Federal Register Vol. 81, No.137,

Federal Register Volume 81, Issue 137 (July 18, 2016)

Page Range46567-46826
FR Document

81_FR_137
Current View
Page and SubjectPDF
81 FR 46714 - Sunshine Act Meeting: Board of Directors and Its Six CommitteesPDF
81 FR 46715 - Sunshine Act: Notice of Agency MeetingPDF
81 FR 46700 - Government in the Sunshine Act Meeting NoticePDF
81 FR 46674 - Sunshine Act MeetingPDF
81 FR 46765 - Mutual Savings Association Advisory CommitteePDF
81 FR 46755 - African Growth and Opportunity Act (AGOA): Request for Public Comments on Annual Review of Country Eligibility for Benefits Under AGOA in Calendar Year 2017; Scheduling of Hearing, and Request for Public CommentsPDF
81 FR 46643 - Countervailing Duty Investigation of Stainless Steel Sheet and Strip From the People's Republic of China: Preliminary Affirmative Determination and Alignment of Final Determination With Final Antidumping Duty DeterminationPDF
81 FR 46647 - Welded ASTM A-312 Stainless Steel Pipe From the Republic of Korea: Final Results of Antidumping Duty Administrative Review; 2013-2014PDF
81 FR 46756 - Public Notice for Waiver of Aeronautical Land-Use AssurancePDF
81 FR 46757 - The Eighth SC-229/The Ninth WG-98 Plenary Meeting Calling Notice, Aircraft Emergency Locator Transmitters (ELTs)PDF
81 FR 46716 - Board of Regents of the University of California, Irvine Nuclear Reactor FacilityPDF
81 FR 46640 - International Trade Data System Test Concerning the Electronic Submission to the Automated Commercial Environment of Data Using the Partner Government Agency Message SetPDF
81 FR 46657 - Government-Industry Advisory Panel; Notice of Federal Advisory Committee MeetingPDF
81 FR 46659 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 2017-2018 Free Application for Federal Student Aid (FAFSA)PDF
81 FR 46672 - Notification of a Public Teleconference of a Work Group Under the Auspices of the Chartered Science Advisory BoardPDF
81 FR 46670 - Oil and Natural Gas Sector: Request for Information, Emerging TechnologiesPDF
81 FR 46757 - RTCA Special Committee 225, Rechargeable Lithium Battery and Battery Systems Twenty-Fourth MeetingPDF
81 FR 46645 - Certain Oil Country Tubular Goods From the Republic of Korea: Initiation and Expedited Preliminary Results of Changed Circumstances ReviewPDF
81 FR 46641 - Rural Business Lending National Stakeholder Forum 2016-Business and Industry Guaranteed Loan ProgramPDF
81 FR 46659 - Intent To Prepare an Environmental Impact Statement for the Lake Okeechobee Watershed Project, Okeechobee, Highlands, Charlotte, Glades, Martin and St. Lucie Counties, FloridaPDF
81 FR 46700 - Indian GamingPDF
81 FR 46603 - Hospital Care and Medical Services for Camp Lejeune VeteransPDF
81 FR 46651 - Gulf of Mexico Fishery Management Council; Public MeetingPDF
81 FR 46649 - Western Pacific Fishery Management Council; Public MeetingsPDF
81 FR 46652 - New England Fishery Management Council; Public MeetingPDF
81 FR 46650 - New England Fishery Management Council; Public MeetingPDF
81 FR 46651 - Pacific Fishery Management Council; WebinarPDF
81 FR 46601 - Prescriptions in Alaska and U.S. Territories and PossessionsPDF
81 FR 46696 - Notice of Kidney Interagency Coordinating Committee MeetingPDF
81 FR 46716 - Advisory Committee on the Medical Uses of Isotopes: Meeting NoticePDF
81 FR 46570 - Requirements for the Disposition of Non-Ambulatory Disabled Veal CalvesPDF
81 FR 46650 - Submission for OMB Review; Comment RequestPDF
81 FR 46642 - Notice of Public Meeting of the Illinois Advisory Committee To Discuss Voting Rights in the StatePDF
81 FR 46666 - Texas Eastern Transmission, LP; Notice of Schedule for Environmental Review of the Access South, Adair Southwest, and Lebanon Extension ProjectsPDF
81 FR 46664 - Proposed Agency Information CollectionPDF
81 FR 46666 - Wickiup Hydro Group, LLC; Notice of Schedule ChangePDF
81 FR 46667 - Notice of Staff Attendance at the Southwest Power Pool Regional Entity Trustee, Members' Committee and Board of Directors' MeetingsPDF
81 FR 46669 - City of Sheridan, WY; Notice of Preliminary Determination of a Qualifying Conduit Hydropower Facility and Soliciting Comments and Motions To IntervenePDF
81 FR 46664 - PJM Interconnection, L.L.C.; Notice of Institution of Section 206 Proceeding and Refund Effective DatePDF
81 FR 46664 - Panda Liberty LLC; Notice of Institution of Section 206 Proceeding and Refund Effective DatePDF
81 FR 46614 - International Fisheries; Pacific Tuna Fisheries; 2016 Bigeye Tuna Longline Fishery Closure in the Eastern Pacific OceanPDF
81 FR 46744 - Equity Market Structure Advisory CommitteePDF
81 FR 46615 - Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Georges Bank Cod Trimester Total Allowable Catch Area Closure for the Common Pool FisheryPDF
81 FR 46673 - Notice of Termination; 10469 1st Regents Bank Andover, MinnesotaPDF
81 FR 46673 - Notice to all Interested Parties of the Termination of the Receivership of 10438, Plantation Federal Bank, Pawleys Island, South CarolinaPDF
81 FR 46673 - Notice of Termination; 10376 First Peoples Bank, Port Saint Lucie, FloridaPDF
81 FR 46694 - Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Public WorkshopPDF
81 FR 46693 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Clinical Laboratory Improvement Amendments Act of 1988 Waiver ApplicationsPDF
81 FR 46702 - Notice of Lodging of Proposed Consent Decree Under the Clean Water ActPDF
81 FR 46677 - Statement of Organization, Functions, and Delegations of AuthorityPDF
81 FR 46675 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
81 FR 46661 - Records Governing Off-the-Record Communications; Public NoticePDF
81 FR 46662 - Combined Notice of FilingsPDF
81 FR 46664 - Combined Notice of FilingsPDF
81 FR 46663 - Combined Notice of Filings #1PDF
81 FR 46668 - Combined Notice of Filings #1PDF
81 FR 46700 - Filing of Plats of Survey: Oregon/WashingtonPDF
81 FR 46758 - Notice of Funding Opportunity for the Tribal Transportation Program Safety FundingPDF
81 FR 46678 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
81 FR 46680 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
81 FR 46677 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 46600 - Security Zones; Seattle's Seafair Fleet Week Moving Vessels, 2016, Puget Sound, WAPDF
81 FR 46601 - Safety Zone, Seafair Air Show Performance, 2016, Seattle, WAPDF
81 FR 46715 - Notice of Permit Modification Received Under the Antarctic Conservation Act of 1978PDF
81 FR 46674 - Privacy Act of 1974; Notice of an Updated System of RecordsPDF
81 FR 46730 - Self-Regulatory Organizations; Investors Exchange LLC; Notice of Filing of Proposed Minor Rule Violation PlanPDF
81 FR 46752 - Agency Information Collection Activities: Proposed Request and Comment RequestPDF
81 FR 46599 - Drawbridge Operation Regulation; Black Warrior River, Eutaw, AlabamaPDF
81 FR 46698 - Marine Mammals; Issuance of PermitsPDF
81 FR 46698 - Endangered Species; Receipt of Applications for PermitPDF
81 FR 46747 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to BZX Rule 11.26(a), Stating it Will Utilize IEX Market Data From the CQS/UQDF for Purposes of Order Handling, Routing, and Related Compliance ProcessesPDF
81 FR 46745 - Self-Regulatory Organizations; Bats BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to BYX Rule 11.26(a), Stating it Will Utilize IEX Market Data From the CQS/UQDF for Purposes of Order Handling, Routing, and Related Compliance ProcessesPDF
81 FR 46731 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend Pilot Program Through January 18, 2017PDF
81 FR 46734 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Its Fee SchedulePDF
81 FR 46739 - Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Detection of Loss of ConnectionPDF
81 FR 46749 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Change To Modify the NYSE Amex Options Fee Schedule Effective July 1, 2016PDF
81 FR 46728 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the SPY Pilot ProgramPDF
81 FR 46746 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Order Approving a Proposed Rule Change Relating to Senior Management AuthorityPDF
81 FR 46723 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Order Approving a Proposed Rule Change Relating to Senior Management AuthorityPDF
81 FR 46721 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fees SchedulePDF
81 FR 46724 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To List and Trade Shares of the First Trust CEF Income Opportunity ETF and the First Trust Municipal CEF Income Opportunity ETFPDF
81 FR 46738 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Fees for Use of Bats BZX Exchange, Inc.PDF
81 FR 46725 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Fees for Use of Bats BZX Exchange, Inc.PDF
81 FR 46719 - Self-Regulatory Organizations; Bats 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 46599 - Notice of Availability of Notice to Lessees and Operators of Federal Oil and Gas, and Sulfur Leases, and Holders of Pipeline Right-of-Way and Right-of-Use and Easement Grants in the Outer Continental Shelf-Requiring Additional SecurityPDF
81 FR 46701 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
81 FR 46647 - North American Free Trade Agreement (NAFTA), Article 1904; Notice of Completion of Panel ReviewPDF
81 FR 46764 - Continental Tire the Americas, LLC, Grant of Petition for Decision of Inconsequential NoncompliancePDF
81 FR 46703 - Petrochoice, LLC, Chisholm, Minnesota, Petrochoice, LLC, Superior, Wisconsin; Amended Certification Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
81 FR 46706 - Notice of Determinations Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
81 FR 46696 - Request for Data and Information on Technologies Used To Identify Substances With the Potential To Cause Acute Systemic ToxicityPDF
81 FR 46705 - Day & Zimmermann, Inc., Kansas Division, Parsons, Kansas; Day & Zimmermann Lone Star LLC, a Wholly Owned Subsidiary Of Day & Zimmermann Group, Inc., Including On-Site Leased Workers From Manpowergroup East Camden, Arkansas; Amended Certification Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
81 FR 46705 - Micro Power Electronics, Inc., a Division Of Electrochem Solutions, Inc., a Subsidiary of Greatbatch, LTD. Including On-Site Leased Workers From Aerotek, Superior Group, Superior Talent, Nesco and Northwest Staffing Beaverton, Oregon; Amended Certification Regarding Eligibility To Apply for Worker Adjustment Assistance and Alternative Trade Adjustment AssistancePDF
81 FR 46704 - Owens-Brockway Glass Container, Inc., a Subsidiary of Owens-Brockway Packaging, Inc., a Subsidiary of Owens-Illinois Group, Inc., a Subsidiary of Owens-Illinois, Inc., Oakland, California; Notice of Affirmative Determination Regarding Application for ReconsiderationPDF
81 FR 46711 - Mitsubishi Motors North America, Inc., A Subsidiary of Mitsubishi Motors Corporation Manufacturing Division, Including On-Site Leased Workers From ETG, HRU Technical Resources, Kelly Temporary Services, Randstad Technologies (Formerly Technisource), STL Commercial Staffing (Formerly Firstaff), MPW Industrial Services, and Allied Barton Security Services, Normal, Illinois; Amended Certification Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
81 FR 46704 - LPL Financial LLC, Business Technology Services Including On-Site Leased Workers From Insight Global, LLC, Sogeti, And SPS Providea San Diego, California; LPL FINANCIAL LLC, BUSINESS TECHNOLOGY SERVICES CHARLOTTE, NORTH CAROLINA LPL Financial LLC Business Technology Services Boston, Massachusetts; Amended Certification Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
81 FR 46697 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
81 FR 46695 - National Eye Institute; Notice of Closed MeetingPDF
81 FR 46703 - AK Steel Corporation Ashland Works, a Subsidiary of AK Steel Holding Corporation Including Workers Whose Wages Were Reported Through RMI International and ESM Group Inc., Including On-Site Leased Workers From Manpower, Inc.; Atlas Industrial Contractors, Inc.; OMI Refractories, LLC DBA Bisco Refractories; Early Construction Company; Enerfab, Inc.; IBM Global Services; Marquis Terminal; Maxim Crane Works; May Contracting Inc.; Minteq International; Phoenix Teq-Ashland, LLC; Premise Health; Superior Environmental Solutions, Inc.; Stein, Inc., And Vesuvius USA Corporation Ashland, Kentucky; Amended Certification Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
81 FR 46705 - D+H USA Corporation, a Subsidiary of DH Corporation, Including On-Site Leased Workers From Alexander Connections, LLC and Volt, Including Workers Whose Unemployment Insurance (UI) Wages Are Reported Through Harland Financial Solutions, Inc., Portland, Oregon; D+H USA Corporation, a Subsidiary of DH Corporation, Including On-Site Leased Workers From Volt, Bothell, Washington; Amended Certification Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
81 FR 46712 - Investigations Regarding Eligibility To Apply for Worker Adjustment AssistancePDF
81 FR 46697 - Center for Mental Health Services; Notice of MeetingPDF
81 FR 46713 - United States-Colombia Trade Promotion Agreement; Notice of Determination Regarding Review of Submission #2016-02PDF
81 FR 46715 - Submission for OMB Review; Comment RequestPDF
81 FR 46752 - TEXAS Disaster #TX-00474PDF
81 FR 46752 - Oklahoma Disaster # OK-00104PDF
81 FR 46718 - Market Test of Experimental Product-Customized DeliveryPDF
81 FR 46718 - New Postal ProductPDF
81 FR 46673 - Filing Dates for the Pennsylvania Special Election in the 2nd Congressional DistrictPDF
81 FR 46698 - Notice of MeetingPDF
81 FR 46751 - Connecticut Disaster #CT-00038PDF
81 FR 46619 - Importation of Sheep, Goats, and Certain Other RuminantsPDF
81 FR 46616 - Almonds Grown in California; Increased Assessment RatePDF
81 FR 46682 - Privacy Act of 1974; System of Records NoticePDF
81 FR 46807 - Equity Assistance Centers (Formerly Desegregation Assistance Centers (DAC))PDF
81 FR 46817 - Final Priority and Requirement-Equity Assistance CentersPDF
81 FR 46820 - Applications for New Awards; Equity Assistance CentersPDF
81 FR 46608 - Determination of Attainment of the 1-Hour Ozone National Ambient Air Quality Standard in the San Joaquin Valley Nonattainment Area in CaliforniaPDF
81 FR 46606 - Approval and Promulgation of Implementation Plans; Louisiana; Permitting of Greenhouse GasesPDF
81 FR 46612 - Extension of the Attainment Date for the Oakridge, Oregon 24-hour PM2.5PDF
81 FR 46652 - Supervisory Highlights: Summer 2016PDF
81 FR 46766 - Notice of MeetingPDF
81 FR 46702 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Open Mobile AlliancePDF
81 FR 46640 - Notice of New Fee SitePDF
81 FR 46578 - Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2PDF
81 FR 46567 - Olives Grown in California; Suspension and Revision of Incoming Size-Grade RequirementsPDF
81 FR 46613 - Nondiscrimination in Health Programs and Activities; CorrectionPDF
81 FR 46582 - Arbitrage Guidance for Tax-Exempt BondsPDF
81 FR 46642 - Foreign-Trade Zone (FTZ) 168-Dallas/Fort Worth, Texas, Authorization of Limited Production Activity, Gulfstream Aerospace Corporation, (Passenger Jet Aircraft), Dallas, TexasPDF
81 FR 46767 - Energy Conservation Program: Final Coverage Determination; Test Procedures for Miscellaneous Refrigeration ProductsPDF

Issue

81 137 Monday, July 18, 2016 Contents Editorial Note:

In the printed version of the Federal Register Table of Contents for Friday, July 15, 2016, FR Doc. 2016-16756 was incorrectly listed under the Commission on Education for the Deaf. This document should have appeared under Drug Enforcement Agency.

