Federal Register Vol. 81, No.42,

Federal Register Volume 81, Issue 42 (March 3, 2016)

Page Range11091-11405
FR Document

Current View
Page and SubjectPDF
81 FR 11304 - Temporary Emergency Committee of the Board of Governors; Sunshine Act MeetingPDF
81 FR 11097 - Women's History Month, 2016PDF
81 FR 11095 - National Colorectal Cancer Awareness Month, 2016PDF
81 FR 11093 - Irish-American Heritage Month, 2016PDF
81 FR 11091 - American Red Cross Month, 2016PDF
81 FR 11343 - Culturally Significant Objects Imported for Exhibition Determinations: “Pergamon and the Hellenistic Kingdoms of the Ancient World” ExhibitionPDF
81 FR 11266 - Farm Credit Administration Board; Sunshine Act; Regular MeetingPDF
81 FR 11309 - Sunshine Act MeetingPDF
81 FR 11288 - Agency Information Collection Activities: Application for T Nonimmigrant Status; Application for Immediate Family Member of T-1 Recipient; and Declaration of Law Enforcement Officer for Victim of Trafficking in Persons, Form I-914 and Supplements A and B; Extension, Without Change, of a Currently Approved CollectionPDF
81 FR 11294 - NASA Advisory Council; Technology, Innovation and Engineering Committee; MeetingPDF
81 FR 11347 - Notice of Intent To Rule on Request To Release Airport Property at the Gainesville Municipal Airport in Gainesville, TexasPDF
81 FR 11346 - Noise Compatibility Program Notice, Lafayette Regional Airport, Lafayette, LouisianaPDF
81 FR 11340 - Women-Owned Small Business Federal Contract Program; Identification of Eligible IndustriesPDF
81 FR 11361 - Proposed Collection; Comment Request for Regulation ProjectPDF
81 FR 11113 - Establishment of the Loess Hills District Viticultural AreaPDF
81 FR 11204 - Proposed Agency Information CollectionPDF
81 FR 11121 - Fluensulfone; Pesticide Tolerance for Emergency ExemptionPDF
81 FR 11209 - Notice of Final Decision To Reissue the Ineos Nitriles USA LLC Land-Ban ExemptionPDF
81 FR 11295 - Vogtle Electric Generating Station, Units 3 and 4; Southern Nuclear Operating Company; Addition of Instruments to Design Reliability Assurance Program (D-RAP)PDF
81 FR 11209 - Clean Air Act Operating Permit Program; Petition for Objection to State Operating Permit for Southwestern Electric Power Company H.W. Pirkey Power Plant in TexasPDF
81 FR 11296 - In The Matter of Duke Energy Corporation, Crystal River Nuclear Generating Station, Independent Spent Fuel Storage Installation: Order Modifying License (Effective Immediately)PDF
81 FR 11302 - Operator Licensing Examination Standards for Power ReactorsPDF
81 FR 11287 - Agency Information Collection Activities: Deferral of Duty on Large Yachts Imported for SalePDF
81 FR 11344 - Environmental Impact Statement-Multiple Reservoirs Land Management PlansPDF
81 FR 11268 - Privacy Act of 1974; Systems of RecordsPDF
81 FR 11118 - Drawbridge Operation Regulation; Saginaw River, Bay City, MIPDF
81 FR 11346 - Public Notice for Waiver for Aeronautical Land-Use Assurance at Fort Worth Spinks Airport, Fort Worth, TXPDF
81 FR 11199 - Intent To Prepare a Draft Beaver Lake Master Plan and Shoreline Management Plan and Environmental Assessment To Investigate Potential Significant Impacts, Either Positive or Negative, to Beaver Lake's Authorized Purposes of Flood Risk Management, Hydropower, Water Supply, Recreation, and Fish and WildlifePDF
81 FR 11275 - Privacy Act of 1974; Effective Date-April 2, 2016; Expiration Date-October 2, 2017PDF
81 FR 11276 - Privacy Act of 1974; CMS Computer Match No. 2016-07; HHS Computer Match No. 1602; Effective Date-April 2, 2016; Expiration Date-October 2, 2017PDF
81 FR 11202 - Jordan Cove Energy Project, L.P.; Amendment of Application for Long-Term, Authorization To Export Liquefied Natural Gas to Non-Free Trade Agreement NationsPDF
81 FR 11274 - Privacy Act of 1974; CMS Computer Match No. 2016-11; HHS Computer Match No. 1601; Effective Date-April 2, 2016; Expiration Date-October 2, 2017PDF
81 FR 11359 - Low Income Taxpayer Clinic Grant Program; Availability of 2016 Supplemental Grant Application PeriodPDF
81 FR 11179 - Welded Stainless Pressure Pipe From India: Postponement of Preliminary Determination of Antidumping Duty InvestigationPDF
81 FR 11187 - Certain Uncoated Paper From Indonesia and the People's Republic of China: Amended Final Affirmative Countervailing Duty Determination and Countervailing Duty Order (Indonesia) and Countervailing Duty Order (People's Republic of China)PDF
81 FR 11173 - Foreign-Trade Zone (FTZ) 76-Bridgeport, Connecticut; Authorization of Production Activity; MannKind Corporation, Subzone 76B (Inhalable Insulin), Danbury, ConnecticutPDF
81 FR 11173 - Foreign-Trade Zone (FTZ) 39-Dallas/Fort Worth, Texas, Authorization of Production Activity, KONE Inc., (Elevator Parts), Allen, TexasPDF
81 FR 11177 - Diamond Sawblades and Parts Thereof From the People's Republic of China: Initiation and Preliminary Results of Changed Circumstances ReviewPDF
81 FR 11110 - Expansion of the Willamette Valley Viticultural AreaPDF
81 FR 11179 - Initiation of Antidumping and Countervailing Duty Administrative ReviewsPDF
81 FR 11174 - Certain Uncoated Paper From Australia, Brazil, Indonesia, the People's Republic of China, and Portugal: Amended Final Affirmative Antidumping Determinations for Brazil and Indonesia and Antidumping Duty OrdersPDF
81 FR 11212 - Twenty-Ninth Update of the Federal Agency Hazardous Waste Compliance DocketPDF
81 FR 11195 - 36(b)(1) Arms Sales NotificationPDF
81 FR 11193 - 36(b)(1) Arms Sales NotificationPDF
81 FR 11359 - Office of the SecretaryPDF
81 FR 11201 - Agency Information Collection Activities; Comment Request; Financial Report for the Endowment Challenge Grant Program and Institutional Service Endowment ActivitiesPDF
81 FR 11282 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed MeetingPDF
81 FR 11281 - National Institute of General Medical Sciences; Notice of Closed MeetingPDF
81 FR 11281 - National Cancer Institute; Notice of Closed MeetingsPDF
81 FR 11280 - National Cancer Institute; Notice of MeetingPDF
81 FR 11347 - Petition for Waiver of CompliancePDF
81 FR 11192 - Endangered and Threatened Species; Take of Anadromous FishPDF
81 FR 11344 - Lone Star Railroad, Inc. and Southern Switching Company-Track Construction and Operation Exemption-in Howard County, TexasPDF
81 FR 11192 - Mid-Atlantic Fishery Management Council (MAFMC); MeetingPDF
81 FR 11273 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
81 FR 11295 - National Council on the Arts 187th MeetingPDF
81 FR 11161 - Safety Zone; Xterra Swim, Myrtle Beach, SC Intracoastal Waterway; Myrtle Beach, SCPDF
81 FR 11289 - Agency Information Collection Activities: Consideration of Deferred Action for Childhood Arrivals, Form I-821D; Extension, Without Change, of a Currently Approved CollectionPDF
81 FR 11205 - Combined Notice of FilingsPDF
81 FR 11267 - Notice to All Interested Parties of the Termination of the Receivership of 10504, Eastside Commercial Bank, Conyers, GeorgiaPDF
81 FR 11267 - Notice to All Interested Parties of the Termination of the Receivership of 10421, First Guaranty Bank and Trust Company of Jacksonville, Jacksonville, FloridaPDF
81 FR 11267 - Notice to All Interested Parties of the Termination of the Receivership of 10279 Community National Bank At Bartow; Bartow, FloridaPDF
81 FR 11267 - Notice to All Interested Parties of the Termination of the Receivership of 10260 Olde Cypress Community Bank, Clewiston, FloridaPDF
81 FR 11168 - Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Northeast Groundfish Fishery; Recreational Management MeasuresPDF
81 FR 11166 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Gag Management MeasuresPDF
81 FR 11270 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMBPDF
81 FR 11206 - ANR Pipeline Company; Notice of Intent To Prepare an Environmental Assessment for the Proposed Collierville Expansion Project and Request for Comments on Environmental IssuesPDF
81 FR 11208 - Combined Notice of Filings #1PDF
81 FR 11290 - Generalized System of Preferences: Possible Modifications, 2015 ReviewPDF
81 FR 11348 - Notice of Proposed Equal Employment Opportunity Program CircularPDF
81 FR 11124 - Freedom of Information Act RegulationsPDF
81 FR 11164 - Semipostal Stamp ProgramPDF
81 FR 11290 - Environmental Impact Statement for the San Juan Promenade Extension Project From El Morro Floating Battery Area to San Juan Bautista PlazaPDF
81 FR 11290 - Minor Boundary Revision at Saratoga National Historical ParkPDF
81 FR 11099 - Application Process for Designation of Rural Area under Federal Consumer Financial Law; Procedural RulePDF
81 FR 11197 - 36(b)(1) Arms Sales NotificationPDF
81 FR 11294 - Section 512 Study: Extension of Comment PeriodPDF
81 FR 11283 - Notice of Proposed Policy Statement on Historic Preservation and Community RevitalizationPDF
81 FR 11304 - Notice of Applications for Deregistration Under Section 8(f) of the Investment Company Act of 1940PDF
81 FR 11309 - Self-Regulatory Organizations; ISE Gemini, LLC; Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change To Amend Rule 804(g)PDF
81 FR 11305 - Self-Regulatory Organizations; International Securities Exchange, LLC; Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change To Amend Rule 804(g)PDF
81 FR 11307 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Adopt a Kill SwitchPDF
81 FR 11337 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend FINRA Rule 7620A (FINRA/Nasdaq Trade Reporting Facility Reporting Fees)PDF
81 FR 11335 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Fees as They Apply to the Equity Options PlatformPDF
81 FR 11311 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Adopting Investigation, Disciplinary, Sanction, and Other Procedural Rules Modeled on the Rules of the New York Stock Exchange LLC and Certain Conforming and Technical ChangesPDF
81 FR 11303 - New Postal ProductPDF
81 FR 11291 - Comment Request for Information Collection for Contractor Information Gathering, Extension Without ChangesPDF
81 FR 11280 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 11282 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 11282 - National Institute of Allergy and Infectious Diseases; Amended Notice of MeetingPDF
81 FR 11302 - Rate AdjustmentPDF
81 FR 11160 - Utility Allowances SubmeteringPDF
81 FR 11358 - Supreme Corporation, Receipt of Petition for Decision of Inconsequential NoncompliancePDF
81 FR 11354 - Decision That Certain Nonconforming Model Year 2006-2007 European Market Ferrari 599 GTB Passenger Cars Manufactured Prior to September 2007 Are Eligible for ImportationPDF
81 FR 11120 - Approval of Arizona Air Plan Revisions; Phoenix, Arizona; Second 10-Year Carbon Monoxide Maintenance PlanPDF
81 FR 11189 - Pacific Fishery Management Council; Notice of Intent To Prepare an Environmental Impact StatementPDF
81 FR 11201 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Annual Performance Report for Gaining Early Awareness and Readiness for Undergraduate ProgramsPDF
81 FR 11104 - Utility Allowances SubmeteringPDF
81 FR 11351 - Denial of Motor Vehicle Defect PetitionPDF
81 FR 11200 - Agency Information Collection Activities; Comment Request; Formula Grant EASIE Electronic Application System for Indian EducationPDF
81 FR 11278 - Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “Consumer Health Data Aggregator Challenge”PDF
81 FR 11151 - Effective Date of Requirement for Premarket Approval for Blood LancetsPDF
81 FR 11140 - General and Plastic Surgery Devices; Reclassification of Blood LancetsPDF
81 FR 11116 - Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972PDF
81 FR 11134 - Airworthiness Directives; BLANIK LIMITED GlidersPDF
81 FR 11132 - Airworthiness Directives; Viking Air Limited AirplanesPDF
81 FR 11166 - Petitions for Reconsideration of Action in a Rulemaking Proceeding; CorrectionPDF
81 FR 11139 - Proposed Establishment of Class E Airspace; Harlan, KYPDF
81 FR 11136 - Proposed Establishment of Class D Airspace: Destin, FL; Duke Field, Eglin AFB, FL; Proposed Revocation of Class D Airspace; Eglin AF Aux No 3 Duke Field, FL; and Proposed Amendment of Class D and E Airspace; Eglin Air Force Base, FL; Eglin Hurlburt Field, FL; and Crestview, FLPDF
81 FR 11102 - Establishment of Class E Airspace, South Naknek, AKPDF
81 FR 11103 - Amendment of Class D and Class E Airspace; Minot, NDPDF
81 FR 11277 - Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “Provider User-Experience Challenge”PDF
81 FR 11363 - Passenger Screening Using Advanced Imaging TechnologyPDF
81 FR 11173 - Deschutes Provincial Advisory CommitteePDF

Issue

81 42 Thursday, March 3, 2016 Contents Agriculture Agriculture Department See

Forest Service

Alcohol Tobacco Tax Alcohol and Tobacco Tax and Trade Bureau RULES Viticultural Areas: Loess Hills District; Establishment, 11113-11116 2016-04760 Willamette Valley; Expansion, 11110-11113 2016-04710 Consumer Financial Protection Bureau of Consumer Financial Protection RULES Application Process for Designation of Rural Area under Federal Consumer Financial Law; Procedural Rule, 11099-11102 2016-04643 Centers Medicare Centers for Medicare & Medicaid Services NOTICES Privacy Act; Computer Matching Program, 11274-11277 2016-04732 2016-04734 2016-04735 Coast Guard Coast Guard RULES Drawbridge Operations: Saginaw River, Bay City, MI, 11118-11120 2016-04743 PROPOSED RULES Safety Zones: Xterra Swim, Myrtle Beach, SC Intracoastal Waterway, Myrtle Beach, SC, 11161-11164 2016-04664 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Copyright Office Copyright Office, Library of Congress NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Section 512 Study; Extension, 11294 2016-04641 Defense Department Defense Department See

Engineers Corps

See

Navy Department

NOTICES Arms Sales, 11193-11199 2016-04642 2016-04683 2016-04684
Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Annual Performance Report for Gaining Early Awareness and Readiness for Undergraduate Programs, 11201 2016-04608 Financial Report for the Endowment Challenge Grant Program and Institutional Service Endowment Activities, 11201-11202 2016-04675 Formula Grant EASIE Electronic Application System for Indian Education, 11200-11201 2016-04600 Employment and Training Employment and Training Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Contractor Information Gathering, 11291-11294 2016-04631 Energy Department Energy Department See

Energy Information Administration

See

Federal Energy Regulatory Commission

NOTICES Authorizations to Export Liquefied Natural Gas: Jordan Cove Energy Project, LP; Amendment of Application, 11202-11203 2016-04733
Energy Information Energy Information Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 11204-11205 2016-04759 Engineers Engineers Corps NOTICES Environmental Assessments; Availability, etc.: Draft Master Plan and Shoreline Management Plan; Beaver Lake Flood Risk Management, Hydropower, Water Supply, Recreation, and Fish and Wildlife, 11199-11200 2016-04736 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Arizona: Phoenix Second 10-Year Carbon Monoxide Maintenance Plan, 11120-11121 2016-04614 Pesticide Tolerances; Emergency Exemptions: Fluensulfone, 11121-11124 2016-04757 NOTICES Clean Air Act Operating Permit Program: Texas: Petition for Objection to State Operating Permit Southwestern Electric Power Co. H.W. Pirkey Power Plant, 11209 2016-04752 Land-Ban Exemptions: Ineos Nitriles USA, LLC, 11209-11212 2016-04756 Twenty-Ninth Update of the Federal Agency Hazardous Waste Compliance Docket, 11212-11266 2016-04692 Farm Credit Farm Credit Administration NOTICES Meetings; Sunshine Act, 11266-11267 2016-04814 Federal Aviation Federal Aviation Administration RULES Amendment of Class D and Class E Airspace: Minot, ND, 11103 2016-04482 Establishment of Class E Airspace: South Naknek, AK, 11102-11103 2016-04489 PROPOSED RULES Airworthiness Directives: BLANIK LIMITED Gliders, 11134-11136 2016-04541 Viking Air Limited Airplanes, 11132-11134 2016-04539 Establishment of Class D Airspace; Revocation of Class D Airspace; and Amendment of Class D and E Airspace: Destin, FL; Duke Field, Eglin AFB, FL; Eglin AF Aux No 3 Duke Field, FL; Eglin Air Force Base, FL; Eglin Hurlburt Field, FL; and Crestview, FL, 11136-11139 2016-04491 Establishment of Class E Airspace: Harlan, KY, 11139-11140 2016-04496 NOTICES Noise Compatibility Programs: Lafayette Regional Airport, Lafayette, LA, 11346-11347 2016-04763 Release of Airport Property Requests: Gainesville Municipal Airport, Gainesville, TX, 11347 2016-04764 Waivers for Aeronautical Land-Use Assurance: Fort Worth Spinks Airport, Fort Worth, TX, 11346 2016-04737 Federal Communications Federal Communications Commission PROPOSED RULES Petitions for Reconsideration of Action in a Rulemaking Proceeding; Correction, 11166 2016-04521 Federal Deposit Federal Deposit Insurance Corporation NOTICES Terminations of Receivership: Community National Bank At Bartow, Bartow, FL, 11267-11268 2016-04659 Eastside Commercial Bank, Conyers, GA, 11267 2016-04661 First Guaranty Bank and Trust Co. of Jacksonville, Jacksonville, FL, 11267 2016-04660 Olde Cypress Community Bank, Clewiston, FL, 11267 2016-04658 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 11205-11206, 11208-11209 2016-04651 2016-04652 2016-04662 Environmental Assessments; Availability, etc.: ANR Pipeline Co., Collierville Expansion Project, 11206-11208 2016-04653 Federal Housing Finance Agency Federal Housing Finance Agency NOTICES Privacy Act; Systems of Records, 11268-11270 2016-04744 Federal Railroad Federal Railroad Administration NOTICES Petitions for Waivers of Compliance, 11347-11348 2016-04670 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 11270-11273 2016-04654 Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 11273 2016-04622 2016-04666 Federal Transit Federal Transit Administration NOTICES Proposed Equal Employment Opportunity Program Circular, 11348-11351 2016-04648 Food and Drug Food and Drug Administration PROPOSED RULES General and Plastic Surgery Devices: Blood Lancets; Reclassification, 11140-11151 2016-04578 Premarket Approval for Blood Lancets; Effective Date of Requirement, 11151-11160 2016-04579 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities; Authorizations: Foreign-Trade Zone 39, Dallas/Fort Worth, TX; KONE Inc. (Elevator Parts), Allen, TX, 11173 2016-04714 Foreign-Trade Zone 76, Bridgeport, CT; MannKind Corp. Subzone 76B (Inhalable Insulin), Danbury, CT, 11173-11174 2016-04715 Forest Forest Service NOTICES Meetings: Deschutes Provinicial Advisory Committee, 11173 2016-03567 Health and Human Health and Human Services Department See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

National Institutes of Health

NOTICES Consumer Health Data Aggregator Challenge; Requirements and Registration, 11278-11280 2016-04596 Provider User-Experience Challenge; Requirements and Registration, 11277-11278 2016-04466
Historic Historic Preservation, Advisory Council NOTICES Policy Statement on Historic Preservation and Community Revitalization, 11283-11287 2016-04640 Homeland Homeland Security Department See

Coast Guard

See

Transportation Security Administration

See

U.S. Citizenship and Immigration Services

See

U.S. Customs and Border Protection

Interior Interior Department See

National Park Service

RULES Freedom of Information Act Regulations, 11124-11131 2016-04647
Internal Revenue Internal Revenue Service RULES Utility Allowances Submetering, 11104-11110 2016-04606 PROPOSED RULES Utility Allowances Submetering, 11160-11161 2016-04618 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 11361 2016-04761 Low Income Taxpayer Clinic Grant Program: 2016 Supplemental Grant Application Period, 11359-11360 2016-04720 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews, 11179-11187 2016-04702 Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Uncoated Paper from Australia, Brazil, Indonesia, the People's Republic of China, 11174-11177 2016-04699 Certain Uncoated Paper from Indonesia and the People's Republic of China, 11187-11189 2016-04717 Diamond Sawblades and Parts Thereof from the People's Republic of China: Initiation and Preliminary Results of Changed Circumstances Review, 11177-11179 2016-04711 Welded Stainless Pressure Pipe from India: Postponement of Preliminary Determination, 11179 2016-04719 International Trade Com International Trade Commission NOTICES Investigations; Determinations, Modifications, and Rulings, etc.: Generalized System of Preferences: Possible Modifications, 2015 Review, 11290-11291 2016-04649 Labor Department Labor Department See

Employment and Training Administration

Library Library of Congress See

Copyright Office, Library of Congress

NASA National Aeronautics and Space Administration NOTICES Meetings: NASA Advisory Council; Technology, Innovation and Engineering Committee, 11294 2016-04766 National Endowment for the Arts National Endowment for the Arts NOTICES Meetings: National Council on the Arts, 11295 2016-04665 National Foundation National Foundation on the Arts and the Humanities See

National Endowment for the Arts

National Highway National Highway Traffic Safety Administration NOTICES Denial of Motor Vehicle Defect Petition, 11351-11354 2016-04605 Importation Eligibility; Approvals: Model Year 2006-2007 European Market Ferrari 599 GTB Passenger Cars Manufactured Prior to September 2007, 11354-11358 2016-04616 Petitions for Inconsequential Noncompliance: Supreme Corp., 11358-11359 2016-04617 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 2016-04629 11280-11282 2016-04630 National Cancer Institute, 2016-04671 11280-11282 2016-04672 National Institute of Allergy and Infectious Diseases, 11282 2016-04628 National Institute of General Medical Sciences, 11281 2016-04673 National Institute on Alcohol Abuse and Alcoholism, 11282-11283 2016-04674 National Oceanic National Oceanic and Atmospheric Administration PROPOSED RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Reef Fish Fishery of the Gulf of Mexico; Gag Management Measures, 11166-11168 2016-04655 Fisheries of the Northeastern United States: Northeast Groundfish Fishery; Recreational Management Measures, 11168-11172 2016-04656 NOTICES Endangered and Threatened Species: Takes of Anadromous Fish, 11192-11193 2016-04669 Environmental Impact Statements; Availability, etc.: Pacific Fishery Management Council, 11189-11192 2016-04612 Meetings: Mid-Atlantic Fishery Management Council, 11192 2016-04667 National Park National Park Service NOTICES Environmental Impact Statements; Availability, etc.: San Juan Promenade Extension Project from El Morro Floating Battery Area to San Juan Bautista Plaza, 11290 2016-04645 Minor Boundary Revision at Saratoga National Historical Park, 11290 2016-04644 Navy Navy Department RULES Certifications and Exemptions under the International Regulations for Preventing Collisions at Sea, 1972, 11116-11118 2016-04547 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Exemptions and Combined License Amendments: Vogtle Electric Generating Station, Units 3 and 4; Southern Nuclear Operating Co.; Addition of Instruments to Design Reliability Assurance Program, 11295-11296 2016-04754 License Modifications: Duke Energy Corp., Crystal River Nuclear Generating Plant Independent Spent Fuel Storage Installation, 11296-11302 2016-04749 Operator Licensing Examination Standards for Power Reactors, 11302 2016-04748 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 11303-11304 2016-04632 Rate Adjustments, 11302-11303 2016-04621 Postal Service Postal Service PROPOSED RULES Semipostal Stamp Program, 11164-11166 2016-04646 NOTICES Meetings; Sunshine Act, 11304 2016-04904 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: American Red Cross Month (Proc. 9399), 11091-11092 2016-04842 Irish-American Heritage Month (Proc. 9400), 11093-11094 2016-04865 National Colorectal Cancer Awareness Month (Proc. 9401), 11095-11096 2016-04871 Women's History Month (Proc. 9402), 11097-11098 2016-04875 Securities Securities and Exchange Commission NOTICES Applications: Deregistrations under the Investment Company Act, 11304-11305 2016-04639 Meetings; Sunshine Act, 11309 2016-04792 Self-Regulatory Organizations; Proposed Rule Changes: EDGX Exchange, Inc., 11335-11337 2016-04634 Financial Industry Regulatory Authority, Inc., 11337-11340 2016-04635 International Securities Exchange, LLC, 11305-11307 2016-04637 ISE Gemini, LLC, 11309-11311 2016-04638 NASDAQ OMX PHLX, LLC, 11307-11309 2016-04636 NYSE MKT, LLC, 11311-11335 2016-04633 Small Business Small Business Administration NOTICES Women-Owned Small Business Federal Contract Program: Identification of Eligible Industries, 11340-11343 2016-04762 State Department State Department NOTICES Culturally Significant Objects Imported for Exhibition: Pergamon and the Hellenistic Kingdoms of the Ancient World, 11343-11344 2016-04834 Surface Transportation Surface Transportation Board NOTICES Track Construction and Operation Exemptions: Lone Star Railroad, Inc. and Southern Switching Co., Howard County, TX, 11344 2016-04668 Tennessee Tennessee Valley Authority NOTICES Environmental Impact Statements; Availability, etc.: Multiple Reservoirs Land Management Plans, 11344-11346 2016-04745 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Railroad Administration

See

Federal Transit Administration

See

National Highway Traffic Safety Administration

NOTICES Commuter Authority Applications: Exec Air Inc. of Naples D/B/A Execair, 11359 2016-04676
Security Transportation Security Administration RULES Passenger Screening Using Advanced Imaging Technology, 11364-11405 2016-04374 Treasury Treasury Department See

Alcohol and Tobacco Tax and Trade Bureau

See

Internal Revenue Service

U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for T Nonimmigrant Status; Application for Immediate Family Member of T-1 Recipient; and Declaration of Law Enforcement Officer for Victim of Trafficking in Persons, etc., 11288 2016-04769 Consideration of Deferred Action for Childhood Arrivals, 11289-11290 2016-04663 Customs U.S. Customs and Border Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Deferral of Duty on Large Yachts Imported for Sale, 11287 2016-04747 Separate Parts In This Issue Part II Homeland Security Department, Transportation Security Administration, 11364-11405 2016-04374 Reader Aids

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

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

81 42 Thursday, March 3, 2016 Rules and Regulations BUREAU OF CONSUMER FINANCIAL PROTECTION 12 CFR Part 1026 RIN 3170-AA58 Application Process for Designation of Rural Area under Federal Consumer Financial Law; Procedural Rule AGENCY:

Bureau of Consumer Financial Protection.

ACTION:

Final rule.

SUMMARY:

The Bureau of Consumer Financial Protection (Bureau) is adopting a procedural rule establishing an application process under which a person may identify an area that has not been designated by the Bureau as a rural area for purposes of a Federal consumer financial law and apply for such area to be so designated. Currently the Bureau designates rural areas for purposes of certain Federal consumer financial laws relating to mortgage lending.

DATES:

This final rule is effective March 3, 2016. The Bureau will begin accepting applications submitted according to the procedure established herein on March 31, 2016.

FOR FURTHER INFORMATION CONTACT:

Carl Owens, Terry J. Randall, and James Wylie, Counsels, Office of Regulations, Consumer Financial Protection Bureau, 1700 G Street NW., Washington, DC 20552, at 202-435-7700.

SUPPLEMENTARY INFORMATION: I. Background A. Rural Area Designations in Federal Consumer Financial Law

Federal consumer financial law provides special provisions and exemptions for certain creditors doing business in rural areas. For example, an exemption from the requirement to establish an escrow account for a higher-priced mortgage loan (escrow exception) partially depends on whether the creditor has extended credit secured by properties in rural areas1 and a special provision permits certain small creditors to originate balloon-payment qualified mortgages if the creditor has extended a sufficient amount of credit secured by properties in rural areas.2

1 12 CFR 1026.35(b), 1026.35(b)(2)(iii)(A), and 1026.35(b)(2)(iv)(A).

2 12 CFR 1026.43(f)(1).

The exemption and special provision listed above were adopted as part of the Bureau's mortgage rules implementing title XIV of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act),3 pursuant to its authority under the Truth in Lending Act (TILA), as amended by the Dodd-Frank Act. The Bureau adopted revisions to these provisions that were published in the Federal Register on October 2, 2015.4 These revisions included raising the loan origination limit for determining eligibility for small creditor status, including the assets of a creditor's affiliates that regularly extended covered transactions in the calculation of the asset limit for small-creditor status, expanding the definition of rural and underserved areas by adding census blocks that are not in urban areas as defined by the U.S. Census Bureau to the existing county-based definition, and extending the transition period that allowed certain small creditors to make balloon-payment qualified mortgages regardless of whether they operated predominantly in rural or underserved areas to April 1, 2016. Title LXXXIX of the Fixing America's Surface Transportation Act, entitled the HELP Rural Communities Act,5 contained amendments to TILA and new provisions relating to the designation by the Bureau of rural areas under “a Federal consumer financial law (as defined under section 1002 of the [Dodd-Frank Act]).”

3 Dodd-Frank Wall Street Reform and Consumer Protection Act, Public Law 111-203, 124 Stat. 1376 (2010).

4 Amendments Relating to Small Creditors and Rural or Underserved Areas Under the Truth in Lending Act (Regulation Z), 80 FR 59943, 59944 (Oct. 2, 2015).

5 HELP Rural Communities Act, Public Law 114-94 (2015).

B. HELP Rural Communities Act Application Process

Section 89002 of the HELP Rural Communities Act requires the Bureau to establish an application process under which a person may apply to have an area designated by the Bureau as a rural area for purposes of a Federal consumer financial law. Section 89002 of the HELP Rural Communities Act also provides details on many of the features of the process, including evaluation criteria for the Bureau's determinations on these applications, a period for public comment on the applications, and a sunset date for the application process of two years after the date of enactment of the HELP Rural Communities Act. The Bureau is issuing this procedural rule to establish the process required by section 89002 of the HELP Rural Communities Act.

Section 89003 of the HELP Rural Communities Act separately made amendments to TILA's test with respect to the Bureau's discretionary authority to establish the escrow exemption and a special provision that permits certain small creditors to originate balloon-payment qualified mortgages. This procedural rule relates solely to the application process under section 89002 and not to those amendments. The Bureau understands that the HELP Rural Communities Act amendments to TILA may create some uncertainty for creditors regarding how the Bureau will exercise its newly expanded discretionary authority with respect to the exemption and special provision in question, particularly in light of the April 1, 2016, expiration of the temporary period that allows certain small creditors to originate balloon-payment qualified mortgages and balloon-payment high cost mortgages, regardless of their operations in rural or underserved areas.6 The Bureau expects to issue another notice in the Federal Register shortly concerning the amendments under section 89003. The Bureau also anticipates providing an interpretation of the term “rural area” in section 89002(a) of the HELP Rural Communities Act in that notice that would define the type of area for which applicants may submit applications pursuant to this rule. The Bureau plans to issue that notice before it begins accepting applications pursuant to this rule on March 31, 2016.

6 Amendments Relating to Small Creditors and Rural or Underserved Areas Under the Truth in Lending Act (Regulation Z), 80 FR 59943, 59968 (amending 12 CFR 1026.43(e)(i)(B)(ii)) (Oct. 2, 2015).

II. Procedural Requirements A. Administrative Procedure Act

No notice of proposed rulemaking is required under the Administrative Procedure Act (APA) because this rule relates solely to agency procedure and practice.7 Because the rule relates solely to agency procedure and practice, it is not substantive, and therefore is not subject to the 30-day delayed effective date for substantive rules under section 553(d) of the APA.8 The Bureau also believes that this final rule meets the requirements for the section 553(d)(3) exception for good cause. Congress, in section 89002(a) of the HELP Rural Communities Act, required the Bureau to establish an application process not later than 90 days after the enactment of the HELP Rural Communities Act. Because the application process has a required sunset period of two years from the enactment of the HELP Rural Communities Act under section 89002(g), there is good cause to establish the procedure immediately to provide the most time possible for applicants to use the application process. Therefore, the Bureau finds that there is good cause to make the final rule effective on March 3, 2016. Though this final rule establishes the application process immediately, the Bureau will not begin accepting applications until March 31, 2016. In addition the Bureau currently expects to issue a notice concerning the amendments under section 89003 of the HELP Rural Communities Act before March 31, 2016, in light of the April 1, 2016, expiration of the temporary provisions referenced in part I above, and the Bureau expects that some potential applicants may wish to consider the content of that notice in determining whether to apply. The delay also will afford some time for the Bureau to prepare internal procedures to receive applications.

7 5 U.S.C. 553(b).

8 5 U.S.C. 553(d).

B. Regulatory Flexibility Act

Because no notice of proposed rulemaking is required, the Regulatory Flexibility Act does not require an initial or final regulatory flexibility analysis.9

9 5 U.S.C. 603-604.

III. Legal Authority

The Bureau is issuing this rule pursuant to its authority under section 1022(b)(1) of the Dodd-Frank Act, which authorizes the Bureau to prescribe rules as may be necessary or appropriate to enable the Bureau to administer and carry out the purposes and objectives of Federal consumer financial law.10 The Bureau is also issuing this rule pursuant to the requirements of section 89002(a) of the HELP Rural Communities Act.11

10 12 U.S.C. 5512(b)(1).

11 Public Law 114-94, Title LXXXIX (2015).

IV. Effective Date

The final rule is effective March 3, 2016. The Bureau will begin accepting applications submitted according to the procedure established herein on March 31, 2016. The HELP Rural Communities Act provides that section 89002, which requires the Bureau to establish this process, shall cease to have any force or effect on December 4, 2017.

V. Paperwork Reduction Act

According to the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.) the Bureau may not conduct or sponsor a collection of information as defined by the PRA and, notwithstanding any other provisions of law, persons are not required to respond to a collection of information unless it displays a current valid Office of Management and Budget (OMB) control number. The collections of information contained in this procedural rule, and identified as such, have been approved by OMB and assigned the control number 3170-0061. The information collection contained in this procedural rule is required to obtain a benefit. The information collection under this procedural rule is an application to request that the Bureau apply a rural designation to a specific geographic area.

VI. Application Process and Instructions A. Submission

The application shall be addressed to the CFPB Rural Application Coordinator, Bureau of Consumer Financial Protection.

It may be submitted using one of the following methods:

Email: [email protected]

Mail: ATTN: CFPB Rural Application Coordinator, Research, Markets, and Regulations Division, Consumer Financial Protection Bureau, 1700 G Street NW., Washington, DC 20552.

Hand Delivery/Courier: ATTN: CFPB Rural Application Coordinator, Research, Markets, and Regulations Division, Consumer Financial Protection Bureau, 1275 First Street NE., Washington, DC 20002.

If the application is submitted by email, it and all attachments described below in part VI.C shall be compiled into a single portable document format (PDF) file. If the application is submitted by mail, hand delivery, or courier, the applicant shall provide three copies of the complete application. The application shall not exceed 10 pages.

B. Content

The application shall contain the following sections:

1. Area Identified

The application shall specifically identify the area requested to be designated as a rural area and the State in which the area is located. An application may identify more than one area if the areas are contiguous (e.g., counties that share a border). Additional areas that are not contiguous (e.g., counties that do not share a border) must be identified in separate applications.

The application shall provide information describing the area identified, for example:

a. The county that comprises the area or in which the area is located; or

b. The Census block that comprises the area, unless the area is comprised entirely of whole counties.

2. Justification for Designation as Rural Area

The applicant shall provide the following information about the evaluation criteria in section 89002(b) of the HELP Rural Communities Act:

a. Census Bureau

The application shall state whether the area identified is classified as rural or urban by the Director of the Bureau of the Census and, if rural, explain the basis for concluding that the area identified was so classified, including by attaching any supporting documentation as described below in part VI.C.

b. Office of Management and Budget

The application shall state whether the area identified is classified as either a metropolitan area, a micropolitan area, or neither by the Director of the Office of Management and Budget and, if neither, explain the basis for concluding that the area identified was so classified, including by attaching any supporting documentation as described below in part VI.C.

c. Department of Agriculture—Rural Development

The application shall state whether the Secretary of Agriculture has determined that properties in the area identified are eligible for programs of the United States Department of Agriculture Office of Rural Development and, if so, explain the basis for concluding that the Secretary has determined as such, including by attaching any supporting documentation as described below in part VI.C.

d. Department of Agriculture—Rural-Urban Commuting Codes

The application shall state the most recent primary and secondary rural-urban commuting codes from the Department of Agriculture for the area identified or of which the area identified is a part, including by attaching any supporting documentation as described below in part VI.C.

e. State Bank Supervisor

The application shall state whether the State bank supervisor, as defined by 12 U.S.C. 1813(r), of the State where the area identified is located has issued a written opinion concerning whether the area identified should be designated as a rural area. Any such written opinion shall be attached as described below in part VI.C.

f. Population Density

The application shall provide the population density of the area identified expressed as the number of persons per square mile using data from the Bureau of the Census and explain the data relied on, including by attaching supporting documentation as described below in part VI.C. The application shall also provide the population density of any nearby area with a greater population density that has been designated by the Bureau as a rural area.

3. Applicant Information

The application shall include the following information about the applicant:

a. Name

The application shall include the name of the applicant.

b. Contact Information

The application shall include information about how to contact the applicant if the Bureau needs additional information about the request.

c. Living or Doing Business in the State

If the applicant is a natural person, the application shall include only a statement affirming that the applicant lives or does business in the State in which the area identified is located. If the applicant is not a natural person, the application shall include a statement affirming that the applicant does business in the State in which the area identified is located and evidence supporting the statement as an attachment as described in part VI.C. Such evidence could include, for example, evidence of incorporation in the State, evidence of licensure to do business in the State, evidence of licensure to conduct a specific type of business in the State, or evidence of an office in the State. The applicant may redact such evidence to withhold sensitive personal information that is not relevant to establishing that the applicant does business in the State where the area identified is located. The applicant may also state on a cover page to the attachment that it wishes the entire attachment to be withheld from the Federal Register publication of the attachment.

C. Attachments

The application shall include any other documents necessary to provide the required information above as attachments.

D. Further Instructions

Applicants should not include personal information other than information identified above in part VI.B.3. The Bureau is required by the HELP Rural Communities Act to publish the application in the Federal Register. The Bureau may redact the application prior to publication in the Federal Register to withhold any unnecessary personal information included in the application.

VII. Process for Considering Applications A. Receipt of Application and Initial Review

Upon receipt of a request pursuant to this process, the Bureau shall review the request for preliminary matters, including:

1. Completeness of the information set forth above in part VI;

2. Ensuring that the area identified is not already designated as a rural area under the Federal consumer financial laws;

3. Determining if there is an application already pending for the same area identified as described in section 89002(d)(2) of the HELP Rural Communities Act; and

4. Determining if an application for the area identified has been denied less than 90 days before the receipt of the application as described in section 89002(f) of the HELP Rural Communities Act.

If the Bureau determines that the applicant has not submitted a complete application (e.g., because the Bureau cannot ascertain the relevant area from the application), it shall contact the applicant and specify the additional information that is needed to complete an application.

If the Bureau determines that the applicant seeks the designation of a rural area for an area that is already designated as a rural area under the Federal consumer financial laws, for an area for which an application is already pending, for an area for which an application has been denied less than 90 days before the receipt of the application, or if the Bureau determines that the applicant neither lives nor does business in the State in which the area is located, the Bureau shall notify the applicant that the Bureau will not consider whether to designate the area as rural and the reason for not considering the application.

B. Publication of Application in the Federal Register

Not later than 60 days after receipt of a complete application, the Bureau shall publish the application in the Federal Register. The Bureau may redact the application prior to publication in the Federal Register to withhold any unnecessary personal information included in the application, as discussed above in part VI.D.

C. Public Comment on Application

The Bureau shall accept public comments on the application for not fewer than 90 days after publication in the Federal Register.

D. Decision on Designation

The Bureau shall review the information contained in the application and the public comments and, not later than 90 days after the end of the public comment period described above in part VII.C, the Bureau shall grant or deny the application in whole or in part and shall publish such grant or denial in the Federal Register along with an explanation of what factors the Bureau relied on in making such determination. The Bureau shall base its decision on the criteria set forth in section 89002(b) of the HELP Rural Communities Act and the rule of construction in section 89002(c) of the HELP Rural Communities Act. A decision to grant an application in whole or in part shall specify the area designated as a rural area, and the time period during which the designation is effective by reference to the duration of the designations of rural areas under the Federal consumer financial laws.

E. Sunset Date

The HELP Rural Communities Act contemplates a process of up to 240 days for each application, including a minimum of 90 days for public comments. The Bureau will consider any application received before April 8, 2017. The Bureau may, in its discretion, consider an application received on or after April 8, 2017, if it determines that it is possible to complete the designation decision process for that application by the sunset date, based on the time remaining, the complexity of the application, and any other relevant factors. The Bureau will notify the applicant if it determines that it cannot complete the application process, in which case the Bureau shall not consider the application nor publish the application in the Federal Register as described above in part VII.B.

Dated: February 26, 2016. Richard Cordray, Director, Bureau of Consumer Financial Protection.
[FR Doc. 2016-04643 Filed 3-2-16; 8:45 am] BILLING CODE 4810-AM-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2015-3108; Airspace Docket No. 12-AAL-15] Establishment of Class E Airspace, South Naknek, AK AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

This action establishes Class E airspace extending upward from 700 feet above the surface at South Naknek NR 2 Airport, South Naknek, AK, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures developed for the airport.

DATES:

Effective 0901 UTC, May 26, 2016. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES:

FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 29591; telephone: 202-267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.9Z at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT:

Richard Roberts, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4517.

SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at South Naknek NR 2 Airport, South Naknek, AK.

History

On November 24, 2015, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to establish Class E airspace extending upward from 700 feet above the surface at South Naknek NR 2 Airport, South Naknek, AK. (80 FR 73150) FAA-2015-3108. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The Rule

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface within a 6.5-mile radius of the South Naknek NR 2 Airport, South Naknek, AK. This airspace is established to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures developed for the airport.

Regulatory Notices and Analyses

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

Environmental Review

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

Lists of Subjects in 14 CFR Part 71

Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

§ 71.1 [Amended]
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth AAL AK E5 South Naknek, AK [New] South Naknek NR 2 Airport, Alaska (Lat. 58°42′08″ N., long. 157°00′09″ W.) That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of South Naknek NR 2 Airport.
Issued in Seattle, Washington, on February 19, 2016. Christopher Ramirez, Manager, Operations Support Group, Western Service Center.
[FR Doc. 2016-04489 Filed 3-2-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2015-7485; Airspace Docket No. 15-AGL-25] Amendment of Class D and Class E Airspace; Minot, ND AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule, correction.

SUMMARY:

This action amends a final rule published in the Federal Register of February 4, 2016, amending Class E surface area airspace and Class E airspace designated as an extension at Minot International Airport, Minot, ND. Adjustment of the geographic coordinates of Minot International Airport and Minot AFB in Class D airspace, and Minot International Airport, Minot Very High Frequency Omnidirectional Range Tactical Air Navigation (VORTAC), and Minot AFB, in Class E airspace extending upward from 700 feet above the surface, are added to the rule. The Title is also amended to include Class D airspace. This does not change the boundaries or operating requirements of the airspace.

DATES:

Effective 0901 UTC, March 31, 2016. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES:

FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC, 29591; telephone: 202-267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.9Z at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION: History

The Federal Register published a final rule amending Class E airspace at Minot International Airport, Minot, ND (81 FR 5903, February 4, 2016) Docket No. FAA-2015-7485. Subsequent to publication, the FAA found in amending the airport reference point for the airports and VORTAC, additional existing controlled airspace was inadvertently omitted from the rule. This action adds adjustment of the geographic coordinates in Class D airspace and Class E airspace extending upward from 700 feet above the surface for the Minot, ND, area.

Correction to Final Rule

Accordingly, pursuant to the authority delegated to me, in the Federal Register of February 4, 2016 (81 FR 5903) FR Doc. 2016-02036, Amendment of Class E Airspace, Minot, ND, is corrected as follows:

§ 71.1 [Amended]
On page 5905, column 1, after line 6, add the following text: Paragraph 5000 Class D Airspace. AGL ND D Minot, ND [Corrected] Minot International Airport, ND (Lat. 48°15′28″ N., long. 101°16′41″ W.)

That airspace extending upward from the surface to and including 4,200 feet MSL within a 4.2-mile radius of the Minot International Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airman. The effective date and time will thereafter be continuously published in the Airport/facility Directory.

AGL ND D Minot, ND [Corrected] Minot Air Force Base, ND (Lat. 48°24′57″ N., long. 101°21′29″ W.)

That airspace extending upward from the surface to and including 4,200 feet MSL within a 5.6-mile radius of Minot AFB. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airman. The effective date and time will thereafter be continuously published in the Airport/facility Directory.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AGL ND E5 Minot, ND [Corrected] Minot AFB, ND (Lat. 48°24′57″ N., long. 101°21′29″ W.) Deering TACAN (Lat. 48°24′55″ N., long. 101°21′58″ W.) Minot International Airport, ND (Lat. 48°15′28″ N., long. 101°16′41″ W.) Minot VORTAC

(Lat. 48°15′37″ N., long. 101°17′13″ W.)

That airspace extending upward from 700 feet above the surface within a 7.1-mile radius of Minot AFB, and within 1.5 miles each side of the Deering TACAN 312° radial extending from the 7.1-mile radius of the AFB to 9.3 miles northwest of the AFB, and that airspace within a 7-mile radius of Minot International Airport, and within 4.8 miles each side of the Minot VORTAC 138° radial extending from the 7-mile radius of Minot International Airport to 12.1 miles southeast of the VORTAC; and that airspace extending upward from 1,200 feet above the surface within a 47-mile radius of Minot AFB, excluding the area north of latitude 49°00′00″ N.

Issued in Fort Worth, Texas, on February 18, 2016. Walter Tweedy, Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2016-04482 Filed 3-2-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9755] RIN 1545-BI91 Utility Allowances Submetering AGENCY:

Internal Revenue Service (IRS), Treasury.

ACTION:

Final and temporary regulations.

SUMMARY:

This document contains final and temporary regulations that amend the utility allowance regulations concerning the low-income housing credit. The final regulations clarify the circumstances in which utility costs paid by a tenant based on actual consumption in a submetered rent-restricted unit are treated as paid by the tenant directly to the utility company. The temporary regulations extend the principles of these submetering rules to situations in which a building owner sells to tenants energy that is produced from a renewable source and that is not delivered by a local utility company. The final and temporary regulations affect owners of low-income housing projects that claim the credit, the tenants in those low-income housing projects, and State and local housing credit agencies. The text of these temporary regulations also serves as the text of the proposed regulations (REG-123867-14) set forth in the notice of proposed rulemaking on this subject in the Proposed Rules section of this issue of the Federal Register.

DATES:

Effective Date: These regulations are effective on March 3, 2016.

Applicability Date: For dates of applicability, see §§ 1.42-12(a)(5) and 1.42-10T(f)-(g).

FOR FURTHER INFORMATION CONTACT:

James Rider (202) 317-4137 (not a toll-free number).

SUPPLEMENTARY INFORMATION: Background

This document contains amendments to § 1.42-10 of the Income Tax Regulations (26 CFR part 1), which concerns the applicable utility allowance relating to the low-income housing credit under section 42 of the Internal Revenue Code. On May 5, 2009, the Treasury Department and the IRS released Notice 2009-44 (2009-21 IRB 1037) (see § 601.601(d)(2)(ii)(b)) to provide guidance on how the utility allowance regulations apply to buildings with a submetering system. On August 7, 2012, the Treasury Department and the IRS published in the Federal Register a notice of proposed rulemaking under section 42(g)(2)(B)(ii) (77 FR 46987) (the 2012 proposed regulations) to provide that utility costs paid by a tenant based on actual consumption in a submetered rent-restricted unit are treated as paid by the tenant directly to the utility company and thus do not count against the maximum rent that the building owner can charge. The 2012 proposed regulations generally incorporated the guidance in Notice 2009-44. The Treasury Department and the IRS received written and electronic comments responding to the 2012 proposed regulations. No requests for a public hearing were made and no public hearing was held.

After consideration of all the comments, the final regulations adopt the 2012 proposed regulations as amended by this Treasury decision, and the temporary regulations extend those rules to the provision of energy that the building owner acquires directly from renewable sources and then provides to low-income tenants. The text of the temporary regulations also serves as the text of the proposed regulations (REG-123867-14) for purposes of the notice of proposed rulemaking on this subject in the Proposed Rules section in this issue of the Federal Register.

Summary of Comments and Explanation of Provisions Comments Specifically Relating to Submetering

Commenters generally stated that the 2012 proposed regulations provided for accurate utility allowance determinations, which would promote energy efficiency and help maintain the financial stability of housing credit properties.

1. Actual-Consumption Submetering Arrangements and Ratio Utility Billing Systems

The 2012 proposed regulations defined an actual-consumption submetering arrangement for utility allowance purposes as not including a ratio utility billing system (RUBS). RUBS uses a formula that allocates a property's utility bill among its units based on the units' relative floor space, number of occupants, or some other quantitative measure, but not actual consumption by the tenant(s) in the unit. A commenter expressed concern that the inability to use RUBS for utility allowance purposes could be interpreted to prohibit the use of RUBS for any low-income housing credit project. This concern is unwarranted. Although the 2012 proposed regulations precluded an arrangement such as RUBS from qualifying as an actual consumption submetering arrangement, they did not prohibit the use of RUBS for low-income housing credit projects. However, any amount paid by a tenant for utilities using RUBS must be included in gross rent. Accordingly, the final regulations follow the approach in the 2012 proposed regulations and continue to define an actual-consumption submetering arrangement as not including RUBS.

2. Administrative Costs of Submetering

The 2012 proposed regulations provided that, if the owner charges a unit's tenants an administrative fee for the owner's actual monthly costs of administering an actual-consumption submetering arrangement, then the fee is not considered gross rent for purposes of section 42(g)(2) so long as the aggregate monthly fee or fees for all of the unit's utilities under one or more actual-consumption submetering arrangements does not exceed the lesser of (A) five dollars per month; or (B) the owner's actual monthly costs paid or incurred for administering the arrangement. One commenter recommended that the final regulations simply require owners to include in gross rent any amounts that exceed five dollars and not require the owner to determine actual monthly cost. According to the commenter, requiring the building owner to determine actual cost is overly burdensome and would lead to technical noncompliance as a result of nominal amounts. Two commenters requested that the final regulations also permit building owners to charge tenants an administrative fee in accordance with State law as currently permitted in Notice 2009-44. According to these commenters, this rule is regionally tuned and therefore allows building owners to recoup the full cost of submetering in a fair manner. The commenters suggested that by not allowing building owners to recover State-approved charges for electricity, the 2012 proposed regulations would create a disincentive for developers to invest in high performance, sustainable low income housing or build additional housing units.

In response to these comments, the final regulations do not include a requirement to determine actual monthly cost, and they generally permit owners to charge tenants an administrative fee in accordance with a State or local law that specifically prescribes a dollar amount for the administrative fee. The final regulations authorize the Treasury Department and the IRS, by publication in the Internal Revenue Bulletin (IRB) (see § 601.601(d)(2)(ii)), both to provide for administrative fees in excess of five dollars per month even in the absence a State or local law doing so and to put an upper bound on administrative fees even if State or local law allows higher fees.

Thus, if a building owner or its agent charges a unit's tenants a fee for administering an actual-consumption submetering arrangement, then gross rent includes any amount by which the aggregate amount of monthly fees for all of the unit's utilities under one or more actual-consumption submetering arrangements exceeds the greater of—(i) five dollars per month; (ii) an amount (if any) designated by publication in the IRB; or (iii) the lesser of a dollar amount (if any) specifically prescribed under a State or local law or a maximum amount (if any) designated by publication in the IRB.

3. Energy Acquired Directly From a Renewable Source

During consideration of the comments on the 2012 proposed regulations, the Treasury Department and the IRS realized that the proposed definition of an actual-consumption submetering arrangement assumed that the building owner was purchasing the utility in question from a local utility company. For example, proposed § 1.42-10(e)(1)(iv) referred to “the utility company rate incurred by the building owner for the particular utility.” This assumption appeared to preclude applying submetering principles to electricity generated from renewable sources by the building owner or by some other person from whom the building owner purchases it directly.

The legislative purposes of the low-income housing credit, however, are fully consistent with applying submetering principles to energy that is acquired without the intervention of a local utility company. Accordingly, this Treasury decision contains temporary regulations that apply those principles to energy that the building owner provides to tenants after having acquired it directly from renewable sources. Qualification for this submetering treatment, however, depends on the charges to the tenants for this energy being comparable to local utility rates. To the extent that tenants consume this energy, charges by the building owner must not exceed the rates that the local utility company would have charged the tenants if they had instead acquired the energy from that company. Information about how to provide comments on the substance of the temporary regulations is in the notice of proposed rulemaking on this subject (REG-123867-14), which is in the Proposed Rules section in this issue of the Federal Register.

Comments Relating to Utility Allowances Generally

In addition to comments responding to the 2012 proposed regulations, the Treasury Department and the IRS received comments relating to the utility allowance regulations that existed prior to these final regulations. The final regulations incorporate certain changes suggested in those comments, as described in this preamble.

1. Role of Agencies Regarding the Utility Allowance Methods

Section 1.42-10(b) provides the rules for determining the applicable utility allowance based upon whether (1) the building receives rental assistance from the Rural Housing Service (RHS) (“RHS-assisted building”), (2) the building has any tenant that receives RHS rental assistance payments (“RHS tenant assistance”), (3) the rents and utility allowances of the building are reviewed by the Department of Housing and Urban Development (HUD) (“HUD-regulated building”), or (4) the building is not described in (1), (2), or (3) (“other buildings”).

For an RHS-assisted building and a building with RHS tenant assistance, the applicable utility allowance is the applicable RHS utility allowance. For a HUD-regulated building, the applicable utility allowance is the applicable HUD utility allowance. In other buildings, for all rent-restricted units occupied by tenants receiving HUD tenant assistance, the applicable utility allowance is the applicable Public Housing Authority (PHA) utility allowance established for the Section 8 Existing Housing Program. For all other tenants in rent-restricted units in other buildings, the applicable utility allowance is the applicable PHA utility allowance, a local utility company estimate, an estimate from the State or local housing credit agency (Agency) that has jurisdiction over the building, the HUD Utility Schedule Model, or an energy consumption model. See § 1.42-10(b)(4)(ii) to determine which utility allowance applies.

Prior to these final regulations, the existing regulations provided that, under the energy consumption model, utility consumption estimates must be calculated by “either a properly licensed engineer or a qualified professional approved by the Agency that has jurisdiction over the building.” The 2012 proposed regulations requested comments on whether approval by the agency with jurisdiction over the building should be required by the regulations for both properly licensed engineers and other qualified professionals or only for qualified professionals that are not properly licensed engineers.

One commenter suggested that the Agency's approval should be required for determinations by both properly licensed engineers and other qualified professionals, because the Agency should have the ability to approve or deny a utility allowance method unless the building is a RHS property or a HUD-regulated building. Other commenters suggested that Agency approval should be required only for professionals who are not properly licensed engineers. According to these commenters, the intent and benefit of a project sponsor using a licensed engineering professional is not only to receive the benefit of the third-party professional's expertise but also to simplify evaluation of the third-party by the Agency. One commenter suggested that when reviewing consumption model estimates, an Agency should need to check for only the seal of an engineer, because State certification of the engineer already imposes standards for expertise, performance, and conduct and exposes the certified individual and firm, if any, to possible sanctions through the professional certification and oversight process.

In response to these comments, the final regulations provide that Agency approval is required only for qualified professionals that are not properly licensed engineers. However, the final regulations also clarify that an Agency continues to have the option to review, and take appropriate action regarding, utility estimates based on the energy consumption model or the other optional methods.

One commenter suggested that the final regulations should clarify that an Agency has the ability to approve or deny any owner's utility allowance, unless the building is an RHS property or a HUD-regulated building. By contrast, another commenter expressed concern that the existing regulations give an Agency too much discretion to approve or disapprove any of the methods of calculating utility allowances. In particular, the commenter suggested that the final regulations require an Agency to accept utility estimates based on an energy consumption model whenever the estimate is calculated by a properly licensed engineer.

The final regulations do not adopt this latter suggestion. The existing regulations appropriately allow an Agency to approve or disapprove a method or to require certain information before permitting use of the method. Additionally, an Agency should have the ability to review the energy consumption model even when the model is used by a properly licensed engineer, who is not subject to Agency approval. Therefore, the final regulations specifically authorize an Agency to approve or disapprove use of the energy consumption model or require information about the model before permitting its use, regardless of the type of professional who calculates the utility estimates.

2. Use of Consumption Data for the Energy Consumption Model

Under the existing regulations prior to these final regulations, use of the energy consumption model was limited to the building's consumption data for the twelve-month period ending no earlier than 60 days prior to the beginning of the 90-day period under § 1.42-10(c)(1). One commenter was concerned about the perceptions that may arise if engineering models yield allowances that are out of line with past consumption. The commenter requested additional guidance on the development of acceptable assumptions for use in engineering models to avoid this problem.

Another commenter stated that it is unclear whether the required building consumption data refers to the calculated consumptions derived from an energy consumption model or a separate set of consumption data such as historical tenant utility billing information. According to the commenter, several Agencies that regulate the acceptable utility allowance methodologies either have had an unclear understanding of what additional information, if any, is required for an engineering analysis under the energy consumption model or have taken the position that actual historical tenant utility bills for the most recent 12-month period are necessary to process an energy consumption model utility allowance submittal.

The commenter also asserted that historical utility data may be inaccessible and, even if the data were accessible, collection of the data imposes an additional paperwork burden on property owners. The commenter further contended that historical utility billing data does not take into account energy-efficient behavior and does not promote energy conservation. According to the commenter, most utility providers do not maintain utility information beyond the most recent 12-month period. As year-to-year variations occur, the most recent 12 months may not be a representative set of consumption data to provide an ongoing utility allowance. The commenter suggested amending the energy consumption model to allow an engineering approach that analyzes specific factors including, but not limited to, unit size, building orientation, design and materials, mechanical systems, appliances, and characteristics of the building location.

For the reasons stated by the commenters, the final regulations remove the provision requiring that an energy consumption model use the building's consumption data for a particular twelve-month period. Instead, the final regulations revise the specific factors used in determining estimates under the energy consumption model to include available historical data.

3. Areas With No Public Housing Authorities

The existing regulations provide that, if the building is neither an RHS-assisted building nor a HUD-regulated building and no tenant in the building receives RHS tenant assistance, then the appropriate utility allowance for the units in the building is the applicable PHA utility allowance. One commenter requested clarification as to which method of calculating utility allowances applies if no PHA exists under these circumstances. Under the existing regulations, if a building owner obtains a local utility company estimate or uses one of the other options for determining the applicable utility allowance, then the selected option replaces the applicable PHA allowance as the appropriate utility allowance. The regulations do not include an option for using the allowance of a neighboring PHA.

Allowing the use of a neighboring PHA's utility allowance might not be appropriate because climate and utility consumption can be dissimilar from one PHA jurisdiction to a neighboring jurisdiction. Comments are requested on how the rules might best address situations in which no PHA exists. Comments should be submitted in the manner described in the notice of proposed rulemaking on submetering (REG-123867-14), which is in the Proposed Rules section in this issue of the Federal Register.

4. Changes in Public Housing Authority Utility Allowances

One commenter requested that a building owner be required to check for a change in a PHA utility allowance only annually. The existing regulations provide that, if the applicable utility allowance for units changes, the building owner must use the new utility allowance to compute gross rents of the units due 90 days after the change (the 90-day period). For example, if a tenant provides a local utility company estimate that shows a higher utility cost than the otherwise applicable PHA utility allowance, then the building owner must lower the rent. The lower rent must be in effect for rent due at the end of the 90-day period. The commenter stated that a building owner must continuously monitor for changes in the PHA utility allowance because a PHA is not required to update utility allowances on a regular, fixed schedule.

The final regulations do not adopt this recommendation because it might result in tenants paying more than the gross rent amount under section 42(g)(2). If a PHA utility allowance were to change after the one-time date suggested by the commenter, then tenants would pay a higher rent until the next annual date to review the PHA utility allowance and the higher rent might exceed the gross-rent limit under section 42(g)(2). Compliance with the 90-day period does not require continuous monitoring. A building owner that checks the PHA utility allowance every 60 days would have at least 30 days in which to adjust rents.

5. HUD-Regulated Building

Prior to these final regulations, the existing regulations defined a HUD-regulated building as one in which neither the building nor any tenant in the building receives RHS assistance and the rents and utility allowances of the building are reviewed by HUD on an annual basis. One commenter recommended amending this definition because HUD does not review the rents and utility allowances on an annual basis for all HUD programs. In response to this comment, the final regulations define a HUD-regulated building to mean one in which the rents and utility allowances of the building are regulated by HUD.

6. Disclosure to Tenants

One commenter suggested that the final regulations address how utility estimates are to be made available to all tenants in the building. Because circumstances may vary and different reasonable options may exist, the final regulations do not adopt this suggestion.

Comments

Information about how to provide comments is in the notice of proposed rulemaking on this subject (REG-123867-14), which is in the Proposed Rules section in this issue of the Federal Register.

Table of Contents

The final regulations update the table of contents to include all of the current provisions under section 42.

Effect on Other Documents

Notice 2009-44 (2009-21 IRB 1037) is obsolete for taxable years beginning on or after March 3, 2016.

Statement of Availability of IRS Documents

Notice 2009-44 is published in the Internal Revenue Bulletin and is available from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, or by visiting the IRS Web site at http://www.irs.gov.

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 impact 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 and, because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking that preceded these final regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business. No comments were received.

Drafting Information

The principal author of these regulations is David Selig, Office of the Associate Chief Counsel (Passthroughs and Special Industries), IRS. 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 adding an entry in numerical order to read in part as follows: Authority:

26 U.S.C. 7805 * * *

Section 1.42-10T also issued under 26 U.S.C. 42(n); * * *

Par. 2. Section 1.42-0 is amended by: 1. Revising the introductory text. 2. Revising the heading and adding entries for § 1.42-1. 3. Adding entries for § 1.42-1T. 4. Adding entries for §§ 1.42-3 through 1.42-18.

The additions and revisions read as follows:

§ 1.42-0 Table of contents.

This section lists the paragraphs contained in §§ 1.42-1 through 1.42-18 and § 1.42-1T.

§ 1.42-1 Limitation on low-income housing credit allowed with respect to qualified low-income buildings receiving housing credit allocations from a State or local housing credit agency.

(a) through (g) [Reserved]

(h) Filing of forms.

(i) [Reserved]

(j) Effective dates.

§ 1.42-1T Limitation on low-income housing credit allowed with respect to qualified low income buildings receiving housing credit allocations from a State or local housing credit agency (temporary).

(a) In general.

(1) Determination of amount of low-income housing credit.

(2) Limitation on low-income housing credit allowed.

(b) The State housing credit ceiling.

(c) Apportionment of State housing credit ceiling among State and local housing credit agencies.

(1) In general.

(2) Primary apportionment.

(3) States with 1 or more constitutional home rule cities.

(i) In general.

(ii) Amount of apportionment to a constitutional home rule city.

(iii) Effect of apportionment to constitutional home rule cities on apportionment to other housing credit agencies.

(iv) Treatment of governmental authority within constitutional home rule city.

(4) Apportionment to local housing credit agencies.

(i) In general.

(ii) Change in apportionment during a calendar year.

(iii) Exchanges of apportionments.

(iv) Written records of apportionments.

(5) Set-aside apportionments for projects involving a qualified nonprofit organization.

(i) In general.

(ii) Projects involving a qualified nonprofit organization.

(6) Expiration of unused apportionments.

(d) Housing credit allocation made by State and local housing credit agencies.

(1) In general.

(2) Amount of a housing credit allocation.

(3) Counting housing credit allocations against an agency's aggregate housing credit dollar amount.

(4) Rules for when applications for housing credit allocations exceed an agency's aggregate housing credit dollar amount.

(5) Reduced or additional housing credit allocations.

(i) In general.

(ii) Examples.

(6) No carryover of unused aggregate housing credit dollar amount.

(7) Effect of housing credit allocations in excess of an agency's aggregate housing credit dollar amount.

(8) Time and manner for making housing credit allocations.

(i) Time.

(ii) Manner.

(iii) Certification.

(iv) Fee.

(v) No continuing agency responsibility.

(e) Housing credit allocation taken into account by owner of a qualified low-income building.

(1) Time and manner for taking housing credit allocation into account.

(2) First-year convention limitation on housing credit allocation taken into account.

(3) Use of excess housing credit allocation for increases in qualified basis.

(i) In general.

(ii) Example.

(4) Separate housing credit allocations for new buildings and increases in qualified basis.

(5) Acquisition of building for which a prior housing credit allocation has been made.

(6) Multiple housing credit allocations.

(f) Exception to housing credit allocation requirement.

(1) Tax-exempt bond financing.

(i) In general.

(ii) Determining use of bond proceeds.

(iii) Example.

(g) Termination of authority to make housing credit allocation.

(1) In general.

(2) Carryover of unused 1989 apportionment.

(3) Expiration of exception for tax-exempt bond financed projects.

(h) [Reserved]

(i) Transitional rules.

§ 1.42-3 Treatment of buildings financed with proceeds from a loan under an Affordable Housing Program established pursuant to section 721 of the Financial Institutions Reform, Recovery, and Enforcement Act of 1989 (FIRREA).

(a) Treatment under sections 42(i) and 42(b).

(b) Effective date.

§ 1.42-4 Application of not-for-profit rules of section 183 to low-income housing credit activities.

(a) Inapplicability to section 42.

(b) Limitation.

(c) Effective date.

§ 1.42-5 Monitoring compliance with low-income housing credit requirements.

(a) Compliance monitoring requirement.

(1) In general.

(2) Requirements for a monitoring procedure.

(i) In general.

(ii) Order and form.

(iii) [Reserved]

(b) Recordkeeping and record retention provisions.

(1) Recordkeeping provision.

(2) Record retention provision.

(3) Inspection record retention provision.

(c) Certification and review provisions.

(1) Certification.

(2) Review.

(ii) [Reserved]

(iii) [Reserved]

(3) [Reserved]

(4) Exception for certain buildings.

(i) In general.

(ii) Agreement and review.

(iii) Example.

(5) Agency reports of compliance monitoring activities.

(d) Inspection provision.

(1) In general.

(2) Inspection standard.

(3) Exception from inspection provision.

(4) Delegation.

(e) Notification-of-noncompliance provisions.

(1) In general.

(2) Notice to owner.

(3) Notice to Internal Revenue Service.

(i) In general.

(ii) Agency retention of records.

(4) Correction period.

(f) Delegation of authority.

(1) Agencies permitted to delegate compliance monitoring functions.

(i) In general.

(ii) Limitations.

(2) Agencies permitted to delegate compliance monitoring functions to another Agency.

(g) Liability.

(h) Effective/applicability dates.

(1) In general.

(2) [Reserved]

§ 1.42-6 Buildings qualifying for carryover allocations.

(a) Carryover allocations.

(1) In general.

(2) 10 percent basis requirement.

(i) Allocation made before July 1.

(ii) Allocation made after June 30.

(b) Carryover-allocation basis.

(1) In general.

(2) Limitations.

(i) Taxpayer must have basis in land or depreciable property related to the project.

(ii) High cost areas.

(iii) Amounts not treated as paid or incurred.

(iv) Fees.

(3) Reasonably expected basis.

(4) Examples.

(c) Verification of basis by Agency.

(1) Verification requirement.

(2) Manner of verification.

(3) Time of verification.

(i) Allocations made before July 1.

(ii) Allocations made after June 30.

(d) Requirements for making carryover allocations.

(1) In general.

(2) Requirements for allocation.

(3) Special rules for project-based allocations.

(i) In general.

(ii) Requirement of section 42(h)(1)(F)(1)(III).

(4) Recordkeeping requirements.

(i) Taxpayer.

(ii) Agency.

(5) Separate procedure for election of appropriate percentage month.

(e) Special rules.

(1) Treatment of partnerships and other flow-through entities.

(2) Transferees.

§ 1.42-7 Substantially bond-financed buildings. [Reserved] § 1.42-8 Election of appropriate percentage month.

(a) Election under section 42(b)(2)(A)(ii)(I) to use the appropriate percentage for the month of a binding agreement.

(1) In general.

(2) Effect on state housing credit ceiling.

(3) Time and manner of making election.

(4) Multiple agreements.

(i) Rescinded agreements.

(ii) Increases in credit.

(5) Amount allocated.

(6) Procedures.

(i) Taxpayer.

(ii) Agency.

(7) Examples.

(b) Election under section 42(b)(2)(A)(ii)(II) to use the appropriate percentage for the month tax-exempt bonds are issued.

(1) Time and manner of making election.

(2) Bonds issued in more than one month.

(3) Limitations on appropriate percentage.

(4) Procedures.

(i) Taxpayer.

(ii) Agency.

§ 1.42-9 For use by the general public.

(a) General rule.

(b) Limitations.

(c) Treatment of units not for use by the general public.

§ 1.42-10 Utility allowances.

(a) Inclusion of utility allowances in gross rent.

(b) Applicable utility allowances.

(1) Buildings assisted by the Rural Housing Service.

(2) Buildings with Rural Housing Service assisted tenants.

(3) Buildings regulated by the Department of Housing and Urban Development.

(4) Other buildings.

(i) Tenants receiving HUD rental assistance.

(ii) Other tenants.

(A) General rule.

(B) Utility company estimate.

(C) Agency estimate.

(D) HUD Utility Schedule Model.

(E) Energy consumption model.

(c) Changes in applicable utility allowance.

(1) In general.

(2) Annual review.

(d) Record retention.

(e) Actual consumption submetering arrangements.

(1) Definition.

(2) Administrative fees.

§ 1.42-11 Provision of services.

(a) General rule.

(b) Services that are optional.

(1) General rule.

(2) Continual or frequent services.

(3) Required services.

(i) General rule.

(ii) Exceptions.

(A) Supportive services.

(B) Specific project exception.

§ 1.42-12 Effective dates and transitional rules.

(a) Effective dates.

(1) In general.

(2) Community Renewal Tax Relief Act of 2000.

(i) In general.

(3) Electronic filing simplification changes.

(4) Utility allowances.

(5) Additional effective dates affecting utility allowances.

(b) Prior periods.

(c) Carryover allocations.

§ 1.42-13 Rules necessary and appropriate; housing credit agencies' correction of administrative errors and omissions.

(a) Publication of guidance.

(b) Correcting administrative errors and omissions.

(1) In general.

(2) Administrative errors and omissions described.

(3) Procedures for correcting administrative errors or omissions.

(i) In general.

(ii) Specific procedures.

(iii) Secretary's prior approval required.

(iv) Requesting the Secretary's approval.

(v) Agreement to conditions.

(vi) Secretary's automatic approval.

(vii) How Agency corrects errors or omissions subject to automatic approval.

(viii) Other approval procedures.

(c) Examples.

(d) Effective date.

§ 1.42-14 Allocation rules for post-2000 State housing credit ceiling amount.

(a) State housing credit ceiling.

(1) In general.

(2) Cost-of-living adjustment.

(i) General rule.

(ii) Rounding.

(b) The unused carryforward component.

(c) The population component.

(d) The returned credit component.

(1) In general.

(2) Limitations and special rules.

(i) General limitations.

(ii) Credit period limitation.

(iii) Three-month rule for returned credit.

(iv) Returns of credit.

(A) Building not qualified within required time period.

(B) Noncompliance with terms of the allocation.

(C) Mutual consent.

(D) Amount not necessary for financial feasibility.

(3) Manner of returning credit.

(i) Taxpayer notification.

(ii) Internal Revenue Service notification.

(e) The national pool component.

(f) When the State housing credit ceiling is determined.

(g) Stacking order.

(h) Nonprofit set-aside.

(1) Determination of set-aside.

(2) Allocation rules.

(i) National Pool.

(1) In general.

(2) Unused housing credit carryover.

(3) Qualified State.

(i) In general.

(ii) Exceptions.

(A) De minimis amount.

(B) Other circumstances.

(iii) Time and manner for making request.

(4) Formula for determining the National Pool.

(j) Coordination between Agencies.

(k) Example.

(l) Effective dates.

(1) In general.

(2) Community Renewal Tax Relief Act of 2000 changes.

§ 1.42-15 Available unit rule.

(a) Definitions.

(b) General section 42(g)(2)(D)(i) rule.

(c) Exception.

(d) Effect of current resident moving within building.

(e) Available unit rule applies separately to each building in a project.

(f) Result of noncompliance with available unit rule.

(g) Relationship to tax-exempt bond provisions.

(h) Examples.

(i) Effective date.

§ 1.42-16 Eligible basis reduced by federal grants.

(a) In general.

(b) Grants do not include certain rental assistance payments.

(c) Qualifying rental assistance program.

(d) Effective date.

§ 1.42-17 Qualified allocation plan.

(a) Requirements.

(1) In general [Reserved].

(2) Selection criteria [Reserved].

(3) Agency evaluation.

(4) Timing of Agency evaluation.

(i) In general.

(ii) Time limit for placed-in-service evaluation.

(5) Special rule for final determinations and certifications.

(6) Bond-financed projects.

(b) Effective date.

§ 1.42-18 Qualified Contracts.

(a) Extended low-income housing commitment.

(1) In general.

(i) Extended use period.

(ii) Termination of extended use period.

(iii) Other non-acceptance.

(iv) Eviction, gross rent increase concerning existing low-income tenants not permitted.

(2) Exception.

(b) Definitions.

(c) Qualified contract purchase price formula.

(1) In general.

(i) Initial determination.

(ii) Mandatory adjustment by the buyer and owner.

(iii) Optional adjustment by the Agency and owner.

(2) Low-income portion amount.

(3) Outstanding indebtedness.

(4) Adjusted investor equity.

(i) Application of cost-of-living factor.

(ii) Unadjusted investor equity.

(iii) Qualified-contract cost-of-living adjustment.

(iv) General rule.

(v) Provision by the Commissioner of the qualified-contract cost-of-living adjustment.

(vi) Methodology.

(vii) Example.

(5) Other capital contributions.

(6) Cash distributions.

(i) In general.

(ii) Excess proceeds.

(iii) Anti-abuse rule.

(d) Administrative discretion and responsibilities of the Agency.

(1) In general.

(2) Actual offer.

(3) Debarment of certain appraisers.

(e) Effective/applicability date.

Par. 3. Section 1.42-0T is added to read as follows:
§ 1.42-0T Table of contents.

This section lists the paragraphs contained in §§ 1.42-5T and 1.42-10T.

