Art Museum have determined that:

    • Pursuant to 25 U.S.C. 3001(3)(C), the one cultural item described above is a specific ceremonial objects needed by traditional Native American religious leaders for the practice of traditional Native American religions by their present-day adherents.

    • Pursuant to 25 U.S.C. 3001(3)(D), the one cultural item described above has ongoing historical, traditional, or cultural importance central to the Native American group or culture itself, rather than property owned by an individual.

    • Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the sacred object and object of cultural patrimony and the Hopi Tribe of Arizona.

    Additional Requestors and Disposition

    Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim this cultural item should submit a written request with information in support of the claim to Aaron F. Miller, NAGPRA Coordinator, Mount Holyoke College Art Museum, 50 College Street, South Hadley, MA 01075, telephone (413) 538-3394, email [email protected], by March 21, 2016. After that date, if no additional claimants have come forward, transfer of control of the sacred object and object of cultural patrimony to the Hopi Tribe of Arizona may proceed.

    The Mount Holyoke College Art Museum is responsible for notifying the Hopi Tribe of Arizona that this notice has been published.

    Dated: February 3, 2016. David Tarler, Acting Manager, National NAGPRA Program.
    [FR Doc. 2016-03411 Filed 2-17-16; 8:45 am] BILLING CODE 4312-50-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-20161; PPWOCRADN0-PCU00RP14.R50000] Notice of Inventory Completion: U.S. Department of Defense, Department of the Navy, Washington, DC AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The U.S. Department of Defense, Department of the Navy (DoN) has completed an inventory of human remains, in consultation with the Aleut Corporation, representatives of the Aleut Repatriation Committee, and the Cultural Heritage Director of the Aleutian/Pribilof Islands Association, Inc., as agents for the Native Village of Atka, AK, and has determined that there is a cultural affiliation between the human remains and members of the Native Village of Atka. Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the DoN. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian tribes, or Native Hawaiian organizations stated in this notice may proceed.

    DATES:

    Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the DoN at the address in this notice by March 21, 2016.

    ADDRESSES:

    Dr. Susan S. Hughes, Archaeologist, Department of the Navy, NAVFAC NW, 1101 Tautog Circle, Silverdale, WA 98315, telephone (360) 396-0083, email [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the DoN. The human remains were removed from the island of Attu, AK, in the Aleutian Islands.

    This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.

    Consultation

    A detailed assessment of the human remains was made by the DoN professional staff in consultation with the Aleut Corporation, the Aleut Repatriation Committee, and the Cultural Heritage Director of the Aleutian/Pribilof Islands Association, Inc., as agents for the Native Village of Atka, AK.

    History and Description of the Remains

    In 1943, human remains representing, at minimum, one individual were removed from Attu Island, at the western end of the Aleutian Islands, AK. The human remains, a skull and associated mandible, came into the possession of William J. Madden II, Senior Medical Officer at the U.S. Naval Aerological Station, Attu, where they were used as an aid in the study of human skull anatomy. In a letter dated May 14, 1948, Dr. Madden states that the human remains were recovered by a civilian construction company while engaged in building a Coast Guard Station on Attu. A historic account of the Coast Guard construction of the Western Aleutian island chain (The Coast Guard at War: IV Loran Volume I Section III, Chapter 3) suggests that the skull may have come from an archeological site at Baxter Bay.

    After the Battle of Attu in the spring of 1943, a U.S.C.G. LORAN Station was built on Attu. A construction party arrived in November of 1943, and began construction of the first LORAN station at Attu on Theodore Point, south of Massacre Bay. A temporary base camp was established at Baxter Cove, 2.5 miles east of the station, the only place where equipment could be offloaded near the site. Tents, a mess hut, and a Loran transmitting equipment storage hut were erected, and a large CAT began construction of the switchback road to the ridge top site. The road became known as Hooligan Highway and was one of the engineering wonders of Attu. An account by Lt. Cmdr. Yates indicates that in the first five hundred feet of road construction at Baxter Cove, the CAT cut through an Aleutian cemetery located under a dummy gun emplacement that the Japanese had abandoned a few months earlier. The construction work turned up “human skulls and bones of prehistoric animals which had been in turn, buried deep below ivory trinkets and tons of bird and fish bones.” In 1949, the LORAN Station was moved to Murder Point, closer to Massacre Bay.

    The skull was transferred into the custody of the Yale University Peabody Museum in 1955 (Catalog No. ANTPA.000227), where it remained until 2014, when it was returned to the Department of the Navy, NAVFAC Northwest, to facilitate its repatriation.

    The skull is represented by a nearly complete cranium and mandible belonging to a young female, aged 15 to 19 years. The dental wear, eruption and mandibular morphology are consistent with the mandible belonging with the cranium. There is damage to the ethmoid and the nasal conchae, with the inferior nasal conchae completely absent. The vomer is present but disarticulated. The sphenoid and right temporal show some postmortem damage. The zygomatic process of the right temporal is missing, as is the right mastoid; the left mastoid process is damaged but mostly present. The mandible is missing the condyles, the right mandibular angle, and its coronoid process. Most of the molars are present, but the incisors and canines were lost post-mortem.

    The individual's age is based upon the unerupted third molars, unfused basal synchondrosis, and incomplete closure of the incisive suture of the palate. There is no clear evidence of chronic or acute health issues. The skull does reveal a small healed, depressed fracture located on the right parietal. The color and condition of the human remains suggests superficial interment with subsequent or partial exposure. Metric and nonmetric data support ethnic identification as Native American/Indigenous Alaska with closest affinity to females sampled from Wales, AK (Southeastern mainland; Aronsen and Kirkham 2014). No known individuals are identified. No funerary objects are associated with the human remains.

    Radiocarbon dates from archeological sites on Attu Island reveal that the island was inhabited between 100 and 2000 years ago (Lefevre et al. 2001). The Department of the Navy has determined that the human remains are affiliated with the Unangax/Aleut people because they have a long history of living on the Aleutian Islands, including the island of Attu. When the 20th century Native Village of Attu at Chichagof Harbor was occupied by the Japanese in 1942, the Native inhabitants were removed to Japan. The village was not re-occupied after the war; its remaining inhabitants settling on Atka Island, the closest settlement to Attu Island (Aleut Repatriation Commission and Cultural Heritage Director, 2002).

    Determinations Made by the Department of the Navy

    Officials of the Department of the Navy have determined that:

    • Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.

    • Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and Members of the Village of Atka, AK.

    Additional Requestors and Disposition

    Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Dr. Susan S. Hughes, Department of the Navy NAVFAC NW, 1101 Tautog Circle, Silverdale, WA 98315, telephone (360) 396-0083, email [email protected], by March 21, 2016. After that date, if no additional requestors have come forward, transfer of control of the human remains to the Native Village of Atka, AK, may proceed.

    The Department of the Navy is responsible for notifying the Native Village of Atka, AK, through its agents, that this notice has been published.

    Dated: January 20, 2016. David Tarler, Acting Manager, National NAGPRA Program.
    [FR Doc. 2016-03408 Filed 2-17-16; 8:45 am] BILLING CODE 4312-50-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-20127; PPWOCRADN0-PCU00RP14.R50000] Notice of Inventory Completion: Thomas Burke Memorial Washington State Museum, University of Washington, Seattle, WA AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The Thomas Burke Memorial Washington State Museum (Burke Museum) has completed an inventory of human remains, in consultation with the appropriate Indian tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and any present-day Indian tribes or Native Hawaiian organizations. Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Burke Museum. If no additional requestors come forward, transfer of control of the human remains to the Indian tribes or Native Hawaiian organizations stated in this notice may proceed.

    DATES:

    Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to the Burke Museum at the address in this notice by March 21, 2016.

    ADDRESSES:

    Peter Lape, Burke Museum, University of Washington, Box 353010, Seattle, WA 98195, telephone (206) 685-3849x2, [email protected]

    SUPPLEMENTARY INFORMATION:

    Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the Burke Museum, University of Washington, Seattle, WA. The human remains were possibly removed from the San Juan Islands, San Juan Island County, WA.

    This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3) and 43 CFR 10.11(d). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.

    Consultation

    A detailed assessment of the human remains was made by the Burke Museum professional staff in consultation with representatives of Lummi Tribe of the Lummi Reservation; Muckleshoot Indian Tribe (previously listed as the Muckleshoot Indian Tribe of the Muckleshoot Reservation, Washington); Nooksack Indian Tribe; Samish Indian Nation (previously listed as the Samish Indian Tribe, Washington); Sauk-Suiattle Indian Tribe; Snoqualmie Indian Tribe (previously listed as the Snoqualmie Tribe, Washington); Stillaguamish Tribe of Indians of Washington (previously listed as the Stillaguamish Tribe of Washington); Suquamish Indian Tribe of the Port Madison Reservation; Swinomish Indian Tribal Community (previously listed as the Swinomish Indians of the Swinomish Reservation of Washington); Tulalip Tribes of Washington (previously listed as the Tulalip Tribes of the Tulalip Reservation, Washington); and Upper Skagit Indian Tribe, (all hereafter referred to as the “The Tribes”).

    History and Description of the Remains

    On an unknown date prior to 1995, human remains representing, at minimum, one individual were possibly removed from San Juan Islands, San Juan Island County, Washington. These remains were identified in 1995 while completing an inventory for NAGPRA compliance. These human remains were located in a box of material marked “Anian Island Burial 3F.” The human remains were in a paper-bag marked “Burial 3”. Also written on the bag in the same pencil, but crossed out, is, “SJ-1, Finds, 7/18/46.”. These human remains to do not match any of the records for the Anian Island burial. They also do not match “Burial 3” from Arden King's 1946 excavations at 45-SJ-1 and there is no mention of burials being found on 7/18/1946 in the field documents. The condition of these human remains is consistent with other burials in shell middens from this area. Additional information provided during consultation indicated this individual was likely buried on the San Juan Islands. The Burke Museum is unable to make a cultural affiliation due to the lack of contextual and exact location information from which the burial was removed. No known individuals were identified. No associated funerary objects are present.

    Determinations Made by the Burke Museum

    Officials of the Burke Museum have determined that:

    • Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice are Native American based on osteological evidence and museum collecting and accessioning history.

    • Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.

    • Pursuant to 25 U.S.C. 3001(2), a relationship of shared group identity cannot be reasonably traced between the Native American human remains and any present-day Indian tribe.

    • Treaties, Acts of Congress, or Executive Orders, indicate that the land from which the Native American human remains were removed is the aboriginal land of The Tribes. The Treaty of Point Elliot was signed on January 22, 1855 by representatives from The Tribes, and ceded aboriginal land included the San Juan Islands region.

    • Pursuant to 43 CFR 10.11(c)(1), the disposition of the human remains may be to The Tribes.

    Additional Requestors and Disposition

    Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request with information in support of the request to Peter Lape, Burke Museum, University of Washington, Box 353010, Seattle, WA 98195, telephone (206) 685-3849 x2, [email protected], by March 21, 2016. After that date, if no additional requestors have come forward, transfer of control of the human remains to The Tribes may proceed.

    The Burke Museum is responsible for notifying The Tribes that this notice has been published.

    Dated: January 15, 2016. David Tarler, Acting Manager, National NAGPRA Program.
    [FR Doc. 2016-03412 Filed 2-17-16; 8:45 am] BILLING CODE 4312-50-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-NAGPRA-20115; PPWOCRADN0-PCU00RP14.R50000] Native American Graves Protection and Repatriation Review Committee; Findings and Recommendations Regarding Human Remains and Associated Funerary Objects for The Osage Nation AGENCY:

    National Park Service, Interior.

    ACTION:

    Findings and recommendations.

    SUMMARY:

    The National Park Service is publishing this notice as part of its administrative responsibilities pursuant to the Native American Graves Protection and Repatriation Act (NAGPRA or the Act). The recommendations, findings, and actions in this notice are advisory only and are not binding on any person. The Native American Graves Protection and Repatriation Review Committee (Review Committee) found that certain human remains and associated items are culturally affiliated with The Osage Nation and that the State of Missouri Department of Natural Resources, State Historic Preservation Office should determine the most appropriate claimant—The Osage Nation or the Indian tribes comprising the Sac and Fox NAGPRA Confederacy—using the criteria under section 7(a)(4) of the Act.

    ADDRESSES:

    The Review Committee meeting transcript containing the proceedings and Review Committee deliberation and findings are available online at www.nps.gov/nagpra/Review or from the National NAGPRA Program upon request ([email protected]).

    SUPPLEMENTARY INFORMATION:

    The recommendations, findings, and actions of the Review Committee are advisory only and not binding on any person. These advisory findings and recommendations do not necessarily represent the views of the National Park Service or Secretary of the Interior. The National Park Service and the Secretary of the Interior have not taken a position on these matters.

    The Review Committee was established by Section 8 of the Act, and is an advisory body governed by the Federal Advisory Committee Act. At its November 18, 2015, public meeting in Norman, OK, the Review Committee heard a request from The Osage Nation as an affected party. The issues before the Review Committee were (1) whether the human remains and associated items from the Clarksville Mound Group (site 23PI6) are culturally affiliated with The Osage Nation; and (2) whether the appropriate disposition of the human remains and associated items from the Clarksville Mound Group (site 23PI6) is to The Osage Nation or the Indian tribes comprising the Sac and Fox NAGPRA Confederacy.

    Between 1962 and 1996, human remains representing, at minimum, 29 individuals were removed from the Clarksville Mound Group (site 23PI6) in Pike County, MO. The Clarksville Mound Group was originally recorded in 1952, and described as a group of six mounds. In 1962, the site was bulldozed in order to develop a sky-ride and tourist attraction, and five of the six mounds were destroyed. In 1995 and 1996, the City of Clarksville, the owner of the site, contacted the Missouri Department of Natural Resources, State Historic Preservation Office (SHPO) for assistance after terminating the lease to the tourist attraction. Human remains were eroding out of the damaged mound, and due to the severity of the erosion problem, the SHPO and the City of Clarksville decided to undertake excavations to remove the threatened burials. The excavations were expanded as more burials were discovered. During the excavations, human remains representing, at minimum, 22 individuals were removed from the site. The two associated funerary objects are one lot of ancalusa shell beads and one Scallorn point. In 2002, additional human remains representing, at minimum, four individuals were transferred to the SHPO by a local collector who had been on the site in 1962. In 2006, additional human remains from the site representing, at minimum, three individuals were transferred to the SHPO by the University of Missouri-Columbia.

    On February 21, 2013, the Sac & Fox Nation of Oklahoma, the Sac & Fox Tribe of the Mississippi in Iowa, and the Sac & Fox Nation of the Missouri in Kansas, through the Sac and Fox NAGPRA Confederacy, submitted a request for repatriation of all the human remains and associated funerary objects from the Clarksville Mound Group (site 23PI6), citing a relationship of shared group identity (cultural affiliation). On July 30, 2013, the SHPO published a Notice of Inventory Completion in the Federal Register (78 FR 45960-45961) for the human remains and associated funerary objects from the Clarksville Mound Group (site 23PI6) in which it determined that a shared group identity could be reasonably traced between the human remains and the Sac & Fox Nation, Oklahoma; Sac & Fox of Missouri in Kansas and Nebraska; and the Sac & Fox Tribe of the Mississippi in Iowa. On August 29, 2013, The Osage Nation timely submitted a written request for transfer of control of the human remains and associated funerary objects removed from the Clarksville Mound Group (site 23PI6). Supporting materials submitted by The Osage Nation asserted that (1) the individuals interred at the Clarksville Mound site dated to the Late Woodland and Emergent Mississippian Period (A.D. 900-1000); (2) this period corresponds to the prehistoric occupation of Missouri by the ancestral Osage; and (3) in accordance with 43 CFR 10.2(e)(1) and 10.14(c), multiple lines of evidence support a cultural affiliation between the prehistoric inhabitants of the Clarksville Mound site and the current people of The Osage Nation. As of July 15, 2015, the SHPO had not made a decision regarding The Osage Nation's request.

    In August 2015, The Osage Nation requested that the Review Committee make a finding of fact regarding the human remains and associated funerary objects removed from Clarksville Mound Group (site 23PI6) in Pike County, MO. The Designated Federal Officer for the Review Committee agreed to the request.

    At its November 18, 2015 meeting, the Review Committee considered the request. The issues before the Review Committee were (1) whether the human remains and associated items from the Clarksville Mound Group (site 23PI6) are culturally affiliated with The Osage Nation; and (2) whether the appropriate disposition of human remains and associated items from the Clarksville Mound Group (site 23PI6) is to The Osage Nation or the Indian tribes comprising the Sac and Fox NAGPRA Confederacy.

    Findings of Fact: All six Review Committee members currently appointed by the Secretary of the Interior participated in the fact finding. By a vote of five to zero (the chair did not vote), the Review Committee found that with regard to issue (1), the human remains and associated items from the Clarksville Mound Group (Site 23PI6) are culturally affiliated with The Osage Nation. Regarding issue (2), by a vote of five to zero (the chair did not vote), the Review Committee “strongly recommends that the [State of Missouri Department of Natural Resources, State Historic Preservation Officer], pursuant to the NAGPRA regulations, determine the most appropriate claimant in this case within the next six months, in consultation with The Osage Nation and the Sac and Fox NAGPRA Confederacy. If the [State of Missouri Department of Natural Resources, State Historic Preservation Officer], cannot make such a determination within six months, the Review Committee requests that the [State of Missouri Department of Natural Resources, State Historic Preservation Officer,] notify the Review Committee of the barrier to doing so.”

    Dated: January 13, 2016. Armand Minthorn, Chair, Native American Graves Protection and Repatriation Review Committee.
    [FR Doc. 2016-03407 Filed 2-17-16; 8:45 am] BILLING CODE 4312-50-P
    INTERNATIONAL TRADE COMMISSION Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Mobile Electronic Devices Incorporating Haptics (Including Smartphones and Smartwatches) and Components Thereof, DN 3120; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing under section 210.8(b) of the Commission's Rules of Practice and Procedure (19 CFR 210.8(b)).

    FOR FURTHER INFORMATION CONTACT:

    Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at EDIS,1 and will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000.

    1 Electronic Document Information System (EDIS): http://edis.usitc.gov.

    General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at USITC.2 The public record for this investigation may be viewed on the Commission's Electronic Document Information System (EDIS) at EDIS. 3 Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.

    2 United States International Trade Commission (USITC): http://edis.usitc.gov.

    3 Electronic Document Information System (EDIS): http://edis.usitc.gov.

    SUPPLEMENTARY INFORMATION:

    The Commission has received a complaint and a submission pursuant to section 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Immersion Corporation on February 11, 2016. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain mobile electronic devices incorporating haptics (including smartphones and smartwatches) and components thereof. The complaint names as respondents Apple Inc. of Cupertino, CA; AT&T Inc. of Dallas, TX; and AT&T Mobility LLC of Atlanta, GA. The complainant requests that the Commission issue a limited exclusion order and cease and desist orders.

    Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or section 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.

    In particular, the Commission is interested in comments that:

    (i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;

    (ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;

    (iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;

    (iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and

    (v) explain how the requested remedial orders would impact United States consumers.

    Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register. There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation.

    Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3120”) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, Electronic Filing Procedures).4 Persons with questions regarding filing should contact the Secretary (202-205-2000).

    4 Handbook for Electronic Filing Procedures: http://www.usitc.gov/secretary/fed_reg_notices/rules/handbook_on_electronic_filing.pdf.

    Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.5

    5 Electronic Document Information System (EDIS): http://edis.usitc.gov.

    This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).

    By order of the Commission.

    Issued: February 12, 2016. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2016-03344 Filed 2-17-16; 8:45 am] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 14-20] Hatem M. Ataya, M.D.; Decision and Order; Introduction and Procedural History

    On July 23, 2014, the Deputy Assistant Administrator, Office of Diversion Control, issued an Order to Show Cause to Hatem M. Ataya (Respondent), of Lapeer, Michigan. ALJ Ex. 1, at 1. The Show Cause Order proposed the revocation of Respondent's DEA Certificates of Registration, pursuant to which he is authorized to dispense controlled substances in schedules II through V, as a practitioner, at the registered address of 971 Baldwin Road, Lapeer, Michigan (FA2278201), and at the registered address of 3217 W. M-55 Suite B, West Branch, Michigan (BA7776353), on the ground that he has committed acts which render his registration inconsistent with the public interest.1 Id. (citing 21 U.S.C. 824(a)(4)). The Order also proposed the denial of Respondent's applications for two additional registrations,2 on the ground that “it is not consistent with the public interest . . . for [him] to be registered with the [Agency] to handle controlled substances.” Id. (citing 21 U.S.C. 823(f)).

    1 The Order alleged that Respondent's registration number FA2278201 expires on June 30, 2016, and that his registration number BA7776353 expires on June 30, 2017. ALJ Ex. 1, at 1.

    2 The applications are for proposed registered locations in Davidson and Flint, Michigan. ALJ Ex. 1, at 1.

    The Show Cause Order alleged that from 2010 through 2013, Respondent “repeatedly violated [his] obligation under federal law by prescribing controlled substances to [his] patients outside of the normal course of professional medical practice.” Id. at 2 (citing 21 CFR 1306.04(a)). Continuing, the Order specifically alleged that Respondent's “practice of regularly prescribing controlled substances to five patients [who were identified by the initials R.E.H., J.W., R.K., R.J.H., and J.H.] despite numerous and repeated red flags of drug abuse and diversion, [his] repeated failures to take appropriate steps to monitor [his] patients' use of controlled substances, and numerous other actions [he] took in the course of treating these patients all indicate that [he] violated [his] obligations under federal law by `prescribing [controlled substances] as much and as frequently as the patient demanded' so that `[in] practical effect, [he] acted as a large-scale “pusher” not as a physician.' ” Id. (quoting U.S. v. Moore, 423 U.S. 122, 143 (1975)). The Show Cause Order then set forth detailed allegations regarding Respondent's prescribing to each of these patients.3 See id. at 2-6.

    3 The patient-specific allegations will be set forth in discussing the evidence pertinent to each patient.

    In addition, the Show Cause Order alleged that on March 26, 2013, Respondent was interviewed by a DEA Diversion Investigator and a local Detective. Id. at 6. The Show Cause Order further alleged that during the interview, Respondent made multiple false statements regarding his controlled substance prescribing practices.4 Id. at 6-7.

    4 The Show Cause Order specifically alleged that Respondent attempted to mislead investigators in an interview on March 26, 2013, when he told a DEA Diversion Investigator and a Lapeer City Detective that he was not aware of any prescription pads being stolen, that patient R.E.H.'s fraudulent practices were in the past and he was no longer a patient, that no controlled substance prescriptions are phoned in, that he attempted to taper patients off of methadone over time, that chronic pain patients must have some diagnostic finding to support their pain and are required to see a specific psychiatrist and attend physical therapy, that each chronic pain patient must sign and annually renew a pain management contract, that MAPS searches are usually run for chronic pain patients on every visit, and that he was unaware of any of his patients dying. Id. at 6-7. The Government alleged that Respondent's patient files and its investigation indicated that these statements and others were false. Id. at 7.

    Following service of the Show Cause Order, Respondent timely requested a hearing on the allegations. ALJ Ex. 2. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Administrative Law Judge (ALJ) Christopher B. McNeil, who commenced to conduct pre-hearing procedures and ordered the parties to submit their respective pre-hearing statements. GX 3. Thereafter, the parties submitted their pre-hearing and supplemental pre-hearing statements. The parties also filed various motions, the most significant of these being (given the issues raised by the Parties in their Exceptions), the Government's Motion to Exclude Respondent's Witnesses (ALJ Ex. 41).

    Also, on September 29, 2014, the ALJ conducted an on-the-record conference with the Parties at which he set the initial date for the evidentiary phase of the proceeding. Tr. 1, 16-17 (Sept. 29, 2014). During the conference, the ALJ authorized the taking of testimony at either the Agency's Arlington, Virginia hearing facility or “by video-teleconferencing in the Detroit DEA Office.” Id. at 19. The ALJ also authorized Respondent and his counsel to appear at either the Arlington hearing facility or the “video-teleconferencing site” and “direct[ed] the Government to make available its DEA District or Field Office for this purpose.” Id. at 19-20.

    On November 3, 2014, the ALJ conducted a further on-the-record conference during which he reviewed the parties' proposed stipulations and ruled on the Government's Motion to Exclude Respondent's Witnesses. See generally Tr. (Nov. 3, 2014). The ALJ granted the Government's motion with respect to twelve of Respondent's proposed fact witnesses on the ground that Respondent had not identified with sufficient particularity their proposed testimony because his pre-hearing statements did “not clearly indicate each and every matter Respondent intend[ed] to introduce in opposition to the allegations.” Id. at 35-36; see also id. at 37-38. The ALJ also granted the Government's motion to exclude the testimony of Respondent's six witnesses who were to “either testify or provide testimonials . . . as to [his] character, reputation, and qualifications as a physician,” ALJ Ex. 39, at 3; stating his agreement with the Government's contention that their testimony was irrelevant and that Respondent did not proffer that “any of these witnesses plan to testify about his treatment of” the five patients. Id.; see also Tr. 38 (Nov. 3, 2014).

    The Government also sought to exclude the testimony of Ms. Michelle Ann Richards, who, according to Respondent, would “testify that she is certified in healthcare compliance consulting, coding, and office management,” and “that she was retained by Respondent to do risk assessment audit and risk mitigation for his practice.” ALJ Ex. 39, at 3. Respondent also stated that Ms. Richards would testify that she had “provided compliance training to Respondent's staff [and] that she is continuing to monitor and implement changes to ensure [his] medical practice with all State and Federal laws.” Tr. 39. In addition to the ground that Respondent had not adequately summarized Ms. Richards' testimony, the Government also argued that the testimony should be barred because Respondent had represented that he “intend[ed] to testify that he has never been out of compliance with such laws,” and that his “ `care and treatment [of the five patients] at all times comported with reasonable and minimally accepted standards and that all prescriptions were issued for a legitimate medical purpose by a registered physician within the course of professional practice.' ” ALJ Ex. 42, at 4-5 (Gov. Mot.) (quoting Resp. Pre-Hearing Statement, at 3-4 (Sept. 15, 2014)). Continuing, the Government reasoned that under agency precedent, “ `mitigation' evidence is not admissible unless and until the registrant fully and unequivocally accepts responsibility for the wrongful or unlawful conduct on which registration consequences are sought.” Id. at 5.

    The ALJ granted the Government's motion, agreeing with both of the Government's arguments. Specifically, the ALJ agreed that Respondent had failed to describe Ms. Richards' testimony “with sufficient particularity” and thus had not complied with his prehearing order. Tr. 39 (Nov. 3, 2014). Also, the ALJ explained that because Respondent intended to testify that in prescribing to the five patients he had “at all times comported with reasonable and minimally accepted standards” and that all of the prescriptions were issued within the usual course of professional practice and for a legitimate medical purpose, this “compels the conclusion that Respondent does not accept responsibility for any failure to conform to the requirements of the” CSA. Id. at 40-41. The ALJ thus concluded that there was “no need to address whether the remedial measures that [Respondent] claims to have instituted are adequate to protect the public interest.” Id. at 41.

    Notably, during the conference, the ALJ did not address Respondent's contention that the ALJ had misinterpreted the Agency's precedents, and that if the case law actually required him to admit to misconduct which he did not engage in, “then that precedent is inconsistent with procedural due process.” ALJ Ex. 45, at 1 (Resp.'s Response in Opposition to Govt's Mot. to Exclude Resp.'s Witnesses). Nor did the ALJ address Respondent's suggestion that he “defer” his ruling “until the hearing itself,” at which time the ALJ and the parties would be in “a better position to determine whether” he “ha[d] sufficiently titrated his contrition to permit the introduction of such testimony.” Id.

    Finally, the Government moved to exclude the testimony of two physicians who Respondent proposed would testify on his behalf as experts. While Respondent identified some eight areas on which he “anticipated” that the experts would testify, ALJ Ex. 39, at 3-5; the Government argued that the disclosure was inadequate because “Respondent has not disclosed any conclusions that the witnesses have actually reached regarding the prescribing conduct at issue.” ALJ Ex. 42, at 6. The Government further argued that “[i]t remains a mystery if these doctors have actually reached any opinions, to which they will subscribe under oath, to support Respondent's view that his prescribing was entirely legitimate.” Id.