Agricultural Marketing Agricultural Marketing Service RULES Suspensions and Revisions of Incoming Size-Grade Requirements: Olives Grown in California, 46567-46570 2016-16704 PROPOSED RULES Increased Assessment Rates: Almonds Grown in California, 46616-46619 2016-16814 Agriculture Agriculture Department See

Agricultural Marketing Service

See

Animal and Plant Health Inspection Service

See

Food Safety and Inspection Service

See

Forest Service

See

Rural Business-Cooperative Service

Animal Animal and Plant Health Inspection Service PROPOSED RULES Importation of Sheep, Goats, and Certain Other Ruminants, 46619-46639 2016-16816 NOTICES International Trade Data System Test: Electronic Submission to the Automated Commercial Environment of Data Using the Partner Government Agency Message Set, 46640 2016-16932 Antitrust Division Antitrust Division NOTICES Membership Changes under the National Cooperative Research and Production Act: Open Mobile Alliance, 46702 2016-16779 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Supervisory Highlights: Summer Edition, 46652-46657 2016-16787 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46675-46682 2016-16882 2016-16872 2016-16873 2016-16874 Statements of Organization, Functions, and Delegations of Authority, 46677 2016-16884 Children Children and Families Administration NOTICES Privacy Act; Systems of Records, 46682-46693 2016-16812 Civil Rights Civil Rights Commission NOTICES Meetings: Illinois Advisory Committee, 46642 2016-16902 Coast Guard Coast Guard RULES Drawbridge Operations: Black Warrior River, Eutaw, AL, 46599-46600 2016-16864 Safety Zones: Seafair Air Show Performance, 2016, Seattle, WA, 46601 2016-16870 Security Zones: Seattle's Seafair Fleet Week Moving Vessels, 2016, Puget Sound, WA, 46600-46601 2016-16871 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Comptroller Comptroller of the Currency NOTICES Meetings: Mutual Savings Association Advisory Committee, 46765-46766 2016-16958 Defense Department Defense Department See

Engineers Corps

NOTICES Meetings: Government-Industry Advisory Panel, 46657-46659 2016-16931
Education Department Education Department RULES Equity Assistance Centers, 46808-46817 2016-16811 Final Priorities: Equity Assistance Centers, 46817-46819 2016-16810 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: 2017-2018 Free Application for Federal Student Aid, 46659-46661 2016-16930 Applications for New Awards: Equity Assistance Centers, 46820-46826 2016-16809 Employment and Training Employment and Training Administration NOTICES Worker Adjustment Assistance Eligibility; Amended Certifications: AK Steel Corp. Ashland Works, Ashland, KY, 46703-46704 2016-16832 Day and Zimmermann, Inc., Parsons, KS, 46705 2016-16839 LPL Financial, LLC, San Diego, CA, 46704 2016-16835 Mitsubishi Motors North America, Inc., Normal, IL, 46711-46712 2016-16836 PetroChoice, LLC, Chisholm, MN, 46703 2016-16842 Worker Adjustment Assistance Eligibility; Determinations, 46706-46711 2016-16841 Worker Adjustment Assistance Eligibility; Reconsiderations: Owens-Brockway Glass Container, Inc., Oakland, CA, 46704 2016-16837 Worker Adjustment Assistance; Amended Certifications: D Plus H USA Corp., Portland, OR, 46705 2016-16831 Worker Adjustment Assistance; Investigations, 46712-46713 2016-16830 Worker and Alternative Trade Adjustment Assistance Eligibility: Micro Power Electronics, Inc., Beaverton, OR, 46705-46706 2016-16838 Energy Department Energy Department See

Federal Energy Regulatory Commission

RULES Energy Conservation Program: Final Coverage Determination; Test Procedures for Miscellaneous Refrigeration Products, 46768-46805 2016-14389
Engineers Engineers Corps NOTICES Environmental Impact Statements; Availability, etc.: Lake Okeechobee Watershed Project Okeechobee, Highlands, Charlotte, Glades, Martin and St. Lucie Counties, FL, 46659 2016-16920 Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; Determination of Attainment of the 1-Hour Ozone National Ambient Air Quality Standard in the San Joaquin Valley Nonattainment Area, 46608-46612 2016-16792 Louisiana; Permitting of Greenhouse Gases, 46606-46608 2016-16791 Oregon; Extension of the Attainment Date for the Oakridge, OR, 24-hour PM2.5 Nonattainment Area, 46612-46613 2016-16789 NOTICES Meetings: Work Group under the Auspices of the Chartered Science Advisory Board, 46672 2016-16929 Requests for Information: Oil and Natural Gas Sector; Emerging Technologies, 46670-46672 2016-16927 Federal Aviation Federal Aviation Administration NOTICES Meetings: Aircraft Emergency Locator Transmitters, 46757 2016-16934 RTCA Special Committee 225, Rechargeable Lithium Battery and Battery Systems, 46757-46758 2016-16926 Waivers of Aeronautical Land-Use Assurances, 46756-46757 2016-16937 Federal Deposit Federal Deposit Insurance Corporation NOTICES Terminations of Receiverships: 1st Regents Bank, Andover, MN, 46673 2016-16890 First Peoples Bank, Port Saint Lucie, FL, 46673 2016-16888 Plantation Federal Bank, Pawleys Island, SC, 46673 2016-16889 Federal Election Federal Election Commission NOTICES Filing Dates: Pennsylvania Special Election in the 2nd Congressional District, 46673-46674 2016-16821 Federal Energy Federal Energy Regulatory Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46664-46666 2016-16899 Combined Filings, 46662-46664, 46668-46669 2016-16877 2016-16878 2016-16879 2016-16880 Environmental Reviews: Texas Eastern Transmission, LP; Access South, Adair Southwest, and Lebanon Extension Projects, 46666-46667 2016-16900 Meetings: Wickiup Hydro Group, LLC; Schedule Change, 46666 2016-16898 Qualifying Conduit Hydropower Facilities: Sheridan, WY, 46669-46670 2016-16896 Records Governing Off-the-Record Communications, 46661-46662 2016-16881 Refund Effective Dates: Panda Liberty, LLC, 46664 2016-16894 PJM Interconnection, LLC, 46664 2016-16895 Staff Attendances, 46667-46668 2016-16897 Federal Highway Federal Highway Administration NOTICES Funding Availability: Tribal Transportation Program Safety Funding, 46758-46764 2016-16875 Federal Maritime Federal Maritime Commission NOTICES Meetings; Sunshine Act, 46674 2016-16961 Fish Fish and Wildlife Service NOTICES Permits: Endangered Species, 46698-46699 2016-16862 Marine Mammals, 46698 2016-16863 Food and Drug Food and Drug Administration RULES Food Additives Permitted for Direct Addition to Food for Human Consumption: Vitamin D2 and Vitamin D3, 46578-46582 2016-16738 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Clinical Laboratory Improvement Amendments Act Waiver Applications, 46693-46694 2016-16886 Meetings: Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Workshop, 46694-46695 2016-16887 Food Safety Food Safety and Inspection Service RULES Requirements for the Disposition of Non-Ambulatory Disabled Veal Calves, 46570-46577 2016-16904 Foreign Trade Foreign-Trade Zones Board NOTICES Limited Production Activities; Authorizations: Gulfstream Aerospace Corp., Foreign-Trade Zone 168, Dallas/Fort Worth, TX, 46642-46643 2016-16371 Forest Forest Service NOTICES New Fee Sites, 46640-46641 2016-16750 General Services General Services Administration NOTICES Privacy Act; Systems of Records, 46674-46675 2016-16868 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Children and Families Administration

See

Food and Drug Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

RULES Nondiscrimination in Health Programs and Activities; Correction, 46613-46614 2016-16680
Homeland Homeland Security Department See

Coast Guard

Indian Affairs Indian Affairs Bureau NOTICES Indian Gaming, 46700 2016-16919 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

Land Management Bureau

See

Ocean Energy Management Bureau

Internal Revenue Internal Revenue Service RULES Arbitrage Guidance for Tax-Exempt Bonds, 46582-46599 2016-16558 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Oil Country Tubular Goods from the Republic of Korea, 46645-46647 2016-16923 Stainless Steel Sheet and Strip From the People's Republic of China, 46643-46645 2016-16947 Welded ASTM A-312 Stainless Steel Pipe from the Republic of Korea, 46647-46649 2016-16945 NAFTA Panel Reviews, 46647 2016-16844 International Trade Com International Trade Commission NOTICES Complaints: Certain Quartz Slabs, 46701-46702 2016-16845 Meetings; Sunshine Act, 46700-46701 2016-17012 2016-17013 Justice Department Justice Department See

Antitrust Division

NOTICES Proposed Consent Decrees under the Clean Water Act, 46702-46703 2016-16885
Labor Department Labor Department See

Employment and Training Administration

NOTICES Determinations of Submission under the United States-Colombia Free Trade Agreement, 46713-46714 2016-16828
Land Land Management Bureau NOTICES Plats of Surveys: Oregon/Washington, 46700 2016-16876 Legal Legal Services Corporation NOTICES Meetings; Sunshine Act, 46714-46715 2016-17081 National Credit National Credit Union Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46715 2016-16827 Meetings; Sunshine Act, 46715 2016-17045 National Highway National Highway Traffic Safety Administration NOTICES Petitions for Decision of Inconsequential Noncompliance; Approvals: Continental Tire the Americas, LLC, 46764-46765 2016-16843 National Institute National Institutes of Health NOTICES Meetings: Kidney Interagency Coordinating Committee, 46696-46697 2016-16907 National Eye Institute, 46695-46696 2016-16833 National Institute of Allergy and Infectious Diseases, 46697 2016-16834 Requests for Information: Technologies Used to Identify Substances with the Potential to Cause Acute Systemic Toxicity, 46696 2016-16840 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Northeastern United States; Northeast Multispecies Fishery: Georges Bank Cod Trimester Total Allowable Catch Area Closure for the Common Pool Fishery, 46615 2016-16891 International Fisheries: Pacific Tuna Fisheries; 2016 Bigeye Tuna Longline Fishery Closure in the Eastern Pacific Ocean, 46614-46615 2016-16893 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46650-46651 2016-16903 Meetings: Gulf of Mexico Fishery Management Council, 46651-46652 2016-16915 New England Fishery Management Council, 46650, 46652 2016-16910 2016-16913 Pacific Fishery Management Council; Webinar, 46651 2016-16909 Western Pacific Fishery Management Council, 46649-46650 2016-16914 National Science National Science Foundation NOTICES Permit Applications: Antarctic Conservation Act, 46715-46716 2016-16869 Nuclear Regulatory Nuclear Regulatory Commission NOTICES License Renewals: Board of Regents of the University of California, Irvine Nuclear Reactor Facility, 46716-46718 2016-16933 Meetings: Advisory Committee on the Medical Uses of Isotopes, 46716 2016-16905 Ocean Energy Management Ocean Energy Management Bureau RULES Regulatory Guidance: Lessees and Operators of Federal Oil and Gas, and Sulfur Leases, and Holders of Pipeline Right-of-Way and Right-of-Use and Easement Grants in the Outer Continental Shelf—Requiring Additional Security, 46599 2016-16846 Postal Regulatory Postal Regulatory Commission NOTICES Market Test of Experimental Product-Customized Delivery, 46718-46719 2016-16823 New Postal Products, 46718 2016-16822 Rural Business Rural Business-Cooperative Service NOTICES Meetings: Rural Business Lending National Stakeholder Forum 2016—Business and Industry Guaranteed Loan Program, 46641-46642 2016-16921 Securities Securities and Exchange Commission NOTICES Meetings: Equity Market Structure Advisory Committee, 46744-46745 2016-16892 Self-Regulatory Organizations; Proposed Rule Changes: Bats BYX Exchange, Inc., 46745-46746 2016-16860 Bats BZX Exchange, Inc., 46725-46728, 46738-46739, 46747-46749 2016-16849 2016-16850 2016-16861 Bats EDGX Exchange, Inc., 46719-46721 2016-16848 C2 Options Exchange, Inc., 46746-46747 2016-16854 Chicago Board Options Exchange, Inc., 46721-46724 2016-16852 2016-16853 International Securities Exchange, LLC, 46728-46730 2016-16855 Investors Exchange, LLC, 46730-46731 2016-16866 Miami International Securities Exchange, LLC, 46734-46737 2016-16858 NASDAQ BX, Inc., 46739-46744 2016-16857 NASDAQ PHLX, LLC, 46731-46734 2016-16859 NASDAQ Stock Market, LLC, 46724-46725 2016-16851 NYSE MKT, LLC, 46749-46751 2016-16856 Small Business Small Business Administration NOTICES Disaster Declarations: Connecticut, 46751-46752 2016-16818 Oklahoma, 46752 2016-16825 Texas, 46752 2016-16826 Social Social Security Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 46752-46754 2016-16865 Substance Substance Abuse and Mental Health Services Administration NOTICES Meetings: Center for Mental Health Services National Advisory Council, 46697 2016-16829 Center for Substance Abuse Prevention National Advisory Council, 46698 2016-16820 Trade Representative Trade Representative, Office of United States NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: African Growth and Opportunity Act; Annual Review of Country Eligibility for Benefits under AGOA in Calendar Year 2017, 46755-46756 2016-16957 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department See

Comptroller of the Currency

See

Internal Revenue Service

U.S. Institute United States Institute of Peace NOTICES Meetings, 46766 2016-16785 Veteran Affairs Veterans Affairs Department RULES Hospital Care and Medical Services for Camp Lejeune Veterans, 46603-46606 2016-16917 Prescriptions in Alaska and U.S. Territories and Possessions, 46601-46602 2016-16908 Separate Parts In This Issue Part II Energy Department, 46768-46805 2016-14389 Part III Education Department, 46808-46826 2016-16811 2016-16810 2016-16809 Reader Aids

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

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81 137 Monday, July 18, 2016 Rules and Regulations DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 932 [Docket No. AMS-SC-16-0031; SC16-932-1 IR] Olives Grown in California; Suspension and Revision of Incoming Size-Grade Requirements AGENCY:

Agricultural Marketing Service, USDA.