§ 1.42-5T Monitoring compliance with low-income housing credit requirements (temporary).

(a)(1) through (a)(2)(ii) [Reserved]

(iii) Effect of guidance published in the Internal Revenue Bulletin.

(b) through (c)(2)(i) [Reserved]

(3) Frequency and form of certification.

(c)(4) through (g) [Reserved]

(h) Effective/applicability dates.

(1) [Reserved]

(2) Effective/applicability dates of the REAC inspection protocol.

§ 1.42-10T Energy obtained directly from renewable sources (temporary).

(a) through (e)(1)(i)(A) [Reserved]

(B) Utility not purchased from or through a local utility company.

(C) Renewable source.

(2) [Reserved]

(f) Date of applicability.

(g) Expiration date.

Par. 4. Section 1.42-10 is amended by: 1. Adding a sentence after the first sentence of paragraph (a). 2. Revising paragraph (b)(3). 3. Revising the first sentence of paragraph (b)(4)(ii)(A). 4. Revising paragraph (b)(4)(ii)(E). 5. Adding paragraph (e).

The additions and revisions read as follows:

§ 1.42-10 Utility allowances.

(a) * * * For purposes of the preceding sentence, if the cost of a particular utility for a residential unit is paid pursuant to an actual-consumption submetering arrangement within the meaning of paragraph (e)(1) of this section, then that cost is treated as being paid directly by the tenant(s) and not by or through the owner of the building. * * *

(b)* * *

(3) Buildings regulated by the Department of Housing and Urban Development. If neither a building nor any tenant in the building receives RHS housing assistance, and the rents and utility allowances of the building are regulated by HUD (HUD-regulated buildings), the applicable utility allowance for all rent-restricted units in the building is the applicable HUD utility allowance.

(4) * * *

(ii) * * *

(A) * * * If none of the rules of paragraphs (b)(1), (2), (3), and (4)(i) of this section apply to determine the appropriate utility allowance for a rent-restricted unit, then the appropriate utility allowance for the unit is the applicable PHA utility allowance. * * *

(E) Energy consumption model. A building owner may calculate utility estimates using an energy and water and sewage consumption and analysis model (energy consumption model). The energy consumption model must, at a minimum, take into account specific factors including, but not limited to, unit size, building orientation, design and materials, mechanical systems, appliances, characteristics of the building location, and available historical data. The utility consumption estimates must be calculated by a properly licensed engineer or other qualified professional. The qualified professional and the building owner must not be related within the meaning of section 267(b) or 707(b). If a qualified professional is not a properly licensed engineer and if the building owner wants to utilize that qualified professional to calculate utility consumption estimates, then the owner must obtain approval from the Agency that has jurisdiction over the building. Further, regardless of the type of qualified professional, the Agency may approve or disapprove of the energy consumption model or require information before permitting its use. In addition, utility rates used for the energy consumption model must be no older than the rates in place 60 days prior to the beginning of the 90-day period under paragraph (c)(1) of this section.

(e) Actual-consumption submetering arrangements—(1) Definition. For purposes of this section, an actual-consumption submetering arrangement for a utility in a residential unit possesses all of the following attributes:

(i) The utility consumed in the unit is described in paragraph (e)(1)(i)(A) of this section or in § 1.42-10T(e)(1)(i)(B);

(A) The utility is purchased from or through a local utility company by the building owner (or its agent or other party acting on behalf of the building owner).

(B) [Reserved]. For further guidance see § 1.42-10T(e)(1)(i)(B) through (e)(1)(i)(C)(3).

(ii) The tenants in the unit are billed for, and pay the building owner (or its agent or other party acting on behalf of the building owner) for, the unit's consumption of the utility;

(iii) The billed amount reflects the unit's actual consumption of the utility. In the case of sewerage charges, however, if the unit's sewerage charges are combined on the bill with water charges and the sewerage charges are determined based on the actual water consumption of the unit, then the bill is treated as reflecting the actual sewerage consumption of the unit; and

(iv) The rate at which the building owner bills for the utility satisfies the following requirements:

(A) To the extent that the utility consumed is described in paragraph (e)(1)(i)(A) of this section, the utility rate charged to the tenants of the unit does not exceed the rate incurred by the building owner for that utility; and

(B) To the extent that the utility consumed is described in § 1.42-10T(e)(1)(i)(B), the utility rate charged to the tenants of the unit does not exceed the rate described in § 1.42-10T(e)(1)(iv)(B).

(2) Administrative fees. If the owner charges a unit's tenants a fee for administering an actual-consumption submetering arrangement, the fee is not considered gross rent for purposes of section 42(g)(2). The preceding sentence, however, does not apply unless the fee is computed in the same manner for every unit receiving the same submetered utility service, nor does it apply to any amount by which the aggregate monthly fee or fees for all of the unit's utilities under one or more actual-consumption submetering arrangements exceed the greater of—

(i) Five dollars per month;

(ii) An amount (if any) designated by publication in the Internal Revenue Bulletin (see § 601.601(d)(2)(ii) of this chapter); or

(iii) The lesser of—

(A) The dollar amount (if any) specifically prescribed under a State or local law; or

(B) A maximum amount (if any) designated by publication in the Internal Revenue Bulletin (see § 601.601(d)(2)(ii) of this chapter).

Par. 5. Section 1.42-10T is added to read as follows:
§ 1.42-10T Energy obtained directly from renewable sources (temporary).

(a) through (e)(1)(i)(A) [Reserved]. For further guidance see § 1.42-10(a) through (e)(1)(i)(A).

(B) Utility not purchased from or through a local utility company. The utility is not described in § 1.42-10(e)(1)(i)(A) and is produced from a renewable source (within the meaning of paragraph (e)(1)(i)(C) of this section).

(C) Renewable source. For purposes of paragraph (e)(1)(i)(B) of this section, a utility is produced from a renewable source if—

(1) It is energy that is produced from energy property described in section 48;

(2) It is energy that is produced from property that is part of a facility described in section 45(d)(1) through (4), (6), (9), or (11); or

(3) It is a utility that is described in guidance published for this purpose in the Internal Revenue Bulletin (see § 601.601(d)(2)(ii) of this chapter).

(ii) through (iv)(A) [Reserved]. For further guidance see § 1.42-10(e)(1)(ii) through (e)(1)(iv)(A).

(B) The rate described in this paragraph (e)(1)(iv)(B) is the rate at which the local utility company would have charged the tenants in the unit for the utility if that entity had provided it to them.

(2) [Reserved]

(f) Date of applicability. This section applies to a building owner's taxable years beginning on or after March 3, 2016. A building owner may apply the provisions of this section to the building owner's taxable years beginning before March 3, 2016.

(g) Expiration date. The applicability of this section expires on March 1, 2019.

Par. 6. Section 1.42-12 is amended by adding paragraph (a)(5) to read as follows:
§ 1.42-12 Effective dates and transitional rules.

(a) * * *

(5) Additional effective dates affecting utility allowances. (i) The following provisions apply to a building owner's taxable years beginning on or after March 3, 2016—

(A) The second sentence in § 1.42-10(a);

(B) Section 1.42-10(b)(3);

(C) The first sentence in § 1.42-10(b)(4)(ii)(A);

(D) Section 1.42-10(b)(4)(ii)(E); and

(E) Section 1.42-10(e).

(ii) A building owner may apply these provisions to the building owner's taxable years beginning before March 3, 2016. Otherwise, the utility allowances provisions that apply to taxable years beginning before March 3, 2016 are contained in § 1.42-10 (see 26 CFR part 1 revised as of April 1, 2015).

John Dalrymple, Deputy Commissioner for Services and Enforcement. Approved: February 8, 2016. Mark J. Mazur, Assistant Secretary of the Treasury (Tax Policy).
[FR Doc. 2016-04606 Filed 3-2-16; 8:45 am] BILLING CODE 4830-01-P
DEPARTMENT OF THE TREASURY Alcohol and Tobacco Tax and Trade Bureau 27 CFR Part 9 [Docket No. TTB-2015-0008; T.D. TTB-134; Ref: Notice No. 152] RIN 1513-AC21 Expansion of the Willamette Valley Viticultural Area AGENCY:

Alcohol and Tobacco Tax and Trade Bureau, Treasury.

ACTION:

Final rule; Treasury decision.

SUMMARY:

The Alcohol and Tobacco Tax and Trade Bureau (TTB) is expanding the approximately 5,360-square mile “Willamette Valley” viticultural area in northwestern Oregon, by approximately 29 square miles. Neither the established viticultural area nor the expansion area is located within any other established viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.

DATES:

This final rule is effective April 4, 2016.

FOR FURTHER INFORMATION CONTACT:

Karen A. Thornton, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., Box 12, Washington, DC 20005; phone 202-453-1039, ext. 175.

SUPPLEMENTARY INFORMATION: Background on Viticultural Areas TTB Authority

Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), authorizes the Secretary of the Treasury to prescribe regulations for the labeling of wine, distilled spirits, and malt beverages. The FAA Act provides that these regulations should, among other things, prohibit consumer deception and the use of misleading statements on labels and ensure that labels provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the FAA Act pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). The Secretary has delegated various authorities through Treasury Department Order 120-01 (dated December 10, 2013, superseding Treasury Order 120-01 (Revised), “Alcohol and Tobacco Tax and Trade Bureau,” dated January 24, 2003), to the TTB Administrator to perform the functions and duties in the administration and enforcement of these laws.

Part 4 of the TTB regulations (27 CFR part 4) authorizes the establishment of definitive viticultural areas and the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) sets forth the standards for the preparation and submission of petitions for the establishment or modification of American viticultural areas (AVAs) and lists the approved AVAs.

Definition

Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region having distinguishing features, as described in part 9 of the regulations, and a name and a delineated boundary, as established in part 9 of the regulations. These designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to the wine's geographic origin. The establishment of AVAs allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may purchase. Establishment of an AVA is neither an approval nor an endorsement by TTB of the wine produced in that area.

Requirements

Section 4.25(e)(2) of the TTB regulations (27 CFR 4.25(e)(2)) outlines the procedure for proposing an AVA and provides that any interested party may petition TTB to establish a grape-growing region as an AVA. Petitioners may use the same process to request changes involving established AVAs. Section 9.12 of the TTB regulations (27 CFR 9.12) prescribes standards for petitions for modifying established AVAs. Petitions to expand an established AVA must include the following:

• Evidence that the area within the proposed expansion area boundary is nationally or locally known by the name of the established AVA;

• An explanation of the basis for defining the boundary of the proposed expansion area;

• A narrative description of the features of the proposed expansion area that affect viticulture, such as climate, geology, soils, physical features, and elevation, that make the proposed expansion area similar to the established AVA and distinguish it from adjacent areas outside the established AVA boundary;

• The appropriate United States Geological Survey (USGS) map(s) showing the location of the proposed expansion area, with the boundary of the proposed expansion area clearly drawn thereon; and

• A detailed narrative description of the proposed expansion area boundary based on USGS map markings.

Petition to Expand the Willamette Valley AVA

TTB received a petition from Steve Thomson, the executive vice president of King Estate Winery in Eugene, Oregon, proposing to expand the established “Willamette Valley” AVA in northwestern Oregon. The Willamette Valley AVA (27 CFR 9.90) was established by T.D. ATF-162, which was published in the Federal Register on December 1, 1983 (48 FR 54221). The Willamette Valley AVA covers approximately 5,360 square miles in Benton, Lane, Linn, Clackamas, Lincoln, Marion, Multnomah, Polk, Tillamook, Washington, and Yamhill Counties. Neither the proposed expansion area nor the established AVA are located within any other established AVA.

The proposed expansion area is located in Lane County and is adjacent to the southern tip of the established Willamette Valley AVA boundary and covers approximately 29 square miles. The King Estate Winery operates one of the two commercial vineyards that cover a total of 508 acres within the proposed expansion area, and provided information that the second vineyard owner also supports the proposed expansion. The King Estate Winery and the second vineyard each have a winery within the proposed expansion area. A third winery is also included in the proposed expansion area; however, it does not operate a vineyard within the proposed expansion area. The vineyards and wineries did not exist at the time the Willamette Valley AVA was established in 1983 and currently are not within any AVA. The petition included letters from the president of the Willamette Valley Wineries Association and the president of the Oregon Winegrowers Association in support of the proposed expansion.

According to the petition, the topography, soils, and climate of the proposed expansion area are similar to those of the established Willamette Valley AVA. The petition states that both the proposed expansion area and the established AVA are composed of rolling hills and valleys between the Coast Range Mountains to the west and the Cascade Mountains to the east. Elevations within the proposed AVA range from 500 feet to 1,200 feet, which is within the range of elevations found in the established AVA. By contrast, the region outside both the proposed expansion area and the Willamette Valley AVA is marked by mountainous terrain with higher elevations. The proposed expansion area and the established AVA are also within the watersheds of both the Willamette and the Siuslaw Rivers, whereas the region to the south of both the proposed expansion area and the established AVA drains exclusively into the Umpqua River.

The petition describes the soils within both the proposed expansion area and the Willamette Valley AVA as having a “xeric” moisture regime of soil classification, meaning that they typically retain low amounts of moisture and generally have depleted their moisture reserves by the end of the growing season. Common soil series within both the proposed expansion area and the established AVA include Bellpine, Jory, Willakenzie, Dupee, and Peavine. The petition states that although Peavine soils are found outside the proposed expansion area and the established AVA, other soils such as Blanchley, Honeygrove Complex, Bohanon, Preacher, Klickitat, Kirney, and Digger Complex soils are also present and are not found in either the proposed expansion area or the Willamette Valley AVA. Additionally, the soils of the surrounding region are described as having an “udic” moisture regime of soil classification, meaning the soils typically retain even amounts of water throughout the year.

The petition compared the climate of the proposed expansion area to the climates of several established AVAs that are also located within the larger Willamette Valley AVA, as well as to the climate of the Umpqua Valley AVA (27 CFR 9.89), which is adjacent to the southernmost point of the Willamette Valley AVA and south of the proposed expansion area. The petition shows that the annual mean temperature, growing season precipitation amounts, and growing degree day accumulations within the proposed expansion area are slightly lower than those of the AVAs within the Willamette Valley AVA. However, the climate data from the proposed expansion area is more similar to the climate data from the AVAs located within the Willamette Valley AVA than to the climate data from the Umpqua Valley AVA.

Notice of Proposed Rulemaking and Comments Received

TTB published Notice No. 152 in the Federal Register on June 18, 2015 (80 FR 34864), proposing to expand the Willamette Valley AVA. In the document, TTB summarized the evidence from the petition regarding the name, boundary, and distinguishing features for the proposed expansion area. For a detailed description of the evidence relating to the name, boundary, and distinguishing features of the proposed expansion area, and for a comparison of the distinguishing features of the proposed expansion area to the surrounding areas and to the established Willamette Valley AVA, see Notice No. 152.

In Notice No. 152, TTB solicited comments on the accuracy of the name, boundary, climatic, and other required information submitted in support of the petition. The comment period closed on August 17, 2015. TTB received two comments in response to Notice No. 152. The first comment (Comment 1) did not directly address the proposed expansion of the Willamette Valley AVA and, instead, issued a general caution against establishing too many AVAs in any given area, as rapid or uncontrolled growth may cause long-term harm to the economy, quality of life, and agricultural diversity of the community. TTB considers this comment to be outside the scope of the proposed rule.

The second comment (Comment 2) identified two typographical errors in the proposed regulatory text of Notice No. 152. The commenter noted that in paragraph (c)(17) of the proposed regulatory text, Oregon State Highway 99 was incorrectly referred to as Interstate Highway 99. TTB agrees that the State highway was incorrectly designated in the proposed regulatory text, and the correction has been made in the final rule text. The commenter also stated that U.S. Highway 26 was incorrectly identified as Interstate Highway 26 in redesignated paragraph (c)(32). Although TTB did not propose to change the text of redesignated paragraph (c)(32) in Notice No. 152, the commenter is correct that the Federal highway is improperly designated in that paragraph as it currently appears in the Code of Federal Regulations. Therefore, TTB is also making that edit in the final rule text of this document.

TTB Determination

After careful review of the petition and comments received, TTB finds that the topography, soil, and climate evidence provided by the petitioner sufficiently demonstrates that the proposed expansion area is similar to the established Willamette Valley AVA and should also be recognized as part of that AVA. Accordingly, under the authority of the FAA Act, section 1111(d) of the Homeland Security Act of 2002, and parts 4 and 9 of the TTB regulations, TTB expands the 5,360-square mile “Willamette Valley” AVA to include the approximately 29-square mile expansion area as described in Notice No. 152, effective 30 days from the publication date of this document.

In the regulatory text of this final rule, TTB is also correcting a typographical error that appeared in proposed paragraph (c)(17) and a second typographical error that was identified by a commenter in redesignated paragraph (c)(32). These corrections will properly identify two roads as a State highway and a Federal highway, respectively. No other changes have been made to the regulatory text.

Boundary Description

See the narrative description of the boundary of the AVA expansion in the regulatory text published at the end of this final rule.

Maps

The petitioner provided the required maps, and they are listed below in the regulatory text.

Impact on Current Wine Labels

Part 4 of the TTB regulations prohibits any label reference on a wine that indicates or implies an origin other than the wine's true place of origin. For a wine to be labeled with an AVA name or with a brand name that includes an AVA name, at least 85 percent of the wine must be derived from grapes grown within the area represented by that name, and the wine must meet the other conditions listed in § 4.25(e)(3) of the TTB regulations (27 CFR 4.25(e)(3)). If the wine is not eligible for labeling with an AVA name and that name appears in the brand name, then the label is not in compliance, and the bottler must change the brand name and obtain approval of a new label. Similarly, if the AVA name appears in another reference on the label in a misleading manner, the bottler would have to obtain approval of a new label. Different rules apply if a wine has a brand name containing an AVA name that was used as a brand name on a label approved before July 7, 1986. See § 4.39(i)(2) of the TTB regulations (27 CFR 4.39(i)(2)) for details.

The expansion of the Willamette Valley AVA will not affect any other existing AVA, and bottlers using “Willamette Valley” as an appellation of origin or in a brand name for wines made from grapes within the established Willamette Valley AVA will not be affected by this expansion. The expansion will allow vintners to use “Willamette Valley” as an appellation of origin for wines made primarily from grapes grown within the expansion area if the wines meet the eligibility requirements for the appellation.

Regulatory Flexibility Act

TTB certifies that this regulation will not have a significant economic impact on a substantial number of small entities. The regulation imposes no new reporting, recordkeeping, or other administrative requirement. Any benefit derived from the use of an AVA name would be the result of a proprietor's efforts and consumer acceptance of wines from that area. Therefore, no regulatory flexibility analysis is required.

Executive Order 12866

It has been determined that this rule is not a significant regulatory action as defined by Executive Order 12866 of September 30, 1993. Therefore, no regulatory assessment is required.

Drafting Information

Karen A. Thornton of the Regulations and Rulings Division drafted this final rule.

List of Subjects in 27 CFR Part 9

Wine.

The Regulatory Amendment

For the reasons discussed in the preamble, TTB amends title 27, chapter I, part 9, Code of Federal Regulations, as follows:

PART 9—AMERICAN VITICULTURAL AREAS 1. The authority citation for part 9 continues to read as follows: Authority:

27 U.S.C. 205.

Subpart C—Approved American Viticultural Areas 2. Section 9.90 is amended by revising paragraph (b) introductory text, adding paragraph (b)(4), removing paragraphs (c)(11) through (13), redesignating paragraphs (c)(14) through (32) as paragraphs (c)(18) through (36), revising newly redesignated paragraph (c)(32), and adding paragraphs (c)(11) through (17) to read as follows:
§ 9.90 Willamette Valley.

(b) Approved maps. The approved maps for determining the boundaries of the Willamette Valley viticultural area are three U.S.G.S. Oregon maps scaled 1:250,000 and one U.S.G.S. Oregon map scaled 1:24,000. They are entitled:

(4) “Letz Creek, OR” (revised 1984).

(c) * * *

(11) Northeast, then southeast along the 1,000 foot contour line approximately 12 miles to its intersection with the R5W/R6W range line;

(12) South along the R5W/R6W range line approximately 0.25 mile to the intersection with the 1,000 foot contour line;

(13) Generally southeast along the meandering 1,000 foot contour line, crossing onto the Letz Creek map, to a point on the 1,000 foot contour line located due north of the intersection of Siuslaw River Road and Fire Road;

(14) South in a straight line approximately 0.55 mile, crossing over the Siuslaw River and the intersection of Siuslaw River Road and Fire Road, to the 1,000 foot contour line;

(15) Generally southeast along the meandering 1,000 foot contour line, crossing onto the Roseburg, Oregon map, to the intersection of the 1,000 foot contour line with the Lane/Douglas County line;

(16) East along the Lane/Douglas County line approximately 3.8 miles to the intersection with the 1,000 foot contour line just east of the South Fork of the Siuslaw River;

(17) Generally north, then northeast along the 1,000 foot contour line around Spencer Butte, and then generally south to a point along the Lane/Douglas County line 0.5 mile north of State Highway 99;

(32) North along R5E/R6E 10.5 miles to a point where it intersects the Mount Hood National Forest boundary (approximately three miles north of U.S. Highway 26);

Signed: February 8, 2016. John J. Manfreda, Administrator. Approved: February 11, 2016. Timothy E. Skud, Deputy Assistant Secretary (Tax, Trade, and Tariff Policy).
[FR Doc. 2016-04710 Filed 3-2-16; 8:45 am] BILLING CODE 4810-31-P
DEPARTMENT OF THE TREASURY Alcohol and Tobacco Tax and Trade Bureau 27 CFR Part 9 [Docket No. TTB-2015-0009; T.D. TTB-135; Ref: Notice No. 153] RIN 1513-AC20 Establishment of the Loess Hills District Viticultural Area AGENCY:

Alcohol and Tobacco Tax and Trade Bureau, Treasury.

ACTION:

Final rule; Treasury decision.

SUMMARY:

The Alcohol and Tobacco Tax and Trade Bureau (TTB) establishes the approximately 12,897-square mile “Loess Hills District” viticultural area in western Iowa and northwestern Missouri. This new viticultural area is not located within any other viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.

DATES:

This final rule is effective April 4, 2016.

FOR FURTHER INFORMATION CONTACT:

Karen A. Thornton, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, 1310 G Street NW., Box 12, Washington, DC 20005; phone 202-453-1039, ext. 175.

SUPPLEMENTARY INFORMATION: Background on Viticultural Areas TTB Authority

Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), authorizes the Secretary of the Treasury to prescribe regulations for the labeling of wine, distilled spirits, and malt beverages. The FAA Act provides that these regulations should, among other things, prohibit consumer deception and the use of misleading statements on labels and ensure that labels provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the FAA Act pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). The Secretary has delegated various authorities through Treasury Department Order 120-01 (dated December 10, 2013, superseding Treasury Order 120-01 (Revised), “Alcohol and Tobacco Tax and Trade Bureau,” dated January 24, 2003), to the TTB Administrator to perform the functions and duties in the administration and enforcement of these laws.

Part 4 of the TTB regulations (27 CFR part 4) authorizes TTB to establish definitive viticultural areas and regulate the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) sets forth standards for the preparation and submission of petitions for the establishment or modification of American viticultural areas (AVAs) and lists the approved AVAs.

Definition

Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region having distinguishing features, as described in part 9 of the regulations, and a name and a delineated boundary, as established in part 9 of the regulations. These designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to the wine's geographic origin. The establishment of AVAs allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may purchase. Establishment of an AVA is neither an approval nor an endorsement by TTB of the wine produced in that area.

Requirements

Section 4.25(e)(2) of the TTB regulations (27 CFR 4.25(e)(2)) outlines the procedure for proposing an AVA and provides that any interested party may petition TTB to establish a grape-growing region as an AVA. Section 9.12 of the TTB regulations (27 CFR 9.12) prescribes standards for petitions for the establishment or modification of AVAs. Petitions to establish an AVA must include the following:

• Evidence that the area within the proposed AVA boundary is nationally or locally known by the AVA name specified in the petition;

• An explanation of the basis for defining the boundary of the proposed AVA;

• A narrative description of the features of the proposed AVA affecting viticulture, such as climate, geology, soils, physical features, and elevation, that make the proposed AVA distinctive and distinguish it from adjacent areas outside the proposed AVA boundary;

• The appropriate United States Geological Survey (USGS) map(s) showing the location of the proposed AVA, with the boundary of the proposed AVA clearly drawn thereon; and

• A detailed narrative description of the proposed AVA boundary based on USGS map markings.

Loess Hills District Petition

TTB received a petition from Shirley Frederiksen, on behalf of the Western Iowa Grape Growers Association and the Golden Hills Resource Conservation and Development organization proposing the establishment of the “Loess Hills District” AVA in western Iowa and northwestern Missouri. The proposed AVA covers a long, narrow north-south orientated swath of land along the Big Sioux and Missouri Rivers, covering 12,897 square miles from Hawarden, Iowa, to Craig, Missouri. There are approximately 66 commercially-producing vineyards covering a total of 112 acres distributed throughout the proposed AVA, along with 13 wineries. The proposed Loess Hills District AVA is not located within any established AVA.

According to the petition, the distinguishing features of the proposed Loess Hills District AVA are its soil, topography, and climate. The proposed AVA is located in a region characterized by extremely deep layers of wind-deposited soil called “loess.” Loess is a loose, crumbly soil comprised of quartz, feldspar, mica, and other materials which were ground into a fine powder by glaciers during the Ice Ages. When the glaciers melted, the water pushed this glacial flour down the Missouri River Valley. When the waters receded, the exposed silt dried and was picked up by the prevailing westerly winds and redeposited over broad areas.

The heaviest, coarsest loess particles were deposited along the Missouri River, within the proposed Loess Hills District AVA, and formed a landscape of rolling-to-steep hills. According to the petition, the rolling topography allows cold air to drain away from the vineyards, thus reducing the threat of frost. By contrast, the terrain in the regions to the north, south, and east of the proposed AVA is marked by broadly undulating hills with shallower slopes and lower elevations than are found within the proposed AVA. The terrain west of the proposed AVA is dominated by wide, flat flood plains.

The loess deposits within the proposed AVA reach depths of up to 300 feet, which are the thickest deposits of loess within the United States. The petition states that the thickness of the loess within the proposed AVA enables roots to extend deep into the soil without being stopped by a restrictive barrier such as denser soils or bedrock. The lack of a restrictive barrier also allows water to drain away from the roots quickly, which reduces the risk of fungal diseases and rot. In comparison, in every direction outside the proposed AVA, the depth of loess is 20 feet or less, which is significantly shallower than within the proposed AVA.

The petition also states that the proposed Loess Hills District AVA has a long growing season and relatively high annual precipitation amounts. The early last-spring-frost date reduces the risk that tender new buds and shoots will be damaged by spring frosts, and the late first-fall-frost date allows adequate time for late-maturing varieties of grapes, including Norton, Chambourcin, and Noiret, to ripen before frost can damage the fruit. The high precipitation amounts provide adequate hydration for the vines, so irrigation is seldom necessary within the proposed AVA. However, the rainfall amounts also pose a risk of erosion due to both the steepness of the hillsides and the loose, crumbly nature of the soils. When compared to the proposed AVA, the regions to the north, east, and west have shorter growing seasons. To the south of the proposed AVA, the growing season is longer. Annual precipitation amounts in the region south of the proposed AVA are higher, while the precipitation amounts in the region to the west are lower than those found within the proposed AVA.

Notice of Proposed Rulemaking and Comments Received

TTB published Notice No. 153 in the Federal Register on June 18, 2015 (80 FR 34857), proposing to establish the Loess Hills District AVA. In the document, TTB summarized the evidence from the petition regarding the name, boundary, and distinguishing features for the proposed AVA. The document also compared the distinguishing features of the proposed AVA to the features of the surrounding areas. For a detailed description of the evidence relating to the name, boundary, and distinguishing features of the proposed AVA, and for a detailed comparison of the distinguishing features of the proposed AVA to the surrounding areas, see Notice No. 153.

In Notice No. 153, TTB solicited comments on the accuracy of the name, boundary, and other required information submitted in support of the petition. The comment period closed on August 17, 2015. TTB did not receive any comments in response to Notice No. 153.

TTB Determination

After careful review of the petition, TTB finds that the evidence provided by the petitioner supports the establishment of the Loess Hills District AVA. Accordingly, under the authority of the FAA Act, section 1111(d) of the Homeland Security Act of 2002, and parts 4 and 9 of the TTB regulations, TTB establishes the “Loess Hills District” AVA in western Iowa and northwestern Missouri, effective 30 days from the publication date of this document.

Boundary Description

See the narrative description of the boundary of the AVA in the regulatory text published at the end of this final rule.

Maps

The petitioner provided the required maps, and they are listed below in the regulatory text.

Impact on Current Wine Labels

Part 4 of the TTB regulations prohibits any label reference on a wine that indicates or implies an origin other than the wine's true place of origin. For a wine to be labeled with an AVA name or with a brand name that includes an AVA name, at least 85 percent of the wine must be derived from grapes grown within the area represented by that name, and the wine must meet the other conditions listed in 27 CFR 4.25(e)(3). If the wine is not eligible for labeling with an AVA name and that name appears in the brand name, then the label is not in compliance and the bottler must change the brand name and obtain approval of a new label. Similarly, if the AVA name appears in another reference on the label in a misleading manner, the bottler would have to obtain approval of a new label. Different rules apply if a wine has a brand name containing an AVA name that was used as a brand name on a label approved before July 7, 1986. See 27 CFR 4.39(i)(2) for details.

With the establishment of this AVA, its name, “Loess Hills District,” will be recognized as a name of viticultural significance under § 4.39(i)(3) of the TTB regulations (27 CFR 4.39(i)(3)). The text of the regulation clarifies this point. Consequently, wine bottlers using the name “Loess Hills District” in a brand name, including a trademark, or in another label reference as to the origin of the wine, will have to ensure that the product is eligible to use the AVA name as an appellation of origin. TTB is not designating “Loess Hills,” standing alone, as a term of viticultural significance due to the current use of “Loess Hills,” standing alone, as a brand name on wine labels.

The establishment of the Loess Hills District AVA will not affect any existing AVA. The establishment of the Loess Hills District AVA will allow vintners to use “Loess Hills District” as an appellation of origin for wines made primarily from grapes grown within the Loess Hills District AVA if the wines meet the eligibility requirements for the appellation.

Regulatory Flexibility Act

TTB certifies that this regulation will not have a significant economic impact on a substantial number of small entities. The regulation imposes no new reporting, recordkeeping, or other administrative requirement. Any benefit derived from the use of an AVA name would be the result of a proprietor's efforts and consumer acceptance of wines from that area. Therefore, no regulatory flexibility analysis is required.

Executive Order 12866

TTB has determined that this final rule is not a significant regulatory action as defined by Executive Order 12866 of September 30, 1993. Therefore, no regulatory assessment is required.

Drafting Information

Karen A. Thornton of the Regulations and Rulings Division drafted this final rule.

List of Subjects in 27 CFR Part 9

Wine.

The Regulatory Amendment

For the reasons discussed in the preamble, TTB amends title 27, chapter I, part 9, Code of Federal Regulations, as follows:

PART 9—AMERICAN VITICULTURAL AREAS 1. The authority citation for part 9 continues to read as follows: Authority:

27 U.S.C. 205.

Subpart C—Approved American Viticultural Areas 2. Add § 9.255 to read as follows:
§ 9.255 Loess Hills District.

(a) Name. The name of the viticultural area described in this section is “Loess Hills District”. For purposes of part 4 of this chapter, “Loess Hills District” is a term of viticultural significance.

(b) Approved maps. The 13 United States Geological Survey (USGS) 1:100,000 scale topographic maps used to determine the boundary of the Loess Hills District viticultural area are titled:

(1) Rock Rapids, Iowa-South Dakota, 1985;

(2) Sioux City North, Iowa-South Dakota-Nebraska, 1986; photoinspected 1990;

(3) Storm Lake, Iowa, 1985; photoinspected 1990;

(4) Ida Grove, Iowa, 1985; photoinspected 1990;

(5) Carroll, Iowa, 1993;

(6) Guthrie Center, Iowa, 1993;

(7) Creston, Iowa, 1993;

(8) Omaha, Nebraska-Iowa, 1985; photoinspected, 1990;

(9) Nebraska City, Nebraska-Iowa-Missouri, 1993;

(10) Falls City, Nebraska-Missouri, 1986; photoinspected 1991;

(11) Harlan, Iowa-Nebraska, 1980;

(12) Blair, Nebraska-Iowa, 1986; photoinspected 1988; and

(13) Sioux City South, Iowa-Nebraska-South Dakota, 1986; photoinspected 1990.

(c) Boundary. The Loess Hills District viticultural area is located in Fremont, Page, Mills, Montgomery, Pottawattamie, Cass, Harrison, Shelby, Audubon, Monona, Crawford, Carroll, Woodbury, Ida, Sac, Plymouth, and Sioux Counties in western Iowa and Atchison and Holt Counties in northwestern Missouri. The boundary of the Loess Hills District viticultural area is as described below:

(1) The beginning point is on the Rock Rapids, Iowa-South Dakota map, in Sioux County, Iowa, at the intersection of the Big Sioux River and an unnamed road known locally as County Road B30 (360th Street), east of Hudson, South Dakota. From the beginning point, proceed east on County Road B30 approximately 3 miles to a road known locally as County Road K22 (Coolidge Avenue); then

(2) Proceed south on County Road K22 approximately 3 miles to a road known locally as County Road B40 (390th Street); then

(3) Proceed east on County Road B40 approximately 4 miles to a road known locally as County Road K30 (Eagle Avenue); then

(4) Proceed south on County Road K30 approximately 13.1 miles, crossing onto the Sioux City North, Iowa-South Dakota-Nebraska map and continuing into Plymouth County, Iowa, to a road known locally as County Road C12 (110th Street), at Craig, Iowa; then

(5) Proceed east on County Road C12 approximately 2 miles to a road known locally as County Road K42 (Jade Avenue), at the marked 436-meter elevation point; then

(6) Proceed south on County Road K42 approximately 10 miles to a road known locally as County Road C38; then

(7) Proceed east on County Road C38 approximately 6.4 miles to a road known locally as County Road K49 (7th Avenue SE), approximately 2 miles south of La Mars, Iowa; then

(8) Proceed south on County Road K49 approximately 4 miles to a road known locally as County Road C44 (230th Street); then

(9) Proceed east on County Road C44 approximately 5 miles to a road known locally as County Road K64 (Oyens Avenue); then

(10) Proceed south on County Road K64 approximately 4.1 miles to a road known locally as County Road C60 (290th Street); then

(11) Proceed east on County Road C60 approximately 5 miles, crossing onto the Storm Lake, Iowa map, to State Highway 140; then

(12) Proceed south on State Highway 140 approximately 3.2 miles to a road known locally as County Road L14 (Knox Avenue) in Kingsley, Iowa; then

(13) Proceed south on County Road L14 approximately 2.7 miles, crossing into Woodbury County, Iowa, to a road known locally as County Road D12 (110th Street); then

(14) Proceed east on County Road D12 approximately 5 miles to a road known locally as County Road L25 (Minnesota Avenue) near Pierson, Iowa; then

(15) Proceed south on County Road L25 approximately 4.5 miles, crossing onto the Ida Grove, Iowa map, to U.S. Highway 20; then

(16) Proceed east on U.S. Highway 20 approximately 22.5 miles, crossing into Ida County, Iowa, to a road known locally as County Road M25 (Market Avenue); then

(17) Proceed south on County Road M25 approximately 9.8 miles to State Highway 175 east of Ida Grove, Iowa; then

(18) Proceed east on State Highway 175 approximately 4.1 miles to a road known locally as Country Highway M31 (Quail Avenue) near Arthur, Iowa; then

(19) Proceed south on Country Highway M31 approximately 4.4 miles to a road known locally as County Road D59 (300th Street); then

(20) Proceed east on County Road D59 approximately 13 miles, crossing into Sac County, Iowa, to a road known locally as County Road M64 (Needham Avenue/Center Street) at Wall Lake, Iowa; then

(21) Proceed south on County Road M64 approximately 6.2 miles to a road known locally as County Road E16 (120th Street); then

(22) Proceed east into Carroll County, Iowa, on County Road E16 approximately 6 miles, crossing onto the Carroll, Iowa map, to Breda, Iowa, and then continue east on State Highway 217 (East Main Street) approximately 5 miles to U.S. Highway 71; then

(23) Proceed south on U.S. Highway 71 approximately 3 miles to a road known locally as County Road E26 (140th Street); then

(24) Proceed east on County Road E26 approximately 5 miles to a road known locally as County Road N38 (Quail Avenue); then

(25) Proceed south on County Road N38 approximately 5 miles to U.S. Highway 30 (Lincoln Highway); then

(26) Proceed east on U.S. Highway 30 approximately 3 miles to a road known locally as County Road N44 (Colorado Street) in Glidden, Iowa; then

(27) Proceed south on County Road N44 approximately 8 miles, crossing onto the Guthrie Center, Iowa map, to a road known locally as County Road E57 (280th Street); then

(28) Proceed east on County Road E57 approximately 2 miles to a road known locally as County Road N44 (Velvet Avenue); then

(29) Proceed south on County Road N44 approximately 5.4 miles to State Highway 141 (330th Street) at Coon Rapids, Iowa; then

(30) Proceed west on State Highway 141 approximately 12 miles to U.S. Highway 71 at Lynx Avenue southeast of Templeton, Iowa; then

(31) Proceed south on U.S. Highway 71 approximately 35.9 miles, crossing into Audubon County, Iowa, and then Cass County, Iowa, and onto the Creston, Iowa map, to U.S. Highway 6/State Highway 83 east of Atlantic, Iowa; then

(32) Proceed west, then southwest, then west on U.S. Highway 6 approximately 18.9 miles, crossing onto the Omaha, Nebraska-Iowa map and into Pottawattamie County, Iowa, to a road known locally as County Road M47 (500th Street) approximately 1 mile west of Walnut Creek; then

(33) Proceed south on County Road M47 approximately 12 miles, crossing into Montgomery County, Iowa to a road known locally as County Road H12 (110th Street); then

(34) Proceed west on County Road H12 approximately 8.9 miles, crossing into Mills County, Iowa, to U.S. Highway 59; then

(35) Proceed south on U.S. Highway 59 approximately 20.2 miles, crossing onto the Nebraska City, Nebraska-Iowa-Missouri map and into Page County, Iowa, to a road known locally as County Road J14 (130th Street); then

(36) Proceed east on County Road J14 approximately 4 miles to a road known locally as County Road M41 (D Avenue); then

(37) Proceed south on County Road M41 approximately 1.7 miles to State Highway 48 at Essex, Iowa; then

(38) Proceed northeast then east on State Highway 48 approximately 1.2 miles to a road known locally as County Road M41 (E Avenue); then

(39) Proceed south on County Road M41 approximately 7 miles to State Highway 2 (210th Street); then

(40) Proceed east on State Highway 2 approximately 8 miles to a road known locally as M Avenue; then

(41) Proceed south on M Avenue, then east on a road known locally as County Road M60 (Maple Avenue), approximately 6.4 total miles, to a road known locally as County Road J52 (270th Street); then

(42) Proceed south in a straight line approximately 3.5 miles to the intersection of 304th Street and Maple Avenue (approximately 1.2 miles southwest of College Springs, Iowa), and then continue south on Maple Avenue for 0.5 mile to a road known locally as County Road J64 (310th Street); then

(43) Proceed west on County Road J64 approximately 4.5 miles to a road known locally as County Road M48 (Hackberry Avenue); then

(44) Proceed south on County Road M48 approximately 1.2 miles to the Iowa-Missouri State line at Blanchard, Iowa, and, crossing into Atchison County, Missouri, where County Road M48 becomes State Road M, and continue generally south on State Road M approximately 11.2 miles, crossing onto the Falls City, Nebraska-Missouri map, to U.S. Highway 136; then

(45) Proceed west on U.S. Highway 136 approximately 1 mile to State Road N; then

(46) Proceed south on State Road N 15 miles, crossing into Holt County, Missouri, to State Road C; then

(47) Proceed west then south on State Road C approximately 3 miles to U.S. Highway 59; then

(48) Proceed northwest on U.S. Highway 59 approximately 2 miles to the highway's first intersection with Interstate Highway 29 near Craig, Missouri; then

(49) Proceed generally north along Interstate Highway 29, crossing into Atchison County, Missouri, and onto the Nebraska City, Nebraska-Iowa-Missouri map, and continuing into Freemont County and Mills County, Iowa, then crossing onto the Omaha, Nebraska-Iowa map and into Pottawattamie County, Iowa; then crossing onto the Harlan, Iowa-Nebraska map and into Harrison County, Iowa; then continuing onto the Blair, Nebraska-Iowa map and into Monona County, Iowa; then crossing onto the Sioux City South, Iowa-Nebraska-South Dakota Map and into Woodbury County for a total of approximately 185 miles, to the intersection of Interstate Highway 29 with the Big Sioux River at Sioux City, Iowa; then

(50) Proceed generally north (upstream) along the meandering Big Sioux River, crossing onto the Sioux City North, Iowa-South Dakota-Nebraska map and into Plymouth County and Sioux County, Iowa, and continuing onto the Rock Rapids, Iowa-South Dakota map for a total of approximately 50 miles, returning to the beginning point.

Signed: January 29, 2016. John J. Manfreda, Administrator. Approved: February 11, 2016. Timothy E. Skud, Deputy Assistant Secretary, (Tax, Trade, and Tariff Policy).
[FR Doc. 2016-04760 Filed 3-2-16; 8:45 am] BILLING CODE 4810-31-P
DEPARTMENT OF DEFENSE Department of the Navy 32 CFR Part 706 Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972 AGENCY:

Department of the Navy, DoD.

ACTION:

Final rule.

SUMMARY:

The Department of the Navy (DoN) is amending its certifications and exemptions under the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), to reflect that the Deputy Assistant Judge Advocate General (DAJAG) (Admiralty and Maritime Law) has determined that USS JOHN P MURTHA (LPD 26) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with certain provisions of the 72 COLREGS without interfering with its special function as a naval ship. The intended effect of this rule is to warn mariners in waters where 72 COLREGS apply.

DATES:

This rule is effective March 3, 2016 and is applicable beginning January 13, 2016.

FOR FURTHER INFORMATION CONTACT:

Commander Theron R. Korsak, (Admiralty and Maritime Law), Office of the Judge Advocate General, Department of the Navy, 1322 Patterson Ave. SE., Suite 3000, Washington Navy Yard, DC 20374-5066, telephone 202-685-5040.

SUPPLEMENTARY INFORMATION:

Pursuant to the authority granted in 33 U.S.C. 1605, the DoN amends 32 CFR part 706.

This amendment provides notice that the DAJAG (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS JOHN P MURTHA (LPD 26) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I paragraph 2 (i)(i), Rule 27 (a)(i) and (b)(i), pertaining to the placement of all-round task lights in a vertical line; Annex I, paragraph 3(a), pertaining to the horizontal distance between the forward and after masthead lights; and Annex I, paragraph 2(k) as described in Rule 30 (a)(i), pertaining to the vertical separation between anchor lights. The DAJAG (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

List of Subjects in 32 CFR Part 706

Marine safety, Navigation (water), and Vessels.

For the reasons set forth in the preamble, the DoN amends part 706 of title 32 of the Code of Federal Regulations as follows:

PART 706—CERTIFICATIONS AND EXEMPTIONS UNDER THE INTERNATIONAL REGULATIONS FOR PREVENTING COLLISIONS AT SEA, 1972 1. The authority citation for part 706 continues to read: Authority:

33 U.S.C. 1605.

2. Section 706.2 is amended by: a. In Table Three, adding, in alpha numerical order, by vessel number, an entry for USS JOHN P MURTHA (LPD 26); b. In Table Four, paragraph 20., adding, in alpha numerical order, by vessel number, an entry for USS JOHN P MURTHA (LPD 26); and c. In Table Five, by adding, in alpha numerical order, by vessel number, an entry for USS JOHN P MURTHA (LPD 26).
§ 706.2 Certifications of the Secretary of the Navy under Executive Order 11964 and 33 U.S.C. 1605. Table Three Vessel Number Masthead lights arc of visibility; rule 21(a) Side lights arc of
  • visibility; rule 21(b)
  • Stern light arc of
  • visibility; rule 21(c)
  • Side lights distance
  • inboard of ship's sides in meters 3(b) Annex 1
  • Stern light, distance
  • forward of stern in meters; rule 21(c)
  • Forward
  • anchor light, height above hull in
  • meters; 2(k) Annex 1
  • Anchor lights
  • relationship of aft light to forward light in meters 2(k) Annex 1
  • *         *         *         *         *         *         * USS JOHN P MURTHA LPD 26 1.72 below. *         *         *         *         *         *         *

    20. * * *

    Table Four Vessel Number Angle in degrees of task lights off vertical as viewed from directly ahead or astern USS JOHN P MURTHA LPD 26 10 *         *         *         *         *         *         * Table Five Vessel Number Masthead
  • lights not over all other lights and obstructions. Annex I,
  • sec. 2(f)
  • Forward
  • masthead light not in forward quarter of ship. Annex I, sec. 3(a)
  • After
  • masthead light less than 1/2 ship's length aft of
  • forward
  • masthead light. Annex I, sec. 3(a)
  • Percentage
  • horizontal
  • separation
  • attained
  • *         *         *         *         *         *         * USS JOHN P MURTHA LPD 26 X 71 *         *         *         *         *         *         *
    Approved: January 13, 2016. A.B. Fischer, Commander, JAGC, U.S. Navy, Deputy Assistant Judge Advocate General (Admiralty and Maritime Law). Dated: February 17, 2016. N.A. Hagerty-Ford, Commander, Judge Advocate General's Corps, U.S. Navy, Federal Register Liaison Officer
    [FR Doc. 2016-04547 Filed 3-2-16; 8:45 am] BILLING CODE 3810-FF-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2015-0934] RIN 1625-AA09 Drawbridge Operation Regulation; Saginaw River, Bay City, MI AGENCY:

    Coast Guard, DHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Coast Guard is amending its regulations regarding drawbridge operations in Saginaw River, Bay City, MI. In a final rule entitled, “Drawbridge Operation Regulation; Saginaw River, Bay City, MI” that appeared in the Federal Register on April 12, 2012, the Coast Guard revised the drawbridge opening schedules for the Saginaw River and inadvertently excluded the CSX Railroad Bridge and the Grand Trunk Western Railroad Bridge. This document amends the regulations by adding these two bridges back into the regulations.

    DATES:

    This rule is effective March 3, 2016.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type [USCG-2015-0934] in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rulemaking.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email Mr. Lee Soule, Bridge Management Specialist, Ninth Coast Guard District; telephone (216) 902-6085, 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 SNPRM Supplemental notice of proposed rulemaking Pub. L. Public Law § Section U.S.C. United States Code II. Background Information and Regulatory History

    The Coast Guard is issuing this final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the publishing of the original final rule [Docket No. USCG-2011-1013] omitted regulatory language that was published in the previous rulemaking NPRM, but was inadvertently left out of the final rule published on April 12, 2012. Therefore, it is unnecessary to issue a rule without prior notice and opportunity to comment because the public was already provided an opportunity to comment on these provisions, had no objections during the previous comment period, and the operation of the bridges is consistent with this rule. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective in less than 30 days after publication in the Federal Register. The regulation change has already taken place and the correction of the regulation will not affect mariners currently operating on this waterway. Therefore, a delayed effective date is unnecessary.

    The NPRM for the regulations, published on December 8, 2011 (76 FR 76637), proposed to revise § 117.647. At the end of the rule, the following characters were included in the NPRM: “* * * * *.” These characters indicated the Coast Guard's intention to retain paragraphs (c) and (d) which were included in the regulations at the time of the NPRM regarding the CSX Railroad Bridge located at mile 18.0 over the Saginaw River and the Grand Trunk Western Railroad Bridge located at mile 19.2 of the Saginaw River. However, the final rule, which was published on April 24, 2012 (77 FR 21864), did not preserve these paragraphs. The purpose of this amendment is to ensure that the regulation accurately reflects the original intention and inclusion of these inadvertently omitted paragraphs.

    III. Discussion of Final Rule

    The purpose of this rule is to correct 33 CFR 117.647 in the Code of Federal Regulations.

    As noted above, this rule restores language that was previously excluded. This rule is correcting the regulation in 33 CFR 117.647 by restoring the listing of drawbridges allowed to remain closed. The CSX Railroad Bridge located at mile 18.0 of the Saginaw River and the Grand Trunk Western Railroad Bridge located on mile 19.2 of the Saginaw River will retain their current operating schedule. This rule will not affect waterway traffic or land transportation needs because the status of the two drawbridges has been in effect since 1994.

    IV. Regulatory Analyses

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

    A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget. The Coast Guard does not consider this rule to be “significant” under that Order because it is an administrative change that corrects inadvertently omitted language that is consistent with the current operation of the bridges. Therefore, this rule does not affect the way vessels operate on the waterway.

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

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

    C. Collection of Information

    This rule calls 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 rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

    Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which 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 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 rule simply promulgates the operating regulations or procedures for drawbridges. This action is 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.

    G. Protest Activities

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

    List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends 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; and Department of Homeland Security Delegation No. 0170.1.

    2. In § 117.647, add paragraphs (c) and (d) to read as follows:
    § 117.647 Saginaw River.

    (c) The draw of the CSX railroad bridge, mile 18.0, need not be opened for the passage of vessels. The owner shall return the draw to an operable condition within a reasonable time when directed by the District Commander to do so.

    (d) The draw of the Grand Trunk Western railroad bridge, mile 19.2, need not be opened for the passage of vessels.

    Dated: February 10, 2016. J.E. Ryan, Rear Admiral, U. S. Coast Guard, Commander, Ninth Coast Guard District.
    [FR Doc. 2016-04743 Filed 3-2-16; 8:45 am] BILLING CODE 9110-04-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2015-0645; FRL-9942-17-Region 9] Approval of Arizona Air Plan Revisions; Phoenix, Arizona; Second 10-Year Carbon Monoxide Maintenance Plan AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking final action to approve a revision to the Arizona State Implementation Plan (SIP). This revision is the second ten-year maintenance plan for carbon monoxide (CO) for the Phoenix metropolitan area in Maricopa County, Arizona. We are also finding adequate and approving transportation conformity motor vehicle emissions budgets (MVEB) for the year 2025 and beyond. We are taking these actions under the Clean Air Act (CAA or the Act).

    DATES:

    This rule is effective on April 4, 2016.

    ADDRESSES:

    The EPA has established docket number EPA-R09-OAR-2015-0645 for this action. Generally, documents in the docket for this action are available electronically at http://www.regulations.gov or in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California 94105-3901. While all documents in the docket are listed at http://www.regulations.gov, some information may be publicly available only at the hard copy location (e.g., copyrighted material, large maps, multi-volume reports), and some may not be available in either location (e.g., confidential business information (CBI)). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section.

    FOR FURTHER INFORMATION CONTACT:

    John Kelly, EPA Region IX, (415) 947-4151, [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document, “we,” “us” and “our” refer to the EPA.

    Table of Contents I. Proposed Action II. Public Comments and EPA Responses III. EPA Action IV. Statutory and Executive Order Reviews I. Proposed Action

    On October 19, 2015 (80 FR 63185), the EPA proposed to approve the Maricopa Association of Governments' (MAG) plan titled “MAG 2013 Carbon Monoxide Maintenance Plan for the Maricopa County Area” (hereinafter, “2013 Maintenance Plan”) into the Arizona SIP.

    We also proposed to find adequate and to approve into the SIP the CO MVEB for the year 2025 and beyond.

    We proposed to approve this plan and the CO MVEB because we determined that they complied with the relevant CAA requirements. Our proposed action contains more information on the plan and MVEB and our evaluation.

    II. Public Comments and EPA Responses

    The EPA's proposed action provided a 30-day public comment period. During this period, we received no comments.

    III. EPA Action

    No comments were submitted. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving this plan into the Arizona SIP. The EPA is also finding adequate and approving the motor vehicle emissions budgets in the plan (see Table 1) because we find they meet the applicable transportation conformity requirements under 40 CFR 93.118(e). Table 1 shows the approved and previously approved MVEBs for the Phoenix CO Maintenance Area.

    Table 1—Approved and Previously Approved Transportation Conformity Motor Vehicle Emissions Budgets for the Phoenix CO Maintenance Area, in Metric Tons per Day (mtpd) Previously
  • approved
  • Previously
  • approved
  • Approved
    Year 2006 2015 2025 CO MVEB 699.7 662.9 559.4
    IV. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

    • is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

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

    In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

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

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

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements.

    Dated: January 25, 2016. Jared Blumenfeld, Regional Administrator, Region IX.

    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart D—Arizona 2. Section 52.120 is amended by adding paragraph (c)(173) to read as follows:
    § 52.120 Identification of plan.

    (c) * * *

    (173) The following plan was submitted on April 2, 2013 by the Governor's designee.

    (i) [RESERVED].

    (ii) Additional materials.

    (A) Arizona Department of Environmental Quality.

    (1) MAG 2013 Carbon Monoxide Maintenance Plan for the Maricopa County Area, adopted by the Maricopa Association of Governments on March 27, 2013.

    [FR Doc. 2016-04614 Filed 3-2-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0475; FRL-9942-10] Fluensulfone; Pesticide Tolerance for Emergency Exemption AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes a time-limited tolerance for residues of fluensulfone, measured as 3,4,4-trifluoro-but-3-ene-1-sulfonic acid, resulting from use of fluensulfone in or on carrots in accordance with the terms of an emergency exemption issued under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This action is in response to the issuance of a crisis emergency exemption under FIFRA section 18 authorizing use of the pesticide on carrots. This regulation establishes a maximum permissible level for residues of fluensulfone in or on carrots. The time-limited tolerance expires on December 31, 2017.

    DATES:

    This regulation is effective March 3, 2016. Objections and requests for hearings must be received on or before May 2, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0475, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

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

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

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

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0475 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before May 2, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0475 by one of the following methods:

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

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

    Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

    II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l)(6), 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a time-limited tolerance for residues of fluensulfone, to be enforced by measuring only the metabolite 3,4,4-trifluoro-but-3-ene-1-sulfonic acid, in or on carrots at 2.0 parts per million (ppm). There are no Canadian or Codex MRLs for residues of fluensulfone in or on carrot at this time. International harmonization is not an issue for this emergency exemption. This time-limited tolerance expires on December 31, 2017.

    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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

    Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

    III. Emergency Exemption for Fluensulfone on Carrots and FFDCA Tolerances

    The Michigan Department of Agriculture and Rural Development asserted that an emergency condition existed in accordance with the criteria for approval of an emergency exemption, and utilized a crisis exemption under FIFRA section 18 to allow the use of fluensulfone on carrots to control plant-parasitic nematodes in carrot fields in Michigan. The Michigan Department of Agriculture and Rural Development invoked the crisis exemption provision on April 14, 2015. After having reviewed the submission, EPA concurred on the emergency action in order to meet the needs of Michigan carrot growers who faced significant economic loss. The crisis exemption program expired on June 15, 2015.

    As part of its evaluation of the Michigan crisis exemption, EPA assessed the potential risks presented by residues of fluensulfone in or on carrots. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary time-limited tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this time-limited tolerance without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although this time-limited tolerance expires on December 31, 2017, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on carrots after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this time-limited tolerance at the time of that application. EPA will take action to revoke this time-limited tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

    Because this time-limited tolerance is being approved under emergency conditions, EPA has not made any decisions about whether fluensulfone meets FIFRA's registration requirements for use on carrots or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of fluensulfone by a State for special local needs under FIFRA section 24(c). Nor does this time-limited tolerance by itself serve as the authority for persons in any State other than Michigan to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the crisis exemption for fluensulfone, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

    IV. Aggregate Risk Assessment and Determination of Safety

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

    Consistent with the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of the crisis exemption and this time-limited tolerance for residues of fluensulfone on carrots at 2.0 parts per million (ppm), measured as 3,4,4-trifluoro-but-3-ene-1-sulfonic acid. EPA's assessment of exposures and risks associated with establishing a time-limited tolerance follows.

    The Agency assessed the use of the fluensulfone use on carrots based on a 0.50 ppm residue level of the parent compound, which is the residue of concern for purposes of risk assessment on carrots (i.e., 100% crop treated) and determined that there would be no resulting change in the estimates from the previous risk assessment for the chemical. Since the publication of the September 24, 2014 final rule, the toxicity profile of fluensulfone has not changed, and the risk assessments that supported the establishment of those tolerances published in the Federal Register remain valid. The dietary risk assessments for fluensulfone are based on residues of the parent compound only. Therefore, EPA relies upon those supporting risk assessments and the findings made in the September 24, 2014 Federal Register document, as well as an updated dietary exposure and risk assessment on carrots. EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to fluensulfone residues.

    A summary of the toxicological endpoints for fluensulfone used for human risk assessment were previously described in a final rule published in the Federal Register of September 24, 2014 (79 FR 56964) (FRL-9914-35). Please refer to this Federal Register document and its supporting documents, available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2012-0593 for a detailed discussion of the aggregate risk assessments and determination of safety for the proposed time-limited tolerance for residues of fluensulfone on carrots at 2.0 parts per million (ppm) when measured as 3,4,4-trifluoro-but-3-ene-1-sulfonic acid.

    V. Analytical Enforcement Methodology

    An analytic method suitable for enforcement purposes has been approved by the Agency. That same method was used in the field trials for carrot and was shown to be appropriate for that crop. The method has an LOQ, defined as the lower limit of method validation, of 0.01 ppm of 3,4,4-trifluoro-but-3-ene-1-sulfonic acid. For carrot, the method has a calculated LOQ of 0.005 ppm of 3,4,4-trifluoro-but-3-ene-1-sulfonic acid. Adequate enforcement methodology, a reverse-phase high performance liquid chromatography with dual mass spectrometry/mass spectrometry (HPLC-MS/MS), is available to enforce the tolerance expression.

    The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]

    International Residue Limits

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

    The Codex has not established a MRL for fluensulfone or 3,4,4-trifluoro-but-3-ene-1-sulfonic acid, in or on carrot.

    VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of fluensulfone, measured as 3,4,4-trifluoro-but-3-ene-1-sulfonic acid, in or on carrots at 2.0 ppm. This tolerance expires on December 31, 2017.

    VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and 408(l)(6). The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    Since tolerances and exemptions that are established in accordance with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

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

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

    VIII. Congressional Review Act

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

    List of Subjects in 40 CFR Part 180

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

    Dated: February 25, 2016. Susan Lewis, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

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

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

    2. In § 180.680, revise paragraph (b) to read as follows:
    § 180.680 Fluensulfone; tolerances for residues.

    (b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of the nematicide fluensulfone, including its metabolites and degradates, in or on the commodities in the table below, resulting from use of the pesticide pursuant to FIFRA section 18 emergency exemptions. Compliance with the tolerance levels specified below is to be determined by measuring only 3,4,4-trifluoro-but-3-ene-1-sulfonic acid. The tolerances expire on the date specified in the table.

    Commodity Parts per million Expiration
  • date
  • Carrot 2.0 12/31/17
    [FR Doc. 2016-04757 Filed 3-2-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF THE INTERIOR Office of the Secretary 43 CFR Part 2 [13XD4523WS DS10200000 DWSN00000.000000 WBS DP10202] RIN 1093-AA19 Freedom of Information Act Regulations AGENCY:

    Office of the Secretary, Interior.

    ACTION:

    Final rule.

    SUMMARY:

    This rule revises the regulations that the Department of the Interior (Department) follows in processing records under the Freedom of Information Act. The revisions clarify and update procedures for requesting information from the Department and procedures that the Department follows in responding to requests from the public.

    DATES:

    This rule is effective on April 4, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Cindy Cafaro, Office of the Executive Secretariat and Regulatory Affairs, 202-208-5342.

    SUPPLEMENTARY INFORMATION: I. Why We're Publishing This Rule and What it Does A. Introduction

    In late 2012, the Department published a final rule updating and replacing the Department's previous Freedom of Information Act (FOIA) regulations. Since that time, in order to maintain the independence of the Office of Inspector General (OIG), the Department and the OIG have agreed to authorize the OIG to process their own FOIA appeals. Additionally, the Department has recently migrated its Web site to a new framework, leading to updated links. Finally, the Department has received feedback from its FOIA practitioners and requesters and identified areas where it is possible to further update, clarify, and streamline the language of some procedural provisions. Therefore, the Department is making the following changes:

    • Section 2.1(e) is amended to identify the regulations applicable to Privacy Act requests.

    • Section 2.5(d) is amended to provide more guidance on what happens when a request does not reasonably describe the records sought.

    • Portions of § 2.6 are amended to make explicit that a fee waiver request is a valid way of responding to a request for additional fee information and that requesters may inform bureaus why they believe they are eligible for discretionary fee waivers, and to emphasize when fee issues must be resolved before processing will begin.

    • A sentence is added to § 2.8(a) to require a bureau that cannot readily reproduce the requested record in the form or format requested to explain why it cannot.

    • Section 2.9(b) is amended to remove a superfluous introductory phrase.

    • Section 2.10 is amended to highlight the requirements a requester seeking expedited processing must meet and the consequences of not meeting those requirements.

    • Section 2.11 is amended to reduce the suggested contact information provided by requesters.

    • Section 2.12(c) is amended to emphasize that reasonable efforts must be made to search for requested records and to clarify when searching for requested records in electronic form or format will not occur.

    • A sentence is added to § 2.15(e) to require bureaus to provide more information to requesters when placing them in a different processing track than requested.

    • Section 2.16(a) is amended to clarify and streamline discussion of when the time period for responding to a request begins and ends.

    • The introductory language of § 2.19(a) is amended to clarify when bureaus may extend the basic time limit.

    • Portions of § 2.20 are amended to make explicit that expedited processing requests are only appropriate before the bureau issues its final response; to require bureaus to provide more information to requesters when denying expedited processing requests; and to clarify that the portion of an appeal that relates to an expedited processing denial, rather than the entire appeal, will be processed ahead of other appeals.

    • Section 2.22(c) and (d) is amended to clarify when records may be released to requesters.

    • Section 2.23(a)(3) is amended to add a clarifying phrase.

    • Section 2.24(b) is amended and expanded to require bureaus to provide more information to requesters in denial notifications.

    • Section 2.25(c) is amended to clarify what information must be provided to requesters, and where, when portions of responsive records have been deleted.

    • Section 2.26 and § 2.27(a) are amended to provide more information on when submitter notification is required.

    • One word in § 2.27(b) is replaced to more closely track the language of Executive Order No. 12600, (52 FR 23781, published June 23, 1987).

    • Section 2.28(a) is amended to clarify that a general description of the request would suffice for submitter notices published under § 2.27(b).

    • Section 2.31(a)(1) and (2) are amended to clarify the information a submitter must provide when objecting to the release of responsive information under Exemption 4.

    • Section 2.37(g) is added and § 2.49(a)(1) is amended so the concept that requesters generally will not be charged if the fee for processing their request is less than $50 is introduced sooner.

    • Section 2.37(h) is added to make the consequences of failure to pay bills for FOIA-related fees explicit.

    • Section 2.37(i) is added to notify requesters they can seek assistance, when considering reformulating their request to meet their needs at a lower cost, from the bureau's designated FOIA contact or FOIA Public Liaison.

    • A sentence is added to § 2.38(b) to require bureaus to provide more information to requesters when placing them in a different fee category than requested.

    • Section 2.39 is amended to replace one word for the sake of grammatical consistency.

    • Section 2.42(d) is amended to further discuss the impact of requester preferences for paper and/or electronic formats.

    • Section 2.44(b) is amended to provide different examples of special services a requester might have to pay for.

    • The introductory language of §§ 2.45(a) and 2.48(a) is amended to clarify what a requester must demonstrate to be entitled to a fee waiver.

    • Section 2.46(b) is amended to clarify when fee waiver requests may be made.

    • Minor grammatical changes are made to § 2.47(a), (c), and (d) to allow a new § 2.47(e) to increase clarity and require bureaus to provide the requester with notice of anticipated fees when denying a request for a fee waiver.

    • Section 2.48(a)(2)(v) is amended to note that representatives of the news media will be presumed to have the ability and intent to disseminate the requested information to a reasonably broad audience of persons interested in the subject.

    • Section 2.49(c) is amended to allow requesters more flexibility in resolving fee issues.

    • Portions of § 2.50 are amended to clarify discussion of advance payments.

    • Section 2.51(b)(1), (b)(2), (b)(3), and (c) are amended to ensure consistent phrasing and to include minor, clarifying additions.

    • Section 2.57(a)(5) and (a)(6) are amended to include minor, clarifying additions.

    • Section 2.60 is amended to reflect that the FOIA Appeals Officer would no longer be the deciding official for FOIA appeals arising from OIG FOIA responses, and small portions of §§ 2.20(c), 2.24(b)(5), 2.47(d), 2.62, and 2.63 would also be amended to reflect this change.

    • Section 2.62 is streamlined to follow the requirements of FOIA more closely.

    • Section 2.66 is amended to provide more information on the role played by FOIA Public Liaisons.

    • Section 2.68 is amended to reflect the new schedule number resulting from the National Archives and Records Administration's recent update to the General Records Schedule pertaining to FOIA records and to add a reference to the Department's Record Schedule pertaining to FOIA records.

    • A word is added to the definition of “multitrack processing” in Section 2.70 to ensure it is consistent with Section 2.14.

    • Sections 2.1(d), 2.1(g), 2.3(c), 2.21(a), 2.41(c), 2.59(a), 2.65, and 2.70 are amended to reflect updated Web site links.

    On September 30, 2015, the Department published a proposed rule in the Federal Register (80 FR 58663) and requested comments over a 60-day period ending on November 30, 2015. All comments received were considered in drafting this final rule.

    B. Discussion of Comments

    Four commenters responded to the invitation for comments, including one commenter from a subcomponent of a Federal agency and three commenters from non-Federal sources. Two of these commenters offered some substantive suggestions on specific existing provisions of the rule that are not being amended; these suggestions are outside the scope of this rulemaking and are not addressed below. While most of the commenters generally supported the proposed changes (and one “applaud[ed]” certain existing provisions), they identified twelve specific issues or recommendations related to the proposed rule, which the Department addressed as follows:

    The Final Rule Should Only Allow Requests for Clarification To Be Sent by Email or Registered Mail

    One commenter suggested that § 2.5(d) be amended to require requests for clarification be sent only via email or registered mail so the agency can “satisfy itself that the request for additional material that was sent was actually received.” The Department has not adopted this suggestion as it is satisfied with the current flexibility in this area and does not want to create additional expenses and inflexibility.

    The Final Rule Should Specify Response Deadlines for Responding to Requests for More Information on the Records Sought

    One commenter suggested that § 2.5(d) “should clarify whether the requester's 20-workday response deadline runs from the date of the Department's notice or from the date that the requester actually receives the Department's notice.” We agree and have modified our edits to this section accordingly and have made analogous edits and clarifications to §§ 2.49(c), 2.51(b)(1), 2.51(b)(2), 2.51(b)(3), and 2.51(c).

    The Final Rule Should Add New Information About How Fee Information Affects the Processing of Requests

    One commenter suggested § 2.6(e) include a statement that “A denial of your waiver request and/or the amount you are willing to pay, will result in an automatic truncation of the process to comply with your FOIA request.” We do not agree with this statement, as it is not always true, and therefore have not adopted this suggestion. Another commenter suggested the Department revisit § 2.6(e) and provided examples of Department of Justice guidance on fee issues from 1983 and 2013. In response to this comment, the Department reviewed both the suggested guidance and the Department of Justice's FOIA regulations (amended in 2015) and added clarifying information to § 2.6(e) consistent with the Department of Justice's FOIA regulations.

    The Final Rule Should Include Additional Language Related to Expedited Processing and Fees

    One commenter suggested adding language to §§ 2.10 and 2.20 explicitly stating that expedited requests do not incur additional fees. We understand the point of this suggestion, but feel it would not add clarity to the rule, especially as there is nothing in any section of the regulations that indicates making such a request would incur additional fees.

    The Final Rule Should Explicitly Solicit Cellphone Numbers

    One commenter suggested adding a specific reference to cellphone numbers to § 2.11. The Department has not adopted this suggestion. The existing reference to “daytime telephone numbers” that encompasses, but does not require, cellphone numbers, is sufficient.

    The Final Rule Should Be Fair to the Requester

    One commenter suggested that the last sentence of § 2.12(c) “is not fair to the requester” and suggests it will be used in bad faith. The language in question is drawn from the Freedom of Information Act itself, and we believe it is fair; therefore this language has not been changed.

    The Final Rule Should Add a Reference to FOIA Public Liaisons to the Section on Basic Time Limits

    One commenter suggested adding information on seeking estimated completion dates from FOIA Public Liaisons to § 2.16(a), which explains the basic concept of basic time limits for responding to requests. This suggestion does not seem to fit in this provision and would be confusing. We therefore decline to adopt it. Another commenter suggested that the language in § 2.16(a) was imprecise. We have carefully considered this suggestion, but believe the existing language is clear.

    The Final Rule's Requester Fee Category Discussion Should Discuss Appeals

    One commenter suggested § 2.38(b) specifically discuss whether the decision that the requester belongs in a specific category can be appealed. Our proposed modifications to § 2.57(a)(5) already do this very thing, so we decline to adopt this change.

    The Final Rule Should Clarify What Fees for Other Services Requesters Will Not Have To Pay

    Two commenters had suggestions concerning § 2.44(b). One commenter suggested noting that “conducting a search that requires the creation of a new computer search program” does not include extracting and compiling the data from an existing database using a query. As the rule is explicit that it applies only to locating records, we have not adopted this suggestion. Another commenter suggested that this provision explicitly exclude fees covered under § 2.42(d). As this section applies to requests for records in forms or formats that we don't already maintain, we have not adopted this suggestion.

    The Final Rule Should Not Be Vague

    One commenter stated § 2.46(b) was “vague” and wondered: “How can one know when the bureau has not completed processing a request? There should be a specific period (no of days), after which it is reasonable to expect that the agency is complying with the request, and therefore a fee waiver request would be too late. In such a situation, if without a fee waiver the requester would opt for the request to be stopped, then there would not have been any man-hours already expended on fulfilling the request.” This commenter therefore suggested § 2.46(b) should include “a specific period (no of days), after which it is reasonable to expect that the agency is complying with the request and therefore a fee waiver request would be too late.” We believe that § 2.46(b) is not vague and provides requesters with as much flexibility in providing fee waiver requests as possible. We therefore decline to adopt this change, as it would negatively affect future requesters.

    The Final Rule Should Limit Modifications of Requests Related to Advanced Fees

    One commenter suggested appending “if you deem the adjudged fee to be beyond your means” at the end of § 2.50(c) because someone might reach some conclusion “that once an advance payment requirement is determined, then it follows that the requester is presumed unable to afford it.” We decline to adopt this change; we have deliberately given requesters the opportunity to modify their request even if they could pay the advance payment and we make no presumptions about a requester will be able to afford the advance payment.

    No Rule Should “Deny an Individual From Obtaining Personal Information About Themselves”

    One commenter's entire comment was: “There must be no rules created that will deny an individual from obtaining personal information about themselves.” No changes have been made to the rule based on this general statement.

    C. Technical and Procedural Comments

    One commenter noted National Archives and Records Administration's recent update to the General Records Schedule pertaining to FOIA records resulted in a new schedule number. We have confirmed this and § 2.68 has been amended accordingly. Additionally, we have slightly amended § 2.25(c) to more closely track the language of the FOIA itself. Additionally, the Department made very minor clarifications in §§ 2.6(d), 2.11, 2.20(g), 2.48(b), and 2.60. In the interests of clarity and consistency, the Department also added phrases to the introductory text of § 2.6(b), a sentence to § 2.6(d), phrases to § 2.10, and phrases to §§ 2.48(a)(2)(v) and 2.48(b). Also in the interests of clarity and consistency, the Department added and deleted phrases from §§ 2.26, 2.27(a), and 2.47(d). Finally, upon further consideration, the Department has decided against amending § 2.50(a) and (b).

    II. Compliance With Laws and Executive Orders 1. Regulatory Planning and Review (Executive Orders 12866 and 13563)

    Executive Order (E.O) 12866 provides that the Office of Information and Regulatory Affairs will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.

    Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

    2. Regulatory Flexibility Act

    The Department of the Interior certifies that this rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Under the FOIA, agencies may recover only the direct costs of searching for, reviewing, and duplicating the records processed for requesters. Thus, fees assessed by the Department are nominal. Further, the “small entities” that make FOIA requests, as compared with individual requesters and other requesters, are relatively few in number.

    3. Small Business Regulatory Enforcement Fairness Act

    This is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

    a. Does not have an annual effect on the economy of $100 million or more.

    b. Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

    c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

    4. Unfunded Mandates Reform Act

    This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. This rule does not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq.) is not required.

    5. Takings (E.O. 12630)

    In accordance with Executive Order 12630, this rule does not have significant takings implications. A takings implication assessment is not required.

    6. Federalism (E.O. 13132)

    In accordance with Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. It would not substantially and directly affect the relationship between the Federal and state governments. A federalism summary impact statement is not required.

    7. Civil Justice Reform (E.O. 12988)

    In accordance with Executive Order 12988, the Office of the Solicitor has determined that this rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Executive Order.

    8. Consultation With Indian Tribes (E.O. 13175)

    Under the criteria in Executive Order 13175, we have evaluated this rule and determined that it has no potential effects on federally recognized Indian tribes. This rule does not have tribal implications that impose substantial direct compliance costs on Indian Tribal governments.

    9. Paperwork Reduction Act

    This rule does not contain information collection requirements, and a submission to the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501 et seq) is not required. We may not conduct or sponsor, and you are not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    10. National Environmental Policy Act

    This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required. Pursuant to Department Manual 516 DM 2.3A(2), Section 1.10 of 516 DM 2, Appendix 1 excludes from documentation in an environmental assessment or impact statement “policies, directives, regulations and guidelines of an administrative, financial, legal, technical or procedural nature; or the environmental effects of which are too broad, speculative or conjectural to lend themselves to meaningful analysis and will be subject late to the NEPA process, either collectively or case-by-case.”

    11. Effects on the Energy Supply (E.O. 13211)

    This rule is not a significant energy action under the definition in Executive Order 13211. A Statement of Energy Effects is not required. This rule will not have a significant effect on the nation's energy supply, distribution, or use.

    List of Subjects in 43 CFR Part 2

    Freedom of information.

    Kristen J. Sarri, Principal Deputy Assistant Secretary for Policy, Management, and Budget.

    For the reasons stated in the preamble, the Department of the Interior amends part 2 of title 43 of the Code of Federal Regulations as follows:

    PART 2—FREEDOM OF INFORMATION ACT; RECORDS AND TESTIMONY 1. The authority citation for part 2 continues to read as follows: Authority:

    5 U.S.C. 301, 552, 552a, 553; 31 U.S.C. 3717; 43 U.S.C. 1460, 1461.

    Subpart A—Introduction 2. Amend § 2.1: a. In paragraph (d), the second sentence, by removing the Web site address “http://www.doi.gov/foia/guidance.cfm” and adding in its place the Web site address “https://www.doi.gov/foia/news/guidance”; b. By revising paragraph (e); and c. In paragraph (g), the first sentence, by removing the Web site address “http://www.doi.gov/foia/libraries.cfm” and adding in its place the Web site address “http://www.doi.gov/foia/libraries”.