    The ALJ granted the Government's motion, reasoning that he could not “tell from the supplemental prehearing statement which witness will espouse each of the opinions presented in the supplemental prehearing statement” and “whether either of the witnesses has a sufficient foundation, obtained through the review of patient records, or otherwise, to express the opinions presented in the supplemental prehearing statement.” Tr. 42. The ALJ also explained that he could not tell which professional standards the witnesses were relying on to reach their opinions. Id. at 42-43. Finally, while the ALJ noted that Respondent proposed that one of the doctors (who was also from Flint, Michigan) would testify that this area “is infested with drug-seeking addicts, who employ sophisticated tricks to deceive and frustrate the most vigilant anti-diversion efforts of healthcare providers,” the ALJ reasoned that this evidence was irrelevant because Respondent “intends to establish that his prescription practice complied fully with the requirements of the” CSA. Id. at 43. Subsequently, the ALJ issued a Journal Entry and Order memorializing his various rulings as well as the various stipulations agreed to by the parties.

    On November 17-18, 2015, the ALJ presided over the evidentiary phase of the proceeding, conducting a video-teleconference with he and the reporter being present in Arlington, Virginia, and the witnesses (including Respondent) and the parties' counsels present at the DEA Detroit, Michigan Field Division Office. Id. at 73-74; id. at 423. Notably, from the outset, the proceeding was marked by telephonic interference and interruptions of the transmission, with interruptions occurring nearly 60 times over the course of a day and half of testimony. See id. at 72 et seq.

    At the hearing, the Government called four witnesses to testify, including Dr. Eugene O. Mitchell, who was accepted as an expert in pain medicine. The Government also submitted for the record an extensive amount of documentary evidence including, inter alia, the medical records of the five patients identified in the Show Cause Order, copies of various prescriptions issued to the patients, and copies of reports obtained from the Michigan Automated Prescription System (MAPS) showing the controlled substance prescriptions obtained and filled by each of the five patients.

    Respondent testified on his own behalf. He also submitted several exhibits for the record. After the hearing, both parties submitted briefs containing their proposed findings of fact and conclusions of law.5

    5 These briefs will be referred to as Post-hearing Briefs.

    Thereafter, the ALJ issued his Recommended Decision (hereinafter cited as R.D.). Therein, the ALJ found that the Government's evidence with respect to Factors Two (Respondent's experience in dispensing controlled substances) and Four (compliance with applicable laws related to controlled substances) supported the conclusion that “Respondent's continued registration would be inconsistent with the public interest.” R.D. 66-68.

    More specifically, with respect to Factor Two, the ALJ found that “Respondent demonstrated a material lack of . . . experience regarding a prescribing source's responsibilities to resolve red flags when prescribing controlled substances for persons presenting with symptoms of chronic pain and terminate from his practice patients whose drug-seeking behavior indicates the potential for abuse or diversion (or both) of controlled substances.” Id. at 67. And with respect to Factor Four, the ALJ found that “[a] preponderance of the evidence establishes that Respondent issued controlled substance prescriptions for the five patients identified [in the Show Cause Order], in a manner that was not in the ordinary course of professional medical practice and was not based upon legitimate medical justification.” Id. (citing 21 CFR 1306.04(a)). The ALJ also found that Respondent violated Michigan law by post-dating controlled substance prescriptions and failing to include “the patient's full name and address” on the prescription. Id. at 67-68 (citing Mich. Comp. Laws §§ 333.7333(7), 338.3161(1)(a)); see also id. at 64 (Finding of Fact (FoF) # 3). Finally, the ALJ found that Respondent violated state and federal law by issuing prescriptions for schedule IV controlled substances which authorized more than five refills. Id. at 68 (citing 21 U.S.C. 829(b); Mich. Comp. Laws § 333.7333(4)); see also id. at 64-65 (FoF#s 3, 5).6

    6 Noting that “the record is silent with respect to the recommendation of the . . . state licensing board,” the ALJ found that this factor “neither supports nor contradicts a finding that Respondent's continued . . . registration is inconsistent with the public interest.” R.D. 66. The ALJ also found that the Government had neither alleged nor provided evidence that Respondent was convicted of a federal or state offense related to the manufacture, distribution, or dispensing of controlled substances, and thus, Factor Three does not support the revocation of his registrations and denial of his pending applications. Id. at 67.

    As for Factor Five—such other conduct which may threaten public health or safety—the ALJ found that the Government had not proved the allegation that Respondent made various false statements to the Diversion Investigator and Detective. Id. at 68. The ALJ based his conclusion on the fact that “the written record of that interview was not present” and “the questions presented and answers given were not sufficiently established in the record so as to permit a determination of Respondent's candor during [the] interview.” Id. Because the Government did not take exception to the ALJ's findings on the issue of Respondent's candor during the interview, I deem it unnecessary to make any findings related to the allegation.

    The ALJ thus concluded that “the Government has established its prima facie case by at least a preponderance of the evidence.” Id. at 69. The ALJ explained that “[w]hen responding to the Government's prima facie case . . . Respondent has the opportunity to demonstrate that he recognizes any noncompliance with controlled substance laws and has taken steps to ensure against future noncompliance.” Id. at 68-69. The ALJ then reasoned that under the Agency's case law, “in the absence of evidence of `sincere[ ] remorse[ ],' a `generalized acceptance of responsibility to the allegations' is not enough to open the hearing so as to permit evidence of remediation.” Id. (citing Govt's Post-Hrng. Br. 48). Finding that “Respondent has not provided substantial evidence meeting this standard,” the ALJ concluded that he “failed to establish a basis that would permit him to rebut the Government's prima facie case.” Id. The ALJ thus recommended that I revoke Respondent registrations and deny his pending applications. Id.

    Both parties filed Exceptions to the ALJ's Recommended Decision. Thereafter, the record was forwarded to my Office for Final Agency Action.

    On review of the record, I noted that it contained no evidence as to whether Respondent is currently authorized under Michigan law to dispense controlled substances. Order at 1 (Nov. 10, 2015). Accordingly, I directed the parties to address whether Respondent currently possesses authority under Michigan law to dispense controlled substances and if Respondent does not possess such authority, to address what consequence attaches for this proceeding. Id.

    On November 17, 2015, the Government submitted its Response. Therein, the Government noted that on July 6, 2015, the Michigan Department of Licensing and Regulatory Affairs had filed an Administrative Complaint with the Board of Medicine Disciplinary Subcommittee. Govt's. Resp., at 7-8; Govt's Resp. Ex. 3, at 8-14 (Administrative Complaint, In re Ataya, No. 43-15-137995 (Mich. Bd. of Med. July 6, 2015)). When Respondent failed to respond to the allegations of the complaint, the allegations were deemed admitted, and on October 30, 2015, the Board revoked his medical license. Gov. Resp. Ex. 3, at 2-3, 5. In his Response to my Order, Respondent states that he does not dispute that the Board has revoked his medical license and that he “no longer has any legal authority to dispense controlled substances, which, as a practical matter, he could not accomplish from the jail cell he has occupied for the past several months anyway.” Respondent's Resp., at 1.

    Having considered the record in its entirety, including the parties' Exceptions, as well as the recent action taken by the Michigan Board of Medicine, I issue this Decision and Final Order. I agree with the ALJ that the record supports findings that Respondent ignored multiple red flags of abuse and/or diversion with respect to each of the five patients (FoF #2). I also agree that the record supports the ALJ's factual findings specific to Respondent's prescribing of controlled substances to each of the five patients (FOF#s 3, 4, 5, 6, and 7), as well as his legal conclusions that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing controlled substances to each of the five patients in violation of 21 CFR 1306.04(a). See R.D. at 66-67. I further agree with the ALJ that Respondent violated federal and state law when he issued prescriptions authorizing more than five refills of schedule IV controlled substances, as well as when he post-dated a prescription and failed to include the patients' names and addresses on numerous prescriptions. Finally, I agree with the ALJ's conclusion that the Government made out a prima facie case that Respondent's registration is inconsistent with the public interest.

    With respect to Respondent's rebuttal case, for reasons explained below, I find troubling the ALJ's handling of the issue of whether Respondent has adequately accepted responsibility for his misconduct. And as for the ALJ's ruling barring Respondent from presenting evidence of his remedial measures, I agree with the ALJ that Respondent did not sufficiently disclose the scope of the proposed testimony. While this alone is sufficient reason to reject Respondent's exception, the ALJ further reasoned that under the Agency's precedent, Respondent is barred from introducing evidence of his remedial measures absent his admission to the allegations before the Government was even required to put on its evidence. Contrary to the ALJ's understanding, while a respondent's failure to acknowledge his misconduct renders evidence of his remedial measures irrelevant, the Agency has never held that a respondent must admit to his misconduct prior to even being able to test the Government's evidence at the hearing.

    I reject, however, Respondent's contention that a remand is warranted for multiple reasons. First, as explained above, I agree with the ALJ's conclusion that Respondent did not adequately disclose the scope of the proposed testimony on the adequacy of his remedial measures. Second, even were I to credit Respondent's admissions at the hearing and give weight to his testimony regarding the remedial measures he has undertaken, I would nonetheless find that his conduct was so egregious that the protection of the public interest warrants the revocation of his registrations and the denial of his pending applications. Finally, because of the recent action of the Michigan Board of Medicine, Respondent is precluded from being registered because he no longer holds authority under state law to dispense controlled substances, and thus evidence of his acceptance of responsibility and remedial measures is irrelevant. See 21 U.S.C. 802(21), 823(f).

    Findings of Fact Respondent's Licensure and Registration Status

    Respondent was formerly licensed as a physician by the Michigan Board of Medicine. However, on July 6, 2015, the Bureau of Professional Licensing, acting on behalf of the Michigan Department of Professional Licensing and Regulatory Affairs, filed a complaint against Respondent. Administrative Complaint, In re Ataya, No. 43-15-137995 (Mich. Bd. of Med. July 6, 2015). The Department also ordered that Respondent's medical license be summarily suspended. Order of Summary Suspension, In re Ataya. Thereafter, on October 30, 2015, the Board of Medicine revoked Respondent's medical license. Final Order, In re Ataya.

    Respondent currently holds two DEA practitioner's registrations, pursuant to which he is authorized to dispense controlled substances in schedules II through V. GX 4, at 1-2. The first of these (BA7776353) is for the registered location of 5097 Miller Road, Flint, Michigan and does not expire until June 30, 2017. Id. at 1. The second (FA2278201) is for the registered location of 971 Baldwin Road, Lapeer, Michigan and does not expire until June 30, 2016. GX 3, at 1. Respondent has also applied for two additional registrations: One at the address of 3390 N. State Road, Davison, Michigan; the other at the address of 3400 Fleckenstein, Flint, Michigan.

    The Investigation of Respondent

    Respondent first came to the attention of law enforcement on January 5, 2012, when a Detective with the City of Lapeer Police Department responded to the death of R.J.H., one of the patients identified in the Show Cause Order. Tr. 90; ALJ Ex. 1, at 1-2. According to the Detective, he knew R.J.H. from his experience in law enforcement and knew him to be an abuser of both “prescription drugs [and] illegal drugs.” Tr. 93. The Detective testified that R.J.H. bore no signs of external injuries and there was no evidence that injuries had led to his death. Id. The police did, however, find three empty prescription vials, including a vial bearing a label for 120 methadone 10 7 and clonazepam (Klonopin), as well as a syringe, on a nightstand in R.J.H.'s bedroom. Id. The Detective subsequently obtained a report from the Michigan Automated Prescription System (MAPS) and found that both the methadone and Klonopin had been prescribed to R.J.H. by Respondent on January 3, 2012. Id. According to the detective, toxicology testing led to the conclusion that R.J.H. had died of an overdose. Id. at 95. The Detective also learned that R.J.H. had overdosed on heroin two days before and was taken to the hospital. Id. at 107; GX 5, at 1.

    7 All numbers which follow the name of a drug refer to the dose per pill in milligrams.

    On January 22, 2012, the Detective responded to the death of J.W. Tr. 95. The authorities found two pill bottles in J.W.'s coat, as well as marijuana. Id. at 96, 108. One vial, which bore a label for 120 methadone, contained only nine methadone pills; however, the vial also included four Klonopin pills and two diazepam. Id. The second vial, which bore a label for 120 Klonopin, contained only 91 pills. Id. According to the Detective, J.W.'s body bore possible needle marks. Id. at 112.

    During his investigation, the Detective determined that on January 19 (three days earlier), J.W. had obtained prescriptions from Respondent for 120 methadone 10 and 120 clonazepam 1. Id. at 96. According to the Detective, the investigation and toxicology test results led to the conclusion that J.W. had died of an overdose. Id. at 96-97.

    During the course of his investigation, the Detective spoke with both J.W.'s mother and niece. The Detective testified that J.W.'s mother said that J.W. did not like methadone and usually sold it to buy other drugs. Id. at 112. According to the Detective, J.S. (J.W.'s niece) told him that J.W. had been released from jail only “a week or two prior to his death.” Id. at 98. J.S.'s niece also told the Detective that she had contacted Respondent's office and told him that her uncle “had a problem” with controlled substances “and asked him not to prescribe any controlled substances” to her uncle. Id.

    J.S. subsequently testified that her uncle's drug problem “was obvious” and that “[e]verybody knew.” Id. at 125. She testified that she spoke with Respondent on the phone a couple of weeks before her uncle was released and told Respondent that her uncle “was sick and he didn't need the medications because he wasn't taking them” and “was selling them.” Id. at 128-29. According to J.S., Respondent initially “blew [her] off.” Id. at 129. However, when J.S. told Respondent that the police “wanted to know why [J.W.] had two prescriptions for Methadone” which he had not filled, Respondent asked for J.W.'s name, address and date of birth. Id. J.S. also told Respondent that J.W. had “nearly died from withdrawal” and asked Respondent not to “give him these strong medications.” Id. While Respondent said that “he wouldn't do it anymore,” id. at 130, as found above, Respondent subsequently issued the methadone and clonazepam prescriptions to J.W.8 Id. at 96.

    8 Respondent testified that he does not recall the phone conversation about which J.S. testified, explaining that he would not remember what patient the conversation involved because he has 7,500 patients. Tr. 485. He also testified that if someone calls and wants to speak to him about a patient, his assistants ask the person “to come with the patient and discuss the matter.” Id. The ALJ did not make a finding as to whether J.S.'s testimony was credible. R.D. at 9-10. I find her testimony credible, noting that while it may be that Respondent would not recall the conversation given the large number of patients he treated, one would recall a conversation she had with a doctor about a family member.

    The Detective also testified regarding an investigation conducted by a subordinate into the death of R.K. on or about July 21, 2012. Id. at 98-100. According to the Detective, there was no evidence that R.K. had died of injuries and upon arriving at the scene, the police found a prescription vial which, according to the label, had been issued by Respondent four days earlier for 90 Xanax. Id. at 100. However, the vial was empty. Id.

    The Detective also obtained a MAPS report for R.K. Id. The MAPS report shows that on July 17, Respondent issued to R.K. a prescription for 90 tablets of methadone 10, which R.K. filled the next day. GX 22, at 16. The cause of R.K.'s death was a drug overdose. Id. at 101. According to a police report, a person with Community Mental Health stated that R.K. was known to abuse heroin, Tramadol, and other prescription medications. GX 5, at 17.

    The Detective testified that because his agency did not have a lot of experience in prescription drug investigations, after R.K.'s death, he sought the assistance of DEA, and on August 13, 2012, met with a DEA Diversion Investigator (DI). Tr. 102. Two days after the meeting, the mother of another of Respondent's patients (J.L.H.) contacted the Lapeer Police and reported that she had taken her daughter to see Respondent the day before and that he had issued her prescriptions for methadone, tramadol and clonazepam. Id. at 102-03. However, the day after J.L.H. saw Respondent, her mother reported that she was unable to contact J.L.H. at her residence and could not get her to answer the door; she thus requested the assistance of the police. Id. at 103. The Detective testified that “[a] neighbor had climbed up on the roof and looked through a second story window and observed [J.L.H.] on the couch unresponsive.” Id. A police officer entered J.L.H.'s home and found her “blue in color and unresponsive.” Id. J.L.H. was taken to the hospital. Id.

    Several months later, the Detective obtained a warrant to search Respondent's Lapeer office for several patient charts, and on March 26, 2013, the Lapeer Police Department, DEA, and members of the Thumb Narcotics Unit (a local multijurisdictional task force) executed the warrant. Id. at 104. However, the Detective and the DI decided to interview Respondent, who was at his Davidson office, prior to searching his Lapeer office. Id.

    During the search of the Lapeer office, the Detective determined that several of the patient files that were being sought under the warrant were not at that office. Id. at 105. Accordingly, the Detective obtained an amended warrant, which authorized searches of Respondent's Flint and Davidson offices. Id. The records were subsequently seized and provided to the DI, who had them scanned. Id.

    The Government also called the DI who worked with the Detective on the investigation. The DI testified that she obtained MAPS reports for Respondent and found that they showed that he prescribed “a lot of combinations of prescriptions for [m]ethadone, [h]ydrocodone, and . . . [a]lprazolam” and that the patients were “getting them on a regular basis.” Id. at 146. The DI also testified that when alprazolam is taken with methadone or hydrocodone, “it enhances the effect of the narcotic causing somewhat of a heroin-type high.” Id. at 147. The DI further testified that she participated in the execution of the search warrant and that she assisted in the seizure of patient charts and conducted employee interviews. Id. at 149. According to the DI, she determined what charts to seize by reviewing MAPS data and conducting “criminal history searches to determine what patients were known to be drug seekers or had a positive criminal history.” Id.

    The DI testified that “many of the charts contained information that [showed] that the patients were not taking the controlled substances as they had been prescribed, or that they had drug addiction issues, or they were narcotic dependent, or any of a number of red flags that were indicated in the charts, and then we sent the patient charts out for expert review.” Id. at 156-57. The DI explained that there were “instances where the patient was coming [back] before the 30-day[s] had expired, and were [sic] obtaining additional prescriptions for the same medication or,” the patients were “obtaining refills of a prescription that had refills written on [it] prior to the time [that] they should have used [ ] the medication up if they were taking it as directed.” Id. at 157.

    The DI testified that the patient records included evidence that pharmacies had called Respondent raising issues of whether the patients “were doctor shopping or obtaining refills early.” Id. at 158. The DI also testified that the files contained “reports from the State alerting [Respondent] about medication issues that they wanted him to be aware of” regarding “his prescribing of certain drugs,” as well as “police reports” and “hospital reports on several patients indicating that they had a history of drug abuse or they had been admitted for a drug-related issue.” Id. The DI testified that she provided Dr. Eugene Mitchell, Jr., with the files of the five patients at issue in this proceeding and asked him to review the files and identify examples of Respondent's issuance of controlled substance prescriptions outside of “the usual course of medical practice” and which lacked a legitimate medical purpose. Id. at 160. According to the DI, these specific charts were selected for review by Dr. Mitchell because “the findings in these files . . . were egregious” and four of the five patients were deceased. Id. at 160-61.9

    9 In addition to obtaining each patient's medical file, the DI used the MAPS data to obtain copies of the original prescriptions from the various pharmacies.

    The DI further testified that in reviewing the patient files she found evidence of other violations of the Controlled Substance Act and DEA regulations. Tr. 172-73. These included instances in which Respondent authorized more than five refills on a prescription; instances in which he issued early refills; instances in which he failed to include a patient's address, which is required information on a prescription; and instances in which Respondent post-dated prescriptions. Id. at 173-74. The DI then testified as to the following examples: (1) A Xanax prescription dated Feb. 9, 2013 issued to R.E.H. authorizing six refills (GX 8, at 23); (2) a Klonopin prescription dated August 14, 2012 issued to J.H. authorizing six refills (GX 19, at 117); and (3) a Xanax prescription dated April 10, 2012 issued to R.K. authorizing six refills (GX 17, at 49). Tr. 184-86.10 The DI also discussed two examples of prescriptions which Respondent issued to Patient R.E.H. without including his address, and did so even after Respondent had received information that R.E.H., who shared the same first name as his father, had attempted to fill a methadone prescription using his father's name and date of birth. Tr. 182-84; see also GX 8, at 42 (methadone and Xanax prescriptions dated April 19, 2012 with patient's address left blank).

    10 The DI also testified regarding two methadone prescriptions Respondent issued to R.E.H. in October 2012, including one which was issued notwithstanding that R.E.H. was a week early, and on which the date of the copy in R.E.H.'s file appears to have been altered. Tr. 175-80. These prescriptions are discussed more fully in the findings regarding Respondent's prescribing to R.E.H.

    The Government Expert's Testimony

    The Government called Dr. Eugene O. Mitchell, Jr., who testified as an expert on pain management. Dr. Mitchell received a Bachelor of Science in Biochemistry in 1975 from the University of Florida and a Bachelor of Science in Medicine in 1979 from the University of Florida's Physician's Assistant Program. GX 25, at 1. Dr. Mitchell subsequently obtained a Doctor of Medicine in 1985 from the Wayne State University School of Medicine. Id. His post-doctoral training includes an internship in internal medicine and a residency in anesthesiology (both at the University of Illinois), and a fellowship in pain medicine at the University of Michigan. Id.

    Dr. Mitchell holds a medical license issued by the State of Michigan and is board certified in both anesthesiology and pain medicine. Id. at 2. He is also a member of numerous professional societies including the American Academy of Pain Medicine and the American Society of Regional Anesthesia and Pain Medicine. Id.

    Since February 2001, Dr. Mitchell has held the position of Clinical Assistant Professor in the Department of Anesthesiology, Division of Interventional Pain Medicine, at the University of Michigan Medical Center. Id. In this position, he lectures medical students on pain medicine and trains fellows in pain medicine as well as residents, interns, and nursing staff. Id. at 3, Tr. 234. He also is active in practice. Id. Dr. Mitchell was qualified as an expert. Id. at 239.

    Dr. Mitchell testified “all controlled substances have the risk of significant morbidities including death from overdose,” “withdrawal from their use,” and “addiction.11  ” Id. He testified that to reduce the risks associated with the abuse and diversion of controlled substances, a physician must “be familiar with the patient's medical history” and review the patient's records so that the physician has “a clear understanding” of the patient's diagnosis. Id. at 240. Also, the physician must review the patient's “history of abuse” and “[a]ny issue of addictive illness,” whether it involves tobacco, alcohol, and both “licit” and “illicit” drugs. Id.

    11 He also testified that the use of controlled substances presents a risk of developing both renal and hepatic disease. Tr. 239.

    Dr. Mitchell further testified that there are various compliance tools that he uses to determine whether patients are abusing or diverting controlled substances. The first of these is a “medication agreement” between the physician and the patient which sets forth the “criteria that [the patient] will adhere to” while “being prescribed controlled substances.” Id. Dr. Mitchell testified that an essential part of the agreement is “a clause that allows the physician to ask the patient” to provide “a random body fluid sample,” whether of blood or urine, “on demand to verify what is or isn't present in” the patient's body. Id. at 241. Dr. Mitchell explained that a further compliance tool is to use the MAPS, Michigan's controlled substance prescription monitoring program, which allows a physician to obtain a list of the controlled substance prescriptions filled by a patient in the State. Id.

    Dr. Mitchell also testified that in Michigan, a task force of physicians developed Guidelines for the “appropriate prescribing” of controlled substances for the treatment of pain. Id. at 243; GX 26. These Guidelines have been issued by both the Board of Medicine and the Board of Osteopathic Medicine & Surgery. GX 26, at 1. The Guidelines “recognize that controlled substances, including opioid analgesics, may be essential in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins.” Id. However, the Guidelines caution “that inappropriate prescribing of controlled substances, including opioid analgesics, may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use” and that “[p]hysicians should be diligent in preventing the diversion of drugs for illegitimate purposes.” Id. According to the Guidelines, they “are not intended to define complete or best practice, but rather to communicate what the Board considers to be within the boundaries of professional practice.” Id. at 2.

    Dr. Mitchell then testified regarding the “typical steps taken by doctors in treating patients who suffer from chronic pain.” Tr. 247. Dr. Mitchell testified that when a new patient seeks treatment, a physician “take[s] a detailed history” and asks the patient “to bring [his/her] records” including imaging findings. Tr. 247; see also GX 26, at 3-4. Dr. Mitchell explained that a physician “document[s] what [his/her] chief complaint is” and why the patient is seeking “to begin care.” Tr. 247.

    Dr. Mitchell testified that the “standard medical doctoring for a new patient encounter” includes a “review of [the patient's] systems” and “[a]n appropriately detailed physical examination.” Id. The physician then makes a diagnosis and creates a treatment plan. Id. The physician also “modulates the treatment plan” in accordance with the patient's disease process.12 Id. at 248.

    12 With respect to the initial evaluation of the patient, the Michigan Guidelines state:

    A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.

    GX 26, at 3. With respect to the creation of a treatment plan, the Guidelines state:

    The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

    Id.

    Re-emphasizing his earlier testimony, Dr. Mitchell testified that as part of the process of formulating a plan involving the long term prescribing of controlled substances, the physician reviews the medication agreement/opioid contract with the patient and explains that if the patient violates the agreement, the patient will be discharged from the practice.13 Id. at 249. Dr. Mitchell further explained that the first time a patient presents with a red flag, regardless of whether the patient has a history of addiction, the red flag should be documented and the patient should be brought in and given the “opportunity to explain what's going on.” Id. at 249-50. Dr. Mitchell explained that there is a spectrum of red flags which runs from such incidents as a patient claiming to have lost a prescription but having “no other infractions,” to a patient whose “urine screens are inappropriate” or whose MAPS report shows they are “multi sourcing. ” Id. at 250.

    13 Relevant to this testimony, the Guidelines state that:

    [i]f the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician may employ the use of a written agreement between physician and patient outlining patient responsibilities, including . . . urine/serum medication levels screening when requested; . . . number and frequency of all prescriptions, refills; and . . . reasons for which drug therapy may be discontinued (i.e., violation of agreement).

    GX 26, at 3. The Guidelines further advise physicians to periodically “monitor patient compliance in medication usage and related treatment plans.” Id. at 4.

    Regarding the five patients identified in the Show Cause Order, Dr. Mitchell testified that he reviewed the patient files including the visit notes, MAPS reports, and copies of the prescriptions which included the pharmacy labels. Id. at 251. Dr. Mitchell testified that he had identified specific prescriptions which he believed were issued outside of the usual course of professional medical practice. Id. at 252. Dr. Mitchell further explained that he has been “practicing medicine for nearly 30 years,” and that he is “familiar with what constitutes general[ly] appropriate behavior regarding prescribing controlled substances.” Id.

    The Patient Specific Evidence R.E.H. The Allegations

    With respect to R.E.H., the Government alleged that from August 5, 2010 through at least March 13, 2013, Respondent repeatedly prescribed controlled substances to the patient even after Respondent knew that R.E.H. “was engaged in the abuse and/or diversion of controlled substances, as well as prescription fraud.” ALJ Ex. 1, at 2. Specifically, the Government alleged that Respondent repeatedly prescribed methadone, a schedule II narcotic controlled substance, and other controlled substances to R.E.H., notwithstanding that he presented “numerous red flags of diversion and/or abuse.” Id. The allegations included that:

    • R.E.H. repeatedly sought early refills;

    • R.E.H. repeatedly claimed that his prescriptions were lost or stolen;

    • pharmacists repeatedly contacted Respondent's office to report suspicious behavior by R.E.H.;

    • MAPS reports in R.E.H.'s file corroborated reports that R.E.H. and his wife were committing prescription fraud;

    • R.E.H. had been recently released from jail; and

    • hospital records in his file showed that R.E.H. was using illegal drugs.

    Id. at 2.