ACTION:

Interim rule with request for comments.

SUMMARY:

This rule implements a recommendation from the California Olive Committee (Committee) to suspend the incoming size-grade authority under the California olive marketing order (order), which regulates the handling of olives in California. The rule also makes conforming changes to the corresponding size-grade requirements in the order's rules and regulations to adapt them to the suspension. The Committee locally administers the order and is comprised of California olive producers and handlers operating within the production area. The suspension and revisions are intended to allow the Committee time to develop new incoming size-grade authority that will reflect currently-available technology and meet the industry's future needs.

DATES:

Effective July 19, 2016; comments received by September 16, 2016 will be considered prior to issuance of a final rule.

ADDRESSES:

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

FOR FURTHER INFORMATION CONTACT:

Peter Sommers, Marketing Specialist, or Jeffrey Smutny, Regional Director, California Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (559) 487-5901, Fax: (559) 487-5906; or Email: [email protected] or [email protected]

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

SUPPLEMENTARY INFORMATION:

This rule is issued under Marketing Agreement 148 and Order No. 932, both as amended (7 CFR part 932), regulating the handling of olives grown in California, hereinafter referred to as the “order.” The agreement and order are effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

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

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

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

This rule suspends the incoming size-grade authority of the marketing order and revises the corresponding size-grade requirements in the order's rules and regulations. The current authority establishes a range of size designations and average count ranges per pound into which the varieties of olives must fall in order to be size-certified by the Federal or Federal-State Inspection Service. The incoming size-grade regulations do not reflect the size-grading capabilities of newer technology available to California olive handlers. Currently, the order mandates that sizing of olives be based on count ranges and average counts per pound, while the new technology sizes olives using their associated mass and volume. Thus, the current size-grade requirements and the sizing capabilities of the new technology are incompatible. This recommendation was passed unanimously by the Committee at a meeting on February 17, 2016.

The incoming regulations include a requirement for olives to be weighed upon receipt. This regulation is not being suspended, since handlers need to weigh the bins of incoming olives so that each producer has a record of their total deliveries to handlers. Thus, this relaxation will require continued weighing of olives but will suspend the requirement that olives be size-graded upon receipt.

By relaxing the sizing requirement, handlers will be able to voluntarily size olives to make accurate payments to their producers on their total deliveries, ensure that the olives they place into their storage tanks are uniform in size for efficient processing, and utilize any olive size for limited-use styles.

Even though there will be no incoming size requirements, handlers will continue to be bound by mandatory inspection and certification of outgoing size requirements listed in the U.S. Standards for Grade of Canned Ripe Olives (7 CFR part 52). Outgoing inspection, based on weight and count, will continue to be used to verify compliance with the U.S. Standards of the previously sorted olives.

Limited-use styles include olives that are no longer in whole form and are sliced, segmented (wedged), chopped, halved, and broken pitted styles. When incoming regulation is in effect, the Committee has authority to identify size-grade categories of olives that are eligible to be used in limited-use styles. With the suspension of the incoming size-grade requirement, handlers will be able to use any size olive for limited-use styles. Therefore, the suspension of incoming size-grade regulation relaxes the requirements for limited-use.

This suspension is necessary in order to provide the industry, and their USDA partners, the opportunity to work on new size-grading requirements that will address and work in tandem with new sizing technology.

This rule suspends language in § 932.51 related to size-grade requirements. In addition, this rule revises language in § 932.151, where “weight” is used to replace “size-grading,” and removes certain references to the “inspection service” or replaces the term with “Committee.” With this change, while incoming regulation is suspended, the Committee will receive information directly from handlers on incoming olive receipts from growers, rather than through the Inspection Service.

Section 932.51 of the order specifies that incoming olives be weighed and size-graded under the supervision of the Federal or Federal-State Inspection Service. The size designations set forth are those found in the U.S. Standards for Grade of Canned Ripe Olives (7 CFR part 52) and include additional size designations specified in § 932.51.

Section 932.51 also establishes authority for handlers to use limited-use olives. As previously stated, once the suspension is in effect, handlers will be able to use any olives in the production of limited-use styles.

As noted above, weight certification will still be required under § 932.51 for all olives received by handlers, so that producers will be able to confirm their total deliveries to handlers.

Section 932.151 of the order's rules and regulations specifies the requirements for incoming olives, which are—weighing, size-grading, and certifying of canning olives and non-canning olives (culls).

The olive industry has been involved in a technological shift since 2012. In addition to electronic reporting technology, which eliminates burdensome paper reports, the industry has begun moving toward more cost-effective and accurate sizing technology. New technology sorts olives by measuring the volume and mass of each olive directly, rather than by count per pound and approximate count per pound. As technology changes and improves, better methods of classifying olives by size need to be in place. With the technology now available, handlers report a 30-percent reduction in labor costs. Those reduced costs contribute to making California olive handlers more competitive with other olive-processing countries.

Since new technology represents a significant departure from existing size-grading techniques, the Committee believes, with industry support, that the correct course of action is to suspend the incoming size-grade requirements. This will give the industry, working with their USDA partners, the time to develop size-grade requirements that reflect changes in technology.

This suspension requires a modification of two Committee forms, Weight and Grade Report (COC-3c) and the Report of Limited and Undersize and Cull Olives Inspection and Disposition (COC-5). Both are approved for use under OMB No. 0581-0178, Generic Vegetables and Specialty Crops, and used by the Federal or Federal-State Inspection Service to certify sizes of incoming olives and limited-use style sizes. In addition, the COC-3c is specified as being an inspection certificate. Since this rule suspends the incoming size-grading requirements, there is no need for the inspection service to certify sizes of olives or issue an inspection certificate.

Following the publication of this rule, the COC-3c will be used by handlers to report to the Committee the incoming weights and volume size distribution of the sample. The COC-5 will be used by handlers to certify limited, undersize, and cull olive disposition.

Initial Regulatory Flexibility Analysis

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

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

There are two handlers subject to regulation under the marketing order and approximately 1,000 olive producers in the production area. Small agricultural service firms are defined by the Small Business Administration (SBA) as those having annual receipts of less than $7,500,000, and small agricultural producers are defined as those having annual receipts of less than $750,000 (13 CFR 121.201).

Based upon information from the Committee and the National Agricultural Statistics Service (NASS), the average producer price for the 2013-14 crop year (the last year information was available) was $1,150 per ton of canning-size olives and $385 per ton for limited-use size olives. The total assessable volume was 85,668 tons. Canning sizes represented 88 percent of the assessable olive volume, while limited-use sizes represented 12 percent of the assessable olive volume.

Based on production, producer prices, and the total number of California olive producers, the average annual producer revenue is less than $750,000. Thus, the majority of olive producers may be classified as small entities. Both of the handlers may be classified as large entities.

This relaxation is expected to positively impact both handlers and producers. Handlers will be able to use new technology as it becomes available to voluntarily size-grade incoming fruit more accurately, helping them be more competitive. Producers will benefit from more-accurate sizing, potentially resulting in higher handler payments to producers. This relaxation will also provide the industry with the opportunity to develop new mandatory sizing requirements conducive to alternative sizing capabilities.

The Committee's Incoming Inspection Workgroup initially discussed this recommendation and its alternatives on January 25, 2016, as did the Inspection Subcommittee prior to the Committee meeting on February 17, 2016. The Committee also considered alternatives to this action, but concluded that the correct course of action would be to recommend suspension. For all the reasons cited herein, the alternative to continue mandatory size-grading was not considered viable, would not give handlers the flexibility they need, and was rejected.

This rule suspends the size-grade requirements of the incoming regulations in § 932.51, beginning with the 2016-2017 crop year. It also revises the rules and regulations in § 932.151 allowing for the continued certification of olives by weight and replaces references to the inspection service with the Committee. In addition, minor modifications are being made to the COC 3 and COC 5 forms.

The suspension and revisions are intended to allow the Committee time to develop new requirements that address advancing technology and equipment; help reduce handling costs, keeping the California industry competitive with other olive-processing countries; and increase handler efficiency.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements are approved by the Office of Management and Budget (OMB) under OMB No. 0581-0178 (Generic Vegetables and Specialty Crops). Minor changes to those requirements are necessary as a result of this action.

AMS has submitted a request to the Office of Management and Budget (OMB) to make minor changes to forms COC-3c and COC-5. The four changes to form COC-3c include removing the block entitled “Cert No.”; deleting the words “inspection certificate” from the block entitled “California Olive Committee”; deleting the statement “This lot was weighed, sampled, and size graded under the direct supervision of the Federal-State Inspection Program” and deleting the signature and date lines associated with that statement; and lastly, removing the words “OFFICIAL INSPECTION CERTIFICATE” and adding the words “Handler Use Only”.

The changes to form COC-5 include changing the words “(5) REQUEST FOR INSPECTION” to “(5) DISPOSITION” and removing the words “(7) INSPECTION CERTIFICATION: The olives inspected conform to the information listed above” and deleting the space for the inspector's signature and the date. Additionally, changes to the form's instructions include removing the words “to be inspected” from the GENERAL instruction, and deleting the instruction for ITEM (7).

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

In addition, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule. Furthermore, the Committee's meeting was widely publicized throughout the California olive industry, and all interested persons were invited to attend the meeting and encouraged to participate in Committee deliberations. Like all Committee and subcommittee meetings, the January 25, 2016, and February 17, 2016, meetings were public meetings, and all entities, both large and small, were able to express their views on this issue.

Also, the Committee has a number of appointed subcommittees that review specific issues and make recommendations to the Committee. The Committee's Inspection Subcommittee met on February 17, 2016, prior to the full Committee meeting on that same day, and discussed this issue in detail. That meeting was the result of a special working group meeting on January 25, 2016. The working group was tasked with reviewing the inspection protocol and related issues, and reporting their findings and recommendations to the Inspection Subcommittee. All three meetings were public meetings, and both large and small entities were encouraged to participate and express their views. Finally, interested persons are invited to submit comments on this interim rule, including the regulatory and informational impacts of this action on small businesses.

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

This rule invites comments on the suspension and revision of incoming size-grade requirements under the California olive marketing order. Any comments received will be considered prior to the finalization of this rule.

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

Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect and that good cause exists for not postponing the effective date of this rule until 60 days after publication in the Federal Register because: the Committee unanimously recommended these changes at a public meeting; this is a relaxation of the marketing order requirements; and this rule provides a 30-day comment period. Any comments received will be considered prior to finalization of this rule.

List of Subjects in 7 CFR Part 932

Marketing agreements, Olives, Reporting and recordkeeping requirements.

For the reasons set forth in the preamble, 7 CFR part 932 is amended as follows:

PART 932—OLIVES GROWN IN CALIFORNIA 1. The authority citation for 7 CFR part 932 continues to read as follows: Authority:

7 U.S.C. 601-674.

§ 932.51 [Amended]
2. In § 932.51, suspend indefinitely paragraphs (a)(1)(ii) through (a)(5).
3. Amend § 932.151 by revising paragraphs (a), (b), (c), (d), (e)(1), (2), and (4), and (f)(1) to read as follows:
§ 932.151 Incoming regulations.

(a) Inspection stations. Natural condition olives shall be weighed only at inspection stations which shall be a plant of a handler or other place having facilities for weighing such olives: Provided, That such location and facilities are satisfactory to the committee: Provided further, That upon prior application to, and approval by, the committee, a handler may receive olives at an inspection station other than the one where the lot was weighed.

(b) Lot identification. (1) Immediately upon receipt of each lot of natural condition olives, the handler shall complete Form COC 3A or 3C, weight and grade report or such other lot identification form as may be approved by the committee, which shall contain at least the following:

(i) Lot number;

(ii) Date;

(iii) Variety; and

(iv) Number and type containers.

(2) The handler shall maintain identity of such lot of olives with its corresponding lot weight and grade report.

(c) Weighing. Each lot of natural condition olives shall be separately weighed to determine the net weight of olives.

(d) Handler incoming responsibility—(1) General. The handler is responsible for the proper performance of all actions connected with the identification of lots of olives, the weighing of boxes or bins, the taking of samples, and the furnishing of necessary personnel for the carrying out of such actions.

(2) Certification. (i) For each lot of olives that are weighed, the handler shall complete Form COC-3A or 3C, weight and grade report, which shall contain at least the following:

(A) Name of handler;

(B) Name of producer;

(C) County of production;

(D) Applicable lot number;

(E) Weight certificate number;

(F) Net weight;

(G) Number and type of containers;

(H) Date received;

(I) Time received; and

(J) Weight of sample.

(ii) The completed Form COC-3A or 3C shall be furnished to the committee, which shall certify thereon that the lot was weighed as required by § 932.51 if in accordance with the facts.

(e) Disposition of noncanning olives—(1)(i) Notification and inspection of noncanning olives. Prior to disposition of noncanning olives the handler shall complete Form COC-5, report of limited and undersize and cull olives inspection and disposition, which shall contain the following:

(A) Type and number of containers;

(B) Type of olives (undersize or culls);

(C) Net weight;

(D) Variety;

(E) Outlet (green olives, olive oil, etc.); and

(F) Consignee.

(ii) Before disposition of such olives, the completed Form COC-5 shall be furnished to the committee.

(2) Control and surveillance. Noncanning olives that have been reported on Form COC-5 shall, unless such olives are disposed of immediately after receipt, be identified by fixing to each bin or pallet of boxes a COC control card which may be obtained from the committee. Such olives shall be kept separate and apart from other olives in the handler's possession and shall be disposed of only in the outlet shown on Form COC-5.

(4) Olives not subject to incoming regulation requirements. Except as otherwise prescribed in § 932.51(b), any lot of olives to be used solely in the production of green olives or canned ripe olives of the “tree ripened” type shall not be subject to incoming regulation: Provided, That the applicable requirements of § 932.51(b) are met and the handler notifies the committee, in writing, that such lot is to be so used. Notice may be given by writing on the weight certificate “Lot to be used solely for use in the production of green olives or tree ripened olives” and a copy of such weight certificate given to the committee.