    The revision reads as follows:

    § 2.1 What should you know up front?

    (e) The Department's regulations for requests made under the Privacy Act of 1974, 5 U.S.C. 552a, are located at subpart K of this part.

    Subpart B—How To Make a Request
    § 2.3—[Amended]
    3. Amend § 2.3(c), the second sentence, by: a. Removing the Web site address “http://www.doi.gov/foia/index.cfm” and adding in its place the Web site address “https://www.doi.gov/foia”; and b. Removing the Web site address “http://www.doi.gov/foia/contacts.cfm” and adding in its place the Web site address “http://www.doi.gov/foia/contacts”. 4. In § 2.5, revise paragraph (d) to read as follows:
    § 2.5 How should you describe the records you seek?

    (d) If the bureau determines that your request does not reasonably describe the records sought, the bureau will inform you what additional information you need to provide in order to reasonably describe the records that you seek so the requested records can be located with a reasonable amount of effort. The bureau will also notify you that it will not be able to comply with your request unless the additional information it has requested is received from you in writing within 20 workdays after the bureau has requested it and that you may appeal its determination. If you receive this type of notification, you may wish to discuss it with the bureau's designated FOIA contact or its FOIA Public Liaison (see § 2.66 of this part). If the bureau does not receive your written response containing the additional information within 20 workdays after the bureau has requested it, the bureau will presume that you are no longer interested in the records and will close the file on the request.

    5. Amend § 2.6 by revising paragraph (b) introductory text and paragraphs (b)(3), (d), and (e) to read as follows:
    § 2.6 How will fee information affect the processing of your request?

    (b) If the bureau anticipates that the fees for processing the request will exceed the amount you have agreed to pay, or if you did not agree in writing to pay processing fees or request a fee waiver and the bureau anticipates the processing costs will exceed $50 (see § 2.37(g) of this part) or will exceed your entitlements (see § 2.39 of this part), the bureau will notify you:

    (3) That it will not be able to fully comply with your request unless you provide a fee waiver request and/or the requested written assurance or advance payment.

    (d) If you are seeking a fee waiver, your request must include a justification that addresses and meets the criteria in §§ 2.45 and 2.48 of this part. Failure to provide sufficient justification will result in a denial of the fee waiver request. If you are seeking a fee waiver, you may also indicate the amount you are willing to pay if the fee waiver is denied. This allows the bureau to process the request for records while it considers your fee waiver request. You may also inform us of why you believe your request meets one or more of the criteria for a discretionary fee waiver under § 2.56 of this part.

    (e) The bureau will begin processing your request only after all issues regarding fees are resolved.

    6. In § 2.8, add a sentence to the end of paragraph (a) to read as follows:
    § 2.8 Can you ask for records to be disclosed in a particular form or format?

    (a) * * * If the bureau cannot readily reproduce the record in that form or format, it must explain why it cannot.

    7. In § 2.9, revise paragraph (b) to read as follows:
    § 2.9 What if your request seeks records about another person?

    (b) The bureau can require you to supply additional information if necessary to verify that a particular person has consented to disclosure or is deceased.

    8. Revise § 2.10 to read as follows:
    § 2.10 May you ask for the processing of your request to be expedited?

    You may ask for the processing of your request to be expedited. If you are seeking expedited processing, your request must include a justification that addresses and meets the criteria in § 2.20 of this part and includes the certification required at § 2.20(b)(2) of this part. Failure to provide sufficient justification or the required certification will result in a denial of the expedited processing request.

    9. Revise § 2.11 to read as follows:
    § 2.11 What contact information should your request include?

    A request should include your name and a way (such as a mailing or email address) for the bureau to send responsive records to you and/or to request additional information or clarification of your request. You may also wish to include a daytime telephone number (or the name and telephone number of an appropriate contact).

    Subpart C—Processing Requests 10. In § 2.12, revise paragraph (c) to read as follows:
    § 2.12 What should you know about how bureaus process requests?

    (c) The bureau will make reasonable efforts to search for the requested records. As part of its reasonable efforts, the bureau will search paper and/or electronic records (for example, emails), as appropriate. The bureau will not search for records in an electronic form or format if these efforts would significantly interfere with the operation of the bureau's automated information system.

    Subpart D—Timing of Responses to Requests 11. In § 2.15, add the following sentence to the end of paragraph (e) to read as follows:
    § 2.15 What is multitrack processing and how does it affect your request?

    (e) * * * If you request placement in a particular processing track but the bureau places you in a different processing track, the bureau will provide you with an explanation of why you were not placed in the processing track you requested.

    12. In § 2.16, revise paragraph (a) to read as follows:
    § 2.16 What is the basic time limit for responding to a request?

    (a) Ordinarily, the bureau has 20 workdays (including the date of receipt) to determine whether to comply with a request, but unusual circumstances may allow the bureau to take longer than 20 workdays (see § 2.19 of this subpart).

    13. In § 2.19, revise paragraph (a) introductory text to read as follows:
    § 2.19 When may the bureau extend the basic time limit?

    (a) The bureau may extend the basic time limit, if unusual circumstances exist, by notifying you in writing of:

    14. In § 2.20, revise paragraphs (c), (f), and (g) to read as follows:
    § 2.20 When will expedited processing be provided and how will it affect your request?

    (c) You may ask for expedited processing of your request by writing to the appropriate FOIA contact in the bureau that maintains the records requested any time before the bureau issues its final response to your request. When making a request for expedited processing of an administrative appeal, submit the request to the appropriate deciding official for FOIA appeals.

    (f) If expedited processing is denied, the bureau will:

    (1) Inform you of the basis for the denial, including an explanation of why the expedited processing request does not meet the Department's expedited processing criteria under this section; and

    (2) Notify you of the right to appeal the decision on expedited processing in accordance with the procedures in subpart H of this part.

    (g) If you appeal the bureau's expedited processing decision, that portion of your appeal (if it is properly formatted under § 2.59 of this part) will be processed before appeals that do not challenge expedited processing decisions.

    Subpart E—Responses to Requests
    § 2.21—[Amended]
    15. In § 2.21(a), the second sentence, remove the Web site address “http://www.doi.gov/foia/news/guidance/index.cfm” and add in its place the Web site address “https://www.doi.gov/foia/news/guidance”. 16. Amend § 2.22: a. By revising paragraph (c); and b. In paragraph (d), by adding the words “released or” after the words “the records will be”.

    The revision reads as follows:

    § 2.22 How will bureaus grant requests?

    (c) The bureau will release records (or portions of records) to you promptly upon payment of any applicable fees (or before then, at its discretion).

    § 2.23—[Amended]
    17. In § 2.23(a)(3), add the words “and/or control” after the words “bureau's possession”.
    18. In § 2.24, revise paragraph (b) to read as follows:
    § 2.24 How will the bureau deny requests?

    (b) The denial notification must include:

    (1) The name and title or position of the person responsible for the denial, along with an office phone number or email address;

    (2) A statement of the reasons for the denial;

    (3) A reference to any FOIA exemption applied by the bureau to withhold records in full or in part;

    (4) An estimate of the volume of any records withheld in full or in part (for example, by providing the number of pages or some other reasonable form of estimation), unless an estimate would harm an interest protected by an exemption used to withhold the records;

    (5) The name and title of the Office of the Solicitor or Office of General Counsel attorney consulted (if the bureau is denying a fee waiver request or withholding all or part of a requested record); and

    (6) A statement that the denial may be appealed under subpart H of this part and a description of the procedures in subpart H of this part.

    19. In § 2.25, revise paragraph (c) to read as follows:
    § 2.25 What if the requested records contain both exempt and nonexempt material?

    (c) If technically feasible, indicating the amount of information deleted and the FOIA exemption under which the deletion was made at the place in the record where the deletion was made.

    Subpart F—Handling Confidential Information 20. Revise § 2.26 to read as follows:
    § 2.26 May submitters of possibly confidential information designate information as confidential when making Departmental submissions?

    (a) The Department encourages, but does not require, submitters to designate confidential information in good faith (in other words, to identify specific information as information the submitter considers protected from disclosure under Exemption 4 of the FOIA, found at 5 U.S.C. 552(b)(4)), at the time of submission or reasonably soon thereafter.

    (b) The designations discussed in paragraph (a) of this section assist the bureau in identifying what information obtained from the submitter is possibly confidential and triggers the requirement for bureau-provided notifications under § 2.27(a)(1) of this subpart.

    21. Amend § 2.27: a. By revising paragraph (a); and b. In paragraph (b), by removing the word “large” and adding in its place the word “voluminous”.

    The revision reads as follows:

    § 2.27 When will the bureau notify a submitter of a request for their possibly confidential information?

    (a) Except as outlined in § 2.29 of this subpart, a bureau must promptly notify a submitter in writing when it receives a FOIA request if:

    (1) The requested information has been designated by the submitter as confidential information under § 2.26(a) of this subpart; or

    (2) The requested information has not been designated as confidential information by the submitter under § 2.26(a) of this subpart, but the bureau identifies it as possibly confidential information.

    22. In § 2.28, revise paragraph (a) to read as follows:
    § 2.28 What information will the bureau include when it notifies a submitter of a request for their possibly confidential information?

    (a) Either a copy of the request, the exact language of the request, or (for notices published under § 2.27(b) of this subpart) a general description of the request;

    23. In § 2.31, revise paragraphs (a)(1) and (2) to read as follows:
    § 2.31 What must a submitter include in a detailed Exemption 4 objection statement?

    (a) * * *

    (1) Whether the submitter provided the information voluntarily and, if so, how disclosure will impair the Government's ability to obtain similar information in the future and/or how the information fits into a category of information that the submitter does not customarily release to the public;

    (2) Whether the Government required the information to be submitted, and if so, how disclosure will impair the Government's ability to obtain similar information in the future and/or how substantial competitive or other business harm would likely result from disclosure; and

    Subpart G—Fees 24. In § 2.37, add paragraphs (g), (h), and (i) to read as follows:
    § 2.37 What general principles govern fees?

    (g) If the fee for processing your request is less than $50, you will not be charged unless multiple requests are aggregated under § 2.54 of this subpart to an amount that is $50 or more.

    (h) If you fail to pay any FOIA-related fee within 30 calendar days of the date of billing, the processing of any new or ongoing requests and/or appeals from you shall ordinarily be suspended.

    (i) If you would like to reformulate your request so it will meet your needs at a lower cost, you may wish to seek assistance from the bureau's designated FOIA contact or its FOIA Public Liaison (see § 2.66 of this part).

    25. In § 2.38, add the following sentence to the end of paragraph (b) to read as follows:
    § 2.38 What are the requester fee categories?

    (b) * * * If you request placement in a particular fee category but the bureau places you in a different fee category, the bureau will provide you with an explanation of why you were not placed in the fee category you requested (for example, if you were placed in the commercial use requester category rather than the category you requested, the bureau will describe how the records would further your commercial, trade, or profit interests).

    § 2.39—[Amended]
    26. In the table at § 2.39(a), remove the word “non-commercial” and add in its place the word “noncommercial”.
    § 2.41—[Amended]
    27. In § 2.41(c), remove the Web site address “http://www.doi.gov/foia/fees-waivers.cfm” and add in its place the Web site address “http://www.doi.gov/foia/fees-waivers”. 28. In § 2.42, revise paragraph (d) to read as follows:
    § 2.42 What duplication fees will you have to pay?

    (d) If the bureau must scan paper records to accommodate your preference to receive records in an electronic format or print electronic records to accommodate your preference to receive records in a paper format, you will pay both the per page amount noted in Appendix A to this part and the time spent by personnel scanning or printing the requested records. For each quarter hour spent by personnel scanning or printing the requested records, the fees will be the same as those charged for a search under § 2.41(b) of this subpart.

    29. In § 2.44, revise paragraph (b) to read as follows:
    § 2.44 What fees for other services will you have to pay?

    (b) Examples of these services include providing multiple copies of the same record, converting records that are not already maintained in a requested format to the requested format, obtaining research data under § 2.69 of this part, sending records by means other than first class mail, and conducting a search that requires the creation of a new computer search program to locate the requested records.

    § 2.45—[Amended]
    30. In § 2.45, in paragraph (a) introductory text, remove the words “under the factors” and add in their place the words “by addressing and meeting each of the criteria”. 31. In § 2.46, revise paragraph (b) to read as follows:
    § 2.46 When may you ask the bureau for a fee waiver?

    (b) You may submit a fee waiver request at a later time if the bureau has not yet completed processing your request.

    32. Amend § 2.47: a. In paragraph (a), by removing the period at the end of the paragraph and adding in its place a semicolon; b. In paragraph (c), by removing the word “and” at the end of the paragraph; c. In paragraph (d), by removing the words “to the FOIA Appeals Officer, under the procedures in § 2.57 of this part, within 30 workdays after” and adding in their place the words “under subpart H of this part and a description of the requirements set forth therein, within 30 workdays from” and removing the period at the end of the paragraph and adding in its place the word “; and”; and d. Adding paragraph (e). The addition reads as follows:
    § 2.47 How will the bureau notify you if it denies your fee waiver request?

    (e) Your anticipated fees, in accordance with § 2.49 of this subpart.

    33. Amend § 2.48 by revising paragraph (a) introductory text and adding a sentence to the end of paragraph (a)(2)(v) to read as follows: “”
    § 2.48 How will the bureau evaluate your fee waiver request?

    (a) In deciding whether your fee waiver request meets the requirements of § 2.45(a)(1) of this subpart, the bureau will consider the criteria listed in paragraphs (a)(1) through (a)(4) of this section. You must address and meet each of these criteria in order to demonstrate that you are entitled to a fee waiver.

    (2) * * *

    (v) * * * If we have categorized you as a representative of the news media under § 2.38, we will presume you have this ability and intent.

    34. In § 2.49, revise paragraphs (a)(1) and (c) to read as follows:
    § 2.49 When will you be notified of anticipated fees?

    (a) * * *

    (1) The anticipated fee is less than $50 (see § 2.37(g) of this subpart).

    (c) If the bureau does not receive your written response containing the additional information that resolves any fee issues, in accordance with paragraphs (b)(2) and/or (b)(4) of this section, within 20 workdays after the bureau has requested it, the bureau will presume that you are no longer interested in the records and will close the file on the request.

    35. In § 2.50, revise paragraphs (c) and (d) to read as follows:
    § 2.50 When will the bureau require advance payment?

    (c) When the bureau notifies you that an advance payment is due under paragraph (a) of this section, it will give you an opportunity to reduce the fee by modifying the request.

    (d) Your payment of the funds you owe the bureau for work it has already completed before records are sent to you is not an advance payment under paragraph (a) of this section.

    § 2.51—[Amended]
    36. Amend § 2.51: a. In paragraph (b)(1), by adding the words “after the bureau has requested the additional clarification” after the words “within 20 workdays”; b. In paragraph (b)(2), by adding the words “after the bureau has requested the additional clarification” after the words “within 20 workdays”; c. In paragraph (b)(3), by removing the words “hears from you within 20 workdays” and add in their place the words “receives a written response from you within 20 workdays after the bureau has requested the additional clarification”; and d. In paragraph (c), by adding the words “after the bureau has requested the additional clarification” after the words “within 20 workdays”. Subpart H—Administrative Appeals
    § 2.57—[Amended]
    37. Amend § 2.57: a. In paragraph (a)(5), by adding the words “or you have been placed in the wrong fee category” after the word “calculated”; and b. In paragraph (a)(6), by adding the words “your request for” after the word “denied”.
    § 2.59—[Amended]
    38. In § 2.59, in paragraph (a), the first sentence, remove the Web site address “http://www.doi.gov/foia/appeals.cfm” and add in its place the Web site address “http://www.doi.gov/foia/appeals”. 39. Revise § 2.60 to read as follows:
    § 2.60 Who makes decisions on appeals?

    (a) The FOIA Appeals Officer is the deciding official for FOIA appeals that do not appeal a decision of the Office of Inspector General.

    (b) The General Counsel is the deciding official for FOIA appeals that appeal a decision of the Office of Inspector General.

    (c) When necessary, the appropriate deciding official for FOIA appeals will consult other appropriate offices, including the Office of the Solicitor or Office of General Counsel for denials of records and fee waivers.

    (d) The deciding official for FOIA appeals normally will not make a decision on an appeal if the request becomes a matter of FOIA litigation.

    40. Revise § 2.62 to read as follows:
    § 2.62 When can you expect a decision on your appeal?

    (a) The basic time limit for responding to an appeal is 20 workdays after receipt of an appeal meeting the requirements of § 2.59 of this subpart.

    (b) If the Department is unable to reach a decision on your appeal within the given time limit for response, the appropriate deciding official for FOIA appeals will notify you of your statutory right to seek review in a United States District Court.

    § 2.63—[Amended]
    41. In § 2.63, in paragraphs (b) and (c), remove the words “FOIA Appeals Officer” and add in their place the words “appropriate deciding official for FOIA appeals”. Subpart I—General Information
    § 2.65—[Amended]
    42. In § 2.65, the first sentence, remove the Web site address “http://www.doi.gov/foia/libraries.cfm” and add in its place the Web site address“http://www.doi.gov/foia/libraries”. 43. In § 2.66, revise paragraph (a) to read as follows:
    § 2.66 What are public liaisons?

    (a) Each bureau has a FOIA Public Liaison who can assist requesters who have concerns about the service they received when seeking records or who are seeking assistance under § 2.3(d) or § 2.37(i) of this part.

    § 2.68—[Amended]
    44. Amend § 2.68: a. In paragraph (a), by removing the number “14” and adding its place the number “4.2” and adding the phrase “, such as DAA-0048-2013-0001” to the end of the paragraph; and b. In paragraph (b), by removing the number “14” and adding its place the number “4.2” and adding the phrase “, such as DAA-0048-2013-0001” to the end of the paragraph.
    § 2.70—[Amended]
    45. Amend § 2.70: a. In the definition of Bureau, by removing the Web site address “http://www.doi.gov/foia/contacts.cfm” and adding in its place the Web site address http://www.doi.gov/foia/contacts; and b. In the definition of Multitrack processing, the second sentence, by adding the word “ordinarily” after the word “are”.
    [FR Doc. 2016-04647 Filed 3-2-16; 8:45 am] BILLING CODE 4310-10-P
    81 42 Thursday, March 3, 2016 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-4229; Directorate Identifier 2015-CE-038-AD] RIN 2120-AA64 Airworthiness Directives; Viking Air Limited Airplanes AGENCY:

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

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for all Viking Air Limited Models DHC-2 Mk. I, DHC-2 Mk. II, and DHC-2 Mk. III airplanes. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as corrosion of the elevator control rod and of the elevator actuating lever on the control column. We are issuing this proposed AD to require actions to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by April 18, 2016.

    ADDRESSES:

    You may send comments by any of the following methods:

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

    Fax: (202) 493-2251.

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

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

    For service information identified in this proposed AD, contact Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; Fax: 250-656-0673; telephone: (North America) (800) 663-8444; email: [email protected]; Internet: http://www.vikingair.com/support/service-bulletins. You may review 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.

    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-2016-4229; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Aziz Ahmed, Aerospace Safety Engineer, FAA, New York Aircraft Certification Office (ACO), 1600 Steward Avenue, Suite 410, Westbury, New York 11590; telephone: (516) 228-7329; fax: (516) 794-5531; 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-2016-4229; Directorate Identifier 2015-CE-038-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

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

    Discussion

    Transport Canada, which is the aviation authority for Canada, has issued AD No. CF-2015-21, dated July 30, 2015 (referred to after this as “the MCAI”), to correct an unsafe condition for all Viking Air Limited Models DHC-2 Mk. I, DHC-2 Mk. II, and DHC-2 Mk. III airplanes. The MCAI states:

    There have been a number of reports of corrosion and/or cracking at the elevator actuating lever on the control column, in the elevator control rod assemblies, and at the rod end plug.

    Undetected corrosion and/or cracking of the elevator control rod assemblies or elevator actuating lever may lead to the failure of the components with consequent loss of aeroplane control.

    The MCAI requires visually inspecting the elevator control rod assemblies, the elevator actuating lever on the control column, and the control column torque tube for corrosion, cracking, and/or other damages, and repairing or replacing damaged parts. The MCAI also requires incorporating revisions into the maintenance program and adds a life limit to certain elevator control rod assemblies. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-4229.

    Related Service Information Under 1 CFR Part 51

    Viking Air Limited has issued DHC-2 Beaver Service Bulletin Number: V2/0005, Revision `C', dated July 17, 2015. The service information describes procedures for doing detailed visual inspections of the elevator control rod assemblies, the elevator actuating lever on the control column, and the control column torque tube for corrosion, cracking, and/or other damages. The service bulletin also describes procedures for repairing or replacing damaged parts. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this NPRM.

    FAA's Determination and Requirements of the Proposed AD

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

    Costs of Compliance

    We estimate that this proposed AD will affect 135 products of U.S. registry. We also estimate that it would take about 11.5 work-hours per product to comply with the basic inspection requirements of this proposed AD. The average labor rate is $85 per work-hour.

    Based on these figures, we estimate the cost of the basic inspection requirements of this proposed AD on U.S. operators to be $131,962.50, or $977.50 per product.

    In addition, we estimate that any necessary follow-on actions would take about 8 work-hours and require parts costing $1,859, for a cost of $2,539 per product. Contact Viking Air Limited at the address identified in the ADDRESSES section of this NPRM for current pricing and lead time. 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 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 AD: Viking Air Limited: Docket No. FAA-2016-4229; Directorate Identifier 2015-CE-038-AD. (a) Comments Due Date

    We must receive comments by April 18, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to Viking Air Limited DHC-2 Mk. I, DHC-2 Mk. II, and DHC-2 Mk. III airplanes, all serial numbers, certificated in any category.

    (d) Subject

    Air Transport Association of America (ATA) Code 27: Flight 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 corrosion of the elevator control rod and of the elevator actuating lever on the control column. We are issuing this AD to detect and correct corrosion and/or cracking of the elevator control rod assemblies and the elevator actuating lever, which if not detected and corrected, could cause these components to fail. This failure could result in loss of control.

    (f) Actions and Compliance

    Comply with this AD within the compliance times specified in paragraphs (g) through (l) of this AD, including all subparagraphs, unless already done.

    (g) Inspections

    Within the next 120 days after the effective date of this AD or within the next 100 hours time-in-service (TIS) after the effective date of this AD, whichever occurs first, do the following inspections in accordance with section I. PLANNING INFORMATION, paragraph D. of Viking DHC-2 Beaver Service Bulletin Number: V2/0005, Revision “C”, dated July 17, 2015:

    (1) For airplanes with an installed elevator control rod assembly, part number (P/N) C2CF619A, do a detailed visual inspection of P/N C2CF619A for corrosion, cracking, and/or other damages.

    (2) For airplanes with an installed elevator control rod assembly, P/N CT2CF1021-1, do a detailed visual inspection of P/N CT2CF1021-1 for corrosion, cracking, and/or other damages.

    (3) For all airplanes, do a detailed visual inspection of the elevator actuating lever on the control column and the control column torque tube for corrosion, cracking and/or other damages.

    (h) Replacement/Repair for P/N C2CF619A

    (1) Before further flight after the inspection required in paragraph (g)(1) of this AD, if corrosion, cracking, or other damages are found, replace P/N C2CF619A with P/N C2CF619A-11 following section I. PLANNING INFORMATION, paragraph D. of Viking DHC-2 Beaver Service Bulletin Number: V2/0005, Revision “C”, dated July 17, 2015, or contact Viking Air Limited at the address specified in paragraph (o) of this AD for an FAA-approved repair and incorporate the repair.

    (2) Within the next 120 days after the effective date of this AD or within the next 100 hours TIS after the effective date of this AD, whichever occurs first, you may replace P/N C2CF619A with P/N C2CF619A-11 instead of doing the inspection required in paragraph (g)(1) of this AD. Do the replacement following section I. PLANNING INFORMATION, paragraph D. of Viking DHC-2 Beaver Service Bulletin Number: V2/0005, Revision “C”, dated July 17, 2015.

    (3) After replacing P/N C2CF619A with P/N C2CF619A-11, you must still do the repetitive inspections of the elevator control rod assemblies following the Airworthiness Limitations section of the FAA-approved maintenance program (e.g., maintenance manual) specified in paragraph (k)(1) of this AD.

    (i) Replacement/Repair for P/N CT2CF1021-1

    (1) Before further flight after the inspection required in paragraph (g)(2) of this AD, if corrosion, cracking, or other damages are found, replace the elevator control rod assembly with P/N CT2CF1021-1 that has been inspected and is free of corrosion, cracking, or other damages following section I. PLANNING INFORMATION, paragraph D. of Viking DHC-2 Beaver Service Bulletin Number: V2/0005, Revision “C”, dated July 17, 2015, or contact Viking Air Limited at the address specified in paragraph (o) of this AD for an FAA-approved repair and incorporate the repair.

    (2) After replacing or repairing P/N CT2CF1021-1, you must still do the repetitive inspections of the elevator control rod assemblies following the Airworthiness Limitations section of the FAA-approved maintenance program (e.g., maintenance manual) specified in paragraph (k)(1) of this AD.

    (j) Repair of the Elevator Actuating Lever

    Before further flight after the inspection required in paragraph (g)(3) of this AD, if corrosion, cracking, or other damages are found, contact Viking Air Limited at the address specified in paragraph (o) of this AD for an FAA-approved repair and incorporate the repair.

    (k) Airworthiness Limitations/Restrictions

    (1) For all airplanes, within the next 30 days after the effective date of this AD, insert the following into the Airworthiness Limitations section of the FAA-approved maintenance program (e.g., maintenance manual). This revision to the Limitation section incorporates repetitive inspections of the elevator control rod assemblies, the elevator actuating lever, and the control column torque tube for corrosion, cracks, and/or other damage. Insert item 20A., of Part 3, in Appendix 2 of Temporary Revision No.: 2-38, dated March 4, 2015, into the VIKING PSM NO.: 1-2-2, AIRCRAFT: DHC-2 BEAVER, SERIES: ALL, PUBLICATION: MAINTENANCE MANUAL; and insert item 20A., in Part 4, of Temporary Revision No.: 2T-14, dated March 4, 2015, into VIKING PSM NO.: 1-2T-2, AIRCRAFT: DHC-2 TURBO BEAVER, SERIES: ALL, PUBLICATION: MAINTENANCE MANUAL.

    (2) For all airplanes, as of the effective date of this AD, do not install P/N C2CF619A or C2CF619A-9 as a replacement part.

    (l) Life Limit for P/N C2CF619A

    As of the effective date of this AD, elevator control rod assemblies, P/N C2CF619A, are life-limited to 15 years and must be replaced with P/N C2CF619A-11 at the following compliance time:

    (1) If, as of the effective date of this AD, the age of the installed P/N C2CF619A is known, it must be replaced before exceeding the life limit or within the next 12 months after the effective date of this AD, whichever occurs later.

    (2) If, as of the effective date of this AD, the age of the installed P/N C2CF619A is not known, it must be replaced within the next 12 months after the effective date of this AD.

    (m) Credit for Actions Accomplished in Accordance With Previous Service Information

    Credit will be given for the inspections required in paragraphs (g)(1), (g)(2), and (g)(3) of this AD if they were done before the effective date of this AD following Viking Air Limited DHC-2 Beaver Service Bulletin Number: V2/0005, Revision ‘NC’, dated March 26, 2012; Viking Air Limited DHC-2 Beaver Service Bulletin Number: V2/0005, Revision ‘A’, dated November 7, 2014; or Viking Air Limited DHC-2 Beaver Service Bulletin Number: V2/0005, Revision ‘B’, dated March 4, 2015.

    (n) 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: Aziz Ahmed, Aerospace Safety Engineer, FAA, New York Aircraft Certification Office (ACO), 1600 Steward Avenue, Suite 410, Westbury, New York 11590; telephone: (516) 228-7329; fax: (516) 794-5531; 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.

    (3) Reporting Requirements: For any reporting requirement in this AD, a federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately 5 minutes per response, including the time for reviewing instructions, completing and reviewing the collection of information. All responses to this collection of information are mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn: Information Collection Clearance Officer, AES-200.

    (o) Related Information

    Refer to MCAI Transport Canada AD No. CF-2015-21, dated July 30, 2015; and Viking Air Limited DHC-2 Beaver Service Bulletin Number: V2/0005, Revision ‘NC’, dated March 26, 2012; Viking Air Limited DHC-2 Beaver Service Bulletin Number: V2/0005, Revision ‘A’, dated November 7, 2014; or Viking Air Limited DHC-2 Beaver Service Bulletin Number: V2/0005, Revision ‘B’, dated March 4, 2015, for related information. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-4229. For service information related to this AD, contact Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; Fax: 250-656-0673; telephone: (North America) (800) 663-8444; email: [email protected]; Internet: http://www.vikingair.com/support/service-bulletins. You may review 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.

    Issued in Kansas City, Missouri, on February 24, 2016. Robert P. Busto, Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-04539 Filed 3-2-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-4231; Directorate Identifier 2015-CE-042-AD] RIN 2120-AA64 Airworthiness Directives; BLANIK LIMITED Gliders AGENCY:

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

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for BLANIK LIMITED Models L-13 Blanik and L-13 AC Blanik gliders (type certificate previously held by LET Aeronautical Works) that would supersede AD 2000-20-11. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as insufficient material strength of the tail-fuselage attachment fitting. We are issuing this proposed AD to require actions to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by April 18, 2016.

    ADDRESSES:

    You may send comments by any of the following methods:

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

    Fax: (202) 493-2251.

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

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

    For service information identified in this proposed AD, contact BLANIK LIMITED, 2nd Floor Beaux Lane House, Mercer Street Lower, Dublin 2, Republic of Ireland; phone: +420 733 662 194; email: [email protected]; Internet: http://www.blanik.aero/%EF%BB%BFcustomer_support. You may review 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.

    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-2016-4231; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Jim Rutherford, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4165; fax: (816) 329-4090; email: [email protected]

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-4231; Directorate Identifier 2015-CE-042-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

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

    Discussion

    On September 28, 2000, we issued AD 2000-20-11, Amendment 39-11922 (65 FR 60845; October 13, 2000) (“AD 2000-20-11”). That AD required actions intended to address an unsafe condition on BLANIK LIMITED Model L-13 Blanik gliders and was based on mandatory continuing airworthiness information (MCAI) originated by the Civil Aviation Authority, which is the aviation authority for the Czech Republic. That MCAI (AD CAA-AD-T-112/1999R1, dated November 23, 1999), was issued to correct an unsafe condition for EVECTOR, spol. s.r.o. Models L 13 SEH VIVAT and L 13 SDM VIVAT gliders and BLANIK LIMITED Models L-13 Blanik and L-13 AC Blanik gliders. The MCAI states:

    To prevent destruction of tail-fuselage attachment fitting which can lead to loss of control of the sailplane. This destruction could be caused due to lower strength of the material used during production.

    You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-4231.

    A review of records since issuance of AD 2000-20-11 revealed that the FAA inadvertently did not address this MCAI for the EVECTOR, spol. s.r.o. Model L 13 SDM VIVAT gliders and the BLANIK LIMITED Model L-13 AC Blanik gliders. This proposed AD would supersede AD 2000-20-11 to add the BLANIK LIMITED Model L-13 AC Blanik gliders to the applicability of the AD.

    The FAA will address the EVECTOR, spol. s.r.o. Model L 13 SDM VIVAT gliders in another AD action.

    Related Service Information Under 1 CFR Part 51

    LET Aeronautical Works has issued LET Mandatory Bulletin No.: L13/085a, dated November 17, 1999. The service information describes procedures for testing the material strength of attachment fitting part number A 102 021 N and instructions for contacting the manufacturer for replacement information if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section of this NPRM.

    FAA's Determination and Requirements of the Proposed AD

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

    Costs of Compliance

    We estimate that this proposed AD will affect 124 products of U.S. registry. We also estimate that it would take about 4 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 the proposed AD on U.S. operators to be $42,160, or $340 per product.

    In addition, we estimate that any necessary follow-on actions would take about 16 work-hours and require parts costing $500, for a cost of $1,860 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 proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by removing Amendment 39-11922 (65 FR 60845; October 13, 2000), and adding the following new AD: Blanik Limited: Docket No. FAA-2016-4231; Directorate Identifier 2015-CE-042-AD. (a) Comments Due Date

    We must receive comments by April 18, 2016.

    (b) Affected ADs

    This AD replaces AD 2000-20-11, Amendment 39-11922 (65 FR 60845; October 13, 2000) (“AD 2000-20-11”).

    (c) Applicability

    This AD applies to BLANIK LIMITED Models L-13 Blanik and L-13 AC Blanik gliders (type certificate previously held by LET Aeronautical Works), all serial numbers, certificated in any category.

    (d) Subject

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

    (e) Reason

    This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as insufficient material strength of the tail-fuselage attachment fitting. We are issuing this AD to detect and correct tail-fuselage fittings with insufficient material strength, which if left uncorrected could result in detachment of the tail from the fuselage with consequent loss of control.

    (f) Actions and Compliance

    Unless already done, do the following actions in paragraphs (f)(1) and (f)(2) of this AD, including all subparagraphs:

    (1) Model L-13 Blanik gliders:

    (i) Within the next 60 days after November 27, 2000 (the effective date retained from AD 2000-20-11), inspect the tail-fuselage attachment fitting, part number (P/N) A 102 021 N, for damage and material hardness following the procedures in LET Mandatory Bulletin No.: L13/085a, dated November 17, 1999.

    (ii) If you find the tail-fuselage attachment fitting is damaged or the material does not meet the hardness requirements specified in the service bulletin during the inspection required in paragraph (f)(1)(i) of this AD, before further flight, you must contact the manufacturer to obtain an FAA-approved replacement part for P/N A 102 021 N and FAA-approved installation instructions and install the replacement part. Use the contact information found in paragraph (h) to contact the manufacturer.

    (iii) As of November 27, 2000 (the effective date retained from AD 2000-20-11), do not install, on any glider, a P/N A 102 021 N attachment fitting that has not passed the inspection required in paragraph (f)(1)(i) of this AD.

    (2) Model L-13 AC Blanik gliders:

    (i) Within the next 60 days after the effective date of this AD, inspect the tail-fuselage attachment fitting, part number (P/N) A 102 021 N, for damage and material hardness following the procedures in LET Mandatory Bulletin No.: L13/085a, dated November 17, 1999.

    (ii) If you find the tail-fuselage attachment fitting is damaged or the material does not meet the hardness requirements specified in the service bulletin during the inspection required in paragraph (f)(2)(i) of this AD, before further flight, you must contact the manufacturer to obtain an FAA-approved replacement part for P/N A 102 021 N and FAA-approved installation instructions and install the replacement part. Use the contact information found in paragraph (h) to contact the manufacturer.

    (iii) As of the effective date of this AD, do not install, on any glider, a P/N A 102 021N attachment fitting that has not passed the inspection required in paragraph (f)(2)(i) of this AD.

    (g) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Jim Rutherford, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4165; fax: (816) 329-4090; email: [email protected] Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.

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

    (h) Related Information

    Refer to MCAI Civil Aviation Authority AD CAA-AD-T-112/1999R1, dated November 23, 1999, for related information. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-4231. For service information related to this AD, contact BLANIK LIMITED, 2nd Floor Beaux Lane House, Mercer Street Lower, Dublin 2, Republic of Ireland; phone: +420 733 662 194; email: [email protected]; Internet: http://www.blanik.aero/%EF%BB%BFcustomer_support. You may review 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.

    Issued in Kansas City, Missouri, on February 24, 2016. Robert P. Busto, Acting Manager, Small Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-04541 Filed 3-2-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2015-7203; Airspace Docket No. 15-ASO-14] Proposed Establishment of Class D Airspace: Destin, FL; Duke Field, Eglin AFB, FL; Proposed Revocation of Class D Airspace; Eglin AF Aux No 3 Duke Field, FL; and Proposed Amendment of Class D and E Airspace; Eglin Air Force Base, FL; Eglin Hurlburt Field, FL; and Crestview, FL AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to establish Class D airspace at Destin, FL, providing the controlled airspace required for the Air Traffic Control Tower at Destin Executive Airport, (formerly Destin-Fort Walton Beach Airport). Additionally, this action would remove Eglin AF Aux No 3 Duke Field from the Class D designation, and establish Duke Field, Eglin AFB, FL in its place. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport. This action also would amend existing Class D and Class E airspace by recognizing the airport's name change. This action also would change the existing Class D airspace designation at Duke Field, Eglin Air Force Base (AFB), FL, and would adjust the geographic coordinates of Eglin AFB, Destin Executive Airport, Duke Field, and Hurlburt Field, to stay in concert with the FAA's database.

    DATES:

    Comments must be received on or before April 18, 2016.

    ADDRESSES:

    Send comments on this rule to: U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Bldg. Ground Floor, Rm. W12-140, Washington, DC 20590-0001; Telephone: 1-800-647-5527; Fax: 202-493-2251. You must identify the Docket Number FAA-2015-7203; Airspace Docket No. 15-ASO-14, at the beginning of your comments. You may also submit and review received comments through the Internet at http://www.regulations.gov. You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone 1-800-647-5527), is on the ground floor of the building at the above address.

    FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/airtraffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: 202-267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.9Z at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

    FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class D airspace at Destin Executive Airport, Destin, FL, and Duke Field Eglin AFB, FL; and remove Class D airspace at Eglin AF Aux No 3 Duke Field; and amend Class D and Class E airspace at Eglin Air Force Base, FL.

    Comments Invited

    Interested persons are invited to comment on this rule by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

    Communications should identify both docket numbers (FAA Docket No. FAA-2015-7203; Airspace Docket No. 15-ASO-14) and be submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number). You may also submit comments through the Internet at http://www.regulations.gov.

    Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2015-7203; Airspace Docket No. 15-ASO-14.” The postcard will be date/time stamped and returned to the commenter.

    All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

    Availability of NPRMs

    An electronic copy of this document may be downloaded from and comments submitted through http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal Holidays. An informal docket may also be examined between 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal Holidays at the office of the Eastern Service Center, Federal Aviation Administration, Room 350, 1701 Columbia Avenue, College Park, Georgia 30337.

    Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking, (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking distribution System, which describes the application procedure.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to establish Class D airspace up to and including 1,600 feet within a 4.4 mile radius of at Destin Executive Airport, Destin, FL, providing the controlled airspace required to support the Air Traffic Control Tower. Additionally, this action would remove the Class D designator for Eglin AF Aux No 3 Duke Field, FL, and replace it with Duke Field, Eglin AFB, FL. This action would also adjust the geographic coordinates in Class D airspace, Class E surface area airspace, and Class E airspace extending upward from 700 feet above the surface for Eglin Air Force Base, FL, Destin Executive Airport, Duke Field, and Hurlburt Field, to stay in concert with the FAA's database. Also, Destin-Fort Walton Beach Airport would be changed to Destin Executive Airport.

    Class D and Class E airspace designations are published in Paragraphs 5000, 6002, and 6005, respectively of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designation listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

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

    Environmental Review

    This proposal would be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, effective September 15, 2015, is amended as follows: Paragraph 5000 Class D Airspace. ASO FL D Destin, FL [New] Destin Executive Airport, FL (Lat. 30°24′00″ N., long. 86°28′17″ W.) Eglin Air Force Base, FL (Lat. 30°29′00″ N., long. 86°31′34″ W.)

    That airspace extending upward from the surface to and including 1,600 feet MSL within a 4.4-mile radius of Destin Executive Airport, excluding that portion north of the triangle beginning at lat. 30°23′39″ N., long. 86°23′13″ W., to lat. 30°27′00″ N., long. 86°30′19″ W., to lat. 30°20′54″ N., long. 86°31′56″ W. This Class D airspace is effective during the operating hours of the Destin Executive Airport tower published in the Airport/Facility Directory. The airspace is incorporated into the Eglin Air Force Base, FL Class D airspace when the tower is closed.

    ASO FL D Eglin Air Force Base, FL [Amended] Eglin Air Force Base, FL (Lat. 30°29′00″ N., long. 86°31′34″ W.) Destin Executive Airport (Lat. 30°24′00″ N., long. 86°28′17″ W.) Duke Field (Lat. 30°38′55″ N., long. 86°31′19″ W.) Hurlburt Field (Lat. 30°25′44″ N., long. 86°41′20″ W.)

    That airspace extending upward from the surface to and including 2,600 feet MSL within a 5.5-mile radius of Eglin AFB, and within a 4.4-mile radius of Destin Executive Airport, excluding the portion north of a line connecting the 2 points of intersection within a 5.2-mile radius centered on Duke Field; excluding the portion southwest of a line connecting the 2 points of intersection within a 5.3-mile radius of Hurlburt Field; excluding a portion east of a line beginning at lat. 30°30′43″ N., long. 86°26′21″ W. extending east to the 5.5-mile radius of Eglin AFB. When the tower at Destin Executive Airport is operational, it excludes Destin's Class D airspace defined as that airspace south of the triangle beginning at lat. 30°23′39″ N., long. 86°23′13″ W. to lat. 30°27′00″ N., long. 86°30′19″ W. to lat. 30°20′54″ N., long. 86°31′56″ W. from the surface to and including 1,600 feet MSL.

    ASO FL D Eglin AF Aux No 3 Duke Field, FL [Removed] ASO FL D Duke Field Eglin AFB, FL [New] Duke Field, FL (Lat. 30°38′55″ N., long. 86°31′19″ W.) Crestview, Bob Sikes Airport (Lat. 30°46′44″ N., long. 86°31′20″ W.) Eglin AFB (Lat. 30°29′00″ N., long. 86°31′34″ W.)

    That airspace extending upward from the surface to and including 2,700 feet MSL within a 5.2-mile radius of Duke Field; excluding the portion north of a line connecting the 2 points of intersection with a 4.2-mile radius circle centered on Bob Sikes Airport; excluding the portion south of a line connecting the 2 points of intersection with a 5.5-mile radius circle centered on Eglin AFB. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.

    ASO FL D Eglin Hurlburt Field, FL [Amended] Eglin, Hurlburt Field, FL (Lat. 30°25′44″ N., long. 86°41′20″ W.) Eglin AFB (Lat. 30°29′00″ N., long. 86°31′34″ W.)

    That airspace extending upward from the surface, to and including 2,500 feet MSL within a 5.3-mile radius of Hurlburt Field; excluding the portion northeast of a line connecting the 2 points of intersection with a 5.5-mile radius circle centered on Eglin AFB. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the airport/Facility Directory.

    Paragraph 6002 Class E Surface Area Airspace. ASO FL E2 Crestview, FL [Amended] Bob Sikes Airport, FL (Lat. 30°46′44″ N., long. 86°31′20″ W.) Duke Field, Eglin AFB (Lat. 30°38′55″ N., long. 86°31′19″ W.)

    Within a 4.2-mile radius of Bob Sikes Airport; excluding the portion south of a line connecting the 2 points of intersection with a 5.2-mile radius circle centered on Duke Field This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.

    Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASO FL E5 Eglin Air Force Base, FL [Amended] Eglin Air Force Base, FL (Lat. 30°29′00″ N., long. 86°31′34″ W.) Destin Executive Airport (Lat. 30°24′00″ N., long. 86°28′17″ W.) Duke Field (Lat. 30°38′55″ N., long. 86°31′19″ W.) Hurlburt Field (Lat. 30°25′44″ N., long. 86°41′20″ W.) Fort Walton Beach Airport (Lat. 30°24′23″ N., long. 86°49′45″ W.)

    That airspace extending upward from 700 feet above the surface within a 7-mile radius of Eglin Air Force Base, and within a 7.8-mile radius of Destin Executive Airport, and within a 7-mile radius of Duke Field, and within a 7-mile radius of Hurlburt Field, excluding a 1.5-mile radius of Fort Walton Beach Airport.

    Issued in College Park, Georgia, on February 23, 2016. Ryan W. Almasy, Acting Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
    [FR Doc. 2016-04491 Filed 3-2-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2016-3108; Airspace Docket No. 15-ASO-16] Proposed Establishment of Class E Airspace; Harlan, KY AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to establish Class E airspace at Harlan, KY, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures (SIAPs) serving Tucker-Guthrie Memorial Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport.

    DATES:

    Comments must be received on or before April 18, 2016.

    ADDRESSES:

    Send comments on this rule to: U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Bldg Ground Floor, Rm W12-140, Washington, DC 20590-0001; Telephone: 1-800-647-5527; Fax: 202-493-2251. You must identify the Docket Number FAA-2016-3108; Airspace Docket No. 15-ASO-16, at the beginning of your comments. You may also submit and review received comments through the Internet at http://www.regulations.gov. You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone 1-800-647-5527), is on the ground floor of the building at the above address.

    FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 29591; telephone: 202-267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.9Z at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

    FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish Class E airspace at Tucker-Guthrie Memorial Airport, Harlan, KY.

    Comments Invited

    Interested persons are invited to comment on this rule by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

    Communications should identify both docket numbers (FAA Docket No. FAA-2016-3108; Airspace Docket No. 15-ASO-16) and be submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number). You may also submit comments through the Internet at http://www.regulations.gov.

    Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-3108; Airspace Docket No. 15-ASO-16.” The postcard will be date/time stamped and returned to the commenter.

    All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

    Availability of NPRMs

    An electronic copy of this document may be downloaded from and comments submitted through http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal Holidays. An informal docket may also be examined between 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal Holidays at the office of the Eastern Service Center, Federal Aviation Administration, Room 350, 1701 Columbia Avenue, College Park, Georgia 30337.

    Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking, (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking distribution System, which describes the application procedure.

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to establish Class E airspace extending upward from 700 feet above the surface within a 13-mile radius of Tucker-Guthrie Memorial Airport, Harlan, KY, providing the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for Tucker-Guthrie Memorial Airport. Controlled airspace is necessary for IFR operations.

    Class E airspace designations are published in Paragraph 6005, of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

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

    Environmental Review

    This proposal would be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, effective September 15, 2015, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASO KY E Harlan, KY [New] Tucker-Guthrie Memorial Airport, KY (Lat. 36°51′36″ N., long. 83°21′31″ W.)

    That airspace extending upward from 700 feet above the surface within a 13-mile radius of Tucker-Guthrie Memorial Airport.

    Issued in College Park, Georgia, on February 23, 2016. Ryan W. Almasy, Acting Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
    [FR Doc. 2016-04496 Filed 3-2-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2016-N-0400] General and Plastic Surgery Devices; Reclassification of Blood Lancets AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed order.

    SUMMARY:

    The Food and Drug Administration (FDA or the Agency) is proposing to reclassify the following three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket review: Single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is identifying proposed special controls for these types of blood lancets that we believe are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also proposing to reclassify multiple use blood lancets for multiple patient use from class I (general controls) exempt from premarket notification into class III (premarket approval). FDA is proposing the reclassification of these four types of blood lancets on its own initiative based on new information.

    DATES:

    Submit either electronic or written comments on the proposed order by June 1, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) by April 4, 2016, (see the “Paperwork Reduction Act of 1995” section of this document). See section X of the SUPPLEMENTARY INFORMATION section of this document for the proposed effective date of any final order that may publish based on this proposal.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-0400 for “General and Plastic Surgery Devices; Reclassification of Blood Lancets.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Submit comments on information collection issues to the Office of Management and Budget (OMB) in the following ways:

    • Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to [email protected] All comments should be identified with the title, “General and Plastic Surgery Devices; Reclassification of Blood Lancets.”

    FOR FURTHER INFORMATION CONTACT:

    Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G422, Silver Spring, MD 20993-0002, 301-796-6524; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION: I. Background

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended, 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).

    Section 513(a)(1) of the FD&C Act defines the three classes of devices. Class I devices are those devices for which the general controls of the FD&C Act (controls authorized by or under section 501, 502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j) or any combination of such sections) are sufficient to provide reasonable assurance of safety and effectiveness; or those devices for which insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of safety and effectiveness or to establish special controls to provide such assurance, but because the devices are not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury, are to be regulated by general controls (section 513(a)(1)(A) of the FD&C Act). Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the Agency deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act). Class III devices are those devices for which insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness, and are purported or represented for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury (section 513(a)(1)(C) of the FD&C Act). Under section 513(d)(1) 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: (1) Receives a recommendation from a device classification panel (an FDA advisory committee); (2) publishes the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) publishes a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

    Devices that were not in commercial distribution before May 28, 1976 (generally referred to as “postamendments devices”) are classified automatically 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: FDA reclassifies the device 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 previously marketed devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807). A person may market a preamendments device that has been classified into class III through premarket notification procedures 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.

    On July 9, 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA). Section 608(a) of FDASIA amended section 513(e) of the FD&C Act, changing the reclassification process from rulemaking to administrative order. Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final order. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: Publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 513(b) of the FD&C Act, and consideration of comments to a public docket. The proposed reclassification order must set forth the proposed reclassification and a substantive summary of the valid scientific evidence concerning the proposed reclassification, including the public health benefits of the use of the device, and the nature and incidence (if known) of the risk of the device. (See section 513(e)(1)(A)(i) of the FD&C Act.)

    Section 513(e)(1) provides that FDA may, by administrative order, reclassify a device based on “new information.” FDA can initiate a reclassification under section 513(e) or an interested person may petition FDA. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See, e.g., Holland-Rantos v. United States Dep't of Health, Educ. & Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)

    Reevaluation of the data previously before the Agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of newly available regulatory authority (see Bell v. Goddard, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in “medical science.” (See Upjohn v. Finch, 422 F.2d at 951.) Whether data before the Agency are past or new data, the “new information” to support reclassification under section 513(e) must be “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Mfrs. Assoc. v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1985).)

    II. Regulatory History of the Device

    Blood lancets were classified in part 878 (21 CFR part 878) in a final rule published in the Federal Register on June 24, 1988 (53 FR 23856) that classified 51 general and plastic surgery devices. This 1988 rule classified blood lancets into class I (general controls). These devices were grouped with other devices under “Manual surgical instrument for general use” in § 878.4800 (21 CFR 878.4800). At the time, blood lancets had been in common use in medical practice for many years, and FDA believed that general controls were sufficient to provide reasonable assurance of the safety and effectiveness of those devices. The rule was amended on April 5, 1989 (54 FR 13826) to clarify that manual surgical instruments for general use made of the same materials as used in preamendment devices were exempt from premarket notification 510(k) review.

    On December 7, 1994, FDA further amended the classification when it published a final rule in the Federal Register (59 FR 63005) that exempted 148 class I devices from premarket notification, with limitations. Blood lancets were one of those devices. FDA determined that manufacturers' submissions of premarket notifications were unnecessary for the protection of the public health and that FDA's review of such submissions would not advance its public health mission.

    On August 26, 2010, FDA and the Centers for Disease Control and Prevention (CDC) issued a joint initial communication warning that the use of fingerstick devices (blood lancets) to obtain blood from more than one patient posed a risk of transmitting bloodborne pathogens. The communication was updated on November 29, 2010 (Ref. 1). FDA's communication update, “Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication: Update 11/29/2010” stated that “[o]ver the past 10-15 years, the CDC and FDA have noted a progressive increase in reports of bloodborne infection transmission (primarily hepatitis B virus [HBV]) resulting from the shared use of fingerstick and POC [or ‘Point of Care’] blood testing devices.” FDA and CDC recommended, among other things, that health care professionals and patients never use a blood lancet for more than one person.

    On November 29, 2010, FDA published a guidance entitled “Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling” (75 FR 73107) (Ref. 2). This guidance includes labeling recommendations to address concerns that both health care providers and patients may be unaware of the serious adverse health risks associated with using the same blood lancet for assisted withdrawal of blood from more than one patient, even when the blood lancet blade is changed for each blood draw. FDA recommends in the guidance that all blood lancets be labeled for use only on a single patient. FDA recommends in the guidance that a statement limiting use to a single patient should also appear on the label attached to the device, if possible. The guidance was for immediate implementation. When final, this order will supersede this labeling guidance.

    On June 26, 2013, FDA held a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Panel) to discuss the potential reclassification of blood lancets (Ref. 3). The Panel discussed new scientific information (see section VII of this document), the risks to health from blood lancets, whether blood lancets should be reclassified or remain in class I, and possible special controls for these devices if reclassified into class II. The Panel agreed that general controls were not sufficient to provide a reasonable assurance of safety and effectiveness of any of the four types of blood lancets (the four types are explained in section III). The Panel believed that because multiple use blood lancets for multiple patient use presented a potential unreasonable risk of illness or injury, and insufficient information existed to establish special controls for these devices, they should be reclassified into class III. The Panel recommended that all other blood lancet devices be reclassified into class II (special controls). FDA is not aware of new information since this Panel meeting that would provide a basis for a different recommendation or findings.

    III. Device Description

    A blood lancet is used to puncture the skin to obtain small blood specimens for testing blood glucose, hemoglobin, and other blood components. Some blood lancets are used with POC blood testing devices, such as blood glucose meters and Prothrombin Time and International Normalized Ratio (PT/INR) anticoagulation meters. Today, probably the most common use for a blood lancet is in diabetes monitoring. These devices are used in both home and professional health care settings. Only a small blood sample is needed for testing of blood glucose level. The blood sample is dropped onto a test strip and inserted into a blood glucose meter for results.

    FDA has identified four subsets of blood lancets:

    1. A single use only blood lancet with an integral sharps injury prevention feature is a disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use;

    2. A single use only blood lancet without an integral sharps injury prevention feature is a disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes;

    3. A multiple use blood lancet for single patient use only is a multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes; and

    4. A multiple use blood lancet for multiple patient use is a multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

    IV. Proposed Reclassification A. Single Patient Use Only Blood Lancets

    FDA is proposing to reclassify the following three subsets of blood lancets from class I (general controls) exempt from premarket review to class II (special controls) and subject to premarket review: (1) Single use only blood lancets with an integral sharps injury prevention feature, (2) single use only blood lancets without an integral sharps injury prevention feature, and (3) multiple use blood lancets for single patient use only. FDA believes that general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness for these devices, and that there is sufficient information to establish special controls to provide such assurance.

    The Food and Drug Administration Modernization Act (FDAMA) (Pub. L. 105-115) added section 510(m) to the FD&C Act. Section 510(m) of the FD&C Act provides that a class II device may be exempted from the premarket notification requirements under section 510(k) of the FD&C Act, if the Agency determines that premarket notification is not necessary to assure the safety and effectiveness of the device. The Agency does not intend to exempt these devices from premarket notification (510(k)) submission as allowed under section 510(m) of the FD&C Act. FDA believes premarket notification is necessary for these devices to provide a reasonable assurance of safety and effectiveness.

    B. Multiple Patient Use Blood Lancets

    FDA is proposing that a fourth subset of blood lancets, multiple use blood lancets for multiple patient use, be reclassified from class I (general controls) without premarket review to class III (premarket approval). FDA believes that insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness for these devices, which present a potential unreasonable risk of illness or injury (see section 513(a)(1)(C) of the FD&C Act).

    Elsewhere in this issue of the Federal Register, FDA is proposing to require the filing of a PMA or notice of completion of a product development protocol (PDP) for these devices, which will be finalized only if FDA reclassifies multiple use blood lancets for multiple patient use to class III.

    FDA continues to believe that multiple use blood lancets for use in multiple patients present significant risks to public health. Specifically, multiple patient use blood lancets pose a risk of transmission of bloodborne pathogen infections, including HBV and hepatitis C. Bloodborne pathogens may be transmitted between patients by blood or blood products taken from a patient with a transmissible infection. FDA believes that certain design characteristics would be required to help mitigate these risks. For example, multiple use blood lancets for use in multiple patients would need to be designed to allow for rigorous, thorough cleaning plus a disinfection or sterilization process capable of reduction of bloodborne pathogens to a clinically acceptable level between each use in a different patient in order to be safe for this intended use. The cleaning and disinfection/sterilization process to be used to render a multiple use blood lancet safe for use in multiple patients would need to be effective in spite of potential health care provider noncompliance with manufacturer's Instructions for Use. More importantly, the multiple use blood lancet for use in multiple patients would need to be designed such that repeat operation of the device is not possible until the device has been thoroughly cleaned and disinfected, using validated processes, by the health care user. Such a mechanism is necessary to prevent health care providers, especially those working in facilities that provide relatively little staff education or supervision, such as assisted living facilities (ALF), from failing to comply with manufacturer recommendations regarding rendering multiple patient use blood lancets safe for use in more than one patient. Therefore, the safety of the multiple use blood lancets for multiple patients, especially the effectiveness of their design and reprocessing instructions to render the device safe for use on more than one patient and the ability of health care providers to follow these instructions completely, must be rigorously demonstrated, independently of any other blood lancet. Because blood lancets for use on multiple patients present a potential unreasonable risk of illness or injury and insufficient information exists for FDA to determine that special controls would provide reasonable assurance of safety and effectiveness of the device, the Agency believes that these devices should be reclassified into class III.

    V. Public Health Benefits and Risks to Health

    As required by section 513(e)(1)(A)(I) of the FD&C Act, FDA is providing a substantive summary of the valid scientific evidence regarding the public health benefit of blood lancets, and the nature and, if known, the incidence of the risk of the devices. Since the 1990s, because of outbreaks of HBV infections associated with blood lancets and meters used in blood glucose monitoring, CDC and FDA have recommended that blood lancets should be limited to one individual's use (Refs. 1 and 4 to 6). Nevertheless, there have been continuing reports of bloodborne pathogen transmission from the shared use of blood lancets. Improper use of blood lancets can endanger public health, and FDA is concerned about the persistent risk of transmission of hepatitis and other bloodborne pathogens when blood lancets are used to obtain blood from more than one patient in health care settings. Certain bloodborne pathogens, such as HBV, are very stable at ambient temperatures and HBV infected patients, who often lack clinical symptoms of hepatitis, can have high concentrations of HBV in their blood or body fluids, thus serving as unsuspected sources of the infectious agent available for transmission to other patients when blood lancets are misused (Refs. 7 to 32).

    These findings were discussed by the June 26, 2013, General and Plastic Surgery Devices Panel. The Panel agreed that the risks to health identified in this section are applicable to blood lancet devices, particularly the risk of cross-contamination between patients when the same lancet is used on multiple patients (Ref. 3).

    After considering the information discussed by the Panel and in published literature, as well as medical device reports relating to blood lancets, and reported outbreaks of various bloodborne pathogen infections, FDA believes that the risks to health associated with the use of blood lancets are (1) bloodborne pathogen transmission, (2) sharp object injuries, (3) local tissue infections, and (4) adverse tissue reaction (not infection). The June 26, 2013, Panel also believed that these were the risks for the device (Ref. 3).

    A. Bloodborne Pathogen Transmission

    Bloodborne pathogens such as HBV, hepatitis C virus, and potentially any other pathogen present in the bloodstream of a patient can be transmitted from one patient to another by the following mechanisms:

    • Reuse of the same lancet blade to draw blood from more than one patient or

    • Failure/inability to adequately clean the base of a multiple use blood lancet resulting in the blood contamination of the next “new” lancet blade when blood is drawn from more than one patient.

    B. Sharp Object Injuries

    The blade of a blood lancet device is designed to pierce the skin and draw blood. Except when the used lancet blade is immediately and automatically covered by a sharps safety feature, which renders the blade inaccessible, the exposed sharp blade of a blood lancet presents a puncture hazard to anyone coming in contact with it. Blade exposure can result due to either the lack of a sharps safety feature or device breakage.

    C. Local Tissue Infections

    Human skin always carries a population of bacteria and often fungi (normal skin flora), which causes no problem for the host when skin is intact. However, puncture injuries to the skin by sharp objects such as blood lancet blades can carry these microbes into the normally sterile tissue below the skin. Such injuries have the potential to cause local skin/soft tissue infections.

    D. Adverse Tissue Reaction (Not Infection)

    Tissue contact with some materials, metals, and material colorants can cause skin inflammation, irritation, or exanthems (rashes). These reactions may be due to either hypersensitivity to a specific compound/metal or to a non-specific reaction.

    VI. Summary of Reasons for Reclassification

    FDA believes that blood lancets for use on a single patient only should be reclassified into class II because special controls, in addition to general controls, can be established to provide reasonable assurance of safety and effectiveness of the device. FDA further believes that blood lancets for use on multiple patients should be reclassified into class III because multiple patient use blood lancets present a potential unreasonable risk of illness or injury and insufficient information exists for FDA to determine that special controls would provide reasonable assurance of safety and effectiveness of the device.

    The June 26, 2013 reclassification Panel recommended that single patient blood lancets be reclassified into class II and multiple patient blood lancets into class III. The Panel did not believe that general controls alone were sufficient to ensure the safety and effectiveness of blood lancets. The Panel believed that special controls could be established to provide reasonable assurance of the safety and effectiveness of single use blood lancets, with and without integral sharps injury prevention features, and multiple use lancets for single patients, but that special controls could not be established to provide reasonable assurance of safety and effectiveness for multiple use lancets for multiple patients. Hence, the Panel agreed that blood lancets for use on a single patient only should be reclassified into class II (special controls), and multiple use lancets for multiple patients should be reclassified into class III (premarket approval).

    VII. Summary of Data Upon Which the Reclassification Is Based

    FDA uses the bloodborne pathogens definition in 29 CFR 1910.1030(b). Bloodborne pathogens, such as HBV, may be transmitted between patients by blood and certain body fluids (Ref. 32). Since HBV-infected patients, who often lack clinical symptoms of hepatitis, have high concentrations of HBV in their blood and HBV is stable at ambient temperatures, transmission of HBV may result from exposure to equipment that has not been adequately disinfected or by the misuse of “single use only” medical devices (e.g., needles and syringes) (Ref. 33).

    The history of recognized bloodborne pathogen transmission by blood lancets may have started in 1923 when an outbreak of jaundice occurred in the Goteborg Hospital diabetic clinic in Sweden, which was described by Schmid, et al. (Ref. 10). All patients had blood drawn for glucose testing from their ear lobes by a spring-activated “Schnepper” device, which was cleaned “perfunctorily” between uses. As a result, 26 clinic patients developed jaundice. Outbreaks of hepatitis in English diabetic patients were described by Graham in 1938 (Ref. 11) and by Droller in 1945 (Ref. 12). In both of these outbreaks, venous blood for glucose measurement was drawn using syringes that were only chemically disinfected between uses while the needles were boiled; cleaning procedures were not mentioned in the reports. Syringes and needles are now single-use-only devices because the procedures used to reprocess these devices many years ago have long been recognized to be inadequate, resulting in outbreaks of hepatitis transmission (Ref. 10). There were also two case reports, in 1985 and 1997, of the transmission of HBV infection due to sharing personal use blood lancets for home glucose monitoring with one other person who already had HBV. One report was from the United States and one was from Hungary (Refs. 13 and 14). In addition, Mendez et al. reported a 75-year-old patient with diabetes who died of acute hepatitis, whose only risk factor for HBV infection appeared to be her diabetic care at a local outpatient facility where she had repeated fingersticks for blood glucose monitoring (Ref. 15).

    During the 1990s, several bloodborne pathogen transmission issues led to CDC and FDA involvement. In 1990, CDC learned of a nosocomial outbreak of HBV transmission due to the use of a spring-loaded lancet device whose disposable platform was not removed and discarded after each use of the device while it was used for the care of multiple patients (Ref. 4).1 CDC reported this outbreak to FDA; FDA then issued a safety alert warning users of the precautions needed for the safe use of this device (Ref. 5). This was the first reported outbreak of HBV transmission associated with the use of a blood lancet device in the United States (Refs. 5 and 7).

    1 Hepatitis B and hepatitis C infections, as well as other bloodborne infections such as HIV infection, are reported to State health departments and, by them, to CDC; FDA does not usually receive such reports directly from health care facilities or personnel, even when a medical device has transmitted the infection.

    CDC's outbreak investigation revealed that a patient who had diabetes and also a chronic HBV infection caused by a relatively rare viral subtype was admitted to the outbreak ward in 1989. Twelve of the 23 patients who acquired HBV after admission to the same ward as the chronic HBV source patient were serotyped, and all were found to have the same viral subtype causing their HBV infections. The first nosocomially infected patient had a very long-term stay on the ward and so served as a source of transmission to other patients over a period of 12 months. Twenty of the 23 outbreak patients had diabetes; they and the three other case-patients all experienced numerous POC fingerstick blood draws with the same type of blood lancet while hospitalized on the outbreak ward. The implicated blood lancet device included a disposable platform to stabilize the patient's finger; the single use lancet blade penetrated a hole in that platform to reach the patient's skin. Half the ward nursing staff who performed fingersticks with this lancet acknowledged not changing the device platform with each use of the lancet. A similar outbreak of hepatitis transmission was reported in 1990 in France in which a similar blood lancet device was implicated. Douvin et al. (Ref. 8) reported that examination of the device implicated in the French outbreak showed visible blood contamination of the lancet platform in 24 percent of studied uses of that device. Shier et al. (Ref. 9) reported in 1993 that the use of another spring-loaded lancet device in a volunteer study of blood glucose levels resulted in visible blood contamination on 29 percent of the device end caps. This device was intended for “personal” use only.

    As a result of the 1990 outbreak of HBV transmission due to blood lancet use in the United States, FDA and CDC recommended that spring-loaded blood lancet devices should have only single use only “platforms” as well as single use only blades; the devices were to be cleaned and disinfected per the manufacturer's instructions (Refs. 4 and 5). The 1990 FDA Safety Alert also advised “Devices [blood lancets] without a removable platform should only be used with one patient in the hospital or outpatient setting. After the patient is discharged, the device may be reused only if it is disinfected according to the manufacturer's instructions. If there are no instructions for disinfection, the device should be discarded.”

    Since 1990, the incidence of diabetes mellitus has increased significantly in the United States, especially in adults aged 65-79 (Refs. 34 and 35). At the same time, clinical practice in the care of these patients increasingly emphasized the need for improved blood glucose level control, resulting in the increased use of POC blood glucose monitoring both in health care facilities and at home (Refs. 36 to 38). Unfortunately, along with the increased incidence of diabetes has come a progressive increase in the reports of bloodborne infection transmission (primarily HBV), resulting from the shared use of fingerstick and POC blood testing devices (Ref. 1). In 2011, the CDC reported that 25 of 29 outbreaks of HBV infection occurring in long-term care facilities since 1996 involved adults with diabetes receiving assisted blood glucose monitoring (Ref. 39).

    In 1997, CDC reported two outbreaks of HBV transmission, one in a nursing home in Ohio and one in a hospital in New York City (NYC) (Ref. 16). Two different blood lancet devices were used at the two sites. However, both lancet devices included the use of an “end cap” that came in contact with patient skin. This was a separate, individual use component of the lancet device used in Ohio; the nursing home was reusing both the lancet and the cap for multiple patients. The end cap was a part of the disposable, single use only lancet blade assembly in the device used in NYC. The exact mechanism of blood transmission was not entirely clear in the NYC setting; staff claimed they had discarded the end cap after each use. CDC postulated that either blood-contaminated nurses gloves worn for the care of multiple patients or the pen-like lancet-holding device itself might have been the source of the blood cross-contamination of the lancet. A similar outbreak was reported by Quale et al. in 1998 from a hospital in New York (Ref. 17). The recognition of 3 cases of nosocomially acquired HBV infection resulted in an investigation that uncovered another 11 cases. Reuse by hospital staff of a disposable lancet end cap with the lancet in multiple patients was identified as the probable cause of hepatitis cross-transmission to patients; contamination of the lancet wound from blood on unchanged gloves worn by nurses during collection of blood samples from multiple patients may also have contributed to the nosocomial transmission of HBV in this outbreak.

    CDC reviewed the incidence of reported outbreaks of HBV and hepatitis C infection in nonhospital health care settings between 1998 and 2008 and noted a significant increase in such nosocomial transmission of bloodborne pathogens (Refs. 18 to 21). N.D. Thompson et al. identified 33 outbreaks of nosocomial hepatitis transmission in nonhospital health care settings (Ref. 18). Of these 33 outbreaks, 15 were found to be due to blood glucose monitoring in long-term care facilities. Only half of these outbreak investigations were published in the scientific literature; the others were recognized by health department investigations and reports to CDC. In 9 of the 15 outbreaks of nosocomial hepatitis in patients with diabetes, blood lancet devices were shared among multiple patients. In two additional outbreaks, lancets were not noted to be shared, but blood-soiled glucose meters were stored together with lancets without cleaning/disinfection of the devices and gloves were not regularly changed between each patient. These failures of proper infection control practice could have led to blood contamination of individual blood lancets in these two facilities.

    N.D. Thompson et al. also investigated blood glucose monitoring practices in long-term care facilities in Pinellas County, FL, in 2007 and found that 22 percent of the participating facilities that used reusable fingerstick devices used them in multiple patients (Ref. 22). Patel et al. reported in 2009 on the efforts of the Virginia Department of Health to improve blood glucose monitoring practices in ALFs in Virginia (Ref. 23). This effort followed two separate outbreaks of HBV infections in two ALFs. In those outbreaks, one of the three acutely symptomatic initial patients died of HBV infection. Of 68 patients undergoing blood glucose monitoring in these 2 facilities, a total of 11 patients acquired HBV infection. Both facilities used reusable blood lancets to obtain blood from multiple patients and did not clean or disinfect them between uses. The Virginia Department of Health then mailed an educational packet on safe blood glucose monitoring practices to all ALFs (640) in the State. A random sample of ALFs was contacted after the educational intervention and invited to participate in a survey to evaluate the response to the educational packet. The results found that 16 percent of the facilities that used lancets to monitor blood glucose levels were still using these devices to obtain blood from multiple patients.

    Y.G. McIntosh et al. investigated outbreaks of nosocomial HBV transmission in four ALFs between 2009 and 2011 and found that in all four facilities, pen-style lancets were used to obtain blood for glucose monitoring from multiple patients even though two facilities provided each patient with dedicated “single patient use only pen-style lancets” according to their policies (Ref. 24). Z. Moore et al. reported another outbreak of nosocomial HBV transmission in an ALF in North Carolina in 2010 in which blood lancet devices were shared among multiple patients. Six of the eight elderly patients who acquired acute HBV in this outbreak died from complications of hepatitis (Ref. 25). M.K. Schaefer et al. surveyed a stratified, random sample of ambulatory surgery centers (ASCs) in three volunteer states in 2009 (Ref. 26). Of the 53 ASCs that performed blood glucose monitoring, 11 (21 percent) reused pen-style blood lancets on multiple patients and 17 (32 percent) also failed to clean and disinfect blood glucose meters after each use.

    Thompson and Schaefer reported the analysis of four outbreaks of nosocomial HBV in ALFs in 2009-2010 (Ref. 27). One was also reported separately by Z. Moore et al. (Ref. 24). Two of the three other outbreaks occurred in Virginia and one in Florida; these 3 outbreaks resulted in 21 new patients acquiring acute HBV. In two of the three facilities, use of reusable blood lancets to draw blood from multiple patients was observed or reported. The third facility denied that it permitted the sharing of reusable lancets. However, used lancets and glucose meters were stored together, along with clean supplies; visible blood contamination was observed on several glucose meters and one reusable lancet by the investigator. Thompson and Schaefer also reported in their paper on two patient notification campaigns resulting from the misuse of reusable blood lancets with preloaded lancet cartridges, intended and cleared only for single patient use, which were used to obtain blood from multiple patients. One episode involved a community health center and was reported when personnel noted that the lancet blades were not retracting properly, which might have resulted in blade use for more than one patient. The second episode occurred at a community health fair in which physician assistant students were offering diabetes screening. During the fair, the students realized that the lancet blades had not been advanced properly so that each patient received a new blade. The first episode exposed 283 patients to a contaminated lancet blade; the second incident exposed approximately 60 patients. The results of the patient notification studies were not reported.

    As a result of this significant increase in such nosocomial transmission of bloodborne pathogens, on August 26, 2010, FDA and the CDC issued a Safety Communication (Ref. 1) and a Clinical Reminder (Ref. 6), respectively, warning that the use of blood lancets to obtain blood from more than one patient risks the transmission of bloodborne pathogen infections from one patient to other patients. Both FDA and CDC recommended that blood lancets should never be used to obtain blood from more than one patient. In addition, the Centers for Medicare and Medicaid Services issued a Survey and Certification Memorandum for Point of Care Devices and Infection Control in Nursing Homes identifying the use of blood lancet devices for more than one patient as an infection control standards deficiency (Ref. 40). On November 29, 2010, FDA issued “Guidance for Industry and Food and Drug Administration Staff: Blood Lancet Labeling,” which provided guidance for lancet manufacturers on the labeling of all blood lancets, including those capable of reuse, as “single patient use only” devices (Ref. 2).

    In 2012, another outbreak of acute HBV was reported in an ALF in Virginia (Ref. 28). The source patient had been recently transferred from another ALF where she had acquired nosocomial HBV infection from the shared use of blood lancets for multiple patients (Ref. 24). This ALF also reused blood lancets to obtain blood from multiple patients for glucose monitoring. This dangerous practice resulted in two new nosocomial HBV infections in this ALF.

    Outbreaks of hepatitis transmission due to use of blood lancets to draw blood from more than one patient for blood glucose monitoring have not been limited to the United States. In 2001, Desenclos et al. described an outbreak of nosocomial hepatitis C transmission in an inpatient ward for children with cystic fibrosis and diabetes in a French hospital in 1994-1995 (Ref. 29). Blood glucose monitoring was done by the nursing staff for the patients with cystic fibrosis as well as for the patients with diabetes using a spring-loaded lancet with a disposable platform to stabilize the finger. These devices were shared among patients between 1986 and 1992 during repeated admissions to the inpatient unit. After 1992, patients were supposed to use only their own lancet devices for blood glucose monitoring. The retrospective prevalence of prior hepatitis C infection was found to be 58 percent in patients with cystic fibrosis and 17 percent in patients with diabetes in 1994. At the time (1994), the prevalence of antibody to hepatitis C in the general public in France was 1.1 percent. The patients with cystic fibrosis had more frequent and longer admissions to the inpatient ward and more of the exposed cystic fibrosis patients (66.7 percent) were screened for hepatitis C infection than were the patients with diabetes admitted to the inpatient ward during the exposure period (39.5 percent). These factors may have influenced the apparent difference in hepatitis C transmission in these two groups of exposed patients.

    In 2005, De Schrijver et al. described an outbreak of acute HBV infection in a nursing home in Antwerp (Ref. 30). The initial report of a fulminant case of acute HBV infection in an 83-year-old resident of the home resulted in an investigation that identified acute HBV infection in another four patients there. Four of the five acutely infected patients had diabetes and received assisted blood glucose sampling by the nursing home staff. The two blood lancet models used in the facility (one each in two sections) were used to obtain blood from multiple patients. The device platforms were not disposable. The lancets were washed only when blood was visible on the device and they were not disinfected. Nurses did not routinely wash their hands or wear gloves when obtaining blood. Two of the five patients with acute nosocomial HBV died of their infections.