    The Show Cause Order also alleged that R.E.H.'s patient file and the prescriptions issued to him show that Respondent prescribed methadone on R.E.H.'s “first visit without undertaking other actions typical of medical professionals[,] such as conducting and documenting a complete medical history and physical examination, requiring that R.E.H. (a self-identified addict) sign a pain management contract or undergo a drug test, running a MAPS search on R.E.H., or creating a written treatment plan.” Id. at 2-3. The Show Cause Order then alleged that Respondent:

    • Never subsequently required R.E.H. to sign a pain management contract;

    • “repeatedly issued prescriptions to [him] with instructions to take his methadone `PRN'—thus directing that this self-identified addict should take this powerful opioid analgesic (properly used in scheduled dosages) on an `as needed' basis”;

    • issued at least one prescription on a date when R.E.H.'s patient file indicates that he did not have an appointment;

    • notwithstanding that he knew that R.E.H. was attempting to fill the prescriptions using his father's birthdate to avoid being detected, Respondent did not take the minimal preventative step of including R.E.H's address on his methadone prescriptions as required by state and federal law;

    • issued a prescription for Xanax to be refilled six times, in violation of state and federal law; and

    • falsified records to post-date a methadone prescription in order to provide R.E.H. with an early refill in violation of state and federal law, circumventing the efforts by his staff noting that an early refill should not be issued.

    Id. at 3. The Evidence

    On August 5, 2010, R.E.H. made his first visit to Respondent. Tr. 254; GX 8, at 143. According to his medical record, R.E.H.'s chief complaint was back pain. Tr. 256; GX 8, at 143. R.E.H. also reported a history of abusing heroin, which is a “significant addictive illness history,” Tr. 257, as well as tobacco abuse and that he was taking methadone; however, there is no indication that Respondent determined how much methadone R.E.H. was taking, which according to Dr. Mitchell was “a critical bit of information . . . because methadone . . . is approximately five times as potent as morphine.” Id. at 256. Dr. Mitchell also explained that Respondent did not determine if R.E.H.'s heroin abuse, which he characterized as a “significant addictive illness history” was “currently active” and whether he had gone (or was going to rehabilitation) for it. Id. at 257.

    Dr. Mitchell further found that Respondent's physical examination was “very cursory for a new patient” as he did not conduct neurological and spinal examinations. Id. at 256. He also did not require that R.E.H. sign a medication contract, id. at 257-58, even though he prescribed 30 tablets of methadone 10, with a dosing instruction of TID or one tablet, to be taken three times per day. Id. at 255. Dr. Mitchell opined that this prescription was not issued in the usual course of medical practice. Id. I agree.

    Even though the prescription should have lasted for ten days, R.E.H. returned to Respondent only six days later and obtained a new prescription, which was for 90 tablets of methadone, TID (three times a day). Id. at 258-59. Dr. Mitchell testified that this was an early refill and thus required that Respondent ask R.E.H. why he needed to refill his prescription four days early and document the reason he needed the early refill. Tr. 259-60. Dr. Mitchell thus found that the prescription was not issued in the usual course of medical practice. Id. at 259. He further explained that R.E.H.'s seeking of the refill was a matter of concern because of R.E.H.'s history of drug abuse.14 Id. at 260.

    14 The transcript includes a question by Government's counsel which suggests that R.E.H.'s second visit occurred on October 11, 2010. See Tr. 260, at Ls 5-6. However, R.E.H.'s medical record includes a progress note for August 11, 2010 and contains no note for an October 11, 2010 visit. See GX 8, at 140-42 (progress notes for visits of Aug. 11, Sept., 21, and Oct. 13, 2010).

    R.E.H.'s third visit occurred on September 21, 2010. Tr. 262. The progress note documents, however, that R.E.H. was “just release [sic] from jail” and that he had been in jail “15 days.” GX 8, at 141; Tr. 262. The note further states that R.E.H.'s methadone dose was increased to 10 mg five times a day for two weeks, suggesting that this had occurred when he was in jail. Id. The note also states: “methadone x 6 months Heroin addiction.” GX 8, at 141.

    Respondent issued R.E.H. a prescription for 90 pills of methadone 10, TID. Id. While this should have provided a 30-day supply and thus lasted until October 21, R.E.H. returned to Respondent on October 13, eight days early, and obtained a new prescription for 90 tablets of methadone 10. Tr. 263-64. Dr. Mitchell testified that R.E.H. was manifesting a pattern of seeking early refills and Respondent's issuance of the prescriptions was not within the usual course of medical practice because there was “no documentation” that Respondent engaged R.E.H. “as to why this is going on.” Id. at 265. Moreover, Respondent did not attempt to determine if R.E.H. was “even taking the medication” by demanding that he provide “a urine sample.” Id. He also did not obtain a MAPS report. Id.

    R.E.H. returned to Respondent on November 1, 2010. GX 8, at 139. While R.E.H. was 11 days early, Respondent issued him another prescription for 90 tablets of methadone 10 with the same dosing instruction. GX 8, at 139; Tr. 266. While R.E.H. was not early at his next visit (November 30), when he again obtained a prescription for 90 methadone 10 (one tablet TID, or three times per day), he returned to Respondent on December 23, and obtained a new prescription, which he increased to 120 tablets (TID) even though he was a week early. Tr. 266-67; GX 8, at 137-38; GX 15, at 15-16. According to Dr. Mitchell, none of the prescriptions Respondent issued in November-December 2010 were issued in the usual course of professional practice. Tr. 268. However, Respondent did not require that R.E.H. sign a pain contract until apparently December 23, 2010.15 Tr. 270-71; GX 8, at 242.

    15 The date does not, however, include the year. GX 8, at 242.

    R.E.H. returned on January 4, 2011. GX 8, at 136; GX 15, at 17. Even though R.E.H. was 18 days early, and notwithstanding that the pain contract required him to use his “medicine at a rate no greater than the prescribed rate” and stated that if he used it at a greater rate, he would be “without medication for a period of time,” GX 8, at 242; Respondent issued him another prescription for 90 tablets of methadone 10 with a dosing instruction of TID and PRN (take as needed). GX 8, at 136; GX 15, at 17. Dr. Mitchell testified that this prescription was not issued in the usual course of professional practice and that the usual course of professional practice would be to discharge a patient seeking a prescription two weeks early. Tr. 269. He also testified that it is not in the usual course of medical practice to prescribe methadone with a dosing instruction of PRN because the drug “has [a] very long half-life” and “takes a while . . . to enter the blood” stream, and the reason the drug is used for pain is to provide “a stable blood level” of medication. Id. at 274.

    Respondent did not, however, discharge R.E.H., who returned on January 26, 2011. GX 8, at 135. Notwithstanding that R.E.H. was eight days early, Respondent issued him a new prescription and increased the quantity to 120 pills and the dosing to four tablets per day. GX 15, at 19-20. Dr. Mitchell testified that this prescription was also not issued within the usual course of medical practice. Tr. 270.

    An entry in R.E.H.'s medical record documents that on February 15, 2011, a pharmacy called and reported that R.E.H. had tried to fill three prescriptions for 120 tablets of methadone in less than one month. GX 8, at 18. The note documented that on January 26, 2011, R.E.H. had filled one such prescription at a different pharmacy using insurance, and that on February 1, 2011, he had filled the second prescription at a second pharmacy paying cash. Id. Moreover, on February 15, R.E.H. had attempted to fill a third prescription at still another pharmacy but was denied, after which he took it to the pharmacy that called Respondent's office. Id.

    Dr. Mitchell testified that “this is obviously very concerning behavior” and that a doctor acting the usual course of medical practice would summon the patient and ask for an explanation. Tr. 276-77. He further testified that it would “[a]bsolutely not” be within the usual course of professional practice to issue a new prescription for a controlled substance in these circumstances. Id. at 277.

    R.E.H.'s file includes a MAPS report which was obtained on the morning of February 17, 2011, two days after the Respondent's office was notified that R.E.H. had filled two prescriptions since January 26 and had attempted to fill a third. GX 8, 236. The MAPS report corroborated the pharmacy's report and showed that R.E.H. had managed to fill Respondent's January 26 prescription on both that date and on February 1, 2011 at two different pharmacies. Id. Of further note, various entries for these two dispensings are circled, thus indicating that someone reviewed them. Id. Dr. Mitchell testified that this raised “another obvious problem with [R.E.H.'s] compliance,” and that given his “known history of heroin abuse . . . appropriate medical care would dictate engaging the patient in this behavior,” followed by “discharging” him and urging him “to go to rehabilitation.” Tr. 279.

    While R.E.H. saw Respondent on both February 17 and 22, 2011, there is no evidence that Respondent even addressed R.E.H.'s drug-seeking behavior, let alone discharged him. Id. at 280-81; see GX 8, at 132-33. While Respondent did not prescribe methadone to R.E.H. at any of his three visits in February 2011, Tr. 281, on March 2, he issued R.E.H. a new prescription for 120 methadone 10, a 30-day supply based on the dosing instruction (QID and PRN). GX 8, at 131; GX 15, at 25. Yet only 21 days later on March 23, Respondent issued to R.E.H. another prescription for 120 methadone 10 (also QID and PRN), and only six days later on March 29, Respondent issued him a prescription for 90 more methadone 10 (TID). Tr. 282; GX 15, at 27-30.

    Dr. Mitchell testified that there was no justification in R.E.H.'s chart for Respondent's issuance of prescriptions, which authorized the dispensing of a three-month supply of the drug. Tr. 283. He also testified that these prescriptions were not issued in the usual course of professional practice. Id.

    The evidence further shows that on June 2, 2011,16 Respondent issued to R.E.H. a prescription for 100 tablets of methadone 10 QID. GX 15, at 37-38. This was followed by additional prescriptions for 120 tablets of methadone 10 QID on June 16, July 12, July 14, August 9, and August 23, 2011. Id. at 41-42, 45-46, 47-48, 51-52, 53-54. The June 16 prescription was 11 days early, and while the July 12 prescription was only four days early, as Dr. Mitchell testified, the July 14 prescription was 28 days early. Tr. 284-85. Moreover, the August 9 prescription was also early, and the August 23 prescription was 16 days early. Id. at 286. Yet there is no progress note for the August 23 prescription and no entry in the log used to document various activities. GX 8, at 15-20 (log entries); id. at 120-21 (progress notes for Aug. 9 and Sept. 13, 2011, but not Aug. 23). Dr. Mitchell testified that Respondent's issuance of the early methadone refills during the June through August period was not within the usual course of professional practice. Id. at 287.

    16 While the Government did not ask Dr. Mitchell about the methadone prescriptions issued in April and May 2011, the pattern of early refills continued, as on April 20, 2011, Respondent issued R.E.H. a new prescription for 90 methadone 10 TID, this being eight days early (ignoring that R.E.H. had also obtained methadone on March 23). GX 15, at 31-32. Thereafter, on May 10, 2011, Respondent issued R.E.H. a prescription for 120 methadone QID, this being 10 days early. Id. at 33-34. Thus, the June 2 prescription was one week early.

    R.E.H.'s patient file also includes copies of two prescriptions for 120 Vicodin ES (QID), which were dated November 17 and 22, 2011. GX 8, at 191-92. The document bearing the November 17 prescription includes the notation: “Please verify—just filled this RX on 11/17 for 30 day supply—then the follow[ing] RX was brought in 11/23/11.” Id. at 192. The document further asked: “please call Walmart” and included the notation of “suspicious RX.” Id.

    Dr. Mitchell testified that “as a stand-alone incident it's very concerning” because “[i]t smacks of prescription forgery.” Tr. 288. However, in R.E.H.'s case, it was “just another incident . . . in his history that just masked a horrible addictive illness, diversion or both.” Id. at 288-89. Dr. Mitchell then explained that a physician's “primary concern” is the welfare of his/her patients, and a physician “need[s] to protect them from their addictive illness and document it and refer them to a” detoxification facility and not just “feed” their addiction “by continuing to write medications.” Id. at 289.

    R.E.H.'s patient file also includes a MAPS report which Respondent obtained on December 9, 2011. GX 8, at 185-90. The report showed that during the months of October and November 2011, R.E.H. had filled six prescriptions for 120 methadone 10 (with four of the prescriptions having been filled between Nov. 10 and 29) and that R.E.H. had used four different pharmacies. Id. at 185-86. However, R.E.H.'s patient file includes progress notes only for visits on October 10 and November 11. Id. at 116-119. Notably, each of the prescriptions listed on the first page of the report has check marks and Respondent's initial/signature 17 is on the page, thus establishing that Respondent reviewed the document. Id. at 185.

    17 This initial/signature is the same as that used on the numerous prescriptions contained in the record.

    Dr. Mitchell testified that the report would indicate “[g]reat concern for what's going on” to a doctor acting in the usual course of medical practice as it showed that R.E.H. was “[o]btaining hundreds of tablets of methadone.” Tr. 291. The report also showed that R.E.H. had obtained other controlled substances (alprazolam and hydrocodone) from two additional pharmacies during these two months. GX 8, at 185-86. Thus, R.E.H. had used a total of six pharmacies. Id.; Tr. 291-92.

    The evidence also showed that Respondent was prescribing methadone and other controlled substances (alprazolam and hydrocodone) to R.S.H., who was R.E.H.'s wife, and that he obtained a MAPS report on her only minutes after obtaining the MAPS report on R.E.H. GX 13, at 161-68. The MAPS report showed that between October 11, 2011 and November 28, 2011, R.S.H. filled seven prescriptions for 120 methadone 10, four prescriptions for 90 alprazolam (in either .5 or 1 mg dose), and prescriptions for 90 and 120 hydrocodone 7.5. Id. at 161-63. Notably, the MAPS reports listed the same address for R.S.H. and R.E.H. Compare GX 13, at 161; with GX 8, at 185.

    Regarding this information, Dr. Mitchell testified that “the concerns speak[ ] for itself [sic]. There's something very troublesome and potentially life threatening going on here with multitudes of refills, repeated incidents,” given “there's some indication that they're cohabiting together and have the same last name.” Tr. 294-95. Dr. Mitchell then testified that it was not within the usual course of professional practice to continue writing methadone and other controlled substance prescriptions given these circumstances. Id. at 295. However, Respondent did not stop issuing methadone and other controlled substance prescriptions to R.E.H. after he learned of this. Id. at 295. Instead, on both December 21 and 22, 2011, Respondent issued R.E.H. two more prescriptions for 120 methadone 10, and he continued issuing methadone prescriptions to R.E.H. for another 15 months. GX 15, at 87-90, 155-56.

    Moreover, on February 29, 2012, Respondent's office received a phone call from a pharmacy, which reported that R.E.H. was using his father's birthdate to fill the prescriptions. GX 8, at 43. The pharmacy also reported that it had called R.E.H.'s father who stated that “he doesn't receive [sic] this script.” Id. As Dr. Mitchell testified, this was evidence that R.E.H. was forging prescriptions. Tr. 296; see also 21 U.S.C. 843(a)(3) (rendering it unlawful to “knowingly or intentionally . . . acquire . . . a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge”). Asked whether it was appropriate for Respondent to continue to issue controlled substance prescriptions to R.E.H., Dr. Mitchell answered: “[a]bsolutely no.” Tr. 297. Yet, on March 6, 2012, Respondent issued another prescription to R.E.H. for 120 methadone 10.18 GX 15, at 107.

    18 There is, however, no progress note for this visit. See GX 8, at 113-14 (notes for visits of Mar. 22 and Feb. 28, 2012 but not for Mar. 6).

    On July 12, 2012 (in the interim, Respondent had continued issuing prescriptions for 120 methadone 10 to R.E.H., several of which were early 19 ), Respondent obtained another MAPS report showing the controlled substance prescriptions filled by R.E.H. GX 8, at 204-12. The report includes the handwritten notation of “was not seen on this day” in 14 separate entries for methadone prescriptions which list Respondent as the authorizing practitioner.20 See id. at 204-09. The report also bears Respondent's signature on the first page. Id. at 204. Dr. Mitchell explained that these entries “typically mean[ ]” either that Respondent was issuing the prescriptions without seeing R.E.H. or that R.E.H. had stolen a prescription pad. Tr. 299. Yet Respondent issued R.E.H. still more prescriptions for 120 methadone 10 on July 24, August 15, September 18, and October 8, 2012, as well as a prescription for 60 methadone 10 on September 4; each of the last four prescriptions was early. GX 15, at 125-36.

    19 The prescriptions were issued on March 22, April 19, May 15, June 6, and June 26. GX 15, at 109-24. Each of the prescriptions was for a 30-day supply, and thus the March 22, June 6, and June 26 prescriptions were early.

    20 The “was not seen on this day” notations are also written in entries for an alprazolam prescription (filled on 1/3/12) and for two hydrocodone prescriptions (filled on 12/30/11 and 11/19/11). GX 8, at 207, 209.

    The evidence further shows that even when Respondent's nurse noted in R.E.H.'s file that R.E.H. was seeking an early refill, Respondent nonetheless issued a post-dated prescription to him. As found above, the evidence shows that on October 8, 2012, Respondent issued R.E.H. a prescription for 120 methadone 10.21 GX 8, at 32. However, a progress note for an October 29, 2012 visit includes a nurse's note stating: “med refills—Ibuprophen—asked for methadone, last refill 10/8/12.” Id. at 100. Also, a note in a log dated October 30, 2012 states: “Pt requests a refill on methadone—and last refill was 10/8/12—not time yet.” Id. at 15. A MAPS report obtained by the Government shows that R.E.H. filled two methadone prescriptions with an issue date of October 8, 2012—one on October 8th, the other on October 30th. GX 20, at 14; see also GX 15, at 135-36 (Rx filled on Oct. 8); id. at 137-38 (Rx filled on Oct. 30). Not only was the second prescription post-dated—a violation of 21 CFR 1306.05(a) which requires that “[a]ll prescriptions for controlled substances shall be dated as of, and signed on, the day when issued”—it was also another early refill which should not have been filled. Tr. 301 (testimony of Dr. Mitchell).

    21 Here again, there is no progress note for this visit. See GX 8, at 100-101 (progress noted for visits on Oct. 3 and 29, 2012). However, a copy of the prescription is in R.E.H.'s patient file.

    On December 12, 2012, R.E.H. was admitted to a hospital after he overdosed on Seroquel. GX 8, at 158. While in the hospital, R.E.H. provided a urine drug test which was positive for cocaine. Id. He also was diagnosed as “polysubstance dependen[t].” Id. at 159. A copy of the hospital report was provided to Respondent and bears his signature. Id. at 158.

    Dr. Mitchell testified that upon learning that R.E.H. was using cocaine, the appropriate response was to refer him to inpatient drug rehabilitation as R.E.H. “obviously” had “a life threatening illness manifested by his addicting behavior” as well as to cease prescribing controlled substances to him. Tr. 303. Asked by the Government whether there ever was a point at which Respondent should have stopped writing controlled substance prescriptions to R.E.H., Dr. Mitchell testified:

    The short answer is yes. But the whole format of the care is so appalling that he never had a drug contract in the beginning and it's just one infraction after another.

    So if you had started from the very beginning, the patient already told you that he has a history of heroin abuse. So if you were to make the decision to treat his . . . back pain . . . there has to be documentation.

    Discussing with the patient about concerns regarding his illness, contract agreed upon and . . . random urine samples as well as MAPS surveys being pulled.

    In my opinion, in this case, after the second early refill, he'd be discharged from the practice. With the option to go to rehabilitation.

    You can't just let him go off and not have some kind of aftercare. I mean—he's a very sick individual . . . regarding his addictive illness.

    Id. at 303-04. Yet even after the December 12, 2012 hospitalization, Respondent continued to issue more methadone prescriptions to R.E.H. See GX 15, at 143 (Rx of 12/27/12); 145 (Rx of 1/22/13); 149 (Rx 2/19/13); 155 (Rx 3/13/13). Moreover, on February 19, 2013, Respondent issued R.E.H. a prescription for 90 Xanax with six refills.22 GX 15, at 151.

    22 However, the pharmacy apparently caught the fact that Respondent had provided too many refills, and noted that only five refills were authorized. GX 15, at 152.

    Following Dr. Mitchell's testimony, Respondent testified on his own behalf. After acknowledging that he had listened to all of Dr. Mitchell's testimony, Respondent was asked by his counsel if Dr. Mitchell is “right or wrong about you ignoring the red flags about patients who are or could be abusing or diverting drugs?” Tr. 484. Respondent answered: “He's right.” Id. Subsequently, the ALJ asked Respondent if he (the ALJ) was “correct in understanding that you've read the order to show cause?” Id. 535. Respondent answered: “I did.” Id. The ALJ then asked Respondent: “Do you agree that the facts that they allege there are all true?” Respondent answered: “I did.” Id. The ALJ followed up by asking: “Your answer was yes you do?” Id. Respondent answered: “Yes.” Id.

    I find (as did the ALJ) that Dr. Mitchell provided credible testimony that Respondent ignored multiple red flags that R.E.H. was abusing and diverting controlled substances and that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice when he continued to prescribe methadone and other drugs in the face of the red flags. While this alone constitutes substantial evidence to support a finding that Respondent violated 21 CFR 1306.04(a) and 21 U.S.C. 841(a)(1) in prescribing to J.E.H., this conclusion is buttressed by Respondent's testimony that Dr. Mitchell was “right” when he testified that Respondent ignored multiple red flags.

    J.W. The Allegations

    The Show Cause Order alleged that from December 23, 2010 through January 4, 2012, Respondent “repeatedly prescribed controlled substances after [he] came to know that J.W. was engaged in the abuse and/or diversion of controlled substances.” ALJ Ex. 1, at 3. Specifically, the Show Cause Order alleged that Respondent repeatedly prescribed controlled substances to J.W. notwithstanding numerous red flags of diversion and/or abuse. Id. These included that:

    • J.W. repeatedly sought early refills;

    • the Michigan Medicaid program notified Respondent that J.W. was doctor-shopping;

    • a pharmacy also notified Respondent that J.W. was doctor-shopping;

    • J.W. was incarcerated;

    • J.W. exhibited withdrawal symptoms; and

    • a MAPS report obtained by Respondent in October of 2011 showed that J.W. was engaged in a persistent pattern of doctor and pharmacy shopping.

    Id.

    The Show Cause Order also alleged that J.W.'s patient file and the prescriptions issued to him show that Respondent:

    • Prescribed Adderall, a schedule II stimulant, to J.W. on his first visit without diagnosing him with Attention Deficit Disorder (ADD), and that he prescribed other controlled substances without taking actions typical of medical professionals such as conducting and documenting a complete medical history and physical examination, or creating a written treatment plan;

    • prescribed numerous controlled substances to J.W. without conducting a MAPS search “that a typical Michigan doctor would have conducted,” and that such a search would have shown that J.W. was engaged in “a dangerous pattern of doctor and pharmacy shopping (through which J.W. obtained 11 monthly prescriptions for Adderall within the first six months of 2011)”;

    • prescribed methadone to J.W. with a PRN (take as needed) dosing instruction “within a week of meeting him and repeatedly thereafter”;

    • “never subjected J.W. to any drug tests”; and

    • “took no action to enforce the pain management contract that J.W. signed on his first visit, in which [J.W.] committed (among other things) to obtain controlled medications from only one provider (Respondent), fill them at one pharmacy, and take them at the prescribed dosages.”

    Id. at 3-4. The Evidence

    J.W. first saw Respondent on December 23, 2010. GX 9, at 42. According to a nurse's notation on the progress note, J.W. was seeking treatment for pain. Id. Respondent prescribed to J.W. 60 tablets of Adderall 20, with a dosing instruction of BID or one tablet to be taken twice a day. GX 16, at 1. One week later, J.W. returned to Respondent, who wrote him a prescription for 90 tablets of methadone 5, with a dosing of TID and PRN. Id. at 3.

    Dr. Mitchell testified that neither prescription was issued in the usual course of professional practice. Tr. 308. As for the Adderall prescription, Dr. Mitchell explained that the drug is “typically” prescribed to treat ADD (Attention Deficit Disorder) or ADHD (Attention Deficit Hyperactivity Disorder). Id. Dr. Mitchell explained that neither J.W.'s chief complaint nor history “would indicate an appropriate diagnosis for the prescribing of Adderall.” Id. Dr. Mitchell also observed that Respondent's assessment and plan also contained “no indication of any appropriate diagnosis for” Adderall. Id. Reviewing the notes for the first visit, Dr. Mitchell also questioned whether Respondent had performed a physical exam, as in the space on the progress note for listing the exam findings, Respondent had scribbled “an S.” GX 9, at 42. Regarding the notation, Dr. Mitchell testified that “I don't know what that signifies.” Id. at 309. While Dr. Mitchell also noted that the margin of the progress note included a listing of various areas with boxes in which Respondent wrote either plus or minus signs, he further testified that he was “not sure what they're trying to communicate.” Id.

    Dr. Mitchell testified that it was inappropriate for Respondent to issue the methadone prescription at J.W.'s second visit. Id. Asked to explain why, Dr. Mitchell testified that:

    There's no documentation that the patient is having any findings based on physical examination that would serve as a foundation for prescribing [me]thadone. Even though the records are reviewed, I don't see any documentation where it states the patient had previously taken [m]ethadone or was on any analgesics whatsoever.

    And then there's some notation that's very hard to make out, it says something Vicodin. I can't really read it, but it's in the middle of the HPI box.

    I'm not really sure what it's trying to communicate. Whether it's regarding prior Vicodin prescription or what. So it's really not legible.

    Id. at 309-10. As he testified regarding Respondent's prescribing to R.E.H., Dr. Mitchell re-iterated that it was not appropriate to prescribe methadone for pain on a PRN basis. Id.

    J.W.'s file includes a fax of a “Notice of Prior Authorization Determination,” which Respondent received from the Michigan Medicaid program on or about January 21, 2011. GX 9, at 69. The form noted that a prior authorization request had been received and provided the name of another physician (Dr. M.) who had prescribed Adderall to J.W.; it also listed a pharmacy other than the one which J.W. had listed on the Pain Management Agreement he entered into at his first visit with Respondent. Compare GX 9, at 69; with id. at 70. As Dr. Mitchell explained, this is “evidence that . . . J.W. [wa]s multi-sourcing for amphetamine from another physician.” Tr. 311. However, in the Pain Management Agreement, J.W. had agreed that he would “not attempt to obtain controlled medicine, including . . . stimulants . . . from any other doctor, provider or facility.” GX 9, at 70; see also Tr. 312. While the Pain Management Agreement also stated that if J.W. broke the agreement, Respondent would stop prescribing controlled substances and discharge him, Respondent did not do so. See GX 9, at 70.

    Dr. Mitchell further explained that upon learning that J.W. was obtaining Adderall from another doctor, Respondent should have engaged J.W. and obtained an explanation for why he was obtaining prescriptions from two different doctors and documented the encounter. Tr. 313. Respondent, however, did not do this. Id. at 314 (GX 9, at 39). Instead, he issued J.W. another prescription for 60 Adderall. Tr. 314; ALJ Ex. 50, at 2; GX 16, at 7-8. Asked whether Respondent's issuance of the prescription was within the usual course of professional practice, Dr. Mitchell answered “no” and added that “[t]he whole beginning for the prescriptions of Adderall were not issued in the course of legitimate methods of practice.” Tr. 314-15.

    On February 16, 2011 (22 days later), J.W. again saw Respondent. GX 9, at 38. Respondent wrote J.W. a new prescription for 60 Adderall even though he was eight days early. Tr. 315. Respondent also wrote J.W. a prescription for 120 methadone 10. GX 16, at 11.

    However, only two days later (Feb. 18), Respondent's office received a phone call from a pharmacy reporting that insurance would not cover J.W.'s methadone prescriptions and that he was seeing Dr. M. who was prescribing Suboxone to him—Dr. M. being the same doctor listed as the medical provider on the prior authorization request form Respondent had received from the Michigan Medicaid program. Compare GX 9, at 4; with id. at 69. Thus, J.W. was simultaneously obtaining prescriptions for both methadone and Suboxone, which according to Dr. Mitchell “is not done.” Tr. 316.