(f) Partially exempted lots. (1) Pursuant to § 932.55, any handler may process any lot of natural condition olives for use in the production of packaged olives which has not first been weighed as an individual lot as required by § 932.51(a)(1)(i) but was combined with any other lot or lots of natural condition olives, only if:

(i) All the olives in the combined lot are delivered to the handler in the same day;

(ii) The total net weight of the olives delivered to the handler by any person in such day does not exceed 500 pounds;

(iii) Each such person had authorized combination of his lot with other lots; and

(iv) The combined lot of the natural condition olives is weighed as required by § 932.51(a)(1)(i) prior to processing the olives.

Dated: July 11, 2016. Elanor Starmer, Administrator, Agricultural Marketing Service.
[FR Doc. 2016-16704 Filed 7-15-16; 8:45 am] BILLING CODE 3410-02-P
DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Part 309 [Docket No. FSIS-2014-0020] RIN 0583-AD54 Requirements for the Disposition of Non-Ambulatory Disabled Veal Calves AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Final rule.

SUMMARY:

The Food Safety and Inspection Service (FSIS) is amending its regulations on ante-mortem inspection to remove a provision that permits establishments to set apart and hold for treatment veal calves that are unable to rise from a recumbent position and walk because they are tired or cold. FSIS is also amending its regulations to require all non-ambulatory disabled cattle to be promptly disposed of after they have been condemned. In addition, after review and consideration of comments to the proposed rule, FSIS is amending the regulations by removing a provision that requires ante-mortem inspection to be conducted in pens. This final rule makes clear that FSIS inspectors have the authority to conduct ante-mortem inspection and condemn non-ambulatory disabled veal calves the moment they arrive on the premises of the establishment. These amendments will improve compliance with the Humane Methods of Slaughter Act of 1978 (HMSA) and the humane slaughter implementing regulations. The amendments will also improve the Agency's inspection efficiency by eliminating the time that FSIS inspectors spend re-inspecting non-ambulatory disabled veal calves.

DATES:

Effective Date: September 16, 2016.

FOR FURTHER INFORMATION CONTACT:

Daniel L. Engeljohn, Ph. D., Assistant Administrator, Office of Policy and Program Development, Food Safety and Inspection Service, U.S. Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 20250-3700; Telephone (202) 205-0495; Fax (202) 720-2025.

SUPPLEMENTARY INFORMATION:

Background

Under 9 CFR 309.3(e), non-ambulatory disabled cattle that are offered for slaughter, including those that have become non-ambulatory disabled after passing ante-mortem inspection, must be condemned and disposed of properly. However, under 9 CFR 309.13(b), non-ambulatory disabled veal calves that are able to rise from a recumbent position and walk after they have been set aside and warmed or rested, and that are found to be otherwise free from disease, may be slaughtered for human consumption under appropriate FSIS supervision.

On May 13, 2015, FSIS published the proposed rule “Requirements for the Disposition of Non-Ambulatory Disabled Veal Calves” (80 FR 27269). FSIS proposed to amend 9 CFR 309.13(b) to remove the set-aside provision. FSIS also proposed to amend 9 CFR 309.3(e) to require all condemned cattle to be promptly disposed of in accordance with 9 CFR 309.13. Under the proposed rule, all non-ambulatory disabled cattle would be condemned and promptly euthanized.

As FSIS explained in the proposed rule, in November 2009, the Humane Society of the United States (HSUS) filed a petition requesting that FSIS amend 9 CFR 309.13(b) to remove the provision that allows veal calves that are non-ambulatory disabled because they are tired or cold to be set aside for treatment and re-inspected at a later time (the set-aside provision).1 The petition stated that the set-aside provision is inconsistent with the language and intent of the HMSA because it fails to ensure that the handling of livestock in connection with slaughter be carried out only by humane methods (see 7 U.S.C. 1902). The petition asserted that the set-aside provision creates an incentive for establishments to use inhumane methods to get non-ambulatory disabled veal calves to rise for re-inspection. Furthermore, the petition stated that removing the set-aside provision would eliminate the uncertainty of determining whether veal calves are non-ambulatory disabled because they are tired or cold or because they are injured or sick, thereby ensuring the appropriate disposition of these calves. Finally, the petition stated that eliminating the time that FSIS inspectors spend re-inspecting calves would improve inspection efficiency (80 FR 27269).

1 The petition is available on the FSIS Web site at http://www.fsis.usda.gov/wps/wcm/connect/9ddd8b7c-983f-4cb1-83e8-9e545e9345d0/Petition_HSUS_Humane_Handling.pdf?MOD=AJPERES.

The petition referred to video footage from an HSUS undercover investigation at an official veal slaughter establishment conducted in August and September 2009. The video footage documented incidents in which establishment personnel attempted to force non-ambulatory disabled veal calves to rise by kicking, prodding, and dragging the calves to their feet. After release of this video footage, FSIS conducted its own investigation that found the establishment repeatedly failed to handle non-ambulatory disabled veal calves in a humane manner. FSIS immediately shut down the establishment, and it was only allowed to re-open under a new name and different ownership after reaching an agreement with FSIS that its facilities would be audited by an outside firm on a regular basis, and that employees would receive special training on humane handling of animals. In addition, Secretary of Agriculture Thomas Vilsack requested that the USDA's Office of Inspector General conduct a criminal investigation. While no Federal charges were filed, two establishment officials were criminally prosecuted by the State of Vermont.

After reviewing the findings of the FSIS investigation and the issues raised in the petition, the Agency tentatively granted the HSUS petition but determined it would be useful to solicit public input on the issues raised in the petition before making a final decision. On February 7, 2011, FSIS published a document in the Federal Register requesting public comments on the HSUS petition (76 FR 6572). FSIS received approximately 74,200 comments in response to the Federal Register document (see 80 FR 27269 for a more detailed discussion of the comments and FSIS's responses). On March 13, 2013, FSIS granted the HSUS petition and announced that the Agency would begin rulemaking when resources allowed.

In January 2014, FSIS conducted another investigation based on video footage captured by an HSUS undercover investigation at a second veal slaughter establishment. This video footage showed two humane handling violations committed by the establishment, including an employee dragging and rolling a non-ambulatory disabled veal calf into a holding pen. The subsequent FSIS investigation found that, while the establishment had a comprehensive systematic approach to its humane handling program, the establishment failed to implement effective humane handling methods, resulting in egregious violations (see 80 FR 27270 for more details on the investigation).

As explained in the proposed rule, published May 13, 2015, prohibiting the slaughter of all non-ambulatory veal calves will improve compliance with the HMSA and the humane slaughter implementing regulations (80 FR 27269). FSIS's 2009 and 2014 investigations of incidents of inhumane handling at official veal slaughter establishments demonstrate that the set-aside provision may create an incentive for establishments to inhumanely force non-ambulatory disabled veal calves to rise. The set-aside provision may also provide an incentive for livestock producers and establishments to send weakened veal calves to slaughter in the hope that the veal calves are able to sufficiently recover in time to pass ante-mortem inspection. Sending such weakened veal calves to slaughter increases the chances that they will go down and be subjected to conditions that are inhumane (80 FR 27271). In addition, FSIS inspectors may not always be able to distinguish between a veal calf that is non-ambulatory disabled because it is tired or cold from a veal calf that is injured or sick. Thus, allowing re-inspection may encourage establishments to hold ill or injured veal calves in an attempt to allow them to recover and pass re-inspection before collapsing.

FSIS is also concerned about the treatment of veal calves during extended hold times. For example, non-compliance records (NRs) from 2012 to 2015 included 33 instances of failing to provide veal calves with access to water.

Finally, removing the set-aside provision will also improve the Agency's inspection efficiency by eliminating the time that FSIS inspectors spend re-inspecting non-ambulatory disabled veal calves.

Final Rule

After consideration of all of the comments, FSIS is finalizing the provisions of the May 13, 2015 proposed rule with one change. The final rule removes a provision in the Federal meat inspection regulations that requires all ante-mortem inspections to be conducted in pens (9 CFR 309.1(b)).

Comments discussed below submitted in response to the proposed rule showed confusion about exactly when animals are “offered for slaughter,” and when inspectors may conduct ante-mortem inspection. Some commenters stated that establishments could exploit a loophole in the regulations by setting aside non-ambulatory disabled veal calves to rest and recover, and offer the calves for ante-mortem inspection at a later time.

Currently, FSIS inspectors are instructed to conduct ante-mortem inspection on transportation vehicles if the animals cannot be unloaded for any reason (see FSIS Directive 6,900.2, Humane Handling and Slaughter of Livestock). To harmonize the regulations with this established policy, FSIS is amending the regulations by removing a provision in 9 CFR 309.1(b) that requires ante-mortem inspection to be performed “in pens”.

FSIS is amending these regulations under 21 U.S.C. 621, which gives FSIS the authority to adopt regulations for the efficient administration of the Federal Meat Inspection Act (FMIA). The amendments in this rule are intended to facilitate more effective implementation of ante-mortem inspection pursuant to 21 U.S.C. 603(a) and of the humane handling requirements established pursuant to 21 U.S.C. 603(b).

Comments and Responses

FSIS received approximately 42,054 comments from animal welfare write-in campaigns that supported the proposed rule. FSIS also received 35 comments from animal welfare organizations, members of Congress, and private citizens that also supported the proposed rule. FSIS received approximately 20 comments from organizations representing meat processors, cattle producers, dairy producers, farm bureaus, and private citizens that opposed the proposed rule.

Comment: Several farm bureaus stated that the current regulations adequately protect non-ambulatory disabled veal calves from inhumane treatment. These commenters noted that FSIS has trained personnel in establishments at all times to ensure that calves are humanely handled, and veal producers have too big of a financial incentive to violate the HMSA.

Response: FSIS is amending the regulations to improve compliance with the HMSA and improve the Agency's inspection efficiency by eliminating the time that FSIS inspectors spend re-inspecting non-ambulatory disabled veal calves.

As explained in the Background section, FSIS conducted investigations in 2009 and 2014 in response to undercover videos taken by HSUS that showed establishments using force to get non-ambulatory disabled veal calves to rise for inspection. Based on the findings of these investigations, FSIS concluded that the set-aside provision may create an incentive for establishments to inhumanely force non-ambulatory disabled veal calves to rise.

Furthermore, the 2014 HSUS video showed that humane handling violations can occur outside the view of FSIS inspectors. FSIS inspectors are unable to continuously monitor non-ambulatory veal calves that have been set apart to warm and rest because they must perform other food safety inspection-related activities between the time that the calves are set apart and the time of inspection after the resting period.

Comment: An industry trade association and veal processor stated that condemnation and prompt disposal of non-ambulatory disabled veal calves would waste potentially healthy animals that can go into the food supply.

Response: The carcasses, parts thereof, meat, or meat food products of non-ambulatory disabled veal calves will be considered unfit for human food and thus adulterated pursuant to 21 U.S.C. 601(m)(3). However, the carcasses of condemned veal calves may have other, inedible-product, uses (e.g., through rendering).

In addition, the estimated cost of the final rule will have a minimal financial impact on the veal industry. Market value estimates for slaughtered veal calves based on CY2015 data reported by the U.S. Department of Agriculture, Agricultural Marketing Service (AMS), were between $264.0 million and $435.8 million. The expected first-year total cost estimate to the U.S. veal industry that would be associated with this rule ranges between $0.374 million and $1.206 million. Thus, the value lost to the U.S. veal industry ranges between 0.14% and 0.28% of the total veal value in a year.

The minimal financial impact to the U.S. veal industry is outweighed by the benefits cited in this rule, including increased compliance with the HMSA and improved inspection efficiency. FSIS predicts that this rule will save the Agency between 180 inspection hours (minimum) and 297 inspection hours (maximum) in total each year. The saved inspection time will allow FSIS personnel to conduct other inspection activities.

Comment: One veal processor stated that the formula fed veal industry has voluntarily undertaken measures in the past eight years to improve conditions for the production and care of veal calves, rendering moot some of the reasons cited for the rule.

Response: FSIS's investigations in 2009 and 2014 and non-compliance records from 2012 to 2015 demonstrate that voluntary measures undertaken by the industry have not adequately prevented the inhumane treatment of non-ambulatory disabled veal calves. Specifically, FSIS has determined that establishments may have an incentive to force non-ambulatory disabled veal calves that have been set aside pursuant to 9 CFR 309.13(b) to rise. Therefore, the Agency has determined that a change in the regulations is needed to remove the set-aside provision and ensure compliance with humane handling requirements at official establishments.

Comment: Several industry trade associations stated that FSIS's 2009 and 2014 investigations in response to HSUS' undercover video footage did not present evidence of a systemic problem of inhumane handling of non-ambulatory disabled veal calves. These commenters stated that FSIS has identified only two incidents of inhumane handling of non-ambulatory disabled veal calves in the 37 years it has enforced the HMSA. In addition, the commenters stated that only two out of 364 suspension actions taken by the Agency in the six-year window involve establishment employees forcing non-ambulatory disabled veal calves to rise.

The same commenters also stated that the lack of non-compliance records (NRs) citing non-ambulatory disabled veal calves suggests the calves are treated with care. These commenters noted that the NRs cited in the proposed rule do not record establishment personnel forcing non-ambulatory disabled veal calves to rise.

A beef producer advocacy group questioned whether FSIS has sufficient scientific evidence or expert testimony to support the Agency's claim that setting aside downed veal calves results in inhumane treatment. The comment also stated that FSIS failed to perform a comprehensive review of the peer-reviewed scientific literature or research regarding factors that lead to downed veal calves.

Response: FSIS disagrees that the number of suspension actions and NRs indicates that a change in the regulations is unnecessary. FSIS proceeded with this rulemaking after conducting a thorough review of the 2009 and 2014 investigations, NRs, peer-reviewed scientific literature, and public comments, as well as consulting with Agency subject-matter experts and staff in the field. FSIS concluded that the totality of evidence showed that, under current regulations, establishments may have a financial incentive to force non-ambulatory disabled calves to rise from a recumbent position and send weakened veal calves to slaughter. Thus, a change in the regulations is necessary to comply with the HMSA and its implementing regulations.

FSIS convened an intra-agency workgroup composed of subject-matter experts to assist with this rulemaking. In addition, the Agency consulted with the FSIS Office of Field Operations to collect data for establishments that slaughter veal calves in order to accurately determine the number of non-ambulatory disabled veal calves that were inspected after the recovery time and then sent for slaughter.