    In 2008, Gotz et al. reported the investigation of two cases of acute HBV infection among patients at a nursing home in the Netherlands (Ref. 31). The nursing home stay of these two patients overlapped with that of a patient with known chronic HBV infection. Early in this time period, the nursing home changed the lancet device used for glucose monitoring from a spring-loaded device with a disposable platform (used for multiple patients) to a device with a rotating drum dispensing new lancet blades, which was also used to draw blood from multiple patients, although it was labeled for single patient use only. This device was used for about a month until the staff realized that active rotation of the drum was occasionally forgotten, resulting in the reuse of a lancet blade on more than one patient. The new device was then removed from the facility and the spring-loaded lancet was returned to use. The two patients with acute HBV received blood glucose monitoring as did the source patient with chronic HBV, sometimes on the same day. Two other patients who also received blood glucose monitoring escaped infection. The investigators stated that they believed the rotating lancet drum device was likely the means of transmission of HBV infection between patients.

    In 2011, Duffell et al. reported on the investigations of five reports of HBV transmission in community health care settings in the United Kingdom (Ref. 32). All of the nine initially reported patients with HBV had diabetes and were receiving blood glucose monitoring. Further investigation identified another 12 patients with acute HBV infection. The care settings in which hepatitis transmission occurred were described as a “private residential home” (one patient), “nursing and residential home” (one patient), “private nursing and residential home” (one patient) and “local care home” (two patients). Eleven of the 21 acutely infected patients had symptomatic HBV; 7 of these patients died, 5 due to the HBV infection. All of the care sites in which acute HBV transmission occurred were using blood lancets intended for single patient use only; these devices were either routinely or occasionally used for multiple patients. One facility also used a single glucometer for multiple patients and did not clean or disinfect it between patients. The authors also noted that information reported on patients found to have acute HBV infection between 1990 and 2003 identified only four patients with blood glucose monitoring as a possible risk factor; one of these patients was infected as a result of in-hospital transmission from another patient on the same ward, although details were not provided. Between 2004 and 2006, the 9 patients described previously in this document were reported and investigation led to the discovery of an additional 12 cases of health care-related HBV transmission due to the improper use of blood lancets during patient blood glucose monitoring.

    VIII. Special Controls

    FDA believes that the special controls identified in the paragraphs that follow—in addition to general controls—are necessary to provide reasonable assurance of safety and effectiveness for this device when it is for single patient use only. Special controls were discussed at the June 26, 2013, reclassification Panel (Ref. 3). The Panel agreed that the special controls as presented would provide a reasonable assurance of safety and effectiveness for these devices, emphasizing in discussions the need for adequate labeling for these devices. FDA believes that the special controls proposed for single use only blood lancets with an integral sharps injury prevention feature in § 878.4850(a)(2), in addition to the general controls, mitigate the risks to health discussed in section V and are necessary to provide reasonable assurance of safety and effectiveness.

    Table 1 depicts how each risk to health would be mitigated by the proposed special controls.

    Table 1—Health Risks and Mitigation Measures for Single Use Only Blood Lancet With an Integral Sharps Injury Prevention Feature Identified risk Mitigation measure Bloodborne pathogen transmission Design characteristics.
  • Mechanical performance testing.
  • Labeling.
  • Sharp object injuries Design characteristics.
  • Mechanical performance testing.
  • Labeling.
  • Local tissue infection Labeling.
  • Sterilization.
  • Adverse tissue reaction (not infection) Biocompatibility.

    FDA believes that the special controls proposed for single use only blood lancets without an integral sharps injury prevention feature in proposed in § 878.4850(b)(2), in addition to the general controls, mitigate these risks to health discussed in section V and are necessary to provide reasonable assurance of safety and effectiveness.

    Table 2 depicts how each risk to health would be mitigated by the proposed special controls.

    Table 2—Health Risks and Mitigation Measures for Single Use Only Blood Lancet Without an Integral Sharps Injury Prevention Feature Identified risk Mitigation measure Bloodborne pathogen transmission Design characteristics.
  • Mechanical performance testing.
  • Labeling.
  • Sharp object injuries Design characteristics.
  • Mechanical performance testing.
  • Labeling.
  • Local tissue infection Labeling.
  • Sterilization.
  • Adverse tissue reaction (not infection) Biocompatibility.

    FDA believes that the special controls proposed for multiple use blood lancets for single patient use only in proposed § 878.4850(c)(2), in addition to the general controls, mitigate these risks to health discussed in section V and are necessary to provide reasonable assurance of safety and effectiveness.

    Table 3 depicts how each risk to health would be mitigated by the proposed special controls.

    Table 3—Health Risks and Mitigation Measures for Multiple Use Blood Lancet for Single Patient Use Only Identified risk Mitigation measure Bloodborne pathogen transmission Design characteristics.
  • Mechanical performance testing.
  • Labeling.
  • Sharp object injuries Design characteristics.
  • Mechanical performance testing.
  • Labeling.
  • Local tissue infection Labeling.
  • Sterilization.
  • Validated cleaning and disinfection.
  • Adverse tissue reaction (not infection) Biocompatibility.
    IX. The Proposed Order

    FDA is issuing this proposed order to reclassify the following three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket review: (1) Single use only blood lancets with an integral sharps injury prevention feature, (2) single use only blood lancets without an integral sharps injury prevention feature, and (3) multiple use blood lancets for single patient use only. FDA is identifying proposed special controls for these types of blood lancets, as identified in section VIII of this document, that are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also proposing to reclassify multiple use blood lancets for multiple patient use from class I (general controls) exempt from premarket notification into class III (premarket approval).

    X. Effective Date

    FDA proposes that any final order based on this draft order become effective on its date of publication in the Federal Register.

    • Blood lancets for single patient use only that have not been offered for sale prior to the effective date of the final order, or have been offered for sale but are required to submit a new 510(k) under 21 CFR 807.81(a)(3): Manufacturers would have to obtain 510(k) clearance before marketing their devices after the effective date of the order. If a manufacturer markets such a device without receiving 510(k) clearance, then FDA would consider taking action against such a manufacturer under its usual enforcement policies.

    • Blood lancets for single patient use only that have been offered for sale prior to the effective date of the final order, and do not already have 510(k) clearance: FDA does not intend to enforce compliance with the 510(k) requirement or special controls until 180 days after the effective date of the final order. After that date, if a manufacturer continues to market such a device but does not have 510(k) clearance or FDA determines that the device is not substantially equivalent or not compliant with special controls, then FDA would consider taking action against such manufacturer under its usual enforcement policies.

    For blood lancets for single patient use that have prior 510(k) clearance, FDA would accept a new 510(k) and would issue a new clearance letter, as appropriate, indicating substantial equivalence and special controls compliance. These devices could serve as predicates for new devices. These clearance letters would be made publicly available in FDA's 510(k) database, and compliance with special controls at the time of clearance would be stated in the publically available 510(k) Summary posted in this database. Since many blood lancets for single patient use are non-prescription (“over the counter”) devices, FDA believes that our public database is a transparent tool allowing consumers to confirm that their devices have been submitted under a new 510(k) and demonstrated conformance to applicable special controls. Elsewhere in this issue of the Federal Register, FDA is proposing to require the filing of a PMA or notice of completion of a PDP for multiple use blood lancets for multiple patient use, which will be finalized only if FDA reclassifies these devices into class III.

    XI. Analysis of Environmental Impact

    We have 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.

    XII. Paperwork Reduction Act of 1995

    This proposed order refers to previously approved information collections found in FDA regulations. 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 801 have been approved under OMB control number 0910-0485. The collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073. The collections of information in 21 CFR part 814, subparts B and E, have been approved under OMB control number 0910-0231.

    The labeling provisions in proposed § 878.4850(a)(2)(vi), (b)(2)(vi), and (c)(2)(vii) are not subject to review by OMB because they do not constitute a “collection of information” under the PRA. Rather, the following labeling: (1) “For use only on a single patient. Discard the entire device after use.”; (2) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”; (3) “Used lancet blades must be discarded safely after a single use.”; (4) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”; and (5) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.” are a “public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)).

    XIII. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e) as amended requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, under section 513(e)(1)(A)(i), as amended by FDASIA, in the proposed order, we are proposing to revoke the requirements in § 878.4800 related to the classification of blood lancets as class I devices and to codify the reclassification of subsets of blood lancets into class II or class III in § 878.4850.

    XIV. References

    The following references are on display in the Division of Dockets Management (see ADDRESSES) 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. U.S. Food and Drug Administration (FDA), “Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (August 26, 2010) and “Update” (November 29, 2010), available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm234889.htm and http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm. 2. U.S. Food and Drug Administration, “Guidance for Industry and Food and Drug Administration Staff: Blood Lancet Labeling” (November 29, 2010), available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm234577.htm. 3. FDA's General and Plastic Surgery Devices Panel transcript and other meeting materials for the June 26, 2013, meeting are available on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm349426.htm. 4. Centers for Disease Control and Prevention (CDC). “Nosocomial Transmission of Hepatitis B Virus Associated With a Spring-Loaded Fingerstick Device—California”, MMWR Morbidity and Mortality Weekly Report, 1990; 39 (35):610-613. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00001743.htm) 5. Food and Drug Administration (FDA), “Safety Alert Medical Devices; Hepatitis B Transmission via Spring-Loaded Lancet Devices” (August 28, 1990), available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm241809.htm. 6. Centers for Disease Control and Prevention (CDC), “CDC Clinical Reminder Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens”, available at http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html. 7. Polish, L., C. Shapiro, F. Bauer, et al., “Nosocomial Transmission of Hepatitis B Virus Associated With the Use of a Spring-Loaded Fingerstick Device”, New England Journal of Medicine, 1992; 326 (11):721-725. 8. Douvin, C., D. Simon, H. Zinelabidine, et al., “An Outbreak of Hepatitis B in an Endocrinology Unit Traced to a Capillary Blood Sampling Device”, New England Journal of Medicine, 1990; 322:57-58. 9. Shier, N., J. Warren, M. Torabi, et al., “Contamination of a Fingerstick Device”, New England Journal of Medicine, 1993; 328:969-970. 10. Schmid, R., “History of Viral Hepatitis: A Tale of Dogmas and Misinterpretations”, Journal of Gastroenterology and Hepatology, 2001; 16(7):718-722. 11. Graham, G., “Diabetes Mellitus: A Survey of Changes in Treatment During the Last Fifteen Years”, The Lancet, 1938 2:1-7. 12. Droller, H., “An Outbreak of Hepatitis in a Diabetic Clinic”, British Medical Journal, 1945; 1(4400):623-625. 13. Stapleton, J., and S. Lemon, “Transmission of Hepatitis B During Blood Glucose Monitoring”, Journal of the American Medical Association 1985; 253:3250. 14. Farkas K and G Jermendy. “Transmission of Hepatitis B Infection During Home Blood Glucose Monitoring”, Diabetic Medicine, 1997; 14:263. 15. Mendez, L., K.R. Reddy, R.A. Di Prima, et al., “Fulminant Hepatic Failure Due to Acute Hepatitis B and Delta Co-Infection: Probable Bloodborne Pathogen Transmission Associated With a Spring-loaded Fingerstick Device”, American Journal of Gastroenterology, 1991; 86:895-897. 16. Centers for Disease Control and Prevention (CDC), “Nosocomial Hepatitis B Virus Infection Associated With Reusable Fingerstick Blood Sampling Devices—Ohio and New York City, 1996”, MMWR Morbidity and Mortality Weekly Report, 1997; 46(10):217-221. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00046679.htm.) 17. Quale, J.M., D. Landman, B. Wallace, et al., “Déjà vu: Nosocomial Hepatitis B Transmission and Fingerstick Monitoring”, The American Journal of Medicine, 1998; 105;296-301. 18. Thompson, N.D., J. Perz, A. Moorman, et al., “Nonhospital Health Care-Associated Hepatitis B and C Virus Transmission: United States, 1998-2008”, Annals of Internal Medicine, 2009; 150:33-39. 19. Khan, A.J., S.M. Cotter, B. Schulz, et al., “Nosocomial Transmission of Hepatitis B Virus Infection Among Residents With Diabetes in a Skilled Nursing Facility”, Infection Control and Hospital Epidemiology, 2002; 23:313-318. 20. Centers for Disease Control and Prevention (CDC), “Transmission of Hepatitis B Virus Among Persons Undergoing Blood Glucose Monitoring in Long-Term-Care Facilities—Mississippi, North Carolina, and Los Angeles County, California, 2003-2004”, MMWR Morbidity and Mortality Weekly Report, 2005; 54(09):220-223. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5409a2.htm.) 21. Thompson, N.D. and J.F. Perz, “Eliminating the Blood: Ongoing Outbreaks of Hepatitis B Virus Infection and the Need for Innovative Glucose Monitoring Techniques”, Journal of Diabetes Science and Technology, 2009; 3(2):283-288. 22. Thompson, N.D., V. Barry, K. Alelis, et al., “Evaluation of the Potential for Bloodborne Pathogen Transmission Associated With Diabetes Care Practices in Nursing Homes and Assisted Living Facilities, Pinellas County”, Journal of the American Geriatrics Society, 2010; 58:914-918. 23. Patel, A.S., M.B. White-Comstock, D. Woolard, et al., “Infection Control Practices in Assisted Living Facilities: A Response to Hepatitis B Virus Infection Outbreaks”, Infection Control and Hospital Epidemiology, 2009; 30:209-214. 24. Centers for Disease Control and Prevention (CDC), “Multiple Outbreaks of Hepatitis B Virus Infection Related to Assisted Monitoring of Blood Glucose Among Residents of Assisted Living Facilities—Virginia, 2009-2011”, MMWR Morbidity and Mortality Weekly Report, 2012; 61(19):339-343. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6119a3.htm?s_cid=mm6119a3_w.) 25. Centers for Disease Control and Prevention (CDC), “Notes From the Field: Deaths From Acute Hepatitis B Virus Infection Associated With Assisted Blood Glucose Monitoring in an Assisted-Living Facility—North Carolina, August-October, 2010”, MMWR Morbidity and Mortality Weekly Report, 2011; 60(6):182. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6006a5.htm?s_cid=mm6006a5_w.) 26. Schaefer, M.K., M. Jhung, M. Dahl, et al., “Infection Control Assessment of Ambulatory Surgical Centers”, Journal of the American Medical Association, 2010; 303 (22):2273-2279. 27. Thompson, N.D. and M.K. Schaeffer, “`Never Events': Hepatitis B Outbreaks and Patient Notifications Resulting From Unsafe Practices During Assisted Monitoring of Blood Glucose, 2009-2010”, Journal of Diabetes Science and Technology, 2011; 5(6):1396-1402. 28. Centers for Disease Control and Prevention (CDC), “Notes From the Field: Transmission of HBV Among Assisted-Living-Facility Residents—Virginia, 2012”, MMWR Morbidity and Mortality Weekly Report, 2013; 62(19):389. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6219a4.htm?s_cid=mm6219a4_w.) 29. Desenclos, J.C., M. Bourdiol-Razes, B. Rolin, et al., “Hepatitis C in a Ward for Cystic Fibrosis and Diabetic Patients: Possible Transmission by Spring-Loaded Finger-Stick Devices for Self-Monitoring of Capillary Blood Glucose”, Infection Control and Hospital Epidemiology, 2001; 22(11):701-707. 30. De Schrijver, K., I. Maes, P. Van Damme, et al., “An Outbreak of Nosocomial Hepatitis B Virus Infection in a Nursing Home for the Elderly in Antwerp (Belgium)”, Acta Clinica Belgica, 2005; 60(2):63-69. 31. Gotz, H.M., M. Schutten, G.J. Borsboom, et al., “A Cluster of Hepatitis B Infections Associated With Incorrect Use of a Capillary Blood Sampling Device in a Nursing Home in the Netherlands, 2007”, Euro Surveillance, 2008; 13(7-9):1-5. 32. Duffell, E.F., L.M. Milne, C. Seng, et al., “Five Hepatitis B Outbreaks in Care Homes in the UK Associated With Deficiencies in Infection Control Practice in Blood Glucose Monitoring”, Epidemiology and Infection, 2011; 139:327-335. 33. Williams, I.T., J.F. Perz, and B.P. Bell, “Viral Hepatitis Transmission in Ambulatory Health Care Settings”, Clinical Infectious Diseases, 2004; 38(11):1592-1598. 34. Centers for Disease Control and Prevention (CDC), “Increasing Prevalence of Diagnosed Diabetes—United States and Puerto Rico, 1995-2010”, MMWR Morbidity and Mortality Weekly Report, 2012; 61(45):918-921. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6145a4.htm?s_cid=mm6145a4_w.) 35. Centers for Disease Control and Prevention (CDC), “Incidence of Diagnosed Diabetes per 1,000 Population Aged 18-79 Years, by Age, 1980-2014”, Atlanta, GA: U.S. Department of Health and Human Services, CDC, National Diabetes Surveillance System. Available at www.cdc.gov/diabetes/statistics/incidence/fig3.htm. Accessed October 19, 2014. 36. Clarke, S.F. and J.R. Foster, “A History of Blood Glucose Meters and Their Role in Self-Monitoring of Diabetes Mellitus”, British Journal of Biomedical Science, 2012; 69(2):83-93. 37. Yoo, E.-H. and S.-Y. Lee, “Glucose Biosensors: An Overview of Use in Clinical Practice”, Sensors, 2010; 10(5):4558-4576. 38. Rajendran, R. and G. Rayman, “Point-of-Care Blood Glucose Testing for Diabetes Care in Hospitalized Patients: An Evidence-Based Review”, Journal of Diabetes Science and Technology, 2014; 8(6):1081-1090. 39. Centers for Disease Control and Prevention (CDC), “Use of Hepatitis B Vaccination for Adults With Diabetes Mellitus: Recommendations of the Advisory Committee on Immunization Practices (ACIP)”, MMWR Morbidity and Mortality Weekly Report, 2011; 60(50):1709-1711. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a4.htm?s_cid=mm6050a4_w.) 40. Centers for Medical Services (CMS), “Survey and Certification Memorandum” (August 27, 2010), available at http://www.cms.gov/surveycertificationgeninfo/downloads/SCLetter10_28.pdf. List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 878 be amended as follows:

    PART 878—GENERAL AND PLASTIC SURGERY DEVICES 1. The authority citation for 21 CFR part 878 continues to read as follows: Authority:

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

    2. Amend § 878.4800 by revising paragraph (a) to read as follows:
    § 878.4800 Manual surgical instrument for general use.

    (a) Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this subchapter.

    3. Add § 878.4850 to subpart E to read as follows:
    § 878.4850 Blood lancets.

    (a) Single use only blood lancet with an integral sharps injury prevention feature—(1) Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.

    (2) Classification. Class II (special controls). The special controls are:

    (i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature;

    (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use;

    (iii) The device must be demonstrated to be biocompatible;

    (iv) Sterility testing must demonstrate the sterility of the device;

    (v) Labeling must include:

    (A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.

    (B) Handwashing instructions for the user before and after use of the device.

    (C) Instructions on cleaning and disinfection of the skin to be pierced.

    (D) Instructions for the safe disposal of the device.

    (E) Labeling must be appropriate for the intended use environment.

    (1) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.

    (2) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.

    (vi) Labeling must also include the following statements, prominently placed:

    (A) “For use only on a single patient. Discard the entire device after use.”

    (B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”

    (b) Single use only blood lancet without an integral sharps injury prevention feature—(1) Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

    (2) Classification. Class II (special controls). The special controls are:

    (i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions;

    (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use;

    (iii) The device must be demonstrated to be biocompatible;

    (iv) Sterility testing must demonstrate the sterility of the device;

    (v) Labeling must include:

    (A) Detailed descriptions, with illustrations, of the proper use of the device.

    (B) Handwashing instructions for the user before and after use of the device.

    (C) Instructions on cleaning and disinfection of the skin to be pierced.

    (D) Instructions for the safe disposal of the device.

    (E) Labeling must be appropriate for the intended use environment.

    (1) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.

    (2) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.

    (vi) Labeling must also include the following statements, prominently placed:

    (A) “For use only on a single patient. Discard the entire device after use.”

    (B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”

    (c) Multiple use blood lancet for single patient use only—(1) Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

    (2) Classification. Class II (special controls). The special controls are:

    (i) The design characteristics of the device must ensure that:

    (A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and

    (B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions; and allow for validated cleaning and disinfection;

    (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use;

    (iii) The device must be demonstrated to be biocompatible;

    (iv) Sterility testing must demonstrate the sterility of the device;

    (v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.

    (vi) Labeling must include:

    (A) Detailed descriptions, with illustrations, of the proper use of the device.

    (B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.

    (C) Handwashing instructions for the user before and after use of the device.

    (D) Instructions on cleaning and disinfection of the skin to be pierced.

    (E) Instructions on the cleaning and disinfection of the device.

    (F) Instructions for the safe disposal of the device.

    (G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.

    (H) Labeling must be appropriate for the intended use environment.

    (1) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.

    (2) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.

    (vii) Labeling must also include the following statements, prominently placed:

    (A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”

    (B) “Used lancet blades must be safely discarded after a single use.”

    (C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”

    (d) Multiple use blood lancet for multiple patient use—(1) Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

    (2) Classification. Class III (premarket approval).

    Dated: February 25, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-04578 Filed 3-2-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 [Docket No. FDA-2016-M-0035] Effective Date of Requirement for Premarket Approval for Blood Lancets AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed order.

    SUMMARY:

    The Food and Drug Administration (FDA) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III. FDA is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring this device to meet the PMA requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the benefits to the public from the use of the device.

    DATES:

    Submit either electronic or written comments on this proposed order by June 1, 2016. See section X of the SUPPLEMENTARY INFORMATION section of this document for the proposed effective date of any final order that may publish based on this proposal.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-M-0035 for “Effective Date of Requirement for Premarket Approval for Blood Lancets.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G422, Silver Spring, MD 20993-0002, 301-796-6524, [email protected]

    SUPPLEMENTARY INFORMATION: I. Background—Regulatory Authorities

    The FD&C Act, as amended, establishes 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)(1) 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: (1) Receives a recommendation from a device classification panel (an FDA advisory committee); (2) publishes the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) publishes 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 classified automatically 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, FDA reclassifies the device 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 part 807 of the regulations (21 CFR part 807).

    A person may market a preamendments device that has been classified into class III through premarket notification procedures, 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.

    Section 515(f) of the FD&C Act provides an alternative pathway for meeting the premarket approval requirement. Under section 515(f), manufacturers may meet the premarket approval requirement if they file a notice of completion of a product development protocol (PDP) approved under section 515(f)(4) of the FD&C Act and FDA declares the PDP completed under section 515(f)(6)(B) of the FD&C Act. Accordingly, the manufacturer of a class III preamendments device may comply with a call for PMAs by filing a PMA or a notice of completion of a PDP. In practice, however, 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 and obtaining approval of a PMA.

    On July 9, 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA). Section 608(b) of FDASIA (126 Stat. 1056) 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.

    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: Publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 513(b) of the FD&C Act, and consideration of comments to a public docket.

    In June 2013, FDA held a meeting of a device classification panel described in section 513(b) of the FD&C Act to discuss the classification of multiple use blood lancets for multiple patient use. Although, to FDA's knowledge, no device is currently being marketed for this use, one device has been cleared for this use. As explained further in section V.A of this document, this device classification panel meeting discussed whether multiple use blood lancets for multiple patient use should be reclassified into class III or remain in class I, and the discussion included whether PMAs should be required for these devices. The panel recommended that, because multiple use blood lancets for multiple patient use present a potential unreasonable risk of illness or injury and insufficient information exists to establish special controls for multiple use blood lancets for multiple patient use, the device should be reclassified into class III. FDA is not aware of new information that would provide a basis for a different recommendation or findings.

    Section 515(b)(2) of the FD&C Act provides that a proposed order to require premarket approval shall contain: (1) The proposed order, (2) proposed findings with respect to the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to have an approved PMA and the benefit to the public from the use of the device, (3) an opportunity for the submission of comments on the proposed order and the proposed findings, and (4) an opportunity to request a change in the classification of the device based on new information relevant to the classification of the device.

    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. If FDA terminates the proceeding, FDA is required to initiate reclassification of the device under section 513(e) of the FD&C Act, unless the reason for termination is that the device is a banned device under section 516 of the FD&C Act (21 U.S.C. 360f).

    A preamendments class III device may be commercially distributed without a PMA until 90 days after FDA issues a final order requiring premarket approval for the device, or 30 months after final classification of the device under section 513 of the FD&C Act becomes effective, whichever is later (section 501(f) of the FD&C Act (21 U.S.C. 351(f)). Elsewhere in this issue of the Federal Register, FDA is issuing a proposed order to reclassify multiple use blood lancets for multiple patient use from class I to class III. Therefore, assuming both the reclassification order and the order to require PMAs are finalized at the same time, the date by which a PMA for multiple use blood lancets for multiple patient use must be filed will be 30 months after the date FDA issues the final order reclassifying multiple use blood lancets for multiple patients. If a PMA is not filed for such device by the later of the two dates, as specified in section 501(f)(2)(B) of the FD&C Act, then the device would be deemed adulterated under section 501(f) of the FD&C Act unless the device is distributed for investigational use under an approved application for an investigational device exemption (IDE).

    In accordance with section 515(b) of the FD&C Act, interested persons are being offered the opportunity to request reclassification of multiple use blood lancets for multiple patient use.

    II. Regulatory History of the Device

    Elsewhere in this issue of the Federal Register, FDA is proposing to reclassify multiple use blood lancets for multiple patient use into class III under section 513(e) of the FD&C Act.

    Blood lancets were classified in part 878 (21 CFR part 878) by a final rule published in the Federal Register on June 24, 1988 (53 FR 23856) that classified 51 general and plastic surgery devices. This 1988 rule classified blood lancets into class I (general controls). These devices were grouped with other devices under “Manual surgical instrument for general use,” 21 CFR 878.4800. At the time, blood lancets had been in common use in medical practice for many years, and FDA believed that general controls were sufficient to provide reasonable assurance of the safety and effectiveness of those devices. This rule was amended on April 5, 1989 (54 FR 13826) to clarify that manual surgical instruments for general use made of the same materials as used in preamendment devices were exempt from premarket notification 510(k) review.

    On December 7, 1994, FDA further amended the classification when it published a final rule in the Federal Register (59 FR 63005) that exempted 148 class I devices from premarket notification, with limitations. Blood lancets were one of those devices. FDA determined that manufacturers' submissions of premarket notifications were unnecessary for the protection of the public health and that FDA's review of such submissions would not advance its public health mission.

    On August 26, 2010, FDA and the Centers for Disease Control and Prevention (CDC) issued joint initial communications warning that the use of fingerstick devices (blood lancets) to obtain blood from more than one patient posed a risk of transmitting bloodborne pathogens. The communication was updated on November 29, 2010 (Ref. 1). FDA's communication update, “Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication: Update 11/29/2010”, stated that “[o]ver the past 10-15 years, the CDC and the FDA have noted a progressive increase in reports of bloodborne infection transmission (primarily hepatitis B virus) resulting from the shared use of fingerstick and POC [or ‘Point of Care’] blood testing devices.” FDA and CDC recommended, among other things, that health care professionals and patients never use a blood lancet for more than one person.

    On November 29, 2010, FDA published a guidance entitled “Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling” (75 FR 73107) (Ref. 2). This guidance includes labeling recommendations to address concerns that both health care providers and patients may be unaware of the serious adverse health risks associated with using the same blood lancet for assisted withdrawal of blood from more than one patient, even when the blood lancet blade is changed for each blood draw. FDA recommends in the guidance that all blood lancets be labeled for use only on a single patient. FDA recommends in the guidance that a statement limiting use to a single patient should also appear on the label attached to the device, if possible. The guidance was for immediate implementation. When final, this order will supersede this labeling guidance.

    On June 26, 2013, FDA held a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Panel) to discuss the potential reclassification of blood lancets (Ref. 3). The Panel discussed new scientific information, the risks to health from blood lancets, whether blood lancets should be reclassified or remain in class I, and possible special controls for these devices if reclassified into class II. The Panel agreed that general controls were not sufficient to provide a reasonable assurance of safety and effectiveness of blood lancets. The Panel believed that because multiple use blood lancets for multiple patient use presented a potential unreasonable risk of illness or injury, and insufficient information existed to establish special controls for these devices, they should be reclassified into class III. The Panel recommended that all other blood lancet devices be reclassified into class II (special controls). FDA is not aware of new information since this Panel meeting that would provide a basis for a different recommendation or finding.

    III. Dates New Requirements Apply

    Assuming FDA finalizes the order proposing reclassification of multiple use blood lancets for multiple patient use found elsewhere in this issue of the Federal Register, this device will be classified into class III. In accordance with sections 501(f)(2)(B) and 515(b) of the FD&C Act, FDA is proposing to require that a PMA be filed with the Agency for multiple use blood lancets for multiple patient use devices and accessories by the last day of the 30th calendar month beginning after the month in which the classification of the device in class III became effective, or on the 90th day after the date of the issuance of a final order under 515(b), whichever is later. Assuming this order is finalized at or near the same time the final order to reclassify these devices into class III, this requirement will take effect 30 months after the reclassification order issues. An applicant whose device was legally in commercial distribution before May 28, 1976, or whose device has been found to be substantially equivalent to such a device, will be permitted to continue marketing such class III devices during FDA's review of the PMA provided that a PMA is timely filed. FDA intends to review any PMA for the device within 180 days. 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.”

    Under the FD&C Act, if any multiple use blood lancets for multiple patient use are currently in distribution and no PMA is submitted for these devices by the last day of the 30th calendar month beginning after the month in which the classification of the device in class III became effective or within 90 days of a final order calling for PMAs, or a denial is rendered on a filed PMA, these devices would be considered adulterated under section 501(f)(1) of the FD&C Act. In addition, no new devices will be permitted in interstate commerce without approval of a PMA. The device may be distributed for investigational use only if the requirements of the IDE regulations are met. The requirements for significant risk devices include submitting an IDE application to FDA for review and approval. An approved IDE is required to be in effect before an investigation of the device may be initiated or continued under § 812.30 (21 CFR 812.30). FDA, therefore, recommends that IDE applications be submitted to FDA at least 30 days before the end of the 30-month period after the issuance of the final order to avoid interrupting any ongoing investigations.

    FDA intends that under § 812.2(d), the publication in the Federal Register of any final order based on this proposal will include a statement that, as of the date on which the filing of a PMA is required, the exemptions in § 812.2(c)(1) and (2) from the requirements of the IDE regulations for preamendments class III devices will cease to apply to any device that is: (1) Not legally on the market on or before that date, or (2) legally on the market on or before that date but for which a PMA is not filed by that date, or for which PMA approval has been denied or withdrawn.

    IV. Device Subject to This Proposal Multiple Use Blood Lancet for Multiple Patient Use (21 CFR 878.4850(d))

    Elsewhere in this issue of the Federal Register, FDA is proposing to identify multiple use blood lancet for multiple patient use in a new 21 CFR 878.4850(d) in the following way: A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

    V. Proposed Findings With Respect to Risks and Benefits Multiple Use Blood Lancet for Multiple Patient Use

    As required by section 515(b) of the FD&C Act, FDA is publishing its proposed findings regarding: (1) The degree of risk of illness or injury designed to be eliminated or reduced by requiring that this device have an approved PMA, and (2) the benefits to the public from the use of the device.

    These findings are based on the reports and recommendations of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Panel) from the meeting on June 26, 2013 (Ref. 3) and any additional information that FDA has obtained. Additional information regarding the risks as well as classification associated with this device type can be found in section V.C as well as in the proposed order published elsewhere in this issue of the Federal Register proposing to reclassify these devices into class III. The device has the potential to benefit the public by puncturing the skin to obtain small blood specimens for testing blood glucose, hemoglobin, and other blood components. In addition, acute care hospitals may consider reusing a single device or using one device with multiple blades to have benefits in that doing so may expedite procedures. The risks associated with the device include bloodborne pathogen transmission, sharp object injuries, local tissue infections, and adverse tissue reaction (not infection).

    A. Summary of Data

    FDA uses the bloodborne pathogens definition in 29 CFR 1910.1030(b). Bloodborne pathogens, such as HBV, may be transmitted between patients by blood and certain body fluids (Ref. 4). Since HBV-infected patients, who often lack clinical symptoms of hepatitis, have high concentrations of HBV in their blood and HBV is stable at ambient temperatures, transmission of HBV may result from exposure to equipment that has not been adequately disinfected or by the misuse of “single use only” medical devices (e.g., needles and syringes) (Ref. 5).

    The history of recognized bloodborne pathogen transmission by blood lancets may have started in 1923 when an outbreak of jaundice occurred in the Goteborg Hospital diabetic clinic in Sweden, which was described by Schmid et al. (Ref. 6). All patients had blood drawn for glucose testing from their ear lobes by a spring-activated “Schnepper” device, which was cleaned “perfunctorily” between uses. As a result, 26 clinic patients developed jaundice. Outbreaks of hepatitis in English diabetic patients were described by Graham in 1938 (Ref. 7) and by Droller in 1945 (Ref. 8). In both of these outbreaks, venous blood for glucose measurement was drawn using syringes that were only chemically disinfected between uses while the needles were boiled; cleaning procedures were not mentioned in the reports. Syringes and needles are now single-use-only devices because the procedures used to reprocess these devices many years ago have long been recognized to be inadequate, resulting in outbreaks of hepatitis transmission (Ref. 6). There were also two case reports, in 1985 and 1997, of the transmission of HBV infection due to sharing personal use blood lancets for home glucose monitoring with one other person who already had HBV. One report was from the United States and one was from Hungary (Refs. 9 and 10). In addition, Mendez et al. reported a 75-year-old patient with diabetes who died of acute hepatitis, whose only risk factor for HBV infection appeared to be her diabetic care at a local outpatient facility where she had repeated fingersticks for blood glucose monitoring (Ref. 11).

    During the 1990s, several bloodborne transmission issues led to CDC and FDA involvement. In 1990, CDC learned of a nosocomial outbreak of HBV transmission due to the use of a spring-loaded lancet device whose disposable platform was not removed and discarded after each use of the device while it was used for the care of multiple patients (Ref. 12).1 CDC reported this outbreak to FDA; FDA then issued a safety alert warning users of the precautions needed for the safe use of this device (Ref. 13). This was the first reported outbreak of HBV transmission associated with the use of a blood lancet device in the United States (Refs. 13 and 14).

    1 Hepatitis B and hepatitis C infections, as well as other bloodborne infections such as HIV infection, are reported to State health departments and, by them, to CDC; FDA does not usually receive such reports directly from health care facilities or personnel, even when a medical device has transmitted the infection.

    CDC's outbreak investigation revealed that a patient who had diabetes and also a chronic HBV infection caused by a relatively rare viral subtype was admitted to the outbreak ward in 1989. Twelve of the 23 patients who acquired hepatitis B after admission to the same ward as the chronic HBV source patient were serotyped, and all were found to have the same viral subtype causing their hepatitis B infections. The first nosocomially infected patient had a very long-term stay on the ward and so served as a source of transmission to other patients over a period of 12 months. Twenty of the 23 outbreak patients had diabetes; they and the three other case-patients all experienced numerous POC fingerstick blood draws with the same type of blood lancet while hospitalized on the outbreak ward. The implicated blood lancet device included a disposable platform to stabilize the patient's finger; the single use lancet blade penetrated a hole in that platform to reach the patient's skin. Half the ward nursing staff who performed fingersticks with this lancet acknowledged not changing the device platform with each use of the lancet. A similar outbreak of hepatitis transmission was reported in 1990 in France in which a similar blood lancet device was implicated. Douvin et al. (Ref. 15) reported that examination of the device implicated in the French outbreak showed visible blood contamination of the lancet platform in 24 percent of studied uses of that device. Shier et al. (Ref. 16) reported in 1993 that the use of another spring-loaded lancet device in a volunteer study of blood glucose levels resulted in visible blood contamination on 29 percent of the device end caps. This device was intended for “personal” use only.

    As a result of the 1990 outbreak of HBV transmission due to blood lancet use in the United States, FDA and CDC recommended that spring-loaded blood lancet devices should have only single use only “platforms” as well as single use only blades; the devices were to be cleaned and disinfected per the manufacturer's instructions (Refs. 12 and 13). The 1990 FDA Safety Alert also advised “Devices (blood lancets) without a removable platform should only be used with one patient in the hospital or outpatient setting. After the patient is discharged, the device may be reused only if it is disinfected according to the manufacturer's instructions. If there are no instructions for disinfection, the device should be discarded.”

    Since 1990, the incidence of diabetes mellitus has increased significantly in the United States, especially in adults aged 65-79 (Refs. 17 and 18). At the same time, clinical practice in the care of these patients increasingly emphasized the need for improved blood glucose level control, resulting in the increased use of POC blood glucose monitoring both in health care facilities and at home (Refs. 19-21). Unfortunately, along with the increased incidence of diabetes has come a progressive increase in the reports of bloodborne infection transmission (primarily HBV), resulting from the shared use of fingerstick and POC blood testing devices (Ref. 1). In 2011, the CDC reported that 25 of 29 outbreaks of HBV infection occurring in long-term care facilities since 1996 involved adults with diabetes receiving blood glucose monitoring (Ref. 22).

    In 1997, CDC reported two outbreaks of HBV transmission, one in a nursing home in Ohio and one in a hospital in New York City (NYC) (Ref. 23). Two different blood lancet devices were used at the two sites. However, both lancet devices included the use of an “end cap” that came in contact with patient skin. This was a separate, individual use component of the lancet device used in Ohio; the nursing home was reusing both the lancet and the cap for multiple patients. The end cap was a part of the disposable, single use only lancet blade assembly in the device used in NYC. The exact mechanism of blood transmission was not entirely clear in the NYC setting; staff claimed they had discarded the end cap after each use. CDC postulated that either blood-contaminated nurses gloves worn for the care of multiple patients or the pen-like lancet-holding device itself might have been the source of the blood cross-contamination of the lancet. A similar outbreak was reported by Quale et al. in 1998 from a hospital in New York (Ref. 24). The recognition of 3 cases of nosocomially acquired HBV infection resulted in an investigation that uncovered another 11 cases. Reuse by hospital staff of a disposable lancet end cap with the lancet in multiple patients was identified as the probable cause of hepatitis cross-transmission to patients; contamination of the lancet wound from blood on unchanged gloves worn by nurses during collection of blood samples from multiple patients may also have contributed to the nosocomial transmission of HBV in this outbreak.

    CDC reviewed the incidence of reported outbreaks of HBV and hepatitis C infection in nonhospital health care settings between 1998 and 2008 and noted a significant increase in such nosocomial transmission of bloodborne pathogens (Refs. 25-28). N.D. Thompson et al. identified 33 outbreaks of nosocomial hepatitis transmission in nonhospital health care settings (Ref. 25). Of these 33 outbreaks, 15 were found to be due to blood glucose monitoring in long-term care and assisted living facilities. Only half of these outbreak investigations were published in the scientific literature; the others were recognized by health department investigations and reports to CDC. In 9 of the 15 outbreaks of nosocomial hepatitis in patients with diabetes, blood lancet devices were shared among multiple patients. In two additional outbreaks, lancets were not noted to be shared, but blood-soiled glucose meters were stored together with lancets without cleaning/disinfection of the devices and gloves were not regularly changed between each patient. These failures of proper infection control practice could have led to blood contamination of individual blood lancets in these two facilities.

    N.D. Thompson et al. also investigated blood glucose monitoring practices in long-term care facilities in Pinellas County, Florida, in 2007 and found that 22 percent of the participating facilities that used reusable fingerstick devices used them in multiple patients (Ref. 29). Patel et al. reported in 2009 on the efforts of the Virginia Department of Health to improve blood glucose monitoring practices in assisted living facilities (ALFs) in Virginia (Ref. 30). This effort followed two separate outbreaks of HBV infections in two assisted living facilities. In those outbreaks, one of the three acutely symptomatic initial patients died of HBV infection. Of 68 patients undergoing blood glucose monitoring in these two facilities, a total of 11 patients acquired HBV infection. Both facilities used reusable blood lancets to obtain blood from multiple patients and did not clean or disinfect the lancets between uses. The Virginia Department of Health then mailed an educational packet on safe blood glucose monitoring practices to all ALFs (640) in the State. A random sample of ALFs was contacted after the educational intervention and invited to participate in a survey to evaluate the response to the educational packet. The results found that 16 percent of the facilities that used lancets to monitor blood glucose levels were still using these devices to obtain blood from multiple patients.

    Y.G. McIntosh et al. investigated outbreaks of nosocomial HBV transmission in four ALFs between 2009 and 2011 and found that in all four facilities, pen-style lancets were used to obtain blood for glucose monitoring from multiple patients even though two facilities provided each patient with dedicated “single patient use only pen-style lancets” according to their policies (Ref. 31). Z. Moore et al. reported another outbreak of nosocomial HBV transmission in an ALF in NC in 2010 in which blood lancet devices were shared among multiple patients. Six of the eight elderly patients who acquired acute HBV in this outbreak died from complications of hepatitis (Ref. 32). M.K. Schaefer et al. surveyed a stratified, random sample of ambulatory surgery centers (ACS) in three volunteer states in 2009 (Ref. 33). Of the 53 ACS that performed blood glucose monitoring, 11 (21 percent) reused pen-style blood lancets on multiple patients and 17 (32 percent) also failed to clean and disinfect blood glucose meters after each use.

    Thompson and Schaefer reported the analysis of four outbreaks of nosocomial HBV in ALFs in 2009-2010 (Ref. 34). One was also reported separately by Z. Moore et al. (Ref. 32). Two of the three other outbreaks occurred in Virginia and one in Florida; these 3 outbreaks resulted in 21 new patients acquiring acute hepatitis B. In two of the three facilities, use of reusable blood lancets to draw blood from multiple patients was observed or reported. The third facility denied that it permitted the sharing of reusable lancets. However, used lancets and glucose meters were stored together, along with clean supplies; visible blood contamination was observed on several glucose meters and one reusable lancet by the investigator. Thompson and Schaefer also reported in their paper on two patient notification campaigns resulting from the misuse of reusable blood lancets with preloaded lancet cartridges, intended and cleared only for single patient use, which were used to obtain blood from multiple patients. One episode involved a community health center and was reported when personnel noted that the lancet blades were not retracting properly, which might have resulted in blade use for more than one patient. The second episode occurred at a community health fair in which physician assistant students were offering diabetes screening. During the fair, the students realized that the lancet blades had not been advanced properly so that each patient received a new blade. The first episode exposed 283 patients to a contaminated lancet blade; the second incident exposed approximately 60 patients. The results of the patient notification studies were not reported.

    As a result of this significant increase in such nosocomial transmission of bloodborne pathogens, on August 26, 2010, FDA and the CDC issued a Safety Communication (Ref. 1) and a Clinical Reminder (Ref. 35), respectively, warning that the use of blood lancets to obtain blood from more than one patient risks the transmission of bloodborne pathogen infections from one patient to other patients. Both FDA and CDC recommended that blood lancets should never be used to obtain blood from more than one patient. In addition, the Centers for Medicare and Medicaid Services issued a Survey and Certification Memorandum for Point of Care Devices and Infection Control in Nursing Homes identifying the use of blood lancet devices for more than one patient as an infection control standards deficiency (Ref. 36). On November 29, 2010, FDA issued “Guidance for Industry and Food and Drug Administration Staff: Blood Lancet Labeling”, which provided guidance for lancet manufacturers on the labeling of all blood lancets, including those capable of reuse, as “single patient use only” devices (Ref. 2).

    In 2012, another outbreak of acute HBV was reported in an ALF in Virginia (Ref. 37). The source patient had been recently transferred from another ALF where she had acquired nosocomial HBV infection from the shared use of blood lancets for multiple patients (Ref. 31). This ALF also reused blood lancets to obtain blood from multiple patients for glucose monitoring. This dangerous practice resulted in two new nosocomial HBV infections in this ALF.

    Outbreaks of hepatitis transmission due to use of blood lancets to draw blood from more than one patient for blood glucose monitoring have not been limited to the United States. In 2001, Desenclos et al. described an outbreak of nosocomial hepatitis C transmission in an inpatient ward for children with cystic fibrosis and diabetes in a French hospital in 1994-1995 (Ref. 38). Blood glucose monitoring was done by the nursing staff for the patients with cystic fibrosis as well as for the patients with diabetes using a spring-loaded lancet with a disposable platform to stabilize the finger. These devices were shared among patients between 1986 and 1992 during repeated admissions to the inpatient unit. After 1992, patients were supposed to use only their own lancet devices for blood glucose monitoring. The retrospective prevalence of prior hepatitis C infection was found to be 58 percent in patients with cystic fibrosis and 17 percent in patients with diabetes in 1994. At the time (1994), the prevalence of antibody to hepatitis C in the general public in France was 1.1 percent. The patients with cystic fibrosis had more frequent and longer admissions to the inpatient ward, and more of the exposed cystic fibrosis patients (66.7 percent) were screened for hepatitis C infection than were the patients with diabetes admitted to the inpatient ward during the exposure period (39.5 percent). These factors may have influenced the apparent difference in hepatitis C transmission in these two groups of exposed patients.

    In 2005, De Schrijver et al. described an outbreak of acute HBV infection in a nursing home in Antwerp (Ref. 39). The initial report of a fulminant case of acute HBV infection in an 83-year-old resident of the home resulted in an investigation that identified acute hepatitis B infection in another four patients there. Four of the five acutely infected patients had diabetes and received assisted blood glucose sampling by the nursing home staff. The two blood lancet models used in the facility (one each in two sections) were used to obtain blood from multiple patients. The device platforms were not disposable. The lancets were washed only when blood was visible on the device and were not disinfected. Nurses did not routinely wash their hands or wear gloves when obtaining blood. Two of the five patients with acute nosocomial hepatitis B died of their infections.

    In 2008, Gotz et al. reported the investigation of two cases of acute HBV infection among patients at a nursing home in the Netherlands (Ref. 40). The nursing home stay of these two patients overlapped with that of a patient with known chronic HBV infection. Early in this time period, the nursing home changed the lancet device used for glucose monitoring from a spring-loaded device with a disposable platform (used for multiple patients) to a device with a rotating drum dispensing new lancet blades, which was also used to draw blood from multiple patients, although it was labeled for single patient use only. This device was used for about a month until the staff realized that active rotation of the drum was occasionally forgotten, resulting in the reuse of a lancet blade on more than 1 patient. The new device was then removed from the facility and the spring-loaded lancet was returned to use. The two patients with acute HBV received blood glucose monitoring as did the source patient with chronic HBV, sometimes on the same day. Two other patients who also received blood glucose monitoring escaped infection. The investigators stated that they believed the rotating lancet drum device was likely the means of transmission of HBV infection between patients.

    In 2011, Duffell et al. reported on the investigations of five reports of HBV transmission in community health care settings in the United Kingdom (Ref. 4). All of the nine initially reported patients with HBV had diabetes and were receiving blood glucose monitoring. Further investigation identified another 12 patients with acute HBV infection. The care settings in which hepatitis transmission occurred were described as a “private residential home” (1 patient), nursing and residential home (1 patient), “private nursing and residential” (1 patient) and “local care home” (2 patients). Eleven of the 21 acutely infected patients had symptomatic HBV; seven of these patients died, five due to the HBV infection. All of the care sites in which acute HBV transmission occurred were using blood lancets designed intended for single patient use only; these devices were either routinely or occasionally used for multiple patients. One facility also used a single glucometer for multiple patients and did not clean or disinfect it between patients. The authors also noted that information reported on patients found to have acute HBV infection between 1990 and 2003 identified only four patients with blood glucose monitoring as a possible risk factor; one of these patients was infected as a result of in-hospital transmission from another patient on the same ward, although details were not provided. Between 2004 and 2006, the 9 patients described previously in this document were reported and investigation led to the discovery of an additional 12 cases of health care-related HBV transmission due to the improper use of blood lancets during patient blood glucose monitoring.

    B. Benefits of the Device

    A blood lancet is used to puncture the skin to obtain small blood specimens for testing blood glucose, hemoglobin, and other blood components. Some blood lancets are used with POC blood testing devices, such as blood glucose meters and Prothrombin Time and International Normalized Ratio (PT/INR) anticoagulation meters. Today, probably the most common use for a blood lancet is in diabetes monitoring. These devices are used in both home and professional health care settings. Only a small blood sample is needed for testing of blood glucose level. The blood sample is dropped onto a test strip and inserted into a blood glucose meter for results.

    Some blood lancets are also used with PT/INR anticoagulation meters. These devices are used in both home and professional health care settings. The PT and INR are used to monitor the effectiveness of the anticoagulant warfarin. Warfarin helps inhibit the formation of blood clots. The formation of blood clots may be associated with atrial fibrillation, the presence of artificial heart valves, deep venous thrombosis, and some cases of pulmonary embolism. Because the use of warfarin may cause excessive bleeding, patients are monitored, typically by PT/INR.

    Because newborns have relatively small amounts of blood compared to adults, it is usually preferred to use as small amount of blood as possible for any screening or other laboratory tests for newborns. Blood lancets may be used to perform heel sticks in newborns. Heel stick is a minimally invasive way of obtaining capillary blood samples. In newborns, heel sticks are the preferred collection method for small volumes of blood.

    The possible benefit of multiple use blood lancets for multiple patient use is that acute care hospitals may consider reusing a single device or using one device with multiple blades to have benefits, in that doing so may expedite procedures.

    C. Risks to Health

    FDA has evaluated the risks to health associated with use of multiple use blood lancets for multiple patient use. In doing so, FDA considered information from the reports and recommendations of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee from the meeting of June 26, 2013, the adverse event reports for these devices in FDA's Manufacturer and User Facility Device Experience (MAUDE) database, and the published scientific literature, which is discussed in FDA's executive summary for the June 26, 2013, panel. Based on this information, FDA has determined the following risks:

    1. Bloodborne Pathogen Transmission

    Bloodborne pathogens such as HBV, hepatitis C virus, and potentially any other pathogen present in the bloodstream of a patient can be transmitted from one patient to another by the following mechanisms:

    • Reuse of the same lancet blade to draw blood from more than one patient or

    • Failure/inability to adequately clean the base of a multiple use blood lancet resulting in the blood contamination of the next “new” lancet blade when blood is drawn from more than one patient.

    2. Sharp Object Injuries

    The blade of a lancet device is designed to pierce the skin and draw blood. Except when the used lancet blade is immediately and automatically covered by a sharps safety feature, which renders the blade inaccessible, the exposed sharp blade of a blood lancet presents a puncture hazard to anyone coming in contact with it. Blade exposure can result due to either the lack of a sharps safety feature or device breakage.

    3. Local Tissue Infections

    Human skin always carries a population of bacteria and often fungi (normal skin flora), which causes no problem for the host when skin is intact. However, puncture injuries to the skin by sharp objects such as lancet blades can carry these microbes into the normally sterile tissue below the skin. Such injuries have the potential to cause local skin/soft tissue infections.

    4. Adverse Tissue Reaction (Not Infection)

    Skin contact with some materials, metals and material colorants can cause skin inflammation, irritation or exanthems (rashes). These reactions may be due to either hypersensitivity to a specific compound/metal or to a non-specific reaction.

    D. Summary of FDA Findings

    FDA believes multiple use blood lancets for multiple patient use should be reclassified from class I to class III. The Panel held on June 26, 2013, discussed and made recommendations regarding the regulatory classification of blood lancets to reclassify multiple use blood lancets for multiple patient use to class III under 513(e) of the FD&C Act. The Panel strongly agreed with FDA that based on the available scientific evidence, multiple use blood lancets for multiple patient use should be reclassified to class III because multiple use blood lancets for multiple patient use present a potential unreasonable risk of illness or injury. They also agreed that insufficient information exists to establish special controls for multiple use blood lancets for multiple patient use, because there is no evidence that these devices can be adequately cleaned and disinfected and that there is no proven method of doing so. Therefore, it is appropriate to regulate them in class III.

    FDA agrees with the Panel's recommendation that these devices present a potential unreasonable risk of illness or injury due to the inherent and significantly increased risk of bloodborne pathogen transmission risk as compared to single use only or single patient only blood lancets. FDA does not believe existing valid scientific evidence, as defined in § 860.7 (21 CFR 860.7), supports a reasonable assurance that the device can be adequately reprocessed between uses on different patients. FDA also believes sufficient information does not exist to establish special controls for blood lancets intended for multiple patient use. Given the availability of safer single patient use blood lancet devices, FDA further believes that the probable benefits to health from use of the device do not outweigh the probable risks. Currently FDA is unaware of technology or other controls that would adequately mitigate against the inherent and significantly increased risk of blood borne pathogen transmission in multiple use blood lancets for use in multiple patients. Therefore, the safety and effectiveness of the multiple use blood lancets for multiple patients, particularly the effectiveness of their reprocessing instructions/methods to render the device safe for use on more than one patient and the ability of health care providers to follow these instructions completely should be independently demonstrated for each device of this type via a PMA application. FDA is proposing to require an individual demonstration that a reasonable assurance of safety and effectiveness exists for each device within this type. The manufacturer of each individual device will have the opportunity to demonstrate the safety and effectiveness of the device for its intended use by submitting a PMA.

    VI. PMA Requirements

    A PMA for this device must include the information required by section 515(c)(1) of the FD&C Act. Such a PMA should also include a detailed discussion of the risks identified previously in this document, as well as a discussion of the effectiveness of the device for which premarket approval is sought. In addition, a PMA must include all data and information on: (1) Any risks known, or that should be reasonably known, to the applicant that have not been identified in this document; (2) the effectiveness of the device that is the subject of the application; and (3) full reports of all preclinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought.

    A PMA must include valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness of the device for its intended use (§ 860.7(c)(2)). FDA defines valid scientific evidence in § 860.7(c)(2)).

    To present reasonable assurance of safety and effectiveness of multiple use blood lancets for multiple patient use, FDA believes manufacturers should submit performance testing, including clinical trials of their device, in order to support PMA approval. Existing published clinical literature may also be leveraged as part of the PMA submission.

    VII. Opportunity To Request a Change in Classification

    Before requiring the filing of a PMA, FDA is required by section 515(b)(2)(D) of the FD&C Act to provide an opportunity for interested persons to request a change in the classification of the device based on new information relevant to the classification. Any proceeding to reclassify the device will be under the authority of section 513(e) of the FD&C Act.

    A request for a change in the classification of this device is to be in the form of a reclassification petition containing the information required by 21 CFR 860.123, including new information relevant to the classification of the device.

    VIII. Analysis of Environmental Impact

    We have 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.

    IX. Paperwork Reduction Act of 1995

    This proposed order refers to collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 814, subparts B and E, have been approved under OMB control number 0910-0231. The collections of information in part 807, subpart E, have been approved under OMB control number 0910-0120. The collections of information under 21 CFR part 801 have been approved under OMB control number 0910-0485.

    X. Proposed Effective Date

    FDA is proposing that any final order based on this proposal become effective on the date of its publication in the Federal Register or at a later date if stated in the final order.

    XI. 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, resulting from changes issued in a final order, in the Code of Federal Regulations (CFR). Therefore, under section 515(b)(1)(A) of the FD&C Act, as amended by FDASIA, in the proposed order, we are proposing to require approval of an application for premarket approval for multiple use blood lancets for multiple patient use and, if this proposed order is finalized, we will make the language in 21 CFR 878.4850(d) consistent with the final version of this proposed order.

    XII. References

    The following references are on display in the Division of Dockets Management (see ADDRESSES) 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. U.S. Food and Drug Administration (FDA), “Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (August 26, 2010) and “Update” (November 29, 2010), available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm234889.htm and http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm. 2. U.S. Food and Drug Administration, “Guidance for Industry and Food and Drug Administration Staff: Blood Lancet Labeling” (November 29, 2010), available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm234577.htm. 3. FDA's General and Plastic Surgery Devices Panel transcript and other meeting materials for the June 26, 2013, meeting, available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/ucm349426.htm. 4. Duffell, E.F., L.M. Milne, C. Seng, et al., “Five Hepatitis B Outbreaks in Care Homes in the UK Associated With Deficiencies in Infection Control Practice in Blood Glucose Monitoring”, Epidemiology and Infection, 2011; 139:327-335. 5. Williams, I.T., J.F. Perz, and B.P. Bell, “Viral Hepatitis Transmission in Ambulatory Health Care Settings”, Clinical Infectious Diseases, 2004; 38(11):1592-1598. 6. Schmid, R., “History of Viral Hepatitis: A Tale of Dogmas and Misinterpretations”, Journal of Gastroenterology and Hepatology, 2001; 16(7):718-722. 7. Graham, G., “Diabetes Mellitus: A Survey of Changes in Treatment During the Last Fifteen Years”, The Lancet, 1938; 2:1-7. 8. Droller, H., “An Outbreak of Hepatitis in a Diabetic Clinic”, British Medical Journal, 1945; 1(4400):623-625. 9. Stapleton, J. and S. Lemon, “Transmission of Hepatitis B During Blood Glucose Monitoring”, Journal of the American Medical Association, 1985; 253:3250. 10. Farkas, K. and G. Jermendy, “Transmission of Hepatitis B Infection During Home Blood Glucose Monitoring”, Diabetic Medicine, 1997; 14:263. 11. Mendez, L., K.R. Reddy, R.A. Di Prima, et al., “Fulminant Hepatic Failure Due to Acute Hepatitis B and Delta Co-Infection: Probable Bloodborne Transmission Associated With a Spring-Loaded Fingerstick Device”, American Journal of Gastroenterology, 1991; 86:895-897. 12. Centers for Disease Control and Prevention (CDC), “Nosocomial Transmission of Hepatitis B Virus Associated With a Spring-Loaded Fingerstick Device—California”, MMWR Morbidity and Mortality Weekly Report, 1990; 39 (35):610-613. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00001743.htm.) 13. Food and Drug Administration (FDA), “Safety Alert Medical Devices; Hepatitis B Transmission via Spring-Loaded Lancet Devices” (August 28, 1990), available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm241809.htm. 14. Polish, L., C.N. Shapiro, F. Bauer, et al., “Nosocomial Transmission of Hepatitis B Virus Associated With the Use of a Spring-Loaded Fingerstick Device”, New England Journal of Medicine, 1992; 326(11):721-725. 15. Douvin, C., D. Simon, H. Zinelabidine, et al., “An Outbreak of Hepatitis B in an Endocrinology Unit Traced to a Capillary-Blood-Sampling Device”, New England Journal of Medicine, 1990; 322:57-58. 16. Shier, N., J. Warren, M. Torabi, et al., “Contamination of a Fingerstick Device”, New England Journal of Medicine, 1993; 328:969-997. 17. Centers for Disease Control and Prevention (CDC), “Increasing Prevalence of Diagnosed Diabetes—United States and Puerto Rico, 1995-2010”, MMWR Morbidity and Mortality Weekly Report, 2012; 61(45):918-921. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6145a4.htm?s_cid=mm6145a4_w.) 18. Centers for Disease Control and Prevention (CDC), “Incidence of Diagnosed Diabetes per 1,000 Population Aged 18-79 Years, by Age, 1980-2014”, Atlanta, GA: U.S. Department of Health and Human Services, CDC, National Diabetes Surveillance System. Available at www.cdc.gov/diabetes/statistics/incidence/fig3.htm. Accessed October 19, 2014. 19. Clarke, S.F. and J.R. Foster, “A History of Blood Glucose Meters and Their Role in Self-Monitoring of Diabetes Mellitus”, British Journal of Biomedical Science, 2012; 69(2):83-93. 20. Yoo, E.-H. and S.-Y. Lee, “Glucose Biosensors: An Overview of Use in Clinical Practice”, Sensors, 2010; 10(5):4558-4576. 21. Rajendran, R. and G. Rayman, “Point-of-Care Blood Glucose Testing for Diabetes Care in Hospitalized Patients: An Evidence-Based Review”, Journal of Diabetes Science and Technology, 2014; 8(6):1081-1090. 22. Centers for Disease Control and Prevention (CDC), “Use of Hepatitis B Vaccination for Adults With Diabetes Mellitus: Recommendations of the Advisory Committee on Immunization Practices (ACIP)”, MMWR Morbidity and Mortality Weekly Report, 2011; 60(50):1709-1711. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a4.htm?s_cid=mm6050a4_w.) 23. Centers for Disease Control and Prevention (CDC), “Nosocomial Hepatitis B Virus Infection Associated With Reusable Fingerstick Blood Sampling Devices—Ohio and New York City, 1996”, MMWR Morbidity and Mortality Weekly Report, 1997; 46(10):217-221. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/00046679.htm.) 24. Quale, J.M., D. Landman, B. Wallace, et al., “Déjà vu: Nosocomial Hepatitis B Transmission and Fingerstick Monitoring”, The American Journal of Medicine, 1998; 105;296-301. 25. Thompson, N.D., J. Perz, A. Moorman, et al., “Nonhospital Health Care-Associated Hepatitis B and C Virus Transmission: United States, 1998-2008”, Annals of Internal Medicine, 2009; 150: 33-39. 26. Khan, A.J., S.M. Cotter, B. Schulz, et al., “Nosocomial Transmission of Hepatitis B Virus Infection Among Residents With Diabetes in a Skilled Nursing Facility”, Infection Control and Hospital Epidemiology, 2002; 23:313-318. 27. Centers for Disease Control and Prevention (CDC), “Transmission of Hepatitis B Virus Among Persons Undergoing Blood Glucose Monitoring in Long-Term-Care Facilities—Mississippi, North Carolina, and Los Angeles County, California, 2003-2004”, MMWR Morbidity and Mortality Weekly Report, 2005; 54(09):220-223. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5409a2.htm.) 28. Thompson, N.D. and J.F. Perz, “Eliminating the Blood: Ongoing Outbreaks of Hepatitis B Virus Infection and the Need for Innovative Glucose Monitoring Technologies”, Journal of Diabetes Science and Technology, 2009; 3(2):283-288. 29. Thompson, N.D., V. Barry, K. Alelis, et al., “Evaluation of the Potential for Bloodborne Pathogen Transmission Associated With Diabetes Care Practices in Nursing Homes and Assisted Living Facilities, Pinellas County”, Journal of the American Geriatrics Society, 2010; 58:914-918. 30. Patel, A.S., M.B. White-Comstock, D. Woolard, et al., “Infection Control Practices in Assisted Living Facilities: A Response to Hepatitis B Virus Infection Outbreaks”, Infection Control and Hospital Epidemiology, 2009; 30:209-214. 31. Centers for Disease Control and Prevention (CDC), “Multiple Outbreaks of Hepatitis B Virus Infection Related to Assisted Monitoring of Blood Glucose Among Residents of Assisted Living Facilities—Virginia, 2009-2011”, MMWR Morbidity and Mortality Weekly Report, 2012; 61(19):339-343. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6119a3.htm?s_cid=mm6119a3_w.) 32. Centers for Disease Control and Prevention (CDC), “Notes From the Field: Deaths From Acute Hepatitis B Virus Infection Associated With Assisted Blood Glucose Monitoring in an Assisted-Living Facility—North Carolina, August-October, 2010,” MMWR Morbidity and Mortality Weekly Report, 2011; 60(6):182. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6006a5.htm?s_cid=mm6006a5_w.) 33. Schaefer, M.K., M. Jhung, M. Dahl, et al., “Infection Control Assessment of Ambulatory Surgical Centers”, Journal of the American Medical Association, 2010; 303(22):2273-2279. 34. Thompson, N.D. and M.K. Schaefer, “`Never Events': Hepatitis B Outbreaks and Patient Notifications Resulting From Unsafe Practices During Assisted Monitoring of Blood Glucose, 2009-2010”, Journal of Diabetes Science and Technology, 2011; 5(6):1396-1402. 35. Centers for Disease Control and Prevention (CDC), “CDC Clinical Reminder: Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens”, available at http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html. 36. Centers for Medical Services (CMS), “Survey and Certification Memorandum” (August 27, 2010) available at http://www.cms.gov/surveycertificationgeninfo/downloads/SCLetter10_28.pdf. 37. Centers for Disease Control and Prevention (CDC), “Notes From the Field: Transmission of HBV Among Assisted-Living-Facility Residents—Virginia, 2012”, MMWR Morbidity and Mortality Weekly Report, 2013; 62(19):389. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6219a4.htm?s_cid=mm6219a4_w.) 38. Desenclos, J.C., M. Bourdiol-Razes, B. Rolin, et al., “Hepatitis C in a Ward for Cystic Fibrosis and Diabetic Patients: Possible Transmission by Spring-Loaded Finger-Stick Devices for Self-Monitoring of Capillary Blood Glucose”, Infection Control and Hospital Epidemiology, 2001; 22(11):701-707. 39. De Schrijver, K., I. Maes, P. Van Damme, et al., “An Outbreak of Nosocomial Hepatitis B Virus Infection in a Nursing Home for the Elderly in Antwerp (Belgium)”, Acta Clinica Belgica, 2005; 60(2):63-69. 40. Gotz, H.M., M. Schutten, G.J. Borsboom, et al., “A Cluster of Hepatitis B Infections Associated With Incorrect Use of a Capillary Blood Sampling Device in a Nursing Home in the Netherlands, 2007”, Euro Surveillance, 2008; 13(7-9):1-5. List of Subjects in 21 CFR Part 878

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 878, as proposed to be amended elsewhere in this issue of the Federal Register, be further amended as follows:

    PART 878—GENERAL AND PLASTIC SURGERY DEVICES 1. The authority citation for 21 CFR part 878 continues to read as follows: Authority:

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

    2. Add paragraph (d)(3) to § 878.4850, under subpart E, to read as follows:
    § 878.4850 Blood Lancets.

    (d) * * *

    (3) Date PMA or notice of completion of a 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 [A DATE WILL BE ADDED 90 DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER CALLING FOR PMAs IN THE FEDERAL REGISTER OR 30 MONTHS AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER RECLASSSIFYING INTO CLASS III, WHICHEVER IS LATER] for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before [A DATE WILL BE ADDED 90 DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER CALLING FOR PMAs IN THE FEDERAL REGISTER OR 30 MONTHS AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER RECLASSSIFYING INTO CLASS III, WHICHEVER IS LATER], been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

    Dated: February 25, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-04579 Filed 3-2-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-123867-14] RIN 1545-BM28 Utility Allowances Submetering AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Notice of proposed rulemaking by cross-reference to temporary regulations.

    SUMMARY:

    This document contains proposed regulations that amend the utility allowance regulations concerning the low-income housing credit. The proposed regulations relate to the circumstances in which utility costs paid by a tenant based on actual consumption in a submetered rent-restricted unit are treated as paid by the tenant directly to the utility company. The proposed regulations extend those rules to situations in which a building owner sells to tenants energy that is produced from a renewable source and that is not delivered by a local utility company. The proposed regulations affect owners of low-income housing projects that claim the credit, the tenants in those low-income housing projects, and the State and local housing credit agencies that administer the credit. In the Rules and Regulations section of this issue of the Federal Register, the IRS is issuing temporary regulations concerning utility allowance regulations when the utility is generated from renewable sources and is not delivered by the local utility company. The text of those regulations also serves as the text of these proposed regulations. This document also contains a notice of a public hearing on these proposed regulations.

    DATES:

    Comments and requests for a public hearing must be received by May 2, 2016.

    ADDRESSES:

    Send submissions to: CC:PA:LPD:PR (REG-123867-14), Room 5203, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG-123867-14), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC, or sent electronically, via the Federal eRulemaking Portal at http://www.regulations.gov/ (IRS REG-123867-14).

    FOR FURTHER INFORMATION CONTACT:

    Concerning the proposed regulations, James Rider at (202) 317-4137; concerning submissions of comments and requests for a public hearing, Oluwafunmilayo Taylor at (202) 317-6901 (not toll-free numbers).

    SUPPLEMENTARY INFORMATION: Background

    Temporary regulations in the Rules and Regulations section of this issue of the Federal Register amend 26 CFR part 1. The temporary regulations provide a special rule for a renewable-source utility arrangement in which the building owner does not pay a local utility company for the utility consumed by the tenant. The text of those regulations also serves as the text of these regulations. The preamble to the temporary regulations explains the temporary regulations and these proposed regulations.

    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 this regulation, and because the regulation does not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Internal Revenue Code, this notice of proposed rulemaking has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

    Comments and Requests for Public Hearing

    Before these proposed regulations are adopted as final regulations, consideration will be given to any written comments (a signed original and eight (8) copies) or electronic comments that are submitted timely to the IRS as prescribed in this preamble under the “ADDRESSES” heading. The IRS and the Treasury Department request comments on all aspects of the proposed regulations. All comments that are submitted by the public will be available for public inspection and copying at www.regulations.gov or upon request. A public hearing will be scheduled if requested in writing by any person that timely submits comments. If a public hearing is scheduled, notice of the date, time, and place for the public hearing will be published in the Federal Register.

    Drafting Information

    The principal author of these regulations is David Selig, Office of the Associate Chief Counsel (Passthroughs and Special Industries), IRS. However, other personnel from the IRS and the Treasury Department participated in their development.

    List of Subjects in 26 CFR Part 1

    Income taxes, Reporting and recordkeeping requirements.

    Proposed Amendments to the Regulations

    Accordingly, 26 CFR part 1 is proposed to be amended as follows:

    PART 1—INCOME TAXES Paragraph 1. The authority citation for part 1 continues to read in part as follows: Authority:

    26 U.S.C. 7805 * * *

    Par. 2. Section 1.42-10(e)(1)(i)(B) and (C), and (e)(1)(iv)(B) are revised to read as follows:
    § 1.42-10 Utility allowances.

    (e) * * * (1) * * *

    (i) * * *

    (B) [The text of the proposed amendments to § 1.42-10(e)(1)(i)(B) is the same as the text of § 1.42-10T(e)(1)(i)(B) published elsewhere in this issue of the Federal Register].

    (C) [The text of the proposed amendments to § 1.42-10(e)(1)(i)(C) is the same as the text of § 1.42-10T(e)(1)(i)(C) published elsewhere in this issue of the Federal Register].

    (iv) * * *

    (B) [The text of the proposed amendments to § 1.42-10(e)(1)(iv)(B) is the same as the text of § 1.42-10T(e)(1)(iv)(B) published elsewhere in this issue of the Federal Register].

    John Dalrymple, Deputy Commissioner for Services and Enforcement.
    [FR Doc. 2016-04618 Filed 3-2-16; 8:45 am] BILLING CODE 4830-01-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2016-0115] RIN 1625-AA00 Safety Zone; Xterra Swim, Myrtle Beach, SC Intracoastal Waterway; Myrtle Beach, SC AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Coast Guard proposes to issue a temporary safety zone on the waters of the Intracoastal Waterway in Myrtle Beach, South Carolina. The Xterra Swim is scheduled to take place on Sunday, April 24, 2016. The temporary safety zone is necessary for the safety of the swimmers, participant vessels, spectators, and the general public during the event. The temporary safety zone will restrict vessel traffic in a portion of the Intracoastal Waterway, preventing non-participant vessels from entering, transiting through, anchoring in, or remaining within the regulated area unless authorized by the Captain of the Port Charleston or a designated representative.

    DATES:

    Comments and related material must be received by the Coast Guard on or before April 4, 2016.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2016-0115 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this proposed rulemaking, call or email Lieutenant John Downing, Sector Charleston Office of Waterways Management, Coast Guard; telephone (843) 740-3184, email [email protected]

    SUPPLEMENTARY INFORMATION: I. Public Participation and 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. 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.

    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).

    II. 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 Pub. L.  Public Law §   Section U.S.C.  United States Code COTP  Captain of the Port III. Basis, Purpose, and Background

    On February 8, 2016, Set Up Events notified the Coast Guard that it will be sponsoring the Xterra Myrtle Beach Swim from 7:15 a.m. to 9:15 a.m. on April 24, 2016. The legal basis for the proposed rule is the Coast Guard's Authority to establish a safety zone: 33 CFR part 165. The purpose of the proposed rule is to ensure safety of life on the navigable water of the United States during the swim portion of the Xterra Myrtle Beach Triathlon.

    IV. Discussion of Proposed Rule

    The Coast Guard proposes to establish a temporary safety zone on the Atlantic Intracoastal Waterway in Myrtle Beach, South Carolina during the Xterra Myrtle Beach Triathlon, on April 24, 2016. Approximately 75 swimmers are anticipated to participate in the race. Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the Captain of the Port Charleston by telephone at (843) 740-7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative. The Coast Guard will provide notice of the safety zone by Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

    V. 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 a number of these statutes and executive orders.

    A. Regulatory Planning and Review

    E.O.s 12866 (“Regulatory Planing and Review”) and 13563 (“Improving Regulation and Regulatory Review”) 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 (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O.13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

    This proposed rule is not a significant regulatory action under section 3(f) of E.O. 12866, as supplemented by E.O. 13563, and does not require an assessment of potential costs and benefits under section 6(a)(3) of E.O. 12866. The Office of Management and Budget (OMB) has not reviewed it under E.O. 12866.

    The economic impact of this proposed rule is not significant for the following reasons: (1) The temporary safety zone would be enforced for only two hours; (2) although persons and vessels would not be able to enter, transit through, anchor in, or remain within the regulated area without authorization from the Captain of the Port Charleston or a designated representative, they would be able to operate in the surrounding area during the enforcement periods; (3) persons and vessels would still be able to enter, transit through, anchor in, or remain within the regulated area if authorized by the Captain of the Port Charleston or a designated representative; and (4) the Coast Guard would provide advance notification of the regulated area to the local maritime community by Local Notice to Mariners and Broadcast Notice to Mariners.

    B. Impact on Small Entities

    Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. 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.

    This rule may affect the following entities, some of which may be small entities: The owner or operators of vessels intending to enter, transit through, anchor in, or remain within the regulated area during the enforcement period. However, for the reasons discussed in Regulatory Planning and Review section above, this rule will not have a significant economic impact on a substantial number of small entities.

    Therefore, 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. 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.

    C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult Lieutenant John Downing using the contact information given in FOR FURTHER INFORMATION CONTACT. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

    Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

    D. Collection of Information

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

    E. Federalism and Indian Tribal Governments

    A rule has implications for federalism under E.O. 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.

    F. Unfunded Mandates Reform Act

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

    G. Taking of Private Property

    This proposed rule would not cause a taking of private property or otherwise have taking implications under E.O. 12630 (“Governmental Actions and Interference with Constitutionally Protected Property Rights”).

    H. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988, (“Civil Justice Reform”), to minimize litigation, eliminate ambiguity, and reduce burden.

    I. Protection of Children

    We have analyzed this proposed rule under E.O. 13045 (“Protection of Children from Environmental Health Risks and Safety Risks”). This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.

    J. Indian Tribal Governments

    This proposed rule does not have tribal implications under E.O. 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.