    Dr. Mitchell testified that in response to this information, the appropriate course would be to discharge the patient and recommend that he go to inpatient drug rehabilitation. Id. at 316. Dr. Mitchell testified that he would “have called the other physician” to tell him/her that J.W. was engaged in “potentially . . . life threatening” behavior. Id. Yet there is no evidence in J.W.'s file that Respondent did this. Id.

    On both March 16 and April 6, 2011, Respondent wrote J.W. additional prescriptions for 60 Adderall. GX 16, at 21-22; id.at 25-26. According to Dr. Mitchell, J.W. was a week early when he received the April 6 prescription.23 Tr. 317. Dr. Mitchell explained that J.W.'s early refills and doctor shopping was “a continued obvious flag to the physician that there's something going on here that can potentially put the patient's life at risk.” Id.

    23 Actually, he was nine days early.

    The evidence also shows that in the first six months of 2011, Respondent wrote J.W. six prescriptions for 60 Adderall.24 GX 21, at 19-25. Dr. Mitchell testified that these prescriptions were not issued in the usual course of professional practice. Tr. 317-18.

    24 While Dr. Mitchell testified that 10 prescriptions were issued to J.W. in this period, three of them were issued by Dr. M., the other by a Dr. R. GX 21, at 19-25.

    The evidence further shows that Respondent issued to J.W. prescriptions for 60 Adderall 30 (BID) and 120 Klonopin (QID) on both July 6 and 26. GX 16, at 41-52. According to Dr. Mitchell, both of the July 26 prescriptions were “approximately a week early” (actually, they were 10 days early), and there was no justification in the patient file for issuing the prescription when Respondent did. Tr. 318.

    On October 25, 2011, Respondent received a fax from the Medical Department of the Lapeer County Jail. The fax stated that J.W. was an inmate and requested information as to his prescriptions and diagnosis. GX 9, at 47. Respondent reported that J.W. was on methadone for chronic pain and Adderall for EDS and ADD. Id. at 47.

    The same day, Respondent obtained a MAPS report on J.W. GX 9, at 48-51; 79-83. The report showed that J.W. was still obtaining controlled substance prescriptions for Suboxone and Adderall from Dr. M., while also obtaining prescriptions for methadone, hydrocodone and Adderall from Respondent. See id. As found above, while J.W. was incarcerated, his niece contacted Respondent and told him that J.W. had “nearly died from withdrawal” and that he was selling his medications; she also asked him to stop prescribing controlled substances to J.W. Tr. 128-29. Dr. Mitchell explained that under these circumstances, he would confront the patient regarding whatever the family reported and “let the patient react and respond.” Tr. 323.

    J.W. did not see Respondent again until December 21, 2011. GX 9, at 25. Regarding the progress note for the visit, Dr. Mitchell testified that “the physical exam is really nothing, it says awake and stable.” Tr. 324. As for J.W.'s chief complaint, Dr. Mitchell testified that Respondent's writing was illegible. Id.; see also GX 9, at 25. Respondent did not issue any prescriptions to J.W. on this day.25 ALJ Ex 50, at 3.

    25 However, on October 18, 2011, J.W. had filled an Adderall prescription which Respondent had written for him on the same day. GX 16, at 57-58.

    J.W. returned on January 4, 2012. On the progress note, Respondent lined through a box next to the words stating “substance abuse +, reviewed w/patie[nt].” GX 9, at 24. However, the progress note is otherwise illegible. See id. Also, Respondent resumed prescribing controlled substances to J.W., issuing him prescriptions for 30 tablets of Valium 10 mg and 120 tablets of Tylenol with Codeine No. 4. ALJ Ex 50, at 3.

    On January 19, 2012, J.W. made his final visit to Respondent and obtained a prescription for 120 tablets of methadone 10 with a dosing instruction of QID and PRN. Tr. 325; GX 16, at 59-60. Asked whether the prescription was issued in the usual course of professional practice, Dr. Mitchell answered “no.” Tr. 325. Asked “why not,” Dr. Mitchell explained: “[w]ell again, the same basis. Where is the justification, based on the patient['s] clinical complaints, a detailed examination, a clear diagnosis that [m]ethadone was justified.” Id. As for at what point during his treatment of J.W. Respondent should have refused to prescribe controlled substance and discharged him, Dr. Mitchell answered:

    Again, it would be early on with the early refills. The behavior that is an obvious flag by the patient for addiction illness. Which he has a history of. History of drug abuse is documented in the chart.

    Id. at 326.

    As found above, Respondent testified that he had listened to all of Dr. Mitchell's testimony. Respondent was then asked by his counsel if Dr. Mitchell is “right or wrong about you ignoring the red flags about patients who are or could be abusing or diverting drugs?” Tr. 484. Respondent answered: “He's right.” Id.

    Based on Dr. Mitchell's credible testimony, I find that the controlled substance prescriptions Respondent provided to J.W. lacked a legitimate medical purpose and were issued outside of the usual course of professional practice and violated the CSA. 21 CFR 1306.04(a); 21 U.S.C. 841(a)(1). This finding is buttressed by Respondent's admission that Dr. Mitchell was correct in his criticism that he ignored red flags.

    R.K. The Allegations

    The Show Cause Order alleged that from January 27, 2011 through July 17, 2012, Respondent repeatedly prescribed controlled substances to R.K. after Respondent knew that R.K. was engaged in the abuse and/or diversion of controlled substances. ALJ Ex. 1, at 4. The Show Cause Order specifically alleged that Respondent repeatedly prescribed to R.K. controlled substances despite the numerous red flags of diversion and/or abuse R.K. presented. Id. These included that:

    • R.K. repeatedly sought early refills;

    • Respondent was notified by the Michigan Department of Community Health Drug Utilization Review that R.K. was doctor shopping;

    • a pharmacist contacted [his] office reporting suspicious conduct by R.K.; and

    • two consecutive drug tests on April 10, 2012 and May 8, 2012 showed that R.K. was not taking the methadone that Respondent had prescribed to him.

    Id.

    The Show Cause Order also alleged that R.K.'s patient file and the prescriptions issued to him show that Respondent:

    • Prescribed controlled substances to R.K. on his first visit without taking actions typical of medical professionals, such as conducting and documenting a complete medical history and physical examination, or creating a written treatment plan;

    • never required R.K. to sign a pain management contract or ran a MAPS report on him;

    • engaged in a pattern of issuing Xanax prescriptions to R.K. on a near monthly basis that authorized multiple refills, and that while the dosing instructions directed R.K. to take 690 tablets in the 10-month period preceding his death, the prescriptions allowed R.K. to obtain up to 2,250 tablets of Xanax;

    • issued a prescription for Xanax to be refilled six times, in violation of state and federal law; and

    • stopped testing R.K. to determine if he was taking the methadone Respondent prescribed after R.K. tested negative on two consecutive monthly drug tests.

    Id. at 4-5. The Evidence

    At the beginning of the Government's examination of Dr. Mitchell about Respondent's prescribing to R.K., the ALJ raised his “concern about evidence that becomes cumulative at some point in a preceding [sic].” 26 Tr. 326. The Government thus did not ask Dr. Mitchell about the prescriptions Respondent issued to R.K. from his first visit (January 27, 2011), through and including R.K.'s visit of October 4, 2011. See id. at 330-36; GX 10, at 52-65.

    26 According to the ALJ, “[t]hat can happen in two ways in this particular preceding [sic]. And one way is that you [the Government] present evidence of many patients and the other way is to present evidence of many forms of failure to treat in a manner that's required in the ordinary course of medical practice.” Tr. 326-27. Continuing, the ALJ explained that:

    So far I've heard more than one instance. In fact, multiple instances of prescribing [m]ethadone on a PRN basis, which the witness has told me is inconsistent with medical practice.

    Not having a complete medical history, not having a physical examination noted in the file, not writing a treatment plan, diagnosing controlled substances without sufficient support in the medical record through objected[sic] testing, imagining [sic] or other data, prescribing controlled substances prematurely before the expiration of the prior prescription, concurrent prescriptions from more than one prescribing source, filling those prescriptions in more than one pharmacy, failure to properly utilize the MAPS data in the record, failure to discharge and failure to enforce the pain medication treatment plan and contract.

    Id. The ALJ then announced that “[t]o the extent that proposed testimony is redundant in these fields, I will be sensitive to an objection that the evidence does not have an informative role and becomes less useful to me as it is cumulative at that point.” Id. The ALJ thus directed the Government to “tailor your questions appropriately” and advised Respondent's counsel that “I will be listening to you for your concern as well.” Id. at 328.

    Contrary to the ALJ's understanding, the Government was entitled to put on evidence regarding each and every allegation it had raised in the Order to Show Cause and its pre-hearing statements. That the Government had previously shown that Respondent failed to obtain a complete history and conduct an adequate physical exam, or that he failed to address red flags such as repeated early refill requests or ignored evidence of doctor shopping and the use of multiple pharmacies, etc., with respect to patients R.E.H. and J.W., does not render evidence as to whether he acted in the same manner with respect to the other three patients redundant. Furthermore, notwithstanding that evidence of a single act of diversion can, in appropriate circumstances, support an order of revocation, it is for the Government to decide, in the exercise of its prosecutorial discretion, on the number of patients (and prescriptions) that are necessary to prove its case.

    On October 20, 2011, Respondent issued R.K. a prescription for 60 tablets of Xanax .5 mg, with a dosing instruction of BID or PRN. ALJ Ex. 50, at 3; Tr. 330. The prescription authorized three refills, ALJ Ex. 50, at 3; and based on the dosing instruction, the prescription provided R.K. with a four-month supply of the drug. However, Dr. Mitchell testified that there was nothing in the progress note for this visit which justified providing R.K. with a four-month supply of the drug. Tr. 330.

    Yet, not even six weeks later on November 29, 2011, Respondent issued R.K. an additional prescription for 60 Xanax .5 mg (BID or PRN), with three refills. ALJ Ex. 50, at 3; Tr. 330. Here again, Dr. Mitchell testified that there was no medical justification in the visit's progress note for providing R.K. with another four-month supply of Xanax. Tr. 330-31.

    On January 17, 2012, Respondent provided R.K. with another prescription for 60 Xanax (BID and PRN), with three refills. ALJ Ex. 50, at 3. Moreover, Respondent increased the strength of the drug to 1 mg. Id. While this prescription alone again provided R.K. with a four-month supply, on February 15, 2012, Respondent provided R.K. with another prescription for 60 Xanax 1(BID and PRN) with three refills. Id.

    On April 10, 2012, Respondent provided R.K. with another prescription for Xanax 1, increasing the quantity to 90 tablets and the dosing to TID (and PRN). Id. Moreover, Respondent authorized six refills, this being a separate violation of the Controlled Substances Act, which, with respect to a schedule IV drug, prohibits refilling a prescription “more than five times” unless the practitioner renews the prescription. See 21 U.S.C. 829(b).

    Notwithstanding the numerous refills R.K. had remaining on both the February 15 and April 10 prescriptions (not to mention the supply R.K. had likely obtained from the earlier prescriptions), Respondent provided him with new prescriptions for 90 Xanax 1 (TID or PRN) on May 8 and May 30, 2012. ALJ Ex. 50, at 4. While these two prescriptions did not authorize any refills, on June 21, 2012, Respondent provided R.K. with another prescription for 90 Xanax 1(TID or PRN), which authorized three refills. Id. Finally, at R.K.'s last visit, Respondent provided him with another prescription for 90 Xanax 1 (TID or PRN). Id.

    According to Dr. Mitchell, from October 20, 2011 through July 17, 2012, R.K. “obtained 1950 tablets of alprazolam,” an amount far in excess (by more than 1,000 pills) of what was necessary based on Respondent's dosing instructions.27 Tr. 331. Dr. Mitchell further testified that Respondent pattern of issuing multi-month prescriptions on top of one another is “not a customary, legitimate medical practice behavior.” Id. at 332.

    27 A review of the MAPS data suggests that the actual figure was 1890 tablets, as one dispensing which occurred on January 15, 2012 is listed twice. GX 22, at 11. Either way, the amount of alprazolam R.K. was able to obtain based on Respondent's prescriptions far exceeded what was necessary based on the dosing instructions.

    The Government also questioned Dr. Mitchell about Respondent's prescribing of methadone to R.K. On March 13, 2012, Respondent first prescribed 90 methadone 5 mg (TID + PRN), a 30-day supply, to R.K. GX 17, at 45-46. However, on April 10, 2012, R.K. tested negative for methadone. GX 10, at 31. A note in the entry states: “ran out week ago.” Id.

    Regarding this incident, Dr. Mitchell testified that “[i]f a patient was truly taking [m]ethadone . . . and they abruptly ran out, they would go through significant medical withdrawal.” Tr. 333. Dr. Mitchell further explained that a physician “would engage the patient, are you taking, what's the problem here? Find out why the chaotic pattern in your lab results, when you are prescribing the medication for them and give them a chance to respond.” Id. Dr. Mitchell also stated that even if he believed in giving the benefit of the doubt to the patient he would still ask the patient why the patient “never bothered to contact” him and would also express his “concern[ ] about what's going on with [the patient's] behavior.” Id. at 334.

    At the April 10 visit, Respondent issued R.K. a new prescription for 90 methadone 10 mg (TID), which was double the strength of what he had previously prescribed. GX 17, at 47-48. Moreover, while Respondent subjected R.K. to another drug test during his next visit (May 8, 2012), R.K. again tested negative for methadone claiming that he had run out several days earlier.28 GX 10, at 31. Yet here again, Respondent issued R.K. a new prescription for 90 methadone 10 TID. GX 17, at 51-52.

    28 The actual notation in R.K. drug screening record states: “last pill Saturday.” GX 10, at 31. In May 2012, May 8 was a Tuesday.

    Dr. Mitchell testified that “[t]here is no legitimate foundation for” the prescription. Tr. 335. And when asked what the appropriate response was to R.K.'s having provided a second negative urine test for methadone, Dr. Mitchell answered: “[d]ischarge.” Id.

    On May 30, 2012, R.K. again saw Respondent, who provided him with a new prescription for 90 methadone 10. GX 10, at 6, 43; GX 17, at 55-56. Notwithstanding that R.K. had provided negative urine samples on his two previous visits, there is no evidence that Respondent required R.K. to provide a new urine sample. Tr. 335. And while Respondent put a slash mark through the box next to the entry “Substance Abuse +, reviewed w/patient,” GX 10, at 43; as Dr. Mitchell explained: “There's no detail, it's just merely a swipe of the pen.” Tr. 336. Continuing, Dr. Mitchell noted that there is “[n]o documentation of, I discussed with the patient two negative urines samples, so forth and so . . . my plan was so forth and so on.” Id.

    Asked by the Government whether there was ever a point when Respondent should have discharged R.K., Dr. Mitchell answered “[y]es.” Id. While Dr. Mitchell explained that he would give the patient the benefit of the doubt, after the second negative urine test, “he would definitely be discharged.” Id. Dr. Mitchell further agreed that every controlled substance prescription Respondent issued to R.K.'s after the second negative urine test was issued outside of the usual course of professional practice. Id. at 336-37.

    During cross examination, Dr. Mitchell agreed that by referring R.K. to a physical therapist to treat the patient's back pain, Respondent was employing a multifaceted treatment plan. Id. at 446. However, Dr. Mitchell found that there was no medical evidence to support Respondent's prescribing of methadone, and there was no evidence that Respondent ever tested R.K. to determine if he was using the medication as prescribed. Id. at 335.

    Based on the above, I find that all of the controlled substance prescriptions issued by Respondent to R.K. on and after October 20, 2011 lacked a legitimate medical purpose and were issued outside of the usual course of professional practice. 21 CFR 1306.04(a).

    R.J.H. The Allegations

    The Show Cause Order alleged that from March 10, 2011 through November 30, 2011, Respondent repeatedly prescribed controlled substances to R.J.H. after he knew that R.J.H. was engaged in the abuse and/or diversion of controlled substances. Id. at 5. Specifically, the Government alleged that Respondent prescribed controlled substances to R.J.H., notwithstanding numerous red flags of diversion and/or abuse, including:

    • R.J.H. repeatedly sought early refills;

    • R.J.H. repeatedly reported lost or stolen prescriptions;

    • another patient reported that R.J.H. was selling his prescription of methadone and taking his girlfriend's prescription as his own; and

    • R.J.H. was requesting controlled substances by name.

    Id. at 5.

    The Government also alleged that R.J.H.'s patient file and the prescriptions issued to him show that Respondent:

    • Prescribed controlled substances to R.J.H. on his initial visit without taking actions typical of medical professionals such as conducting and documenting a complete medical history and physical examination, requiring that R.J.H. (a self-identified addict) sign a pain management contract or submit to a drug test, running a MAPS search on R.J.H., and creating a written treatment plan, which was periodically re-evaluated;

    • never subjected R.J.H. to drug tests;

    • never ran a MAPS report on R.J.H.;

    • never required R.J.H. to sign a pain management agreement; and

    • repeatedly prescribed methadone to R.J.H. to be taken “PRN.”

    Id. at 5. The Evidence

    The Government's presentation with respect to R.J.H. focused primarily on the manner in which Respondent escalated the amount of methadone he prescribed and ignored various red flags. R.J.H. first saw Respondent on March 10, 2011, at which time Respondent documented that R.J.H. had a history of narcotic abuse. GX 11, at 3, 57; see also Tr. 341. At the visit, Respondent issued to R.J.H. a prescription for 30 tablets of methadone 5 to be taken twice a day, providing a 15-day supply. GX 18, at 1-2; ALJ Ex. 50, at 4. Thereafter, on a March 24, 2011, Respondent issued to R.J.H. a prescription for 90 tablets of methadone TID, providing a 30-day supply, and on April 5, 2011, he issued to R.J.H. a prescription for 40 tablets of methadone 10 (QID and PRN). GX 18, at 5-6, 9-10; ALJ Ex. 50, at 4. Moreover, on April 19, 2011, Respondent issued to R.J.H. a prescription for 120 tablets of Methadone 10 (QID and PRN). GX 18, at 11-12; ALJ Ex. 50, at 4. Thus, between the March 10 and April 19 prescriptions, Respondent had quadrupled R.J.H.'s daily methadone dose from 10 to 40 milligrams.

    Dr. Mitchell testified that this was “a significant escalation in” the total “24 hour dose” of R.J.H.'s methadone regimen. Tr. 338. Dr. Mitchell further explained there was “no” justification for Respondent's having quadrupled R.J.H.'s daily dose. Id.

    Progress notes in R.J.H.'s file show that R.J.H. had appointments with Respondent on both May 18 and May 26, 2011. GX 11, at 52-53. Moreover, on May 17, 2011, Respondent wrote R.J.H. a new prescription for 120 tablets of methadone 10 QID and PRN), and on May 26, 2011, he wrote R.J.H. another prescription for 120 tablets of methadone 10 (QID and PRN). GX 18, at 15-16, 19-20. Attempting to interpret Respondent's handwriting on the May 26 progress note, Dr. Mitchell thought that R.J.H had reported “that the prescription was stolen,” Tr. 339, and according to a notation on the May 26 prescription, R.J.H. told the pharmacist that “he was beat[en] up and his meds were stolen.” GX 18, at 20. A further notation on the prescription states: “Early refill Ok'd by Dr. Ataya Police Report on file. Per Christina @Dr. Ataya's.” Id.

    Dr. Mitchell testified that when a patient claims that his medication has been stolen, “there needs to be some action on the patient['s]” part. Tr. 339. According Dr. Mitchell, “part of the opioid contract [is] that if medications are stolen, you have to make a police report.” Id. There is, however, no police report in R.J.H.'s file. See generally GX 11. Nor is there an opioid contract. See also generally id.; Tr. 341.

    On June 8, R.J.H. again saw Respondent. GX 11, at 51. A nurse's note on the progress note states: “meds (stolen).” Id. Dr. Mitchell testified that the appropriate response to this information would be to discharge the patient. Tr. 340-41. Dr. Mitchell subsequently explained that the point at which Respondent should have discharged R.J.H. was “after the second report of medications being stolen” without verification “of that event happening.” Id. at 342. Dr. Mitchell further noted that while Respondent documented that R.J.H. “has a history of narcotic abuse,” there is no evidence that Respondent required him to sign a pain management contract. Id. at 341. Dr. Mitchell also found no evidence that Respondent conducted any drug tests on R.J.H. and there were no MAPS reports in R.J.H.'s file. Id. at 341-42.

    The evidence also shows that on June 7, 2011, an employee of Respondent documented that he/she “was told by another patient that [R.J.H.] was selling his prescription of methadone, and taking his girlfriend[']s prescription as his own.” GX 11, at 9. While Respondent did not prescribe methadone to R.J.H. at the June 8 visit,29 on June 15, 2011, he issued R.J.H. another prescription for 60 tablets of methadone 5 to be taken twice a day or PRN. GX 18, at 21-24.

    29 Rather, he prescribed 30 tablets of Tylenol with Codeine No. 3 (“Tylenol 3”).

    While this prescription should have lasted R.J.H. for 30 days, only six days later on June 21, 2011, Respondent issued to R.J.H. a prescription for 60 tablets of methadone 10, thereby doubling the daily dose. Id. at 25-26. Thus, this refill was early by 24 days.

    Moreover, Respondent continued to provide R.J.H. with additional early refills. Specifically, only 15 days later on July 6, Respondent issued to R.J.H. a prescription for 60 methadone 10 (BID/PRN). Id. at 27-28. Even ignoring the June 15 prescription, this refill was early by 15 days.

    Only 13 days later on July 19, 2011, Respondent issued to R.J.H. a prescription for 120 of methadone 10 (QID, or four times a day), thereby doubling the daily dose and quantity. Id. at 29-30. And on August 11, 2011, he issued to R.J.H. another prescription for 120 tablets of methadone 10 to be taken four times a day or PRN. Id. at 31-32. Even ignoring the prescriptions prior to July 19, this prescription was still one week early.30

    30 Thereafter, Respondent issued additional methadone prescriptions to R.J.H. on an approximately monthly basis up until January 3, 2012, the same day he overdosed on heroin and was hospitalized. GX 23, at 6-8. As found above, R.J.H. died of an overdose on or about January 5, 2012. GX 5, at 1.

    As Dr. Mitchell testified, there was no justification for Respondent's rapid escalation of R.J.H.'s daily dose. Also, Respondent ignored red flags such as R.J.H.'s claim on two occasions that his prescription had been stolen, the report that he was selling his methadone and using his girlfriend's, and R.J.H.'s repeated seeking of early refills, some of which were weeks early. Moreover, while Respondent knew that R.J.H. had a history of narcotic abuse he did not require him to sign a pain contract, never conducted a drug test on him, and never obtained a MAPS report. Based on the above, I find that Respondent lacked a legitimate medical purpose and acted outside of the usual course of professional practice when prescribed methadone to R.J.H. 21 CFR 1306.04(a).

    J.H. The Allegations

    The Show Cause Order alleged that from June 10, 2010 through August 12, 2012, Respondent repeatedly prescribed controlled substances to J.H. even after he knew that she was engaged in the abuse and/or diversion of controlled substances. ALJ Ex. 1, at 5. Specifically, the Government alleged that Respondent repeatedly prescribed controlled substances to her notwithstanding numerous red flags of diversion and/or abuse, including that:

    • J.H. repeatedly sought early refills;

    • J.H. requested controlled medications by name;

    • J.H. was in frequent contact with Respondent's office regarding her pain medications;

    • J.H. tested negative for controlled substances that Respondent had prescribed to her;

    • Respondent diagnosed J.H. as narcotic dependent;

    • hospital records in Respondent's file show that J.H. tested positive for illegal drugs; and

    • J.H. exhibited symptoms of withdrawal.

    Id. at 5-6.

    The Show Cause Order also alleged that J.H.'s patient files and the prescriptions Respondent issued to her show that he:

    • Issued controlled substance prescriptions to J.H. on her initial visit without taking actions typical of medical professionals such as conducting and documenting a complete medical history and physical examination, and creating a written treatment plan;

    • diagnosed J.H. as being narcotic dependent but took no actions such as referring her to rehabilitation or a specialist, or even minimal precautionary steps such as requiring her to sign a pain management contract, subjecting her to comprehensive drug tests, or even running MAPS reports on her, and that MAPS reports would have shown that she was engaged in doctor and pharmacy shopping;

    • prescribed two different benzodiazepines—Klonopin and Xanax—to J.H. even after she reported that she would not be using Xanax but using Klonopin instead;

    • repeatedly prescribed methadone to J.H. to be taken “PRN”; and

    • prescribed Adderall to J.H. without any basis for doing so, continued to prescribe Adderall after drug tests showed that she was not taking the drug, stopped conducting drug tests to determine if J.H. was taking the Adderall he prescribed, and only stopped prescribing the drug when the Michigan Medicaid program asked him to substantiate his prescriptions.

    Id. at 6. The Evidence

    The progress note for J.H.'s November 10, 2010 visit shows that on that date, Respondent diagnosed J.H. as “narcotic dependent.” GX 12, at 125; Tr. 343. While Dr. Mitchell stated that he did not know if Respondent was “trying to indicate a history of abuse by that statement or he wasn't familiar with the definitions of addiction versus dependence,” he explained that the decision to start a patient on methadone “depends on the history you gleaned from the patient and what the old medical records showed,” because “you're essentially becoming their addictionologist and beginning treatment for them.” Id. at 346. However, according to Dr. Mitchell, when a physician determines that a patient is narcotic dependent, it is not appropriate to prescribe methadone without requiring the patient to sign an opioid agreement, conduct drug tests, and obtain a prescription monitoring program report. Id. at 346-47.

    There is, however, no evidence that Respondent required J.H. to enter an opioid agreement. Tr. 347; see also GX 12 (J.H.'s patient file). Moreover, while Respondent did eventually obtain a MAPS report, he did not do so until November 30, 2012, more than two years after he diagnosed her as narcotic dependent.31 See GX 12, at 8-13.

    31 The report shows prescriptions beginning only on August 31, 2011. GX 12, at 8-13. The report shows several instances in which J.H. obtained small amounts of hydrocodone and acetaminophen with codeine from a dentist in the May 2012 time period, and a further prescription for a small amount of hydrocodone from another dentist on September 14, 2011. GX 12, at 8, 13. However, every other prescription listed in this report was issued by Respondent.

    Of note, the Government also submitted a MAPS report it obtained showing J.H.'s prescriptions from January 8, 2010 through February 2013. However, the questioning regarding the MAPS reports was interrupted by telephonic interference seven times and is not clear what the precise questions were and which of the MAPS reports the Government was referring to in its questions. Tr. 348-49.

    The evidence shows that on November 26, 2010, Respondent issued to J.H. a prescription for 90 methadone 5 (TID), a 30-day supply. GX 19, at 21-22. Yet, according to J.H.'s file, on December 1, 2010, she was suffering from narcotic withdrawal. Tr. 349. Dr. Mitchell testified that when confronted with this situation, the appropriate response of a physician acting within the bounds of professional practice is to send the patient “to the hospital.” Id. When then asked if it was an appropriate response to continue to issue controlled substance medication to the patient, Dr. Mitchell testified “absolutely not.” 32 Id. at 349-50. At this point, the ALJ declared the line of questioning “redundant” and no further clarification was obtained as to whether Dr. Mitchell was referring to prescribing or administering. Yet the evidence shows that Respondent continued to prescribe methadone and other controlled substances to her. GX 24.

    32 A DEA regulation, however, expressly authorizes a physician to administer (but not prescribe) a “narcotic drug[ ] to a person for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment.” 21 CFR 1306.07(b). This is so even when the physician “is not specifically registered to conduct a narcotic treatment program.” Id. However, the physician may not administer “more than one day's medication” at a time and may not do this for “more than three days.” Id.

    The evidence further shows that on September 8, 2010, J.H. called Respondent's office “and stated that she stopped Xanax 33 and went back to Klonopin b/c she didn't like the way it made her feel.” GX 12, at 7. Respondent provided J.H. with prescriptions for 60 clonazepam on September 15, October 13, November 10, and a prescription for 30 tablets on November 30, 2010. GX 24, at 5-8.