In the proposed rule, FSIS cited 33 NRs between 2012 and 2014 to support these conclusions. In addition, the Agency has conducted a review of NRs issued in 2015. In 2015, the Agency found one instance of excessive use of an electric prod in an attempt to force a non-ambulatory disabled veal calf to rise, one instance of ambulatory veal calves walking over a non-ambulatory veal calf, three instances of veal calves in holding pens without water, and one instance of veal calves in a holding pen for longer than 24 hours without feed. These findings reinforce the Agency's conclusions that establishments may have an incentive to force veal calves to rise and send weakened calves to slaughter. In addition, as was demonstrated in the 2014 HSUS video, FSIS believes that many of these occurrences happen outside the view of inspection personnel.

FSIS also conducted a thorough review of relevant peer-reviewed scientific literature, including peer-reviewed literature cited in the petition submitted by HSUS, regarding factors that can lead to non-ambulatory disabled veal calves. Based on its findings, the Agency concluded that there is a direct correlation between the growing and transport conditions of veal calves, and whether these calves arrive at an establishment non-ambulatory disabled.2 Thus, the Agency estimates that by incentivizing growers and transporters to improve animal welfare conditions, this final rule will lead to stronger, healthier calves being offered for slaughter.3

2 González, L.A., Schwartzkopf-Genswein, K.S., Bryan, M., Silasi, R., and Brown F. (2015). “Relationship between transport conditions and welfare outcomes during commercial long haul transport of cattle in North America”. American Society of Animal Science, 90(10):3640-51 doi: 10.2527/jas2011-4796.

3 Trunkfield, H.R., and Broom, D.M. (1990). “The Welfare of Calves During Handling and Transport”. Applied Animal Behaviour Science, v. 28, p. 135-152.

Comment: Several farm bureaus stated that complete elimination of non-ambulatory disabled veal calves from animals intended for slaughter for human food is an unrealistic goal. These commenters, along with industry trade groups and a veal processor, noted that otherwise healthy calves could be non-ambulatory disabled for a myriad of reasons, including the age and size of calves, adverse weather conditions, transportation time, calf hydration status, and length of time between unloading and stunning process.

Response: The Agency acknowledges that many circumstances may contribute to calves arriving at establishments in a non-ambulatory disabled condition. However, FSIS's current regulations may provide an incentive for livestock producers and establishments to send weakened veal calves to slaughter in the hope that the veal calves are able to sufficiently recover to pass ante-mortem inspection. Sending such weakened veal calves to slaughter increases the chances that they will go down and be subjected to conditions that are inhumane. In addition, a study conducted by researchers from the University of Manitoba Department of Animal Science, and Agriculture and Agri-Food Canada's Lethbridge Research Centre indicated that there is a direct correlation between calves that arrive at an establishment non-ambulatory disabled and poor animal welfare conditions before and during transport.4 The study indicated that animal condition upon loading is an important risk factor in the outcome of the journey.

4 González, L.A., Schwartzkopf-Genswein, K.S., Bryan, M., Silasi, R., and Brown F. (2015). “Relationship between transport conditions and welfare outcomes during commercial long haul transport of cattle in North America”. American Society of Animal Science, 90(10):3640-51 doi: 10.2527/jas2011-4796.

This final rule will not lead to a complete elimination of non-ambulatory disabled veal calves that arrive at slaughter establishments; however, it will likely create an incentive for growers and transporters to improve animal welfare conditions and send healthier and stronger animals that can handle the stress and other risk factors associated with transportation to slaughter establishments. This will, in turn, reduce the number of non-ambulatory disabled veal calves that arrive at establishments.

Comment: One veal processor stated that the proposed rule should apply only to bob veal calves and should exclude formula fed and non-formula fed veal calves. The same commenter stated that the growing conditions of formula fed veal calves, including vaccinations, iron rich diets, and group loose-housing pens, make formula fed veal calves less susceptible to diseases than bob veal calves.

Response: The final rule will apply to all non-ambulatory disabled veal calves and does not distinguish bob veal calves from formula and non-formula fed veal calves. Although the Agency acknowledges that formula fed veal calves are typically stronger and less susceptible to disease than bob veal calves, and the Agency's regulatory impact analysis reveals that a higher percentage of bob veal calves will most likely be affected by this final rule, FSIS's 2014 investigation showed that humane handling violations do occur at formula fed veal calf slaughter establishments.

Comment: A private citizen recommended that the rule distinguish between fatigued versus diseased animals to prevent the waste of otherwise healthy animals. An industry trade association, a veal processor, and a doctor of veterinary medicine questioned FSIS's assertion that prohibiting the slaughter of all non-ambulatory disabled veal calves will eliminate uncertainty in determining the disposition of these calves. These commenters stated that inspectors are capable of determining whether a calf is diseased or injured rather than tired or cold.

Response: In 2009, FSIS amended 9 CFR 309.3(e) to remove the case-by-case disposition determination of cattle that became non-ambulatory disabled after ante-mortem inspection in order to reduce the uncertainty in determining the proper disposition of these cattle and increase FSIS inspector efficiency (74 FR 11463). FSIS has used the same rationale here.

This final rule eliminates the time that FSIS inspectors spend determining whether veal calves are non-ambulatory disabled because they are tired or cold or because they have diseases, such as enteritis (80 FR 27270). This final rule also eliminates the time that FSIS inspectors spend inspecting the veal calves that were set apart.

Comment: Two animal welfare groups and an individual noted that FSIS requires non-ambulatory disabled adult cattle to be condemned and disposed of, and requested that FSIS extend the same requirement to non-ambulatory disabled veal calves. In contrast, two farm bureau organizations stated that non-ambulatory disabled veal calves should not be treated the same as adult cattle, noting that veal calves are not a risk for bovine spongiform encephalopathy (BSE), and do not pose the same food safety concerns as adult cattle.

Response: FSIS issued a final rule in 2007 that prohibited the slaughter of non-ambulatory disabled cattle because of the threat of BSE, but created an exception for non-ambulatory disabled veal calves to be set apart and re-inspected. As explained in the proposed rule, while cattle younger than 30 months do not present a serious risk of BSE, they are susceptible to other systemic and metabolic diseases,5 and injury because of inadequate immunoglobulin transfer, nutritional inadequacies of an all-liquid iron deficient diet, activity restriction, and stress (80 FR 27270). As is discussed above, the Agency has also concluded that the set-aside provision implemented in 2007 should nonetheless be removed because it may have created an incentive for establishments to inhumanely force non-ambulatory disabled veal calves to rise from a recumbent position. In addition, this final rule will increase inspection efficiency by eliminating the time that FSIS inspectors spend re-inspecting non-ambulatory disabled veal calves if they are again offered for slaughter.

5 McDonough, Sean P., Stull, Carolyn L., and Osburn, Bennie I. (1994). “Enteric Pathogens in Intensively Reared Veal Calves”. American Journal of Veterinary Research, v. 55, no. 11, p. 1516-1519.

Comment: Several animal welfare groups requested that FSIS clarify when livestock are “offered” for slaughter. These commenters stated that establishments could exploit a loophole by setting aside non-ambulatory disabled veal calves to rest and recover, and “offer” the calves for ante-mortem inspection at a later time. One animal welfare group stated that animals should be considered “offered” for slaughter upon delivery at the slaughter establishment, following the same interpretation as when humane regulations apply per FSIS Directive 6900.2, Ch. II(I) (rev. August 15, 2011).

Response: FSIS has already explained to inspectors when animals destined for slaughter are subject to humane handling regulations and FSIS inspections in FSIS Directive 6,900.2, Humane Handling and Slaughter of Livestock. The Directive states that once a vehicle carrying livestock enters, or is in line to enter, an official establishment's premises, the vehicle is considered to be a part of the establishment's premises, and the animals within the vehicle are to be handled in accordance with humane handling regulations. The Directive states that FSIS inspectors can conduct ante-mortem inspections at the vehicle. This Directive is in accord with the final rule that implements the HMSA (44 FR 68809; November 30, 1979), which states in the preamble that “the Department intends to enforce the Act with regard to any inhumane activity occurring on the premises of an official establishment.”

In addition, in the final rule FSIS is removing a provision in 9 CFR 309.1(b) that requires ante-mortem inspection to be made “in pens.” This amendment harmonizes the regulations with current practice, and closes the potential loophole that may have allowed establishments to set aside non-ambulatory disabled veal calves to rest and recover, and “offer” them for slaughter at a later time. It also prevents establishments and transporters from diverting non-ambulatory disabled animals to other establishments. FSIS will update FSIS Directive 6,100.1, Ante-Mortem Livestock Inspection, to reflect this change. Inspectors have the option to perform the humane handling portion of ante-mortem inspection directly on the truck, and wait to complete ante-mortem inspection once the animals are in holding pens.

FSIS inspectors may not be present in the early morning hours when animals typically arrive and are offloaded. FSIS may assign additional personnel to the establishment during off-hours to monitor the arrival of the animals if FSIS identifies the need to do so.

Comment: Two animal welfare organizations and a food safety organization stated that the definition given for “promptly” in the preamble to the proposed rule is too vague and gives too much discretion to establishments. One animal welfare organization asked FSIS to explain the “facts and circumstances” to be taken into account by inspectors and establishment employees when an animal is found to be non-ambulatory disabled.

Response: The Agency disagrees that it gave too much discretion to establishments. As FSIS explained in the proposed rule, all condemned non-ambulatory disabled cattle must be euthanized within a reasonable time in view of all of the facts and circumstances (80 FR 27271). The facts and circumstances that FSIS inspectors will take into account when assessing compliance with the “promptly” requirement include whether the animal is suffering (e.g., injured, dehydrated, or vulnerable to being stepped on by ambulatory cattle), and extenuating circumstances such as weather conditions and emergencies.

Comment: One food safety organization requested that FSIS consider prohibiting the slaughter of other farm animals that can be susceptible to “downer” illnesses, including swine, sheep, and goats.

Response: The proposed rule and request for comments addressed the disposition of non-ambulatory disabled veal calves only. In 2013, FSIS denied a petition submitted on behalf of Farm Sanctuary that requested the Agency to amend its ante-mortem inspection regulations to require non-ambulatory disabled pigs, sheep, goats, and other amenable livestock species to be condemned. In 2014, FSIS received another petition on behalf of Farm Sanctuary and various other animal advocacy organizations that requested the Agency to amend its ante-mortem inspection regulations to prohibit the slaughter of non-ambulatory disabled pigs. FSIS will conduct a full independent review and analysis of this petition to determine the validity of the requested rulemaking.

Comment: Several industry members stated that the annual economic impact of the proposed regulatory changes will be significantly higher on the veal industry than portrayed in the proposed rule. These commenters stated that the veal industry had much higher production costs in 2015 than in previous years.

An industry trade association and veal processor also questioned FSIS's use of deleted records in the Agency's Public Health Information System (PHIS) to determine the number of non-ambulatory disabled veal calves that are currently re-inspected and released for slaughter. These commenters stated that the use of deleted records in PHIS is not a close approximation of the actual number of non-ambulatory disabled veal calves released for slaughter in veal establishments.

Response: FSIS updated its cost estimate to reflect 2015 prices. The estimated market value of bob veal increased to $20.00-$560.00 per head in 2015, while the market value of formula and non-formula fed veal increased to $1,000.00-$1,300.00 per head in 2015.6

6 Data derived from USDA/AMS Weekly Veal Market Summary, Vol 18, Numbers 1-41. At: http://www.ams.usda.gov/mnreports/lswveal.pdf.

FSIS also changed its methodology for determining the number of non-ambulatory disabled veal calves that were inspected after the recovery time and then sent for slaughter. FSIS collected additional data via the FSIS Office of Field Operations for the establishments that slaughter veal calves, and estimated the number of non-ambulatory disabled veal calves based on this data. As a result, FSIS adjusted its estimated number of non-ambulatory disabled veal calves for all three veal categories.

On the basis of these updated numbers, FSIS adjusted its estimated annual cost for the final rule. The new estimated annual cost to the U.S. veal industry ranges between $0.374 million and $1.206 million compared to $0.002 million and $0.161 million in the proposed rule.

Comment: Several farm bureaus asked if the proposed rule will improve the efficiency of the inspection process. These commenters stated that calves are often rested in the same unloading area where the inspectors work, and inspection of recovered calves only amounts to a minor inconvenience and takes up little of the inspectors' time.

Response: FSIS has conducted an analysis of PHIS data, and has determined that it takes an inspector approximately 15 minutes to inspect a calf after recovery. Because FSIS will no longer have to inspect non-ambulatory disabled veal calves to determine their disposition, the Agency will save between 180 hours (minimum) and 297 hours (maximum) in total. This time will allow inspectors the ability to engage in other inspection activities.

Executive Orders 12866 and 13563, and the Regulatory Flexibility Act

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

Baseline

FSIS has updated the baseline for the final regulatory impact analysis (FRIA) to reflect the most recent available data. Table 1 compares the total veal calves slaughtered in calendar year (CY) 2015 (FRIA), CY2014, and CY2013 (preliminary regulatory impact analysis (PRIA)).

Table 1—Total Veal Calves Inspected and Slaughtered CY2013 (Proposed Rule) vs. CY2014 vs. CY2015 (Final Rule) Veal calf type Sum of the head count CY2013
  • (1,000)
  • CY2014
  • (1,000)
  • CY2015
  • (1,000)
  • Bob Veal 405.6 248.3 173.6 Formula Fed Veal 310.8 282.8 253.8 Non-Formula Fed Veal 8.6 7.4 6.7 Total 725.5 538.5 434.1 Source: FSIS, Public Health Information System (PHIS)

    In CY2015, federally-inspected veal calf establishments slaughtered a total of 434,051 veal calves (Table 2). Market value estimates for slaughtered veal calves based on CY2015 data reported by the U.S. Department of Agriculture, Agricultural Marketing Service (AMS), were between $264.0 million and $435.9 million.7 FSIS used the minimum and maximum veal calf prices reported by USDA/AMS. These prices were $20.00-$560.00 for bob veal and $1,000.00-$1,300.00 for formula fed and non-formula fed veal calves.

    7 Bob Veal Market Value: $20.00-$560.00 per head. Formula and non-formula fed veal market value: $1,000.00-$1,300.00 per head. Data derived from USDA/AMS Weekly Veal Market Summary, Vol 18, Numbers 1-41. At: http://www.ams.usda.gov/mnreports/lswveal.pdf.

    Table 2—Total Veal Calves Inspected and Slaughtered and Market Value, CY 2015 Veal calf type Sum of head count
  • (1,000)
  • Min market value *
  • ($1,000,000)
  • Max market value *
  • ($1,000,000)
  • Bob Veal 173.6 $3.5 $97.2 Formula Fed Veal 253.8 253.8 329.9 Non Formula Fed Veal 6.7 6.7 8.7 Grand Total * 434.1 264.0 435.9 Notes: Head Slaughtered source—FSIS, Public Health Information System (PHIS). * Sum may not add up due to rounding.