    K. Energy Effects

    We have analyzed this proposed rule under E.O. 13211 (“Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use”). We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under E.O. 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

    L. Technical Standards

    The National Technology Transfer and Advancement Act, codified as a note to 15 U.S.C. 272, directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

    This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

    M. Environment

    We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a temporary safety zone issued in conjunction with a regatta or marine parade. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

    N. Protest Activities

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

    List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:

    PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority:

    33 U.S.C. 1226, 1231; 50 U.S.C. 191; 33 CFR 1.05-1(g), 6.04-1, and 160.5; Department of Homeland Security Delegation No. 0170.1.

    2. Add a temporary § 165.T07-0115 to read as follows:
    § 165.T07-0115 Safety Zone; Xterra Swim, Myrtle Beach SC.

    (a) Regulated area. The rule establishes a temporary safety zone on certain waters of Intracoastal Waterway, Myrtle Beach, South Carolina. The temporary safety zone consists of the following two points of position and the North shore: 33°45.076 N., 78°50.790 W., to 33°45.323 N., 78°50.214 W. All coordinates are North American Datum 1983.

    (b) Definition. As used in this section, “designated representative” means Coast Guard Patrol Commanders, including Coast Guard coxswains, petty officers, and other officers operating Coast Guard vessels, and Federal, state, and local officers designated by or assisting the Captain of the Port Charleston in the enforcement of the regulated areas.

    (c) Regulations. (1) All persons and vessels are prohibited from entering, transiting through, anchoring in, or remaining within the regulated area, except persons and vessels participating in the Xterra Swim, Myrtle Beach, or serving as safety vessels.

    (2) Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the Captain of the Port Charleston by telephone at (843) 740-7050, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Charleston or a designated representative.

    (3) The Coast Guard will provide notice of the regulated area by Marine Safety Information Bulletins, Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene designated representatives.

    (d) Enforcement period. This rule will be enforced on April 24, 2016 from 7:15 a.m. until 9:15 a.m.

    Dated: February 26, 2016. G.L. Tomasulo, Captain, U.S. Coast Guard, Captain of the Port Charleston.
    [FR Doc. 2016-04664 Filed 3-2-16; 8:45 am] BILLING CODE 9110-04-P
    POSTAL SERVICE 39 CFR Part 551 Semipostal Stamp Program AGENCY:

    Postal ServiceTM.

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule would revise the provisions governing the Postal Service's discretionary Semipostal Stamp Program to simplify and expedite the process for selecting causes for semipostal stamps, and facilitate the issuance of five such stamps over a 10-year period. It would also remove certain restrictions on the commencement date for the Postal Service's discretionary Semipostal Stamp Program, and clarify how many semipostal stamps issued under that program may be on sale at any one time.

    DATES:

    Comments must be received on or before April 4, 2016.

    ADDRESSES:

    Mail or deliver written comments to the Manager, Stamp Products & Exhibitions, U.S. Postal Service®, 475 L'Enfant Plaza SW., Room 3306, Washington DC 20260. You may inspect and photocopy all written comments at the Stamp Products & Exhibitions office by appointment only between the hours of 9 a.m. and 4 p.m., Monday through Friday, by calling 202-268-6711 in advance. Email and faxed comments are not accepted.

    FOR FURTHER INFORMATION CONTACT:

    Lori Mazzone, Manager, Stamp Products & Exhibitions, 202-268-6711, [email protected]

    SUPPLEMENTARY INFORMATION: Background

    The Semipostal Authorization Act, Pub. L. 106-253, grants the Postal Service discretionary authority to issue and sell semipostal stamps to advance such causes as it considers to be “in the national public interest and appropriate.” See 39 U.S.C. 416(b). On June 12, 2001, the Postal Service published a final rule establishing the regulations in 39 CFR part 551 for the discretionary Semipostal Stamp Program (66 FR 31826). Minor revisions were made to these regulations to implement Pub. L. 107-67, 115 Stat. 514 (2001), and to reflect minor organizational changes in the Postal Service (67 FR 5215 (February 5, 2002)). On February 19, 2004, the Postal Service published a final rule clarifying the cost-offset policy for semipostal stamps (69 FR 7688), and on February 9, 2005, the Postal Service also published an additional minor clarifying revision to these cost-offset regulations (70 FR 6764).

    Most recently, on January 22, 2016, the Postal Service published a proposed amendment to 39 CFR 551.5 to remove certain restrictions on the commencement date for the discretionary Semipostal Stamp Program, and clarify how many semipostal stamps issued under that program may be on sale at any one time (81 FR 3762).

    Upon further consideration, however, it was determined that a further revision of the rules concerning the discretionary Semipostal Stamp Program was necessary to facilitate its smooth and efficient operation. Accordingly, the Postal Service now proposes and invites comments upon a more detailed revision of 39 CFR part 551. This proposal supersedes (but incorporates) the amendments previously published on January 22, 2016. The proposed changes are summarized below.

    Proposed Changes

    The proposed revision of § 551.3 streamlines and simplifies the selection process for the causes to receive funds raised through the sale of semipostal stamps, and states the Postal Service's intention to issue five such stamps over the statutory ten-year period. It also notifies the public that no further consideration will be given to previously submitted proposals but that such proposals may be resubmitted under the revised regulations. The paragraph relating to proposals regarding the same subject and proposals for the sharing of funds between two agencies is edited for clarity and moved to § 551.4, concerning submission requirements and criteria, where it more appropriately belongs.

    The proposed revision of § 551.4 sharpens the submission requirements and, among other things, makes Postal Service employees ineligible to submit proposals for semipostal stamps.

    The proposed revision of § 551.5(a) would remove certain restrictions on the commencement date of the discretionary Semipostal Stamp Program. Under current regulations, the 10-year period for the discretionary semipostal stamp program commences on a date determined by the Office of Stamp Services, but that date must be after the sales period of the Breast Cancer Research stamp (BCRS) is concluded. Most recently, Public Law 114-99 (December 11, 2015) extended that sales period to December 31, 2019. Under the proposed revision, the 10-year period will commence on a date determined by the Office of Stamp Services, but the date need not be after the BCRS sale period concludes.

    The proposed revision of § 551.5(b) would clarify that although only one semipostal stamp under the discretionary Semipostal Stamp Program under 39 U.S.C. 416 (a “discretionary program semipostal stamp”) will be offered for sale at any one time, other semipostal stamps required to be issued by Congress (such as the BCRS) may be on sale when a discretionary program semipostal stamp is on sale. Current regulations state that the Postal Service will offer only one semipostal stamp for sale at any given time during the 10-year period (not specifying whether it is a discretionary program semipostal stamp or a semipostal stamp required by Congress). Under the proposed revision, the one-at-a-time limitation on the sale of semipostal stamps would apply only to discretionary program semipostal stamps.

    To minimize confusion regarding applicable postage rates, the proposed revision of § 551.6 specifies that for purposes of calculating the price of a semipostal, the First-Class Mail® single-piece stamped first-ounce rate of postage will be considered “the rate of postage that would otherwise regularly apply.”

    List of Subjects in 39 CFR Part 551

    Administrative practice and procedure.

    In accordance with 39 U.S.C. 416(e)(2), the Postal Service invites public comment on the following proposed amendments to the Code of Federal Regulations. For the reasons stated in the preamble, the Postal Service proposes to revise 39 CFR part 551 as follows:

    PART 551—[AMENDED] 1. The authority citation for 39 CFR part 551 continues to read as follows: Authority:

    39 U.S.C. 101, 201, 203, 401, 403, 404, 410, 414, 416.

    2. Revise § 551.3 to read as follows:
    § 551.3 Procedure for selection of causes and recipient executive agencies.

    The Postal Service has discretionary authority to select causes and recipient executive agencies to receive funds raised through the sale of semipostal stamps. These regulations apply only to such discretionary semipostal stamps and do not apply to semipostal stamps that are mandated by Act of Congress, such as the Breast Cancer Research stamp. The procedure for selection of causes and recipient executive agencies is as follows:

    (a) The Office of Stamp Services will accept proposals from interested persons for future semipostal stamps beginning on May 16, 2016, or the effective date of this regulation, whichever is later. The Office of Stamp Services will begin considering proposals on July 1, 2016, or 45 days after the effective date of this regulation, whichever is later. The Postal Service intends to issue five semipostal stamps under these regulations during the 10-year period established by Congress in 39 U.S.C. 416(g). Each semipostal stamp will be sold for no more than two years. Proposals may be submitted and will be considered on a rolling basis until May 15, 2023, or seven years after the effective date of this regulation, whichever is later. The Office of Stamp Services may publicize this request for proposals in the Federal Register or through other means, as it determines in its discretion. Proposals for semipostal stamps made prior to May 16, 2016, or the effective date of this regulation, whichever is later, will not be given further consideration. Nothing in these regulations should be construed as barring the resubmission of previously submitted causes and recipient executive agencies.

    (b) Proposals will be received by the Office of Stamp Services, which will review each proposal under § 551.4.

    (c) The Office of Stamp Services will forward those proposals that satisfy the requirements of § 551.4 to the Citizens' Stamp Advisory Committee for its consideration.

    (d) Based on the proposals received from the Office of Stamp Services, the Citizens' Stamp Advisory Committee may make recommendations on causes and eligible recipient executive agencies to the postmaster general. The Citizens' Stamp Advisory Committee may recommend more than one cause and eligible recipient executive agency at the same time.

    (e) Meetings of the Citizens' Stamp Advisory Committee are closed, and deliberations of the Citizens' Stamp Advisory Committee are pre-decisional in nature.

    (f) In making decisions concerning semipostal stamps, the postmaster general may take into consideration such factors, including the recommendations of the Citizens' Stamp Advisory Committee, as the postmaster general determines are appropriate. The decision of the postmaster general shall be the final agency decision.

    (g) The Office of Stamp Services will notify each executive agency in writing of a decision designating that agency as a recipient of funds from a semipostal stamp.

    (h) As either a separate matter, or in combination with recommendations on a cause and recipient executive agencies, the Citizens' Stamp Advisory Committee may recommend to the postmaster general a design (i.e., artwork) for the semipostal stamp. The postmaster general will make a final decision on the design to be featured.

    (i) The decision of the postmaster general to exercise the Postal Service's discretionary authority to issue a semipostal stamp is final and not subject to challenge or review.

    3. Revise § 551.4 to read as follows:
    § 551.4 Submission requirements and selection criteria.

    (a) Proposals on recipient executive agencies and causes must satisfy the following requirements:

    (1) Interested persons must timely submit the proposal by U.S. Mail to the Office of Stamp Services, Attn: Semipostal Discretionary Program, 475 L'Enfant Plaza SW., Room 3300, Washington, DC 20260-3501, or in a single Adobe Acrobat (.pdf) file sent by email to [email protected] Indicate in the Subject Line: Semipostal Discretionary Program. For purposes of this section, interested persons include, but are not limited to, individuals, corporations, associations, and executive agencies under 5 U.S.C. 105.

    (2) The proposal must be signed by the individual or a duly authorized representative and must provide the mailing address, phone number, fax number (if available), and email address of a designated point of contact.

    (3) The proposal must describe the cause and the purposes for which the funds would be used.

    (4) The proposal must demonstrate that the cause to be funded has broad national appeal, and that the cause is in the national public interest and furthers human welfare. Respondents are encouraged to submit supporting documentation demonstrating that funding the cause would benefit the national public interest.

    (5) The proposal must include a letter from an executive agency or agencies on agency letterhead representing that:

    (i) It is an executive agency as defined in 5 U.S.C. 105,

    (ii) It is willing and able to implement the proposal, and

    (iii) It is willing and able to meet the requirements of the Semipostal Authorization Act, if it is selected. The letter must be signed by a duly authorized representative of the agency.

    (6) (i) A proposal may designate one or two recipient executive agencies to receive funds, but if more than one executive agency is proposed, the proposal must specify the percentage shares of differential revenue, net of the Postal Service's reasonable costs, to be given to each agency. If percentage shares are not specified, it is presumed that the proposal intends that the funds be split evenly between the agencies. If more than two recipient executive agencies are proposed to receive funds and the proposal is selected, the postmaster general will provide the recipient executive agencies with an opportunity to jointly decide which two agencies will receive funds. If the agencies are unable to reach a joint decision within 20 days, the postmaster general shall either decide which two agencies will receive funds or select another proposal.

    (ii) If more than one proposal is submitted for the same cause, and the proposals would have different executive agencies receiving funds, the funds may be evenly divided among the executive agencies, with no more than two agencies being designated to receive funds, as determined by the postmaster general.

    (b) Proposals become the property of the Postal Service and are not returned to interested persons who submit them. Interested persons who submit proposals are not entitled to any remuneration, compensation, or any other form of payment, whether their proposals are selected or not, for any reason.

    (c) The following persons may not submit proposals:

    (1) Employees of the United States Postal Service;

    (2) Any contractor of the Postal Service that may stand to benefit financially from the Semipostal Stamp Program; or

    (3) Members of the Citizens' Stamp Advisory Committee and their immediate families, and contractors of the Postal Service, and their immediate families, who are involved in any decision-making related to causes, recipient agencies, or artwork for the Semipostal Stamp Program.

    (d) Consideration for evaluation will not be given to proposals that request support for any of the following: Anniversaries; public works; people; specific organizations or associations; commercial enterprises or products; cities, towns, municipalities, counties, or secondary schools; hospitals, libraries, or similar institutions; religious institutions; causes that do not further human welfare; or causes determined by the Postal Service or the Citizens' Stamp Advisory Committee to be inconsistent with the spirit, intent, or history of the Semipostal Authorization Act.

    (e) Artwork and stamp designs may not be submitted with proposals.

    5. Revise § 551.5 to read as follows:
    § 551.5 Frequency and other limitations.

    (a) The Postal Service is authorized to issue semipostal stamps for a 10-year period beginning on the date on which semipostal stamps are first sold to the public under 39 U.S.C. 416. The Office of Stamp Services will determine the date of commencement of the 10-year period.

    (b) The Postal Service will offer only one discretionary semipostal stamp for sale at any given time during the 10-year period, although a discretionary semipostal stamp may be offered for sale at the same time as one or more congressionally mandated semipostal stamps.

    (c) The sales period for any given discretionary semipostal stamp is limited to no more than two years, as determined by the Office of Stamp Services.

    (d) Prior to or after the issuance of a given discretionary semipostal stamp, the Postal Service may withdraw the semipostal stamp from sale, or to reduce the sales period, if, inter alia:

    (1) Its sales or revenue statistics are lower than expected,

    (2) The sales or revenue projections are lower than expected, or

    (3) The cause or recipient executive agency does not further, or does not comply with, the statutory purposes or requirements of the Semipostal Authorization Act.

    6. Revise § 551.6 to read as follows:
    § 551.6 Pricing.

    (a) The Semipostal Authorization Act, as amended by Public Law 107-67, section 652, 115 Stat. 514 (2001), prescribes that the price of a semipostal stamp is the rate of postage that would otherwise regularly apply, plus a differential of not less than 15 percent. The price of a semipostal stamp shall be an amount that is evenly divisible by five. For purposes of this provision, the First-Class Mail® single-piece stamped first-ounce rate of postage will be considered the rate of postage that would otherwise regularly apply.

    (b) The prices of semipostal stamps are determined by the Governors of the United States Postal Service in accordance with the requirements of 39 U.S.C. 416.

    Stanley F. Mires, Attorney, Federal Compliance.
    [FR Doc. 2016-04646 Filed 3-2-16; 8:45 am] BILLING CODE 7710-12-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 15 and 74 [OET Docket Nos. 14-165, 14-166 and 12-268; Report No. 3037] Petitions for Reconsideration of Action in a Rulemaking Proceeding; Correction AGENCY:

    Federal Communications Commission.

    ACTION:

    Petition for reconsideration; correction.

    SUMMARY:

    On February 12, 2016, the Commission published a summary of Commission's document, Report No. 3037, 81 FR 7491, announcing that oppositions to Petitions for Reconsideration must been filed by February 29, 2016, and replies to an opposition must be filed on or before March 25, 2016. This document corrects the due date for replies to an opposition.

    DATES:

    Replies to an opposition to the petition for reconsideration published February 12, 2016 (81 FR 7491) must be filed on or before March 10, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Hugh Van Tuyl, Policy and Rules Division, Office of Engineering and Technology, (202) 418-7506, email: [email protected] Paul Murray, Policy and Rules Division, Office of Engineering and Technology, (202) 418-0688, email: [email protected]

    Correction

    In the Federal Register of February 12, 2016, in FR Doc. 2016-02899, on page 7491, in the second column, correct the DATES caption to read:

    DATES:

    Oppositions to Petitions for Reconsideration must been filed by February 29, 2016. Replies to an opposition must be filed on or before March 10, 2016.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2016-04521 Filed 3-2-16; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 160211104-6104-01] RIN 0648-BF70 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Gag Management Measures AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    NMFS proposes to implement management measures described in a framework action to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP), as prepared by the Gulf of Mexico Fishery Management Council (Council). If implemented, this action would revise the recreational closed season for gag and the recreational minimum size limits for gag and black grouper in the Gulf of Mexico (Gulf) exclusive economic zone. The purpose of this proposed rule is to optimize recreational opportunities to harvest gag and to address inconsistencies in the recreational minimum size limits for gag and black grouper in the Gulf and South Atlantic.

    DATES:

    Written comments must be received on or before April 4, 2016.

    ADDRESSES:

    You may submit comments on the proposed rule, identified by “NOAA-NMFS-2016-0010” by either of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2016-0010, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Richard Malinowski, Southeast Regional Office, NMFS, 263 13th Avenue South, St. Petersburg, FL 33701.

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    Electronic copies of the framework action, which includes an environmental assessment, a regulatory impact review, and a Regulatory Flexibility Act (RFA) analysis may be obtained from the Southeast Regional Office Web site at http://sero.nmfs.noaa.gov/sustainable_fisheries/gulf_fisheries/reef_fish/2016/gag_and_black_grouper_framework/index.html.

    FOR FURTHER INFORMATION CONTACT:

    Richard Malinowski, Southeast Regional Office, NMFS, telephone: 727-824-5305, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Gulf reef fish fishery, which includes gag and black grouper, is managed under the FMP. The FMP was prepared by the Council and is implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

    Background

    The Magnuson-Stevens Act requires NMFS and regional fishery management councils to achieve on a continuing basis the optimum yield from federally managed fish stocks. This mandate is intended to ensure that fishery resources are managed for the greatest overall benefit to the nation, particularly with respect to providing food production and recreational opportunities, while also protecting marine ecosystems.

    The 2014 Southeast Data, Assessment and Review (SEDAR 33) benchmark stock assessment indicates that the Gulf gag stock is not overfished or undergoing overfishing as of 2012, the last year of data used in SEDAR 33. However, as described in the framework action, the Council's Reef Fish Advisory Panel, the Council's Science and Statistical Committee (SSC), and public testimony, all suggested that the Council use caution when setting the gag annual catch limits (ACL) and annual catch targets (ACT). Therefore, the Council decided not to modify the Gulf gag ACL or ACT in this framework action.

    Additionally, the 2010 SEDAR 19 benchmark assessment for black grouper found that the Gulf black grouper stock was neither overfished nor undergoing overfishing.

    Management Measures Contained in This Proposed Rule

    This rule would revise the recreational closed season for gag and the recreational minimum size limits for gag and black grouper in the Gulf.

    Gag Recreational Closed Season

    The current closed season for the gag recreational sector is January 1 through June 30 and December 3 through December 31, annually. This closed season was established in Amendment 32 to the FMP to help prevent the gag recreational ACL from being exceeded (77 FR 6988, February 10, 2012).

    This rule would revise the gag recreational closed season to be from January 1 to May 31, annually. The intent of this revised closed season would be to reduce the amount of dead discards of gag that occur during the Gulf's recreational season for red snapper that begins on June 1, annually, and to extend the gag recreational fishing season beyond the current December closure date to provide the opportunity for the recreational sector to harvest the recreational ACL. The gag recreational ACT was only exceeded once, and the recreational ACL has never been exceeded since ACLs and ACTs were established for gag in 2011.

    Gag and Black Grouper Minimum Size Limits

    The current gag and black grouper recreational minimum size limits in Gulf Federal waters are both set at 22 inches (55.9 cm), total length (TL). The current gag and black grouper minimum size limit in South Atlantic Federal waters is 24 inches (61.0 cm), TL for both species and for both the commercial and recreational sectors. For the state of Florida, in state waters off Monroe County in the Gulf, the recreational minimum size limit for gag and black grouper is 24 inches (61.0 cm), TL. This proposed rule would increase the recreational minimum size limit for both species to 24 inches (61.0 cm), TL, to be consistent with the Federal waters of the South Atlantic and state waters off Monroe County, Florida. The Council decided that the benefits of having a size limit for these species that is consistent with both the South Atlantic and the state size limits for the waters off Monroe County, Florida, will outweigh any impacts of increased discard rates for these species. Furthermore, gag are sometimes misidentified as black grouper and having the same recreational minimum size limit for gag and black grouper may assist the public in complying with the applicable regulations for gag and black grouper. Additionally, increasing the recreational minimum size limit for these species is expected to provide the opportunity for more gag and black grouper to become sexually mature and spawn.

    Classification

    Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the framework action, the FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.

    This proposed rule has been determined to be not significant for purposes of Executive Order 12866.

    The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for this determination is as follows:

    A description of this proposed rule, why it is being considered, and the objectives of this proposed rule are contained in the preamble and in the SUMMARY section of the preamble. The Magnuson-Stevens Act provides the statutory basis for this proposed rule.

    This proposed rule, if implemented, would not be expected to directly affect any small entities. This proposed rule would modify the gag and black grouper recreational minimum size limits and the gag recreational season in the Gulf. Only recreational anglers, who may fish from shore, man-made structures, private, rental, or charter vessels, and headboats, are allowed a bag or possession limit of grouper species in the Gulf. Captains or crew members on charter vessels or headboats, as well as commercial vessels, cannot harvest or possess gag or black grouper under the recreational bag limits. As a result of only recreational anglers being allowed a bag or possession limit, only recreational anglers would be directly affected by the proposed changes to the gag and black grouper recreational minimum size limits and the gag recreational season dates. Recreational anglers, however, are not considered to be small entities under the RFA and the economic effects of this proposed rule on these anglers are outside the scope of the RFA.

    Charter vessels and headboats (for-hire vessels) sell fishing services to recreational anglers. Because the proposed change in the gag and black grouper minimum size limits and the change to the gag recreational season would not directly alter the services sold by these vessels, this proposed rule would not directly apply to or regulate their operations. Any change in demand for these fishing services, and associated economic effects, as a result of changing the minimum size limits and recreational season would be a consequence of behavioral change by anglers, secondary to any direct effect on anglers and, therefore, an indirect effect of the proposed rule. Because the effects on for-hire vessels would be indirect, they fall outside the scope of the RFA.

    The information provided above supports a determination that this rule would not have a significant economic impact on a substantial number of small entities. Because this rule, if implemented, is not expected to have a significant economic impact on any small entities, an initial regulatory flexibility analysis is not required and none has been prepared.

    No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, record-keeping, or other compliance requirements are introduced by this proposed rule. Accordingly, this rule does not implicate the Paperwork Reduction Act.

    List of Subjects in 50 CFR Part 622

    Black grouper, Fisheries, Fishing, Gag, Gulf, Recreational, Reef fish, Size limits.

    Dated: February 25, 2016. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 622 is proposed to be amended as follows:

    PART 622—FISHERIES OF THE CARIBBEAN, GULF OF MEXICO, AND SOUTH ATLANTIC 1. The authority citation for part 622 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq.

    2. In § 622.34, paragraph (e) is revised to read as follows:
    § 622.34 Seasonal and area closures designed to protect Gulf reef fish.

    (e) Seasonal closure of the recreational sector for gag. The recreational sector for gag, in or from the Gulf EEZ, is closed from January 1 through May 31. During the closure, the bag and possession limits for gag in or from the Gulf EEZ are zero.

    3. In § 622.37, paragraphs (b)(1) and (b)(5)(ii) are revised to read as follows:
    § 622.37 Size limits.

    (b) * * *

    (1) Gag—(i) For a person not subject to the bag limit specified in § 622.38 (b)(2)—22 inches (55.9 cm), TL.

    (ii) For a person subject to the bag limit specified in § 622.38(b)(2)—24 inches (61.0 cm), TL.

    (5) * * *

    (ii) For a person subject to the bag limit specified in § 622.38(b)(2)—24 inches (61.0 cm), TL.

    [FR Doc. 2016-04655 Filed 3-2-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 160120042-6042-01] RIN 0648-BF69 Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Northeast Groundfish Fishery; Recreational Management Measures AGENCY:

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

    ACTION:

    Proposed rule; request for comments.

    SUMMARY:

    NMFS proposes to modify recreational fishery management measures for Gulf of Maine cod and haddock, including daily bag limits, size limits, and seasonal possession restrictions. This action is necessary to increase recreational fishing opportunities and catch of cod and haddock in a manner consistent with anticipated catch limit increases. The intended effect of this action is to ensure the recreational fishery can achieve but not exceed its catch limits.

    DATES:

    Comments must be received by March 18, 2016.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2016-0011, by either of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal.

    1. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2016-0011.

    2. Click the “Comment Now!” icon, complete the required fields, and

    3. Enter or attach your comments.

    - OR -

    Mail: Submit written comments to: John K. Bullard, Regional Administrator, National Marine Fisheries Service, 55 Great Republic Drive, Gloucester, MA 01930. Mark the outside of the envelope, “Comments on groundfish recreational fishing management measures.”

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).

    In support of the proposed action, NMFS prepared a supplemental environmental assessment (EA) to Framework Adjustment 55 to the Northeast Multispecies Fishery Management Plan. The Framework 55 EA was prepared by the New England Fishery Management Council. Copies of the Framework 55 EA and supplemental EA are available from: John K. Bullard, Regional Administrator, National Marine Fisheries Service, 55 Great Republic Drive, Gloucester, MA 01930. The Framework 55 EA and supplement are also accessible via the Internet at: http://www.greateratlantic.fisheries.noaa.gov/sustainable/species/multispecies/.

    FOR FURTHER INFORMATION CONTACT:

    William Whitmore, Fishery Policy Analyst, phone: 978-281-9182; email: [email protected]

    SUPPLEMENTARY INFORMATION: Proposed Modifications to Recreational Management Measures

    We are proposing to increase recreational fishing opportunities for Gulf of Maine (GOM) cod and haddock starting May 1, 2016. The proposed changes would allow anglers to retain one cod per day during the months of August and September and keep up to 15 haddock per day for most of the fishing year. Table 1, below, summarizes the proposed measures compared to the fishing year 2015 measures.

    Table 1—Proposed Changes to GOM Cod and Haddock Recreational Management Measures Stock Current measures Per day
  • possession
  • limit (fish per
  • angler)
  • Minimum fish size Season when
  • possession is
  • permitted
  • Proposed measures Per day
  • possession
  • limit (fish per
  • angler)
  • Minimum fish size Season when
  • possession is
  • permitted
  • GOM Cod * Possession Prohibited Year-Round 1 24 inches (61.0 cm). August 1-September 30. GOM Haddock 3 17 inches (43.2 cm) May 1- August 31, 2015 and November 1-February 29, 2016 15 17 inches (43.2 cm). Year Round Except April 15-30. * The recreational cod prohibition is proposed to be rescinded in Framework 55. This action would establish the actual recreational fishing effort regulations if the prohibition is removed.
    Background Framework Adjustment 55 Proposes To Increase Recreational Catch Limits

    The Northeast Fishery Science Center (Center) conducted operational stock assessments for all 20 groundfish stocks in September 2015. The assessment concluded that the GOM haddock stock biomass continues to increase, and as a result, a substantial catch-limit increase (150 percent) is anticipated for the 2016 fishing year. The assessment also concluded that, although GOM cod remains overfished and subject to overfishing, biomass has increased slightly. A 30-percent increase to the catch limit for GOM cod is expected for 2016.

    These catch limit increases will be proposed in a separate rulemaking for Framework Adjustment 55 to the Northeast Multispecies Fishery Management Plan (FMP) which is expected to be published in the Federal Register in the next few weeks. Final approval of the recreational measures proposed in this action is contingent upon approval of the catch limit increases proposed in Framework 55. Framework 55 also proposes to remove the GOM cod retention prohibition in the recreational fishery. If catch limits or management measures other than those to be proposed in Framework 55 rulemaking are implemented, we will adjust recreational measures as necessary to ensure that catch from the recreational fishery will remain within the final catch limits implemented for fishing year 2016.

    A peer-reviewed bioeconomic model, developed by the Center, was used to estimate 2016 recreational GOM cod and haddock mortality under various combinations of minimum sizes, possession limits, and closed seasons. Catch data and model projections suggest that the recreational fleet is not expected to exceed its fishing year 2015 catch limits for GOM cod or haddock. Based on the Framework 55 catch limits recommended by the Council for the 2016 fishing year, analyses indicate that recreational catch for both GOM cod and haddock could be increased (Table 2).

    Table 2—Projected Fishing Year 2015 and 2016 Recreational Catch Information for GOM Cod and Haddock Stock Fishing year 2015 Catch limit (mt) Projected catch (mt) Percent of catch limit caught Fishing year 2016 Catch limit (mt) * Percent of catch limit
  • increase from 2015
  • GOM Cod 121 69 57 157 30 GOM Haddock 372 301 81 926 149 * NMFS will propose fishing year 2016 recreational catch limits in a separate Framework 55 rulemaking.
    How Management Alternatives and the Proposed Measures Were Developed

    Each year, pursuant to the regulations within the FMP, we may consult with the New England Fishery Management Council and modify recreational management measures to help the fishery achieve optimum yield while ensuring that catch limits are not exceeded. The Center's bioeconomic model results were presented to the Council, its Recreational Advisory Panel (RAP), and its Groundfish Oversight Committee in November and December 2015. These groups concurred that fishing effort on GOM haddock should be increased and suggested that bag limits increase from 3 to 15 fish per angler per day. The Council, RAP, and Committee also recomended that the fishing season for GOM haddock should be substantially extended.

    The Council, RAP, and Committee agreed that the GOM cod recreational retention prohibition should be removed. However, they debated when anglers should be permitted to retain GOM cod (Table 3). The Marine Recreational Information Program (MRIP) gathers fishing effort and catch data in two month “waves” (for example, wave 1 is January-February; wave 2 is March-April). Since MRIP data is provided in waves, the bioeconomic model used to develop recreational management measures estimates effort and catch by 2 month waves as well. As a result, seasonal closures and openings are typically implemented in line with the MRIP waves.

    Additional information and analyses on these alternatives is included in a supplemental Environmental Assessment (see ADDRESSES).

    Table 3—Estimated Fishing Year 2016 Mortality of GOM Cod and Haddock by Management Alternative * Alternative Haddock Bag
  • limit
  • Size limit (in/cm) Open
  • season
  • Total
  • mortality (mt)
  • Total
  • mortality as
  • percent of
  • quota
  • Cod Bag
  • limit
  • Size limit (in/cm) Open
  • season
  • Total
  • mortality (mt)
  • Total
  • mortality as
  • percent of
  • quota
  • Angler trips
    Current Recreational Measures 3 17/43.2 Waves 3, 4, 6, 1 405 44% 0 n/a Closed 66 42% 117,139 2016 RAP Recommendation 15 17/43.2 All year, except April 15-30 709 76% 1 24/61.0 Jul-Aug 132 84% 168,125 2016 Committee Recommendation 15 17/43.2 All year, except April 15-30 707 76% 1 24/61.0 Sept-Oct 114 73% 167,549 2016 Council Recommendation 15 17/43.2 All year, except April 15-30 707-709 76% 1 24/61.0 Aug-Sept 114-132 73-84% 167,549-168,125 * The model cannot split a wave of data; the numbers provided under alternative 4 are a range between alternatives 2 and 3. Council recommended Framework 55 fishing year 2016 GOM haddock recreational catch limit = 928 mt. Council recommended Framework fishing year 2016 GOM cod recreational catch limit = 157 mt.

    There was general agreement among the Council, RAP, and Committee that the GOM cod daily bag limit could not exceed more than 1 fish per person per day. The RAP debated whether anglers should be able to retain that one cod during the months of July and August (wave 4) or September and October (wave 5). According to the model, opening wave 4 would result in slightly more trips being taken compared to opening wave 5; however, both options are expected to keep catch within the proposed limits. Most RAP members initially supported opening wave 5 because it would result in less cod being caught, which may provide additional conservation benefits. The RAP also discussed that opening wave 5 would extend the primary summer fishing season further into the fall, potentially creating additional fishing opportunities that would help charter and party boat businesses. However, opening wave 5 would not benefit private anglers as much because fewer private anglers fish in the fall compared to the summer. Because allowing cod retention during July and August, when most anglers are fishing, would provide the greatest overall benefits, the RAP endorsed opening wave 4.

    The Groundfish Committee considered the RAP's recommendation and evaluated the trade-offs between opening waves 4 or 5. The Committee recommended opening wave 5, citing a preference to extend the recreational fishing season further into the fall.

    The Council proposed a compromise, recommending that anglers should be able to retain one cod during the months of August and September (the second month of wave 4 and the first month of wave 5). We propose to adopt the Council's recommendations in this action.

    We intend to modify our bioeconomic model so we can project effort and catch at a monthly level, but there is some concern that a revised model may not work if there is insufficient data at the monthly level. Since MRIP effort and catch data is reported by 2-month waves, reducing the length of time from two months to one would reduce the amount of samples that would be incorporated into the model, potentially increasing variability and uncertainty in the model, which could cause the model to fail. We believe this to be unlikely, but still a possibility.

    The increased flexibility from the proposed measure appears to outweigh the potential data trade-off. There is a substantial “buffer” between the catch forecasted by the model and the proposed catch limits, and we will be modifying the model in the future to reduce management uncertainty where possible. We believe that the Council's suggestion is appropriate and are therefore proposing it for this action.

    We are providing a 15-day comment period for this rule. A 15-day comment period, coupled with extensive public comment periods at three different Council-related meetings during the development of this action, provides sufficient opportunity for public input on the proposed measures. The Council did not recommend management measures to NMFS until December 2015; as a result were unable to develop a proposed rule any sooner than this. Recreational fishing businesses and fishermen are currently scheduling fishing trips and these proposed measures will provide them with additional information to assist their planning efforts. Since these measures increase fishing opportunities, announcing these measures quickly will provide additional support to recreational-fishing businesses.

    Classification

    Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has made a determination that this proposed rule is consistent with the Northeast Multispecies FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.

    The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities.

    As explained above, the purpose of this action is to modify recreational fishing management measures to increase recreational fishing opportunities, effort, and catch consistent with the catch limit increases anticipated in Framework 55. This action is needed to help the recreational fishery achieve its optimum yield without overfishing.

    The regulated entities most likely to be affected by this action are private anglers, and charter/party vessel fishing corporations. Other than private anglers, which are not businesses, all charter/party fishing businesses are considered small businesses per the SBA guidelines because they all have less than $7.5 million in annual receipts. As a result, the impacts of these measures are not considered to be disproportional.

    All of the measures proposed in this action are expected to have a positive economic impact on participants as new regulations would allow for additional fishing opportunities. Additional fishing opportunities would generate additional effort (trips) and result in more revenue for recreational fishing businesses. This rule would not impose significant negative economic impacts.

    Since no small entities would be placed at a competitive disadvantage to large entities, and the regulations would not reduce the profit for any small entities, an initial regulatory flexibility analysis is not required and none has been prepared.

    This action has been determined to be not significant for purposes of Executive Order (E.O.) 12866.

    List of Subjects in 50 CFR Part 648

    Fisheries, Fishing, Recordkeeping and reporting requirements.

    Dated: February 25, 2016. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 648 is proposed to be amended as follows:

    PART 648—FISHERIES OF THE NORTHEASTERN UNITED STATES 1. The authority citation for part 648 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq.

    2. In § 648.89, revise paragraphs (b)(1), (c)(1)(ii), (c)(2), and (c)(8) to read as follows:
    § 648.89 Recreational and charter/party vessel restrictions.

    (b) Recreational minimum fish sizes—(1) Minimum fish sizes. Unless further restricted under this section, persons aboard charter/party vessel permitted under this part and not fishing under the NE multispecies DAS program or under the restrictions and conditions of an approved sector operations plan, and private recreational fishing vessels in or possessing fish from the EEZ, may not possess fish smaller than the minimum fish sizes, measured in total length, as follows:

    Species Minimum Size Inches cm Cod: Inside GOM Regulated Mesh Area1 24 61.0 Outside GOM Regulated Mesh Area1 22 55.9 Haddock: Inside GOM Regulated Mesh Area 17 43.2 Outside GOM Regulated Mesh Area 18 45.7 Pollock 19 48.3 Witch Flounder (gray sole) 14 35.6 Yellowtail Flounder 13 33.0 American Plaice (dab) 14 35.6 Atlantic Halibut 41 104.1 Winter Flounder (blackback) 12 30.5 Redfish 9 22.9 1 GOM Regulated Mesh Area specified in § 648.80(a)

    (c) * * *

    (1) * * *

    (ii) Each person on a private recreational fishing vessel, fishing from August 1 through September 30, may possess no more than one cod per day in, or harvested from, the EEZ when fishing in the GOM Regulated Mesh Area specified in § 648.80(a)(1); with the exception that each person on a private recreational vessel in possession of cod caught outside the GOM Regulated Mesh Area specified in § 648.80(a)(1) may transit this area with more than one such cod per person up to the possession limit specified at § 648.89(c)(1)(i), provided all bait and hooks are removed from fishing rods and any cod on board has been gutted and stored.

    (2) Charter/party vessels (i) Each person on a charter/party fishing vessel permitted under this part and not fishing under a NE multispecies DAS program or on a sector trip may possess unlimited cod when fishing outside of the GOM Regulated Mesh Area specified in § 648.80(a)(1).

    (ii) Each person on a charter/party fishing vessel permitted under this part, fishing from August 1 through September 30, and not fishing under the NE multispecies DAS program or on a sector trip, may possess no more than one cod per day in the GOM Regulated Mesh Area specified in § 648.80(a)(1); with the exception that each person on a charter/party vessel in possession of cod caught outside the GOM Regulated Mesh Area specified in § 648.80(a)(1) may transit this area with more than one such cod up to any possession limit under § 648.89(c)(2)(ii), provided all bait and hooks are removed from fishing rods and any cod on board has been gutted and stored.

    (iii) For purposes of counting fish, fillets will be converted to whole fish at the place of landing by dividing the number of fillets by two. If fish are filleted into a single (butterfly) fillet, such fillet shall be deemed to be from one whole fish.

    (iv) Cod harvested by charter/party vessels with more than one person aboard may be pooled in one or more containers. Compliance with the possession limits will be determined by dividing the number of fish on board by the number of persons on board. If there is a violation of the possession limits on board a vessel carrying more than one person, the violation shall be deemed to have been committed by the owner or operator of the vessel.

    (v) Cod must be stored so as to be readily available for inspection.

    (8) Haddock. (i) Each person on a private recreational vessel may possess unlimited haddock in, or harvested from, the EEZ when fishing outside of the GOM Regulated Mesh Area specified in § 648.80(a)(1).

    (ii) Each person on a private recreational fishing vessel, fishing from May 1 through April 14, may possess no more than 15 haddock per day in, or harvested from, the EEZ when fishing in the GOM Regulated Mesh Area specified in § 648.80(a)(1); with the exception that each person on a private recreational vessel in possession of haddock caught outside the GOM Regulated Mesh Area specified in § 648.80(a)(1) may transit this area with more than 15 such haddock per person up to the possession limit specified at § 648.89(c)(8)(i), provided all bait and hooks are removed from fishing rods and any haddock on board has been gutted and stored.

    (iii) Each person on a charter/party fishing vessel permitted under this part and not fishing under a NE multispecies DAS program or on a sector trip may possess unlimited haddock when fishing outside of the GOM Regulated Mesh Area specified in § 648.80(a)(1).

    (iv) Each person on a charter/party fishing vessel permitted under this part, fishing from May 1 through April 14, and not fishing under the NE multispecies DAS program or on a sector trip, may possess no more than 15 haddock per day in the GOM Regulated Mesh Area specified in § 648.80(a)(1); with the exception that each person on a charter/party vessel in possession of haddock caught outside the GOM Regulated Mesh Area specified in § 648.80(a)(1) may transit this area with more than fifteen such haddock up to any possession limit under § 648.89(c)(8)(iii), provided all bait and hooks are removed from fishing rods and any cod on board has been gutted and stored.

    (v) For purposes of counting fish, fillets will be converted to whole fish at the place of landing by dividing the number of fillets by two. If fish are filleted into a single (butterfly) fillet, such fillet shall be deemed to be from one whole fish.

    (vi) Haddock harvested in or from the EEZ by private recreational fishing boats or charter or party boats with more than one person aboard may be pooled in one or more containers. Compliance with the possession limit will be determined by dividing the number of fish on board by the number of persons on board. If there is a violation of the possession limit on board a vessel carrying more than one person, the violation shall be deemed to have been committed by the owner or operator of the vessel.

    (vii) Haddock must be stored so as to be readily available for inspection.

    [FR Doc. 2016-04656 Filed 3-2-16; 8:45 am] BILLING CODE 3510-22-P
    81 42 Thursday, March 3, 2016 Notices DEPARTMENT OF AGRICULTURE Forest Service Deschutes Provincial Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Deschutes Provincial Advisory Committee (PAC) will meet in Bend, Oregon. The committee is authorized pursuant to the implementation of E-19 of the Record of Decision and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to provide advice and make recommendations to promote a better integration of forest management activities between Federal and non-Federal entities to ensure that such activities are complementary. PAC information can be found at the following Web site: http://www.fs.usda.gov/detail/deschutes/workingtogether/advisorycommittees.

    DATES:

    The meeting will be held on March 9, 2016, from 9:00 a.m. to 3:00 p.m.

    All PAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under For Information Contact.

    ADDRESSES:

    The meeting will be held at the Deschutes Historical Museum, 129 NW Idaho Avenue, Bend, Oregon.

    Written comments may be submitted as described under Supplementary Information. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at Deschutes National Forest Headquarters Office. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Beth Peer, PAC Coordinator, by phone at 541-383-4769 or via email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is:

    1. Forest Plan Revision: How can the PAC engage in the Process and the Outcomes;

    2. Sustainable Recreation: The future of wildland trails and the role of the PAC;

    3. Wilderness Management and the role of the PAC; and

    4. Timber and Fuels Management: Where we have been, where we are now, and where we might go in the future.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by March 8, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Beth Peer, Deschutes PAC Coordinator, 63095 Deschutes Market Road, Bend, Oregon 97701; by email to [email protected], or via facsimile to 541-383-4755.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility, please contact the person listed in the section titled For Further Information Contact. All reasonable accommodation requests are managed on a case by case basis.

    Dated: February 8, 2016. John Allen, Forest Supervisor.
    [FR Doc. 2016-03567 Filed 3-2-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-70-2015] Foreign-Trade Zone (FTZ) 39—Dallas/Fort Worth, Texas, Authorization of Production Activity, KONE Inc., (Elevator Parts), Allen, Texas

    On October 29, 2015, KONE Inc. submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board for its facility within FTZ 39—Site 21, in Allen, Texas.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (80 FR 68836, November 6, 2015). The FTZ Board has determined that no further review of the activity is warranted at this time. The production activity described in the notification is authorized, subject to the FTZ Act and the Board's regulations, including Section 400.14.

    Dated: February 20, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-04714 Filed 3-2-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-75-2015] Foreign-Trade Zone (FTZ) 76—Bridgeport, Connecticut; Authorization of Production Activity; MannKind Corporation, Subzone 76B (Inhalable Insulin), Danbury, Connecticut

    On October 29, 2015, MannKind Corporation submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board for its facilities within Subzone 76B, in Danbury, Connecticut.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (80 FR 70751, November 16, 2015). The FTZ Board has determined that no further review of the activity is warranted at this time. The production activity described in the notification is authorized, subject to the FTZ Act and the Board's regulations, including Section 400.14.

    Dated: February 26, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-04715 Filed 3-2-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-602-807, A-351-842, A-560-828, A-570-022, A-471-807] Certain Uncoated Paper From Australia, Brazil, Indonesia, the People's Republic of China, and Portugal: Amended Final Affirmative Antidumping Determinations for Brazil and Indonesia and Antidumping Duty Orders AGENCY:

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

    SUMMARY:

    Based on affirmative final determinations by the Department of Commerce (the Department) and the International Trade Commission (the ITC), the Department is issuing antidumping duty orders on certain uncoated paper from Australia, Brazil, Indonesia, the People's Republic of China (PRC), and Portugal. Also, as explained in this notice, the Department is amending its final affirmative determinations with respect to Brazil and Indonesia.

    DATES:

    Effective Date: March 3, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Eve Wang at (202) 482-6231 (Australia), Julia Hancock at (202) 482-1394 (Brazil), Blaine Wiltse at (202) 482-6345 (Indonesia), Stephanie Moore at (202) 482-3692 (PRC), or Kabir Archuletta at (202) 482-2593 (Portugal), AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.

    SUPPLEMENTARY INFORMATION: Background

    In accordance with sections 735(d) and 777(i)(1) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.210(c), on January 20, 2016, the Department published its affirmative final determinations in the less-than-fair-value (LTFV) investigations of certain uncoated paper from Australia, Brazil, Indonesia, the PRC, and Portugal.1 On February 22, 2016, the ITC notified the Department of its affirmative determinations that an industry in the United States is materially injured within the meaning of section 735(b)(1)(A)(i) of the Act, by reason of the LTFV imports of certain uncoated paper from Australia, Brazil, Indonesia, the PRC, and Portugal and its determination that critical circumstances do not exist with respect to imports of subject merchandise from Australia that are subject to the Department's affirmative critical circumstances finding.2

    1See Certain Uncoated Paper From Australia: Final Determination of Sales at Less Than Fair Value and Affirmative Final Determination of Critical Circumstances, In Part, 81 FR 3108 (January 20, 2016) (Australia Final); Certain Uncoated Paper From Brazil: Final Determination of Sales at Less Than Fair Value, 81 FR 3115 (January 20, 2016) (Brazil Final); Certain Uncoated Paper From Indonesia: Final Determination of Sales at Less Than Fair Value; 81 FR 3101 (January 20, 2016) (Indonesia Final); Certain Uncoated Paper From the People's Republic of China: Final Determination of Sales at Less Than Fair Value, 81 FR 3112 (January 20, 2016) (PRC Final); and Certain Uncoated Paper From Portugal: Final Determination of Sales at Less Than Fair Value and Final Negative Determination of Critical Circumstances, 81 FR 3105 (January 20, 2016) (Portugal Final).

    2See Letter to Christian Marsh, Deputy Assistant Secretary of Commerce for Enforcement and Compliance, from Meredith Broadbent, Chairman of the U.S. International Trade Commission, regarding certain uncoated paper from Australia, Brazil, China, Indonesia, and Portugal (February 22, 2016) (ITC Letter). See also Certain Uncoated Paper from Australia, Brazil, China, Indonesia, and Portugal, USITC Investigation Nos. 701-TA-528-529 and 731-TA-1264-1268 (Final), USITC Publication 4592 (February 2016).

    Scope of the Orders

    The scope of these orders includes uncoated paper in sheet form; weighing at least 40 grams per square meter but not more than 150 grams per square meter; that either is a white paper with a GE brightness level 3 of 85 or higher or is a colored paper; whether or not surface-decorated, printed (except as described below), embossed, perforated, or punched; irrespective of the smoothness of the surface; and irrespective of dimensions (Certain Uncoated Paper).

    3 One of the key measurements of any grade of paper is brightness. Generally speaking, the brighter the paper, the better the contrast between the paper and the ink. Brightness is measured using a GE Reflectance Scale, which measures the reflection of light off a grade of paper. One is the lowest reflection, or what would be given to a totally black grade, and 100 is the brightest measured grade. “Colored paper” as used in this scope definition means a paper with a hue other than white that reflects one of the primary colors of magenta, yellow, and cyan (red, yellow, and blue) or a combination of such primary colors.

    Certain Uncoated Paper includes (a) uncoated free sheet paper that meets this scope definition; (b) uncoated ground wood paper produced from bleached chemi-thermo-mechanical pulp (BCTMP) that meets this scope definition; and (c) any other uncoated paper that meets this scope definition regardless of the type of pulp used to produce the paper.

    Specifically excluded from the scope are (1) paper printed with final content of printed text or graphics and (2) lined paper products, typically school supplies, composed of paper that incorporates straight horizontal and/or vertical lines that would make the paper unsuitable for copying or printing purposes. For purposes of this scope definition, paper shall be considered “printed with final content” where at least one side of the sheet has printed text and/or graphics that cover at least five percent of the surface area of the entire sheet.

    Imports of the subject merchandise are provided for under Harmonized Tariff Schedule of the United States (HTSUS) categories 4802.56.1000, 4802.56.2000, 4802.56.3000, 4802.56.4000, 4802.56.6000, 4802.56.7020, 4802.56.7040, 4802.57.1000, 4802.57.2000, 4802.57.3000, and 4802.57.4000. Some imports of subject merchandise may also be classified under 4802.62.1000, 4802.62.2000, 4802.62.3000, 4802.62.5000, 4802.62.6020, 4802.62.6040, 4802.69.1000, 4802.69.2000, 4802.69.3000, 4811.90.8050 and 4811.90.9080. While HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the orders is dispositive.

    Amendment to Final Determinations

    A ministerial error is defined as an error in addition, subtraction, or other arithmetic function, clerical error resulting from inaccurate copying, duplication, or the like, and any other similar type of unintentional error which the Secretary considers ministerial.4

    4See section 735(e) of the Act.

    Brazil Amended Final Determination

    Pursuant to section 735(e) of the Act and 19 CFR 351.224(e) and (f), the Department is amending the Brazil Final to reflect the correction of a ministerial error it made in the final margin assigned to one of the respondents. In addition, because the Department calculated the “all-others” rate based on a weighted-average of the respondents' margins using publicly-ranged quantities for their sales of subject merchandise, we have revised the all-others rate.5

    5See the “Estimated Weighted-Average Dumping Margins” section below.

    On January 19, 2016, Petitioners submitted a ministerial error allegation claiming that the Department made a ministerial error with regard to one of the respondent's bank charges, and the SAS programming which implemented the bank charge at issue. The Department reviewed the record and agrees that we made ministerial errors within the meaning of Section 735(e) and 19 CFR 351.224(f). Specifically, the Department made an unintentional error with regard to one of the respondent's bank charges and SAS programming which implemented the bank charge at issue.6 We have corrected these errors in this notice.

    6See Memorandum to Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, from Paul Walker, Program Manager, Office V, “Antidumping Duty Investigation of Certain Uncoated Paper from Brazil: Analysis of Ministerial Error Allegation,” dated concurrently with this notice.

    Indonesia Amended Final Determination

    Pursuant to section 735(e) of the Act and 19 CFR 351.224(e) and (f), the Department is amending the Indonesia Final to reflect the correction of ministerial errors it made in the final margin assigned to the sole cooperative respondent. In addition, because the Department applied the respondent's final margin to the “all-others” rate and further, relied on the highest transaction-specific dumping margin as adverse facts available, we have revised the other final rates.7

    7See the “Estimated Weighted-Average Dumping Margins” section below.

    On January 19, 2016, PT Anugerah Kertas Utama/PT Riau Andalan Kertas/APRIL Fine Paper Macao Commercial Offshore Limited (collectively, APRIL) submitted timely filed allegations that the Department made ministerial errors in our final determination. On January 21, 2016, Petitioners submitted rebuttal comments on APRIL's allegations. APRIL alleged the Department made two ministerial errors in its final determination: The exclusion of APRIL's home market billing adjustments and an inconsistency in the Department's calculation of APRIL's difference in merchandise adjustment (DIFMER). The Department reviewed the record and agrees that we made ministerial errors within the meaning of section 735(e) of the Act and 19 CFR 351.224(f). Specifically, the Department made unintentional errors with regard to the exclusion of APRIL's home market billing adjustments and with regard to the calculation of APRIL's DIFMER.8 We have corrected these errors in this notice.

    8See Memorandum to Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, from Melissa G. Skinner, Director, Office II, “Less-Than-Fair-Value Investigation of Certain Uncoated Paper from Indonesia: Allegations of Ministerial Errors in the Final Determination,” dated February 17, 2016.

    Antidumping Duty Orders

    As stated above, on February 22, 2016, in accordance with section 735(d) of the Act, the ITC notified the Department of its final determinations in these investigations, in which it found material injury with respect to certain uncoated paper from Australia, Brazil, Indonesia, the PRC, and Portugal and its determination that critical circumstances do not exist with respect to imports of subject merchandise from Australia that are subject to the Department's affirmative critical circumstances finding.9 Therefore, in accordance with section 735(c)(2) of the Act, we are issuing these antidumping duty orders. Because the ITC determined that imports of certain uncoated paper from Australia, Brazil, Indonesia, the PRC, and Portugal are materially injuring a U.S. industry, unliquidated entries of such merchandise from Australia, Brazil, Indonesia, the PRC, and Portugal, entered or withdrawn from warehouse for consumption, are subject to the assessment of antidumping duties.

    9See ITC Letter.

    Therefore, in accordance with section 736(a)(1) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to assess, upon further instruction by the Department, antidumping duties equal to the amount by which the normal value of the merchandise exceeds the export price (or constructed export price) of the merchandise, for all relevant entries of certain uncoated paper from Australia, Brazil, Indonesia, the PRC, and Portugal. Antidumping duties will be assessed on unliquidated entries of certain uncoated paper from Australia, Indonesia, the PRC, and Portugal entered, or withdrawn from warehouse, for consumption on or after August 26, 2015, and in the case of Brazil, on August 27, 2015, the date of publication of the preliminary determinations,10 but will not include entries occurring after the expiration of the provisional measures period and before publication of the ITC's final injury determination as further described below.

    10See Certain Uncoated Paper From Australia: Preliminary Determination of Sales at Less Than Fair Value, Negative Preliminary Determination of Critical Circumstances, and Postponement of Final Determination, 80 FR 51783 (August 26, 2015) (Australia Prelim); Certain Uncoated Paper From Brazil: Preliminary Determination of Sales at Less Than Fair Value and Postponement of Final Determination, 80 FR 52029 (August 27, 2015) (Brazil Prelim); Certain Uncoated Paper From Indonesia: Preliminary Determination of Sales at Less Than Fair Value and Postponement of Final Determination, 80 FR 51771 (August 26, 2015) (Indonesia Prelim); Certain Uncoated Paper From the People's Republic of China: Preliminary Determination of Sales at Less Than Fair Value and Postponement of Final Determination, 80 FR 51768 (August 26, 2015) (PRC Prelim); and Certain Uncoated Paper From Portugal: Preliminary Determination of Sales at Less Than Fair Value and Postponement of Final Determination, 80 FR 51777 (August 26, 2015) (Portugal Prelim).

    Suspension of Liquidation

    In accordance with section 735(c)(1)(B) of the Act, we will instruct CBP to continue to suspend liquidation on all relevant entries of certain uncoated paper from Australia, Brazil, Indonesia, the PRC, and Portugal. These instructions suspending liquidation will remain in effect until further notice.

    We will also instruct CBP to require cash deposits equal to the amounts as indicated below. Accordingly, effective on the date of publication of the ITC's final affirmative injury determinations, CBP will require, at the same time as importers would normally deposit estimated duties on this subject merchandise, a cash deposit equal to the estimated weighted-average dumping margins listed below.11 The relevant all-others and PRC-wide rates apply to all producers or exporters not specifically listed, as appropriate. For the purpose of determining cash deposit rates, the estimated weighted-average dumping margins for imports of subject merchandise from Indonesia and the PRC will be adjusted, as appropriate, for export subsidies found in the final determinations of the companion countervailing duty investigations of this merchandise imported from Indonesia and the PRC.12 13

    11See section 736(a)(3) of the Act.

    12See Indonesia Final, 81 FR 3103; see also, PRC Final, 81 FR, at 3114.

    13 We are not adjusting the PRC rates for estimated domestic subsidy pass-through because there is no cost-to-price linkage to a subsidized program and, thus, we have no basis upon which to make such an adjustment in that case.

    Provisional Measures

    Section 733(d) of the Act states that instructions issued pursuant to an affirmative preliminary determination may not remain in effect for more than four months, except where exporters representing a significant proportion of exports of the subject merchandise request the Department to extend that four-month period to no more than six months. At the request of exporters that account for a significant proportion of certain uncoated paper from Australia, Brazil, Indonesia, the PRC, and Portugal, we extended the four-month period to six months in each case.14 In the underlying investigations, the Department published the preliminary determinations on August 26, 2015, and August 27, 2015. Therefore, the extended period, beginning on the date of publication of the preliminary determinations, ended on February 21, 2016, and in the case of Brazil, on February 22, 2016. Furthermore, section 737(b) of the Act states that definitive duties are to begin on the date of publication of the ITC's final injury determination.

    14See Australia Prelim, Brazil Prelim, Indonesia Prelim, PRC Prelim, and Portugal Prelim.

    Therefore, in accordance with section 733(d) of the Act and our practice, we will instruct CBP to terminate the suspension of liquidation and to liquidate, without regard to antidumping duties, unliquidated entries of certain uncoated paper from Australia, Indonesia, the PRC, and Portugal entered, or withdrawn from warehouse, for consumption after February 21, 2016, and in the case of Brazil, on February 22, 2016, the dates on which the provisional measures expired, until and through the day preceding the date of publication of the ITC's final injury determinations in the Federal Register. Suspension of liquidation will resume on the date of publication of the ITC's final determination in the Federal Register.

    Critical Circumstances

    With regard to the ITC's negative critical circumstances determination on imports of subject merchandise from Australia, we will instruct CBP to lift suspension and to refund any cash deposits made to secure the payment of estimated antidumping duties with respect to entries of subject merchandise entered, or withdrawn from warehouse, for consumption on or after May 28, 2015 (i.e., 90 days prior to the date of publication of the Australia Prelim), but before August 26, 2015, (i.e., the date of publication of the Australia Prelim).

    Estimated Weighted-Average Dumping Margins

    The weighted-average antidumping duty margin percentages are as follows:

    15 The Department determined that International Paper do Brasil Ltda. and International Paper Exportadora Ltda. constituted a single entity. See Brazil Final, 81 FR, at 3116.

    Exporter/manufacturer Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • Australia: Paper Australia Pty. Ltd 222.46 All Others 138.87 Brazil: International Paper do Brasil Ltda. and International Paper Exportadora Ltda.15 41.39 Suzano Papel e Celulose S.A 22.37 All Others 27.11
    Exporter/
  • manufacturer
  • Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • Cash
  • deposit
  • Indonesia: Great Champ Trading Limited 17.46 0.00 Indah Kiat Pulp & Paper TBK/Pabrik Kertas Tjiwi Kimia/PT. Pindo Deli Pulp and Paper Mills (APP/SMG) 17.46 0.00 April Fine Paper Macao Commercial OffShore Limited/PT Anugerah Kertas Utama/PT Riau Andalan Kertas (APRIL) 2.10 2.10 All Others 2.10 2.10 Note: The cash deposit rates are adjusted to account for the applicable export subsidy rate of 51.75 percent for Great Champ Trading Limited and APP/SMG.
    Exporter Producer Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • Cash deposit
    PRC: Greenpoint Global Trading (Macao Commercial Offshore) Ltd. Asia Symbol (Guangdong) Paper Co., Ltd.; and Asia Symbol (Shangong) Pulp & Paper Co., Ltd 84.05 83.92 PRC-Wide Entity 149.00 148.87 Note: The cash deposit rates are adjusted to account for the applicable export subsidy rate of 0.13 percent for Asia Symbol and the PRC-Wide Entity.
    Exporter/manufacturer Weighted-
  • average
  • dumping
  • margin
  • (percent)
  • Portugal: Portucel S.A.16 7.80 All-Others 7.80

    This notice constitutes the antidumping duty orders with respect to certain uncoated paper from Australia, Brazil, Indonesia, the PRC, and Portugal pursuant to section 736(a) of the Act. Interested parties can find a list of antidumping duty orders currently in effect at http://enforcement.trade.gov/stats/iastats1.html.

    16 In Portugal Final, we determined to treat several companies as a single entity with Portucel S.A.

    These orders are published in accordance with section 736(a) of the Act and 19 CFR 351.211(b).

    Dated: February 25, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-04699 Filed 3-2-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-900] Diamond Sawblades and Parts Thereof From the People's Republic of China: Initiation and Preliminary Results of Changed Circumstances Review AGENCY:

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

    SUMMARY:

    Pursuant to section 751(b) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.216 and 19 CFR 351.221(c)(3), the Department of Commerce (the Department) is initiating a changed circumstances review of the antidumping duty order on diamond sawblades and parts thereof (diamond sawblades) from the People's Republic of China (the PRC) with respect to Wuhan Wanbang Laser Diamond Tools Co., Ltd. Based on the information on the record, we preliminarily determine that Wuhan Wanbang Laser Diamond Tools Co., Ltd., is the successor-in-interest to Wuhan Wanbang Laser Diamond Tools Co. for purposes of determining antidumping duty liability. We invite interested parties to comment on these preliminary results.

    DATES:

    Effective March 3, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Yang Jin Chun AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5760.

    SUPPLEMENTARY INFORMATION: Background

    The Department published the antidumping duty order on diamond sawblades and parts thereof from the People's Republic of China on November 4, 2009.1 In its December 22, 2015, request for a changed circumstances review, Wuhan Wanbang Laser Diamond Tools Co., Ltd., informed the Department that, effective May 4, 2015, Wuhan Wanbang Laser Diamond Tools Co. (1) changed its legal status from a limited liability company to a joint-stock limited company and (2) changed its name to Wuhan Wanbang Laser Diamond Tools Co., Ltd.2 Wuhan Wanbang Laser Diamond Tools Co. is a respondent in the ongoing administrative review of the antidumping duty order on diamond sawblades from the PRC covering the period November 1, 2013, through October 31, 2014.3 Both Wuhan Wanbang Laser Diamond Tools Co. and Wuhan Wanbang Laser Diamond Tools Co., Ltd., are respondents in the ongoing administrative review of the same order covering the period November 1, 2014, through October 31, 2015.4 Pursuant to section 751(b) of the Act, and 19 CFR 351.216(c) and 19 CFR 351.221(c)(3), Wuhan Wanbang Laser Diamond Tools Co., Ltd., requested that the Department initiate an expedited changed circumstances review and determine that Wuhan Wanbang Laser Diamond Tools Co., Ltd., is the successor-in-interest to Wuhan Wanbang Laser Diamond Tools Co.

    1See Diamond Sawblades and Parts Thereof From the People's Republic of China and the Republic of Korea: Antidumping Duty Orders, 74 FR 57145 (November 4, 2009).

    2See Wuhan Wanbang Laser Diamond Tools Co., Ltd.'s request for a changed circumstances review dated December 22, 2015 (review request).

    3See Diamond Sawblades and Parts Thereof From the People's Republic of China: Preliminary Results of Antidumping Duty Administrative Review; 2013-2014, 80 FR 75854, 75855 (December 4, 2015).

    4See Initiation of Antidumping and Countervailing Duty Administrative Reviews, 81 FR 736, 738 (January 7, 2016).

    As explained in the memorandum from the Acting Assistant Secretary for Enforcement and Compliance, the Department has exercised its discretion to toll all administrative deadlines due to the recent closure of the Federal Government. All deadlines in this segment of the proceeding have been extended by four business days. The revised deadline for the initiation of this review is now February 25, 2016.5

    5See Memorandum for the Record from Acting Assistant Secretary Ron Lorentzen entitled “Tolling of Administrative Deadlines as a Result of the Government Closure during Snowstorm `Jonas' ” dated January 27, 2016.

    Scope of the Order

    The products covered by the order are all finished circular sawblades, whether slotted or not, with a working part that is comprised of a diamond segment or segments, and parts thereof, regardless of specification or size, except as specifically excluded below. Within the scope of the order are semifinished diamond sawblades, including diamond sawblade cores and diamond sawblade segments. Diamond sawblade cores are circular steel plates, whether or not attached to non-steel plates, with slots. Diamond sawblade cores are manufactured principally, but not exclusively, from alloy steel. A diamond sawblade segment consists of a mixture of diamonds (whether natural or synthetic, and regardless of the quantity of diamonds) and metal powders (including, but not limited to, iron, cobalt, nickel, tungsten carbide) that are formed together into a solid shape (from generally, but not limited to, a heating and pressing process).

    Sawblades with diamonds directly attached to the core with a resin or electroplated bond, which thereby do not contain a diamond segment, are not included within the scope of the order. Diamond sawblades and/or sawblade cores with a thickness of less than 0.025 inches, or with a thickness greater than 1.1 inches, are excluded from the scope of the order. Circular steel plates that have a cutting edge of non-diamond material, such as external teeth that protrude from the outer diameter of the plate, whether or not finished, are excluded from the scope of the order. Diamond sawblade cores with a Rockwell C hardness of less than 25 are excluded from the scope of the order. Diamond sawblades and/or diamond segment(s) with diamonds that predominantly have a mesh size number greater than 240 (such as 250 or 260) are excluded from the scope of the order. Merchandise subject to the order is typically imported under heading 8202.39.00.00 of the Harmonized Tariff Schedule of the United States (HTSUS). When packaged together as a set for retail sale with an item that is separately classified under headings 8202 to 8205 of the HTSUS, diamond sawblades or parts thereof may be imported under heading 8206.00.00.00 of the HTSUS. On October 11, 2011, the Department included the 6804.21.00.00 HTSUS classification number to the customs case reference file, pursuant to a request by U.S. Customs and Border Protection (CBP).6 The tariff classification is provided for convenience and customs purposes; however, the written description of the scope of the order is dispositive.

    6See Diamond Sawblades and Parts Thereof From the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review, 76 FR 76128, 76130 (December 6, 2011).

    Initiation of Changed Circumstances Review

    Pursuant to section 751(b)(1) of the Act and 19 CFR 351.216(d), the Department will conduct a changed circumstances review upon receipt of a request from an interested party or receipt of information concerning an antidumping duty order which shows changed circumstances sufficient to warrant a review of the order. Based on the request from Wuhan Wanbang Laser Diamond Tools Co., Ltd. (Wuhan Wanbang Co., Ltd.) and in accordance with section 751(b)(1) of Act and 19 CFR 351.216(b), we are initiating a changed circumstances review to determine whether Wuhan Wanbang Co., Ltd., is the successor-in-interest to Wuhan Wanbang Laser Diamond Tools Co. (Wuhan Wanbang Co.). If we conclude that an expedited action is warranted, we may combine the notices of initiation and preliminary results of a changed circumstances review under 19 CFR 351.221(c)(3)(ii). In this instance, because we have on the record the information necessary to make a preliminary finding, we find that expedited action is warranted and have combined the notices of initiation and preliminary results.

    Preliminary Results of Expedited Changed Circumstances Review

    In making a successor-in-interest determination, the Department examines several factors including, but not limited to, changes in management, production facilities, supplier relationships, and customer base.7 While no single factor or combination of these factors will necessarily provide a dispositive indication of a successor-in-interest relationship, the Department will generally consider the new company to be the successor to the previous company if the new company's operations are not materially dissimilar to those of its predecessor.8 Thus, if the evidence demonstrates that, with respect to the production and sales of the subject merchandise, the new company operates as the same business entity as the former company, the Department will accord the new company the same antidumping treatment as its predecessor.9

    7See, e.g., Pressure Sensitive Plastic Tape from Italy: Preliminary Results of Antidumping Duty Changed Circumstances Review, 75 FR 8925 (February 26, 2010), unchanged in Pressure Sensitive Plastic Tape From Italy: Final Results of Antidumping Duty Changed Circumstances Review, 75 FR 27706 (May 18, 2010); and Brake Rotors From the People's Republic of China: Final Results of Changed Circumstances Antidumping Duty Administrative Review, 70 FR 69941 (November 18, 2005) (Brake Rotors), citing Brass Sheet and Strip from Canada; Final Results of Antidumping Duty Administrative Review, 57 FR 20460 (May 13, 1992).

    8See, e.g., Brake Rotors.

    9Id. See also e.g., Notice of Initiation and Preliminary Results of Antidumping Duty Changed Circumstances Review: Certain Frozen Warmwater Shrimp From India, 77 FR 64953 (October 24, 2012), unchanged in Final Results of Antidumping Duty Changed Circumstances Review: Certain Frozen Warmwater Shrimp From India, 77 FR 73619 (December 11, 2012).

    In its review request and in its responses to our two supplemental questionnaires,10 Wuhan Wanbang Co., Ltd., has provided evidence for us to preliminarily determine that it is the successor-in-interest to Wuhan Wanbang Co. Wuhan Wanbang Co., Ltd., states that its management, production facilities, and customer/supplier relationships have not changed as a result of changes to the legal status and name of the company.11 Wuhan Wanbang Co., Ltd., provided documents showing changes to the legal status and name of the company.12 Further, Wuhan Wanbang Co., Ltd., provided internal documents evidencing that: its domestic and overseas customers and suppliers have been the same before and after the changes to the company's legal status and name.13 Wuhan Wanbang Co., Ltd., also provided a list of members of the management team and supporting documentation indicating that Wuhan Wanbang Co.'s managers hold the same position in Wuhan Wanbang Co., Ltd., and documentation showing only small, insignificant changes to the members of the board of directors.14

    10See the review request and Wuhan Wanbang Co., Ltd.'s supplemental responses dated January 21, 2016, and February 3, 2016.

    11Id.

    12See, e.g., the review request at Exhibits 4 and 5.

    13See the review request at Exhibit 3, the January 21, 2016, supplemental response at Exhibits S-1 through S-3, and the February 3, 2016, supplemental response at Exhibits S2-1 through S2-3.

    14See the review request at Exhibit 3 and the January 21, 2016, supplemental response at Exhibit S-4.

    Based on record evidence, we preliminarily determine that Wuhan Wanbang Co., Ltd., is the successor-in-interest to Wuhan Wanbang Co. for purposes of antidumping duty liability because the changes to the legal status and name of the company resulted in no significant changes to management, production facilities, supplier relationships, and customers. As a result, we preliminarily determine that Wuhan Wanbang Co., Ltd., operates as the same business entity as Wuhan Wanbang Co. Thus, we preliminarily determine that Wuhan Wanbang Co., Ltd., should receive the same antidumping duty cash deposit rate with respect to the subject merchandise as Wuhan Wanbang Co., its predecessor company.

    Because cash deposits are only estimates of the amount of antidumping duties that will be due, changes in cash deposit rates are not made retroactive and, therefore, no change will be made to Wuhan Wanbang Co., Ltd.'s cash deposit rate as a result of these preliminary results. If Wuhan Wanbang Co., Ltd., believes that the deposits paid exceed the actual amount of dumping, it is entitled to request an administrative review during the anniversary month of the publication of the order of those entries, i.e., November, to determine the proper assessment rate and receive a refund of any excess deposits.15 As a result, if these preliminary results are adopted in our final results of this changed circumstances review, we will instruct CBP to suspend shipments of subject merchandise made by Wuhan Wanbang Co., Ltd., at Wuhan Wanbang Co.'s cash deposit rate effective on the publication date of our final results.

    15See Certain Hot-Rolled Lead and Bismuth Carbon Steel Products From the United Kingdom: Final Results of Changed-Circumstances Antidumping and Countervailing Duty Administrative Reviews, 64 FR 66880 (November 30, 1999).

    Public Comment

    Interested parties may submit case briefs no later than 14 days after the publication of this notice.16 Rebuttal briefs, which must be limited to issues raised in case briefs, may be filed not later than five days after the deadline for filing case briefs.17 Parties who submit case briefs or rebuttal briefs in this changed circumstance review are requested to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities. Interested parties who wish to comment on the preliminary results must file briefs electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov. An electronically-filed document must be received successfully in its entirety by the ACCESS no later than 5:00 p.m. Eastern Time on the date the document is due. Interested parties that wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS, within 14 days of publication of this notice.18 Parties will be notified of the time and date of any hearing, if requested.19

    16See 19 CFR 351.309(c)(ii).

    17See 19 CFR 351.309(d).

    18See 19 CFR 351.310(c). See also 19 CFR 351.303 for general filing requirements.

    19See 19 CFR 351.310.

    Notifications to Interested Parties

    Consistent with 19 CFR 351.216(e), we intend to issue the final results of this changed circumstances review no later than 270 days after the date on which this review was initiated, or within 45 days after the publication of the preliminary results if all parties in this review agree to our preliminary results. The final results will include the Department's analysis of issues raised in any written comments.

    This notice of initiation and preliminary results is in accordance with section 751(b)(1) of the Act, 19 CFR 351.216(b) and (d), and 19 CFR 351.221(b)(1).

    Dated: February 26, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-04711 Filed 3-2-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-533-867] Welded Stainless Pressure Pipe From India: Postponement of Preliminary Determination of Antidumping Duty Investigation AGENCY:

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

    DATES:

    Effective Date: March 3, 2016.

    FOR FURTHER INFORMATION CONTACT:

    James Terpstra, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3965.

    SUPPLEMENTARY INFORMATION: Background

    On October 20, 2015, the Department of Commerce (“Department”) initiated an antidumping duty investigation on welded stainless pressure pipe from India.1 As explained in the Memorandum from the Acting Assistant Secretary for Enforcement and Compliance, the Department has exercised its discretion to toll all administrative deadlines due to the recent closure of the Federal Government. All deadlines in this segment of the proceeding have been extended by four business days. The revised deadline for the preliminary determination of this investigation is no later than March 14, 2016.2

    1See Welded Stainless Pressure Pipe from India: Initiation of Antidumping Duty Investigation, 80 FR 65696 (October 27, 2015).

    2See Memorandum to the File from Ron Lorentzen, Acting Assistant Secretary for Enforcement and Compliance, “Tolling of Administrative Deadlines as a Result of the Government Closure during Snowstorm `Jonas',” dated January 27, 2016 (“Tolling Memorandum”).

    Postponement of Preliminary Determination

    Section 733(b)(1) of the Tariff Act of 1930, as amended (“the Act”), requires the Department to issue the preliminary determination in an antidumping duty investigation within 140 days after the date on which the Department initiated the investigation. However, if the petitioner makes a timely request for a postponement, section 733(c)(1)(A) of the Act allows the Department to postpone making the preliminary determination until no later than 190 days after the date on which the Department initiated the investigation. On February 9, 2016, Petitioners 3 submitted a timely request pursuant to section 733(c)(1)(A) of the Act and 19 CFR 351.205(e).4

    3 Bristol Metals LLC, Felker Brothers Corporation, Marcegaglia USA, Inc., and Outokumpu Stainless Pipe, Inc. (collectively, “Petitioners”).

    4See letter from Petitioners, “Welded Stainless Pressure Pipe from India: Request Extension for Preliminary Determination,” dated February 9, 2015.

    The Department finds that because there are no compelling reasons to deny Petitioners' request, the Department is postponing the deadline for the preliminary determination to no later than 190 days after the day on which the investigation was initiated, in accordance with section 733(c)(1)(A) of the Act, plus an additional four business days in accordance with the Tolling Memorandum. Accordingly, the Department will issue the preliminary determination no later than May 3, 2016. In accordance with section 735(a)(1) of the Act and 19 CFR 351.210(b)(1), the deadline for the final determination of this investigation will continue to be 75 days after the date of the preliminary determination, unless postponed at a later date.