    33 Respondent had prescribed 30 alprazolam .25 mg to J.H. on August 31, 2010. GX 24, at 4.

    However, on December 1, 2010, he issued J.H. a prescription for 60 alprazolam 1.34 Id. at 8. Moreover, only one week later on December 8, Respondent issued J.H. a prescription for 90 clonazepam. Id. While on January 4, 2011, Respondent issued her another prescription for 90 clonazepam, on January 13, he issued her a prescription for 30 alprazolam 1. Id. In the ensuing months, Respondent continued to provide J.H. with both clonazepam and alprazolam prescriptions, even though both drugs are benzodiazepines.35 According to Dr. Mitchell, there was “[n]o” medical reason for Respondent to prescribe both drugs after J.H. stated that she did not like how the alprazolam made her feel. Tr. 351.

    34 J.H. filled the Nov. 30 clonazepam prescription and the December 1 alprazolam prescription on the days they were they were issued.

    35 The evidence shows that during 2011, Respondent issued J.H. prescriptions for 90 clonazepam on Feb. 2, Mar. 1, April 5, May 3, June 1, June 28, July 26, August 25 (with three refills which were filled on Sept. 21, Oct. 15, and Nov. 10), and Dec. 13. GX 24, at 9-12. During 2011, he also issued J.H. prescriptions for 90 alprazolam 1 on Mar. 15, for 30 alprazolam .5 on April 20, and for 30 alprazolam .25 on June 21. Id. at 9-11.

    During 2012, Respondent issued J.H. a prescription for 90 clonazepam on Jan. 5, with three refills that were filled on Feb. 1, Feb. 19, and Mar. 10; a prescription for 90 clonazepam on Mar. 28; a prescription for 120 clonazepam on April 25, with three refills, two of which were filled on May 15 and June 6; a second prescription for 120 clonazepam on April 25, which was filled on July 4; and two prescriptions for 90 clonazepam on August 14, one of which was filled the same date, the other being filled on December 8. Id. at 14-17. Respondent also issued her a prescription for 15 alprazolam .5 on May 22, 2012. Id. at 15-16.

    The evidence also shows that on August 3, 2011, Respondent issued J.H. a prescription for 30 Adderall 10, with a dosing instruction to take one tablet daily. GX 19, at 71-72. However, at J.H.'s August 31, 2011 appointment, J.H. tested negative for the drug; a note on the drug screening results sheet states: “last Adderall 2 days ago.” GX 12, at 61. Respondent, however, issued her a new prescription for 30 Adderall 10 at the visit. GX 19, at 77-78.

    Dr. Mitchell testified that J.H.'s clean urine tests raised the same concerns (i.e., that the patient was either abusing or diverting the drug to others) as he testified to when asked about the significance of a negative test for methadone. Tr. 352. He also testified that Respondent's issuance of a new Adderall prescription after the negative test result raised the same concern that the prescription was “outside the typical practice of medicine.” Id.

    Finally, the Government questioned Dr. Mitchell as to whether there was a point at which Respondent should have stopped prescribing controlled substances to J.H. Id. at 355. According to Dr. Mitchell, “in the face of [J.H.'s] history of drug abuse . . . [a]fter the second negative urine that would be a [sic] unavoidable, irrevocable sign to discharge her from the practice.” Id. However, while the Patient Drug Screening Results form states that J.H. was negative for amphetamine on October 11, 2011 and includes the notation “Ran out 8 days ago,” GX 12, at 61; on the date of this test, Respondent had last issued her an Adderall prescription on August 31, 2011, and that prescription provided her with a 30-day supply.36 As there is no evidence as to how long amphetamines would still be present in a patient's urine after the last use, no weight can be given to this testimony. What is notable, however, is that over the entire course of Respondent's prescribing to J.H., which lasted from June 10, 2010 through August 12, 2012, Respondent conducted only three urine tests, with the last one being done on November 15, 2011. GX 12, at 61.

    36 According to the ALJ, the parties stipulated that Respondent issued a prescription for 60 Adderall 10 on October 1, 2011. ALJ Ex. 50, at 5. However, the patient file does not contain a prescription for this date (as opposed to October 11, 2011) and the MAPS report which the Government obtained does not list any Adderall/amphetamine prescription as having been issued between August 31 and October 11, 2011. GX 24, at 12-13.

    Notwithstanding that no weight can be given to Dr. Mitchell's testimony regarding the October 11, 2011 drug tests, I find that the evidence otherwise supports a finding that Respondent provided J.H. with controlled substance prescriptions which lacked a legitimate medical purpose and were issued outside of the usual course of professional practice. 21 CFR 1306.04(a). As the evidence shows, while Respondent knew that J.H. was dependent on narcotics, he: (1) Did not require her to sign an opioid agreement; (2) did not obtain a MAPS report on her until two years after he determined that she was dependent; (3) conducted only three drug tests over the course of the 26 months that he prescribed to her; (4), did not refer her to treatment when she was suffering from withdrawal even though he had given her a 30-day methadone prescription only five days earlier and continued to prescribe methadone to her; and (5) repeatedly prescribed both alprazolam and clonazepam to her, even after she had told him that she did not like the way the Xanax (alprazolam) made her feel.

    Concluding its direct examination, the Government asked Dr. Mitchell: “Of the prescriptions that we have discussed today, are there any that you've found to be legitimate, issued for [a] legitimate purpose or within the usual practice of medicine?” Tr. 356. Dr. Mitchell answered: “Not for the controlled substances.”Id.

    Respondent's Testimony

    Respondent testified on his own behalf. According to Respondent, he graduated from medical school in Damascus, Syria in 1993, and after moving to the United States, he did an internal medicine residency which he completed in 2002. Tr. 469. Thereafter, Respondent started practicing at nursing homes and assisted living facilities and also worked as an urgent care and ER physician. Id.; see also RX J. Respondent did this until 2009 when he purchased a “very small practice” of 120 patients in Davidson, Michigan from a retired physician. Tr. 470. Respondent testified that in the meantime he studied hospice and palliative medicine and became board certified in 2012. Id. at 469. On some date which Respondent did not specify, Respondent also began working at a medical practice in Lapeer, Michigan, which had 150 patients. Id. at 471.

    According to Respondent, when he started his internal medicine practice, he “did not expect this influx of chronic pain patient[s], and . . . was not planning to have a clinic for chronic pain patients.” Id. at 482. While addressing the DI's testimony regarding the statements he made in the 2013 interview, Respondent offered various statements regarding the “general” “way” in which he practices medicine. Id. at 484. Specifically, he testified that in 2011 and 2012, “we start to do it [i.e., obtain MAPS reports] more often, but definitely not in every visit.” Id. at 482. He further asserted that “we do referral [of] patients for diagnostic, for another specialty, depends on their need.” Id. He also asserted that he attempts to control his patients' symptoms, while “try[ing] to taper them off the medication, if possible, while they are getting another treatment like the physical therapy or going to the pain management, some going to counseling.” Id. at 484.

    As found above, Respondent acknowledged that he had “listened to all of” Dr. Mitchell's testimony. Id. Respondent then testified that Dr. Mitchell was “right” about his having ignored the red flags that the five patients were diverting or abusing drugs. Id.

    Respondent further testified that he had reviewed multiple online Continuing Medical Education courses,37 and that the week before the hearing, he attended a three-day “course about prescribing medication and dealing with the addicted patients.” Id. at 486, 495. He also stated that he was referring his patients who have chronic pain to “pain management.” Id. at 496. However, he then testified that it takes six to twelve weeks for a patient to obtain an appointment with pain management in the Lapeer, Michigan area and that in the meantime, he has “to continue the patient's treatment.” 38 Id.

    37 However, it is unclear the extent to which these courses actually addressed the prescribing of controlled substances and the monitoring of patients for abuse and diversion. While Respondent also testified that he has subscribed to Audio Digest, a CME program which provides lessons on a CD with a questionnaire, he then acknowledged that this program “[h]as nothing to do with” his prescribing practices and involves “medical education in general internal medicine.” Tr. 504-05.

    38 Following his testimony regarding his referring his chronic pain patients to pain management, Respondent's counsel asked him if he had also employed “some outside help to do criminal background checks of [his] existing patients, look at your current policies and procedures as they relate to pharmaceuticals that,” at which point the transmission cut out. Tr. 497-98. When, however, the transmission was re-established, Respondent's counsel asked only: “Did you make any efforts to hire outside consultants to come and make some recommendations regarding your office?” Id. at 498.

    Respondent further asserted that “[s]ince the interview on the show cause, it came to [his] attention some wrong way in doing and dealing with patients” and he “went back and review[ed] what he's been doing and inquire[d].” Id. at 495. He also testified that he had invested in electronic medical records because with three offices, it was a “major problem . . . following the patients.” Id. He also hired a consultancy to review his practice's policies and procedures which met with his employees and discussed issues such as “communicat[ing] with the patients, keeping their records, follow[ing] their records, referring the patients, and talking to the families and patients.” 39 Id. at 499. Finally, Respondent bought a safe. Id.

    39 This, however, did not occur until mid-September 2014. Tr. 509.

    On cross-examination, Respondent further asserted that after being served with the Show Cause Order, he started doing more frequent drug screening “to identify any problematic patients.” Id. at 512. However, he also explained that “before we tried to do drug screening but it was very expensive for the patient because [it was] not covered” by a local insurance plan. Id. Moreover, he offered no further detail as to how frequent the screenings were.

    Asked whether, in the period 2010-2012, he believed that doctors should not prescribe controlled substances to patients who are abusing or diverting them, Respondent testified: “If it is a proof they are abusing or diverting, yes.” Id. at 520. Asked to explain what he meant by proof of abuse and diversion, Respondent answered:

    Well, counseling the patient in the room and talking to them about their pain and their using their pain medication and the way, and what is their answer, for me I will take whatever the patient tell me.

    If they said no, they are not abusing the medication, they are not diverting the medication, and I am entitled to treat their symptoms and make sure they are not going in withdrawal and take care of the patient.

    Id. at 521. Asked whether he believed this today as much as he did in the 2010-2012 period, Respondent answered: “[y]es.” Id.

    The Government then asked Respondent whether he “believe[s] that doctors should detect when patients are abusing or diverting controlled substances?” Id. Respondent's counsel objected, on the ground that it was outside the scope of his direct examination and the ALJ sustained the objection.40 Id. at 522. So too, when the Government asked Respondent if “[d]octors should respond to red flags of abuse and diversion of controlled substances,” Tr. 526, Respondent objected, and the ALJ sustained the objection. Id.

    40 When the Government attempted to re-ask the question, Respondent's counsel again objected on the ground that because Respondent has testified that Dr. Mitchell was correct in his criticism of his practice, “how much stronger can we say that we adopt Dr. Mitchell's testimony as to us ignoring those red flags and prescribing in the face of those.” Tr. 524. The ALJ against sustained the objection.

    Next, the Government asked Respondent: “[w]hat are the signs for abuse and diversion of controlled substances?” Id. Respondent's counsel objected. After the ALJ overruled the objection, Respondent testified: “[w]hat do you mean diversion exactly?” Id. This prompted the ALJ to instruct Respondent that “if you don't know how to answer the question, just tell me that you don't know.” Id. Respondent answered: “I do not.” Id.

    The Government then asked Respondent what signs he looks for to see if a patient is abusing medication. Id. at 527-28. Respondent answered:

    Well, if they're using, now a patient if he is taking the pain medication and they have extra pain and taking medication, extra pill or extra two, this is a view that what you intend that it is abusing, well, it's still a pain medication they are using to control their symptoms. I don't understand what exactly what answer you want for that.

    I'm telling you exactly what I think. If the patient using the pain medication instructed to control their pain medication, now if they come earlier to take medication that's if they have a chronic problem and they need it, somebody can call them abusing, some people calling them they are controlling their pain symptoms.

    Id.

    After again admitting that he “did not pay attention too much to this [sic] signs with the red flags and things,” id., Respondent asserted that in determining whether patients are abusing controlled substances, “[w]e do the drug screen” and “[w]e run a MAP with the electronic medical records if they are taking the medication the right way and taking the other alternative medications.” Id. at 529. Asked by the ALJ how he is now treating pain management patients, Respondent explained that if patients “ask for more medication or [to] change to a specific medication and . . . looking in the drugs screen, if they are utilizing the medication.” Id. After apparently more telephonic interference, Respondent added that when patients ask for an early refill or a different medication or to increase their pain medication, “to confirm we'll do the drug screen and we'll run the MAP.” Id. at 531.41

    41 The Government then asked Respondent what steps “a doctor should and could take in response to any signs that a patient is abusing their controlled substance medications?” Id. at 531-32. The ALJ sustained Respondent's objection stating that he had “a record of that.” Id. at 532.

    After confirming that Respondent was adhering to his earlier testimony that Dr. Mitchell was correct that he had ignored red flags of abuse and diversion, the Government asked Respondent whether he also agreed with Dr. Mitchell's testimony that he had “issued prescriptions outside of the usual course of practice or for nonlegitimate medical purposes?” Id. at 534. Respondent's counsel objected, asserting that “[w]e've said everything Dr. Mitchell has said about prescribing in the face of red flags is correct.” Id. at 535. The ALJ did not, however, rule on the objection. See id. Instead, the ALJ asked Respondent if he had read the Show Cause Order, and after Respondent acknowledged that he had, the ALJ asked if he “agree[d] that the facts that they allege there are all true?” Id. Respondent answered “[y]es.” Id. 42

    42 Subsequently, during a colloquy with the ALJ as to whether it could cross-examine Respondent regarding the specific prescriptions discussed by Dr. Mitchell and whether he agreed with Dr. Mitchell's testimony that the prescriptions “were issued illegitimately and outside of the usual course,” the Government observed that Respondent was shaking his head; the Government thus argued “that there is some ambiguity as to whether or not he's really admitting that he has actually issued those unlawfully.” Tr. 538-39. The ALJ explained: “[n]ot according to my record” and that he had seen “the shaking of the head.” Id. at 539. The record does not, however, reflect the manner in which Respondent shook his head, and notwithstanding the tenor of the Government's statement, I am not free to speculate as to whether Respondent was disputing or acknowledging that he acted unlawfully.

    Notably, in his Post-Hearing Brief, Respondent states that Dr. Mitchell's testimony establishes that he “wrote a substantial number of prescriptions . . . without a legitimate medical purpose and/or in the usual course of a practitioner's professional practice and/or in the face of paradigmatic `red flags' of diversion or abuse such as repeated requests for early refills, facially-evident documentation of doctor shopping, and testing results inconsistent with use of the prescribed controlled substances.” Resp. Post-Hrng Br. at 12.

    Discussion

    As noted above, both parties filed exceptions to the ALJ's Recommended Decision. Having reviewed their briefs, I conclude that some of their exceptions are best addressed prior to discussing whether the Government is entitled to prevail under the public interest standard. These include Respondent's contention that the ALJ committed prejudicial error when he barred him from cross-examining the Diversion Investigator regarding the use of confidential informants. See Resp. Exceptions, at 9-12. As for the Government, it argues that the ALJ erred when he allowed Respondent to present his case by VTC. Gov. Exceptions, at 3-9.

    Respondent's Exception to the ALJ's Ruling Limiting Cross-Examination

    As found above, at the hearing, a DEA Diversion Investigator testified regarding the investigation she conducted of Respondent's prescribing practices. On cross-examination, Respondent's counsel attempted to question the DI about two undercover agents who, according to the proffer, went to Respondent, and while posing as patients, attempted to entice him to prescribe controlled substances in exchange for cash. Tr. 222. The Government objected to this line of questioning, arguing that the evidence “was not offered as part of the basis for the order to show cause.” Id.

    In response to the objection, Respondent argued that the Agency “is required to consider not just the evidence that [the Government] brought in on the direct, but evidence that we can bring out on cross examination.” Id. Respondent then proffered that Respondent told the undercover agents that “he would not” prescribe to them. Id. Respondent argues that this “is exculpatory” because Respondent “had no idea who he was talking to” and this evidence “would be very relevant to [assessing] his state of mind.” Id. at 222-23.

    The ALJ sustained the objection, on the ground that Respondent had failed to disclose in advance of the hearing that he “wanted to cover this subject.” Id. at 223. Continuing, the ALJ explained that “[i]f you knew about these things, and you wanted me to consider them, then you had a duty and the opportunity to come forward and tell me. And I saw nothing like that in your pre-hearing statements, or that of prior counsel.” Id. at 223-24.

    Respondent then argued that his counsel had not had “the time that the Government had to prepare” for the hearing and that there was no prejudice to the Government, because “these are their witnesses.” Id. at 224-25. The ALJ rejected the contention, explaining that “you had knowledge of this undercover operation. If you wanted to bring it to my attention, you clearly had it for a while.” Id. at 226.43

    43 The record shows that Respondent became aware that two undercover officers had visited Respondent from the return of the state search warrant which listed the two officers' files as being among the items seized. Resp. Ex. A, at 7. However, the return was executed on March 27, 2013, id. at 6; which was well in advance of the hearing.

    Even assuming that the Government's direct examination of the DI as to what steps she took in investigating Respondent opened the door to this line of inquiry, the ALJ did not abuse his discretion in sustaining the Government's objection. See Gunderson v. Department of Labor, 601 F.3d 1013, 1021 (10th Cir. 2010) (applying abuse of discretion standard in reviewing ALJ's exclusion of evidence); Walter A. Yoder & Sons, Inc. v. NLRB, 754 F.2d 531, 534 (4th Cir. 1985) (applying abuse of discretion standard in reviewing ALJ's decision to limit cross-examination). Moreover, the warrant return listed the actual names (as well as the undercover names) of both undercover officers. Thus, Respondent had ample opportunity to present this evidence either through calling the undercover officers to testify or by introducing any documentation he placed in their respective patient files regarding the incidents. See Randall L. Wolff, 77 FR 5106, 5120 n.23 (2012).

    To be sure, DEA has recognized that in some instances, evidence of “prior good acts” can refute evidence that a registrant knowingly or intentionally diverted controlled substances. See Jayam Krishna-Iyer, 74 FR 459, 462 n.6 (2009). Here, however, the Government put forward extensive evidence to show that Respondent acted with the requisite knowledge to support the conclusion that he lacked a legitimate medical purpose and acted outside of the usual course of professional practice and thereby violated the CSA on some 100 occasions when he prescribed to the five patients. See 21 CFR 1306.04(a); see also 21 U.S.C. 841(a)(1). Moreover, even if Respondent's testimony regarding Dr. Mitchell's criticism of his prescribing practices was ambiguous as to whether he was also admitting that he violated 21 CFR 1306.04(a), his post-hearing brief has resolved the issue. Accordingly, even if I had found that the ALJ abused his discretion in not permitting Respondent to cross-examine the DI about the two undercover visits, I would still conclude that this does not rise to the level of prejudicial error. See Gunderson, 601 F.3d at 1021(“An error is prejudicial only `if it can be reasonably concluded that with . . . such evidence, there would have been a contrary result.' ”) (quoting Sanjuan v. IBP, Inc., 160 F.3d 1291, 1296 (10th Cir. 1998)); see also Air Canada v. Department of Trans., 148 F.3d 1142, 1156 (D.C. Cir. 1998) (“As incorporated into the APA, the harmless error rule requires the party asserting error to demonstrate prejudice from the error.”) (citing 5 U.S.C. 706).

    In his Exceptions, Respondent further notes that the ALJ “frames this issue as one `regarding arguably exculpatory evidence that has been withheld by the Government.' ” Exceptions, at 9 (citing R.D. at 60-62). He then states that he adopts and incorporates by reference the ALJ's view, and requests that I consider it as a separate argument.

    Therein, the ALJ noted that the Agency has not adopted “[t]he rule from Brady v. Maryland,” 373 U.S. 83, 87 (1963), which requires the prosecution in a criminal case to disclose material exculpatory evidence to the defendant. R.D. at 61. Citing MacKay v. DEA, 664 F.3d 808, 819 (10th Cir. 2011), the ALJ correctly noted that “even if Brady did apply in this case, the excluded evidence would have no outcome [sic] on my final recommendation.” R.D. at 62. The ALJ nonetheless proceeded to discuss several cases in which other ALJs had either: (1) Ordered the Government to review its files for exculpatory evidence, or (2) suggested that DEA should provide for disclosure of exculpatory evidence because three other federal agencies provide for such disclosure. Id. The ALJ noted that the Agency has held that there is “`an ongoing duty to ensure that material evidence and argument made to a fact-finder is not knowingly contradicted by other material evidence in the Government's possession, but not otherwise disclosed.” Id. (quoting Randall L. Wolff, 77 FR 5106, 5124 (2012)). However, based on an earlier case in which the Agency held that an ALJ did not have authority to require the Government to “disclose any exculpatory information in its possession when such information is timely requested by a respondent,” see Nicholas A. Sychak, 65 FR 75959, 75960-61 (2000), the ALJ opined “that the DEA's view of releasing exculpatory evidence is `just trust me.' ” R.D. at 62.

    Unacknowledged by the ALJ is that several federal appeals courts have held that Brady does not apply to administrative proceedings. See Mister Discount Stockbrokers, Inc. v. SEC, 768 F.2d 875, 878 (7th Cir. 1985); NLRB v. Nueva Eng. Inc., 761 F.2d 961, 969 (4th Cir. 1985). Cf. Echostar Comm. Corp. v. FCC, 292 F.3d 749, 755-56 (D.C. Cir. 2002) (rejecting litigant's claim that “the Agency's decision to deny it discovery . . . denied it due process”); Silverman v. CFTC, 549 F.2d 28, 33 (7th Cir. 1977) (“There is no basic constitutional right to pretrial discovery in administrative proceedings.”) (citations omitted).

    Instead, this Agency follows the holding of McClelland v. Andrus, 606 F.2d 1278 (D.C. Cir. 1979). Therein, the D.C. Circuit held that “discovery must be granted [in an administrative proceeding] if in the particular situation a refusal to do so would so prejudice a party as to deny him due process.” Id. at 1285-86; see also Margy Temponeras, 77 FR 45675, 45676 n.4 (2012); Beau Boshers, 76 FR 19401, 19403-04 (2011). However, “the party seeking discovery must rely on more than speculation and must show that the evidence is relevant, material, and that the denial of access to the [evidence] is prejudicial.” Boshers, 76 FR at 19403 (citing Echostar, 292 F. 3d at 756; Silverman v. CFTC, 549 F.2d 28, 34 (7th Cir. 1977)). As explained previously, while evidence that Respondent refused to prescribe controlled substances to the undercover officers is relevant and material in assessing his experience as a dispenser of controlled substances, in light of his concession that he knowingly diverted controlled substances some 100 times to the five patients, he cannot show prejudice.44 I thus reject the exception.45

    44 It is noted that Respondent requested that the ALJ provide him with a copy of the Agency's investigative files on him; the ALJ correctly held that he had no power to compel the Agency to provide Respondent with its investigative files. ALJ Ex. 3, at 5.

    45 I have considered the Government's Exception regarding the ALJ's decision to allow Respondent to present his case by Video Teleconferencing technology. While I acknowledge that technical difficulties caused a number of interruptions during the hearing in this matter, the record nonetheless contains overwhelming evidence supporting my Decision and Order.

    Discussion

    Section 304(a) of the Controlled Substances Act (CSA) provides that a registration to “dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a)(4) (emphasis added). With respect to a practitioner, the Act requires the consideration of the following factors in making the public interest determination:

    (1) The recommendation of the appropriate State licensing board or professional disciplinary authority.

    (2) The applicant's experience in dispensing . . . controlled substances.

    (3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.

    (4) Compliance with applicable State, Federal, or local laws relating to controlled substances.

    (5) Such other conduct which may threaten the public health and safety.

    Id. 823(f).46

    46 Section 304(a) also provides that a registration to “dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has had his State license or registration suspended, revoked, or denied by competent state authority and is no longer authorized by State law to engage in the manufacturing, distribution, or dispensing of controlled substances.” 21 U.S.C. 824(a)(3). Likewise, the CSA defines “[t]he term `practitioner' [to] mean[ ] a physician . . . licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices . . . to distribute, dispense, [or] administer . . . a controlled substance in the course of professional practice.” 21 U.S.C. 802(21). See also id. § 823(f) (“The Attorney General shall register practitioners . . . to dispense . . . controlled substances in schedule II, III, IV, or V . . . if the applicant is authorized to dispense controlled substances under the laws of the State in which he practices.”).

    “[T]hese factors are . . . considered in the disjunctive.” Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I “may rely on any one or a combination of factors, and may give each factor the weight [I] deem[ ] appropriate in determining whether a registration should be revoked.” Id.; see also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to consider each of the factors, I “need not make explicit findings as to each one.” MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).47

    47 In short, this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant's misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration. MacKay, 664 F.3d at 821.

    The Government has the burden of proving, by a preponderance of the evidence, that the requirements for revocation or suspension pursuant to 21 U.S.C. 824(a) are met. 21 CFR 1301.44(e). However, “once the [G]overnment establishes a prima facie case showing a practitioner has committed acts which render his registration inconsistent with the public interest, the burden shifts to the practitioner to show why his continued registration would be consistent with the public interest.” MacKay, 664 F.3d at 817 (citing Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008) (citing cases)).

    In this matter, the Government's evidence focused on factors two, four, and five. Having reviewed the record in its entirety and having considered all of the factors, I find that the Government's evidence with respect to factors two and four satisfies its prima facie burden of showing that Respondent has committed acts “which render his registration . . . inconsistent with the public interest.” 21 U.S.C. 824(a)(4).

    Factors Two and Four—Respondent's Experience in Dispensing Controlled Substances and Compliance With Applicable Laws Related to Controlled Substances

    Under a longstanding DEA regulation, a prescription for a controlled substance is not “effective” unless it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a). Continuing, the regulation provides that “an order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of [21 U.S.C. 829] and . . . the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.” Id.

    As the Supreme Court has explained, “the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.” Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)).

    Both this Agency and the federal courts have held that establishing a violation of the prescription requirement “requires proof that the practitioner's conduct went `beyond the bounds of any legitimate medical practice, including that which would constitute civil negligence.' ” Laurence T. McKinney, 73 FR 43260, 43266 (2008) (quoting United States v. McIver, 470 F.3d 550, 559 (4th Cir. 2006)). See also United States v. Feingold, 454 F.3d 1001, 1010 (9th Cir. 2006) (“[T]he Moore Court based its decision not merely on the fact that the doctor had committed malpractice, or even intentional malpractice, but rather on the fact that his actions completely betrayed any semblance of legitimate medical treatment.”).

    Thus, in Moore, the Supreme Court reinstated the conviction of a physician under 21 U.S.C. 841(a)(1) and what is now 21 CFR 1306.04(a) for prescribing controlled substances outside of the usual course of professional practice. 423 U.S. at 139-43. The Court explained:

    The evidence presented at trial was sufficient for the jury to find that respondent's conduct exceeded the bounds of “professional practice.” As detailed above, he gave inadequate physical examinations or none at all. He ignored the results of the tests he did make. He did not give methadone at the clinic and took no precautions against its misuse and diversion. He did not regulate the dosage at all, prescribing as much and as frequently as the patients demanded. . . . In practical effect, he acted as a large scale “pusher”—not as a physician.

    Id. at 142-43.

    Under the CSA, it is fundamental that a practitioner must establish a bona fide doctor-patient relationship in order to act “in the usual course of . . . professional practice” and to issue a prescription for a “legitimate medical purpose.” See, e.g., Moore, 423 U.S. at 142-43; United States v. Lovern, 590 F.3d 1095, 1100-01 (10th Cir. 2009); United States v. Smith, 573 F.3d 639, 657 (8th Cir. 2009); Jack A. Danton, 76 FR 60900, 60904 (2011) (finding violations of 21 CFR 1306.04(a) “where a physician has utterly failed to comply with multiple requirements of state law for evaluating her patients and determining whether controlled substances are medically indicated and thus has ` “completely betrayed any semblance of legitimate medical treatment” ' ”) (quoting McKinney, 73 FR at 43266 (quoting Feingold, 454 F.3d at 1010)).