    The U.S. veal industry is made up of establishments in the small and very small Hazard Analysis and Critical Control Point (HACCP)-size categories.8 In CY 2015, there were 118 federally inspected and nine state inspected establishments that slaughtered veal calves. Of the 118 federally inspected establishments, 90 (76%) were very small, and 28 (24%) were small HACCP size establishments.

    8 HACCP size: Very Small Establishment = Less than 10 employees or less than $2.5 million in annual sales; Small Establishment = 10-499 employees; Large Establishment = 500 or more employees.

    Expected Cost of the Final Rule

    The expected costs of the final rule for the veal establishments are a result of the lost market value of the non-ambulatory disabled veal calves that the affected establishments will no longer be able to slaughter for human food. The addition of the word “promptly” to 9 CFR 309.3(e) does not have any expected costs, nor does the removal of the requirement that ante-mortem inspection be conducted “in pens” (9 CFR 309.1(b)).

    FSIS collected additional data via the FSIS Office of Field Operations for the establishments that slaughter veal calves. As a result, FSIS adjusted its estimated annual cost for the FRIA based on new calculated non-ambulatory disabled veal ratios and the 2015 prices.

    In CY 2015, there were eight establishments that accounted for 99.96% of the formula fed veal calves slaughtered in the U.S. Taking into account that extreme weather conditions and transit fatigue during the winter and summer months can affect the number of non-ambulatory disabled veal calves, FSIS recalculated its cost estimates, using the 2015 prices.

    Table 3—Total Veal Calves Slaughtered and Market Value * Veal calf type Sum of the head count
  • (1,000)
  • Min number of NAD veal Max number of NAD veal Minimum
  • market value
  • ($million)
  • Maximum
  • market value
  • ($million)
  • Minimum
  • market value lost
  • ($million)
  • Maximum
  • market value lost
  • ($million)
  • Bob Veal 173.6 352 455 $3.5 $97.2 $0.007 $0.255 Formula Fed Veal 253.8 358 713 253.8 329.9 0.358 0.927 Non Formula Fed Veal 6.7 9 19 6.7 8.7 0.009 0.024 Grand Total 434.1 720 1,187 264.0 435.9 0.374 1.206 * The values are based on 2015 prices. The slaughter head counts are based on CY 2015 PHIS data.

    Based on the new data, FSIS adjusted the maximum number of formula fed veal calves that might be condemned due to this rule upward to 713 (253,837 * 0.00281), with an estimated maximum cost of $0.927 million. The minimum number of formula fed veal calves that might be condemned due to this rule is 358 (253,837 * 0.00141), with an estimated minimum cost of $0.358 million.

    FSIS also adjusted the maximum number of bob veal and non-formula fed veal calves. For the bob veal, five establishments accounted for 83% of the total bob veal calves slaughtered in the United States. The maximum number of bob veal calves affected by the final rule was adjusted to 455 (173,556 * 0.00262), with an estimated maximum cost of $0.255 million. The minimum number of bob veal calves that might be condemned due to this rule is 352 (173,556 * 0.00203), with an estimated minimum cost of $0.358 million.

    For non-formula fed veal calves, FSIS assumed the same non-ambulatory disabled rates as for the formula fed veal calves. The maximum number of non-formula fed veal calves affected by the final rule was adjusted to 19 (6,658 * 0.00281), with an estimated maximum cost of $0.025 million. The minimum number of non-formula fed veal calves that might be condemned due to this rule is 9 (6,658 * 0.00141), with an estimated minimum cost of $0.009 million.

    As illustrated in table 2, the expected first year total costs to the U.S. veal industry due to the final rule ranges between $0.374 million and $1.026 million. The estimated costs have a minimal impact on the veal industry. The value lost to the U.S. veal industry ranges between 0.14% and 0.28% of the total veal value in a year.

    Expected Benefits of the Final Rule

    FSIS predicts that this rule would provide Agency personnel with savings in terms of inspection time. According to PHIS data, it takes an inspector approximately 15 minutes to re-inspect a calf. Because FSIS will not have to re-inspect the veal calves that are non-ambulatory disabled, the Agency will save anywhere from 180 hours (minimum) to 297 hours (maximum) in total (table 4). The saved inspection time will allow the inspector the ability to engage in other inspection activities.

    Table 4—Benefit In Terms of Time Saving Time to do ante-mortem inspection Bob veal Formula fed veal Non-formula fed veal Total Minimum Number of Veal Calves Affected 352 358 9 719 Maximum Number of Veal Calves Affected 455 713 19 1,187 Minimum Time Saved 88 89 2 180 Maximum Time Saved 114 178 5 297 Source: PHIS.

    The final rule will ensure the humane disposition of the non-ambulatory disabled veal calves. The rule will also increase the efficiency and effective implementation of inspection and humane handling requirements at official establishments. In addition, the rule will incentivize growers and transporters of cattle to improve animal welfare, both before and during transport.

    A recent study conducted by researchers from the University of Manitoba Department of Animal Science's Agriculture and Agri-Food Canada, Lethbridge Research Centre, shows that there is a correlation between transport and transport conditions such as temperature, length of the trip, and space allowance (density of animals to size), and cattle arriving at the establishment dead, lame, or non-ambulatory disabled. The study notes that, out of all classes of cattle, calves and cull cattle are “more likely to be dead and non-ambulatory during the journey.” The authors indicate that animal condition upon loading plays an important risk factor in the outcome of the journey. The study concludes that cattle arriving at an establishment dead, lame, or non-ambulatory disabled is an indication of extremely poor welfare conditions.9 The final rule will therefore reduce the number of calves that arrive at establishments non-ambulatory disabled by incentivizing growers and transporters to improve animal welfare conditions and send healthier and stronger animals to slaughter establishments.

    9 González, L.A., Schwartzkopf-Genswein, K.S., Bryan, M., Silasi, R., and Brown F. (2015). “Relationship between transport conditions and welfare outcomes during commercial long haul transport of cattle in North America”. American Society of Animal Science, 90(10):3640-51 doi: 10.2527/jas2011-4796.

    Regulatory Flexibility Act Assessment

    The FSIS Administrator certifies that, for the purpose of the Regulatory Flexibility Act (5 U.S.C. 601-602), the final rule will not have a significant economic impact on a substantial number of small entities in the United States. The Agency estimates that this rule would possibly affect 127 (118 federally inspected) small and very small HACCP size veal slaughter establishments. Although many small and very small establishments are affected by this rule, the volume of veal that will not be eligible for slaughter is very low. Further, the estimated total annual cost per establishment is between $2,945 (total minimum cost/number of establishments = $374,000/127) and $8,087 (total maximum cost/number of establishments = $1,027,000/127).

    Paperwork Reduction Act

    There are no paperwork or recordkeeping requirements associated with this final rule under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

    E-Government Act

    FSIS and USDA are committed to achieving the purposes of the E-Government Act (44 U.S.C. 3601, et seq.) by, among other things, promoting the use of the Internet and other information technologies and providing increased opportunities for citizen access to Government information and services, and for other purposes.

    Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under this rule: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) no administrative proceedings will be required before parties may file suit in court challenging this rule.

    Executive Order 13175

    This rule has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” E.O. 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects 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.

    FSIS has assessed the impact of this rule on Indian tribes and determined that this rule does not, to our knowledge, have tribal implications that require tribal consultation under E.O. 13175. If a Tribe requests consultation, the Food Safety and Inspection Service will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified herein are not expressly mandated by Congress.

    USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.

    How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized representative.

    Send your completed complaint form or letter to USDA by mail, fax, or email:

    Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410, Fax: (202) 690-7442, Email: [email protected].

    Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).

    Additional Public Notification

    Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS Web page located at: http://www.fsis.usda.gov/federal-register.

    FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Update is available on the FSIS Web page. Through the Web page, FSIS is able to provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

    List of Subjects in 9 CFR Part 309

    Animal diseases, Meat inspection, Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, FSIS amends 9 CFR part 309 as follows:

    PART 309—ANTE-MORTEM INSPECTION 1. The authority citation for part 309 continues to read as follows: Authority:

    21 U.S.C. 601-695; 7 CFR 2.18, 2.53.

    2. Amend § 309.1 by revising the heading and the first sentence of paragraph (b) to read as follows:
    § 309.1 Ante-mortem inspection on premises of official establishments.

    (b) Such ante-mortem inspection shall be made on the premises of the establishment at which the livestock are offered for slaughter before the livestock shall be allowed to enter into any department of the establishment where they are to be slaughtered or dressed or in which edible products are handled. * * *

    3. Amend § 309.3 by revising paragraph (e) to read as follows:
    § 309.3 Dead, dying, disabled, or diseased and similar livestock.

    (e) Establishment personnel must notify FSIS inspection personnel when cattle become non-ambulatory disabled after passing ante-mortem inspection. Non-ambulatory disabled cattle that are offered for slaughter must be condemned and promptly disposed of in accordance with § 309.13.

    § 309.13 [Amended]
    4. Amend § 309.13(b) by removing the sentence “Veal calves that are unable to rise from a recumbent position and walk because they are tired or cold may be set apart and held as provided in this paragraph.”
    Done in Washington, DC, on: July 11, 2016. Alfred V. Almanza, Acting Administrator.
    [FR Doc. 2016-16904 Filed 7-15-16; 8:45 am] BILLING CODE 3410-DM-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 172 [Docket No. FDA-2013-N-0888] Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 and Vitamin D3 AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Final rule.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is amending the food additive regulations to expand the safe uses of vitamin D2 as a nutrient supplement in edible plant-based beverages intended for use as milk alternatives and in edible plant-based yogurt alternatives and vitamin D3 as a nutrient supplement in milk at levels higher than those currently permitted. We are taking this action in response to a food additive petition filed by Dean Foods Company and WhiteWave Foods Company.

    DATES:

    This rule is effective July 18, 2016. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by August 17, 2016. The Director of the Federal Register approves the incorporation by reference of certain publications listed in the rule as of July 18, 2016.

    ADDRESSES:

    You may submit objections and requests for a hearing as follows:

    Electronic Submissions

    Submit electronic objections in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection 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 objection, that information will be posted on http://www.regulations.gov.

    • If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection 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 objections submitted to the Division of Dockets Management, FDA will post your objection, 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-2013-N-0888 for “Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 and Vitamin D3 Final Rule.” Received objections 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 an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Judith Kidwell, Center for Food Safety and Applied Nutrition (CFSAN) (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1071.

    SUPPLEMENTARY INFORMATION:

    I. Background

    In a document published in the Federal Register of August 16, 2013 (78 FR 49990), FDA announced that Dean Foods Company (Dean Foods) and WhiteWave Foods Company (WhiteWave), c/o Hogan Lovells US LLP, Columbia Square, 555 13th Street NW., Washington, DC 20004, had jointly filed a food additive petition (FAP 3A4801). The petition proposed to amend 21 CFR 172.379 to provide for the safe use of vitamin D2 as a nutrient supplement in edible plant-based food products intended for use as alternatives to milk and milk products and to amend 21 CFR 172.380 to provide for the safe use of vitamin D3 as a nutrient supplement in milk at levels higher than those currently permitted. After the notice of filing published, the petitioners amended the petition to limit the proposed use of vitamin D2 to only edible plant-based beverages intended as alternatives to milk (e.g., soy-, rice-, almond-, coconut-based beverages) and edible plant-based yogurt alternatives. This final rule is a complete response to the petition.

    Dean Foods/WhiteWave have requested that we amend § 172.379 to authorize the use of vitamin D2 as a nutrient supplement at levels not to exceed 84 International Units (IU) per 100 grams (g) in edible plant-based beverages intended for use as milk alternatives and not to exceed 89 IU per 100 g in edible plant-based yogurt alternatives. Dean Foods/WhiteWave requested that the proposed use of 84 IU vitamin D2 per 100 g in edible plant-based beverages replace the current allowable maximum use of 50 IU per 100 g in soy beverages authorized under § 172.379(c). Specifically, Dean Foods/WhiteWave requested that we amend § 172.379(c) to eliminate the “soy beverages” category, and instead create a new category of food that may be supplemented with vitamin D2. This category, “edible plant-based beverages intended for use as milk alternatives”, would include soy beverages intended as milk alternatives, and would have a maximum allowable use of 84 IU vitamin D2 per 100 g. This category would also include other edible plant-based beverages made from rice, almond, and coconut, among other foods, that are intended as milk alternatives. Dean Foods/WhiteWave also requested that we amend § 172.380 to allow for the addition of vitamin D3 as a nutrient supplement in milk at levels not to exceed 84 IU per 100 g milk. For milk with more than the amount of vitamin D provided for in the milk standard of identity in 21 CFR 131.110(b)(2), the milk would be required to be named by use of a nutrient content claim and a standardized term in accordance with 21 CFR 130.10.

    Vitamin D comprises a group of fat-soluble seco-sterols and comes in many forms. The two major physiologically relevant forms are vitamin D2 and vitamin D3. Vitamin D without a subscript represents either vitamin D2 or vitamin D3 or both. Vitamin D is affirmed as generally recognized as safe (GRAS) for use in food as a nutrient supplement in accordance with 21 CFR 184.1950(c)(1) and 21 CFR 184.1(b)(2), with the following specific limitations:

    Category of food Maximum
  • levels in food
  • (as served)
  • Breakfast cereals 350 IU/100 grams (g). Grain products and pasta 90 IU/100 g. Milk 42 IU/100 g. Milk products 89 IU/100 g.

    Additionally, under § 184.1950(c)(2) and (3), vitamin D is affirmed as GRAS for use in infant formulas and margarine, respectively. Under § 172.380, vitamin D3 is approved for use as a food additive as a nutrient supplement in calcium-fortified fruit juices and fruit juice drinks, meal replacement and other type bars, soy protein-based meal replacement beverages represented for special dietary use in reducing or maintaining body weight, certain cheese and cheese products, meal replacement beverages that are not intended for special dietary use in reducing or maintaining body weight, and foods represented for use as a sole source of nutrition for enteral feeding.

    Under § 172.379, vitamin D2 is approved for use as a food additive as a nutrient supplement in soy beverages, soy beverage products, soy-based butter substitute spreads, and soy-based cheese substitutes, and soy-based cheese substitute products.

    Under § 172.381, vitamin D2 bakers yeast is approved for use as a food additive as a source of vitamin D2 and as a leavening agent in yeast-leavened baked goods and baking mixes and yeast-leavened baked snack foods.