    This notice is issued and published pursuant to section 733(c)(2) of the Act and 19 CFR 351.205(f)(1).

    Dated: February 26, 2016. Paul Piquado. Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-04719 Filed 3-2-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration Initiation of Antidumping and Countervailing Duty Administrative Reviews AGENCY:

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

    SUMMARY:

    The Department of Commerce (“the Department”) has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with January anniversary dates. In accordance with the Department's regulations, we are initiating those administrative reviews.

    DATES:

    Effective: March 3, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Brenda E. Waters, Office of AD/CVD Operations, Customs Liaison Unit, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW, Washington, DC 20230, telephone: (202) 482-4735.

    SUPPLEMENTARY INFORMATION: Background

    The Department has received timely requests, in accordance with 19 CFR 351.213(b), for administrative reviews of various antidumping and countervailing duty orders and findings with January anniversary dates.

    All deadlines for the submission of various types of information, certifications, or comments or actions by the Department discussed below refer to the number of calendar days from the applicable starting time.

    Notice of No Sales

    If a producer or exporter named in this notice of initiation had no exports, sales, or entries during the period of review (“POR”), it must notify the Department within 30 days of publication of this notice in the Federal Register. All submissions must be filed electronically at http://access.trade.gov in accordance with 19 CFR 351.303.1 Such submissions are subject to verification in accordance with section 782(i) of the Tariff Act of 1930, as amended (“the Act”). Further, in accordance with 19 CFR 351.303(f)(1)(i), a copy must be served on every party on the Department's service list.

    1See Antidumping and Countervailing Duty Proceedings: Electronic Filing Procedures; Administrative Protective Order Procedures, 76 FR 39263 (July 6, 2011).

    Respondent Selection

    In the event the Department limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, the Department intends to select respondents based on U.S. Customs and Border Protection (“CBP”) data for U.S. imports during the period of review. We intend to place the CBP data on the record within five days of publication of the initiation notice and to make our decision regarding respondent selection within 30 days of publication of the initiation Federal Register notice. Comments regarding the CBP data and respondent selection should be submitted seven days after the placement of the CBP data on the record of this review. Parties wishing to submit rebuttal comments should submit those comments five days after the deadline for the initial comments.

    In the event the Department decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act:

    In general, the Department has found that determinations concerning whether particular companies should be “collapsed” (i.e., treated as a single entity for purposes of calculating antidumping duty rates) require a substantial amount of detailed information and analysis, which often require follow-up questions and analysis. Accordingly, the Department will not conduct collapsing analyses at the respondent selection phase of this review and will not collapse companies at the respondent selection phase unless there has been a determination to collapse certain companies in a previous segment of this antidumping proceeding (i.e., investigation, administrative review, new shipper review or changed circumstances review). For any company subject to this review, if the Department determined, or continued to treat, that company as collapsed with others, the Department will assume that such companies continue to operate in the same manner and will collapse them for respondent selection purposes. Otherwise, the Department will not collapse companies for purposes of respondent selection. Parties are requested to (a) identify which companies subject to review previously were collapsed, and (b) provide a citation to the proceeding in which they were collapsed. Further, if companies are requested to complete the Quantity and Value (“Q&V”) Questionnaire for purposes of respondent selection, in general each company must report volume and value data separately for itself. Parties should not include data for any other party, even if they believe they should be treated as a single entity with that other party. If a company was collapsed with another company or companies in the most recently completed segment of this proceeding where the Department considered collapsing that entity, complete Q&V data for that collapsed entity must be submitted.

    Respondent Selection—Wooden Bedroom Furniture From the PRC

    In the event that the Department limits the number of respondents for individual examination in the antidumping duty administrative review of wooden bedroom furniture from the PRC, for the purposes of this segment of the proceeding, i.e., the 2015 review period, the Department intends to select respondents based on volume data contained in responses to a Q&V questionnaire. All parties are hereby notified that they must timely respond to the Q&V questionnaire. The Department's Q&V questionnaire along with certain additional questions will be available in a document package on the Department's Web site at http://enforcement.trade.gov/download/prc-wbf/ on the date this notice is published. The responses to the Q&V questionnaire should be filed with the respondents' Separate Rate Application or Separate Rate Certification (see the “Separate Rates” section below) and their response to the additional questions and must be received by the Department by no later than 30 days after publication of this notice. Please be advised that due to the time constraints imposed by the statutory and regulatory deadlines for antidumping duty administrative reviews, the Department does not intend to grant any extensions for the submission of responses to the Q&V questionnaire

    Deadline for Withdrawal of Request for Administrative Review

    Pursuant to 19 CFR 351.213(d)(1), a party that has requested a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that the Department may extend this time if it is reasonable to do so. In order to provide parties additional certainty with respect to when the Department will exercise its discretion to extend this 90-day deadline, interested parties are advised that the Department does not intend to extend the 90-day deadline unless the requestor demonstrates that an extraordinary circumstance has prevented it from submitting a timely withdrawal request. Determinations by the Department to extend the 90-day deadline will be made on a case-by-case basis.

    Separate Rates

    In proceedings involving non-market economy (“NME”) countries, the Department begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is the Department's policy to assign all exporters of merchandise subject to an administrative review in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.

    To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, the Department analyzes each entity exporting the subject merchandise under a test arising from the Final Determination of Sales at Less Than Fair Value: Sparklers from the People's Republic of China, 56 FR 20588 (May 6, 1991), as amplified by Final Determination of Sales at Less Than Fair Value: Silicon Carbide from the People's Republic of China, 59 FR 22585 (May 2, 1994). In accordance with the separate rates criteria, the Department assigns separate rates to companies in NME cases only if respondents can demonstrate the absence of both de jure and de facto government control over export activities.

    All firms listed below that wish to qualify for separate rate status in the administrative reviews involving NME countries must complete, as appropriate, either a separate rate application or certification, as described below. In addition, all firms that wish to qualify for separate-rate status in the antidumping duty administrative review of wooden bedroom furniture from the PRC must complete, as appropriate, either a separate-rate certification or application, as described below, and respond to the additional questions and the Q&V questionnaire on the Department's Web site at http://enforcement.trade.gov/download/prc-wbf/. For these administrative reviews, in order to demonstrate separate rate eligibility, the Department requires entities for whom a review was requested, that were assigned a separate rate in the most recent segment of this proceeding in which they participated, to certify that they continue to meet the criteria for obtaining a separate rate. The Separate Rate Certification form will be available on the Department's Web site at http://enforcement.trade.gov/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the certification, please follow the “Instructions for Filing the Certification” in the Separate Rate Certification. Separate Rate Certifications are due to the Department no later than 30 calendar days after publication of this Federal Register notice. For the antidumping duty administrative review of wooden bedroom furniture from the PRC, Separate Rate Certifications, as well as a response to the Q&V questionnaire and the additional questions in the document package, are due to the Department no later than 30 calendar days after publication of this Federal Register notice. The deadline and requirement for submitting a Certification applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers who purchase and export subject merchandise to the United States.

    Entities that currently do not have a separate rate from a completed segment of the proceeding 2 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. In addition, companies that received a separate rate in a completed segment of the proceeding that have subsequently made changes, including, but not limited to, changes to corporate structure, acquisitions of new companies or facilities, or changes to their official company name,3 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. The Separate Rate Status Application will be available on the Department's Web site at http://enforcement.trade.gov/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the Separate Rate Status Application, refer to the instructions contained in the application. Separate Rate Status Applications are due to the Department no later than 30 calendar days of publication of this Federal Register notice. For the antidumping duty administrative review of wooden bedroom furniture from the PRC, Separate Rate Status Applications, as well as a response to the Q&V questionnaire and the additional questions in the document package, are due to the Department no later than 30 calendar days after publication of this Federal Register notice. The deadline and requirement for submitting a Separate Rate Status Application applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers that purchase and export subject merchandise to the United States.

    2 Such entities include entities that have not participated in the proceeding, entities that were preliminarily granted a separate rate in any currently incomplete segment of the proceeding (e.g., an ongoing administrative review, new shipper review, etc.) and entities that lost their separate rate in the most recently completed segment of the proceeding in which they participated.

    3 Only changes to the official company name, rather than trade names, need to be addressed via a Separate Rate Application. Information regarding new trade names may be submitted via a Separate Rate Certification.

    For exporters and producers who submit a separate-rate status application or certification and subsequently are selected as mandatory respondents, these exporters and producers will no longer be eligible for separate rate status unless they respond to all parts of the questionnaire as mandatory respondents.

    Furthermore, this notice constitutes public notification to all firms for which an antidumping duty administrative review of wooden bedroom furniture has been requested, and that are seeking separate rate status in the review, that they must submit a timely separate rate application or certification (as appropriate) as described above, and a timely response to the Q&V questionnaire and the additional questions in the document package on the Department's Web site in order to receive consideration for separate-rate status. In other words, the Department will not give consideration to any timely separate rate certification or application made by parties who failed to respond in a timely manner to the Q&V questionnaire and the additional questions. All information submitted by respondents in the antidumping duty administrative review of wooden bedroom furniture from the PRC is subject to verification. As noted above, the separate rate certification, the separate rate application, the Q&V questionnaire, and the additional questions will be available on the Department's Web site on the date of publication of this notice in the Federal Register.

    Initiation of Reviews

    In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than January 31, 2017.

    BILLING CODE 3510-DS-P EN03MR16.003 EN03MR16.004 EN03MR16.005 EN03MR16.006 EN03MR16.007 BILLING CODE 3510-DS-C Duty Absorption Reviews

    During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an antidumping duty order under 19 CFR 351.211 or a determination under 19 CFR 351.218(f)(4) to continue an order or suspended investigation (after sunset review), the Secretary, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine, consistent with FAG Italia v. United States, 291 F.3d 806 (Fed Cir. 2002), as appropriate, whether antidumping duties have been absorbed by an exporter or producer subject to the review if the subject merchandise is sold in the United States through an importer that is affiliated with such exporter or producer. The request must include the name(s) of the exporter or producer for which the inquiry is requested.

    Gap Period Liquidation

    For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional-measures “gap” period, of the order, if such a gap period is applicable to the POR.

    Administrative Protective Orders and Letters of Appearance

    Interested parties must submit applications for disclosure under administrative protective orders in accordance with 19 CFR 351.305. On January 22, 2008, the Department published Antidumping and Countervailing Duty Proceedings: Documents Submission Procedures; APO Procedures, 73 FR 3634 (January 22, 2008). Those procedures apply to administrative reviews included in this notice of initiation. Parties wishing to participate in any of these administrative reviews should ensure that they meet the requirements of these procedures (e.g., the filing of separate letters of appearance as discussed at 19 CFR 351.103(d)).

    Revised Factual Information Requirements

    On April 10, 2013, the Department published Definition of Factual Information and Time Limits for Submission of Factual Information: Final Rule, 78 FR 21246 (April 10, 2013), which modified two regulations related to antidumping and countervailing duty proceedings: The definition of factual information (19 CFR 351.102(b)(21)), and the time limits for the submission of factual information (19 CFR 351.301). The final rule identifies five categories of factual information in 19 CFR 351.102(b)(21), which are summarized as follows: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by the Department; and (v) evidence other than factual information described in (i)-(iv). The final rule requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. The final rule also modified 19 CFR 351.301 so that, rather than providing general time limits, there are specific time limits based on the type of factual information being submitted. These modifications are effective for all segments initiated on or after May 10, 2013. Please review the final rule, available at http://enforcement.trade.gov/frn/2013/1304frn/2013-08227.txt, prior to submitting factual information in this segment.

    Any party submitting factual information in an antidumping duty or countervailing duty proceeding must certify to the accuracy and completeness of that information.7 Parties are hereby reminded that revised certification requirements are in effect for company/government officials as well as their representatives. All segments of any antidumping duty or countervailing duty proceedings initiated on or after August 16, 2013, should use the formats for the revised certifications provided at the end of the Final Rule. 8 The Department intends to reject factual submissions in any proceeding segments if the submitting party does not comply with applicable revised certification requirements.

    7See section 782(b) of the Act.

    8See Certification of Factual Information To Import Administration During Antidumping and Countervailing Duty Proceedings, 78 FR 42678 (July 17, 2013) (“Final Rule”); see also the frequently asked questions regarding the Final Rule, available at http://enforcement.trade.gov/tlei/notices/factual_info_final_rule_FAQ_07172013.pdf.

    Revised Extension of Time Limits Regulation

    On September 20, 2013, the Department modified its regulation concerning the extension of time limits for submissions in antidumping and countervailing duty proceedings: Final Rule, 78 FR 57790 (September 20, 2013). The modification clarifies that parties may request an extension of time limits before a time limit established under Part 351 expires, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the time limit established under Part 351 expires. For submissions which are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. on the due date. Examples include, but are not limited to: (1) Case and rebuttal briefs, filed pursuant to 19 CFR 351.309; (2) factual information to value factors under 19 CFR 351.408(c), or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2), filed pursuant to 19 CFR 351.301(c)(3) and rebuttal, clarification and correction filed pursuant to 19 CFR 351.301(c)(3)(iv); (3) comments concerning the selection of a surrogate country and surrogate values and rebuttal; (4) comments concerning U.S. Customs and Border Protection data; and (5) quantity and value questionnaires. Under certain circumstances, the Department may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, the Department will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. This modification also requires that an extension request must be made in a separate, stand-alone submission, and clarifies the circumstances under which the Department will grant untimely-filed requests for the extension of time limits. These modifications are effective for all segments initiated on or after October 21, 2013. Please review the final rule, available at http://www.thefederalregister.org/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm, prior to submitting factual information in these segments.

    These initiations and this notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.221(c)(1)(i).

    Dated: February 25, 2016. Gary Taverman, Associate Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2016-04702 Filed 3-2-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-560-829, C-570-023] Certain Uncoated Paper From Indonesia and the People's Republic of China: Amended Final Affirmative Countervailing Duty Determination and Countervailing Duty Order (Indonesia) and Countervailing Duty Order (People's Republic of China) AGENCY:

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

    SUMMARY:

    Based on affirmative final determinations by the Department of Commerce (the Department) and the International Trade Commission (ITC), the Department is issuing countervailing duty (CVD) orders on certain uncoated paper from Indonesia and the People's Republic of China (PRC). Also, as explained in this notice, the Department is amending its final affirmative determination with respect to Indonesia to correct the rates assigned to APRIL Fine Paper Macao Commercial Offshore Limited/PT Anugrah Kertas Utama/PT Riau Andalan Kertas/PT Intiguna Primatama/PT Riau Andalan Pulp & Paper/PT Esensindo Cipta Cemerlang (the APRIL companies); Great Champ Trading Limited (Great Champ); Indah Kiat Pulp & Paper TBK/Pabrik Kertas Tjiwi Kimia/PT Pindo Deli Pulp and Paper Mills (IK/TK/PD); and All-Others.

    DATES:

    Effective Date: March 3, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Indonesia: David Goldberger, Office II, telephone: (202) 482-4136; PRC: Joy Zhang, Office III, telephone: (202) 482-1168; AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.

    SUPPLEMENTARY INFORMATION: Background

    On January 8, 2016, the Department issued its final determinations in the CVD investigations of certain uncoated paper from Indonesia and the PRC.1

    1See Certain Uncoated Paper From Indonesia: Final Affirmative Countervailing Duty Determination, 81 FR 3104 (January 20, 2016) (Indonesia Final Determination); Certain Uncoated Paper From the People's Republic of China: Final Affirmative Countervailing Duty Determination, 81 FR 3110 (January 20, 2016).

    On January 19, 2016, the Department received a timely allegation from Asia Symbol (Guangdong) Paper Co., Ltd. (AS Guangdong) and its cross-owned affiliates, Asia Symbol (Guangdong) Omya Minerals Co., Ltd. (AS Omya), Asia Symbol (Shandong) Pulp & Paper Co. (AS Shandong), and Greenpoint Global Trading (Macao Commercial Offshore) Limited (Greenpoint) (collectively, Asia Symbol) that the Department made ministerial errors in the final determination in the CVD investigation of certain uncoated paper from the PRC.2 On January 27, 2016, the Department received comments from the petitioners 3 on Asia Symbol's ministerial error allegation.4 The Department analyzed the allegation submitted by Asia Symbol and determined that no ministerial errors exist, as defined by section 705(e) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.224(f).5

    2See Letter from Asia Symbol, “Certain Uncoated Paper from the People's Republic of China: Ministerial Error Comments, dated January 19, 2016.

    3 The petitioners are United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union (USW); Domtar Corporation; Finch Paper LLC; P.H. Glatfelter Company; and Packaging Corporation of America (collectively, the petitioners).

    4See Letter from the petitioners, “Certain Uncoated Paper From the People's Republic of China: Petitioners' Response To Asia Symbol's Ministerial Error Comments,” dated January 27, 2016.

    5See Memorandum “Allegations of Ministerial Errors in the Final Determination,” dated February 1, 2016.

    On January 19, 2016, the APRIL companies submitted a timely ministerial error allegation, as amended on January 28, 2016, and requested that the Department correct the alleged ministerial error in the subsidy rate calculations.6 No other interested party submitted ministerial error allegations or rebuttals to the APRIL companies' submissions. The Department analyzed the allegation submitted by the APRIL companies and determined that ministerial errors exist, as defined by section 705(e) of the Act and 19 CFR 351.224(f). 7 See “Amendment to the Indonesia CVD Final Determination” section, below for further discussion.

    6See Letter from the APRIL companies, “Certain Uncoated Paper from Indonesia: Ministerial Error Comments,” dated January 19, 2016; Letter from the APRIL companies, “Certain Uncoated Paper from Indonesia: Amended Ministerial Error Comments—AKU—APRIL,” dated January 28, 2016.

    7See Memorandum “Ministerial Error Allegations in the Final Determination,” dated February 17, 2016 (Ministerial Error Decision Memorandum).

    On February 22, 2016, the ITC notified the Department of its final determinations pursuant to section 705(b)(1)(A)(i) and section 705(d) of the Act, that an industry in the United States is materially injured by reason of subsidized imports of subject merchandise from Indonesia and the PRC.8

    8See Letter to Christian Marsh, Deputy Assistant Secretary of Commerce for Enforcement and Compliance, from Meredith Broadbent, Chairman of the U.S. International Trade Commission, regarding certain uncoated paper from Australia, Brazil, China, Indonesia, and Portugal (February 22, 2016). See also Certain Uncoated Paper from Australia, Brazil, China, Indonesia, and Portugal, USITC Investigation Nos. 701-TA-528-529 and 731-TA-1264-1268 (Final), USITC Publication 4592 (February 2016).

    Scope of the Orders

    The merchandise subject to these orders includes uncoated paper in sheet form; weighing at least 40 grams per square meter but not more than 150 grams per square meter; that either is a white paper with a GE brightness level 9 of 85 or higher or is a colored paper; whether or not surface-decorated, printed (except as described below), embossed, perforated, or punched; irrespective of the smoothness of the surface; and irrespective of dimensions (Certain Uncoated Paper).

    9 One of the key measurements of any grade of paper is brightness. Generally speaking, the brighter the paper the better the contrast between the paper and the ink. Brightness is measured using a GE Reflectance Scale, which measures the reflection of light off a grade of paper. One is the lowest reflection, or what would be given to a totally black grade, and 100 is the brightest measured grade. “Colored paper” as used in this scope definition means a paper with a hue other than white that reflects one of the primary colors of magenta, yellow, and cyan (red, yellow, and blue) or a combination of such primary colors.

    Certain Uncoated Paper includes (a) uncoated free sheet paper that meets this scope definition; (b) uncoated ground wood paper produced from bleached chemi-thermo-mechanical pulp (BCTMP) that meets this scope definition; and (c) any other uncoated paper that meets this scope definition regardless of the type of pulp used to produce the paper.

    Specifically excluded from the scope of these orders are (1) paper printed with final content of printed text or graphics and (2) lined paper products, typically school supplies, composed of paper that incorporates straight horizontal and/or vertical lines that would make the paper unsuitable for copying or printing purposes. For purposes of this scope definition, paper shall be considered “printed with final content” where at least one side of the sheet has printed text and/or graphics that cover at least five percent of the surface area of the entire sheet.

    Imports of the subject merchandise are provided for under Harmonized Tariff Schedule of the United States (HTSUS) categories 4802.56.1000, 4802.56.2000, 4802.56.3000, 4802.56.4000, 4802.56.6000, 4802.56.7020, 4802.56.7040, 4802.57.1000, 4802.57.2000, 4802.57.3000, and 4802.57.4000. Some imports of subject merchandise may also be classified under 4802.62.1000, 4802.62.2000, 4802.62.3000, 4802.62.5000, 4802.62.6020, 4802.62.6040, 4802.69.1000, 4802.69.2000, 4802.69.3000, 4811.90.8050 and 4811.90.9080. While HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope is dispositive.

    Amendment to the Indonesia CVD Final Determination

    As discussed above, after analyzing the comments received, we determined, in accordance with section 705(e) of the Act and 19 CFR 351.224(e), that we made ministerial errors in certain calculations for the Indonesia Final Determination with respect to the APRIL companies. This amended final CVD determination corrects these errors and revises the ad valorem subsidy rate for the APRIL companies to 21.21 percent, Great Champ to 103.99 percent, IK/TK/PD to 109.14 percent, and All-Others to 21.21 percent.10

    10See Ministerial Error Decision Memorandum at 3.

    Countervailing Duty Orders

    In accordance with sections 705(b)(1)(A)(i) and 705(d) of the Act, the ITC notified the Department of its final determinations that the industry in the United States producing certain uncoated paper is materially injured by reason of subsidized imports of certain uncoated paper from Indonesia and the PRC. Therefore, in accordance with section 705(c)(2) of the Act, we are publishing these CVD orders.

    As a result of the ITC's final determinations, in accordance with section 706(a) of the Act, the Department will direct U.S. Customs and Border Protection (CBP) to assess, upon further instruction by the Department, CVDs on unliquidated entries of certain uncoated paper entered, or withdrawn from warehouse, for consumption on or after June 29, 2015, the date on which the Department published its preliminary CVD determinations in the Federal Register,11 and before October 27, 2015, the date on which the Department instructed CBP to discontinue the suspension of liquidation in accordance with section 703(d) of the Act. Section 703(d) of the Act states that the suspension of liquidation pursuant to a preliminary determination may not remain in effect for more than four months. Therefore, entries of certain uncoated paper made on or after October 27, 2015, and prior to the date of publication of the ITC's final determinations in the Federal Register are not liable for the assessment of CVDs due to the Department's discontinuation, effective October 27, 2015, of the suspension of liquidation.

    11See Certain Uncoated Paper From Indonesia: Preliminary Affirmative Countervailing Duty Determination and Alignment of Final Determination With Final Antidumping Determination, 80 FR 36971 (June 29, 2015); Certain Uncoated Paper From the People's Republic of China: Preliminary Affirmative Countervailing Duty Determination and Alignment of Final Determination With Final Antidumping Determination, 80 FR 36968 (June 29, 2015).

    Suspension of Liquidation

    In accordance with section 706 of the Act, the Department will direct CBP to reinstitute the suspension of liquidation of certain uncoated paper from Indonesia and the PRC, effective the date of publication of the ITC's notice of final determinations in the Federal Register, and to assess, upon further advice by the Department pursuant to section 706(a)(1) of the Act, CVDs for each entry of the subject merchandise in an amount based on the net countervailable subsidy rates for the subject merchandise. On or after the date of publication of the ITC's final injury determinations in the Federal Register, CBP must require, at the same time as importers would normally deposit estimated duties on this merchandise, a cash deposit equal to the rates noted below:

    Indonesia Company Amended
  • subsidy rate
  • (percent)
  • APRIL Fine Paper Macao Commercial Offshore Limited/PT Anugrah Kertas Utama/PT Riau Andalan Kertas/PT Intiguna Primatama/PT Riau Andalan Pulp & Paper/PT Esensindo Cipta Cemerlang 21.21 Great Champ Trading Limited 103.99 Indah Kiat Pulp & Paper TBK/Pabrik Kertas Tjiwi Kimia/PT Pindo Deli Pulp and Paper Mills 109.14 All-Others 21.21
    People's Republic of China Company Subsidy rate
  • (percent)
  • Asia Symbol (Guangdong) Paper Co., Ltd. (AS Guangdong), Asia Symbol (Shandong) Pulp & Paper Co., Ltd. (AS Shandong), Asia Symbol (Guangdong) Omya Minerals Co., Ltd. (AS Omya), and Greenpoint Global Trading (Macao Commercial Offshore) Limited (Greenpoint) (collectively, Asia Symbol Companies) 7.23 Shandong Sun Paper Industry Joint Stock Co., Ltd. (Shandong Sun Paper), and Sun Paper (Hong Kong) Co., Ltd. (Sun Paper HK) (collectively, Sun Paper Companies) 176.75 UPM (China) Co. Ltd. (UPM) 176.75 All-Others 7.23

    This notice constitutes the CVD orders with respect to certain uncoated paper from Indonesia and the PRC, pursuant to section 706(a) of the Act. Interested parties may contact the Department's Central Records Unit, Room B8024 of the main Commerce Building, for a copy of an updated list of CVD orders currently in effect.

    These orders are issued and published in accordance with section 706(a) of the Act and 19 CFR 351.211(b).

    Dated: February 25, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-04717 Filed 3-2-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE456 Pacific Fishery Management Council; Notice of Intent To Prepare an Environmental Impact Statement AGENCY:

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

    ACTION:

    Notice of intent to prepare an environmental impact statement (EIS); request for comments.

    SUMMARY:

    NMFS and the Pacific Fishery Management Council (Council) announce their intent to prepare an EIS in accordance with the National Environmental Policy Act (NEPA) of 1969 to analyze the impacts on the human (biological, physical, social, and economic) environment of gear changes in the Pacific Coast Groundfish Fishery's Trawl Catch Share Program, also called the Trawl Rationalization Program. This notice also requests written comment.

    DATES:

    Public scoping will be conducted through this notice. Comments must be received by 5 p.m. Pacific Standard Time on April 4, 2016 (see SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    You may submit comments on issues and alternatives by any of the following methods:

    Email: [email protected]

    Mail: Submit written comments to William W. Stelle, Jr., Regional Administrator, West Coast Region, NMFS, 7600 Sand Point Way NE., Seattle, WA 98115-0070; Attn: Jamie Goen.

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS.

    FOR FURTHER INFORMATION CONTACT:

    Jamie Goen, NMFS West Coast Region at 206-526-4656 or [email protected]

    SUPPLEMENTARY INFORMATION: Background for Agency Action

    There are more than 90 species managed under the Pacific Coast Groundfish Fishery Management Plan (Groundfish FMP). These groundfish stocks support an array of commercial, recreational, and tribal fishing interests in state and Federal waters off the coasts of Washington, Oregon, and California. In addition, groundfish are harvested incidentally in non-groundfish fisheries; most notably, the trawl fisheries for pink shrimp and California halibut.

    The Trawl Catch Share Program was implemented in 2011, changing how the groundfish limited entry trawl fishery is managed. The Trawl Catch Share Program replaced the need for some, but not all, of the trip-limit structure in Federal regulations, and modified regulations for the at-sea fleets. Some of the remaining pre-Trawl Catch Share Program regulations may unnecessarily constrain harvest efficiency and effectiveness under a catch share framework. Pre-Trawl Catch Share Program regulations that managed the fleet as a whole may need to be updated or may no longer be appropriate for managing individuals operating under the incentives provided by catch shares.

    Proposed Action

    The proposed action is to revise groundfish gear regulations for the Trawl Catch Share Program, including trawl gear configuration and gear use. The proposed action may include the following gear regulation changes:

    • Loosening or eliminating the minimum mesh size requirement for bottom trawl;

    • Updating the procedure for measuring mesh sizes;

    • Loosening or eliminating cod-end regulations;

    • Loosening or eliminating selective flatfish trawl gear requirements and restrictions (Large and small footrope distinctions would remain.);

    • Loosening or eliminating chafing gear regulations;

    • Allowing vessels to carry and/or use multiple gear types on a single trip;

    • Allowing a gear to be fished in multiple management areas on the same trip; and

    • Allowing a vessel's next gear deployment to start before all fish from the previous deployment have been stowed.

    The proposed action may affect fishing in the Trawl Catch Share Program by any or all of the gear types that participate in the fishery, including bottom trawl (small and large footrope), midwater trawl, and legal groundfish nontrawl gear. The intent of the proposed action is to further the goals of Amendment 20 to the Groundfish FMP and the Trawl Catch Share Program consistent with Magnuson-Stevens Fishery Conservation and Management Act requirements and other applicable laws.

    Alternatives

    NEPA requires that agencies evaluate reasonable alternatives to the proposed action, which address the purpose and need for agency action. The Council adopted a preliminary range of alternatives for analysis and public review at its September 2015 meeting, and further refined the range at its November 2015 meeting.

    The range of alternatives for this action are organized within eight gear-related issues (Issue A through Issue H) and parallel the bulleted list in the “Proposed Action” section. The range of alternatives for each issue is described below. The Council is currently scheduled to select a final preferred alternative at its March 8-14, 2016, meeting. However, there is a possibility that final Council decision-making could occur at its April or June meetings.

    Issue A—Minimum Mesh Size

    Mesh size requirements are intended to reduce the catch of juvenile and small unmarketable fish. This action would change the minimum mesh size for bottom trawl and midwater trawl. Alternative A1 (No-action) would continue to be 4.5 inches for bottom trawl and 3 inches for midwater trawl. Alternative A2 would shift the minimum mesh size to 4 inches for bottom trawl only. Alternative A3 would not specify a minimum mesh size for bottom trawl or midwater trawl.

    Issue B—Measuring Mesh Size

    The alternatives under Issue B apply to how mesh size is measured and could apply to any of the minimum mesh size alternatives under Issue A. Alternative B1 (No-action) would continue to measure trawl mesh size between the inside of the one knot to the inside of the opposing knot, regardless of twine size. Alternative B2 would measure the opening between opposing knots or, in knotless webbing, between opposing corners, regardless of twine size.

    Issue C—Codend

    The codend is the terminal, closed end of a trawl net. Alternative C1 (No-action) would require only single-walled codends in any trawl. Double-walled codends would still be prohibited. Alternative C2 would remove codend restrictions from Federal regulations.

    Issue D—Selective Flatfish Trawl

    Selective flatfish trawl (SFFT) is a type of small footrope trawl. Alternative D1 (No-action) would require a two-seamed net with no more than two riblines, excluding the codend. The breastline would remain no longer than 3 feet. No floats along the center third of the headrope or attached to the top panel would be allowed, except on riblines. The footrope would be less than 105 feet long. The headrope would not be less than 30 percent longer than the footrope under this alternative. The areas fished with SFFT are as follows (§ 660.130(c)(2)(i)):

    • North of 40°10′ N. latitude, selective flatfish gear is required shoreward of the Rockfish Conservation Area (RCA).

    • South of 40°10′ N. latitude, selective flatfish gear is permitted, but not required, shoreward of the RCA.

    • The use of selective flatfish trawl gear is permitted seaward of the RCA coastwide.

    Alternative D2 would modify the SFFT definition to allow a two-seam or a four-seam net. Areas fished would remain as stated in the No-action Alternative.

    Alternative D3 would modify the SFFT definition to allow a two-seam or a four-seam net. The SSFT requirement shoreward of the RCA north of 40°10′ N. latitude would be eliminated. It would be replaced with a small footrope requirement (like the requirement south of 40°10′ N. latitude). Requirements shoreward of the RCA south of 40°10′ N. latitude and seaward of the RCA coastwide would remain as stated in the No-action Alternative.

    Issue E—Chafing Gear

    Chafing gear is webbing or other material attached to the codend to protect it from wear. The decision on codends under Issue C (Alternatives C1 and C2) may affect the issue of chafing gear should Alternative C2 be chosen. Alternative C2 would allow double-walled codends, and chafing gear could be used to create a double-walled codend.

    Alternative E1 (No-action) would continue to have chafing gear for bottom trawl encircle no more than 50 percent of the net's circumference and could be in one or more sections. It could be used on only the last 50 meshes, measured from the terminal edge (closed end) of the codend. Only the front edge (that closest to the open end of the codend) and sides of each section of chafing gear could be attached to the codend. Except at the corners, the terminal edge (that edge closest to the closed end of the codend) of each section of chafing gear could not be attached to the net. The chafing gear would have to be attached outside of any riblines and restraining straps.

    Alternative E2 would align bottom trawl chafing gear restrictions with recent changes to midwater trawl chafing gear restrictions specified in regulation at 50 CFR 660.130(b)(4)(i) and (ii). These changes would allow the chafing gear to cover more of the codend than the No-action Alternative. Generally, the bottom trawl chafing gear restriction would be revised to read as follows:

    Chafing gear may cover the bottom and sides of the codend in either one or more sections. Only the front edge (edge closest to the open end of the codend) and sides of each section of chafing gear may be attached to the codend; except at the corners, the terminal edge (edge closest to the closed end of the codend) of each section of chafing gear must not be attached to the net. Chafing gear is not permitted on the top codend panel except that a band of mesh (a “skirt”) may encircle the net under or over transfer cables, lifting or splitting straps (chokers), riblines, and restraining straps, but must be the same mesh size and coincide knot-to-knot with the net to which it is attached and be no wider than 16 meshes.

    Alternative E3 would eliminate chafing gear restrictions for bottom trawl and midwater trawl gear. Chafing gear could be used, but regulations would not restrict how much of the codend or net it covers nor where it is connected to the net.

    Issue F—Multiple Gears

    A vessel may carry a number of different gears while participating in the groundfish trawl sector. This issue considers allowing multiple types of fishing gear on the vessel during a single trip. The term “fixed gear” as used in Issue F is shorthand for all legal groundfish non-trawl gear. Under the gear switching provision in the Shorebased Individual Fishing Quota (IFQ) Program, several fixed gears are permissible. As stated in the regulations at § 660.130(k) on gear switching, participants can also fish for IFQ species “using any legal groundfish non-trawl gear.” Referring to the definitions section at § 660.11 in Federal regulations, legal groundfish non-trawl gear includes non-trawl gear used by both the limited entry fixed gear and open access fisheries as follows:

    • Longline,

    • trap or pot,

    • set net (anchored gillnet or trammel net, which are permissible south of 38° N. lat. only),

    • hook-and-line (fixed or mobile, including commercial vertical hook-and-line), and

    • spear.

    Alternative F1 (No-action) would restrict vessels to one type of trawl gear (bottom or midwater) onboard per trip. For bottom trawl gear, both small footrope and large footrope could be on the vessel and fished during a single fishing trip. Multiple fixed gear types would be allowed onboard each trip. Trawl gear and fixed gear would not be permitted onboard during the same trip. Only one type of gear can be fished per trip.

    Alternative F2 would allow multiple trawl gear types (bottom and midwater) onboard on the same trip. The same as under the No-action Alternative, multiple fixed gear types would be allowed onboard during each trip. Trawl vessels would not be allowed to have trawl and fixed gear onboard on the same trip. Vessel operators could use only one gear type per trip (bottom trawl, midwater trawl, or fixed gear). For bottom trawl gear, both small footrope and large footrope could be fished during a single fishing trip.

    Alternative F3 would allow multiple gear types onboard on the same trip. In addition, they could be used on the same trip as follows:

    • Gear Type Sub-option A: Any trawl gear could be used (bottom and midwater).

    • Gear Type Sub-option B: Any legal IFQ groundfish gear could be used.

    • Sorting Sub-option A: Vessel operators must separate catch by gear type. Landings must be recorded on a separate electronic fish ticket by gear type.

    • Sorting Sub-option B: Catch by gear type could be comingled.

    Under Alternative F3, gear type sub-options would be independent of sorting options.

    Issue G—Fishing in Multiple IFQ Management Areas

    The Shorebased IFQ Program includes IFQ management areas, specified in regulation at § 660.140(c)(2), that are based on the stock information for select species, harvest allocations, and the corresponding quota share for species. The IFQ management areas are as follows:

    • Between the U.S./Canada border and 40°10′ N. latitude,

    • Between 40°10′ N. latitude and 36° N. latitude,

    • Between 36° N. latitude and 34°27′ N. latitude, and

    • Between 34°27′ N. latitude and the U.S./Mexico border.

    Alternative G1 (No-action) would maintain the restriction that vessels participating in the Shorebased IFQ Program may not fish in more than one IFQ management area on the same trip.

    Alternative G2 would allow fishing in multiple IFQ management areas on the same trip. This would create opportunities to shift from one management area to another during a fishing trip. If retaining catch from multiple IFQ management areas on a single trip, then the catch would have to be sorted by IFQ management area and recorded on separate electronic fish tickets.

    Issue H—Fishing Before Previous Catch Is Stowed

    To track catch accurately to the haul level, regulations require previous catch to be stowed before a new haul is brought onboard the vessel. Alternative H1 (No-action) would continue to prohibit vessels in the Shorebased IFQ Program from bringing a haul on board before all catch from the previous haul has been stowed. Alternative H2, in the Shorebased IFQ Program, would allow a new haul to be brought onboard and dumped on deck before all catch from the previous haul has been stowed. Catch from different hauls would have to be kept separate until the observers could complete their collection of catch for sampling.

    Preliminary Identification of Environmental Issues

    A principal objective of the scoping and public input process is to identify potentially significant impacts to the human environment that should be analyzed in depth in the EIS. If, during the preparation of this EIS, NMFS determines that a finding of no significant impact can be supported, it may prepare an Environmental Assessment (EA) and issue a retraction of this notice. Alternatively, NMFS may still continue with the preparation of an EIS. Information and analysis prepared for this action also may be used when scoping future groundfish actions to help decide whether to prepare an EA or EIS.

    Some alternatives may have significant impacts on the human environment. The proposed action to change mesh size, change codend restrictions, and eliminate selective flatfish trawl gear may negatively impact some species listed under the Endangered Species Act (ESA), including salmon and eulachon. In addition, there may be an impact on stock productivity for many species if changing the trawl mesh size or removing codend restrictions causes smaller fish to be harvested. There may be increased uncertainty in total mortality estimates for all species from allowing multiple gears to be fished during a trip. The EIS will also consider the cumulative effects of the proposed action with any past, present or reasonably foreseeable future actions. In particular, the gear changes in the Trawl Catch share Program will need to be considered in light of upcoming changes to monitoring with electronic monitoring and changes to habitat and overfished species protections with Essential Fish Habitat and RCA actions. Through the public scoping process and as the EIS is drafted, additional potentially significant impacts may be identified.

    Request for Comments

    NMFS provides this notice to: (1) Advise the public and other agencies of its plans to analyze effects related to the action, and (2) obtain suggestions and information that may be useful to the scope of issues and the full range of alternatives to include in the EIS.

    NMFS invites comment from all interested parties to ensure that the full range of issues related to gear changes in the Pacific Coast Groundfish Fishery's Trawl Catch Share Program are identified. NMFS is specifically inviting comments on the proposed alternatives described above. In addition, NMFS invites comments on the potential impacts of these alternatives and further details of how fishermen are likely to operate under these alternatives. For example, NMFS invites comments on the potential impacts of the alternatives given changes being considered by the Council on electronic monitoring, essential fish habitat, and rockfish conservation areas. Comments should be as specific as possible.

    Written comments concerning the proposed action and the environmental review should be directed to NMFS as described above (see ADDRESSES). All comments and materials received, including names and addresses, will become part of the administrative record and may be released to the public.

    Public Scoping Process

    Public scoping will be conducted through this notice. In addition, further participation by the public will occur throughout the Council's decision-making process. All decisions during the Council process benefit from written and oral public comments delivered prior to or during the Council meeting. These public comments are considered integral to scoping for developing this EIS. Future Council meetings that offer opportunities for public involvement include the March 8-14, 2016, meeting in Sacramento, California (DoubleTree by Hilton Sacramento, 2001 Point West Way, Sacramento, CA 95815). Other future opportunities for public involvement may arise and will be posted in the Council Briefing Book (on the Council's Web site (http://www.pcouncil.org/council-operations/briefing-books/) prior to the meeting. For further information on these meetings, visit the Council's Web site, http://www.pcouncil.org/council-operations/council-meetings/future-meetings/.

    Special Accommodations

    The Council meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kris Kleinschmidt at [email protected] or (503) 820-2280 at least 5 days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: February 26, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-04612 Filed 3-2-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE476 Mid-Atlantic Fishery Management Council (MAFMC); Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The Mid-Atlantic Fishery Management Council's (MAFMC) Collaborative Research Committee will hold a closed meeting to review and make recommendations on collaborative research project proposals.

    DATES:

    The meeting will be held on Wednesday, March 23, 2016, from 9:30 a.m. to 4:30 p.m. For agenda details, see SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    The meeting will be held at the Double Tree by Hilton Baltimore—BWI Airport, 890 Elkridge Landing Road, Linthicum, Maryland 21090; telephone: (410) 859-8400.

    Council address: Mid-Atlantic Fishery Management Council, 800 N. State Street, Suite 201, Dover, DE 19901; telephone: (302) 674-2331 or on their Web site at www.mafmc.org.

    FOR FURTHER INFORMATION CONTACT:

    Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.

    SUPPLEMENTARY INFORMATION: Agenda

    The MAFMC's Collaborative Research Committee will hold a closed meeting to review and make recommendations on collaborative research project proposals. In December 2015, the Council published a Request for Proposals (RFP) for collaborative research projects that address seven research priorities. During the meeting, the Collaborative Research Committee will review and make funding recommendations on the proposals that were submitted in response to the RFP.

    Special Accommodations

    These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: February 29, 2016. Tracey L. Thompson, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-04667 Filed 3-2-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE472 Endangered and Threatened Species; Take of Anadromous Fish AGENCY:

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

    ACTION:

    Notice; availability of joint state/tribal hatchery plans and request for comment.

    SUMMARY:

    Notice is hereby given that the Washington Department of Fish and Wildlife, the Port Gamble S'Klallam Tribe, the Skokomish Tribe, and the United States Fish and Wildlife Service have submitted 10 Hatchery and Genetic Management Plans, to be considered jointly, to NMFS pursuant to the limitation on take prohibitions for actions conducted under Limit 6 of the 4(d) Rule for salmon and steelhead promulgated under the Endangered Species Act (ESA). The plans specify the propagation of five species of salmon in the Hood Canal region of Washington State. This document serves to notify the public of the availability for comment of the proposed evaluation of the Secretary of Commerce (Secretary) as to whether implementation of the joint plans will appreciably reduce the likelihood of survival and recovery of ESA-listed Puget Sound Chinook salmon and Puget Sound steelhead.

    This notice further advises the public of the availability for review of a draft Environmental Assessment of the effects of the NMFS determination on the subject joint plans.

    DATES:

    Comments must be received at the appropriate address or fax number (see ADDRESSES) no later than 5 p.m. Pacific time on April 4, 2016.

    ADDRESSES:

    Written comments on the proposed evaluation and pending determination should be addressed to the NMFS Sustainable Fisheries Division, 1201 NE Lloyd Blvd., Portland, OR 97232. Comments may be submitted by email. The mailbox address for providing email comments is: [email protected] Include in the subject line of the email comment the following identifier: Comments on Hood Canal hatchery programs.

    FOR FURTHER INFORMATION CONTACT:

    Charlene Hurst at (503) 230-5409 or by email at [email protected]

    SUPPLEMENTARY INFORMATION: ESA-Listed Species Covered in This Notice

    Chinook salmon (Oncorhynchus tshawytscha): Threatened, naturally produced and artificially propagated Puget Sound.

    Steelhead (O. mykiss): Threatened, naturally produced and artificially propagated Puget Sound.

    Chum salmon (O. keta): Threatened, naturally produced and artificially propagated Hood Canal summer-run.

    Bull trout (Salvelinus confluentus): Threatened Puget Sound/Washington Coast.

    Background

    The Washington Department of Fish and Wildlife, the Port Gamble S'Klallam Tribe, the Skokomish Tribe, and the United States Fish and Wildlife Service have submitted to NMFS plans for 10 jointly operated hatchery programs in the Hood Canal region. The plans were submitted from November 2012 to September 2013, pursuant to limit 6 of the 4(d) Rule for ESA-listed salmon and steelhead. The hatchery programs release ESA-listed Chinook salmon and steelhead and non-listed fall Chinook, coho, fall chum, and pink salmon into the Hood Canal region. Nine of the ten programs are currently operating; the Hamma Hamma Chinook Supplementation program is expected to resume in the near future.

    As required by the ESA 4(d) Rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005), the Secretary is seeking public comment on her pending determination as to whether the joint plans for hatchery programs in Hood Canal would appreciably reduce the likelihood of survival and recovery of the ESA-listed Puget Sound salmon and steelhead.

    Under section 4(d) of the ESA, the Secretary is required to adopt such regulations as she deems necessary and advisable for the conservation of species listed as threatened. NMFS has issued a final ESA 4(d) Rule for salmon and steelhead, adopting in Limit 6 regulations necessary and advisable to harmonize statutory conservation requirements with tribal rights and the Federal trust responsibility to tribes (50 CFR 223.209).

    This 4(d) Rule applies the prohibitions enumerated in section 9(a)(1) of the ESA. NMFS did not find it necessary and advisable to apply the take prohibitions described in section 9(a)(1)(B) and 9(a)(1)(C) to artificial propagation activities if those activities are managed in accordance with a joint plan whose implementation has been determined by the Secretary to not appreciably reduce the likelihood of survival and recovery of the listed salmonids. As specified in limit 6 of the 4(d) Rule, before the Secretary makes a decision on the joint plan, the public must have an opportunity to review and comment on the pending determination.

    Authority

    Under section 4 of the ESA, the Secretary of Commerce is required to adopt such regulations as she deems necessary and advisable for the conservation of species listed as threatened. The ESA salmon and steelhead 4(d) Rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005) specifies categories of activities that contribute to the conservation of listed salmonids and sets out the criteria for such activities. Limit 6 of the updated 4(d) Rule (50 CFR 223.203(b)(6)) further provides that the prohibitions of paragraph (a) of the updated 4(d) Rule (50 CFR 223.203(a)) do not apply to activities associated with a joint state/tribal artificial propagation plan provided that the joint plan has been determined by NMFS to be in accordance with the salmon and steelhead 4(d) Rule (65 FR 42422, July 10, 2000, as updated in 70 FR 37160, June 28, 2005).

    Dated: February 29, 2016. Angela Somma, Chief, Endangered Species Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-04669 Filed 3-2-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Transmittal No. 15-61] 36(b)(1) Arms Sales Notification AGENCY:

    Defense Security Cooperation Agency, Department of Defense.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.

    FOR FURTHER INFORMATION CONTACT:

    Sarah A. Ragan or Heather N. Harwell, DSCA/LMO, (703) 604-1546/(703) 607-5339.

    The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 15-61 with attached Policy Justification and Sensitivity of Technology.

    Dated: February 29, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. EN03MR16.002 Transmittal No. 15-61 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as Amended

    (i) Prospective Purchaser: Government of Thailand

    (ii) Total Estimated Value:

    Major Defense Equipment * $18,570,385 Other $ 8,373,060 TOTAL $26,943,445

    (iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase:

    Major Defense Equipment (MDE) includes:

    Sixteen (16) Evolved Seasparrow Missiles (ESSM) (Fourteen (14) tactical missiles and two (2) telemetry missiles)

    Three (3) MK25 Quad Pack canisters

    Ten (10) MK783 shipping containers

    Also included with this request is additional equipment; training; and technical services.

    (iv) Military Department: U.S. Navy (XX-P-AKO)

    (v) Prior Related Cases, if any: FMS case AKM—$18,186,188—29 Sep 2014

    (vi) Sales Commission, Fee, etc., Paid, Offered, or Agreed to be Paid: None

    (vii) Sensitivity of Technology Contained in the Defense Article or Defense Services Proposed to be Sold: See Annex attached

    (viii) Date Report Delivered to Congress: 28 October 2015

    *As defined in Section 47(6) of the Arms Export Control Act

    POLICY JUSTIFICATION Government of Thailand—Evolved Seasparrow Missiles (ESSM)

    The Government of Thailand requested a possible sale of Major Defense Equipment for its Evolved Seasparrow Missile (ESSM) program. The total estimated value of MDE is $18,570,385. The total overall estimated value is $26,943,445.

    Major Defense Equipment (MDE) includes:

    Sixteen (16) Evolved Seasparrow Missiles (ESSM) (Fourteen (14) tactical missiles and two (2) telemetry missiles)

    Three (3) MK25 Quad Pack canisters

    Ten (10) MK783 shipping containers

    Also included with this request is additional equipment; training; and technical services.

    This proposed sale will contribute to the foreign policy and national security of the United States by increasing the ability of Thailand to contribute to regional security and improving interoperability with the U.S. Navy.

    Thailand will use the ESSM to provide ship battlespace self-defense and firepower, which will improve its capability to meet current and future naval threats.

    The proposed sale of these equipment and support will not alter the basic military balance in the region.

    The principal contractors are:

    Raytheon Missile Systems (RMS), Tucson, Arizona

    BAE Systems, Aberdeen, South Dakota

    SAAB, 9LV MK4 Combat Management System, Sweden

    Lockheed Martin, Baltimore, MD

    There are no known offset agreements proposed in connection with this potential sale.

    Implementation of this proposed sale will not require the assignment of any additional U.S. Government or contractor representatives to Thailand.

    There is no adverse impact on U.S. defense readiness as a result of this proposed sale.

    Transmittal No. 15-61 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act Annex Item No. vii

    (vii) Sensitivity of Technology:

    1. This sale will involve the release of sensitive technology to Thailand. The Evolved Seasparrow missile weapons system is classified up to CONFIDENTIAL. The missile includes the guidance section, warhead section, transition section, propulsion section, control section and Thrust Vector Control (TVC), of which the guidance section and transition section are classified CONFIDENTIAL. Documentation to be provided to Thailand includes:

    a. Parametric documents (CONFIDENTIAL)

    b. Missile Handling/Maintenance Procedures (UNCLASSIFIED only)

    c. General Performance Data (CONFIDENTIAL)

    d. Firing Guidance (CONFIDENTIAL)

    e. Dynamics Information (CONFIDENTIAL)

    2. The sale of the Evolved Seasparrow Missiles under this FMS case will result in the transfer of sensitive technological information and or/restricted information contained in the missile guidance section. Certain operating frequencies and performance characteristics are classified SECRET because they could be used to develop tactics and/or countermeasures that might reduce weapon system effectiveness.

    3. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, primarily performance characteristics, engagement algorithms and transmitter specific frequencies, the information could be used to develop countermeasures which might reduce weapon system effectiveness.

    4. A determination has been made that Thailand can provide substantially the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.

    5. All of the defense articles and services listed in this transmittal have been authorized for release and export to the Government of Thailand.

    [FR Doc. 2016-04683 Filed 3-2-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Transmittal No. 15-62] 36(b)(1) Arms Sales Notification AGENCY:

    Department of Defense, Defense Security Cooperation Agency.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.

    FOR FURTHER INFORMATION CONTACT:

    Sarah A. Ragan or Heather N. Harwell, DSCA/LMO, (703) 604-1546/(703) 607-5339.

    The following is a copy of a letter to the Speaker of the House of Representatives, and corrected Transmittal 15-62 with attached Policy Justification and Sensitivity of Technology.

    Dated: February 29, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. EN03MR16.001 Transmittal No. 15-62 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(l) of the Arms Export Control Act, as amended

    (i) Prospective Purchaser: Government of Japan

    (ii) Total Estimated Value:

    Major Defense Equipment * $ .689 billion Other $ .511 billion TOTAL $1.20 billion

    (iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase:

    Major Defense Equipment (MDE):

    Three (3) RQ-4 Block 30 (I) Global Hawk Remotely Piloted Aircraft with Enhanced Integrated Sensor Suite (EISS)

    Eight (8) Kearfott Inertial Navigation System/Global Positioning System (INS/GPS) units (2 per aircraft with 2 spares)

    Eight (8) LN-251 INS/GPS units (2 per aircraft with 2 spares)

    Also included with this request are operational-level sensor and aircraft test equipment, ground support equipment, operational flight test support, communications equipment, spare and repair parts, personnel training, publications and technical data, U.S. Government and contractor technical and logistics support services, and other related elements of logistics support.

    (iv) Military Department: Air Force (X7-D-SAI)

    (v) Prior Related Cases, if any: None

    (vi) Sales Commission, Fee, etc., Paid, Offered, or Agreed to be Paid: None

    (vii) Sensitivity of Technology Contained in the Defense Article or Defense Services Proposed to be Sold: See Attached Annex.

    (viii) Date Report Delivered to Congress: 10 February 2016

    * As defined in Section 47(6) of the Arms Export Control Act

    POLICY JUSTIFICATION Government of Japan-RQ-4 Block 30 (I) Global Hawk Remotely Piloted Aircraft

    The Government of Japan has requested a possible sale of:

    Major Defense Equipment (MDE):

    Three (3) RQ-4 Block 30 (I) Global Hawk Remotely Piloted Aircraft with Enhanced Integrated Sensor Suite (EISS)

    Eight (8) Kearfott Inertial Navigation System/Global Positioning System (INS/GPS) units (2 per aircraft with 2 spares)

    Eight (8) LN-251 INS/GPS units (2 per aircraft with 2 spares)

    Also included with this request are operational-level sensor and aircraft test equipment, ground support equipment, operational flight test support, communications equipment, spare and repair parts, personnel training, publications and technical data, U.S. Government and contractor technical and logistics support services, and other related elements of logistics support. The estimated value of MDE is $.689 billion. The total estimated value is $1.2 billion.

    This proposed sale will contribute to the foreign policy and national security of the United States. Japan is one of the major political and economic powers in East Asia and the Western Pacific and a key partner of the United States in ensuring regional peace and stability. This transaction is consistent with U.S. foreign policy and national security objectives and the 1960 Treaty of Mutual Cooperation and Security.

    The proposed sale of the RQ-4 will significantly enhance Japan's intelligence, surveillance, and reconnaissance (ISR) capabilities and help ensure that Japan is able to continue to monitor and deter regional threats. The Japan Air Self Defense Force (JASDF) will have no difficulty absorbing these systems into its armed forces.

    The proposed sale of this equipment and support will not alter the basic military balance in the region.

    The principal contractor will be Northrop Grumman Corporation in Rancho Bernardo, California. There are no known offset agreements in connection with this potential sale.

    Implementation of this proposed sale will require the assignment of contractor representatives to Japan to perform contractor logistics support and to support establishment of required security infrastructure.

    There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.

    Transmittal No. 15-62 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as amended Annex Item No. vii

    (vii) Sensitivity of Technology:

    1. The RQ-4 Block 30 Global Hawk hardware and software are UNCLASSIFIED. The highest level of classified information required for operation may be SECRET depending on the classification of the imagery or Signals Intelligence (SIGINT) utilized on a specific operation. The RQ-4 is optimized for long range and prolonged flight endurance. It is used for military intelligence, surveillance, and reconnaissance. Aircraft system, sensor, and navigational status are provided continuously to the ground operators through a health and status downlink for mission monitoring. Navigation is via inertial navigation with integrated global positioning system (GPS) updates. The vehicle is capable of operating from a standard paved runway. Real time missions are flown under the control of a pilot in a Ground Control Element (GCE). It is designed to carry a non-weapons internal payload of 3,000 lbs consisting primarily of sensors and avionics. The following payloads are integrated into the RQ-4: Enhanced Imagery Sensor Suite that includes multi-use infrared, electro-optical, ground moving target indicator, and synthetic aperture radar and a space to accommodate other sensors such as SIGINT. The RQ-4 will include the GCE, which consists of the following components:

    a. The Mission Control Element (MCE) is the RQ-4 Global Hawk ground control station for mission planning, communication management, aircraft and mission control, and image processing and dissemination. It can be either fixed or mobile. In addition to the shelter housing the operator workstations, the MCE includes an optional 6.25 meter Ku-Band antenna assembly, a Tactical Modular Interoperable Surface Terminal, a 12-ton Environmental Control Unit (heating and air conditioning), and two 100 kilowatt electrical generators. The MCE, technical data, and documentation are UNCLASSIFIED. The MCE may operate at the classified level depending on the classification of the data feeds.

    b. The Launch and Recovery Element (LRE) is a subset of the MCE and can be either fixed or mobile. It provides identical functionality for mission planning and air vehicle command and control (C2). The launch element contains a mission planning workstation and a C2 workstation. The primary difference between the LRE and MCE is the lack of any wide-band data links or image processing capability within the LRE and navigation equipment at the LRE to provide the precision required for ground operations, take-off, and landing. The LRE, technical data, and documentation are UNCLASSIFIED. The EISS includes infrared/electro-optical, synthetic aperture radar imagery, ground moving target indicator and space to accommodate optional SIGINT, Maritime, datalink, and automatic identification system capabilities. The ground control element includes a mission control function and a launch and recovery capability.

    c. The RQ-4 employs a quad-redundant Inertial Navigation System/Global Positioning System (INS/GPS) configuration. The system utilizes two different INS/GPS systems for greater redundancy. The system consists of two LN-251 units and two Kearfott KN-4074E INS/GPS Units. The LN-251 is a fully integrated, non-dithered navigation system with an embedded Selective Availability/Anti-Spoofing Module (SAASM), P(Y) code or Standard Positioning Service (SPS) GPS. It utilizes a Fiber-Optic Gyro (FOG) and includes three independent navigation solutions: blended INS/GPS, INS-only, and GPS-only. The Kearfott KN-4074E features a Monolithic Ring Laser Gyro (MRLG) and accelerometer. The inertial sensors are tightly coupled with an embedded SAASM P(Y) code GPS. Both systems employ cryptographic technology that can be classified up to SECRET.

    2. If a technology advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.

    3. All defense articles and services listed in this transmittal have been authorized for release and export to the Government of Japan.

    [FR Doc. 2016-04684 Filed 3-2-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Transmittal No. 16-12] 36(b)(1) Arms Sales Notification AGENCY:

    Department of Defense, Defense Security Cooperation Agency.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.

    FOR FURTHER INFORMATION CONTACT:

    Sarah A. Ragan or Heather N. Harwell, DSCA/LMO, (703) 604-1546/(703) 607-5339. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-12 with attached Policy Justification.

    Dated: February 26, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. BILLING CODE 5001-06-P EN03MR16.000 BILLING CODE 5001-06-C Transmittal No. 16-12 Notice of Proposed Issuance of Letter of Offer Pursuant to Section 36(b)(1) of the Arms Export Control Act, as amended

    (i) Prospective Purchaser: Government of Iraq

    (ii) Total Estimated Value:

    Major Defense Equipment * $   0 million Other $350 million Total $350 million

    (iii) Description and Quantity or Quantities of Articles or Services under Consideration for Purchase:

    Non-Major Defense Equipment (MDE):

    The Iraq Air Force is requesting a five-year sustainment package for its KA-350 fleet that includes contract logistics, training, and contract engineering services. Also included in this possible sale are operational and intermediate depot level maintenance, spare parts, component repair, publication updates, maintenance training, and logistics.

    (iv) Military Department: Air Force (X7-D-QBQ)

    (v) Prior Related Cases, if any: FMS Case: IQ-D-QAX-$169M-13 September 2011, IQ-D-QBK-$750K-19 November 2009

    (vi) Sales Commission, Fee, etc., Paid, Offered, or Agreed to be Paid: None

    (vii) Sensitivity of Technology Contained in the Defense Article or Defense Services Proposed to be Sold: None

    (viii) Date Report Delivered to Congress: 23 February 2016

    * as defined in Section 47(6) of the Arms Export Control Act.

    Policy Justification Government of Iraq-KA-350 Sustainment, Logistics, and Spares Support

    The Government of Iraq is requesting a five-year sustainment package for its KA-350 fleet that includes; operational and intermediate depot level maintenance, spare parts, component repair, publication updates, maintenance training, and logistics. There is no Major Defense Equipment associated with this case. The overall total estimated value is $350 million.

    The Iraq Air Force (IqAF) operates five (5) King Air 350 ISR (intelligence, surveillance, and reconnaissance) and one (1) King Air 350 aircraft. The KA-350 aircraft are Iraq's only ISR-dedicated airborne platforms and are used to support Iraqi military operations against Al-Qaeda affiliates and Islamic State of Iraq and the Levant (ISIL) forces. The purchase of a sustainment package will allow the IqAF to continue to operate its fleet of six (6) KA-350 aircraft beyond September 2016 (end of the existing Contract Logistics Support (CLS) effort). Iraq will have no difficulty absorbing this support.

    The proposed sale will contribute to the foreign policy and national security goals of the United States by helping to improve a critical capability of the Iraq Security Forces in defeating ISIL.

    The proposed sale of this equipment and support will not alter the basic military balance in the region.

    The prime contractor will be Beechcraft Defense Company, Wichita, KS. There are no known offset agreements proposed in connection with this potential sale.

    Implementation of this proposed sale will not require the assignment of any additional U.S. Government or contractor representatives to Iraq.

    There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.

    All defense articles and services listed in this transmittal have been authorized for release and export to the Government of Iraq.

    [FR Doc. 2016-04642 Filed 3-2-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Army, Corps of Engineers Intent To Prepare a Draft Beaver Lake Master Plan and Shoreline Management Plan and Environmental Assessment To Investigate Potential Significant Impacts, Either Positive or Negative, to Beaver Lake's Authorized Purposes of Flood Risk Management, Hydropower, Water Supply, Recreation, and Fish and Wildlife AGENCY:

    Department of the Army, U.S. Army Corps of Engineers, DOD.

    ACTION:

    Notice of intent.

    SUMMARY:

    The Draft Environmental Assessment (EA) is being prepared pursuant to the National Environmental Policy Act (NEPA), Council on Environmental Quality (CEQ) regulations (40 CFR, 1500-1517), and the U.S. Army Corps of Engineers (USACE) implementing regulation, Policy and Procedures for Implementing NEPA, Engineer Regulation (ER) 200-2-2 (1988). The study is being conducted in accordance with the requirements of 36 CFR 327.30, dated July 27, 1990 and ER 1130-2-406, dated October 31, 1990. The EA will evaluate potential impacts (beneficial and adverse) to socioeconomic conditions, cultural and ecological resources, recreation, aesthetics, infrastructure, lake water quality, terrestrial and aquatic fish and wildlife habitats, federally-listed threatened and endangered species, and cumulative impacts associated with past, current, and reasonably foreseeable future actions at Beaver Lake.

    Following the public scoping period and after consideration of all comments received during scoping, USACE will prepare a Draft EA. The Draft EA will be made available for public review and comment. Based on the EA analysis, USACE will either issue a Finding of No Significant Impact or announce its intent to prepare an environmental impact statement (EIS). If USACE determines that an EIS is needed, either during preparation of the EA or after completing the EA, USACE will issue in the Federal Register a Notice of Intent (NOI) to prepare an EIS. In that case, the current scoping process would serve as the scoping process that normally would follow an NOI to prepare an EIS. USACE would not solicit additional scoping comments but would consider any comments on the scope of the EA received during this scoping process in preparing the EIS.

    ADDRESSES:

    Submit written comments to Mr. Craig Hilburn, Chief of Environmental Branch, U.S. Army Corps of Engineers, Planning and Environmental Division, Environmental Branch, Little Rock District, P.O. Box 867, Little Rock, AR 72203-0867. Comments will be accepted through April 5, 2016.

    FOR FURTHER INFORMATION CONTACT:

    For questions or comments regarding the Draft Beaver Lake Master Plan and Shoreline Management Plan EA, please contact Mr. Craig Hilburn, (501) 324-5735 or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    1. Beaver Lake: Beaver Lake is a multiple purpose water resource development project primarily for flood risk management, municipal and industrial water supply, and hydropower generation. Additional purposes include water recreation, and fish and wildlife management, to the extent that those additional purposes do not adversely affect flood risk management, power generation, or other authorized purposes of the project (Flood Control Act of 1944 as amended in 1946, 1954, 1958, 1962, 1965 and 1968 and the Water Resources Act of 1992). Beaver Lake is a major component of a comprehensive plan for water resource development in the White River Basin of Missouri and Arkansas. Additional beneficial uses include increased power output of downstream power stations resulting from the regulated flow from the Beaver Lake project.

    2. Study Location: The Beaver Lake Civil Works project on the White River is situated in northwest Arkansas (Benton, Carroll, Madison, and Washington counties). The total area contained in the Beaver project, including both land and water surface, consists of 38,138 acres, including 1,432 acres in flowage easement. The region is characterized by plateaus, ridges, and valleys featuring oak-hickory forests with scattered shortleaf pine. When the lake is at the top of the conservation pool, the water area comprises 28,252 acres and 473 miles of shoreline within fee. The shoreline is irregular with topography ranging from steep bluffs to gentle slopes.

    3. Study History: The Beaver Lake Master Plan was originally approved December 13, 1963. An updated Master Plan was approved in October 1969. There have been 23 supplements to this plan, all of which are incorporated into the current Master Plan, approved in April 1976. The Beaver Lake Shoreline Management Plan was first approved in October 1975 and revised to the currently approved plan in April 2008. Updates to these plans are necessary due to several factors, including updates in Corps policies/regulations, current and projected future demands on fixed resources, and increases in environmental and management issues that have created sustainability concerns.

    4. Scoping/Public Involvement. Public meetings will be held at the following locations and times: Tuesday, March 15, 2016, 4-7 p.m., Hilton Garden Inn—Fayetteville, 1325 North Palak Drive, Fayetteville, AR; Wednesday March 16, 2016, 4-7 p.m., Best Western Inn of the Ozarks Conference Center, 207 W. Van Buren, Eureka Springs, AR; Thursday March 17, 2016, 4-7 p.m., Four Points by Sheraton Bentonville, 211 SE Walton Boulevard, Bentonville, AR.

    The Public Scoping process provides information about the study to the public, serves as a mechanism to solicit agency and public input on alternatives and issues of concern, and ensures full and open participation in Scoping and review of the Draft EA. Comments received as a result of this notice, public meetings, and news releases will be used to assist the preparers in identifying potential impacts to the quality of the human or natural environment. The Corps invites other Federal agencies, Native American Tribes, State and local agencies and officials, private organizations, and interested individuals to participate in the Scoping process by forwarding written comments to (see ADDRESSES). Interested parties may also request to be included on the mailing list for public distribution of announcements and documents.

    5. Issues/Alternatives: The EA will evaluate effects from a range of alternatives developed to address potential environmental concerns of the area. Anticipated issues to be addressed in the EA include impacts on: (1) Hydropower, (2) flooding, (3) recreation, (4) water supply, (5) fish and wildlife resources and habitats, and (6), other impacts identified by the public, agencies or USACE studies.

    Courtney W. Paul, Colonel, U.S. Army, District Engineer.
    [FR Doc. 2016-04736 Filed 3-2-16; 8:45 am] BILLING CODE 3720-58-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0025] Agency Information Collection Activities; Comment Request; Formula Grant EASIE Electronic Application System for Indian Education AGENCY:

    Office of Elementary and Secondary Education (OESE), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before May 2, 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-0025. 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-115, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Kimberly Smith, 202-453-6469.

    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: Formula Grant EASIE Electronic Application System for Indian Education.

    OMB Control Number: 1810-0021.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 11,300.

    Total Estimated Number of Annual Burden Hours: 9,103.

    Abstract: The Indian Education Formula Grant (CFDA 84.060A) requires the annual submission of the application from the local educational agency and/or tribe. The amount of each applicant's award is determined by formula, based upon the reported number of American Indian/Alaska Native students identified in the application, the state per pupil expenditure, and the total appropriation available. Applicants provide the data required for funding electronically, and the Office of Indian Education is able to apply electronic tools to facilitate the review and analysis leading to grant awards. The system has been named Formula Grant Electronic Application System for Indian Education (EASIE), and is located in the EDFacts System (ESS) Web site.

    Dated: February 26, 2016. Tomakie Washington, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-04600 Filed 3-2-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2015-ICCD-0144] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Annual Performance Report for Gaining Early Awareness and Readiness for Undergraduate Programs AGENCY:

    Office of Postsecondary Education (OPE), 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 4, 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-0144. 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 Nofertary Fofana, 202-453-7952.

    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: Annual Performance Report for Gaining Early Awareness and Readiness for Undergraduate Programs.

    OMB Control Number: 1840-0777.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments; Private Sector.

    Total Estimated Number of Annual Responses: 127.

    Total Estimated Number of Annual Burden Hours: 1,270.

    Abstract: The Annual Performance Report for Partnership and State Projects for Gaining Early Awareness and Readiness for Undergraduate Programs (GEAR UP) is a required report that grant recipients must submit annually. The purpose of this information collection is for accountability. The data is used to report on progress in meeting the performance objectives of GEAR UP, program implementation, and student outcomes. The data collected includes budget data on Federal funds and match contributions, demographic data, and data regarding services provided to students.

    Dated: February 26, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, <E T="03">Office of Management.</E>
    [FR Doc. 2016-04608 Filed 3-2-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0026] Agency Information Collection Activities; Comment Request; Financial Report for the Endowment Challenge Grant Program and Institutional Service Endowment Activities AGENCY:

    Office of Postsecondary Education (OPE), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before May 2, 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-0026. 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 Christopher McCormick, 202-502-7580.

    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: Financial Report for the Endowment Challenge Grant Program & Institutional Service Endowment Activities.

    OMB Control Number: 1840-0564.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: Private Sector.

    Total Estimated Number of Annual Responses: 2,500.

    Total Estimated Number of Annual Burden Hours: 3,125.

    Abstract: This financial reporting form will be utilized for Title III Part A, Title III Part B and Title V Program Endowment Activities and Title III Part C Endowment Challenge Grant Program. The purpose of this Annual Financial Report is to have the grantees report annually the kind of investments that have been made, the income earned and spent, and whether any part of the Endowment Fund Corpus has been spent. This information allows us to give technical assistance and determine whether the grantee has complied with the statutory and regulatory investment requirements. This collection is being submitted as a revision because several small items have been added to the reporting form. These new items are intended to clarify questions already included in previous versions of this form and are not expected to add any significant burden for respondents.

    Dated: February 29, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-04675 Filed 3-2-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY [FE Docket No. 12-32-LNG] Jordan Cove Energy Project, L.P.; Amendment of Application for Long-Term, Authorization To Export Liquefied Natural Gas to Non-Free Trade Agreement Nations AGENCY:

    Office of Fossil Energy, DOE.

    ACTION:

    Notice of amendment.

    SUMMARY:

    The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an amendment (Amendment), filed on October 5, 2015, by Jordan Cove Energy Project, L.P. (Jordan Cove) of its pending Application in this proceeding. The Application, filed on March 23, 2012, seeks authority to export domestically produced liquefied natural gas (LNG) in a volume equivalent to 292 Bcf/yr (0.8 Bcf/day) from a proposed terminal to be located on Coos Bay in the State of Oregon to nations with which the United States does not have a Free Trade Agreement (FTA) requiring national treatment for trade in natural gas (non-FTA nations). DOE published a “Notice of Application” in the Federal Register on June 6, 2012. 77 Fed.Reg. 33446. DOE/FE received five motions to intervene in the proceeding and numerous comments for and against the proposed export authorization.

    The Amendment seeks to increase the volume of LNG for which Jordan Cove requests export authorization from the equivalent of 292 Bcf/yr to the equivalent of 350 Bcf/yr of natural gas (0.96 Bcf/day). On March 24, 2014, the Department of Energy issued DOE/FE Order No. 3413, conditionally granting Jordan Cove's Application.1 DOE/FE has not yet issued a final order on the pending Application.

    1Jordan Cove Energy Project, L.P., DOE/FE Order No. 3413, FE Docket No. 12-32-LNG, Order Conditionally Granting Long-Term Multi-Contract Authorization To Export Liquefied Natural Gas By Vessel From the Jordan Cove LNG Terminal in Coos Bay, Oregon to Non-Free Trade Agreement Nations (Mar. 24, 2014).

    In its Amendment, Jordan Cove states that it is increasing its requested volume by 58 Bcf/yr in order to reflect the maximum production capacity of the Facility of 6.8 million metric tons per annum (mtpa) of LNG.2 According to Jordan Cove, the 6.8 million mtpa of LNG equates to 350 Bcf/yr of natural gas, which may be available for export.3 Jordan Cove asserts that the Amendment to increase the volume of its requested authorization does not alter the findings in the conditional export authorization in DOE/FE Order No. 3413 that the proposed exports have not been shown to be inconsistent with the public interest. Nor, Jordan Cove submits, will the increase in authorized export volumes entail environmental consequences.4

    2 Amendment at 3.

    3 Amendment at 5.

    4 Amendment at 8.

    Additional details can be found in Jordan Cove's Amendment, posted on the DOE/FE Web site at: http://www.fossil.energy.gov/programs/gasregulation/authorizations/2012_applications/2015-10-05_JCEP_Amendment_of_NFTA__Appli.pdf.

    Because the Amendment represents a substantive and material change in the Application, DOE has determined to publish this notice in the Federal Register, thereby providing the pubic with an opportunity to intervene, comment, and/or protest the Amendment. The Applicant separately has served the Amendment on each of the parties that have previously intervened in this proceeding.

    Protests, motions to intervene, notices of intervention, and written comments addressing the Amendment are invited.

    DATES:

    Protests, motions to intervene or notices of intervention, as applicable, requests for additional procedures, and written comments are to be filed using procedures detailed in the Public Comment Procedures section no later than 4:30 p.m., Eastern time, March 23, 2016.

    ADDRESSES:

    Electronic Filing by email: [email protected].

    Regular Mail: U.S. Department of Energy (FE-34), Office of Regulation and International Engagement, Office of Fossil Energy, P.O. Box 44375, Washington, DC 20026-4375.

    Hand Delivery or Private Delivery Services (e.g., FedEx, UPS, etc.): U.S. Department of Energy (FE-34), Office of Regulation and International Engagement, Office of Fossil Energy, Forrestal Building, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585.

    FOR FURTHER INFORMATION CONTACT: Larine Moore or Benjamin Nussdorf, U.S. Department of Energy (FE-34), Office of Regulation and International Engagement, Office of Fossil Energy, Forrestal Building, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-9478; (202) 586-7991. Cassandra Bernstein, U.S. Department of Energy (GC-76), Office of the Assistant General Counsel for Electricity and Fossil Energy, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-9793.
    SUPPLEMENTARY INFORMATION: DOE/FE Evaluation

    The Amendment will be reviewed in conjunction with our review of the underlying Application pursuant to section 3(a) of the NGA, 15 U.S.C. 717b(a), and DOE will consider any issues required by law or policy. To the extent determined to be relevant, these issues will include the domestic need for the natural gas proposed to be exported, the adequacy of domestic natural gas supply, U.S. energy security, and the cumulative impact of the requested authorization and any other LNG export application(s) previously approved on domestic natural gas supply and demand fundamentals. DOE may also consider other factors bearing on the public interest, including the impact of the proposed exports on the U.S. economy (including GDP, consumers, and industry), job creation, the U.S. balance of trade, and international considerations; and whether the Amendment is consistent with DOE's policy of promoting competition in the marketplace by allowing commercial parties to freely negotiate their own trade arrangements. As part of this analysis, DOE will consider the following two studies examining the cumulative impacts of LNG:

    Effect of Increased Levels of Liquefied Natural Gas on U.S. Energy Markets, conducted by the U.S. Energy Information Administration upon DOE's request (2014 EIA LNG Export Study); 5 and

    5 The 2014 EIA LNG Export Study, published on Oct. 29, 2014, is available at: https://www.eia.gov/analysis/requests/fe/.

    The Macroeconomic Impact of Increasing U.S. LNG Exports, conducted jointly by the Center for Energy Studies at Rice University's Baker Institute for Public Policy and Oxford Economics, on behalf of DOE (2015 LNG Export Study).6

    6 The 2015 LNG Export Study, dated Oct. 29, 2015, is available at: http://energy.gov/sites/prod/files/2015/12/f27/20151113_macro_impact_of_lng_exports_0.pdf.