    However, while the Government frequently relies on a physician's failure to establish a bona-fide doctor-patient relationship to prove a violation of 21 CFR 1306.04(a), no “specific set of facts ha[s] to be present in order to find that a physician stepped outside of his role and issued prescriptions without a legitimate medical purpose.” United States v. McKay, 715 F.3d 807, 823 (10th Cir. 2013). Thus, as the Tenth Circuit explained, the question is whether sufficient evidence “exist[s] for a fact finder to affirmatively determine that the physician issued the drugs for an improper purpose.” Id.

    As found above, Dr. Mitchell offered extensive and uncontested testimony that included identifying specific acts and omissions by Respondent, which support the conclusion that Respondent acted outside of the usual course of professional practice and without a legitimate medical purpose when he prescribed controlled substances to each of the five patients. He also opined that none of the prescriptions he discussed complied with 21 CFR 1306.04(a). Tr. 356.

    In his post-hearing brief, Respondent states that Dr. Mitchell's testimony establishes that he “wrote a substantial number of prescriptions . . . without a legitimate medical purpose and/or in the usual course of a practitioner's professional practice and/or in the face of paradigmatic `red flags' of diversion or abuse such as repeated requests for early refills, facially-evident documentation of doctor shopping, and testing results inconsistent with use of the prescribed controlled substances.” Resp. Proposed Recommended Rulings, Findings of Fact and Conclusions of Law, at 12. Respondent, however, also attempts to portray himself as a soft touch, suggesting that it is “culturally ingrained” that he could “not say no” to patients, and that he prescribed “with some naivety and perhaps even full-blown gullibility,” which was “laid bare when the size of his practice grew exponentially faster than he and his staff” were capable of managing. Respondent's Post-Hrng. Submission, at 1-2. See also id. (“These proceedings have also opened [his] eyes to the fact that his knowledge and experience as a medical practitioner contained gaps that proved easy to exploit.”).

    The ALJ embraced this argument. See R.D. at 43 (quoting Resp. Post-Hrng. Submission, at 2) (Respondent's “lack of knowledge, experience, and familiarity with accepted protocols for prescribing controlled substances, combined with some naivety and perhaps full-blown gullibility, where laid bare when the size of his practice great exponentially faster. . . .”); see also id. at 43-44 (“Here, it appeared [Respondent] became a very popular weak link used by those seeking to circumvent [controlled substance prescribing] protocols.”). The ALJ also stated his agreement “with the proposition appearing in [his] post-hearing brief that `his practice did not consist of a “pill mill”' and that however misguided, he was nevertheless treating his patients, not merely processing their prescriptions in furtherance of a larger criminal enterprise.” R.D. 47 (quoting Resp. Prop. Recommended Rulings, etc., at 12) (first emphasis added; second emphasis in original). See also id. at 44 (“I found no evidence to suggest the failures in his practice were the results of avarice or greed . . . .”).

    Contrary to the ALJ's understanding, the Government was not required to prove that Respondent was motivated by avarice or greed to establish a violation of 21 CFR 1306.04(a) and 21 U.S.C. 841(a)(1). Nor did the ALJ reconcile the inconsistency between his findings that that Respondent violated 21 CFR 1306.04(a) with respect to each of the patients—findings which establish that he knowingly diverted drugs—with his embrace of Respondent's claim that he was merely naïve and gullible. Indeed, Respondent offered no testimony to support the claims made in his brief that he prescribed out of naivety or gullibility, or that his inability to say no was “culturally ingrained.”

    As for the ALJ's embrace of Respondent's claim that he was not running a pill mill and was treating his patients, to be sure, there is some evidence that Respondent referred patients for MRIs, a sleep study, and alternative treatments such a chiropractor and physical therapy. However, the overwhelming weight of the evidence shows that Respondent issued the prescriptions knowing that the patients were either abusing or diverting the drugs.

    With respect to R.E.H., Dr. Mitchell found Respondent's initial evaluation to be inadequate based on Respondent's failure to adequately develop his substance abuse history and how much methadone he was currently taking. He further found that Respondent did not perform an adequate physical examination. He therefore concluded that Respondent acted outside of the usual course of professional practice in issuing the initial methadone prescriptions. Based on this testimony, I find that Respondent did not establish a bona fide doctor-patient relationship and I further conclude that at no point in the course of his treatment of R.E.H. did Respondent do so.

    Dr. Mitchell further described a plethora of instances in which Respondent provided R.E.H. with early refills and failed to document that he had engaged R.E.H. as to why he needed the early refills. Dr. Mitchell pointed out that Respondent failed to enforce his medication contract which required R.E.H. to use his medicine only at the prescribed rate. He also pointed out that Respondent continued to prescribe without obtaining urine samples, and only rarely obtained a MAPS report. Moreover, even when he did obtain and review a MAPS report, the MAPS report showed that R.E.H. had filled the same prescriptions at different pharmacies, and yet Respondent failed to even address R.E.H.'s behavior and continued to prescribe methadone to him. So too, Respondent was notified on multiple occasions that R.E.H. was trying to fill multiple prescriptions and presenting forged prescriptions, and yet did nothing to address this obvious drug-seeking behavior and continued to prescribe to him. Finally, even after he received a report that R.E.H. had tested positive for cocaine and was diagnosed as polysubstance dependent, he continued to prescribe to R.E.H. In short, given the numerous times that R.E.H. sought early refills, coupled with the information Respondent obtained from MAPS reports, pharmacies and the hospital, Respondent cannot credibly argue that he was merely gullible or naïve. Rather, Respondent knowingly diverted controlled substances to R.E.H.

    The same holds true with respect to Respondent's prescribings to J.W. Here too, Dr. Mitchell testified that there was no clinical basis to diagnose J.W. with a condition that would support prescribing both Adderall and methadone. He also testified that it was inappropriate to prescribe methadone on a PRN basis. Moreover, Respondent ignored evidence that J.W. was obtaining Adderall from another physician, in violation of the medication contract, as well as that J.W. was obtaining Suboxone from the other physician. J.W. also sought early refills on multiple occasions, yet Respondent continued to prescribe to him.

    Also, the same day that Respondent was informed that J.W. was in the county jail, Respondent obtained a MAPS report which showed that J.W. had continued to obtain controlled substances for Suboxone and Adderall from another doctor at the same time he was obtaining prescriptions from Respondent. Moreover, Respondent was notified by J.W.'s niece that her uncle was selling his medications. Yet notwithstanding this information, after J.W. was released from jail, Respondent eventually resumed prescribing controlled substances to him. Here again, the evidence amply refutes the contention that Respondent was merely gullible or naïve.

    With respect to R.K., the evidence showed that Respondent issued multiple prescriptions for Xanax, which frequently authorized multiple refills, resulting in R.K. obtaining, in a nine-month period, approximately 1,000 pills more than were necessary based on Respondent's dosing instructions. Given that R.K.'s chart contained copies of the prescriptions, Respondent cannot credibly argue that he was duped by R.K. into issuing the excessive prescriptions. Also, while Respondent prescribed methadone to R.K., on two occasions, R.K. tested negative for the drug, stating after the first test that he had run out a week earlier, and after the second, stating that he had run out several days earlier. Yet there was no documentation that R.K. had undergone withdrawal, this being a clear indication that R.K. was diverting the drug. Respondent continued to prescribe the drug to R.K. (going so far as to double the strength after the first negative test) and did not subject him to any more drug tests after the second test. The evidence thus shows that Respondent was willfully blind to what R.K. was doing with the drugs. Moreover, Dr. Mitchell testified that there was no medical evidence to support the methadone prescriptions. Here again, the evidence amply refutes the contention that Respondent issued the prescriptions because he was gullible or naïve.

    Respondent knew that R.J.H. had a history of drug abuse. Yet over the course of just six weeks, Respondent quadrupled R.J.H.'s daily dosage of methadone with no medical justification. Moreover, within three months of R.J.H.'s seeing Respondent, R.J.H. had twice claimed that his prescriptions were stolen, and the day before the second such incident, Respondent's office had been told by another patient that R.J.H. was selling his prescription and using his girlfriend's medication. Yet Respondent issued him another prescription and continued to prescribe methadone to him, even though R.J.H. sought early refills. Here again, the evidence refutes Respondent's contention that he issued the prescriptions because he was gullible or naïve.

    So too, the evidence with respect to J.H. refutes Respondent's claim that he was gullible or naïve. Here the evidence shows that only five days after Respondent issued her a prescription for a 30-day supply of methadone, she was suffering from narcotic withdrawal. Yet, instead of sending her for treatment, Respondent continuing prescribing controlled substances to her. Moreover, over the course of his treatment of J.H., on multiple occasions, Respondent prescribed either alprazolam or clonazepam to her, both being benzodiazepines, even though he had recently prescribed the other drug to her. Also, even after J.H. reported that she did not like how alprazolam made her feel, he still issued her more prescriptions for the drug. So too, even after J.H. tested negative for Adderall, he issued her a new prescription for the drug. Finally, over the course of the 26 months Respondent treated her, he only drug tested her three times, with all three tests occurring in a three-month period. I thus conclude that Respondent knew or was willfully blind to the fact that J.H. was either abusing or diverting her drugs to others.

    In addition to his issuance of numerous unlawful prescriptions, Respondent also violated federal law by writing a methadone prescription for R.E.H. which he dated as having been issued on November 8, 2012, when he likely issued it on October 30, 2012. Notably, the evidence shows that on October 8, 2012, Respondent issued R.E.H. a methadone prescription, which R.E.H. filled the same day. GX 15, at 135-36. The evidence also shows that on October 30, R.E.H. was seeking more methadone and his medical record states that it was not time yet and includes a copy of a prescription bearing an issue date of November 8, 2012. GX 8, at 15; id. at 31. The evidence further shows that a second prescription with an issue date of October 8, 2012 (which appears to have been altered) was filled on October 30, 2012. GX 15, at 137-38; GX 20, at 14. Moreover, there are no notes corresponding to a visit by R.E.H. on November 8, 2012, and the MAPS data contains no entry for a methadone prescription with an issue date of November 8, 2012. See GX 8, at 15; id. at 99-100; see also GX 20.

    Under a DEA regulation, “[a]ll prescriptions for controlled substances shall be dated as of, and signed on, the day when issued.” 21 CFR 1306.05(a). Based on Respondent's failure to address the DI's testimony regarding this prescription and there being no evidence that R.E.H. saw Respondent on November 8, 2012, I find that Respondent violated this regulation when he post-dated the prescription.48

    48 Even if it was R.E.H. who altered the date to “10/08/12,” if Respondent's intent was to provide R.E.H. with a prescription that he could not fill until November 8, than he should have written on the prescription “the earliest date on which a pharmacy” could fill it. 21 CFR 1306.12(b)(ii). In any event, Respondent was still required to date the prescription as of the date he issued it.

    The evidence also shows that Respondent repeatedly failed to include the patients' addresses on their prescriptions. See, e.g., GX 8, at 21, 23, 27-38, 40-42, 52, 54-57, 64, 233, 240, 248-49, 253-54 (Pt. R.E.H.); see also GX 9, at 5-6, 45, 54, 57-59, 61-63, 68 (Pt. J.W.). This too is a violation of 21 CFR 1306.05(a).

    Finally, the evidence shows that on several occasions, Respondent issued prescriptions that authorized six refills. GX 8, at 23 (Xanax Rx issued to R.E.H.); GX 17, at 49 (Xanax Rx issued to R.K.); GX 19, at 117 (Klonopin Rx issued to J.H.). Respondent violated DEA regulations when he issued the prescriptions because, with respect to schedule III and IV controlled substances, a prescription may not “refilled more than five times.” 21 CFR 1306.22(a).

    Accordingly, I find that the Government's evidence with respect to Factors Two and Four conclusively establishes that Respondent has committed such acts as to render his registrations “inconsistent with the public interest.” 21 U.S.C. 824(a)(4); see also id. § 823(f). I further conclude that his misconduct is especially egregious and supports the revocation of his existing registrations and the denial of his pending applications.

    Moreover, while the Government put on no evidence as to Factor One—the recommendation of the state licensing board—in response to my November 10, 2015 order, the Parties have acknowledged that on October 30, 2015, the Michigan Board of Medicine revoked Respondent's medical license and that he is longer legally authorized to dispense controlled substances in the State in which he is registered and seeks additional registrations.49

    49 No evidence was presented regarding Factor Three—Respondent's conviction record for offenses related to the manufacture, distribution or dispensing of controlled substances. However, the Agency has held that the absence of a conviction is not dispositive of the public interest inquiry. Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied, MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011). As for Factor Five, as explained above, the Government did not take exception to the ALJ's findings regarding the allegation that Respondent made various false statements in the interview.

    Sanction

    Under Agency precedent, where, as here, “the Government has proved that a registrant has committed acts inconsistent with the public interest, a registrant must “ `present sufficient mitigating evidence to assure the Administrator that [he] can be entrusted with the responsibility carried by such a registration.” ' ” Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988))). “Moreover, because `past performance is the best predictor of future performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995), [DEA] has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for [his] actions and demonstrate that [he] will not engage in future misconduct.” Medicine Shoppe, 73 FR at 387; see also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. DEA, 419 F.3d at 483 (“admitting fault” is “properly consider[ed] ” by DEA to be an “important factor[ ]” in the public interest determination).50

    50 However, while a registrant must accept responsibility and demonstrate that he will not engage in future misconduct in order to establish that his/her continued registration is consistent with the public interest, DEA has repeatedly held these are not the only factors that are relevant in determining the appropriate sanction. See, e.g., Joseph Gaudio, 74 FR 10083, 10094 (2009); Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007). Obviously, the egregiousness and extent of a registrant's misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19386, 19387-88 (2011) (explaining that a respondent can “argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation”); Paul H. Volkman, 73 FR 30630, 30644 (2008); see also Paul Weir Battershell, 76 FR 44359, 44369 (2011) (imposing six-month suspension, noting that the evidence was not limited to security and recordkeeping violations found at first inspection and “manifested a disturbing pattern of indifference on the part of [r]espondent to his obligations as a registrant”); Gregory D. Owens, 74 FR 36751, 36757 n.22 (2009).

    The Agency has also held that “ `[n]either Jackson, nor any other agency decision, holds . . . that the Agency cannot consider the deterrent value of a sanction in deciding whether a registration should be [suspended or] revoked.' ” Gaudio, 74 FR at 10094 (quoting Southwood, 72 FR at 36504); see also Robert Raymond Reppy, 76 FR 61154, 61158 (2011); Michael S. Moore, 76 FR 45867, 45868 (2011). This is so, both with respect to the respondent in a particular case and the community of registrants. See Gaudio, 74 FR at 10095 (quoting Southwood, 71 FR at 36503). Cf. McCarthy v. SEC, 406 F.3d 179, 188-89 (2d Cir. 2005) (upholding SEC's express adoptions of “deterrence, both specific and general, as a component in analyzing the remedial efficacy of sanctions”).

    The ALJ found that Respondent “failed to take the full and unconditional acceptance of responsibility required by” the Agency's case law. R.D. at 55. As support for this conclusion, the ALJ noted that during his cross-examination of Dr. Mitchell, Respondent “challenged multiple aspects of the Government's evidence regarding [his] treatment of the patients that were fundamental to the Government's case against him.” Id. The ALJ also found that “Respondent's repeated and persistent pre-hearing assertions that his prescription practice was within the usual course of medical practice stand as compelling evidence that [he] had not accepted responsibility for his actions under the high standard established by the” Agency. Id. Thus, the ALJ declined to credit Respondent's testimony that he did not dispute Dr. Mitchell's criticism of his prescribing practices with respect to the five patients, notwithstanding that he characterized Respondent's testimony as “unequivocally stat[ing]” as much. Id. The ALJ did not, however, reconcile his finding with his statement during the hearing that “right now I have fairly compelling evidence that [Respondent] has accepted responsibility, even though he didn't tell me he did so or he was going to do so in his prehearing statement.” Tr. 491. Moreover, as discussed previously, because Respondent did not provide notice in his pre-hearing statements that he intended to admit to the truth of the Government's allegations, the ALJ granted the Government's motion to bar him from introducing evidence of his remedial measures.51

    51 As found above, Respondent did offer extensive testimony of his remedial measures. However, Respondent was barred from introducing testimony by a third party on the issue.

    Respondent takes exception to the ALJ's finding that he did not accept responsibility for his misconduct. Resp. Exceptions, at 2-9. He argues that the ALJ misapplied Agency precedent, “in effect penaliz[ing] him for his failure to immediately confess wrongdoing in response to naked allegations.” Id. at 4-5 n.11. Alternatively, he argues that:

    [i]f the applicable precedent really provides that the gateway to presentation of mitigation evidence requires [him to] demonstrate penitence in the form of “accepting responsibility for” conduct in which he did not engage . . . and/or to admit to counterfactual matters, e.g., that some of the prescriptions at issue were written outside of a legitimate[] physician patient relationship, then that precedent is inconsistent with procedural due process. Id. at 4; see also id. at 5 n.11 (“to the extent that the Agency concludes the [ALJ's] application was proper, however, the precedent is inconsistent with procedural due process”). Respondent thus seeks “a functional remand to allow the parties to fully develop [his] remediation evidence and to allow” for the consideration of “that evidence in assessing the appropriate sanction.” Id. at 9.

    While I find some of Respondent's arguments well taken, I reject his exception. As for the ALJ's pre-hearing ruling barring Respondent from eliciting the testimony of Ms. Richards, (who would have testified regarding a risk assessment audit and the training she provided to Respondent's staff), in his Recommended Decision, the ALJ asserted that he would have allowed Ms. Richards to testify if Respondent had “informed the Government in its prehearing statements that he acknowledged the noncompliance of his prescription practice.” R.D. at 60. However, while not mentioned in the Recommended Decision, the ALJ granted the Government's motion based also on Respondent's failure to describe Ms. Richard's testimony “with sufficient particularity.” Tr. 39 (Nov. 3, 2014). This was an independent and adequate ground to bar her testimony, and yet, Respondent does not challenge the ALJ's ruling on this basis.

    Had the ALJ's ruling barring Ms. Richard's testimony been based solely on Respondent's failure to state in his pre-hearing statements that he was acknowledging his misconduct, I would agree with Respondent. Contrary to the ALJ's understanding, although the Agency has held that proof of remedial measures is rendered irrelevant where a respondent fails to accept responsibility for his knowing or intentional misconduct, none of the cases cited by the Government or the ALJ have held that a respondent, as a condition of being able to offer evidence of his remedial measures, is required to admit to the allegations before he even has the opportunity to challenge the Government's evidence and the Agency has never held as much. Indeed, while the Agency frequently places dispositive weight on a respondent's failure to fully acknowledge his misconduct, in each of the cases cited by the ALJ, the Agency discussed the respondent's failure to acknowledge his/her/its misconduct only after discussing the evidence put forward by the Government and determining which allegations had been proved. See, e.g., Joe Morgan, 78 FR 61961, 61963 (2013) (“where the Government has proved that a respondent has knowingly or intentionally diverted controlled substances, a registrant's acceptance of responsibility is an essential showing for rebutting the Governments prima facie case)” (emphasis added); Medicine Shoppe-Jonesborough, 73 FR at 387.

    Notwithstanding that the Government provided, in its prehearing statements, notice of the evidence it intended to rely on in supporting the allegations of the Show Cause Order, Respondent was entitled to challenge the reliability of that evidence at the hearing and to show that the allegations were untrue. However, I decline to decide the question of whether it was consistent with principles of due process to require Respondent, as a condition of being able to subsequently present evidence of his remedial measures, to admit to his misconduct before it had even been proven on the record.52 Notably, while Respondent suggests that if the ALJ's reading of the Agency's precedent was correct—as explained above, it was not—“the precedent is inconsistent with procedural due process,” and the ALJ reasoned that Respondent's “concern regarding due process is not wholly unfounded,” R.D. at 56, neither Respondent nor the ALJ offered anything more than these conclusory assertions. Moreover, as explained previously, the ALJ's original ruling barring Respondent from putting on Ms. Richard's testimony was also supported by the independent basis that Respondent failed to adequately disclose the nature of her proposed testimony with sufficient particularity.53

    52 The constitutional question presented by this scenario can be avoided by waiting until the hearing itself and moving to bar or strike the testimony and evidence of remedial measures when the Respondent fails to acknowledge the misconduct proven by the Government. However, where, as here, a respondent fails to provide an adequate disclosure of its proposed evidence of its remedial measures, the Government can still move to bar the admission of the evidence prior to the hearing.

    53 In his Exceptions, Respondent “incorporates as if fully set out herein the [ALJ's] additional observations as to recent Agency precedent's misapplication of Hoxie v. DEA, 419 F.3d 477 (6th Cir. 2005).” Resp. Exceptions, at 4 n.11 (citing R.D. at 58). According to the ALJ, the Agency has been misreading the Sixth Circuit's Hoxie decision because “while admitting fault is an important factor, it is not the sole factor.” R.D. 58. The ALJ criticized the Agency's decisions in two cases, which he viewed as being “representative of the coercive pressure to either fully accept responsibility or contest all possible allegations.” R.D. 56 (discussing Jeri Hassman, M.D., 75 FR 8194 (2010), and George Mathew, M.D., 75 FR 66138 (2010)). According to the ALJ, his discussion was “intended to present the argument that the DEA is holding registrants to an unfair standard. Although accepting responsibility for one's actions is an important factor to consider once the Government proves its prima facie case, there is much more to determining what constitutes the public interest than this one criterion.” R.D. at 58. However, the ALJ then noted that in Respondent's case, “the outcome would arguably not be different if [he] had been allowed to present additional rehabilitation witnesses. His admitted misconduct while treating patients and his lackluster efforts of rehabilitation require that result.” R.D. 58-59.

    I respectfully disagree with the ALJ's assertion that the Agency “is holding registrants to an unfair standard.” On the contrary, given the harm to public safety caused by the diversion of controlled substances, the Agency's policy of requiring those respondents, who have been shown to have engaged in knowing or intentional misconduct to acknowledge their misconduct, is fully within the Agency's discretion. Hoxie is not to the contrary. As the Tenth Circuit explained in MacKay, a case which received barely a mention by the ALJ:

    When faced with evidence that a doctor has a history of distributing controlled substances unlawfully, it is reasonable for the . . . Administrator to consider whether that doctor will change his or her behavior in the future. And that consideration is vital to whether [his] continued registration is in the public interest. Without Dr. MacKay's testimony, the . . . Administrator had no evidence that Dr. MacKay recognized the extent of his misconduct and was prepared to remedy his prescribing practices.

    664 F.3d at 820. Absent evidence that a registrant acknowledges his misconduct in intentionally or knowingly diverting controlled substances, there is no basis to conclude that the registrant is prepared to remedy his prescribing practices and allowing the registrant to maintain his registration “is inconsistent with the public interest.” 21 U.S.C. 824(a)(4). As for the ALJ's further contention that there is “more to determining what constitute the public interest than this one criterion,” R.D. 58, the Agency considers other factors including the egregiousness of the proven misconduct. Thus, in cases of less egregious misconduct, the Agency has frequently imposed sanctions less than a denial or revocation notwithstanding that a respondent failed to fully acknowledge his misconduct. However, the intentional or knowing diversion of controlled substances strikes at the CSA's core purpose of preventing drug abuse and diversion.

    As for the ALJ's reliance on Hassman and Mathew, neither of these cases supports his assertion that the Agency is imposing an unfair standard on registrants. As for Hassman, the ALJ's characterization of the Agency's decision as having “found that the respondent had issued several prescriptions not for a legitimate medical purpose for several of her patients,” R.D. at 56, is a gross understatement of the Agency's findings in the case, which established that the respondent had issued hundreds of unlawful prescriptions to some 15 patients, and continued to deny material facts even when there was conclusive proof to the contrary. See, e.g., 75 FR at 8200-237. And his reliance on Mathew is especially remarkable given that Dr. Mathew was implicated in prescribing controlled substances for two separate internet prescribing rings and did not testify in the proceeding.

    Of further note, while both physicians sought judicial review of the respective agency decision, in each case, the Court of Appeals denied their petitions in an unpublished decision. See Hassman v. DEA, 515 Fed. App'x. 667 (9th Cir. 2013) (Holding that “[n]one of her proffered statements amount to an admission of wrongdoing; they are nothing more than further denials and claims that she was the unwitting victim of cunning patients. While Hassman offered some evidence of corrective measures, the DEA was entitled to give greater weight to the evidence indicating that Hassman has not learned from or improved upon her past misconduct.”); Mathew v. DEA, 472 Fed Appx. 453 (9th Cir. 2012).

    Nor was Respondent the only party displeased with the ALJ's ruling on the issue of the adequacy of his acceptance of responsibility. Indeed, the Government argues that the ALJ obstructed its cross-examination of Respondent on this very issue. Gov. Exceptions, at 9-18. The Government sets forth various instances in which the ALJ precluded it from conducting a meaningful inquiry into the sincerity of Respondent's acceptance of responsibility and the scope of his present understanding of lawfully appropriate prescribing practices. See id. at 10-11; 17-18.

    The Government further points to various incongruities in the ALJ's decision, including his conclusion that Respondent “ `failed to take the full and unconditional acceptance of responsibility,' ” while later in the same paragraph, finding that Respondent “ `unequivocally stated that he did not dispute the evidence brought against him.' ” Gov. Exceptions, at 12 (quoting R.D. 55). To similar effect, the Government argues that notwithstanding the various instances in which the ALJ cut off its cross-examination of Respondent, the ALJ later explained that he could not evaluate Respondent's contention that he should be able to continue to prescribe controlled substances subject to various restrictions, “ `without first providing the Government a full and fair opportunity to first thoroughly test the depth of [Respondent's] acknowledgment of noncompliance.' ” Gov. Exceptions, at 12 (quoting R.D. 63).

    The Government also argues that “[t]he ALJ's decisions make it difficult for the Administrator to know if Respondent would have `acknowledg[ed] that his conduct violated the law' at hearing.” Gov. Exceptions, at 13 (citing Morgan, 78 FR 61961, 61980 (2013)). I agree, and while Respondent bore the burden of production on the issue, given the ALJ's on-the-record statement that “right now I have fairly compelling evidence that [Respondent] has accepted responsibility, even though he didn't tell me he did so or he was going to do so in his prehearing statement,” Tr. 491, it was not unreasonable for Respondent's counsel to conclude that it was not necessary to further develop the record on this issue.54

    54 While Respondent's counsel raised numerous objections to the Government's attempts to cross-examine him as to the sincerity of his acceptance of responsibility, Respondent's counsel was obliged to zealously defend his client. Thus, the state of the record is primarily attributable to the ALJ's undue limitation of the Government's cross-examination.

    I conclude, however, that a remand is unwarranted for multiple reasons. As explained above, see supra n.53, while a registrant must accept responsibility and demonstrate that he will not engage in future misconduct in order to establish that his/her continued registration is consistent with the public interest, the Agency has repeatedly held that it is entitled to consider the egregiousness and extent of a registrant's misconduct in determining the appropriate sanction. See Dreszer, 76 FR at 19387-88; Volkman, 73 FR at 30644. Indeed, while proceedings under 21 U.S.C. 823 and 824 are remedial in nature, there are cases in which, notwithstanding a finding that a registrant has credibly accepted responsibility, the misconduct is so egregious and extensive that the protection of the public interest nonetheless warrants the revocation of a registration or the denial of an application. See Fred Samimi, 79 FR 18698, 18714 (2014) (denying recommendation to grant restricted registration, explaining that “even assuming . . . that Respondent has credibly accepted responsibility for his misconduct, this is a case where actions speak louder than words”).

    Here, the evidence shows that Respondent is an egregious violator of the CSA in that he ignored countless red flags presented by the patients that they were either abusing or diverting (or both) the controlled substances he prescribed for them. And with respect to Patients J.H. and R.E.H., the evidence shows that this went on for several years. Given the egregiousness of his misconduct, the Agency's interest in protecting the public by both preventing him from being able to dispense controlled substances as well as by deterring misconduct by others is substantial. I thus conclude that continuing Respondent's existing registrations and granting his applications for the additional registrations would be “inconsistent with the public interest.” 21 U.S.C. 823(f), 824(a)(4).