    Vitamin D is essential for human health. The major function of vitamin D is the maintenance of blood serum concentrations of calcium and phosphorus by enhancing the absorption of these minerals in the small intestine. Vitamin D deficiency can lead to abnormalities in calcium and bone metabolism, such as rickets in children or osteomalacia in adults. Excessive intake of vitamin D elevates blood plasma calcium levels (hypercalcemia) by increased intestinal absorption and/or mobilization from the bone.

    To ensure that vitamin D is not added to the U.S. food supply at levels that could raise safety concerns, FDA affirmed vitamin D as GRAS with specific limitations as listed in § 184.1950. Under § 184.1(b)(2), an ingredient affirmed as GRAS with specific limitations may be used in food only within such limitations, including the category of food, functional use of the ingredient, and level of use. Any addition of vitamin D to food beyond those limitations set out in § 184.1950 requires either a food additive regulation or an amendment of § 184.1950.

    To support their petition, Dean Foods/WhiteWave submitted dietary exposure estimates of vitamin D from the proposed uses of vitamin D2 and vitamin D3, as well as all dietary sources from naturally occurring sources of vitamin D and uses in accordance with our approved food additive regulations (§§ 172.379, 172.380, and 172.381) and our GRAS affirmation regulation (§ 184.1950). They also included dietary supplements in their estimates and compared these intake estimates to the Tolerable Upper Intake Level (UL) for vitamin D established by the Institute of Medicine (IOM) of the National Academies. Dean Foods/WhiteWave also submitted a number of publications pertaining to human clinical studies on vitamin D. Based on this information, Dean Foods/WhiteWave concluded that the proposed uses of vitamin D2 in edible plant-based beverages intended as alternatives to milk, edible plant-based yogurt alternatives, and vitamin D3 in milk are safe.

    II. Evaluation of Safety

    To establish with reasonable certainty that a food additive is not harmful under its intended conditions of use, we consider the projected human dietary exposure to the additive, the additive's toxicological data, and other relevant information (such as published literature) available to us. We compare the estimated daily intake (EDI) of the additive from all food sources to an acceptable daily intake level established by toxicological data. The EDI is determined by projections based on the amount of the additive proposed for use in particular foods and on data regarding the amount consumed from all food sources of the additive. We commonly use the EDI for the 90th percentile consumer of a food additive as a measure of high chronic dietary intake.

    A. Acceptable Daily Intake Level for Vitamin D

    In 2011, the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board at the IOM conducted an extensive review of relevant published scientific literature on vitamin D to update current dietary reference intakes and ULs for vitamin D. Based on this information, the IOM revised the ULs for vitamin D and developed a report on their findings (Ref. 1). In their 2011 assessment of vitamin D, the IOM established a UL of 1,000 IU per day (IU/p/d) for infants 0 months to 6 months of age and a UL of 1,500 IU/p/d for infants 6 months to 12 months of age. For children 1 year to 3 years of age, the IOM established a UL of 2,500 IU/p/d; for children 4 years to 8 years of age, the IOM established a UL of 3,000 IU/p/d. For children 9 years to 18 years of age and adults, the IOM established a UL of 4,000 IU/p/d.

    The IOM considers the UL as the highest average daily intake level of a nutrient that poses no risk of adverse effects when the nutrient is consumed over long periods of time. The UL is determined using a risk assessment model developed specifically for nutrients. The dose-response assessment, which concludes with an estimate of the UL, is built upon three toxicological concepts commonly used in assessing the risk of exposures to chemical substances: No-observed-adverse-effect level, lowest-observed-effect level, and application of an uncertainty factor. We considered the ULs established by the IOM relative to the intake estimates as the primary basis for assessing the safety of the petitioned uses of vitamin D2 and vitamin D3. We also reviewed scientific articles on the safety of vitamin D submitted in the petition, as well as other relevant published studies available to FDA.

    B. Estimated Daily Intake for Vitamin D

    For the proposed uses of vitamin D2 and vitamin D3, Dean Foods/WhiteWave provided dietary intake estimates of vitamin D for 11 population groups, assuming maximum levels of vitamin D in all foods that could be fortified (except for one scenario where typical fortification levels in infant formula were used), as well as in the petitioned foods. They also included exposure from dietary supplements as reported in the 2003-2008 National Health and Nutrition Survey (NHANES) 30-day dietary supplement use data (http://wwwn.cdc.gov/nchs/nhanes/search/datapage.aspx?Component=dietary) and from naturally occurring food sources.

    The exposure estimates performed by Dean Foods/WhiteWave are appropriate. However, there are some exposure parameters that have changed since the estimates were completed in 2013. In particular, Dean Foods/WhiteWave provided estimates that included vitamin D exposure from fortification of edible plant-based dairy analogs other than edible plant-based yogurt alternatives, which they are no longer seeking to fortify. Dean Food/WhiteWave also included fortification of meal replacement bars at a level of 500 IU/40 g in anticipation of the approval of FAP 2A4788 (Abbott Laboratories); however, this use was subsequently withdrawn from the petition before the final rule issued (see 79 FR 46993, August 12, 2014). In addition, more recent 24-hour recall dietary supplement data from the 2009-2012 NHANES (http://wwwn.cdc.gov/nchs/nhanes/search/datapage.aspx?Component=dietary) have become available that may better represent current vitamin D exposure from dietary supplements than the 30-day dietary supplement use data from the 2003-2008 NHANES used by Dean Foods/WhiteWave. Moreover, a recent published study suggests that it may be appropriate to include dietary sources of the vitamin D metabolite, 25-hydroxyvitamin D (25(OH)D), in vitamin D exposure estimates to take into account discrepancies seen between dietary intake and blood serum levels of vitamin D (Ref. 2). The foods that were identified in the study as sources of 25(OH)D were beef, pork, chicken, turkey, and eggs. The study also indicated that 25(OH)D may have a potency five times that of vitamin D. For these reasons, we have used the 2009-2012 NHANES data to estimate dietary exposure to vitamin D from: (1) The petitioned uses in milk, edible plant-based beverages intended as milk alternatives, and edible plant-based yogurt alternatives; and (2) cumulative exposure from all current sources of vitamin D (i.e., naturally occurring sources, approved fortified sources, and dietary supplements), the petitioned uses of vitamin D in milk, edible plant-based beverages intended as milk alternatives, and edible plant-based yogurt, and exposure from sources of 25(OH)D, which have been adjusted to account for the difference in potency between 25(OH)D and vitamin D.

    For the overall U.S. population 1 year of age and older, the cumulative exposure at the 90th percentile from all food sources of vitamin D, including the proposed uses, dietary supplements, and 25(OH)D, was estimated to be 2,000 IU/p/d. The cumulative exposure for infants 0 to 6 months of age and infants 6 to 12 months of age from all food sources of vitamin D, including the proposed uses, dietary supplements, and 25(OH)D, was estimated to be 948 IU/p/d and 988 IU/p/d, respectively, for the 90th percentile consumer (Ref. 3).

    C. Safety of the Petitioned Uses of Vitamin D2

    We reviewed and evaluated the information submitted by Dean Foods/WhiteWave regarding the safety of the dietary intake of vitamin D from the proposed uses in milk, edible plant-based beverages intended as milk alternatives, and edible plant-based yogurt alternatives. Dean Food/WhiteWave submitted reports of scientific studies published subsequent to the 1997 IOM report and issuance of the final rule (79 FR 46993) authorizing the use of vitamin D3 in meal replacement beverages that are not intended for special dietary use in reducing or maintaining body weight and in foods represented for use as a sole source of nutrition for enteral feeding. Dean Food/WhiteWave concluded that these publications support a conclusion that the proposed use of vitamin D is safe.

    We reviewed the published reports of scientific studies on vitamin D submitted by Dean Food/WhiteWave, as well as other relevant published studies available to us since our previous evaluations of six food additive petitions for fortifying a variety of foods with vitamin D (77 FR 52228, August 29, 2012; 74 FR 11019, March 16, 2009; 70 FR 69435, November 16, 2005; 70 FR 37255, June 29, 2005; 70 FR 36021, June 22, 2005; 68 FR 9000, February 27, 2003). These studies did not raise any new safety concerns regarding the current or proposed uses of vitamin D. The most recent food additive petition resulted in our amendment of the food additive regulations in § 172.380 to allow for the safe use of vitamin D3 in meal replacement beverages that are not intended for special dietary use in reducing or maintaining body weight and in foods represented for use as a sole source of nutrition for enteral feeding (79 FR 46993). The six earlier food additive petitions also resulted in amendments of the food additive regulations to allow for the safe use of vitamin D as a nutrient supplement in certain foods.

    We considered the ULs established by the IOM relative to the intake estimates as the primary basis for assessing the safety of the petitioned uses of vitamin D. Depending on the age group, the IOM UL for vitamin D for the U.S. population 1 year of age and older ranges from 2,500 IU/p/d to 4,000 IU/p/d. The estimated dietary exposure to vitamin D from all food sources, including the proposed uses, at the 90th percentile for the U.S. population (1 years of age and older) is estimated to be 2,000 IU/p/d, which is below the lowest IOM UL of 2,500 IU/p/d in the range of ULs for the overall U.S. population (1 year of age and older). Estimated exposure to vitamin D from all food sources, including the proposed uses, for infants 0 months to 6 months of age at the 90th percentile is 948 IU/p/d; for infants 6 months to 12 months of age, estimated exposure to vitamin D is 988 IU/p/d. Both of these estimates are below the IOM UL of 1,000 IU/p/d for infants 0 months to 6 months of age and 1,500 IU/p/d for infants 6 months to 12 months of age. Because the 90th percentile EDI of vitamin D from all current and proposed food sources for each population group is less than the corresponding IOM UL for that population group, we conclude that dietary intake of vitamin D2 from the proposed use as a nutrient supplement in edible plant-based beverages intended as milk alternatives and edible plant-based yogurt alternatives and the proposed increased maximum permitted level of vitamin D3 in milk are safe (Ref. 4).

    III. Incorporation by Reference

    FDA is incorporating by reference two monographs from the Food Chemicals Codex 9th Edition (FCC 9), which was approved by the Office of the Federal Register. You may purchase a copy of the material from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852, 1-800-227-8772, http://www.usp.org/.

    The current regulation for the use of vitamin D3 in food (§ 172.380) indicates that the additive must meet the specifications in the FCC 8. The more current FCC is the 9th Edition. The current regulation for vitamin D2 (§ 172.379) indicates the additive must meet the specifications in the 7th edition of the FCC (FCC 7). Because the specifications for vitamin D2 and vitamin D3 in FCC 9 are identical to those in FCC 7 and FCC 8, respectively, Dean Foods/WhiteWave requested that the respective regulations be updated to reference the specifications in FCC 9. Therefore, we are amending §§ 172.379 and 172.380 by adopting the specifications for vitamin D2 and vitamin D3 in FCC 9 in place of FCC 7 and FCC 8, respectively.

    IV. Conclusion

    Based on all data relevant to vitamin D that we reviewed, we conclude that the petitioned uses of vitamin D in milk and edible plant-based beverages intended as milk alternatives and edible plant-based yogurt alternatives within the limits proposed by Dean Food/WhiteWave are safe. Consequently, we are amending the food additive regulations as set forth in this document.

    V. Public Disclosure

    In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in § 171.1(h), we will delete from the documents any materials that are not available for public disclosure.

    VI. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as stated in the August 16, 2013, Federal Register document of petition for FAP 3A4801. We stated that we had determined, under 21 CFR 25.32(k), that this action “is of a type that does not individually or cumulatively have a significant effect on the human environment” such that neither an environmental assessment nor an environmental impact statement is required. We have not received any new information or comments that would affect our previous determination.

    VII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

    VIII. Objections

    If you will be adversely affected by one or more provisions of this regulation, you may file with the Division of Dockets Management (see ADDRESSES) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.

    Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    Our review of this petition was limited to section 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348). This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (4) of the FD&C Act applies. In our review of this petition, FDA did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this additive. Accordingly, this final rule should not be construed to be a statement that a food containing this additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all food additive final rules and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

    X. References

    References marked with an asterisk (*) are on display at the Division of Dockets Management (see ADDRESSES), under Docket No. FDA-2013-N-0888, 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. References without asterisks are not on display; they are available as published articles and books.

    1. Committee to Review Dietary Reference Intakes for Vitamin D and Calcium, Food and Nutrition Board, Institute of Medicine, “Dietary Reference Intakes for Calcium and Vitamin D,” National Academies Press, Washington, DC, 2011. 2. Taylor, C., K. Patterson, J. Roseland, et al., “Including Food 25-Hydroxyvitamin D in Intake Estimates May Reduce the Discrepancy Between Dietary and Serum Measures of Vitamin D Status,” Journal of Nutrition, 144:654-659, 2014. *3. FDA Memorandum from D. Folmer, CFSAN Chemistry Review Group, Division of Petition Review, to J. Kidwell, Regulatory Group I, Division of Petition Review, January 27, 2016. *4. FDA Memorandum from T. Tyler, CFSAN Toxicology Team, Division of Petition Review, to J. Kidwell, Division of Petition Review, February 10, 2016. List of Subjects in 21 CFR Part 172

    Food additives, Incorporation by reference, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 172 is amended as follows:

    PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION 1. The authority citation for part 172 continues to read as follows: Authority:

    21 U.S.C. 321, 341, 342, 348, 371, 379e.

    2. Amend § 172.379 by revising the first sentence in paragraph (b) and revising the table in paragraph (c) by removing the entry for “Soy beverages” and adding entries for “Edible plant-based beverages intended as milk alternatives” and “Edible plant-based yogurt alternatives” in alphabetical order to read as follows:
    § 172.379 Vitamin D2.

    (b) Vitamin D2 meets the specifications of the 2015 Food Chemical Codex, 9th edition (through Third Supplement), effective December 1, 2015, pp. 1260-1261, which is incorporated by reference. * * *

    (c) * * *

    Category of food Maximum
  • levels in food
  • (as served)
  • Edible plant-based beverages intended as milk alternatives 84 IU/100 g. Edible plant-based yogurt alternatives 89 IU/100 g. *    *    *    *    *    
    3. Amend § 172.380 by revising the first sentence in paragraph (b) and by adding paragraph (c)(8) to read as follows:
    § 172.380 Vitamin D3.

    (b) Vitamin D3 meets the specifications of the 2015 Food Chemical Codex, 9th edition (through Third Supplement), effective December 1, 2015, pp. 1261-1262, which is incorporated by reference. * * *

    (c) * * *

    (8) At levels not to exceed 84 IU per 100 g (800 IU/quart) in milk that contains more than 42 IU vitamin D per 100 g (400 IU/quart) and that meets the requirements for foods named by use of a nutrient content claim and a standardized term in accordance with § 130.10 of this chapter.