    Additionally, DOE will consider the following environmental documents:

    Addendum to Environmental Review Documents Concerning Exports of Natural Gas From the United States, 79 FR 48132 (Aug. 15, 2014); 7 and

    7 The Addendum and related documents are available at: http://energy.gov/fe/draft-addendum-environmental-review-documents-concerning-exports-natural-gas-united-states.

    Life Cycle Greenhouse Gas Perspective on Exporting Liquefied Natural Gas From the United States, 79 FR 32260 (June 4, 2014).8

    8 The Life Cycle Greenhouse Gas Report is available at: http://energy.gov/fe/life-cycle-greenhouse-gas-perspective-exporting-liquefied-natural-gas-united-states.

    Parties that may oppose the Amendment to the Application should address the basis for their opposition to the Amendment, as well as other issues deemed relevant to the Amendment, in their comments and/or protests.

    The National Environmental Policy Act (NEPA), 42 U.S.C. 4321 et seq., requires DOE to give appropriate consideration to the environmental effects of its proposed decisions. No final decision will be issued in this proceeding until DOE has met its environmental responsibilities.

    Public Comment Procedures

    In response to this Notice, any person may file a protest, comments, or a motion to intervene or notice of intervention, as applicable. Interested persons will be provided 20 days from the date of publication of this Notice in which to submit comments, protests, motions to intervene, or notices of intervention. Comments and protests should address the implications of the Amendment. Because the public previously was given an opportunity to intervene in, protest, and comment on the Application, DOE/FE may disregard comments or protests on the Application that do not bear directly on the Amendment.

    Any person wishing to become a party to the proceeding must file a motion to intervene or notice of intervention. The filing of comments or a protest with respect to the Application will not serve to make the commenter or protestant a party to the proceeding, although protests and comments received from persons who are not parties will be considered in determining the appropriate action to be taken on the Application. All protests, comments, motions to intervene, or notices of intervention must meet the requirements specified by the regulations in 10 CFR part 590.

    Filings may be submitted using one of the following methods: (1) Emailing the filing to [email protected], with FE Docket No. 12-32-LNG in the title line; (2) mailing an original and three paper copies of the filing to the Office of Regulation and International Engagement at the address listed in ADDRESSES; or (3) hand delivering an original and three paper copies of the filing to the Office of Regulation and International Engagement at the address listed in ADDRESSES. All filings must include a reference to FE Docket No. 12-32-LNG. PLEASE NOTE: If submitting a filing via email, please include all related documents and attachments (e.g., exhibits) in the original email correspondence. Please do not include any active hyperlinks or password protection in any of the documents or attachments related to the filing. All electronic filings submitted to DOE must follow these guidelines to ensure that all documents are filed in a timely manner. Any hardcopy filing submitted greater in length than 50 pages must also include, at the time of the filing, a digital copy on disk of the entire submission.

    A decisional record on the Amendment will be developed through responses to this notice by parties, including the parties' written comments and replies thereto. Additional procedures will be used as necessary to achieve a complete understanding of the facts and issues. If an additional procedure is scheduled, notice will be provided to all parties. If no party requests additional procedures, a final Opinion and Order may be issued based on the official record, including the Amendment and responses filed by parties pursuant to this notice, in accordance with 10 CFR 590.316.

    The Amendment is available for inspection and copying in the Division of Natural Gas Regulation docket room, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585. The docket room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. The Amendment and any filed protests, motions to intervene or notice of interventions, and comments will also be available electronically by going to the following DOE/FE Web address: http://www.fe.doe.gov/programs/gasregulation/index.html.

    Issued in Washington, DC, on February 26, 2016. Amy R. Sweeney, Director, Division of Natural Gas Regulation, Office of Oil and Natural Gas.
    [FR Doc. 2016-04733 Filed 3-2-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY U.S. Energy Information Administration Proposed Agency Information Collection AGENCY:

    U.S. Energy Information Administration (EIA), Department of Energy.

    ACTION:

    Notice and request for OMB review and comment.

    SUMMARY:

    EIA has submitted an information collection request to the Office of Management and Budget (OMB) for extension of the following Oil and Gas Reserves System Survey Forms pursuant to the Paperwork Reduction Act of 1995: Form EIA-23L, “Annual Survey of Domestic Oil and Gas Reserves (Field Version)”; Form EIA-64A, “Annual Report of the Origin of Natural Gas Liquids Production”; and Form EIA-23S, “Annual Survey of Domestic Oil and Gas Reserves, (Summary Version)” Form EIA-23L is the only form that EIA proposes to change. There are no proposed changes to Forms EIA-64A and EIA-23S.

    The proposed collection will be used to prepare electronic annual reports of U.S. proved reserves data that fulfill EIA's congressional mandate to provide accurate annual estimates of U.S. proved crude oil and natural gas reserves. The U.S. Government also uses the resulting information in EIA's reports to develop national and regional estimates of proved reserves of domestic crude oil and natural gas to facilitate national energy policy decisions.

    DATES:

    Comments regarding this collection must be received on or before April 4, 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, please advise the DOE Desk Officer at OMB of your intention to make a submission as soon as possible. The Desk Officer may be telephoned at 202-395-4718 or contacted by email at [email protected].

    ADDRESSES:

    Written comments should be sent to the

    DOE Desk Officer, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10102, 735 17th Street NW., Washington, DC 20503, [email protected]. And to Steven G. Grape, U.S. Energy Information Administration, Mail Stop EI-24, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585, [email protected].
    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information should be directed to Mr. Grape, as listed above. The information collection instrument and instructions are available on the EIA Web site at:

    Form EIA-23L, http://www.eia.gov/survey/#eia-23l Form EIA-23S, http://www.eia.gov/survey/#eia-23s Form EIA-64A, http://www.eia.gov/survey/#eia-64a.
    SUPPLEMENTARY INFORMATION:

    This information collection request contains:

    (1) OMB No. 1905-0057.

    (2) Information Collection Request Title: Oil and Gas Reserves System.

    (3) Type of Request: Revision of the currently approved Form EIA-23L; extension without changes of Form EIA-64A; and continued suspension of collection of the currently approved Form EIA-23S.

    (4) Purpose: In response to Public Law 95-91 Section 657, estimates of U.S. oil and gas reserves are to be reported annually. Many U.S. government agencies have an interest in proved oil and gas reserves and the quality, reliability, and usefulness of reserves estimates. Among these are the U.S. Energy Information Administration (EIA), Department of Energy; Bureau of Ocean Energy Management (BOEM), Department of Interior; Internal Revenue Service (IRS), Department of the Treasury; and the Securities and Exchange Commission (SEC). Each of these organizations has specific purposes for collecting, using, or estimating proved reserves. EIA has a congressional mandate to provide accurate annual estimates of U.S. proved crude oil, natural gas, and natural gas liquids reserves, and EIA presents annual reserves data in EIA reports to meet this requirement. The BOEM maintains estimates of proved reserves to carry out their responsibilities in leasing, collecting royalty payments, and regulating the activities of oil and gas companies on Federal lands and water. Accurate reserve estimates are important, as the BOEM is second only to the IRS in generating Federal revenue. For the IRS, proved reserves and occasionally probable reserves are an essential component of calculating taxes for companies owning or producing oil and gas. The SEC requires publicly traded petroleum companies to annually file a reserves statement as part of their 10-K filing. The basic purpose of the 10-K filing is to provide public investors with a clear and reliable financial basis to assess the relative value, as a financial asset, of a company's reserves, especially in comparison to other similar oil and gas companies.

    The Government also uses the resulting information to develop national and regional estimates of proved reserves of domestic crude oil and natural gas to facilitate national energy policy decisions. These estimates are essential to the development, implementation, and evaluation of energy policy and legislation. Data are used directly in EIA Web reports concerning U.S. crude oil and natural gas reserves, and are incorporated into a number of other Web reports and analyses.

    EIA proposes to make the following changes to Form EIA-23L, “Annual Survey of Domestic Oil and Gas Reserves”:

    • Change the title of Form EIA-23L to “Annual Report of Domestic Oil and Gas Reserves (County Level)”;

    • Collect additional parent company and subsidiary company (if applicable) information on the cover page;

    • Change the title of Schedule A to “Operated Proved Reserves, Production, and Related Data by County”;

    • Operators will be instructed to file their proved reserves by county rather than by field. Line Item 2.0 will be named “County Data (operated basis);”

    • Line Item 2.1.4 “Field Code”, will be changed to “County Name;”

    • Line Item 2.1.5 “MMS Code” will be changed to “Type Code;”

    • Line Item 2.1.6. “Field Name” will be changed to “Field, Play, or Prospect Name (Optional)”;

    • Line Items 2.1.9 “water depth” and 2.1.10 “field discovery year” will be replaced with 2.1.9 “# of producing wells on December 31, [survey year]”, 2.1.10 “# of wells completed or purchased [in survey year]”;

    • Line Item 2.1.11, “Prospect Name (optional) will be replaced with “# of wells abandoned or sold [in survey year]”; and

    • Line Item 2.1.12-15, Column (F) “Extensions”, Column (G) “New Field Discoveries”, and Column (H) “New Reservoir Discoveries in Old Fields” will be replaced with Column (F) “Extensions and Discoveries”.

    Comments and Feedback are requested on these proposed changes to Form EIA-23L. Secondary reports that use the data include EIA's Annual Energy Review, Annual Energy Outlook, Petroleum Supply Annual, and Natural Gas Annual;

    (5) Annual Estimated Number of Respondents: Forms EIA-23L/23S/64A: 1,250.

    (6) Annual Estimated Number of Total Responses: Forms EIA-23L/23S/64A: 1,250.

    (7) Annual Estimated Number of Burden Hours: 32,850.

    Form EIA-23L Annual Report of Domestic Oil and Gas Reserves (County Level): 36 hours per operator (320 intermediate-size operators); 97 hours per operator (160 large operators); 13 hours per operator (170 small operators): 29,250 hours Form EIA-23S Annual Survey of Domestic Oil and Gas Reserves (Summary Version) Report: 4 hours (small operators): 0 hours (Currently suspended) Form EIA-64A “Annual Report of the Origin of Natural Gas Liquids Production”: 6 hours per operator (600 natural gas plant operators): 3,600 hours

    (8) Annual Estimated Reporting and Recordkeeping Cost Burden: Forms EIA-23L/23S/64A: EIA estimates that there are no capital and start-up costs associated with this data collection. The information is maintained in the normal course of business. The cost of burden hours to the respondents is estimated to be $2,365,857 (32,850 burden hours times $72.02 per hour). Therefore, other than the cost of burden hours, EIA estimates that there are no additional costs for generating, maintaining and providing the information.

    Statutory Authority:

    Section 13(b) of the Federal Energy Administration Act of 1974, Pub. L. 93-275, codified at 15 U.S.C. 772(b).

    Issued in Washington, DC, February 26, 2016. Nanda Srinivasan, Director, Office of Survey Development and Statistical Integration, U.S. Energy Information Administration.
    [FR Doc. 2016-04759 Filed 3-2-16; 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: CP09-12-001.

    Applicants: Narragansett Electric Company.

    Description: Compliance filing of Information Supporting Maximum Blanket Certificate Rate of the Narragansett Electric Company.

    Filed Date: 6/17/13.

    Accession Number: 20130617-5088.

    Comments Due: 5 p.m. ET 3/16/16.

    Docket Numbers: RP16-627-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Negotiated Rates—BBPC d/b/a Great Eastern contract 791252 to be effective 3/1/2016.

    Filed Date: 2/24/16.

    Accession Number: 20160224-5035.

    Comments Due: 5 p.m. ET 3/7/16.

    Docket Numbers: RP16-628-000.

    Applicants: LA Storage, LLC.

    Description: § 4(d) Rate Filing: LA Storage 2016 Annual Adjustment of Fuel Retainage Percentage Filing to be effective 3/1/2016.

    Filed Date: 2/24/16.

    Accession Number: 20160224-5062.

    Comments Due: 5 p.m. ET 3/7/16.

    Docket Numbers: RP16-629-000.

    Applicants: Texas Eastern Transmission, LP.

    Description: § 4(d) Rate Filing: Negotiated Rate Eff 4-1-2016 for J Aron contract 8940246 to be effective 4/1/2016.

    Filed Date: 2/25/16.

    Accession Number: 20160225-5048.

    Comments Due: 5 p.m. ET 3/8/16.

    Docket Numbers: RP16-630-000.

    Applicants: Transcontinental Gas Pipe Line Company.

    Description: § 4(d) Rate Filing: Transco Annual Fuel Tracker to be effective 4/1/2016.

    Filed Date: 2/25/16.

    Accession Number: 20160225-5049.

    Comments Due: 5 p.m. ET 3/8/16.

    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 25, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-04662 Filed 3-2-16; 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: PR16-12-001.

    Applicants: Columbia Gas of Maryland, Inc.

    Description: Tariff filing per 284.123(b)(1): PR16-12 CMD Amended SOC to be effective 1/1/2015; Filing Type: 1000.

    Filed Date: 2/22/16.

    Accession Number: 201602225223.

    Comments/Protests Due: 5 p.m. ET 3/14/16.

    Docket Numbers: PR16-13-001.

    Applicants: Columbia Gas of Ohio, Inc.

    Description: Tariff filing per 284.123(b)(1): COH Amended SOC PR16-13 to be effective 4/30/2015; Filing Type: 1000.

    Filed Date: 2/22/16.

    Accession Number: 201602225181.

    Comments/Protests Due: 5 p.m. ET 3/14/16.

    Docket Numbers: PR16-26-000.

    Applicants: Enable Oklahoma Intrastate Transmission, LLC.

    Description: Tariff filing per 284.123(b)(2) +(g): EOIT Petition for Section 311 Rate Approval to be effective 4/1/2016; Filing Type: 1310.

    Filed Date: 2/19/16.

    Accession Number: 201602195134.

    Comments Due: 5 p.m. ET 3/11/16.

    284.123(g) Protests Due: 5 p.m. ET 4/19/16.

    Docket Numbers: RP16-622-000.

    Applicants: Natural Gas Pipeline Company of America.

    Description: § 4(d) Rate Filing: BG Energy Negotiated Rate to be effective 4/1/2016.

    Filed Date: 2/23/16.

    Accession Number: 20160223-5062.

    Comments Due: 5 p.m. ET 3/7/16.

    Docket Numbers: RP16-623-000.

    Applicants: Natural Gas Pipeline Company of America.

    Description: § 4(d) Rate Filing: Nicor Negotiated Rate to be effective 4/1/2016.

    Filed Date: 2/23/16.

    Accession Number: 20160223-5078.

    Comments Due: 5 p.m. ET 3/7/16.

    Docket Numbers: RP16-624-000.

    Applicants: MoGas Pipeline LLC.

    Description: § 4(d) Rate Filing: MoGas Negotiated Rate Agreement Waynesville Filing to be effective 3/1/2016.

    Filed Date: 2/23/16.

    Accession Number: 20160223-5087.

    Comments Due: 5 p.m. ET 3/7/16.

    Docket Numbers: RP16-625-000.

    Applicants: Northern Natural Gas Company.

    Description: § 4(d) Rate Filing: 20160222 Housekeeping Filing to be effective 4/1/2016.

    Filed Date: 2/23/16.

    Accession Number: 20160223-5149.

    Comments Due: 5 p.m. ET 3/7/16.

    Docket Numbers: RP16-626-000.

    Applicants: Southern Star Central Gas Pipeline, Inc.

    Description: § 4(d) Rate Filing: Fuel Filing—Eff. April 1, 2016 to be effective 4/1/2016.

    Filed Date: 2/24/16.

    Accession Number: 20160224-5026.

    Comments Due: 5 p.m. ET 3/7/16.

    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: RP16-597-001.

    Applicants: Tallgrass Interstate Gas Transmission, L.

    Description: Compliance filing Compliance to 587-W Amendment to be effective 4/1/2016.

    Filed Date: 2/23/16.

    Accession Number: 20160223-5105.

    Comments Due: 5 p.m. ET 3/7/16.

    Docket Numbers: RP16-598-001.

    Applicants: Rockies Express Pipeline LLC.

    Description: Compliance filing Compliance with Order No. 587-W Amendment to be effective 4/1/2016.

    Filed Date: 2/23/16.

    Accession Number: 20160223-5104.

    Comments Due: 5 p.m. ET 3/7/16.

    Docket Numbers: RP16-599-001.

    Applicants: Trailblazer Pipeline Company LLC.

    Description: Compliance filing Order 587-W Amendment to be effective 4/1/2016.

    Filed Date: 2/23/16.

    Accession Number: 20160223-5109.

    Comments Due: 5 p.m. ET 3/7/16.

    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 24, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-04652 Filed 3-2-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP16-64-000] ANR Pipeline Company; Notice of Intent To Prepare an Environmental Assessment for the Proposed Collierville Expansion Project and Request for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the Collierville Expansion Project involving construction and operation of facilities by ANR Pipeline Company (ANR) in Shelby County, Tennessee. The Commission will use this EA in its decision-making process to determine whether the project is in the public convenience and necessity.

    This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies on the project. You can make a difference by providing us with your specific comments or concerns about the project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the EA. To ensure that your comments are timely and properly recorded, please send your comments so that the Commission receives them in Washington, DC on or before March 28, 2016.

    If you sent comments on this project to the Commission before the opening of this docket on January 20, 2016, you will need to file those comments in Docket No. CP16-64-000 to ensure they are considered as part of this proceeding.

    This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this proposed project and encourage them to comment on their areas of concern.

    If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the proposed facilities. The company would seek to negotiate a mutually acceptable agreement. However, if the Commission approves the project, that approval conveys with it the right of eminent domain. Therefore, if easement negotiations fail to produce an agreement, the pipeline company could initiate condemnation proceedings where compensation would be determined in accordance with state law.

    ANR provided landowners with a fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility on My Land? What Do I Need To Know?” This fact sheet addresses a number of typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. It is also available for viewing on the FERC Web site (www.ferc.gov).

    Public Participation

    For your convenience, there are three methods you can use to submit your comments to the Commission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or [email protected] Please carefully follow these instructions so that your comments are properly recorded.

    (1) You can file your comments electronically using the eComment feature on the Commission's Web site (www.ferc.gov) under the link to Documents and Filings. This is an easy method for submitting brief, text-only comments on a project;

    (2) You can file your comments electronically by using the eFiling feature on the Commission's Web site (www.ferc.gov) under the link to Documents and Filings. With eFiling, you can provide comments in a variety of formats by attaching them as a file with your submission. New eFiling users must first create an account by clicking on “eRegister.” If you are filing a comment on a particular project, please select “Comment on a Filing” as the filing type; or

    (3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project Docket No. (CP16-64-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.

    Summary of the Proposed Project

    ANR proposes to construct and modify aboveground facilities in Shelby County, Tennessee; specifically:

    • A new 4,700 horsepower compressor station; and

    • modifications at the existing Collierville Meter Station, including a new 12-inch ultrasonic meter run and other piping and appurtenant modifications.

    The Collierville Expansion Project would expand the delivery capability of the existing Collierville Meter Station by an additional 200,000 dekatherms per day of natural gas. According to ANR, its project would serve the Tennessee Valley Authority's 1,070 megawatt Allen Combined Cycle Power Plan Project in Memphis, Tennessee.

    The general location of the project facilities is shown in appendix 1.1

    1 The appendices referenced in this notice will not appear in the Federal Register. Copies of appendices were sent to all those receiving this notice in the mail and are available at www.ferc.gov using the link called “eLibrary” or from the Commission's Public Reference Room, 888 First Street NE., Washington, DC 20426, or call (202) 502-8371. For instructions on connecting to eLibrary, refer to page 6 of this notice.

    Land Requirements for Construction

    Construction of the proposed facilities would disturb about 19.7 acres of land for the compressor station piping and aboveground facilities, 1.4 acres of which are associated with existing permanent ANR easements and rights-of-way. Following construction, ANR would maintain about 7.5 acres for permanent operation of the project's facilities, 1.4 acres of which are associated with existing permanent ANR easements and rights-of-way. The remaining acreage would be restored and revert to former uses. The location of the proposed compressor station was chosen in coordination with the property owner and based on its relative proximity to ANR's existing 501 mainline. Modifications to the Collierville Meter Station would be within existing facility boundaries or existing permanent easement.

    The EA Process

    The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from an action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires us 2 to discover and address concerns the public may have about proposals. This process is referred to as “scoping.” The main goal of the scoping process is to focus the analysis in the EA on the important environmental issues. By this notice, the Commission requests public comments on the scope of the issues to address in the EA. We will consider all filed comments during the preparation of the EA.

    2 “We,” “us,” and “our” refer to the environmental staff of the Commission's Office of Energy Projects.

    In the EA we will discuss impacts that could occur as a result of the construction and operation of the proposed project under these general headings:

    • Geology and soils;

    • land use;

    • water resources, fisheries, and wetlands;

    • cultural resources;

    • vegetation and wildlife;

    • air quality and noise;

    • endangered and threatened species;

    • public safety; and

    • cumulative impacts.

    We will also evaluate reasonable alternatives to the proposed project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.

    The EA will present our independent analysis of the issues. The EA will be available in the public record through eLibrary. Depending on the comments received during the scoping process, we may also publish and distribute the EA to the public for an allotted comment period. We will consider all comments on the EA before making our recommendations to the Commission. To ensure we have the opportunity to consider and address your comments, please carefully follow the instructions in the Public Participation section, beginning on page 2.

    With this notice, we are asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of this project to formally cooperate with us in the preparation of the EA.3 Agencies that would like to request cooperating agency status should follow the instructions for filing comments provided under the Public Participation section of this notice.

    3 The Council on Environmental Quality regulations addressing cooperating agency responsibilities are at Title 40, Code of Federal Regulations, Part 1501.6.

    Consultations Under Section 106 of the National Historic Preservation Act

    In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, we are using this notice to initiate consultation with the Tennessee State Historic Preservation Office (SHPO), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.4 We will define the project-specific Area of Potential Effects (APE) in consultation with the SHPO as the project develops. On natural gas facility projects, the APE at a minimum encompasses all areas subject to ground disturbance (examples include construction right-of-way, contractor/pipe storage yards, compressor stations, and access roads). Our EA for this project will document our findings on the impacts on historic properties and summarize the status of consultations under section 106.

    4 The Advisory Council on Historic Preservation's regulations are at Title 36, Code of Federal Regulations, Part 800. Those regulations define historic properties as any prehistoric or historic district, site, building, structure, or object included in or eligible for inclusion in the National Register of Historic Places.

    Environmental Mailing List

    The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project. We will update the environmental mailing list as the analysis proceeds to ensure that we send the information related to this environmental review to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project.

    Copies of the EA will be sent to the environmental mailing list for public review and comment. If you would prefer to receive a paper copy of the document instead of the CD version or would like to remove your name from the mailing list, please return the attached Information Request (appendix 2).

    Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want to become an “intervenor” which is an official party to the Commission's proceeding. Intervenors play a more formal role in the process and are able to file briefs, appear at hearings, and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene. Instructions for becoming an intervenor are in the User's Guide under the “e-filing” link on the Commission's Web site.

    Additional Information

    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 at www.ferc.gov using the “eLibrary” link. Click on the eLibrary link, click on “General Search” and enter the docket number, excluding the last three digits in the Docket Number field (i.e., CP16-64). Be sure you have selected an appropriate date range. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or for TTY, contact (202) 502-8659. The eLibrary link also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rulemakings.

    In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. 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.

    Finally, public meetings or site visits will be posted on the Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: February 26, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-04653 Filed 3-2-16; 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 corporate filings:

    Docket Numbers: EC16-81-000.

    Applicants: Enterprise Solar, LLC, Escalante Solar I, LLC, Escalante Solar II, LLC, Escalante Solar III, LLC, Granite Mountain Solar East, LLC, Granite Mountain Solar West, LLC, Iron Springs Solar, LLC.

    Description: Application for Authorization Under Section 203 of the Federal Power Act and Request for Waivers, Expedited Action, and Shortened Comment Period of Enterprise Solar, LLC, et. al.

    Filed Date: 2/25/16.

    Accession Number: 20160225-5199.

    Comments Due: 5 p.m. ET 3/17/16.

    Take notice that the Commission received the following exempt wholesale generator filings:

    Docket Numbers: EG16-60-000.

    Applicants: East Ridge Transmission, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of The East Ridge Transmission, LLC.

    Filed Date: 2/26/16.

    Accession Number: 20160226-5280.

    Comments Due: 5 p.m. ET 3/18/16.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER16-453-001.

    Applicants: Northeast Transmission Development, LLC, PJM Interconnection, L.L.C.

    Description: Tariff Amendment: NTD submits Response to Deficiency Letter issued Jan. 29, 2016 in ER16-453 to be effective 2/1/2016.

    Filed Date: 2/26/16.

    Accession Number: 20160226-5205.

    Comments Due: 5 p.m. ET 3/18/16.

    Docket Numbers: ER16-1008-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Second Revised ISA No. 3577, Queue No. Y1-086 per Assignment to be effective 1/26/2016.

    Filed Date: 2/25/16.

    Accession Number: 20160225-5192.

    Comments Due: 5 p.m. ET 3/17/16.

    Docket Numbers: ER16-1009-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Amendment to WMPA SA No. 3203, Queue No. W3-079 to be effective 10/27/2014.

    Filed Date: 2/26/16.

    Accession Number: 20160226-5049.

    Comments Due: 5 p.m. ET 3/18/16.

    Docket Numbers: ER16-1010-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 2181 MKEC to Prairie Wind Transmission Novation Cancellation to be effective 2/16/2016.

    Filed Date: 2/26/16.

    Accession Number: 20160226-5082.

    Comments Due: 5 p.m. ET 3/18/16.

    Docket Numbers: ER16-1011-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 2182 Westar and MKEC to Prairie Wind Transmission Novation Cancellation to be effective 2/16/2016.

    Filed Date: 2/26/16.

    Accession Number: 20160226-5084.

    Comments Due: 5 p.m. ET 3/18/16.

    Docket Numbers: ER16-1012-000.

    Applicants: Southern California Edison Company.

    Description: Tariff Cancellation: Notices of Cancellation LGIA and Distribution Service Agmt Sun Valley Project to be effective 4/19/2016.

    Filed Date: 2/26/16.

    Accession Number: 20160226-5178.

    Comments Due: 5 p.m. ET 3/18/16.

    Docket Numbers: ER16-1013-000.

    Applicants: Interstate Power and Light Company, ITC Midwest LLC.

    Description: § 205(d) Rate Filing: Amended IPL Operating and Transmission Agreement Exhibits to be effective 4/26/2016.

    Filed Date: 2/26/16.

    Accession Number: 20160226-5207.

    Comments Due: 5 p.m. ET 3/18/16.

    Docket Numbers: ER16-1014-000.

    Applicants: The Dayton Power and Light Company.

    Description: § 205(d) Rate Filing: FERC Rate Schedule No. 2 to be effective 5/1/2016.

    Filed Date: 2/26/16.

    Accession Number: 20160226-5239.

    Comments Due: 5 p.m. ET 3/18/16.

    Docket Numbers: ER16-1015-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) Rate Filing: 2016 Revised Added Facilities Rate for Rate Schedules to be effective 1/1/2016.

    Filed Date: 2/26/16.

    Accession Number: 20160226-5275.

    Comments Due: 5 p.m. ET 3/18/16.

    Docket Numbers: ER16-1016-000.

    Applicants: Southern California Edison Company.

    Description: Tariff Cancellation: Notice of Cancellation Tie-Line Facilities Agreement Sun Valley Project to be effective 4/19/2016.

    Filed Date: 2/26/16.

    Accession Number: 20160226-5283.

    Comments Due: 5 p.m. ET 3/18/16.

    Docket Numbers: ER16-1017-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: First Revised Interconnection Service Agreement No. 3800, Queue No. AA1-040 to be effective 1/27/2016.

    Filed Date: 2/26/16.

    Accession Number: 20160226-5330.

    Comments Due: 5 p.m. ET 3/18/16.

    Take notice that the Commission received the following electric securities filings:

    Docket Numbers: ES16-23-000.

    Applicants: Southern Indiana Gas and Electric Company, Inc.

    Description: Application of Southern Indiana Gas and Electric Company, Inc. for Authority to Issue Short-Term Debt.

    Filed Date: 2/26/16.

    Accession Number: 20160226-5081.

    Comments Due: 5 p.m. ET 3/18/16.

    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 26, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-04651 Filed 3-2-16; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9943-28-Region 6] Clean Air Act Operating Permit Program; Petition for Objection to State Operating Permit for Southwestern Electric Power Company H.W. Pirkey Power Plant in Texas AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of final action.

    SUMMARY:

    Pursuant to Clean Air Act (CAA) Section 505(b)(2) and 40 CFR 70.8(d), the Environmental Protection Agency (EPA) Administrator signed an Order, dated February 3, 2016, granting in part and denying in part the petition asking EPA to object to an operating permit issued by the Texas Commission on Environmental Quality for the Southwestern Electric Power Company (SWEPCO) H.W. Pirkey Power Plant (Title V operating permit number O31). The EPA's February 3, 2016 Order responds to the petition, dated October 30, 2014, submitted by the Environmental Integrity Project (EIP) and Sierra Club. Sections 307(b) and 505(b)(2) of the CAA provide that a petitioner may ask for judicial review by the United States Court of Appeals for the appropriate circuit of those portions of the Order that deny issues raised in the petition. Any petition for review shall be filed within 60 days from the date this notice appears in the Federal Register, pursuant to section 307(b) of the CAA.

    ADDRESSES:

    You may review copies of the final Order, the petition, and other supporting information at EPA Region 6, 1445 Ross Avenue, Dallas, Texas 75202-2733. Contact the individual listed below to view documents. You may view the hard copies Monday through Friday, from 9:00 a.m. to 3:00 p.m., excluding Federal holidays. If you wish to examine these documents, you should make an appointment at least 24 hours before the visiting day. Additionally, the final February 3, 2016 Order is available electronically at: http://www.epa.gov/title-v-operating-permits/order-responding-2014-petition-requesting-administrator-object-title-v.

    FOR FURTHER INFORMATION CONTACT:

    Aimee Wilson at (214) 665-7596, email address: [email protected] or the above EPA, Region 6 address.

    SUPPLEMENTARY INFORMATION:

    The CAA affords EPA a 45-day period to review, and object, as appropriate, to a title V operating permit proposed by a state permitting authority. Section 505(b)(2) of the CAA authorizes any person to petition the EPA Administrator, within 60 days after the expiration of this review period, to object to a title V operating permit if EPA has not done so. Petitions must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the state, unless the petitioner demonstrates that it was impracticable to raise such objections during the comment period or unless the grounds for the objection arose after this period.

    The Petitioners maintain that the SWEPCO title V operating permit is inconsistent with the Act based on the following contentions: (1) The proposed permit for the Pirkey Power Plant impermissibly provides for exemptions from title V applicable requirements during planned maintenance, startup, and shutdown (MSS) activities; and (2) the proposed permit must clarify that credible evidence may be used by citizens to enforce the terms and conditions of the permit. The claims are described in detail in Section IV of the Order.

    Pursuant to sections 505(b) and 505(e) of the Clean Air Act (42 U.S.C. 7661d(b) and (e)) and 40 CFR 70.7(g) and 70.8(d), the Texas Commission on Environmental Quality (TCEQ) has 90 days from the receipt of the Administrator's order to resolve the objections identified in Claim 1 of the Order and submit a proposed determination or termination, modification, or revocation and reissuance of the SWEPCO title V permit in accordance with EPA's objection. The Order issued on February 3, 2016 responds to the Petition and explains the basis for EPA's decision.

    Dated: February 24, 2016. Ron Curry, Regional Administrator, Region 6.
    [FR Doc. 2016-04752 Filed 3-2-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9943-23-Region 5] Notice of Final Decision To Reissue the Ineos Nitriles USA LLC Land-Ban Exemption AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of final decision on a Request by Ineos Nitriles USA LLC of Lima, Ohio to Reissue its Exemption from the Land Disposal Restrictions under the Resource Conservation and Recovery Act.

    SUMMARY:

    Notice is hereby given by the U.S. Environmental Protection Agency (U.S. EPA or Agency) that an exemption to the land disposal restrictions under the 1984 Hazardous and Solid Waste Amendments to the Resource Conservation and Recovery Act (RCRA) has been granted to Ineos Nitriles USA LLC (formerly known as Ineos USA LLC) (Ineos) of Lima, Ohio for four Class I injection wells located in Lima, Ohio. As required by 40 CFR part 148, Ineos has demonstrated, to a reasonable degree of certainty, that there will be no migration of hazardous constituents out of the injection zone or into an underground source of drinking water for at least 10,000 years. This final decision allows the continued underground injection by Ineos of those hazardous wastes designated by the codes in Table 1 through its four Class I hazardous waste injection wells identified as #1, #2, #3, and #4. This decision constitutes a final U.S. EPA action for which there is no administrative appeal.

    DATES:

    This action is effective as of March 3, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Stephen Roy, Lead Petition Reviewer, U.S. EPA, Region 5, Underground Injection Control Branch, WU-16J, 77 W. Jackson Blvd., Chicago, Illinois 60604-3590; telephone number: (312) 886-6556; fax number (312) 692-2951; email address: [email protected] Copies of the petition and all pertinent information are on file and are part of the Administrative Record. Please contact the lead reviewer to review the Administrative Record.

    SUPPLEMENTARY INFORMATION:

    Ineos submitted a request for reissuance of its existing exemption from the land disposal restrictions for hazardous waste in August, 2005. U.S. EPA reviewed all data pertaining to the petition including, but not limited to, well construction, well operations, regional and local geology, seismic activity, penetrations of the confining zone, and computational models of the injection zone. U.S. EPA has determined that the hydrogeological and geochemical conditions at the site and the nature of the waste streams are such that injected fluids will not migrate out of the injection zone within 10,000 years, as set forth at 40 CFR part 148. The injection zone includes the injection interval into which fluid is directly emplaced and the overlying arrestment interval into which fluid may diffuse. The injection interval for the Ineos facility is composed of the Lower Eau Claire Formation, the Mt. Simon Sandstone and the Middle Run Formation between 2,631 and 3,241 feet below ground level. The arrestment interval is composed of the Lower Black River Group, the Wells Creek Formation, the Knox Dolomite and the Upper Eau Claire Formation between 1,631 and 2,631 feet below ground level. The confining zone is composed of the Upper Black River Group between 1,427 and 1,631 feet below ground level. The confining zone is separated from the lowermost underground source of drinking water (at a depth of approximately 400 feet below ground level) by a sequence of permeable and less permeable sedimentary rocks. This sequence provides additional protection from fluid migration into drinking water sources.

    U.S. EPA issued a draft decision, which described the reasons for granting this exemption in more detail, a fact sheet, which summarized these reasons, and a public notice on September 10, 2015, pursuant to 40 CFR 124.10. The public comment period ended on October 13, 2015. U.S. EPA received comments from one citizen during the comment period. U.S. EPA has prepared a response to these comments, which can be viewed at the following URL: http:\\epa.gov\region5\water\uic\ineos-response-to-comments. The response is part of the Administrative Record for this decision. U.S. EPA is issuing the final exemption with no changes from the draft decision.

    Conditions

    This exemption is subject to the following conditions. Non-compliance with any of these conditions is grounds for termination of the exemption.

    (1) The exemption applies to the four existing hazardous waste injection wells, #1, #2, #3, and #4, located at the Ineos facility at 1900 Fort Amanda Road, Lima, Ohio;

    (2) Injection of hazardous waste is limited to the parts of the Lower Eau Claire Formation, the Mt. Simon Sandstone and the Middle Run Formation at depths between 2,631 and 3,241 feet below ground level;

    (3) The only RCRA-restricted wastes that may be injected are those designated by the RCRA waste codes found in Table 1;

    (4) Maximum concentrations of chemicals that are allowed to be injected are listed in Table 2;

    (5) The average specific gravity of the injected waste stream must be between 1.00 and 1.05 over a three month period;

    (6) Ineos may inject up to 175 gallons per minute through each of its four wells, based on a monthly average;

    (7) This exemption is approved for the 20-year modeled injection period, which ends on January 31, 2025. Ineos may petition U.S. EPA for reissuance of the exemption beyond that date, provided that a new and complete petition and no-migration demonstration is received at U.S. EPA, Region 5, by June 30, 2024;

    (8) Ineos must submit a quarterly report containing the fluid analyses of the injected waste and indicate the chemical and physical properties, including the concentrations, of all the injected chemical constituents listed in Table 2 to U.S. EPA;

    (9) Ineos must submit an annual report containing the results of a bottom hole pressure survey (fall-off test) performed on one well each year to U.S. EPA. The survey must be performed after shutting down the well for sufficient time to conduct a valid observation of the pressure fall-off curve under 40 CFR 146.68(e)(1). The annual report must include a comparison of reservoir parameters determined from the fall-off test with parameters used in the approved no-migration petition;

    (10) Ineos must submit the results of radioactive tracer surveys and annulus pressure tests for its four wells to U.S. EPA annually;

    (11) Ineos must notify U.S. EPA in writing if any well loses mechanical integrity and prior to any workover or plugging;

    (12) Ineos must fully comply with all requirements set forth in Underground Injection Control Permits #UIC 03-02-003-PTO-1, UIC 03-02-004-PTO-1, UIC 03-02-005-PTO-01 and 03-02-006-PTO-1 issued by the Ohio Environmental Protection Agency;

    (13) Upon the expiration, cancellation, reissuance, or modification of the permits referenced above, this exemption is subject to review by U.S. EPA; and

    (14) Whenever U.S. EPA determines that the basis for approval of a petition under 40 CFR 148.23 and 148.24 may no longer be valid, U.S. EPA may terminate this exemption and will require a new demonstration in accordance with 40 CFR 148.20.

    Table 1—List of RCRA Waste Codes Approved for Injection D001 D002 D003 D004 D005 D006 D007 D008 D009 D010 D011 D018 D019 D035 D038 F039 K011 K013 K014 P003 P005 P030 P063 P069 P098 P101 P106 P120 U001 U002 U003 U007 U008 U009 U019 U031 U044 U053 U056 U057 U080 U112 U122 U123 U124 U125 U129 U140 U147 U149 U151 U152 U154 U159 U161 U169 U188 U191 U196 U211 U213 U219 U220 U239

    These waste codes are identified in 40 CFR part 261, subpart C and subpart D.

    Table 2—Concentration Limits of Chemical Contaminants That Are Hazardous at Less Than 0.001 Mg/L Chemical constituent Waste code Health based limit
  • (mg/L)
  • Concentration limit at the wellhead
  • (mg/L)
  • (Note 2)
  • Concentration
  • reduction
  • factor
  • (C/C0)
  • Acetaldehyde U001 0.11 2,000 5.5 × 10−5 Acetamide Note 2 1.0 × 10−5 10,000 1.0 × 10−9 Acetic acid Note 2 6.0 × 10−6 6,000 1.0 × 10−9 Acetone U002 3.5 2,000 1.75 × 10−3 Acetone cyanohydrin P069 0.005 6,000 8.33 × 10−7 Acetonitrile K011, K013, K014, U003 0.21 100,000 2.1 × 10−6 Acrolein P003 0.005 2,000 2.5 × 10−6 Acrylamide K011, K013, K014, U007 8 × 10−6 6,000 1.33 × 10−9
  • Note 1
  • Acrylic acid U008 17.5 60,000 2.92 × 10−4 Acrylonitrile K011, K013, K014, U009 6.0 × 10−5 24,000 2.5 × 10−9 Allyl alcohol P005 0.175 2,000 8.75 × 10−5 Antimony F039 0.006 100 6.0 × 10−5 Arsenic D004 0.05 100 5.0 × 10−4 Barium D005 2 100 2.0 × 10−2 Benzene D018, K011, K013, K014, U019 0.005 400 1.25 × 10−5 1,3-Butanediol Note 2 1.0 × 10−6 1,000 1.0 × 10−9 1,4-Butanediol Note 2 1.4 × 10−5 14,000 1.0 × 10−9 Butanetriol Note 2 4.0 × 10−6 4,000 1.0 × 10−9 Butanol U140 3.5 4,000 8.75 × 10−4 Butyrolactone Note 2 5.0 × 10−6 5,000 1.0 × 10−9 Cadmium D006 0.005 100 5.0 × 10−5 Carbon tetrachloride D019, U211 0.005 100 5.0 × 10−5 Chloroform U044 0.006 100 6.0 × 10−5 Chromium D007 0.1 100 1.0 × 10−3 Cobalt Note 1.0 × 10−7 100 1.0 × 10−9 Crotonaldehyde U053 0.002 200 1.0 × 10−5 Crotonitrile Note 2 1.0 × 10−6 1,000 1.0 × 10−9 Cyclohexane U056 9.0 × 10−5 100 9.0 × 10−7 Cyclohexanone U057 180 100 1.8 Diethylenetriamine pentaacetic acid Note 2 1.0 × 10−6 1,000 1.0 × 10−9 Dimethylhydantoin Note 2 1.0 × 10−6 1,000 1.0 × 10−9 Ethanol Note 2 2.0 × 10−6 2,000 1.0 × 10−9 Ethyl acetate U112 31.5 100 3.15 × 10−1 Ethylenediamine tetracetonitrile Note 2 4.0 × 10−6 4,000 1.0 × 10−9 Formic acid U123 0.01 20,000 5.0 × 10−7 Formaldehyde U122 7 4,000 1.75 × 10−3 Formamide Note 2 4.0 × 10−6 4,000 1.0 × 10−9 Fumaronitrile Note 2 4.0 × 10−6 4,000 1.0 × 10−9 Furan U124 3.5 × 10−3 100 3.5 × 10−4 Furfural U125 0.11 100 1.1 × 10−3 Glyconitrile Note 2 7.0 × 10−6 7,000 1.0 × 10−9 HCN (Free) K011, K013, K014, P030, P063, P098, P106 0.2 3,200 6.25 × 10−5 HCN (Total) K011, K013, K014, P030, P063, P098, P106 0.7 21,200 3.3 × 10−5 Hexamethylenetetramine (or acid) Note 2 1.0 × 10−6 1,000 1.0 × 10−9 Iminodiacetonitrile Note 2 1.0 × 10−6 1,000 1.0 × 10−9 Isobutanol U140 11 200 5.5 × 10−2 Isopropyl alcohol Note 2 1.2 × 10−6 1,200 1.0 × 10−9 Lead D008 0.001 100 1.0 × 10−5 Lindane U129 2.0 × 10−4 1,000 2.0 × 10−7 Maleic anhydride U147 3.5 100 3.5 × 10−2 Maleonitrile Note 2 2.0 × 10−5 20,000 1.0 × 10−9 Malonitrile U149 0.005 2,000 2.5 × 10−6 Mercury D009, U151 0.002 100 2.0 × 10−5 Methanol U154 17.5 40,000 4.38 × 10−4 Methyacrylonitrile U152 0.0035 400 8.75 × 10−6 Methylethylhydantoin Note 2 1.0 × 10−6 1,000 1.0 × 10−9 Methylene chloride U080 5.3 × 10−3 100 5.0 × 10−5 Methyl ethyl ketone D035, U159 21 1,000 2.1 × 10−2 Methyl isobutyl ketone U161 2.0 × 10−3 100 2.0 × 10−5 2-Methylpyridine U191 2.0 × 10−3 1,000 2.0 × 10−6 3-Methylpyridine Note 2 1.0 × 10−6 1,000 1.0 × 10−9 Nickel F006 0.001 100 1.0 × 10−5 Nicotinonitrile Note 2 6.0 × 10−6 6,000 1.0 × 10−9 Nitrilotiracetonitrile Note 2 1.0 × 10−6 1,000 1.0 × 10−9 Nitrobenzene U169 1.8 × 10−2 100 1.8 × 10−4 Oleic acid Note 2 1.0 × 10−6 1,000 1.0 × 10−9 Oleoylsarconsinate Note 2 1.0 × 10−6 1,000 1.0 × 10−9 Phenol U188 21 100 2.1 × 10−1 1,2-Propanediol Note 2 6.0 × 10−8 60 1.0 × 10−9 1,3-Propanediol Note 2 2.0 × 10−6 2,000 1.0 × 10−9 Propanol Note 2 2,0 × 10−6 2,000 1.0 × 10−9 Propionitrile P101 0.005 2,000 2.5 × 10−6 Propylenediamine tetracetonitrile Note 2 1.0 × 10−6 1,000 1.0 × 10−9 Pyroazole Note 2 4.0 × 10−6 4,000 1.0 × 10−9 Pyridine D038, U196 0.035 2,000 1.75 × 10−5 Selenium D010 0.05 100 5.0 × 10−4 Silver D011 0.175 100 1.75 × 10−3 Sodium cyanide D003, K011, K013, P030, P063, P106 1.4 1,200 1.17 × 10−3 Strontium Note 2 1.0 × 10−7 100 1.0 × 10−9 Succinic acid Note 2 8.0 × 10−7 800 1.0 × 10−9 Succinotrile Note 2 6.0 × 10−6 6,000 1.0 × 10−9 Tetrahydrofuran U213 0.002 5,000 4.0 × 10−7 Thiourea U219 1.0 × 10−2 100 1.0 × 10−4 Toluene U220 1 100 1.0 × 10−2 Vanadium P120 0.004 100 4.0 × 10−5 Vanadium pentoxide P120 0.315 400 7.88 × 10−4 Xylene U239 10 100 1.0 × 10−1 Zinc Note 2 10.5 400 2.63 × 10−2

    Note 1—Worst-case constituent. Health Based Limit (HBL) contour for no-migration boundary set at 1.0 × 10−9 for this constituent. The HBL values are from the compilation by EPA Region 6, revised 2005.

    Note 2—Constituents not associated with an EPA RCRA waste code or listed in HBL guidelines are assigned the minimum C/C0 of 1.0 × 10−9. A provisional “HBL” for these constituents is then derived from the product of C/C0 and the concentration limit at the wellhead. If a RCRA waste code is promulgated for any of these constituents, the HBL selected by EPA will be compared to the provisional “HBL” on this table. If the EPA HBL is more stringent, the Concentration Limit at the Wellhead will be reduced or migration of the constituent will be reconsidered in detail.

    Electronic Access. You may access this Federal Register document electronically from the Government Printing Office under the “Federal Register” listings at FDSys (http://www.thefederalregister.org/fdsys/browse/collection.action?collectionCode=FR).

    Dated: February 1, 2016. Tinka G. Hyde, Director, Water Division.
    [FR Doc. 2016-04756 Filed 3-2-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9943-17-OLEM] Twenty-Ninth Update of the Federal Agency Hazardous Waste Compliance Docket AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    Since 1988, the Environmental Protection Agency (EPA) has maintained a Federal Agency Hazardous Waste Compliance Docket (“Docket”) under Section 120(c) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Section 120(c) requires EPA to establish a Docket that contains certain information reported to EPA by Federal facilities that manage hazardous waste or from which a reportable quantity of hazardous substances has been released. As explained further below, the Docket is used to identify Federal facilities that should be evaluated to determine if they pose a threat to public health or welfare and the environment and to provide a mechanism to make this information available to the public.

    This notice includes the complete list of Federal facilities on the Docket and also identifies Federal facilities reported to EPA since the last update of the Docket on August 17, 2015. In addition to the list of additions to the Docket, this notice includes a section with revisions of the previous Docket list. Thus, the revisions in this update include 7 additions, 22 corrections, and 42 deletions to the Docket since the previous update. At the time of publication of this notice, the new total number of Federal facilities listed on the Docket is 2,326. Since the last update, EPA has identified a discrepancy in the total number of facilities published in the Federal Register. The number of Docket sites in the Federal Register did not match the number of sites on EPA's Master Docket List. EPA has reconciled the discrepancies and the list is now and both lists are now matching a current. This publication contains the entire Docket list to clarify the number of sites.

    DATES:

    This list is current as of February 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Electronic versions of the Docket and more information on its implementation can be obtained at http://www.epa.gov/fedfac/previous-federal-agency-hazardous-waste-compliance-docket-updates by clicking on the link for Update #29 to the Federal Agency Hazardous Waste Compliance Docket or by contacting Benjamin Simes ([email protected]), Federal Agency Hazardous Waste Compliance Docket Coordinator, Federal Facilities Restoration and Reuse Office (Mail Code 5106P), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460.

    SUPPLEMENTARY INFORMATION: Table of Contents 1.0 Introduction 2.0 Regional Docket Coordinators 3.0 Revisions of the Previous Docket 4.0 Process for Compiling the Updated Docket 5.0 Facilities Not Included 6.0 Facility NPL Status Reporting, Including NFRAP Status 7.0 Information Contained on Docket Listing 1.0 Introduction

    Section 120(c) of CERCLA, 42 United States Code (U.S.C.) § 9620(c), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), requires EPA to establish the Federal Agency Hazardous Waste Compliance Docket. The Docket contains information on Federal facilities that manage hazardous waste and such information is submitted by Federal agencies to EPA under Sections 3005, 3010, and 3016 of the Resource Conservation and Recovery Act (RCRA), 42 U.S.C. 6925, 6930, and 6937. Additionally, the Docket contains information on Federal facilities with a reportable quantity of hazardous substances that has been released and such information is submitted by Federal agencies to EPA under Section 103 of CERCLA, 42 U.S.C. 9603. Specifically, RCRA Section 3005 establishes a permitting system for certain hazardous waste treatment, storage, and disposal (TSD) facilities; RCRA Section 3010 requires waste generators, transporters and TSD facilities to notify EPA of their hazardous waste activities; and RCRA Section 3016 requires Federal agencies to submit biennially to EPA an inventory of their Federal hazardous waste facilities. CERCLA Section 103(a) requires the owner or operator of a vessel or onshore or offshore facility to notify the National Response Center (NRC) of any spill or other release of a hazardous substance that equals or exceeds a reportable quantity (RQ), as defined by CERCLA Section 101. Additionally, CERCLA Section 103(c) requires facilities that have “stored, treated, or disposed of” hazardous wastes and where there is “known, suspected, or likely releases” of hazardous substances to report their activities to EPA.

    CERCLA Section 120(d) requires EPA to take steps to assure that a Preliminary Assessment (PA) be completed for those sites identified in the Docket and that the evaluation and listing of sites with a PA be completed within a reasonable time frame. The PA is designed to provide information for EPA to consider when evaluating the site for potential response action or inclusion on the National Priorities List (NPL).

    The Docket serves three major purposes: (1) To identify all Federal facilities that must be evaluated to determine whether they pose a threat to human health and the environment sufficient to warrant inclusion on the National Priorities List (NPL); (2) to compile and maintain the information submitted to EPA on such facilities under the provisions listed in Section 120(c) of CERCLA; and (3) to provide a mechanism to make the information available to the public.

    The initial list of Federal facilities to be included on the Docket was published in the Federal Register on February 12, 1988 (53 FR 4280). Since then, updates to the Docket have been published on November 16, 1988 (53 FR 46364); December 15, 1989 (54 FR 51472); August 22, 1990 (55 FR 34492); September 27, 1991 (56 FR 49328); December 12, 1991 (56 FR 64898); July 17, 1992 (57 FR 31758); February 5, 1993 (58 FR 7298); November 10, 1993 (58 FR 59790); April 11, 1995 (60 FR 18474); June 27, 1997 (62 FR 34779); November 23, 1998 (63 FR 64806); June 12, 2000 (65 FR 36994); December 29, 2000 (65 FR 83222); October 2, 2001 (66 FR 50185); July 1, 2002 (67 FR 44200); January 2, 2003 (68 FR 107); July 11, 2003 (68 FR 41353); December 15, 2003 (68 FR 69685); July 19, 2004 (69 FR 42989); December 20, 2004 (69 FR 75951); October 25, 2005 (70 FR 61616); August 17, 2007 (72 FR 46218); November 25, 2008 (73 FR 71644); October 13, 2010 (75 FR 62810); November 6, 2012 (77 FR 66609); March 18, 2013 (78 FR 16668); January 6, 2014 (79 FR 654), December 31, 2014 (79 FR 78850); and August 17, 2015 (80 FR 49223). This notice constitutes the twenty-ninth update of the Docket.

    This notice provides some background information on the Docket. Additional information on the Docket requirements and implementation are found in the Docket Reference Manual, Federal Agency Hazardous Waste Compliance Docket found at http://www.epa.gov/fedfac/docket-reference-manual-federal-agency-hazardous-waste-compliance-docket-interim-final or obtained by calling the Regional Docket Coordinators listed below. This notice also provides changes to the list of sites included on the Docket in three areas: (1) Additions, (2) Deletions, and (3) Corrections. Specifically, additions are newly identified Federal facilities that have been reported to EPA since the last update and now are included on the Docket; the deletions section lists Federal facilities that EPA is deleting from the Docket.1 The information submitted to EPA on each Federal facility is maintained in the Docket repository located in the EPA Regional office of the Region in which the Federal facility is located; for a description of the information required under those provisions, see 53 FR 4280 (February 12, 1988). Each repository contains the documents submitted to EPA under the reporting provisions and correspondence relevant to the reporting provisions for each Federal facility.

    1 See Section 3.2 for the criteria for being deleted from the Docket.

    In prior updates, information was also provided regarding No Further Remedial Action Planned (NFRAP) status changes. However, information on NFRAP and NPL status is no longer being provided separately in the Docket update as it is now available at: http://www.epa.gov/fedfac/fedfacts-information-about-federal-electronic-docket-facilities or by contacting the EPA HQ Docket Coordinator at the address provided in the FOR FURTHER INFORMATION CONTACT section of this notice.

    2.0 Regional Docket Coordinators

    Contact the following Docket Coordinators for information on Regional Docket repositories:

    Martha Bosworth (HBS), US EPA Region 1, 5 Post Office Square, Suite 100, Mail Code: OSRR07-2, Boston MA 02109-3912, (617) 918-1407.

    Helen Shannon (ERRD), US EPA Region 2, 290 Broadway, New York, NY 10007-1866, (212) 637- 4260.

    Joseph Vitello (3HS12), US EPA Region 3, 1650 Arch Street, Philadelphia, PA 19107, (215) 814-3354.

    Dawn Taylor (4SF-SRSEB), US EPA Region 4, 61 Forsyth St. SW., Atlanta, GA 30303, (404) 562-8575.

    Michael Chrystof (SR-6J), US EPA Region 5, 77 W. Jackson Blvd., Chicago, IL 60604, (312) 353-3705.

    Philip Ofosu (6SF-RA), US EPA Region 6, 1445 Ross Avenue, Dallas, TX 75202-2733, (214) 665-3178.

    Paul Roemerman (SUPRERSP), US EPA Region 7, 11201 Renner Blvd., Lenexa, KS 66219, (913) 551-7694.

    Ryan Dunham (EPR-F), US EPA Region 8, 1595 Wynkoop Street, Denver, CO 80202, (303) 312-6627.

    Leslie Ramirez (SFD-6-1), US EPA Region 9, 75 Hawthorne Street, San Francisco, CA 94105, (415) 972-3978.

    Monica Lindeman (ECL, ABU), US EPA Region 10, 1200 Sixth Avenue, Suite 900, ECL-112, Seattle, WA 98101, (206) 553-5113.

    3.0 Revisions of the Previous Docket

    This section includes a discussion of the additions and deletions to the list of Docket facilities since the previous Docket update.

    3.1 Additions

    In this notice, 7 Federal facilities are being added to the Docket, primarily because of new information obtained by EPA (for example, recent reporting of a facility pursuant to RCRA Sections 3005, 3010, or 3016 or CERCLA Section 103). CERCLA Section 120, as amended by the Defense Authorization Act of 1997, specifies that EPA take steps to assure that a Preliminary Assessment (PA) be completed within a reasonable time frame for those Federal facilities that are included on the Docket. Among other things, the PA is designed to provide information for EPA to consider when evaluating the site for potential response action or listing on the NPL.

    3.2 Deletions

    In this notice, 42 Federal facilities are being deleted from the Docket. There are no statutory or regulatory provisions that address deletion of a facility from the Docket. However, if a facility is incorrectly included on the Docket, it may be deleted from the Docket. The criteria EPA uses in deleting sites from the Docket include: A facility for which there was an incorrect report submitted for hazardous waste activity under RCRA (e.g., 40 CFR 262.44); a facility that was not Federally-owned or operated at the time of the listing; a facility included more than once (i.e., redundant listings); or when multiple facilities are combined under one listing. (See Docket Codes (Categories for Deletion of Facilities) for a more refined list of the criteria EPA uses for deleting sites from the Docket. Facilities being deleted no longer will be subject to the requirements of CERCLA Section 120(d).

    3.3 Corrections

    Changes necessary to correct the previous Docket are identified by both EPA and Federal agencies. The corrections section may include changes in addresses or spelling, and corrections of the recorded name and ownership of a Federal facility. In addition, changes in the names of Federal facilities may be made to establish consistency in the Docket or between the Superfund Enterprise Management System (SEMS) and the Docket. For the Federal facility for which a correction is entered, the original entry is as it appeared in previous Docket updates. The corrected update is shown directly below, for easy comparison. This notice includes 22 corrections.

    4.0 Process for Compiling the Updated Docket

    In compiling the newly reported Federal facilities for the update being published in this notice, EPA extracted the names, addresses, and identification numbers of facilities from four EPA databases—the WebEOC, the Biennial Inventory of Federal Agency Hazardous Waste Activities, the Resource Conservation and Recovery Act Information System (RCRAInfo), and SEMS—that contain information about Federal facilities submitted under the four provisions listed in CERCLA Section 120(c).

    EPA assures the quality of the information on the Docket by conducting extensive evaluation of the current Docket list and contacts the other Federal Agency (OFA) with the information obtained from the databases identified above to determine which Federal facilities were, in fact, newly reported and qualified for inclusion on the update. EPA is also striving to correct errors for Federal facilities that were previously reported. For example, state-owned or privately-owned facilities that are not operated by the Federal government may have been included. Such problems are sometimes caused by procedures historically used to report and track Federal facilities data. Representatives of Federal agencies are asked to contact the EPA HQ Docket Coordinator at the address provided in the FOR FURTHER INFORMATION CONTACT section of this notice if revisions of this update information are necessary.

    5.0 Facilities Not Included

    Certain categories of facilities may not be included on the Docket, such as: (1) Federal facilities formerly owned by a Federal agency that at the time of consideration was not Federally-owned or operated; (2) Federal facilities that are small quantity generators (SQGs) that have never generated more than 1,000 kg of hazardous waste in any month; (3) Federal facilities that are solely hazardous waste transportation facilities, as reported under RCRA Section 3010; and (4) Federal facilities that have mixed mine or mill site ownership.

    An EPA policy issued in June 2003 provided guidance for a site-by-site evaluation as to whether “mixed ownership” mine or mill sites, typically created as a result of activities conducted pursuant to the General Mining Law of 1872 and never reported under Section 103(a), should be included on the Docket. For purposes of that policy, mixed ownership mine or mill sites are those located partially on private land and partially on public land. This policy is found at http://www.epa.gov/fedfac/policy-listing-mixed-ownership-mine-or-mill-sites-created-result-general-mining-law-1872. The policy of not including these facilities may change; facilities now omitted may be added at some point if EPA determines that they should be included.

    6.0 Facility NPL Status Reporting, Including NFRAP Status

    EPA typically tracks the NPL status of Federal facilities listed on the Docket. An updated list of the NPL status of all Docket facilities, as well as their NFRAP status, is available at http://www.epa.gov/fedfac/fedfacts-information-about-federal-electronic-docket-facilities or by contacting the EPA HQ Docket Coordinator at the address provided in the FOR FURTHER INFORMATION CONTACT section of this notice. In prior updates, information regarding NFRAP status changes was provided separately.

    7.0 Information Contained on Docket Listing

    The information is provided in four tables. The first table is a list of new Federal facilities that are being added to the Docket. The second table is a list of Federal facilities that are being deleted from the Docket. The third table is for corrections. The fourth table is the complete Docket list, this list is current and includes the changes from Update #29.

    The Federal facilities listed in each table are organized by the date reported. Under each heading is listed the name and address of the facility, the Federal agency responsible for the facility, the statutory provision(s) under which the facility was reported to EPA, and a code.2

    2 Each Federal facility listed in the update has been assigned a code that indicates a specific reason for the addition or deletion. The code precedes this list.

    The statutory provisions under which a Federal facility is reported are listed in a column titled “Reporting Mechanism.” Applicable mechanisms are listed for each Federal facility: For example, Sections 3005, 3010, 3016, 103(c), or Other. “Other” has been added as a reporting mechanism to indicate those Federal facilities that otherwise have been identified to have releases or threat of releases of hazardous substances. The National Contingency Plan 40 CFR 300.405 addresses discovery or notification, outlines what constitutes discovery of a hazardous substance release, and states that a release may be discovered in several ways, including: (1) A report submitted in accordance with Section 103(a) of CERCLA, i.e., reportable quantities codified at 40 CFR part 302; (2) a report submitted to EPA in accordance with Section 103(c) of CERCLA; (3) investigation by government authorities conducted in accordance with Section 104(e) of CERCLA or other statutory authority; (4) notification of a release by a Federal or state permit holder when required by its permit; (5) inventory or survey efforts or random or incidental observation reported by government agencies or the public; (6) submission of a citizen petition to EPA or the appropriate Federal facility requesting a preliminary assessment, in accordance with Section 105(d) of CERCLA; (7) a report submitted in accordance with Section 311(b)(5) of the Clean Water Act; and (8) other sources. As a policy matter, EPA generally believes it is appropriate for Federal facilities identified through the CERCLA discovery and notification process to be included on the Docket.

    The complete list of Federal facilities that now make up the Docket and the NPL and NFRAP status are available to interested parties and can be obtained at http://www.epa.gov/fedfac/fedfacts-information-about-federal-electronic-docket-facilities or by contacting the EPA HQ Docket Coordinator at the address provided in the FOR FURTHER INFORMATION CONTACT section of this notice. As of the date of this notice, the total number of Federal facilities that appear on the Docket is 2,326.

    Dated: February 24, 2016. Charlotte Bertrand, Acting Director, Federal Facilities Restoration and Reuse Office, Office of Land and Emergency Management. Categories for Deletion of Facilities

    (1) Small-Quantity Generator. Show citation box.

    (2) Never Federally Owned and/or Operated.

    (3) Formerly Federally Owned and/or Operated but not at time of listing.

    (4) No Hazardous Waste Generated.

    (5) (This code is no longer used.)

    (6) Redundant Listing/Site on Facility.

    (7) Combining Sites Into One Facility/Entries Combined.

    (8) Does Not Fit Facility Definition.

    Categories for Addition of Facilities

    (15) Small-Quantity Generator with either a RCRA 3016 or CERCLA 103 Reporting Mechanism.

    (16) One Entry Being Split Into Two (or more)/Federal Agency Responsibility Being Split.

    (17) New Information Obtained Showing That Facility Should Be Included.

    (18) Facility Was a Site on a Facility That Was Disbanded; Now a Separate Facility.

    (19) Sites Were Combined Into One Facility.

    (19A) New Currently Federally Owned and/or Operated Facility Site.

    Categories for Corrections of Information About Facilities

    (20) Reporting Provisions Change.

    (20A) Typo Correction/Name Change/Address Change.

    (21) Changing Responsible Federal Agency. (If applicable, new responsible Federal agency submits proof of previously performed PA, which is subject to approval by EPA.)

    (22) Changing Responsible Federal Agency and Facility Name. (If applicable, new responsible Federal Agency submits proof of previously performed PA, which is subject to approval by EPA.)

    (24) Reporting Mechanism Determined To Be Not Applicable After Review of Regional Files.

    EN03MR16.008 EN03MR16.009 EN03MR16.010 EN03MR16.011 EN03MR16.012 EN03MR16.013 EN03MR16.014 EN03MR16.015 EN03MR16.016 EN03MR16.017 EN03MR16.018 EN03MR16.019 EN03MR16.020 EN03MR16.021 EN03MR16.022 EN03MR16.023 EN03MR16.024 EN03MR16.025 EN03MR16.026 EN03MR16.027 EN03MR16.028 EN03MR16.029 EN03MR16.030 EN03MR16.031 EN03MR16.032 EN03MR16.033 EN03MR16.034 EN03MR16.035 EN03MR16.036 EN03MR16.037 EN03MR16.038 EN03MR16.039 EN03MR16.040 EN03MR16.041 EN03MR16.042 EN03MR16.043 EN03MR16.044 EN03MR16.045 EN03MR16.046 EN03MR16.047 EN03MR16.048 EN03MR16.049 EN03MR16.050 EN03MR16.051 EN03MR16.052 EN03MR16.053 EN03MR16.054 EN03MR16.055 EN03MR16.056 EN03MR16.057 EN03MR16.058
    [FR Doc. 2016-04692 Filed 3-2-16; 8:45 am] BILLING CODE 6560-50-C
    FARM CREDIT ADMINISTRATION Farm Credit Administration Board; Sunshine Act; Regular Meeting AGENCY:

    Farm Credit Administration.

    SUMMARY:

    Notice is hereby given, pursuant to the Government in the Sunshine Act, of the regular meeting of the Farm Credit Administration Board (Board).

    DATES:

    The regular meeting of the Board will be held at the offices of the Farm Credit Administration in McLean, Virginia, on March 10, 2016, from 9:00 a.m. until such time as the Board concludes its business.

    FOR FURTHER INFORMATION CONTACT:

    Dale L. Aultman, Secretary to the Farm Credit Administration Board, (703) 883-4009, TTY (703) 883-4056.

    ADDRESSES:

    Farm Credit Administration, 1501 Farm Credit Drive, McLean, Virginia 22102-5090. Submit attendance requests via email to [email protected] See SUPPLEMENTARY INFORMATION for further information about attendance requests.

    SUPPLEMENTARY INFORMATION:

    This meeting of the Board will be open to the public (limited space available). Please send an email to [email protected] at least 24 hours before the meeting. In your email include: Name, postal address, entity you are representing (if applicable), and telephone number. You will receive an email confirmation from us. Please be prepared to show a photo identification when you arrive. If you need assistance for accessibility reasons, or if you have any questions, contact Dale L. Aultman, Secretary to the Farm Credit Administration Board, at (703) 883-4009. The matters to be considered at the meeting are:

    Open Session A. Approval of Minutes • February 11, 2016 B. New Business • Final Rule: Capital—Tier 1/Tier 2 Framework • Bookletter: Lending to Similar Entities Dated: March 1, 2016. Dale L. Aultman, Secretary, Farm Credit Administration Board.
    [FR Doc. 2016-04814 Filed 3-1-16; 4:15 pm] BILLING CODE 6705-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of the Termination of the Receivership of 10504, Eastside Commercial Bank, Conyers, Georgia

    Notice is hereby given that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for Eastside Commercial Bank, Conyers, Georgia (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of Eastside Commercial Bank on July 18, 2014. The liquidation of the receivership assets has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

    Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.1, 1601 Bryan Street, Dallas, TX 75201.

    No comments concerning the termination of this receivership will be considered which are not sent within this time frame.

    Dated: February 29, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-04661 Filed 3-2-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of the Termination of the Receivership of 10260 Olde Cypress Community Bank, Clewiston, Florida

    Notice is hereby given that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for Olde Cypress Community Bank, Clewiston, Florida (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of Olde Cypress Community Bank on July 16, 2010. The liquidation of the receivership assets has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

    Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 32.1, 1601 Bryan Street, Dallas, TX 75201.

    No comments concerning the termination of this receivership will be considered which are not sent within this time frame.

    Dated: February 29, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-04658 Filed 3-2-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of the Termination of the Receivership of 10421, First Guaranty Bank and Trust Company of Jacksonville, Jacksonville, Florida

    Notice is hereby given that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for First Guaranty Bank and Trust Company of Jacksonville, Jacksonville, Florida (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of First Guaranty Bank and Trust Company of Jacksonville on January 27, 2012. The liquidation of the receivership assets has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

    Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 32.1, 1601 Bryan Street, Dallas, TX 75201.

    No comments concerning the termination of this receivership will be considered which are not sent within this time frame.

    Dated: February 29, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-04660 Filed 3-2-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of the Termination of the Receivership of 10279 Community National Bank At Bartow; Bartow, Florida

    Notice is hereby given that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for Community National Bank At Bartow, Bartow, Florida (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of Community National Bank At Bartow on August 20, 2010. The liquidation of the receivership assets has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

    Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation; Division of Resolutions and Receiverships; Attention: Receivership Oversight Department 32.1; 1601 Bryan Street; Dallas, TX 75201.

    No comments concerning the termination of this receivership will be considered which are not sent within this time frame.

    Dated: February 29, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-04659 Filed 3-2-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL HOUSING FINANCE AGENCY [No. 2016-N-02] Privacy Act of 1974; Systems of Records AGENCY:

    Federal Housing Finance Agency.

    ACTION:

    Notice of complete revision to an existing system of records.

    SUMMARY:

    In accordance with the requirements of the Privacy Act of 1974, as amended, 5 U.S.C. 552a (Privacy Act), the Federal Housing Finance Agency (FHFA) gives notice of a complete revision to an existing Privacy Act system of records.

    The existing system is Correspondence Tracking System (FHFA-3) and is being revised in its entirety. The system is being revised to clarify and update the categories of individuals covered by the system, the categories of records in the system, and the purposes of the system; to reduce the number of routine uses of the information; and to update where to send notifications, and requests or appeals. The revised System will contain information that FHFA will use for tracking and responding to general Correspondence, Consumer Complaints, Congressional correspondence, and inquiries to FHFA's Ombudsman.

    DATES:

    To be assured of consideration, comments should be received on or before April 4, 2016. This revised system of records will become effective on April 12, 2016 without further notice unless comments necessitate otherwise. FHFA will publish a new notice if the effective date is delayed to review comments or if changes are made based on comments received.

    ADDRESSES:

    Submit comments to FHFA only once, identified by “2016-N-02,” using any one of the following methods:

    Agency Web site: www.fhfa.gov/open-for-comment-or-input.

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. If you submit your comment to the Federal eRulemaking Portal, please also send it by email to FHFA at [email protected] to ensure timely receipt by the agency. Please include “Comments/No. 2016-N-02” in the subject line of the message.

    Hand Delivered/Courier: The hand delivery address is: Alfred M. Pollard, General Counsel, Attention: Comments/No. 2016-N-02, Federal Housing Finance Agency, Eight Floor, 400 7th Street SW., Washington, DC 20219. The package should be delivered to the Seventh Street entrance Guard Desk, First Floor, on business days between 9 a.m. and 5 p.m.

    U.S. Mail, United Parcel Service, Federal Express, or Other Mail Service: The mailing address for comments is: Alfred M. Pollard, General Counsel, Attention: Comments/No. 2016-N-02, Federal Housing Finance Agency, Eighth Floor, 400 7th Street SW., Washington, DC 20219. Please note that all mail sent to FHFA via the U.S. Postal Service is routed through a national irradiation facility, a process that may delay delivery by approximate two weeks.

    See SUPPLEMENTARY INFORMATION for additional information on submission and posting of comments.
    FOR FURTHER INFORMATION CONTACT:

    Megan Moore, Special Advisor, Office of the Director at (202) 649-3018; or David A. Lee, Senior Agency Official for Privacy, [email protected], (202) 649-3803 (not toll free numbers), Federal Housing Finance Agency, 400 7th Street SW., Washington DC 20219. The telephone number for the Telecommunications Device for the Hearing Impaired is (800) 877-8339.

    SUPPLEMENTARY INFORMATION: I. Comments

    Instructions: FHFA seeks public comments on the revised system of records and will take all comments into consideration before issuing the final notice. See 5 U.S.C. 552a(e)(4) and (11). In addition to referencing “Comments/No. 2016-N-02,” please reference the title and number of the system of records your comment addresses: “Correspondence Tracking System (FHFA-3).”

    Posting and Public Availability of Comments: All comments received will be posted without change on the FHFA Web site at http://www.fhfa.gov, and will include any personal information provided, such as your name, address (home and email) telephone number and any other information you provide. In addition, copies of all comments received will be available for examination by the public on business days between the hours of 10 a.m. and 3 p.m., at the Federal Housing Finance Agency, 400 7th Street SW., Washington DC 20219. To make an appointment to inspect comments, please call the Office of General Counsel at (202) 649-3804.

    II. Introduction

    This notice informs the public of FHFA's proposal to revise in its entirety an existing system of records. This notice satisfies the Privacy Act requirement that an agency publish a system of records notice in the Federal Register when there is an addition to the agency's system of records. It has been recognized by Congress that application of all requirements of the Privacy Act to certain categories of records may have an undesirable and often unacceptable effect upon agencies in the conduct of necessary public business. Consequently, Congress established general exemptions and specific exemptions that could be used to exempt records from provisions of the Privacy Act. Congress also required that exempting records from provisions of the Privacy Act would require the head of an agency to publish a determination to exempt a record from the Privacy Act as a rule in accordance with the Administrative Procedure Act. The Director of FHFA has determined that records and information in this revised system of records are not exempt from requirements of the Privacy Act.

    As required by the Privacy Act, 5 U.S.C. 552a(r), and pursuant to paragraph 4c of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” dated February 8, 1996 (61 FR 6428, 6435 (February 20, 1996)), FHFA has submitted a report describing the revised system of records covered by this notice, to the Committee on Oversight and Government Reform of the House of Representatives, the Committee on Homeland Security and Governmental Affairs of the Senate, and the Office of Management and Budget.

    The revised system of records described above is set forth in its entirety below.

    Dated: February 25, 2016. Melvin L. Watt, Director, Federal Housing Finance Agency. FHFA-3 SYSTEM NAME:

    Correspondence Tracking System.

    SECURITY CLASSIFICATION:

    Sensitive but unclassified.

    SYSTEM LOCATION:

    Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219, and any alternate work site utilized by employees of the Federal Housing Finance Agency (FHFA) or by individuals assisting such employees.

    CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:

    An individual or entity who submits a request or inquiry to FHFA. This does not include inquiries or requests made under the Freedom of Information Act (5 U.S.C. 552) or the Privacy Act of 1974, as amended (5 U.S.C. 552a) which are covered by FHFA's System of Records Notice FHFA-13 Freedom of Information and Privacy Act Records.

    CATEGORIES OF RECORDS IN THE SYSTEM:

    Contact information such as name, address (home, property, mailing, and/or business), telephone numbers including cellular telephone numbers (personal and business), email (personal and business), and any other personally identifiable information an individual or entity voluntarily provides to FHFA.

    AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

    Federal Housing Enterprises Financial Safety and Soundness Act of 1992, as amended (12 U.S.C. 4501 et seq.).

    PURPOSE(S):

    The purpose of the system is to capture and track correspondence that FHFA receives from external sources (the general public, Congress, FHFA regulated entities, other federal entities, and state and local governments). The system will capture information about the sender of the correspondence and the nature of the correspondence. The system will help ensure FHFA responds to the inquiry in a timely and accurate manner.

    ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSE OF SUCH USES:

    In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, these records or information contained therein may specifically be disclosed outside FHFA as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:

    (1) When (a) it is suspected or confirmed that the security or confidentiality of information in the system of records has been compromised; (b) FHFA has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by FHFA or another agency or entity) that rely upon the compromised information; and (c) the disclosure is made to such agencies, entities, and persons who are reasonably necessary to assist in connection with FHFA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.

    (2) Records in this system may, in the discretion of FHFA, be disclosed to any individual during the course of any inquiry or investigation conducted by FHFA, or in connection with civil or administrative litigation, if FHFA has reason to believe that the individual to whom the record is disclosed may have further information about the matters related therein, and those matters appeared to be relevant at the time to the subject matter of the inquiry.

    (3) A record or information in this system may be disclosed to any individual with whom FHFA contracts to reproduce, by typing, photocopy or other means, any record within this system for use by FHFA and its employees in connection with their official duties or to any individual who is utilized by FHFA to perform clerical or stenographic functions relating to the official business of FHFA.

    (4) To appropriate federal, state, and local authorities responsible for investigating or prosecuting a violation of, or for enforcing or implementing a statute, rule, regulation, or order issued, when the information indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule, or order issued pursuant thereto.

    (5) To a court, magistrate, or other administrative body in the course of presenting evidence, including disclosures to counsel or witnesses in the course of civil discovery, litigation, or settlement negotiations or in connection with criminal proceedings, when FHFA is a party to the proceeding or has a significant interest in the proceeding, to the extent that the information is determined to be relevant and necessary.

    (6) Disclosure may be made to a Congressional office from the record of an individual in response to an inquiry from the Congressional office made at the request of that individual.

    (7) To contractor personnel, interns, and others performing or working on a contract or project for FHFA.

    (8) To a regulated entity for the purposes of responding to an inquiry or request.

    (9) To another Federal agency if the records are relevant and necessary to carry out FHFA's authorized functions, or if the other Federal agency is the proper agency to respond to the individual submitting an inquiry or request to FHFA.

    (10) To the National Archives and Records Administration, Office of Government Information Services (OGIS), to the extent necessary to fulfill its responsibilities in 5 U.S.C. 552(b), to review administrative agency policies, procedures and compliance with the Freedom of Information Act (FOIA), and to facilitate OGIS' offering of mediation services to resolve disputes between persons making FOIA requests and administrative agencies.

    DISCLOSURE TO CONSUMER REPORTING AGENCIES:

    None.

    POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE:

    Records are maintained in electronic format, paper form, and magnetic disk or tape. Electronic records are stored in computerized databases. Paper and magnetic disk, or tape records are stored in locked file rooms, locked file cabinets and/or safes.

    RETRIEVABILITY:

    Records may be retrieved by any of the following: Name, telephone number, street address, email address, or assigned file number.

    SAFEGUARDS:

    Records are safeguarded in a secured environment. Buildings where records are stored have security cameras and 24-hour security guard service. Computerized records are safeguarded through use of access codes and other information technology security measures. Paper records are safeguarded by locked file rooms, locked file cabinets, and/or safes. Access to the records is restricted to those who require the records in the performance of official duties related to the purposes for which the system is maintained.

    RETENTION AND DISPOSAL:

    Records are retained and disposed of in accordance with the appropriate National Archives and Records Administration General Records Schedules and FHFA Retention Schedules.

    SYSTEM MANAGER(S) AND ADDRESS:

    Office of Congressional Affairs and Communications, Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219.

    NOTIFICATION PROCEDURES:

    Direct inquiries as to whether this system contains a record pertaining to an individual to the Privacy Act Officer. Inquiries may be mailed to the Privacy Act Officer, Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219, or electronically at http://www.fhfa.gov/AboutUs/FOIAPrivacy/Pages/Privacy.aspx in accordance with the procedures set forth in 12 CFR part 1204.

    RECORD ACCESS PROCEDURES:

    Direct requests for access to a record to the Privacy Act Officer. Requests may be mailed to the Privacy Act Officer, Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219, or can be submitted electronically at http://www.fhfa.gov/AboutUs/FOIAPrivacy/Pages/Privacy.aspx in accordance with the procedures set forth in 12 CFR part 1204.

    CONTESTING RECORD PROCEDURES:

    Direct requests to contest or appeal an adverse decision for a record to the Privacy Act Appeals Officer. Requests may be mailed to the Privacy Act Appeals Officer, Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219, or can be submitted electronically at http://www.fhfa.gov/AboutUs/FOIAPrivacy/Pages/Privacy.aspx in accordance with the procedures set forth in 12 CFR part 1204.

    RECORD SOURCE CATEGORIES:

    Information is provided by individuals and entities.

    EXEMPTIONS CLAIMED FOR THE SYSTEM:

    None.

    [FR Doc. 2016-04744 Filed 3-2-16; 8:45 am] BILLING CODE 8070-01-P
    FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB AGENCY:

    Board of Governors of the Federal Reserve System.

    SUMMARY:

    Notice is hereby given of the final approval of a proposed information collection by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

    FOR FURTHER INFORMATION CONTACT:

    Federal Reserve Board Acting Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503.

    Final approval under OMB delegated authority of the extension for three years, with revision, of the following report:

    Report title: Retail Payment Surveys.

    Agency form number: FR 3066a, b, c, and d.

    OMB Control number: 7100-0351.

    Frequency: FR 3066a and b: Triennial (once every three years) with an annual component; FR 3066c: Triennial: and FR 3066d: Annual and on occasion.

    Respondents: Depository and financial institutions, payment networks, payment processors, and payment instrument issuers.

    Estimated annual burden hours: For 2016 surveys: FR 3066a: 43,200 hours; FR 3066b: 1,000 hours; FR 3066c: 450 hours; FR 3066d: 600 hours. For 2017 and 2018 surveys: FR 3066a: 1,700 hours; FR 3066b: 150 hours; FR 3066d: 1,200 hours.

    Estimated average hours per response: For 2016 surveys: FR 3066a: 32 hours; FR 3066b: 8 hours; FR 3066c: 3 hours; FR 3066d: 12 hours. For 2017 and 2018 surveys: FR 3066a: 10 hours; FR 3066b: 5 hours; FR 3066d: 12 hours.

    Number of respondents: FR 3066a: 1,350; FR 3066b: 125; FR 3066c: 150; FR 3066d: 50.

    General description of report: The FR 3066 series is broadly authorized under sections 2A and 12A of the Federal Reserve Act. Section 2A requires that the Board of Governors of the Federal Reserve System and the Federal Open Market Committee (FOMC) maintain long run growth of the monetary and credit aggregates commensurate with the economy's long run potential to increase production, so as to promote effectively the goals of maximum employment, stable prices, and moderate long-term interest rates (12 U.S.C. 225a). In addition, under section 12A of the Federal Reserve Act, the FOMC is required to implement regulations relating to the open market operations conducted by Federal Reserve Banks with a view to accommodating commerce and business and with regard to the regulations' bearing upon the general credit situation of the country (12 U.S.C. 263). The authority of the Federal Reserve to collect economic data to carry out the requirements of these provisions is implicit. Accordingly, the Federal Reserve is generally authorized to collect the information called for by the FR 3066 series by sections 2A and 12A of the Federal Reserve Act.

    In addition, the Board is responsible for implementing and drafting regulations, interpretations, and other guidance for various payments, consumer protection, and other laws (including provisions of the Federal Reserve Act other than those cited above). The information obtained from the Federal Reserve Payments Study may be used in support of the Board's development and implementation of regulations, interpretations, and supervisory guidance for these laws. Therefore, the survey questions in the FR 3066 are authorized pursuant to the Board's authority under one or more of the following statutes:

    • Expedited Funds Availability Act section 609 (12 U.S.C. 4008) • Electronic Fund Transfer Act section 904 (15 U.S.C. 1693b) and section 920 (15 U.S.C. 1693o-2) • Truth In Lending Act section 105 (15 U.S.C. 1604) • The Check Clearing for the 21st Century Act section 15 (12 U.S.C. 5014) • Federal Reserve Act section 11 (Examinations and reports, Supervision over Reserve Banks, and Federal Reserve Note provisions, 12 U.S.C. 248); section 11A (Pricing of Services, 12 U.S.C. 248a); section 13 (FRB deposits and collections, 12 U.S.C. 342); and section 16 (Issuance of Federal Reserve Notes, par clearance, and FRB clearinghouse, 12 U.S.C. 248-1, 360, and 411)

    Additionally, depending upon the survey respondent, the information collection may be authorized under a more specific statute. Specifically, the Board is authorized to collect information from state member banks under section 9 of the Federal Reserve Act (12 U.S.C. 324); from bank holding companies (and their subsidiaries) under section 5(c) of the Bank Holding Company Act (12 U.S.C. 1844(c)); from savings and loan holding companies under 12 U.S.C. 1467a(b) and 5412, from Edge and agreement corporations under sections 25 and 25A of the Federal Reserve Act (12 U.S.C. 602 and 625); and from U.S. branches and agencies of foreign banks under section 7(c)(2) of the International Banking Act of 1978 (12 U.S.C. 3105(c)(2)), and under section 7(a) of the Federal Deposit Insurance Act (12 U.S.C. 1817(a)).

    Participation in the survey is voluntary. Although the Board has the authority to require participation by state member banks, bank holding companies (and their subsidiaries), savings and loan holding companies, Edge and agreement corporations, and U.S. branches and agencies of foreign banks supervised by the Federal Reserve, it has not done so.

    Respondents to the various surveys are requested to report confidential business information, such as information requested in the FR 3066a (for depository and financial institutions) about the number and value of deposits in various customer accounts, broken out by type; image check deposits vs. paper check deposits, ACH entries, wire transfers, debit and prepaid card transactions, credit card transactions, mobile payments, and third-party fraud. The other surveys request similar types of confidential “number and value” information appropriate to the surveyed entities: e.g., for the Network, Processor and Issuer Payments Survey (FR 3066b), the number, value and type of transactions involving credit cards (both general purpose and private label), debit cards, and prepaid cards from each of the respondents (card networks, retail merchants, and processors). Only aggregate data from the surveys, such as estimated volumes and trends in cash usage, noncash payments, check distribution, and established and emerging payment instruments, are proposed to be publicly released.

    Under exemption 4 of the Freedom of Information Act (“FOIA”), 5 U.S.C. 552(b)(4), “trade secrets and commercial or financial information obtained from a person and privileged or confidential” may be excluded from disclosure. The confidential business information collected voluntarily from individual respondents may be withheld, as release of such information would impair the Board's ability to collect such information in the future. Moreover, disclosure of such confidential business information could cause substantial competitive harm to the survey respondents. See National Parks & Conservation Ass'n v. Morton, 498 F.2d 765, 770 (D.C. Cir. 1974).

    Abstract: The FR 3066a, FR 3066b, FR 3066c, and FR 3066d are the latest iteration of the Federal Reserve Payments Study (FRPS), which has been conducted by FRB Atlanta and the Board since 2000. The FRPS originated from a system-wide effort to improve the measurement and public availability of information on volumes and trends in checks and other noncash payments. Despite the retail payments system's critical importance in supporting everyday commerce, there was a significant gap in quantitative information on U.S. retail payments before 2000. The FRPS filled this gap by providing a reliable and transparent non-mandatory survey-based approach to collecting payments industry data on retail payment volumes and trends.

    The FR 3066a currently collects information on the national volume (number and value) of major categories and subcategories of established and emerging methods of payment from a nationally representative stratified random sample of depository institutions.1 Most questions in the surveys consist of payment and related transactions organized as number-value pairs. The FR 3066b currently comprises 15 different surveys, each specific to a particular payment instrument and/or respondent type (respondents only answer surveys that apply to their organizations). It collects information from a census of payment networks, processors, and issuers. The FR 3066c currently collects data from samples of individual checks obtained from a set of depository institutions. The FR 3066d is an ad-hoc supplement to the other FR 3066 surveys.

    1 To obtain comprehensive coverage of total national volumes the survey may also include non-depository financial institutions.

    Current Actions: On November 25, 2015 the Federal Reserve published a notice in the Federal Register (80 FR 73760) requesting public comment for 60 days on the extension, with revision, of the FR 3066a, b, c, and d. The comment period for this notice expired on January 25, 2016. The Federal Reserve received four comment letters addressing this information collection, which are summarized and addressed below.

    Summary Discussion of Public Comments and Responses

    The Federal Reserve received written comments from one payment industry association, one merchant trade association, one payment card network, and one private citizen. All commenters supported the data collection effort, and noted that the information is widely used by payment system participants as a benchmark and to gain insights into payment system trends. Commenters believed that providing the data requested in the surveys would generally not be burdensome to respondents.

    At the Federal Reserve's request, contractors assisting with the survey design conducted industry outreach calls to obtain comments on the clarity of the survey forms and the feasibility of providing the requested data items. Institutions represented in the calls included financial institutions, networks, and processors of several types and sizes. Specific questions were not included in the initial request for public comment.

    A variety of revisions to the surveys resulted from outreach discussions with participants as well, and generally involved clarifications or restatements of questions in order to address issues brought up in these discussions. The detailed discussion below addresses the specific substantive issues that arose from the written comments and outreach efforts, and the Federal Reserve's modifications to the surveys in response to the comments. In addition to these modifications, minor clarifications would be made to the surveys in response to the comments.

    Detailed Discussion of Public Comments and Responses Depository and Financial Institution Payments Survey (FR 3066a)

    The Federal Reserve proposed to collect annual 2015 data instead of one month as in the 2013 version, as the resulting data can be more easily compared with data collected in the FR 3066b, and avoid concerns about seasonal effects. While some institutions noted an inability to report a full calendar year of information for some items, others reported no difficulty or even a reduction in burden. The survey will provide instructions on how to respond when annual data is difficult to report, and will accommodate the reporting of best available information from institutions experiencing difficulty reporting the full year. For example, the survey will accommodate the reporting of an alternative time period, indicated via a notes field provided at the end of each section.

    Substantial clarifications have been added throughout the surveys, based on discussions with outreach participants. These discussions led to a comprehensive set of revisions specifically made to clarify the surveys, and thereby reduce the burden of response. A glossary of terms, frequently asked questions document, user-friendly Web tools, and an 800-number help line will be provided to ease response. Materials will continue to be developed and clarified as necessary to help facilitate response.

    Written comments directed at the 3066a primarily discussed the ACH and the Unauthorized Third-Party Payment Fraud sections. In particular, one comment argued that the institution originating the payment is “in the best position to monitor and report on transaction volume, value, and returns.” This argument suggested that questions about ACH debit payments should be collected from the perspective of the originating depository financial institution (ODFI), or the payee's depository institution. In order to be responsive to this concern, questions were added to collect ACH debits from this perspective. In addition, to address concerns with the reporting of unauthorized third-party fraud payments, questions on the number of returned ACH debits, along with a breakdown of various categories of returns were also added from the ODFI perspective.

    Consistent with the design of the sampling and estimation methods, past surveys collected ACH debit payments and related information from the perspective of the receiving depository financial institution (RDFI). In order to preserve comparability with past surveys and compatibility with the sampling and estimation methods, these questions were retained. One comment suggested that surveying RDFIs would not generate reliable data. Collecting information from both parties to the transaction should shed light on these concerns and help to improve understanding of the ACH data overall.

    One comment requested that a “near real-time” line item be added to the ACH section. Meanwhile, as discussed above, concerns about the ability of depository institutions to respond to ACH questions resulted in additional questions in the ACH section. Also, the related “same-day” settlement question was removed given the de minimis amount of such activity known to have occurred through ACH operators in 2015. The Federal Reserve believes that, for the 2015 version of the survey, questions regarding new payment initiation methods remain in other parts of the surveys. While settlement speed is not currently addressed in the surveys, some alternative payment initiation methods, such as account-to-account products that may post relatively quickly and often settle through the ACH, are measured in other sections in 3066a and 3066b.

    Additional comments expressed concerns with some ACH definitions in the survey that may appear confusing. These definitions have been used in past surveys, however, and participants have generally found them clear. In part, confusion about these questions may have stemmed from the omission of some descriptive information from the posted surveys. A glossary and fuller descriptive information on these terms are published in the detailed report and surveys from 2013. As in past surveys, the glossary and fuller descriptions of the questions, revised appropriately, will be provided in the complete survey distributed to participants.

    One comment suggested adding questions about mobile debit card routing options provided on debit cards. These questions were not added in the present survey, in part because the materiality of the question has not been established. Questions about the provisioning of mobile wallets are new to the survey, and additional questions may be added in the future if a baseline can be established.

    Networks, Processors, and Issuers Payments Surveys (FR 3066b)

    Substantial clarifications have been added to the surveys, based on discussions with outreach participants. In addition, some questions were deleted and some added based on feedback received.

    In a sweeping change affecting most surveys, a new question allowing the option to select the preferred basis to use for allocations of detailed payments data and, separately, fraud data was added. In the previous version of the survey, participants were asked to allocate details on the basis of Net, Authorized and Settled transactions (NAST). NAST will remain the default selection, but participants may choose Total authorized transactions, or Net Purchase Transactions as the basis instead. This change is expected to substantially reduce the burden of providing details for some respondents.

    Allocations between contact and contactless payments were dropped, based on comments suggesting such allocations would be difficult or impossible to provide.

    Revisions to the general-purpose prepaid card surveys were made to make the data and terminology more consistent with the FR 3063a Government-Administered, General Use Prepaid Card Survey.

    Some comments addressed specific concerns with the ability to distinguish or report certain requested items in the survey. Our survey process is designed to accommodate such concerns, and we will work with participants to collect those data participants can report.

    The deferred payment processor survey was discontinued.

    General-Purpose Cards

    One comment requested that a question be designed to capture net chargebacks from the general-purpose card networks. The Federal Reserve believes that the current question “chargebacks (issuer-initiated)” is equivalent to the requested item, and could be contrasted with the question “adjustments and returns (acquirer-initiated).” A more detailed examination of chargebacks is beyond the scope of the current surveys.

    Another comment suggested the omission of the question to identify the volumes of “3-D secure” authentication, which is typically provided by the card networks. As an alternative, the comment suggested including a variety of other types of authentication that might not be tracked by or reported to the networks. Discussions with card networks suggested that the ability to report the use of alternative authentication methods was not possible. The Federal Reserve will retain this question, but notes that the “Online Payment Authentication Methods Processor” survey (formerly the “Secure Online Payment Processor survey) is designed to collect information on such other authentication methods.

    Another comment addressed concerns about the collection of information on the “tokenization” of payments from card networks. Such solutions can be implemented in various ways by parties to the transaction. It would be difficult to comprehensively measure the variety of tokenization schemes being used. The Federal Reserve believes it is important to collect information from survey respondents that is feasible, even when the universe of competing methods cannot be measured in the survey. Given that the surveys sometimes collect partial information, it is important to recognize any limitations on new and emerging trends, especially at the analysis and reporting stages.

    A comment suggested collecting “counterfeit” fraud for remote payments. The survey collects counterfeit card fraud, which, according to card network definitions, means that a fake version of the card is created and used at a merchant's point-of-sale card terminal, an in-person situation. Remote payment fraud is classified by the card networks as an “unauthorized use of account number.” The Federal Reserve believes this definition will capture the type of fraud requested in the comment.

    A comment requested some detail on mobile wallet provisioning. As mobile wallet questions are new for this survey, the Federal Reserve will not expand mobile wallet questions until a baseline can be established.

    Private-Label Cards

    One comment requested the addition of questions on the number of cards in force with multi-factor authentication mechanisms. The revised survey includes a question on the use of chips for private-label cards for the first time. Additional questions may be considered once a baseline is established.

    EBT

    A comment suggested collecting additional detail on authentication methods used for EBT payments. The Federal Reserve believes that EBT payments are almost exclusively PIN authenticated. Past survey efforts have not been successful in obtaining much detail underlying EBT payments, and the survey detail already requested may be difficult to obtain. No additional questions concerning authentication methods will be added at this time. If the situation improves, the Federal Reserve will seek to collect additional relevant detail in the future.

    Mobile Wallet

    A comment requested clarity with respect to the definition of a remote mobile transaction. Across all surveys, a remote payment is one in which the payment transaction is performed remotely, regardless of where or how the good or service is obtained. In an example with a remote card preauthorization, but with a payment made in person, the survey definition is that the payment is an in-person payment.

    A comment suggested breaking out fraudulent mobile wallet transactions into person-present and remote categories. This requested breakout was added to the final proposed survey.

    A comment suggested tracking the number of fraudulently provisioned cards to mobile wallets. The Federal Reserve does not know how such a question should fit into the present survey framework at this time, but believes that information on the number of fraudulent mobile wallet transactions may serve as a useful alternative measure.

    Board of Governors of the Federal Reserve System, February 29, 2016. Robert deV. Frierson, Secretary of the Board.
    [FR Doc. 2016-04654 Filed 3-2-16; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than March 17, 2016.

    A. Federal Reserve Bank of Dallas (Robert L. Triplett III, Senior Vice President) 2200 North Pearl Street, Dallas, Texas 75201-2272:

    1. Leis Family Group comprised of The Revocable Trust of Dorvin D. Leis, Garland, Texas; Charles S. Leis, Eagle, Idaho, Stephen T. Leis, Kihie, Hawaii, and Edward B. Tomlinson, II, Rowlett, Texas, as trustees and in their individual capacity; and Stanley B. Leis, Eagle, Idaho; to retain voting shares of Texas Brand Bancshares, Inc., and therefore indirectly retain additional voting shares of Texas Brand Bank, both of Garland, Texas.

    Board of Governors of the Federal Reserve System, February 26, 2016. Michael J. Lewandowski, Associate Secretary of the Board.
    [FR Doc. 2016-04622 Filed 3-2-16; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than March 18, 2016.

    A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:

    1. Andrew R. Clements and Aaron M. Clements, both of Elmwood, Nebraska; to become members of the Clements Family control group and to acquire voting shares of American Exchange Company, and thereby indirectly acquire voting shares of American Exchange Bank, both in Elmwood, Nebraska.

    Board of Governors of the Federal Reserve System, February 29, 2016. Michael J. Lewandowski, Associate Secretary of the Board.
    [FR Doc. 2016-04666 Filed 3-2-16; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; CMS Computer Match No. 2016-11; HHS Computer Match No. 1601; Effective Date—April 2, 2016; Expiration Date—October 2, 2017 AGENCY:

    Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).

    ACTION:

    Notice of computer matching program.

    SUMMARY:

    In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a computer matching program that CMS plans to conduct with the State-based Administering Entities.

    DATES:

    Comments are invited on all portions of this notice. Submit public comments on or before April 1, 2016. The computer matching program will become effective no sooner than 40 days after the report of the computer matching program is sent to the Office of Management and Budget (OMB) and copies of the agreement are sent to Congress, or 30 days after publication in the Federal Register, whichever is later.

    ADDRESSES:

    The public should send comments to: CMS Privacy Officer, Division of Security, Privacy Policy and Governance, Information Security and Privacy Group, Office of Enterprise Information, CMS, Room N1-24-08, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. 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:

    Elizabeth Kane, Acting Director, Verifications Policy & Operations Division, Eligibility and Enrollment Policy and Operations Group, Center for Consumer Information and Insurance Oversight, CMS, 7501 Wisconsin Avenue, Bethesda, MD 20814, Office Phone: (301) 492-4418, Facsimile: (443) 380-5531, Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Computer Matching and Privacy Protection Act of 1988 (Pub. L. 100-503), amended the Privacy Act (5 U.S.C. 552a) by describing the manner in which computer matching involving Federal agencies could be performed and adding certain protections for individuals applying for and receiving Federal benefits. Section 7201 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) further amended the Privacy Act regarding protections for such individuals. The Privacy Act, as amended, regulates the use of computer matching by Federal agencies when records in a system of records are matched with other Federal, state, or local government records. It requires Federal agencies involved in computer matching programs to:

    1. Negotiate written agreements with the other agencies participating in the matching programs;

    2. Obtain the Data Integrity Board approval of the match agreements;

    3. Furnish detailed reports about matching programs to Congress and OMB;

    4. Notify applicants and beneficiaries that their records are subject to matching; and,

    5. Verify match findings before reducing, suspending, terminating, or denying an individual's benefits or payments.

    This matching program meets the requirements of the Privacy Act of 1974, as amended.

    Walter Stone, CMS Privacy Officer, Centers for Medicare & Medicaid Services. CMS Computer Match No. 2016-11 HHS Computer Match No. 1601

    Name: “Computer Matching Agreement between the Department of Health and Human Services, Centers for Medicare & Medicaid Services and the State-Based Administering Entities for Determining Eligibility for Enrollment in Applicable State Health Subsidy Programs under the Patient Protection and Affordable Care Act.”

    SECURITY CLASSIFICATION:

    Unclassified.

    PARTICIPATING AGENCIES:

    Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), and the State-Based Administering Entities.

    AUTHORITY FOR CONDUCTING MATCHING PROGRAM:

    Sections 1411 and 1413 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively, the ACA) require the Secretary of HHS to establish a program for applying for and determining eligibility for enrollment in applicable State health subsidy programs and authorizes the use of secure, electronic interfaces and an on-line system for the verification of eligibility.

    The Computer Matching and Privacy Protection Act of 1988 (CMPPA) (Pub. L. 100-503), amended the Privacy Act (5 U.S.C. 552a) requires the parties participating in a matching program to execute a written agreement specifying the terms and conditions under which the matching will be conducted. CMS has determined that status verification checks to be conducted by the Federally-facilitated Exchange (FFE), and State-based Administering Entities using the data transmitted through the CMS Federal Data Services Hub constitute a “computer matching program” as defined in the CMPPA.

    PURPOSE(S) OF THE MATCHING PROGRAM:

    The purpose of the Computer Matching Agreement is to establish the terms, conditions, safeguards, and procedures under which CMS will disclose certain information to State-based Administering Entities in accordance with the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act (Pub. L. 111-152), which are referred to collectively as the Affordable Care Act (ACA), amendments to the Social Security Act made by the ACA, and the implementing regulations. The Administering Entities will use the data, accessed through the Hub, to make eligibility determinations for enrollment in an applicable State health subsidy program. This Computer Matching Agreement also establishes the terms, conditions, safeguards, and procedures under which State Medicaid/CHIP agencies shall provide data to CMS (as the Federally-facilitated Marketplace (FFM)), State-based Marketplaces (SBMs) and BHPs to verify whether an applicant or enrollee who has submitted an application to the FFM or a SBM has current eligibility or enrollment in a Medicaid/CHIP program.

    DESCRIPTION OF RECORDS TO BE USED IN THE MATCHING PROGRAM:

    This computer matching program will be conducted with data maintained by CMS in the Health Insurance Exchanges Program, CMS System No. 09-70-0560, as amended. The system is described in the System of Records Notice published at 78 FR 63211 (Oct. 23, 2013).

    INCLUSIVE DATES OF THE MATCH:

    The matching program will become effective no sooner than 40 days after the report of the matching program is sent to the Office of Management and Budget and copies of the agreement are sent to Congress, or 30 days after publication in the Federal Register, whichever is later. The matching program will continue for 18 months from the effective date and may be extended for an additional 12 months thereafter, if certain conditions are met.

    [FR Doc. 2016-04732 Filed 3-2-16; 8:45 am] BILLING CODE 4120-03-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS Computer Match No. 2016-08; HHS Computer Match No. 1605] Privacy Act of 1974; Effective Date—April 2, 2016; Expiration Date—October 2, 2017 AGENCY:

    Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS)

    ACTION:

    Notice of Computer Matching Program.

    SUMMARY:

    In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a computer matching program that CMS plans to conduct with the Department of Veterans Affairs, Veterans Health Administration (VHA).

    DATES:

    Effective Dates: Comments are invited on all portions of this notice. Submit public comments on or before April 1, 2016. This computer matching program will become effective no sooner than 40 days after the report of the computer matching program is sent to the Office of Management and Budget (OMB) and copies of the agreement are sent to Congress, or 30 days after publication in the Federal Register, whichever is later.

    ADDRESSES:

    The public should send comments to: CMS Privacy Officer, Division of Security, Privacy Policy and Governance, Information Security and Privacy Group, Office of Enterprise Information, CMS, Room N1-24-08, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. 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:

    Elizabeth Kane, Acting Director, Verifications Policy & Operations Division, Eligibility and Enrollment Policy and Operations Group, Center for Consumer Information and Insurance Oversight, CMS, 7501 Wisconsin Avenue, Bethesda, MD 20814, Office Phone: (301) 492-4418, Facsimile: (443) 380-5531, E-Mail: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Computer Matching and Privacy Protection Act of 1988 (Pub. L. 100-503), amended the Privacy Act (5 U.S.C. 552a) by describing the manner in which computer matching involving Federal agencies could be performed and adding certain protections for individuals applying for and receiving Federal benefits. Section 7201 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) further amended the Privacy Act regarding protections for such individuals. The Privacy Act, as amended, regulates the use of computer matching by Federal agencies when records in a system of records are matched with other Federal, state, or local government records. It requires Federal agencies involved in computer matching programs to:

    1. Negotiate written agreements with the other agencies participating in the matching programs;

    2. Obtain the Data Integrity Board approval of the match agreements;

    3. Furnish detailed reports about matching programs to Congress and OMB;

    4. Notify applicants and beneficiaries that their records are subject to matching; and,

    5. Verify match findings before reducing, suspending, terminating, or denying an individual's benefits or payments.

    This matching program meets the requirements of the Privacy Act of 1974, as amended.

    Walter D. Stone, CMS Privacy Officer, Centers for Medicare & Medicaid Services. CMS Computer Match No. 2016-07 HHS Computer Match No. 1605

    Name: “Computer Matching Agreement between the Department of Health and Human Services, Centers for Medicare & Medicaid Services and the Department of Veterans Affairs, Veterans Health Administration for the Verification of Eligibility for Minimum Essential Coverage under the Patient Protection and Affordable Care Act through a Veterans Health Administration Health Benefits Plan.”

    SECURITY CLASSIFICATION:

    Unclassified.

    PARTICIPATING AGENCIES:

    Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), and the Department of Veterans Affairs, Veterans Health Administration.

    AUTHORITY FOR CONDUCTING MATCHING PROGRAM:

    Sections 1411 and 1413 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively, the ACA) require the Secretary of HHS to establish a program for applying for and determining eligibility for applicable State health subsidy programs and authorize the use of secure, electronic interfaces and an on-line system for the verification of eligibility.

    The Computer Matching and Privacy Protection Act of 1988 (CMPPA) (Pub. L. 100-503), amended the Privacy Act (5 U.S.C. 552a) and requires the parties participating in a matching program to execute a written agreement specifying the terms and conditions under which the matching will be conducted. CMS has determined that status verification checks to be conducted by the CMS Federal Data Services Hub and Federally-facilitated Exchange using the data source provided to CMS by VHA constitute a “computer matching program” as defined in the CMPPA.

    PURPOSE(S) OF THE MATCHING PROGRAM:

    The purpose of the Computer Matching Agreement is to establish the terms, conditions, safeguards, and procedures under which the VHA will provide records, information, or data to CMS for verifying eligibility for minimum essential coverage through a Veterans Health Care Program. A Veterans Health Care Program constitutes minimum essential coverage as defined in Section 5000A(f) of the Internal Revenue Code of 1986, 26 U.S.C. 5000A, as amended by § 1501 of the ACA. The VHA data will be used by (1) CMS in its capacity as a Federally-facilitated Exchange and the Federal eligibility and enrollment platform, and (2) agencies administering applicable State health subsidy programs. These entities will receive the results of verifications using information received by CMS through the CMS Federal Data Services Hub from Applicants and Enrollees that will be matched with the VHA data.

    DESCRIPTION OF RECORDS TO BE USED IN THE MATCHING PROGRAM:

    The computer matching program will be conducted with data maintained by CMS in the Health Insurance Exchanges Program, CMS System No. 09-70-0560, as amended. The system is described in System of Records Notice published at 78 FR 63211 (Oct. 23, 2013).

    The computer matching program also will be conducted with data maintained in a VHA system of records. The VHA system of records for this matching program is titled “Enrollment and Eligibility Records (VA) (147VA16); published at 74 FR 44901 (August 31, 2009) under Routine Use #14; and the Health Administration Center Civilian Health Medical Record—VA (CHAMPVA) (54VA16) using routine use No. 25, and Spina Bifida Healthcare Program published at 74 FR 34398 (July 15, 2009) using routine use No. 13.

    INCLUSIVE DATES OF THE MATCH:

    This computer matching program will become effective no sooner than 40 days after the report of the computer matching program is sent to the Office of Management and Budget and copies of the agreement are sent to Congress, or 30 days after publication in the Federal Register, whichever is later. The matching program will continue for 18 months from the effective date and may be extended for an additional 12 months thereafter, if certain conditions are met.

    [FR Doc. 2016-04735 Filed 3-2-16; 8:45 am] BILLING CODE 4120-03-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; CMS Computer Match No. 2016-07; HHS Computer Match No. 1602; Effective Date—April 2, 2016; Expiration Date—October 2, 2017 AGENCY:

    Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).

    ACTION:

    Notice of Computer Matching Program.

    SUMMARY:

    In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a computer matching program that CMS plans to conduct with the Defense Enrollment Eligibility Reporting System (DEERS), Defense Manpower Data Center (DMDC), Department of Defense (DoD).

    DATES:

    Comments are invited on all portions of this notice. Submit public comments on or before April 1, 2016. This computer matching program will become effective no sooner than 40 days after the report of the computer matching program is sent to the Office of Management and Budget (OMB) and copies of the agreement are sent to Congress, or 30 days after publication in the Federal Register, whichever is later.

    ADDRESSES:

    The public should send comments to: CMS Privacy Officer, Division of Security, Privacy Policy and Governance, Information Security and Privacy Group, Office of Enterprise Information, CMS, Room N1-24-08, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. 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:

    Elizabeth Kane, Acting Director, Verifications Policy & Operations Division, Eligibility and Enrollment Policy and Operations Group, Center for Consumer Information and Insurance Oversight, CMS, 7501 Wisconsin Avenue, Bethesda, MD 20814, Office Phone: (301) 492-4418, Facsimile: (443) 380-5531, E-Mail: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Computer Matching and Privacy Protection Act of 1988 (Pub. L. 100-503), amended the Privacy Act (5 U.S.C. 552a) by describing the manner in which computer matching involving Federal agencies could be performed and adding certain protections for individuals applying for and receiving Federal benefits. Section 7201 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) further amended the Privacy Act regarding protections for such individuals. The Privacy Act, as amended, regulates the use of computer matching by Federal agencies when records in a system of records are matched with other Federal, state, or local government records. It requires Federal agencies involved in computer matching programs to:

    1. Negotiate written agreements with the other agencies participating in the matching programs;

    2. Obtain the Data Integrity Board approval of the match agreements;

    3. Furnish detailed reports about matching programs to Congress and OMB;

    4. Notify applicants and beneficiaries that their records are subject to matching; and,

    5. Verify match findings before reducing, suspending, terminating, or denying an individual's benefits or payments.

    This computer matching program meets the requirements of the Privacy Act of 1974, as amended.

    Walter Stone, CMS Privacy Officer, Centers for Medicare & Medicaid Services. CMS Computer Match No. 2016-07 HHS Computer Match No. 1602

    Name: “Computer Matching Agreement between the Department of Health and Human Services, Centers for Medicare & Medicaid Services and the Department of Defense, Defense Manpower Data Center, for Verification of Eligibility For Minimum Essential Coverage Under The Patient Protection And Affordable Care Act Through a Department of Defense Health Benefits Plan.”

    SECURITY CLASSIFICATION:

    Unclassified.

    PARTICIPATING AGENCIES:

    Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), and the Department of Defense (DoD), Defense Manpower Data Center (DMDC).

    AUTHORITY FOR CONDUCTING MATCHING PROGRAM:

    Sections 1411 and 1413 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively, the ACA) require the Secretary of HHS to establish a program for applying for and determining eligibility for applicable State health subsidy programs and authorize the use of secure, electronic interfaces and an on-line system for the verification of eligibility.

    The Computer Matching and Privacy Protection Act of 1988 (CMPPA) (Pub. L. 100-503), amended the Privacy Act (5 U.S.C. 552a) and requires the parties participating in a matching program to execute a written agreement specifying the terms and conditions under which the matching will be conducted. CMS has determined that status verification checks to be conducted by the CMS Federal Data Services Hub and Federally-facilitated Exchange using the data source provided to CMS by DoD constitute a “computer matching program” as defined in the CMPPA.

    PURPOSE(S) OF THE MATCHING PROGRAM:

    The purpose of the Computer Matching Agreement is to establish the terms, conditions, safeguards, and procedures under which the DoD will provide records, information, or data to CMS for verifying eligibility for minimum essential coverage through a TRICARE Health Care Program. A TRICARE Health Care Program constitutes minimum essential coverage as defined in Section 5000A(f) of the Internal Revenue Code of 1986, 26 U.S.C. 5000A, as amended by § 1501 of the ACA. The DoD data will be used by (1) CMS in its capacity as a Federally-facilitated Exchange and the Federal eligibility and enrollment platform, and (2) agencies administering applicable State health subsidy programs. These entities will receive the results of verifications using information received by CMS through the CMS Federal Data Services Hub from Applicants and Enrollees that will be matched with the DoD data.

    DESCRIPTION OF RECORDS TO BE USED IN THE MATCHING PROGRAM:

    This computer matching program will be conducted with data maintained by CMS in the Health Insurance Exchanges Program, CMS System No. 09-70-0560, as amended. The system is described in System of Records Notice published at 78 FR 63211 (Oct. 23, 2013).

    This computer matching program will also be conducted with data maintained in the Defense Enrollment Eligibility Reporting Systems (DEERS), System No. DMDC 02 DoD, published November 04, 2015, 80 FR 68304, located at the DISA DECC Columbus in Columbus, OH. Routine Use 6f supports DoD's disclosure to CMS.

    INCLUSIVE DATES OF THE MATCH:

    This computer matching program will become effective no sooner than 40 days after the report of the computer matching program is sent to the Office of Management and Budget and copies of the agreement are sent to Congress, or 30 days after publication in the Federal Register, whichever is later. The matching program will continue for 18 months from the effective date and may be extended for an additional 12 months thereafter, if certain conditions are met.

    [FR Doc. 2016-04734 Filed 3-2-16; 8:45 am] BILLING CODE 4120-03-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “Provider User-Experience Challenge” AGENCY:

    Office of the National Coordinator for Health Information Technology, HHS.

    ACTION:

    Notice.

    SUMMARY:

    Like the Consumer Health Data Aggregator Challenge, the Provider User-Experience Challenge incents the development of applications for health care providers that use open, standardized APIs to enable innovative ways for providers to interact with patient health data. This challenge will focus on demonstrating how data made accessible to apps through Application Programming Interfaces (APIs) can positively impact providers' experience with EHRs by making clinical workflows more intuitive, specific to clinical specialty, and actionable. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).

    DATES:

    Phase 1 • Challenge launch: March 1, 2016 • Submissions due: May 30 • Evaluation period: May 31-June 28 • Phase 1 winners announced: June 30 Phase 2 • Submission period begins: May 31 • Submissions due: November 7 • Evaluation period: November 14-December 14 • Phase 2 winners announced: December 15, 2016 FOR FURTHER INFORMATION CONTACT:

    Adam Wong, [email protected] (preferred), 202-720-2866.

    SUPPLEMENTARY INFORMATION: Award Approving Official

    Karen DeSalvo, National Coordinator for Health Information Technology.

    Subject of Challenge Competition

    The Provider User-Experience Challenge is intended to spur development of third-party applications for use by clinicians and use FHIR to pull various patient health data into a dashboard. The challenge has two phases—the first requiring submission of technical and business plans for the application (app), the second a working app that is available for providers. Phase 2 of the competition will not be limited to only those who won Phase 1—all Phase 1 competitors, and those who did not participate in Phase 1, can submit a final app at the end of Phase 2.

    The final application must meet the following requirements:

    • Uses FHIR Draft Standard for Technical Use 2 (DSTU2) • Aggregate all data as specified in the 2015 Edition Common Clinical Data Set (Data column in https://www.healthit.gov/sites/default/files/commonclinicaldataset_ml_11-4-15.pdf) • Verified compatibility with different health IT developer systems implemented in production settings, 1 of which must be from the top 10 systems measured by Meaningful Use attestation per HealthIT.gov. Apps must be integrated with a minimum of 3 unique health IT developer systems in 2 unique provider settings • Has been tested with patients and used in production settings • Available to providers through at least one of the following modes: Direct from Web, iOS Store, or Android stores Phase 1

    Participants interested in competing for Phase 1 awards will need to submit an app development plan that must include:

    • Mockup/wireframes • Technical specifications, including but not limited to planned data sources, system architecture • Business/sustainability plan • Provider partnership

    To augment technical development and enhance the likelihood of a successful app that will continue to exist beyond the end of the challenge, a progress update/matchmaking event will be held that will seek to connect participants with provider partners. Up to five app proposals will be recognized as winners and awarded up to $15,000 each.

    Phase 2

    The second phase will entail the actual development of the apps, verification of technical capabilities, user testing/piloting, and public release of the apps. This will include remote testing with providers and health IT developers to test the technical abilities of the apps to connect to in-production systems. Participants will submit:

    • Working prototype of the app • Video demonstrating the app (maximum of 5 minutes, on YouTube or Vimeo) • Slide deck describing app (maximum of 10 slides)

    The grand prize winner will receive $50,000 and a second place winner will receive $25,000. There will be an additional $25,000 prize for the app that connects to the greatest number of unique health IT developer systems implemented in production settings, which can be won by the grand or 2nd place winner.

    Eligibility Rules for Participating in the Competition: To be eligible to win a prize under this challenge, an individual or entity:

    1. Shall have registered to participate in the competition under the rules promulgated by the Office of the National Coordinator for Health Information Technology.

    2. Shall have complied with all the requirements under this section.

    3. In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States.

    4. May not be a Federal entity or Federal employee acting within the scope of their employment.

    5. Shall not be an HHS employee working on their applications or submissions during assigned duty hours.

    6. Shall not be an employee of the Office of the National Coordinator for Health IT.

    7. Federal grantees may not use Federal funds to develop COMPETES Act challenge applications unless consistent with the purpose of their grant award.

    8. Federal contractors may not use Federal funds from a contract to develop COMPETES Act challenge applications or to fund efforts in support of a COMPETES Act challenge submission.

    An individual or entity shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during a competition if the facilities and employees are made available to all individuals and entities participating in the competition on an equitable basis.

    Entrants must agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from my participation in this prize contest, whether the injury, death, damage, or loss arises through negligence or otherwise.

    Entrants must also agree to indemnify the Federal Government against third party claims for damages arising from or related to competition activities.

    Submission Requirements

    In order for a submission to be eligible to win this Challenge, it must meet the following requirements:

    1. No HHS or ONC logo—The product must not use HHS' or ONC's logos or official seals and must not claim endorsement.

    2. Functionality/Accuracy—A product may be disqualified if it fails to function as expressed in the description provided by the user, or if it provides inaccurate or incomplete information.

    3. Security—Submissions must be free of malware. Contestant agrees that ONC may conduct testing on the product to determine whether malware or other security threats may be present. ONC may disqualify the product if, in ONC's judgment, the app may damage government or others' equipment or operating environment.

    Registration Process for Participants: To register for this Challenge, participants can access http://www.challenge.gov and search for “Provider User-Experience Challenge.”

    Prize • Phase 1: Up to 5 winners each receive up to $15,000. • Phase 2: One final winner receives $50,000; 2nd place receives $25,000; and an additional $25,000 connector prize. • Total: Up to $175,000 in prizes.

    Payment of the Prize: Prize will be paid by contractor.

    Basis Upon Which Winner Will Be Selected: The review panel will make selections based upon the following criteria:

    Phase 1 • Technical feasibility of plan, including number of EHR sources targeted. • Adherence to data privacy and security best practices. • Strength of business/sustainability plan. • Impact potential in clinical setting. • Provider and/or health IT developer partnerships. Phase 2 • Number, sources, and types of data aggregation using FHIR. • Functionality and quality of data aggregation. • Privacy and security of patient data. • Impact potential in clinical setting. • User experience and visual appeal. Additional Information

    General Conditions: ONC reserves the right to cancel, suspend, and/or modify the Contest, or any part of it, for any reason, at ONC's sole discretion.

    Intellectual Property: Each entrant retains title and full ownership in and to their submission. Entrants expressly reserve all intellectual property rights not expressly granted under the challenge agreement. By participating in the challenge, each entrant hereby irrevocably grants to Sponsor and Administrator a limited, non-exclusive, royalty-free, worldwide license and right to reproduce, publically perform, publically display, and use the Submission to the extent necessary to administer the challenge, and to publically perform and publically display the Submission, including, without limitation, for advertising and promotional purposes relating to the challenge.

    Authority:

    15 U.S.C. 3719.

    Dated: February 23, 2016. Karen DeSalvo, National Coordinator for Health Information Technology.
    [FR Doc. 2016-04466 Filed 3-1-16; 11:15 am] BILLING CODE 4150-45-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the National Coordinator for Health Information Technology; Announcement of Requirements and Registration for “Consumer Health Data Aggregator Challenge” AGENCY:

    Office of the National Coordinator for Health Information Technology, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Consumer Health Data Aggregator Challenge is intended to spur the development of third-party, consumer-facing applications that use open, standardized Application Programming Interfaces (APIs) to help consumers aggregate their data in one place and under their control. This challenge will focus on solving the problem that many consumers have today—the ability to easily and electronically access their health data from different health care providers using a variety of different health IT systems.

    The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).

    DATES:

    Phase 1 • Challenge launch: March 1, 2016 • Submissions due: May 30 • Evaluation period: May 31-June 28 • Phase 1 winners announced: June 30 Phase 2 • Submission period begins: May 31 • Submissions due: November 7 • Evaluation period: November 14-December 14 • Phase 2 winners announced: December 15, 2016 FOR FURTHER INFORMATION CONTACT:

    Adam Wong, [email protected] (preferred), 202-720-2866.

    SUPPLEMENTARY INFORMATION: Award Approving Official

    Karen DeSalvo, National Coordinator for Health Information Technology.

    Subject of Challenge Competition

    The Consumer Health Data Aggregator Challenge is intended to spur development of third-party applications for consumers that use FHIR to pull their health data into one place. The challenge has two phases. Phase 1 requires the submission of technical and business plans for the application (app) while Phase 2 requires that a working app be available for consumers. Phase 2 of the competition will not be limited to only those who won Phase 1—all Phase 1 competitors, and those who did not participate in Phase 1, can submit a final app at the end of Phase 2.

    The final application must meet the following requirements:

    • Uses FHIR Draft Standard for Technical Use 2 (DSTU2).

    • Aggregate all data as specified in the 2015 Edition Common Clinical Data Set (Data column in https://www.healthit.gov/sites/default/files/commonclinicaldataset_ml_11-4-15.pdf).

    • Verified compatibility with different health IT developer systems implemented in production settings, 1 of which must be from the top 10 systems measured by Meaningful Use attestation per HealthIT.gov. Apps must be integrated with a minimum of 3 unique health IT developer systems in 2 unique provider settings.

    • Has been tested with patients and used in production settings.

    • Available to consumers through at least one of the following modes: mobile Web, iOS Store, or Android Store.

    Phase 1

    Participants interested in competing for Phase 1 awards will need to submit an app development plan that must include:

    • Mockup/wireframes • Technical specifications, including but not limited to planned data sources, system architecture • Business/sustainability plan • Provider partnership

    To augment technical development and enhance the likelihood of a successful app that will continue to exist beyond the end of the challenge, a progress update/matchmaking event will be held that will seek to connect participants with provider partners. Up to five app proposals will be recognized as winners and awarded up to $15,000 each.

    Phase 2

    The second phase will entail the actual development of the apps, verification of technical capabilities, user testing/piloting, and public release of the apps. This will include remote testing with providers and health IT developers to test the technical abilities of the apps to connect to in-production systems. Participants will submit:

    • Working prototype of the app • Video demonstrating the app (maximum of 5 minutes, on YouTube or Vimeo) • Slide deck describing app (maximum of 10 slides)

    The grand prize winner will receive $50,000 and a second place winner will receive $25,000. There will be an additional $25,000 prize for the app that connects to the greatest number of unique health IT developer systems implemented in production settings, which can be won by the grand or 2nd place winner.

    Eligibility Rules for Participating in the Competition

    To be eligible to win a prize under this challenge, an individual or entity:

    1. Shall have registered to participate in the competition under the rules promulgated by the Office of the National Coordinator for Health Information Technology.

    2. Shall have complied with all the requirements under this section.

    3. In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States.

    4. May not be a Federal entity or Federal employee acting within the scope of their employment.

    5. Shall not be an HHS employee working on their applications or submissions during assigned duty hours.

    6. Shall not be an employee of the Office of the National Coordinator for Health IT.

    7. Federal grantees may not use Federal funds to develop COMPETES Act challenge applications unless consistent with the purpose of their grant award.

    8. Federal contractors may not use Federal funds from a contract to develop COMPETES Act challenge applications or to fund efforts in support of a COMPETES Act challenge submission.

    An individual or entity shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during a competition if the facilities and employees are made available to all individuals and entities participating in the competition on an equitable basis.

    Entrants must agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from my participation in this prize contest, whether the injury, death, damage, or loss arises through negligence or otherwise.

    Entrants must also agree to indemnify the Federal Government against third party claims for damages arising from or related to competition activities.

    Submission Requirements

    In order for a submission to be eligible to win this Challenge, it must meet the following requirements:

    1. No HHS or ONC logo—The product must not use HHS' or ONC's logos or official seals and must not claim endorsement.

    2. Functionality/Accuracy—A product may be disqualified if it fails to function as expressed in the description provided by the user, or if it provides inaccurate or incomplete information.

    3. Security—Submissions must be free of malware. Contestant agrees that ONC may conduct testing on the product to determine whether malware or other security threats may be present. ONC may disqualify the product if, in ONC's judgment, the app may damage government or others' equipment or operating environment.

    Registration Process for Participants

    To register for this Challenge, participants can access http://www.challenge.gov and search for “Consumer Health Data Aggregator Challenge.”

    Prize • Phase 1: Up to 5 winners each receive up to $15,000. • Phase 2: One final winner receives $50,000; 2nd place receives $25,000; and an additional $25,000 connector prize. • Total: Up to $175,000 in prizes. Payment of the Prize

    Prize will be paid by contractor.

    Basis Upon Which Winner Will Be Selected

    The review panel will make selections based upon the following criteria:

    Phase 1 • Technical feasibility of plan, including number of EHR sources targeted. • Adherence to data privacy and security best practices. • Strength of business/sustainability plan. • Provider and/or health IT developer partnerships. Phase 2 • Number, sources, and types of data aggregation using FHIR. • Functionality and quality of data aggregation. • Privacy and security of patient data. • User experience and visual appeal. Additional Information

    General Conditions: ONC reserves the right to cancel, suspend, and/or modify the Contest, or any part of it, for any reason, at ONC's sole discretion.

    Intellectual Property: Each entrant retains title and full ownership in and to their submission. Entrants expressly reserve all intellectual property rights not expressly granted under the challenge agreement. By participating in the challenge, each entrant hereby irrevocably grants to Sponsor and Administrator a limited, non-exclusive, royalty-free, worldwide license and right to reproduce, publically perform, publically display, and use the Submission to the extent necessary to administer the challenge, and to publically perform and publically display the Submission, including, without limitation, for advertising and promotional purposes relating to the challenge.

    Authority:

    15 U.S.C. 3719.

    Dated: February 23, 2016. Karen DeSalvo, National Coordinator for Health Information Technology.
    [FR Doc. 2016-04596 Filed 3-1-16; 11:15 am] BILLING CODE 4150-45-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Cancer Advisory Board Ad Hoc Subcommittee on Global Cancer Research.

    The teleconference meeting will be open to the public.

    Name of Committee: National Cancer Advisory Board; Ad Hoc Subcommittee on Global Cancer Research.

    Date: March 23, 2016.

    Time: 2:00 p.m. to 3:00 p.m.

    Agenda: Preview global cancer research outline for presentation at the June 2016 Joint BSA and NCAB Meeting.

    Place: National Cancer Institute, Shady Grove Shady Grove, 9609 Medical Center Drive, Rockville, MD 20850, (Telephone Conference Call)—Dial in number: 1-866-692-3158 and Passcode: 9875262.

    Contact Person: Edward T. Trimble, M.D., M.P.H., Executive Secretary, NCAB Ad Hoc Subcommittee on Global Cancer Research, Director, Center for Global Health, National Cancer Institute—Shady Grove, National Institutes of Health, 9609 Medical Center Drive, Room 3W562, Bethesda, MD 20892, 240-276-5796, [email protected]

    Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS)
    Dated: February 29, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-04671 Filed 3-2-16; 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; Member Conflict: Neurological Epidemiology.

    Date: March 10, 2016.

    Time: 9:30 a.m. to 11:30 a.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Valerie Durrant, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3148, MSC 7770, Bethesda, MD 20892, (301) 827-6390, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Pregnancy and Neonatology.

    Date: March 23, 2016.

    Time: 1:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Virtual Meeting).

    Contact Person: Antonello Pileggi, M.D., Ph.D., Scientific Review Officer, Center for Scientific Review, National Institute of Heath, 6701 Rockledge Drive, Room 6166, Bethesda, MD 20892-7892, (301) 402-6297, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Regeneration and Developmental Biology.

    Date: March 23, 2016.

    Time: 12:00 p.m. to 5:00 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: Raya Mandler, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5217, MSC 7840, Bethesda, MD 20892, 301-402-8228, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Basic Research on HIV Persistence.

    Date: March 24, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The Fairmont Washington, DC, 2401 M Street NW., Washington, DC 20037.

    Contact Person: Kenneth A. Roebuck, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5106, MSC 7852, Bethesda, MD 20892 (301) 435-1166, [email protected]

    Name of Committee: AIDS and Related Research Integrated Review Group; AIDS-associated Opportunistic Infections and Cancer Study Section.

    Date: March 25, 2016.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Ritz Carlton Hotel, 1150 22nd Street NW., Washington, DC 20037.

    Contact Person: Eduardo A. Montalvo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5108, MSC 7852, Bethesda, MD 20892, (301) 435-1168, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Risk, Prevention and Health Behavior.

    Date: March 28, 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: Martha M. Faraday, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3110, MSC 7808, Bethesda, MD 20892, (301) 435-3575, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Language and Communication.

    Date: March 28, 2016.

    Time: 1:00 p.m. to 3:00 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: Biao Tian, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3089B, MSC 7848, Bethesda, MD 20892 (301) 402-4411, [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 25, 2016. Carolyn Baum, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-04630 Filed 3-2-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of General Medical Sciences; 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 General Medical Sciences Special Emphasis Panel; Limited Pilot for NIGMS Legacy Community-Wide Scientific Resources.

    Date: April 4, 2016.

    Time: 1:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Natcher Building, Room 3An.12N, 45 Center Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Margaret J. Weidman, Ph.D., Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, 45 Center Drive, Room 3AN18B, Bethesda, MD 20892, 301-594-3663, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS)
    Dated: February 29, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-04673 Filed 3-2-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; 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 Cancer Institute Special Emphasis Panel; Multi-level Interventions in Cancer Care Delivery.

    Date: April 6-7, 2016.

    Time: 10:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Cancer Institute, Shady Grove, 9609 Medical Center Drive, Room 3W034, Rockville, MD 20850 (Telephone Conference Call).

    Contact Person: Kenneth L. Bielat, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room 7W244, Bethesda, MD 20892-9750, 240-276-6373, [email protected].

    Name of Committee: National Cancer Institute Special Emphasis Panel; Physical Sciences Oncology Centers (PSOC).

    Date: April 13-14, 2016.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda Marriott Suites, 6711 Democracy Blvd., Bethesda, MD 20817.

    Contact Person: Reed A. Graves, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, 9609 Medical Center Drive, Room 7W264, Bethesda, MD 20892-9750, 240-276-6384, [email protected].

    Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Program Project I (P01).

    Date: June 1-2, 2016.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852.

    Contact Person: Shakeel Ahmad, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W112, Bethesda, MD 20892-8328, 240-276-6349, [email protected].

    Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Program Project III (P01).

    Date: June 9-10, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Doubletree by Hilton Hotel Bethesda, 8120 Wisconsin Avenue Bethesda, MD 20814.

    Contact Person: Sanita Bharti, Ph.D., Scientific Review Officer, Research Program Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W618, Rockville, MD 20850, 240-276-5909, [email protected].

    Name of Committee: National Cancer Institute Special Emphasis Panel; NCI SPORE I Review.

    Date: June 15-16, 2016.

    Time: 8:00 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852.

    Contact Person: Majed M. Hamawy, Ph.D., Scientific Review Officer, Research Programs Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W120, Bethesda, MD 20892-8328, 240-276-6457, [email protected].

    Information is also available on the Institute's/Center's home page: http://deainfo.nci.nih.gov/advisory/sep/sep.htm, where an agenda and any additional information for the meeting will be posted when available.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS)
    Dated: February 29, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-04672 Filed 3-2-16; 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; PAR13-345: Pediatric Formulations and Drug Delivery Systems.

    Date: March 16, 2016.

    Time: 12:00 p.m. to 4:00 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: Eugene Carstea, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5194, MSC 7846, Bethesda, MD 20892, (301) 408-9756, [email protected]

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Brain Disorders and Clinical Neuroscience.

    Date: March 23, 2016.

    Time: 12:30 p.m. to 2:30 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: Alexei Kondratyev, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5200, MSC 7846, Bethesda, MD 20892, 301-435-1785, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Drug Abuse.

    Date: March 24, 2016.

    Time: 12:30 p.m. to 3:00 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:

    Richard D. Crosland, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4190, MSC 7850, Bethesda, MD 20892, 301-435-1220, [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 26, 2016. Anna Snouffer, Deputy Director, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-04629 Filed 3-2-16; 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; Amended Notice of Meeting

    Notice is hereby given of a change in the meeting of the National Institute of Allergy and Infectious Diseases Special Emphasis Panel, March 02, 2016, 10:00 a.m. to March 02, 2016, 01:00 p.m., National Institutes of Health, 5601 Fishers Lane, Rockville, MD, 20892 which was published in the Federal Register on February 09, 2016, 81FR6872.

    This notice is being amended to change the date of the meeting from March 02, 2016 to March 16, 2016; and to change the start time from 10:00 a.m. to 1:00 p.m. and the end time from 4:00 p.m. to 6:00 p.m. The meeting is closed to the public.

    Dated: February 26, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-04628 Filed 3-2-16; 8:45 am] BILLING CODE 4140-01-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 review of loan repayment applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the review of loan repayment 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; NIAAA Clinical and Pediatric LRP Review.

    Date: April 25, 2016.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate Loan Repayment applications.

    Place: National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, 5635 Fishers Lane Rockville, MD 20892 (Telephone Conference Call).

    Contact Person: Katrina L. Foster, Ph.D., Scientific Review Officer, National Institute on Alcohol Abuse & Alcoholism, National Institutes of Health, 5635 Fishers Lane, Room. 2019, Rockville, MD 20852, 301-443-4032, [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 29, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-04674 Filed 3-2-16; 8:45 am] BILLING CODE 4140-01-P
    ADVISORY COUNCIL ON HISTORIC PRESERVATION Notice of Proposed Policy Statement on Historic Preservation and Community Revitalization AGENCY:

    Advisory Council on Historic Preservation.

    ACTION:

    The Advisory Council on Historic Preservation seeks public comments on its draft Policy Statement on Historic Preservation and Community Revitalization.

    SUMMARY:

    The Advisory Council on Historic Preservation (ACHP) is planning on issuing a “Policy Statement on Historic Preservation and Community Revitalization.” A Working Group, comprised of ACHP members and other preservation organizations, has drafted a policy and invites your views and comments. The Working Group will use your comments to finalize the draft policy before it is presented to the full ACHP membership for consideration and adoption.

    DATES:

    Submit comments on or before April 4, 2016.

    ADDRESSES:

    Address all comments concerning this proposed policy to Charlene Dwin Vaughn, Assistant Director, Office of Federal Agency Programs, Advisory Council on Historic Preservation, 401 F Street NW., Room 301, Washington, DC 20001. You may also submit comments by facsimile at 202-517-6384 or by electronic mail to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Charlene Dwin Vaughn, 202-517-0207

    SUPPLEMENTARY INFORMATION:

    The Advisory Council on Historic Preservation (ACHP) is an independent federal agency, created by the National Historic Preservation Act that promotes the preservation, enhancement, and sustainable use of our nation's diverse historic resources, and advises the President and Congress on national historic preservation policy.

    Section 106 of the National Historic Preservation Act (Section 106), 54 U.S.C. 306108, requires federal agencies to consider the effects of their undertakings on historic properties and provide the ACHP a reasonable opportunity to comment with regard to such undertakings. The ACHP has issued the regulations that set forth the process through which federal agencies comply with these duties. These regulations are codified under 36 CFR part 800.

    I. Background on the Draft Policy Statement

    In March 2013, the ACHP issued a report entitled Managing Change: Preservation and Rightsizing in America. It can be accessed at http://www.achp.gov/RightsizingReport.pdf. The report focused on communities that were addressing rightsizing. The concept of rightsizing applied to communities undergoing substantial change due to economic decline, population loss, increased amounts of vacancy and abandonment, decline in local services, increased homelessness and poverty, declining educational opportunities, and systemic blight. Rightsizing has been occurring in communities around the Nation for decades as they respond to transformative events. The report contained the findings and recommendations of extensive research, on-site visits, and ACHP participation on panels and seminars during which stakeholders shared their views regarding the effect of rightsizing on the community.

    The primary findings of the report included the following observations:

    —Historic preservation tools are not used to maintain the historic integrity of rightsizing communities; —Historic preservation needs to be better integrated in local planning and economic development; —Federal programs that can support rightsizing in a manner that builds on community historic resources are not readily available; —The early initiation of project review under Section 106 of the National Historic Preservation Act (NHPA) can facilitate the analysis of alternative redevelopment strategies that can integrate historic properties; and —Federal programs that are targeted to extensive demolition in a community do not always reflect the preference of the residents in a community.

    As the ACHP explored options to implement the recommendations in the report, it was concluded that the development of a policy statement would be appropriate to advance historic preservation.

    In 2006, the ACHP adopted a “Policy Statement on Affordable Housing and Historic Preservation” to assist stakeholders in utilizing historic properties for affordable housing projects with minimal delays. It can be accessed at http://www.achp.gov/docs/fr7387.pdf. This Policy Statement was well received by stakeholders. The principles outlined in the document are still used when conducting historic preservation reviews for affordable housing projects.

    The purpose of developing the Policy Statement on Historic Preservation and Community Revitalization in 2016 is to ensure that preservation is considered as a tool that will assist federal, state and local governments plan and implement revitalization projects and programs in a manner that reuses and rehabilitates historic properties.

    The Working Group convened by the ACHP to assist in developing the policy statement began meeting in December 2014. Representatives of the Working Group included, Brad White, Expert Member of the ACHP, as the Chairman, the US Department of Housing and Urban Development, US Department of Agriculture, Department of Health and Human Services, the National Park Service, the National Trust for Historic Preservation, the American Assembly, Cleveland Restoration Society, Preservation Research Office, Historic Districts Council, Rightsizing Network, Michigan State Historic Preservation Office, and Indiana Historic Preservation Office. After consulting for approximately one year to discuss the major problem areas that needed to be addressed in rightsizing and legacy cities, a working draft of the Policy Statement was drafted, and distributed to ACHP members for review.

    The comments received from ACHP members resulted in revisions to the draft policy statement to achieve the following:

    —Focus on rural and tribal communities as well as Legacy Cities; —Emphasize the value of preparing local architectural and archeological surveys; —Emphasize how the principles apply to Section 106 of the National Historic Preservation Act; —Reference the role of field, regional, and state offices in preserving local assets; —Address how Section 106 reviews can be expedited; and —Define how creative mitigation measures can facilitate preservation in communities.

    The ACHP invites comments from the public on the draft Policy Statement (see text at the end of this notice), particularly as it relates to the following questions:

    1. How can the principles in the draft Policy Statement help communities balance the goal of historic preservation and the revitalization of neighborhoods and communities?

    2. How will the principles in the draft Policy Statement establish a framework for decision making when communities receive federal funding to assist distressed neighborhoods?

    3. How will State Historic Preservation Officers and Certified Local Governments apply the principles in their review of local revitalization programs?

    4. Will the draft Policy Statement assist federal, state and local officials, developers, residents, and other stakeholders to explore alternatives for preserving historic properties in planning revitalization projects?

    5. How can the adoption of creative mitigation measures help a community to preserve its historic properties?

    6. What form of guidance will be needed to implement the principles in this draft Policy Statement?

    7. Are there any other major obstacles to using historic preservation tools in community revitalization projects that have not been addressed in this draft Policy Statement?

    The ACHP appreciates receiving public input on the draft Policy Statement. Your comments will ensure that we have taken a holistic approach in advancing historic preservation as a viable tool that can help diverse communities who are recipients of federal, state, and local assistance.

    II. Text of the Draft Policy DRAFT ADVISORY COUNCIL ON HISTORIC PRESERVATION (ACHP) POLICY STATEMENT ON HISTORIC PRESERVATION AND COMMUNITY REVITALIZATION (February 19, 2016)

    Introduction. The 2010 US Census revealed that, as a result of the decline in the economy beginning in 2008, an estimated 19 million properties were abandoned throughout the nation. As a result of the economic downturn, many buildings, in particular historic properties, became vacant and abandoned, resulting in severe blight around the Nation. Many economists compared the impacts of the economic downturn in 2008 to that of the Great Depression in the 1930s. Natural disasters, economic downturns, and the mortgage foreclosure crisis all occurred at the beginning of the 21st century and eroded urban, rural, and tribal communities. While these events resulted in significant economic impacts across the country, they accelerated declines in population, tax base, industry, jobs, and housing markets caused by structural changes to the economy in the Midwest, Northeast, and Mid-Atlantic regions. The estimated demolition of 200,000 properties annually during this period exemplified the extreme actions many communities took that resulted in the loss of homes, buildings, and even entire neighborhoods, many of which included older historic buildings that were listed in or eligible for listing in the National Register of Historic Places. Although older communities known as “legacy cities” have been confronted with these issues, research has revealed that suburban, rural, and tribal communities have dealt with similar problems.

    One class of communities, many of which were located in industrial centers, was hit particularly hard, struggling with economic challenges that transcend market cycles such as the recent recession. These communities, marked by population loss exceeding 20 percent, require a holistic approach to bring about their revitalization. Many are older communities with historic architecture, social cohesiveness, and walkable neighborhoods—features which have increasingly grown more attractive in real estate markets that are in the process of recovering.

    In 1966 when Congress passed the National Historic Preservation Act (NHPA), it determined that “the historical and cultural foundations of the nation should be preserved in order to give a sense of orientation to the American people.” Further, it stated that “in the face of ever increasing extensions of urban centers, highways, and residential, commercial, and industrial developments, the present governmental and nongovernmental historic preservation programs are inadequate to ensure future generations a genuine opportunity to appreciate and enjoy the nation's rich heritage.”

    The congressional findings in the NHPA remain applicable today, particularly since the economic crisis of 2008. The Advisory Council on Historic Preservation (ACHP), established by the NHPA to advise the President and Congress on matters relating to historic preservation, considers local community revitalization critical to stabilizing these economically depressed communities. In overseeing federal project reviews required by Section 106 of NHPA, patterns and trends have revealed that historic preservation reviews are often not completed before federal funds are allocated for redevelopment. Preservation options are not considered and opportunities to reuse existing assets are missed. Communities, therefore, need guidance that illustrates how historic preservation can help them to determine the disposition of vacant and abandoned properties, promote rehabilitation, create affordable housing, direct growth to target areas that have infrastructure, use new infill construction to stabilize neighborhoods, and develop mixed use projects.

    The ACHP issued a report entitled, Managing Change: Preservation and Rightsizing in America, in March 2013, which focused on communities addressing “rightsizing.” Rightsizing applies when communities have shrinking populations, vacancy and abandonment, and systemic blight issues. The report defined it as “the process of change confronting communities that have drastically reduced population and excess infrastructure with a dwindling tax base, in need of planning to recalibrate.” It also identified the role of historic preservation in rightsizing as well as noting relevant existing federal programs and policies. The extensive research, newspaper and journal articles, and organizational and institutional reports on rightsizing revealed that consideration of historic preservation issues in rightsizing decisions was often the exception. The ACHP report noted that rightsizing should include revitalization. Likewise, it noted that rightsizing is not uniquely an urban phenomenon. Rather, it encompasses diverse communities, including older suburbs and rural villages. All are in need of technical assistance, education, and outreach to help residents, developers, and local officials use historic preservation tools.

    Purpose. In accordance with Section 202 of the NHPA, the ACHP is issuing this Policy Statement to provide federal agencies, the individuals, organizations, or governments that apply for federal assistance, and public and private partners with a flexible and creative approach to developing local revitalization plans that use historic properties. It is intended to help address the substantial challenges facing communities that have experienced significant population and job loss, as well as other communities requiring strategies for revitalization. The Policy Statement is designed to assist federal agencies and their grantees and applicants, State Historic Preservation Officers (SHPOs), Tribal Historic Preservation Officers (THPOs), Certified Local Governments (CLGs), and local governments in complying with the requirements of Section 106 of the NHPA. Section 106 requires federal agencies to take into account the effects of their undertakings on historic properties and afford the ACHP a reasonable opportunity to comment. With a predictable and consistent policy framework, federal agencies and communities will be encouraged to integrate historic preservation in revitalization strategies. The policy acknowledges that consideration of alternatives to avoid or minimize harm to historic properties is essential when planning revitalization projects. Further, by engaging diverse stakeholders in the planning process, revitalization projects can achieve multiple community goals.

    Consistent with previous work completed by the ACHP, the purpose of this policy is to ensure that historic preservation is considered as a tool to stabilize and enhance communities that have suffered from massive structural changes to their economy. It also recognizes that other communities, under less severe economic distress, will benefit from implementing the strategies described in the principles below.

    The policy addresses the value of local communities developing historic property surveys, including those located in older neighborhoods with historic districts, to use as a tool in community revitalization. Only when local officials are aware of the historic significance of properties in a community can they make informed decisions about treatment and reuse. The National Register is also used to determine whether federal activities must comply with Section 106. Likewise, a property must first be listed on the National Register before it can qualify as a “certified historic structure” for receiving the 20 percent Federal Historic Preservation Tax Credit for the rehabilitation of historic, income-producing buildings. Other tax incentives are often coupled with this credit to revitalize historic neighborhoods, such as the Federal Low-Income Housing Tax Credit and state historic preservation tax incentives. Recent studies have documented that these tax incentive programs contribute to economic development and job production. Further, they are one of the primary tools for revitalizing neighborhoods that were once considered blighted.

    The ACHP is pleased to issue this Policy Statement on Historic Preservation and Community Revitalization as we celebrate the 50th Anniversary of the NHPA. The principles outlined above include sound guidance to assist communities in their efforts to incorporate historic preservation into project planning. As communities develop revitalization plans to improve local neighborhoods and target areas, they should work with federal and state agencies, SHPOs, THPOs, developers, residents, and other stakeholders to implement the following principles. While many are related to the Section 106 consultation, some can be applied independently of this review.

    Implementing Principles

    I. Historic preservation values should be considered in the revitalization of both rural and urban communities.

    II. Historic preservation should be incorporated in local planning for sustainability, smart growth, and community resilience.

    III. Historic property surveys, including those in historic districts, are tools that should be used by communities to provide for federal, state, and local planning and revitalization projects.

    IV. Effective citizen engagement allows community residents to identify resources they care about and share their views on local history and cultural significance.

    V. Indian tribes may have an interest in urban and rural community revitalization projects that may affect sites of historic, religious, and cultural significance to them.

    VI. Private resources can contribute to local revitalization efforts and leverage public funds.

    VII. Tax credits can be used to promote historic preservation projects that preserve local assets.

    VIII. Early consideration of alternatives to avoid or minimize adverse effects to historic properties is essential to ensure proper integration of historic properties in revitalization plans.

    IX. Development of flexible and programmatic solutions can help expedite historic preservation reviews as well as more effectively and proactively address situations involving recurring loss of historic properties.

    X. Creative mitigation can facilitate future preservation in communities.

    These principles are interpreted below to provide context for stakeholders who may consider applying them to their communities.

    I. Historic preservation values should be considered in the revitalization of both rural and urban communities.

    The NHPA was established in 1966 to ensure that local revitalization and economic development projects were responsive to historic preservation values. Unfortunately, the provisions of the NHPA requiring consideration of historic properties in project planning have not been applied consistently by federal, state, and local governments. This is particularly the case when federal funds are allocated to local communities to address substantial amounts of vacancies, abandonments, and the related blight afflicting communities. Historic properties should be viewed as community assets and their treatment should be informed by an analysis of alternatives, including stabilization, rehabilitation, new infill construction, and demolition. Suburban, rural, and tribal communities have experienced many of the same or similar issues as urban areas over the past decades. Historic preservation tools can assist many of these communities, particularly when integrated in project planning as prescribed by Section 106 of the NHPA. The adaptation and reuse of historic properties is a viable alternative that should be given due consideration by federal, state, and local officials when renewing communities. Although historic preservation is often ignored by stakeholders who assume that redevelopment will allow them to spend project funds exclusively on new construction, decades of historic preservation projects affirm that historic assets can also revive a community. Therefore, historic preservation should be an option that is regularly considered by officials, in planning the revitalization of neighborhoods, target areas, and communities in urban, rural, and tribal areas where there is considerable economic decline and blight.

    II. Historic preservation should be incorporated in local planning for sustainability, smart growth, and community resilience.

    The core principles in sustainability, smart growth, and community resilience programs administered by federal government have been embraced by urban and rural communities nationwide during the past decade. Smart growth is a cohesive group of planning tools that are focused on creating a development pattern that can be replicated throughout a region or locality, while sustainable communities are focused on conserving and improving existing resources, including making historic assets such as buildings, neighborhoods and communities greener, stronger and more livable. Both smart growth and sustainability embrace historic preservation, emphasizing the value in reusing historic properties. Successful historic preservation techniques often bring together both historic properties and sensitive new construction to create a dynamic and attractive environment. Preserving historic properties and neighborhoods in a community not only retains streetscapes and original settings, but also can create a focal point for a community to embrace its history, culture, and sense of place, all of which benefit revitalization ef