    There is further reason to conclude that a remand is unwarranted. As found above, the State of Michigan has now revoked Respondent's medical license, thus rendering him without authority to dispense controlled substances in the State in which he holds his registrations and seeks the additional registrations. Thus, Respondent no longer meets the CSA's prerequisite for obtaining and maintaining a registration. See 21 U.S.C. 802(21) (defining “the term `practitioner' [to] mean[ ] a . . . physician . . . or other person licensed, registered or otherwise permitted, by . . . the jurisdiction in which he practices . . . to distribute, dispense, [or] administer . . . a controlled substance in the course of professional practice”); see also id. § 823(f) (“The Attorney General shall register practitioners . . . to dispense . . . controlled substances . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.”).

    Thus, pursuant to 21 U.S.C. 824(a)(3), the Attorney General is also authorized to suspend or revoke a registration issued under section 823, “upon a finding that the registrant . . . has had his State license or registration suspended [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the Act, DEA has long held that the revocation of a practitioner's registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the State in which he practices medicine. See James L. Hooper, 76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx . 826 (4th Cir. 2012); see also Maynard v. DEA, 117 Fed. Appx. 941, 945 (5th Cir. 2004); Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988).

    The Government nonetheless argues that because this issue was “never raised in the Order to Show Cause,” a decision on this ground “could arguably upend basic protections afforded to DEA registrants and would surely diminish the perceived fairness of the . . . administrative process.” Govt's Resp. to Admin. Order, at 11. The Government acknowledges that it “is certainly empowered to issue an Order to Show Cause (or an Amended Order to Show Cause) alleging this factual basis and legal ground for revocation or denial” and to submit evidence. Id. However, it then contends that to impose a sanction “based on events that occurred outside of the administrative litigation process . . . runs up against `one of the fundamental tenets of Due Process,' ” this being that the “ `Agency must provide a Respondent with notice of those acts which the Agency intends to rely on in seeking . . . revocation . . . so as to provide a full and fair opportunity to challenge the factual and legal basis for the Agency's action.' ” Id. at 11-12. (quoting Farmacia Yani, 80 FR 29053, 29059 (2015)).

    For his part, Respondent does not dispute that the Michigan Board has revoked his medical license and that he “no longer has any legal authority to dispense controlled substances.” Respondent's Resp. to Admin. Order, at 1. However, he then states that as a procedural matter, he agrees with the Government that “simply skipping ahead to a 21 U.S.C. 824(a)(3) revocation that the parties never litigated would likely be inconsistent with due process.” Id. at 4. Respondent acknowledges that “it might well be within the Administrator's purview . . . to invite the Government to issue an Amended Order to Show Cause seeking revocation [under section] 824(a)(3) grounds because of [his] loss of his license.” Id. at 4-5.

    I reject both parties' contention that I cannot rely on Respondent's loss of his state authority absent the Government's submission of an amended show cause order. Because the possession of state authority is a prerequisite for obtaining a registration and for maintaining a registration, the issue can be raised sua sponte even at this stage of the proceeding.55 Indeed, under the Government's position, had I rejected the Government's case, I would be required to grant Respondent's applications even though he does not meet a statutory requirement for obtaining a registration.

    55 Under the Administrative Procedure Act (APA), an agency “may take official notice of facts at any stage in a proceeding—even in the final decision.” U.S. Dept. of Justice, Attorney General's Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979).

    Notably, the Government's position is fundamentally inconsistent with the position it has taken in numerous cases where it has issued an Order to Show Cause based on public interest grounds only to subsequently move for summary disposition upon learning that the applicable state board had taken action which rendered the practitioner without state authority. See, e.g., Morgan, 78 FR at 61973-74 (upholding ALJ's granting of government motion for summary disposition based on physician's loss of state authority which occurred post-hearing and holding that due process did not require amending the show cause order; motion for summary disposition provided adequate notice); Roy E. Berkowitz, 74 FR 36758, 36759-60 (2009) (rejecting argument that revocation based on loss of state authority was improper based on board action not alleged in the Show Cause Order; “The rules governing DEA hearings do not require the formality of amending a show cause order to comply with the evidence. The Government's failure to file an amended Show Cause Order alleging that Respondent's state CDS license had expired does not render the proceeding fundamentally unfair.”). See also Kamal Tiwari, et al., 76 FR 71604 (2011); Silviu Ziscovici, 76 FR 71370 (2011); Deanwood Pharmacy, 68 FR 41662 (2003); Michael D. Jackson, 68 FR 24760; Robert P. Doughton, 65 FR 30614 (2000); Michael G. Dolin, 65 FR 5661 (2000).

    Here, by virtue of my order directing the parties to address the issues of: (1) Whether Respondent currently possesses authority to dispense controlled substances, and (2) if Respondent does not possess such authority, what consequence attaches for this proceeding, Respondent was provided with a meaningful opportunity to show that he retains his state authority. Of consequence, Respondent does not dispute that he no longer holds authority to dispense controlled substances under Michigan law, this being the only material fact that must be adjudicated in determining whether Respondent's registrations can be revoked and his applications denied under 21 U.S.C. 823(f) and 824(a)(3) as well as the Agency's precedent. That there are no dispositive legal arguments to preclude my reliance on this basis as an additional ground to revoke Respondent's registrations and to deny his applications is not the result of constitutionally inadequate notice. Rather, it is the result of the statute itself, which makes the possession of state authority mandatory for obtaining and maintaining a registration and renders irrelevant the issues of acceptance of responsibility and the adequacy of remedial measures. Accordingly, I will order that Respondent's registrations be revoked and that his pending applications be denied.

    Order

    Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 28 CFR 0.100(b), I order that DEA Certificates of Registration BA7776353 and FA2278201 issued to Hatem M. Ataya, M.D., be, and they hereby are, revoked. Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that all pending applications submitted by Hatem M. Ataya, M.D. be, and they hereby are, denied. This Order is effective immediately.56

    56 Based on the extensive findings of egregious misconduct by Respondent, I conclude that the public interest necessitates that this Order be effective immediately.

    Dated: February 10, 2016. Chuck Rosenberg, Acting Administrator.
    [FR Doc. 2016-03359 Filed 2-17-16; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Manufacturer of Controlled Substances Registration: Mallinckrodt, LLC ACTION:

    Notice of registration.

    SUMMARY:

    Mallinckrodt, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mallinckrodt, LLC registration as a manufacturer of those controlled substances.

    SUPPLEMENTARY INFORMATION:

    By notice dated September 16, 2015, and published in the Federal Register on September 23, 2015, 80 FR 57388, Mallinckrodt, LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice.

    The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Mallinckrodt, LLC to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.

    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the following basic classes of controlled substances:

    Controlled substance Schedule Gamma Hydroxybutyric Acid (2010) I Tetrahydrocannabinols (7370) I Codeine-N-oxide (9053) I Dihydromorphine (9145) I Difenoxin (9168) I Morphine-N-oxide (9307) I Normorphine (9313) I Norlevorphanol (9634) I Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) (9821) I Amphetamine (1100) II Methamphetamine (1105) II Lisdexamfetamine (1205) II Methylphenidate (1724) II Nabilone (7379) II 4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333) II Codeine (9050) II Dihydrocodeine (9120) II Oxycodone (9143) II Hydromorphone (9150) II Diphenoxylate (9170) II Ecgonine (9180) II Hydrocodone (9193) II Levorphanol (9220) II Meperidine (9230) II Methadone (9250) II Methadone intermediate (9254) II Dextropropoxyphene, bulk (non-dosage forms) (9273) II Morphine (9300) II Oripavine (9330) II Thebaine (9333) II Opium tincture (9630) II Opium, powdered (9639) II Oxymorphone (9652) II Noroxymorphone (9668) II Alfentanil (9737) II Remifentanil (9739) II Sufentanil (9740) II Tapentadol (9780) II Fentanyl (9801) II

    The company plans to manufacturer bulk active pharmaceutical ingredients (API) for distribution to its customers.

    Dated: February 10, 2016. Louis J. Milione, Deputy Assistant Administrator.
    [FR Doc. 2016-03357 Filed 2-17-16; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Cedarburg Pharmaceuticals, Inc. ACTION:

    Notice of application.

    DATES:

    Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before April 18, 2016.

    ADDRESSES:

    Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152.

    SUPPLEMENTARY INFORMATION:

    The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

    In accordance with 21 CFR 1301.33(a), this is notice that on November 4, 2015, Cedarburg Pharmaceuticals, Inc., 870 Badger Circle, Grafton, Wisconsin 53024 applied to be registered as a bulk manufacturer of nabilone (7379), a basic class of controlled substance listed in schedule II.

    The company plans to manufacturer bulk active pharmaceutical ingredients (API) for distribution to its customers.

    Dated: February 10, 2016. Louis J. Milione, Deputy Assistant Administrator.
    [FR Doc. 2016-03350 Filed 2-17-16; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Manufacturer of Controlled Substances Registration: Euticals, Inc. ACTION:

    Notice of registration.

    SUMMARY:

    Euticals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Euticals, Inc. registration as a manufacturer of those controlled substances.

    SUPPLEMENTARY INFORMATION:

    By notice dated September 16, 2015, and published in the Federal Register on September 23, 2015, 80 FR 57391, Euticals, Inc., 2460 W. Bennett Street, Springfield, Missouri 65807-1229 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice.

    The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Euticals, Inc. to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.

    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the following basic classes of controlled substances:

    Controlled substance Schedule Gamma Hydroxybutyric Acid (2010) I Amphetamine (1100) II Lisdexamfetamine (1205) II Methylphenidate (1724) II Phenylacetone (8501) II Methadone (9250) II Methadone intermediate (9254) II Oripavine (9330) II Tapentadol (9780) II

    The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers.

    In reference to oripavine (9330), the company plans to acquire the listed controlled substance in bulk from a domestic source in order to manufacture other controlled substances in bulk for distribution to its customers.

    Dated: February 10, 2016. Louis J. Milione, Deputy Assistant Administrator.
    [FR Doc. 2016-03355 Filed 2-17-16; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Registration: Catalent Pharma Solutions, LLC ACTION:

    Notice of registration.

    SUMMARY:

    Catalent Pharma Solutions, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Catalent Pharma Solutions, LLC registration as an importer of this controlled substance.

    SUPPLEMENTARY INFORMATION:

    By notice dated August 21, 2015, and published in the Federal Register on August 31, 2015, 80 FR 52510, Catalent Pharma Solutions, LLC, 3031 Red Lion Road, Philadelphia, Pennsylvania 19114 applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were submitted for this notice.

    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Catalent Pharma Solutions, LLC to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.

    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of hydromorphone (9150), a basic class of controlled substance listed in schedule II.

    The company plans to import the above listed controlled substance for a clinical trial study. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under to 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.

    Dated: February 10, 2016. Louis J. Milione, Deputy Assistant Administrator.
    [FR Doc. 2016-03358 Filed 2-17-16; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Registration: Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC ACTION:

    Notice of registration.

    SUMMARY:

    Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC applied to be registered as an importer of a basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC registration as an importer of this controlled substance.

    SUPPLEMENTARY INFORMATION:

    By notice dated October 13, 2015, and published in the Federal Register on October 21, 2015, 80 FR 63839, Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC, 3500 Dekalb Street, Saint Louis, Missouri 63118 applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were submitted for this notice.

    The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Sigma Aldrich International GMBH-Sigma Aldrich Co. LLC, to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.

    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of butylone (7541), a basic class of controlled substance listed in schedule I.

    The company plans to import the above listed controlled substance for analytical research and testing of equipment. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial sale.

    Dated: February 10, 2016. Louis J. Milione, Deputy Assistant Administrator.
    [FR Doc. 2016-03353 Filed 2-17-16; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 15-1] Arvinder Singh, M.D.; Decision and Order

    On October 16, 2014, the Deputy Assistant Administrator, Office of Diversion Control, issued an Order to Show Cause to Arvinder Singh, M.D. (Respondent), of Clifton Park, New York. ALJ Ex. 1. The Show Cause Order proposed the denial of Respondent's application for a DEA Certificate of Registration as a practitioner on three grounds.

    First, the Show Cause Order alleged that on August 4, 2003, Respondent, following a jury trial, was convicted on 16 counts of health care fraud in violation of 18 U.S.C. 1347, one count of conspiracy to distribute controlled substances in violation of 21 U.S.C. 846, and 24 counts of unlawful distribution of controlled substances in violations of 21 U.S.C. 841(a)(1) and 18 U.S.C. 2. Id. at 1-2. (citing 21 U.S.C. 824(a)(2)).

    Second, the Show Cause Order alleged that Respondent's convictions for violating the Controlled Substances Act “were based on a scheme in which [he] left pre-signed but otherwise blank prescriptions for [his] nursing staff to fill in and issue Schedule II controlled substances prescriptions to patients when neither [he] nor any other physician saw the patient at the time such prescriptions were issued.” Id. at 2. The Show Cause Order alleged that Respondent's scheme also violated 21 CFR 1306.04(a) and 1306.05(a), and that this conduct constituted acts inconsistent with the public interest. Id. (citing 21 U.S.C. 824(a)(4) and 823(f)).

    Third, the Show Cause Order alleged that on May 8, 2004, the U.S. Department of Health and Human Services (HHS) excluded Respondent from participation in federal health care programs for a period of 15 years based on his convictions for Health Care Fraud and for violating the Controlled Substances Act. Id. The Government further alleged that because “the amount of the financial loss” was in excess of $5,000; the time period of Respondent's illegal activity exceeded more than one year; and Respondent had been convicted of the CSA violations; HHS imposed a 15-year exclusion, which was three times the minimum exclusion period. Id. (citing 21 U.S.C. 824(a)(5)).

    Following service of the Show Cause Order, Respondent requested a hearing on the allegations. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Chief Administrative Law Judge (hereinafter, CALJ) John J. Mulrooney, II. Following pre-hearing procedures, the CALJ conducted a hearing at which both parties introduced documentary evidence and called witnesses to testify. Thereafter, both parties submitted briefs containing their proposed findings of fact, conclusions of law, and arguments regarding the ultimate disposition of this matter.

    On February 10, 2015, the CALJ issued his Recommended Decision. Therein, the CALJ found that the Government had established a prima facie case to deny Respondent's application for registration as a practitioner on multiple grounds.1 R.D. at 37.

    1 Pursuant to 21 U.S.C. 823(f), “[t]he Attorney General may deny an application for [a practitioner's] registration . . . if [she] determines that the issuance of such registration . . . would be inconsistent with the public interest.” In making this determination, section 823(f) directs the Agency to consider the following factors:

    (1) The recommendation of the appropriate State licensing board or professional disciplinary authority.

    (2) The applicant's experience in dispensing . . . controlled substances.

    (3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.

    (4) Compliance with applicable State, Federal, or local laws relating to controlled substances.

    (5) Such other conduct which may threaten the public health and safety.

    Id. § 823(f).

    “These factors are . . . considered in the disjunctive.” Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). I “may rely on any one or a combination of factors[,] and may give each factor the weight [I] deem[ ] appropriate in determining whether a registration should be revoked. Id.; see also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to consider each of the factors, I “need not make explicit findings as to each one.” MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).

    These included that Respondent had been convicted of twenty-four counts of violating 21 U.S.C. 841(a)(1) in that he unlawfully caused and aided and abetted the illegal distribution of schedule II controlled substances by providing pre-signed but otherwise blank prescriptions to nurses who worked for him, who filled in the prescriptions with the name of the patient, the name of the drug, the quantity and dosing instructions, and provided the prescriptions to the patients, notwithstanding that the nurses were not legally authorized to dispense controlled substance prescriptions and Respondent did not see the patients. R.D. at 32-33. As discussed in the Recommended Decision, this conduct implicated three of the public interest factors and supports the conclusion that granting Respondent's application “would be inconsistent with the public interest.” 21 U.S.C. 823(f); see also R.D. at 32-37; 2 21 CFR 1306.05(a) (“All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.”).

    2See R.D. at 32-33 (discussing application of factor three—“the applicant's conviction record under Federal . . . laws relating to the . . . distribution[ ] or dispensing of controlled substances.”); id. at 33-36 (discussing application of factor two—“[t]he applicant's experience in dispensing . . . controlled substances”—and factor four—“[c]ompliance with applicable laws . . . related to controlled substances”).

    In addition to the above, the evidence also shows that Respondent “has been excluded . . . from participation in” federal health care programs pursuant to the mandatory exclusion provisions of 42 U.S.C. 1320a-7(a). See 21 U.S.C. 824(a)(5) (“[a] registration pursuant to section 823 of this title to . . . dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has been excluded (or directed to be excluded) from participation in a program pursuant to section 1320a-7(a) of Title 42”).3 More specifically, the evidence shows that on May 28, 2004, the Office of Inspector General, Department of Health and Human Services, excluded Respondent “from participat[ing] in the Medicare, Medicaid, and all Federal health care programs . . . for a minimum period of 15 years.” GX 6. The exclusion was based on Respondent's convictions “of criminal offense[s] related to”: (1) “the delivery of an item or service under the Medicare program”; (2) “fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct in connection with the delivery of a health care item or service or any act or omission in a health care program operated or financed by any Federal, State, or local government agency”; and (3) “the unlawful manufacture, distribution, prescription or dispensing of a controlled substance.” Id. (citing 42 U.S.C. 1320a-7(a)(1), (3), (4)). As the ALJ found, these convictions fall within the mandatory exclusion provisions of 42 U.S.C. 1320a-7(a).

    3 Notwithstanding that 21 U.S.C. 824(a)(5) addresses the Agency's authority to suspend or revoke a registration upon a finding that a registrant has been excluded from participation in federal health care programs under the mandatory exclusion provisions of 42 U.S.C. 1320a-7(a), DEA “ `has consistently held that where a registration can be revoked under section 824, it can, a fortiori, be denied under section 823 since the law would not require an agency to indulge in the useless act of granting a license on one day only to withdraw it on the next.' ” Kwan Bo Jin, 77 FR 35021, 35021 n.2 (2012) (quoting Serling Drug Co. v. Detroit Prescription Wholesaler, Inc., 40 FR 11918, 11919 (1975)). See also John R. Amato, 40 FR 22852 (1975) (Denying application where practitioner's state license had been revoked, holding that section 823(f) “must logically give the Administrator the authority to deny a registration if the practitioner is not authorized by the State to dispense controlled substances. . . . To hold otherwise would mean that all applications would have to be granted only to be revoked the next day under 21 U.S.C. 824(a)(3). This [A]gency has consistently held that where a registration can be revoked under section 824, it can, a fortiori, be denied under section 823.”).

    Turning to whether Respondent had produced sufficient evidence to rebut the Government's prima facie case, the CALJ found that “Respondent continues to dispute the nature of the criminal charges and their severity.” R.D. 38. The CALJ further found that “instead of accepting responsibility for the crimes for which he was convicted, he has emphasized isolated excerpts from orders and transcripts where he perceives he has been `exonerated,' and/or occasions when DEA or the state licensing agency `had no problems' with him.” Id. (citations omitted). Continuing, the CALJ explained that “[t]he Respondent has not accepted responsibility for his actions, persuasively expressed remorse for his conduct, or presented evidence that could reasonably support a finding that the Administrator should entrust him with a registration.” Id.

    The CALJ also found that Respondent's misconduct was egregious and “militates persuasively in favor of denial of his application.” Id. at 39. On the other hand, because Respondent's misconduct “ended nearly fifteen years earlier” and he “has paid his debt to society,” the CALJ found that granting his application would not “adversely impact compliance expectations on the regulated community in a significant way,” and thus, the Agency's interest in “general deterrence should not, standing alone, constitute an insurmountable impediment to granting” his application. Id.

    However, the CALJ then found that “[t]he issue of specific deterrence . . . is a dramatically different issue.” Id. The CALJ explained that “virtually every documentary, testimonial, and argumentative contribution made by the Respondent in these proceedings makes it overwhelmingly clear that he does not believe he was mistaken in any way.” Id. The CALJ thus concluded that “until . . . Respondent can convincingly show he accepts the authority of the law and those bodies charged with enforcing it and regulating his activities, granting him a DEA registration will gravely endanger the public.” Id. at 40. The CALJ thus recommended that Respondent's application be denied. Id.

    Respondent filed Exceptions to the Recommended Decision and the Government filed a response to Respondent's Exceptions. Thereafter, the record was forwarded to my Office for Final Agency Action.

    Having considered the record in its entirety (including Respondent's Exceptions), I adopt the CALJ's findings of fact and conclusions of law to the extent they are discussed herein. Because I agree with the CALJ's ultimate findings that: (1) Multiple grounds exist to deny Respondent's application, (2) Respondent has failed to adequately acknowledge his misconduct, (3) Respondent's misconduct was egregious, and (4) the Agency's interest in specific deterrence supports the denial of his application, I will adopt the CALJ's recommendation that I deny Respondent's application. A discussion of Respondent's Exceptions follows.

    Invoking Gonzales v. Oregon, 546 U.S. 243 (2006), Respondent's first contention is that “the [A]gency has relied on factors which Congress has not intended it to consider.” Exceptions, at 1. Fleshing out his argument, Respondent contends that during the hearing, “[t]he Government has not shown a single case of [d]iversion.” Id. at 2. He argues that the Government “failed to even scratch the surface of the case where it is apparent that billing issues were criminalized through the use of [the] CSA despite no evidence of [d]iversion or [p]ublic [s]afety [i]ssues, by creating a [sic] interpretive rule, as in Gonzales” and that “Congress does not allow DEA to use its policing power to regulate Medical Practices or make its own rules to prosecute doctors.” Id.

    Gonzales, however, offers no comfort to Respondent because here, the Government's case is based on his convictions for aiding and abetting violations of a duly enacted statute—21 U.S.C. 841(a)(1).4 Moreover, while most prosecutions under 21 U.S.C. 841(a)(1) are based on allegations of drug dealing, the statute encompasses any knowing or intentional distribution or dispensing of a controlled substance, “[e]xcept as authorized by” the Controlled Substances Act. 21 U.S.C. 841(a)(1). As the Court of Appeals explained in affirming his convictions:

    4 In discussing Respondent's conviction record for the unlawful distribution of controlled substances under factor three, the Recommended Decision refers to 18 U.S.C. 841(a)(1) in several places. See R.D. 32. The correct provision is 21 U.S.C. 841(a)(1).

    [n]urses are not authorized by law to write [Schedule II controlled substance] prescriptions, which must be written in triplicate by licensed physicians only.5 [Respondent] developed a scheme that enabled nurses to see patients alone, to issue prescriptions for Schedule II [c]ontrolled [s]ubstances, and to bill for such services. He and the other physicians would pre-sign the triplicate forms and provide them to non-physician personnel to use during patient visits. These employees, although not trained or legally authorized to do so, filled in all the required prescription information—drug type, dosage, and quantity—and provided the prescriptions to the patients.

    5 The CSA leaves to state law the determination of the classes of health care providers that are authorized to prescribe controlled substances. See 21 U.S.C. 823(f) (“The Attorney General shall register [a] practitioner[ ] . . . to dispense . . . controlled substances . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.”); id. § 802(21) (“The term `practitioner' means a physician, dentist, veterinarian . . . or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices . . . to dispense . . . a controlled substance in the course of professional practice. . . .”). See also 21 CFR 1306.03(a) (“A prescription for a controlled substance may be issued only by an individual practitioner who is . . . [a]uthorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession and . . . [e]ither registered or exempted from registration . . . .”).

    United States v. Singh, 390 F.3d 168, 176 (2d Cir. 2004). Indeed, the Court of Appeals noted that “[d]ata extracted from Singh's office records revealed that the nurses issued prescriptions for at least 76,000 tablets of Schedule II Controlled Substances when Singh was not present in the Practice suite.” Id.

    Contrary to Respondent's contention, the Government was not required to show that any of the drugs obtained through these prescriptions were diverted. See Exceptions, at 2. As the Supreme Court recognized in Gonzales, one of the purposes of the CSA's prescription regulation (21 CFR 1306.04(a)) is to “ensure[ ] patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse.” 546 U.S. at 274. Respondent's nurses lacked the necessary training in medicine to properly supervise his patients and to determine whether additional prescriptions were warranted. Thus, by providing his nurses with pre-signed and otherwise blank prescriptions, Respondent's conduct created a substantial risk that the drugs would be diverted and abused. Moreover, as Respondent did not see the patients on those occasions when his nurses provided the prescriptions to the patients, he has no idea whether any of the drugs were abused or diverted. Yet, as the CALJ found, Respondent still does not understand this. R.D. 37-38.

    Respondent also argues “that billing issues were criminalized through the use of [the] CSA despite no evidence of Diversion or Public Safety Issues.” Exceptions, at 2. However, in affirming his convictions for health care fraud, see 18 U.S.C. 1347, the Second Circuit reviewed the sufficiency of the evidence presented at trial and found that there were numerous instances in which Respondent billed for office visits as if he had seen the patients when, in fact, the patients were seen only by his nurses. See Singh, 390 F.3d at 187-89. Not only are Respondent's convictions res judicata, the crime of health care fraud does not require proof of either diversion or public safety issues. See 18 U.S.C. 1347(a).

    Respondent further argues that the CALJ ignored substantial evidence in concluding that he failed to acknowledge his misconduct. Exceptions, at 3. Respondent argues that:

    I admitted right from the start in 1999 that I made the mistake of leaving Pre-Signed Prescriptions for legitimate patients of the practice with treatment plan spelled [out] in the chart, and not for Diversion. I never tried to trivialize it. . . . I admitted to the truth. The Agency wants me to admit Diversion (drug trafficking) when there was none.

    Id.

    My review of the record finds no instance of the Agency attempting to elicit from Respondent an admission that he engaged in drug trafficking. What the record does show, however, is that Respondent still fails to acknowledge the risk of diversion created by his practice of providing pre-signed but otherwise blank prescriptions to his nurses and authorizing them to issue the prescriptions to the patients he did not see.6

    6 At one point, Respondent testified “that there was no medical safety issue. And, yes, as you [the CALJ] now present it to me—and I apologize for that. This prescription could have been diverted, yes. There is no doubt about that.” Tr. 269. However, on further questioning by the CALJ as to whether pre-signing the prescriptions was a safety issue, Respondent testified: “No. Safety, I also—no, I didn't mean no safety issue with blank prescription, no, not at all.” Id. Respondent then explained that “[t]here was no public safety [issue] in the sense that there was no issue that patient could be harmed. I was thinking entirely differently.” Id.

    The CALJ then asked: “[s]o there was no safety issue with some patient who you didn't know was going to get the prescription, with whatever drugs that were written on it that you didn't know, . . . there was no way in your view that any of those patients could be harmed?” Tr. 269-70. Respondent answered: “They were following my previous protocol.” Id. at 270.

    Later, the CALJ asked: “[s]he [the Nurse] was exercising her judgment for patients that you didn't know for medications that you had no idea because you signed them?” Id. at 278. Respondent answered: “I knew the patients Your Honor. I knew the patients were coming in.” Id. In response, the CALJ asked: “Back to that again?” Id. Respondent answered: “No. I get back, yes, Your Honor. I apologize. I fully agree that, yes, it could be a great hazard. It could have been a great hazard.” Id.

    In response, the CALJ stated: “I know those are your words, but they're not very convincing the way that you say it. I must say that your tenor, it's not very convincing that you think that.” Id. I find no reason to reject the CALJ's assessment of Respondent's demeanor and the credibility of his testimony. See Universal Camera, 340 U.S. at 496.

    Moreover, at the hearing, Respondent continued to dispute the extent of his misconduct in pre-signing prescriptions. Respondent testified that he engaged in this practice only after November 25, 1997, when another physician suddenly left his practice, and “I left a few, you know, eight or 10 prescriptions pre[-]signed without any patient name.” Tr. 250. The CALJ then asked Respondent: “So your testimony is that there were—in the entire practice that you had there were only eight to 10 times that you pre[-]signed prescriptions?” Id. Respondent answered: “That's right, Your Honor.” Id.

    The CALJ again asked: “And that's your testimony under oath?” Id. at 250-51. Respondent answered: “Yes, that's my testimony under oath. And all other prescriptions nurses handed were pre[-]filled and then handed to the patient. Even if I was not there they can give that because after that we learned our lesson. We cannot do this.” Id. at 251.

    After Respondent asserted that the difference between pre-signed and pre-filled prescriptions was that the former did not have a patient's name, the CALJ again asked: “So . . . it's your recollection that there were only eight to 10 times that this occurred?” Id. Respondent answered: “That's correct, Your Honor.” Id. Following up, the CALJ asked: “there were only eight to 10 total pre[-]signed prescriptions that you ever made in your life?” Id. After Respondent ascertained that the CALJ meant that the prescriptions had been signed but otherwise “left blank,” Respondent answered “[y]es.” Id. 252.

    The evidence further shows that on December 2, 1997, Investigators from the New York State Bureau of Controlled Substances went to his office at Albany Memorial Hospital and found six blank pre-signed prescriptions in the possession of his nurse. RX 12, at 2. At the hearing, Respondent testified that “[a]fter the investigation, we stopped doing that.” 7 Tr. 398. Yet later in his testimony, Respondent testified that this practice continued until some unspecified date in February 1998, when he hired another doctor for the practice, id. at 405-6, before returning to his original story and asserting that he had provided pre-signed prescriptions only on December 2, 1997 and had “stopped that right away” after the State's Investigator had come to his office. Id. at 411-12.

    7 According to the Investigator's Report, Respondent's wife was present at his Albany office and “called his attorney, who showed up at the office within minutes” but “would not allow the [Investigator] to make photocopies of those blanks on” that date. RX 12, at 2. (The pre-signed prescriptions were, however, surrendered several days later. Id.) I therefore find that Respondent was aware of the investigation on December 2, 1997.

    Respondent, however, was convicted of twenty-four counts of causing an act to be done and aiding and abetting the unlawful distribution of schedule II controlled substances based on his having provided pre-signed but otherwise blank prescriptions to his employees. See GX 2, at 21-24 (Superseding Indictment); GX 5, at 1 (District Court's Judgment). Moreover, Respondent was convicted of having committed this offense beginning as early as November 25, 1996, and was convicted of nineteen such offenses before November 25, 1997, the date on which his physician-employee quit the practice. See GX 2, at 21-24; GX 5, at 1.

    As for his testimony that he stopped providing pre-signed prescriptions after becoming aware of the investigation, Respondent was convicted of having committed the offense on five occasions in January 1998, more than a month after he became aware of the investigation. See GX 2, at 23-24; GX 5, at 1. Moreover, the Court of Appeals found that on July 27, 1999—nearly 18 months after the visit by the State Investigator—federal agents executed search warrants at Respondent's offices in Albany and Port Chester, as well as his home, and found still more pre-signed prescriptions. See 390 F.3d at 178.

    Likewise, with respect to his convictions for health care fraud, Respondent asserted that there were only 15 or 20 times when he billed an office visit as if he had seen the patient when the patient had only been seen by a nurse. Id. at 254. While Respondent admitted that “the billing mistake was actually a big mistake” and “was stupid of me,” id. at 255, here too, he attempted to minimize his misconduct asserting, in essence, that he was confused because “in some states . . . if [the] doctor has set a plan, the nurse can do it as to this doctor's plan, [and the visit] can be billed under [the] doctor.” Id. at 257. Unexplained is why, if Respondent had overbilled only 15 to 20 times, the District Court ordered him to pay more than $227,000 in restitution to approximately 250 payees.8 See GX 5, at 7-13. The amount of the restitution he was ordered to pay likewise refutes his assertion that the overbilling was not motivated by money. See Tr. 262 (Respondent's testimony denying that the overbilling was financially motivated).

    8 Of further note, the Court of Appeals also rejected Respondent's challenge to his convictions for health care fraud, explaining that his “contention that the billing codes and rules were sufficiently ambiguous to preclude a finding of fraudulent intent on his part is belied by the evidence. There are in fact no ambiguities in the billing requirements.” 390 F.3d at 187. See also id. at 187-88 (“Nor could a rational jury find ambiguities sufficient to negate fraudulent intent . . . in the Medicare rules that allow billing for services performed by registered nurses when those services are `incident to' a physician's services. The requirements for `incident to' billing are that the physician must be present in the office suite and available to provide assistance. This requirement is plain enough, and there is ample proof that Singh did not comply with it.”).

    Finally, Respondent argues that the CALJ improperly ignored the State's recommendation; he also provides a laundry list of exhibits that he believes the CALJ ignored. As for the decision of the Peer Committee of the New York State Department of Education Committee in the Professions, the State has not made a recommendation to the Agency as to whether to grant a new registration to Respondent. While the State's decision to issue Respondent a new medical license establishes that he again holds authority under state law to dispense controlled substances and thereby satisfies the CSA's prerequisite for obtaining a practitioner's registration, this “Agency has long held that `the Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.' ” David A. Ruben, 78 FR 38363, 38379 n.35 (2013) (quoting Mortimer Levin, 57 FR 8680, 8681 (1992)).

    Notably, under New York law, “an applicant . . . does not have to admit past wrongdoing the applicant does not believe he committed . . . in order to be readmitted to his profession.” GX 9F, at 12 (citation omitted). To be sure, in exercising its sovereign power to regulate the medical profession, the State of New York may follow this policy. See Ruben, 78FR at 38837 n.53. However, DEA is charged with protecting the public interest, see 21 U.S.C. 823(f), and based on the threat to public health and safety caused by intentional and knowing misconduct involving controlled substances, it is fully within DEA's authority to require an applicant for registration to acknowledge the full extent of his misconduct which has been proven on the record of the proceeding. See MacKay v. DEA, 664 F.3d 808, 821 (10th Cir. 2011) (discussing Jayam Krishna-Iyer, 74 FR 459, 462 (2009)). And while both MacKay and Krishna-Iyer involved practitioners who engaged in intentional diversion (i.e., drug trafficking), the same consideration applies here, where, even though there is no evidence that the drugs the patients obtained using the pre-signed prescriptions were diverted, Respondent engaged in intentional or knowing misconduct which created a substantial risk of diversion.

    Thus, while Respondent has put forward evidence of his remedial measures, his continued refusal to acknowledge the full scope of his criminal conduct precludes a finding that his registration would be consistent with the public interest. See R.D. at 37-38. Indeed, in his post-hearing brief, Respondent goes so far as to characterize his convictions for violating 21 U.S.C. 841(a)(1) as “technical convictions.” Resp. Post-Hrng. Br., at 12. They were not.

    Moreover, as I have previously explained, the record contains no support for Respondent's assertion (Exceptions at 4) that he was required to admit to having issued prescriptions outside of the usual course of professional practice and for other than a legitimate medical purpose (i.e., drug trafficking). See 21 CFR 1306.04(a). What he was required to acknowledge was the full scope of his criminal behavior and the risk of diversion it created, which, as established by his convictions and the Second Circuit's opinion, went on for a far longer period and to a far greater extent than he was willing to acknowledge during this proceeding.

    Accordingly, I find the CALJ's conclusion that Respondent has not accepted responsibility for his misconduct to be fully supported by the record and that he has not put forward sufficient evidence “that could reasonably support a finding that” he can be entrusted with a registration. R.D. at 38. Because I also agree with the CALJ's finding that Respondent's misconduct was egregious and that he still “does not believe he was mistaken in any way,” I also agree that these factors support the denial of his application. See id. at 39. I therefore adopt the CALJ's recommendation that I deny Respondent's application.

    Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that the application of Arvinder Singh, M.D., for a DEA Certificate of Registration as a practitioner, be, and it hereby is, denied. This Order is effective immediately.

    Dated: February 10, 2016. Chuck Rosenberg, Acting Administrator.
    [FR Doc. 2016-03361 Filed 2-17-16; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF LABOR Employment and Training Administration Notice of Availability of Funds and Funding Opportunity Announcement for: Summer Jobs and Beyond: Career Pathways for Youth (CPY) AGENCY:

    Employment and Training Administration, Labor.

    ACTION:

    Funding Opportunity Announcement (FOA).

    Funding Opportunity Number: FOA-ETA-16-08.

    SUMMARY:

    The Employment and Training Administration (ETA), U.S. Department of Labor, announces the availability of up to $20,000,000 in grant funds authorized by section 169(c) of the Workforce Innovation and Opportunity Act (WIOA), Public Law 113-128, Dislocated Worker Demonstration Projects, and the Consolidated Appropriation Act of 2016, Public Law 114-113 for the pilot grant program, Summer Jobs and Beyond: Career Pathways for Youth (CPY). ETA plans to award approximately 10-11 grants of approximately $2,000,000 each to Local Workforce Development Boards (LWDB). This program is designed to provide employment-related services to eligible youth who are new entrants to the workforce, including those with limited current or past work experience.

    The program will provide youth with work experience opportunities, including summer and year‐round part‐time job opportunities for in-school youth and employment and work experience opportunities throughout the year for out-of-school youth, and exposure to career pathways in in‐demand job sectors. The grants will require partnerships between LWDBs and local summer employment programs, employers, Local Education Agencies (LEAs), and re‐engagement centers. Other community partners may provide services to eligible youth that assist in the development of work experience and entry into career pathways.

    The complete FOA and any subsequent FOA amendments in connection with this solicitation are described in further detail on ETA's Web site at http://www.doleta.gov/grants/ or http://www.grants.gov. The Web sites provide application information, eligibility requirements, review and selection procedures, and other program requirements governing this solicitation.

    DATES:

    The closing date for receipt of applications under this Announcement is March 25, 2016. We must receive applications no later than 4:00:00 p.m. Eastern Time.

    FOR FURTHER INFORMATION CONTACT:

    Janice Sheelor, Grants Management Specialist, Office of Grants Management, at (202) 693-3538. Applicants should email all technical questions to [email protected] and reference the Funding Opportunity Number listed in this notice.

    The Grant Officer for this FOA is Latifa Jeter.

    Signed February 9, 2016 in Washington, DC. Eric D. Luetkenhaus, Grant Officer/Division Chief, Employment and Training Administration.
    [FR Doc. 2016-03336 Filed 2-17-16; 8:45 am] BILLING CODE 4510-FT-P
    DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Representative Fee Request ACTION:

    Notice.

    SUMMARY:

    The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, “Representative Fee Request,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq. Public comments on the ICR are invited.

    DATES:

    The OMB will consider all written comments that agency receives on or before March 21, 2016.

    ADDRESSES:

    A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201508-1240-002 or by contacting Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected]

    Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email: [email protected] Commenters are encouraged, but not required, to send a courtesy copy of any comments by mail or courier to the U.S. Department of Labor-OASAM, Office of the Chief Information Officer, Attn: Departmental Information Compliance Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210; or by email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected]

    Authority:

    44 U.S.C. 3507(a)(1)(D).

    SUPPLEMENTARY INFORMATION:

    An attorney or other representative may represent an individual filing for compensation benefits with the OWCP. The representative is entitled to request a fee for services under the Federal Employees' Compensation Act and under the Longshore and Harbor Workers' Compensation Act; however, the OWCP must approve the fee before the representative can make any demand for payment. This ICR sets forth the criteria for the information the respondent must present in order to have the fee approved by the OWCP. The information collection does not impose a particular form or format for the application, provided all required information is presented. The Federal Employees' Compensation Act and Longshore and Harbor Workers' Compensation Act authorize this information collection. See 5 U.S.C. 8127 and 33 U.S.C. 928.

    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1240-0049.

    OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the Federal Register on September 11, 2015 (80 FR 54804).

    Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within thirty (30) days of publication of this notice in the Federal Register. In order to help ensure appropriate consideration, comments should mention OMB Control Number 1240-0049. The OMB is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Agency: DOL-OWCP.

    Title of Collection: Representative Fee Request.

    OMB Control Number: 1240-0049.

    Affected Public: Private Sector—businesses or other for-profits.

    Total Estimated Number of Respondents: 9,307.

    Total Estimated Number of Responses: 9,307.

    Total Estimated Annual Time Burden: 4,654 hours.

    Total Estimated Annual Other Costs Burden: $8,609.

    Dated: February 9, 2016. Michel Smyth, Departmental Clearance Officer.
    [FR Doc. 2016-03426 Filed 2-17-16; 8:45 am] BILLING CODE 4510-CR-P
    DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Request for Employment Information ACTION:

    Notice.

    SUMMARY:

    The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, “Request for Employment Information” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.). Public comments on the ICR are invited.

    DATES:

    The OMB will consider all written comments that agency receives on or before March 21, 2016.

    ADDRESSES:

    A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201507-1240-003 or by contacting Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to [email protected]

    Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email: [email protected] Commenters are encouraged, but not required, to send a courtesy copy of any comments by mail or courier to the U.S. Department of Labor—OASAM, Office of the Chief Information Officer, Attn: Departmental Information Compliance Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210; or by email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to [email protected]

    Authority:

    44 U.S.C. 3507(a)(1)(D).

    SUPPLEMENTARY INFORMATION:

    This ICR seeks to extend approval under the PRA for the Request for Employment Information, Form CA-1027, information collection used to collect data about a claimant's private sector employment. The OWCP uses the information to determine continued eligibility for benefits under the Federal Employees' Compensation Act (FECA). FECA section 4(b) authorizes this information collection. See 5 U.S.C. 8106(b).

    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1240-0047.

    OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the Federal Register on August 24, 2015 (80 FR 51322).

    Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within thirty (30) days of publication of this notice in the Federal Register. In order to help ensure appropriate consideration, comments should mention OMB Control Number 1240-0047. The OMB is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Agency: DOL-OWCP.

    Title of Collection: Request for Employment Information.

    OMB Control Number: 1240-0047.

    Affected Public: Private Sector—businesses or other for-profits.

    Total Estimated Number of Respondents: 154.

    Total Estimated Number of Responses: 154.

    Total Estimated Annual Time Burden: 39 hours.

    Total Estimated Annual Other Costs Burden: $74.

    Dated: February 8, 2016. Michel Smyth, Departmental Clearance Officer.
    [FR Doc. 2016-03428 Filed 2-17-16; 8:45 am] BILLING CODE 4510-CH-P
    DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No OSHA-2015-0014] Maritime Advisory Committee for Occupational Safety and Health (MACOSH) AGENCY:

    Occupational Safety and Health Administration (OSHA), Labor.

    ACTION:

    Notice of MACOSH Membership.

    SUMMARY:

    On April 29, 2015, the Secretary of Labor announced the renewal of the Maritime Advisory Committee for Occupational Safety and Health (MACOSH). The MACOSH charter was signed on April 30, 2015, and will expire after two years on April 30, 2017. On January 20, 2016, Secretary Perez selected 15 members and a Special Agency Liaison to serve on the Committee. The Committee is diverse and balanced, both in terms of segments of the maritime industry represented (e.g., shipyard employment, longshoring, marine terminal, and commercial fishing industries), and in the views and interests represented by the members.

    FOR FURTHER INFORMATION CONTACT:

    For press inquiries: Frank Meilinger, OSHA's Office of Communications, U.S. Department of Labor, Room N-3647, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693-1725; email [email protected]

    For general information about MACOSH: Ms. Amy Wangdahl, Director, Office of Maritime and Agriculture, OSHA, U.S. Department of Labor, Room N-3609, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693-2066; email [email protected]

    SUPPLEMENTARY INFORMATION:

    MACOSH will contribute to OSHA's performance of its duties under the Occupational Safety and Health Act of 1970 (29 U.S.C. 651 et seq.). Authority to establish this Committee is at Sections 6(b)(1) and 7(b) of the OSH Act, Section 41 of the Longshore and Harbor Workers' Compensation Act (33 U.S.C. 941), Secretary of Labor's Order 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR part 1912. The Committee will advise OSHA on matters relevant to the safety and health of employees in the maritime industry. This includes advice on maritime issues that will result in more effective enforcement, training, and outreach programs, and streamlined regulatory efforts. The maritime industry includes shipyard employment, longshoring, marine terminal, and commercial fishing industries. The Committee will function solely as an advisory body in compliance with the provisions of the FACA and OSHA's regulations covering advisory committees (29 CFR part 1912).

    Background

    The maritime industry has historically experienced a high incidence of work-related fatalities, injuries, and illnesses. OSHA targeted this industry for special attention due to that experience. This targeting included development of guidance or outreach materials specific to the industry, rulemakings to update requirements, and other activities. MACOSH will advise the Secretary through the Assistant Secretary of Labor for Occupational Safety and Health on matters relevant to the safety and health of employees in the maritime industry. The Committee's advice will result in more effective enforcement, training and outreach programs, and streamlined regulatory efforts.

    Appointment of Committee Members

    OSHA received nominations of highly qualified individuals in response to the Agency's request for nominations (80 FR 31620, June 3, 2015). The Secretary selected to serve on the Committee individuals who have broad experience relevant to the issues to be examined by the Committee. The MACOSH members are:

    Robert Fiore, International Longshoremen's Association; Ed Ferris, International Longshore and Warehouse Union; James A. Reid, International Association of Machinists and Aerospace Workers; Matthew Layman, United States Coast Guard; Miriam Bolaffi, United States Navy; David Turner, Ceres Terminals, Incorporated; Gunther Hoock, Signal Administration; Larry Liberatore, American Society of Safety Engineers; James Rone, Washington State Department of Labor and Industries; Chelsea Woodward, U.S. Department of Health and Human Services; National Institute of Occupational Safety and Health; Robert Godinez, International Brotherhood of Boilermakers—Iron Ship Builders; Donald V. Raffo, General Dynamics Corp.; Solomon Egbe, Ports America Chesapeake; Amy Sly Liu, Marine Chemist Association; and James R. Thornton, American Industrial Hygiene Association.

    The Special Agency Liaison to MACOSH is:

    Leonard Howie, Director, Office of Workers' Compensation Programs. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210, authorized the preparation of this notice pursuant to Sections 6(b)(1), and 7(b) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655(b)(1), 656(b)), the Federal Advisory Committee Act (5 U.S.C. App. 2), Section 41 of the Longshore and Harbor Workers' Compensation Act (33 U.S.C. 941), Secretary of Labor's Order 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR part 1912.

    Signed at Washington, DC, on February 12, 2016. David Michaels, Assistant Secretary of Labor for Occupational Safety and Health.
    [FR Doc. 2016-03377 Filed 2-17-16; 8:45 am] BILLING CODE 4510-26-P
    NATIONAL SCIENCE FOUNDATION National Science Board; Sunshine Act Meetings; Notice

    The National Science Board's ad hoc Task Force on NEON Performance and Plans, pursuant to NSF regulations (45 CFR part 614), the National Science Foundation Act, as amended (42 U.S.C. 1862n-5), and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice in regard to the scheduling of a meeting for the transaction of National Science Board business, as follows:

    DATE AND TIME:

    Wednesday, February 17, 2016 from 8:30 p.m.-9:30 p.m. EST.

    SUBJECT MATTER:

    Task Force Chair's opening remarks; approval of minutes of the closed January 28, 2016 meeting; Task Force Chair's update; and Discussion.

    STATUS:

    Closed.

    This meeting will be held by teleconference originating at the National Science Board Office, National Science Foundation, 4201 Wilson Blvd., Arlington, VA 22230.

    Please refer to the National Science Board Web site (www.nsf.gov/nsb) for information or schedule updates, or contact: Elise Lipkowitz ([email protected]), National Science Foundation, 4201 Wilson Blvd., Arlington, VA 22230.

    Ann Bushmiller, NSB Senior Legal Counsel.
    [FR Doc. 2016-03425 Filed 2-16-16; 11:15 am] BILLING CODE 7555-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2011-0011] Criteria and Design Features for Inspection of Water-Control Structures Associated With Nuclear Power Plants AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Regulatory Guide; issuance.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 2 of Regulatory Guide (RG) 1.127, “Criteria and Design Features for Inspection of Water-Control Structures Associated with Nuclear Power Plants.” This RG describes a method that the staff of the NRC considers acceptable for designing water-control structures (e.g., dams, slopes, canals, reservoirs, and associated conveyance facilities) such that periodic inspections may be performed. In addition, this guide describes an acceptable inspection and monitoring program for water-control structures. Water-control structures include those used in the emergency cooling water system and those relied upon for flood protection.

    DATES:

    Revision 2 to RG 1.127 is available on February 18, 2016.

    ADDRESSES:

    Please refer to Docket ID NRC-2011-0011 when contacting the NRC about the availability of information regarding this document. You may obtain publically-available information related to this document using the following methods:

    • Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2011-0011. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    • NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Document collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The ADAMS accession number for each document referenced in this notice (if that document is available in ADAMS) is provided the first time that a document is referenced. Revision 2 of RG 1.127, is available in ADAMS under Accession No. ML15107A412. The regulatory analysis may be found in ADAMS under Accession No. ML093060317.

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

    Regulatory guides are not copyrighted, and NRC approval is not required to reproduce them.

    FOR FURTHER INFORMATION CONTACT:

    Robert Pettis, Office of Nuclear Reactor Regulation, telephone: 301-415-3214, email: [email protected], Kenneth Karwoski, Office of Nuclear Reactor Regulation, telephone: 301-415-2752, email: [email protected], or Mark Orr, Office of Nuclear Regulatory Research, telephone: 301-415-6003, email: [email protected] All are on the staff of the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    SUPPLEMENTARY INFORMATION: I. Introduction

    The NRC is issuing a revision to an existing guide in the NRC's “Regulatory Guide” series. This series was developed to describe and make available to the public information regarding methods that are acceptable to the NRC staff for implementing specific parts of the agency's regulations, techniques that the NRC staff uses in evaluating specific issues or postulated events, and data that the NRC staff needs in its review of applications for permits and licenses.

    Revision 2 of RG 1.127 was issued with a temporary identification as Draft Regulatory Guide, DG-1245. The RG is being updated to provide licensees and applicants with the most current guidance and to help ensure that applicants and licensees are able to demonstrate compliance with the applicable regulations.

    II. Additional Information

    DG-1245 was published in the Federal Register on January 23, 2015 (80 FR 3661) for a 60-day public comment period. The public comment period closed on March 24, 2015. Public comments on DG-1245 and the staff responses to the public comments are available under ADAMS Accession No. ML15107A414.

    III. Congressional Review Act

    This RG is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.

    IV. Backfitting and Issue Finality

    This RG does not constitute backfitting as defined in section 50.109 of title 10 of the Code of Federal Regulations (10 CFR) (the Backfit Rule), and is not otherwise inconsistent with the issue finality provisions in 10 CFR part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants.” This RG provides guidance on one possible means for meeting NRC's regulatory requirements for developing appropriate Inservice Inspection Programs (ISI) and surveillance programs for dams, slopes, canals, and other water-control structures associated with emergency cooling and flood protection water systems as required by General Design Criterion 45, “Inspection of Cooling Water System,” of Appendix A, “General Design Criteria for Nuclear Power Plants,” to 10 CFR part 50, “Domestic Licensing of Production and Utilization Facilities.”

    Existing licensees and applicants for standard design certifications will not be required to comply with the new positions set forth in this RG, unless the licensee or standard design certification applicant seeks a voluntary change to its licensing basis with respect to ISI or surveillance programs for water-control structures, and where the NRC determines that the safety review must include consideration of the ISI or surveillance program. Further information on the staff's use of the RG is contained in the RG under Section D. Implementation.

    Dated at Rockville, Maryland, this 11th day of February, 2016.

    For the Nuclear Regulatory Commission.

    Thomas H. Boyce, Chief, Regulatory Guidance and Generic Issues Branch, Division of Engineering, Office of Nuclear Regulatory Research.
    [FR Doc. 2016-03346 Filed 2-17-16; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on Plant License Renewal; Notice of Meeting

    The ACRS Subcommittee on Plant License Renewal will hold a meeting on March 2, 2016, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.

    The meeting will be open to public attendance.

    The agenda for the subject meeting shall be as follows:

    Tuesday, March 2, 2016—1:00 p.m. Until 5:00 p.m.

    The Subcommittee will review the Fermi Unit 2 License Renewal Application. The Subcommittee will hear presentations by and hold discussions with representatives of the NRC staff, DTE Electric Company, and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.

    Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Kent Howard (Telephone 301-415-2989 or Email: [email protected]) five days prior to the meeting, if possible, so that appropriate arrangements can be made. Thirty-five hard copies of each presentation or handout should be provided to the DFO thirty minutes before the meeting. In addition, one electronic copy of each presentation should be emailed to the DFO one day before the meeting. If an electronic copy cannot be provided within this timeframe, presenters should provide the DFO with a CD containing each presentation at least thirty minutes before the meeting. Electronic recordings will be permitted only during those portions of the meeting that are open to the public. Detailed procedures for the conduct of and participation in ACRS meetings were published in the Federal Register on October 21, 2015 (80 FR 63846).

    Detailed meeting agendas and meeting transcripts are available on the NRC Web site at http://www.nrc.gov/reading-rm/doc-collections/acrs. Information regarding topics to be discussed, changes to the agenda, whether the meeting has been canceled or rescheduled, and the time allotted to present oral statements can be obtained from the Web site cited above or by contacting the identified DFO. Moreover, in view of the possibility that the schedule for ACRS meetings may be adjusted by the Chairman as necessary to facilitate the conduct of the meeting, persons planning to attend should check with these references if such rescheduling would result in a major inconvenience.

    If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (Telephone 240-888-9835) to be escorted to the meeting room.

    Dated: February 3, 2016. Mark L. Banks, Chief, Technical Support Branch, Advisory Committee on Reactor Safeguards.
    [FR Doc. 2016-03370 Filed 2-17-16; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Radiation Protection and Nuclear Materials; Notice of Meeting

    The ACRS Subcommittee on Radiation Protection and Nuclear Materials will hold a meeting on March 2, 2016, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.

    The meeting will be open to public attendance.

    The agenda for the subject meeting shall be as follows:

    Tuesday, March 2, 2016—8:30 a.m. Until 12:00 p.m.

    The Subcommittee will review draft NUREG/CR-7209, “A Compendium of Spent Fuel Transportation Package Response Analyses to Severe Fire Accident Scenarios.” The Subcommittee will hear presentations by and hold discussions with the NRC staff and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.

    Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Christopher Brown (Telephone 301-415-7111 or Email: [email protected]) five days prior to the meeting, if possible, so that appropriate arrangements can be made. Thirty-five hard copies of each presentation or handout should be provided to the DFO thirty minutes before the meeting. In addition, one electronic copy of each presentation should be emailed to the DFO one day before the meeting. If an electronic copy cannot be provided within this timeframe, presenters should provide the DFO with a CD containing each presentation at least thirty minutes before the meeting. Electronic recordings will be permitted only during those portions of the meeting that are open to the public. Detailed procedures for the conduct of and participation in ACRS meetings were published in the Federal Register on October 21, 2015 (80 FR 63846).

    Detailed meeting agendas and meeting transcripts are available on the NRC Web site at http://www.nrc.gov/reading-rm/doc-collections/acrs. Information regarding topics to be discussed, changes to the agenda, whether the meeting has been canceled or rescheduled, and the time allotted to present oral statements can be obtained from the Web site cited above or by contacting the identified DFO. Moreover, in view of the possibility that the schedule for ACRS meetings may be adjusted by the Chairman as necessary to facilitate the conduct of the meeting, persons planning to attend should check with these references if such rescheduling would result in a major inconvenience.

    If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (Telephone 240-888-9835) to be escorted to the meeting room.

    Dated: February 4, 2016. Mark L. Banks, Chief, Technical Support Branch, Advisory Committee on Reactor Safeguards.
    [FR Doc. 2016-03371 Filed 2-17-16; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Reliability and PRA Notice of Meeting

    The ACRS Subcommittee on Reliability and PRA will hold a meeting on March 1, 2016, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.

    The meeting will be open to public attendance with the exception of portions that m