    Dated: July 11, 2016. Susan Bernard, Director, Office of Regulations, Policy and Social Sciences, Center for Food Safety and Applied Nutrition.
    [FR Doc. 2016-16738 Filed 7-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9777] RIN 1545-BG41; RIN 1545-BH38 Arbitrage Guidance for Tax-Exempt Bonds AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Final regulations.

    SUMMARY:

    This document contains final regulations on the arbitrage restrictions under section 148 of the Internal Revenue Code (Code) applicable to tax-exempt bonds and other tax-advantaged bonds issued by State and local governments. These final regulations amend existing regulations to address certain market developments, simplify certain provisions, address certain technical issues, and make existing regulations more administrable. These final regulations affect State and local governments that issue tax-exempt and other tax-advantaged bonds.

    DATES:

    Effective Date: These final regulations are effective on July 18, 2016.

    Applicability Date: For dates of applicability, see §§ 1.141-15, 1.148-11, 1.150-1(a)(2)(iii), and 1.150-2(j).

    FOR FURTHER INFORMATION CONTACT:

    Spence Hanemann, (202) 317-6980 (not a toll-free number).

    SUPPLEMENTARY INFORMATION:

    Paperwork Reduction Act

    The collection of information contained in these final regulations has been reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) under control number 1545-1347. The collection of information in these final regulations is in § 1.148-4(h)(2)(viii), which contains a requirement that the issuer maintain in its records a certificate from the hedge provider. For a hedge to be a qualified hedge, existing regulations require, among other items, that the actual issuer identify the hedge on its books and records. The identification must specify the hedge provider, the terms of the contract, and the hedged bonds. These final regulations require that the identification also include a certificate from the hedge provider specifying certain information regarding the hedge.

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

    Books and records relating to a collection of information must be retained as long as their contents might become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.

    Background

    This document contains amendments to the Income Tax Regulations (26 CFR part 1) on the arbitrage investment restrictions under section 148 of the Code and related provisions. On June 18, 1993, the Department of the Treasury (the Treasury Department) and the IRS published comprehensive final regulations in the Federal Register (TD 8476, 58 FR 33510) on the arbitrage investment restrictions and related provisions for tax-exempt bonds under sections 103, 148, 149, and 150, and, since that time, those final regulations have been amended in certain limited respects (the regulations issued in 1993 and the amendments thereto collectively are referred to as the Existing Regulations).

    A notice of proposed rulemaking was published in the Federal Register (72 FR 54606; REG-106143-07) on September 26, 2007 (the 2007 Proposed Regulations). The 2007 Proposed Regulations proposed amendments to the Existing Regulations. Comments on the 2007 Proposed Regulations were received and a public hearing was held on January 30, 2008.

    Another notice of proposed rulemaking was published in the Federal Register (78 FR 56842; REG-148659-07) on September 16, 2013 (the 2013 Proposed Regulations). The 2013 Proposed Regulations proposed additional amendments to the Existing Regulations (the 2007 Proposed Regulations and the 2013 Proposed Regulations collectively are referred to as the Proposed Regulations). Comments on the 2013 Proposed Regulations were received and a public hearing was held on February 5, 2014. The 2013 Proposed Regulations addressed the definition of issue price, among other topics.

    A partial withdrawal of notice of proposed rulemaking and notice of proposed rulemaking was published in the Federal Register (80 FR 36301; REG-138526-14) on June 24, 2015, re-proposing amendments to the definition of issue price. After consideration of all the comments, the remaining portions of the Proposed Regulations are adopted as amended by this Treasury decision (the Final Regulations).

    Summary of Comments and Explanation of Revisions

    This section discusses significant aspects of the comments received from the public regarding the Proposed Regulations. It also explains the revisions made in the Final Regulations.

    1. Section 1.148-1 Definitions and Elections A. Working Capital Expenditures and Replacement Proceeds Definition i. Introduction

    The Existing Regulations impose various restrictions on the use of tax-exempt bond financing for working capital expenditures. One way the Existing Regulations limit working capital financings is through the concept of replacement proceeds, a special category of funds included within the broad definition of gross proceeds to which the arbitrage investment restrictions under section 148 apply. Under the Existing Regulations, replacement proceeds arise if an issuer reasonably expects as of the issue date that: (1) The term of an issue will be longer than reasonably necessary for the governmental purposes of the issue; and (2) there will be available amounts (as defined in the Existing Regulations) for expenditures of the type being financed during the period the issue remains outstanding longer than necessary. The Existing Regulations provide certain safe harbors that prevent the creation of replacement proceeds.

    ii. Modified Safe Harbor for Short-Term Working Capital Financings

    The 2013 Proposed Regulations proposed to shorten the bond maturity necessary to satisfy the safe harbor for most short-term working capital financings from two years to 13 months to conform with the permitted temporary investment period for working capital expenditures under § 1.148-2(e)(3) and the administrative standard in Rev. Proc. 2002-31, 2002-1 CB 916. One commenter suggested extending this safe harbor to all working capital expenditure financings, rather than just those for restricted working capital expenditures (as defined in the Existing Regulations). This change, which would be implemented by deleting the word “restricted” from the safe harbor, would conform the safe harbor to the proposed extension of the temporary investment period for working capital expenditure financings in the 2013 Proposed Regulations (see section 2 of this preamble). The change also would benefit issuers by expanding the eligible purposes for short-term working capital financings to include extraordinary working capital expenditures. The Final Regulations adopt this comment.

    iii. New Safe Harbor for Longer-Term Working Capital Financings

    The 2013 Proposed Regulations proposed to add a new safe harbor that would prevent the creation of replacement proceeds for longer-term working capital financings to enhance certainty for issuers experiencing financial distress. This new safe harbor would require an issuer to: (1) Determine the first year in which it expects to have available amounts for working capital expenditures; (2) monitor for actual available amounts in each year beginning with the year it first expects to have such amounts; and (3) apply such available amounts in each year either to redeem or to invest in (or some combination of redeeming and investing in) certain tax-exempt bonds (eligible tax-exempt bonds). The safe harbor would require any amounts invested in eligible tax-exempt bonds to be invested (or reinvested) continuously, so long as the bonds using the safe harbor remain outstanding. In a narrow exception to this requirement, the safe harbor would permit such amounts not to be invested during a period of no more than 30 days per fiscal year in which such amounts are pending reinvestment. These requirements aimed to minimize the burden on the tax-exempt bond market.

    The 2013 Proposed Regulations proposed to require an issuer to test for available amounts on the first day of its fiscal year and to apply such amounts to redeem or invest in eligible tax-exempt bonds within 90 days. Commenters sought greater flexibility with respect to the timing of testing the yearly available amounts and the use of such available amounts, based on considerations associated with potential unrepresentative cash positions on particular dates and potential expected short-term cash needs to finance governmental purposes.

    To promote administrability and consistency, the Final Regulations retain the first day of the fiscal year as the required annual testing date for available amounts. The Treasury Department and the IRS have concluded that commenters' suggested solutions were complex in application and could produce a result that is unrepresentative of available amounts throughout the rest of the year. By requiring testing on the first day of the fiscal year, the Final Regulations provide an administrable testing date that mirrors the general rule for other replacement proceeds, under which an issuer also must determine its available amounts on the first day of every fiscal year during the period when its bonds are outstanding longer than reasonably necessary. To address commenters' concerns about the need for greater flexibility to address short-term cash flow deficits, the Final Regulations include several other revisions to this safe harbor for longer-term working capital financings. The Final Regulations reduce the total amount the issuer must apply to redeem or invest in eligible tax-exempt bonds to take into account the expenditure of available amounts during the first 90 days of the fiscal year and amounts held in bona fide debt service funds to the extent that those amounts are included in available amounts. Further, the Final Regulations allow an issuer to sell eligible tax-exempt bonds acquired pursuant to the safe harbor, provided that the proceeds of that sale are used within 30 days for a governmental purpose (working capital or otherwise) and the issuer has no other available amounts that it could use for that purpose. Alternatively, an issuer may sell such investments and use those amounts to redeem eligible tax-exempt bonds. Together, these amendments to the Proposed Regulations aim to address issuers' concerns about cash flows in a manner consistent with the existing restrictions on financing working capital expenditures with bonds outstanding longer than reasonably necessary.

    Commenters also urged a small, but significant, change to the definition of “available amount” to address situations in which an issuer has proceeds of more than one bond issue that finance working capital expenditures. The definition of available amount in the Existing Regulations specifically excludes proceeds of “the” issue, but not proceeds of other issues. The use of this existing definition for the new safe harbor would have the effect of requiring an issuer to apply proceeds of other issues to redeem or invest in eligible tax-exempt bonds to meet the safe harbor rather than using such proceeds for the intended governmental purpose. The Final Regulations adopt this comment and revise the definition of available amount to exclude proceeds of “any” issue.

    Commenters also recommended that the maximum amount required to be applied under the safe harbor to redeem or invest in eligible tax-exempt bonds be reduced from that proposed under the Proposed Regulations, which would set that maximum amount at an amount equal to the outstanding principal of the bonds subject to the safe harbor. The commenters' suggestion would reduce the maximum amount in the Proposed Regulations by the amount of certain other eligible tax-exempt bonds redeemed by the issuer. The Final Regulations do not adopt this recommendation. The Final Regulations retain the measure of the maximum amount required to be applied to redeem or invest in eligible tax-exempt bonds under this safe harbor at the outstanding principal amount of the relevant bonds to ensure that issuers redeem the bonds that are the subject of the safe harbor whenever possible.

    The 2013 Proposed Regulations proposed to define eligible tax-exempt bonds for purposes of the new safe harbor to mean those tax-exempt bonds that are not subject to the alternative minimum tax (non-AMT tax-exempt bonds). Commenters requested clarification that eligible tax-exempt bonds for these investments also include certain State and Local Government Series securities (SLGS or, individually, a SLGS security), specifically Demand Deposit SLGS, and certain interests in regulated investment companies that invest in tax-exempt bonds and pass through to their owners income at least 95 percent of which is tax-exempt under section 103. The commenters noted that these two types of investments are included in the existing definition of tax-exempt bonds for purposes of the arbitrage investment restrictions. Commenters noted particularly that Demand Deposit SLGS are much easier to acquire than tax-exempt bonds and also have limited arbitrage potential. The purpose of the requirement to redeem or invest available amounts in certain tax-exempt bonds is to reduce the burden on the tax-exempt bond market of longer-term tax-exempt bonds issued for working capital expenditure financings. Although Demand Deposit SLGS are taxable obligations that do not reduce the burden on the tax-exempt bond market, the Treasury Department and the IRS recognize that including these as eligible tax-exempt bonds provides issuers a simple method of investing with little possibility of earning arbitrage. An interest in a regulated investment company that invests in non-AMT tax-exempt bonds is easier to buy and sell than a bond, and purchasing such an interest reduces the burden on the tax-exempt bond market. Thus, paralleling the existing definition of “tax-exempt bonds” applicable for purposes of the arbitrage investment restrictions, the Final Regulations clarify that eligible tax-exempt bonds include both Demand Deposit SLGS and an interest in a regulated investment company if at least 95% of the income to the holder is from non-AMT tax-exempt bonds.

    Commenters also recommended that the Final Regulations expressly address the treatment of refunding bonds issued to refinance working capital expenditures for purposes of the new safe harbor. The Final Regulations provide that this safe harbor applies to refunding bonds in the same way that it applies to other bonds.

    iv. Other Technical Changes to Working Capital Rules

    The 2013 Proposed Regulations proposed to remove a restriction against financing a working capital reserve, a complex restriction that penalized those State and local governments that previously have maintained the least amount of reserves. Commenters supported this change. The Final Regulations adopt this change as proposed.

    The 2013 Proposed Regulations proposed to expand the factors listed in an anti-abuse rule that may justify a bond maturity in excess of those in the safe harbors that prevent the creation of replacement proceeds to include extraordinary working capital items. The Treasury Department and the IRS received no unfavorable comments on this change. The Final Regulations adopt this change as proposed.

    Commenters also raised several issues with respect to the working capital rules that the Treasury Department and the IRS have concluded are beyond the scope of this project and, therefore, did not address in the Final Regulations (see section 12 of this preamble).

    2. Section 1.148-2 General Arbitrage Yield Restriction Rules—Temporary Period Spending Exception to Yield Restriction

    The Existing Regulations provide various temporary periods for investment of proceeds of tax-exempt bonds without yield restriction. No express temporary period covers proceeds used for working capital expenditures that are not restricted working capital expenditures, such as extraordinary working capital items. The 2013 Proposed Regulations proposed to broaden the existing 13 month temporary period for restricted working capital expenditures to include all working capital expenditures. One commenter supported and none opposed this proposed change. The Final Regulations adopt this change as proposed.

    3. Section 1.148-3 General Arbitrage Rebate Rules A. Arbitrage Rebate Computation Credit

    The Existing Regulations allow an issuer to take a credit against payment of arbitrage rebate to help offset the cost of computing rebate. The 2007 Proposed Regulations proposed to increase the credit and proposed to add an inflation adjustment to this credit, based on changes in the Consumer Price Index. The Treasury Department and the IRS received no comments on this change. The Final Regulations adopt this change as proposed.

    B. Recovery of Overpayment of Rebate

    Generally, under the Existing Regulations, an issuer computes the amount of arbitrage rebate that it owes under a method that future values payments and receipts on investments using the yield on the bond issue. Under this method, an arbitrage payment made on one computation date is future valued to the next computation date to determine the amount of arbitrage rebate owed on that subsequent computation date. The Existing Regulations provide that an issuer may recover an overpayment of arbitrage rebate with respect to an issue of tax-exempt bonds if the issuer establishes to the satisfaction of the Commissioner that an overpayment occurred. The Existing Regulations further define an overpayment as the excess of “the amount paid” to the United States for an issue under section 148 over the sum of the rebate amount for that issue as of the most recent computation date and all amounts that are otherwise required to be paid under section 148 as of the date the recovery is requested. Thus, even if the future value of the issuer's arbitrage rebate payment on a computation date, computed under the method for determining arbitrage rebate, is greater than the issuer's rebate amount on that date, an issuer is only entitled to a refund to the extent that the amount actually paid exceeds that rebate amount. The Existing Regulations limit the amount of the refund in this manner because the Treasury Department and the IRS were concerned about whether the IRS had statutory authority to pay interest on arbitrage rebate payments. To permit a refund in an amount calculated in whole or in part based upon a future value of the amount actually paid would effectively result in an interest payment on that payment.

    An example in the Existing Regulations has caused confusion because it could be interpreted to mean that an issuer can receive a refund of a rebate payment when the future value of such rebate payment exceeds the rebate amount on the next computation date, even though the actual amount of the previous rebate payment does not exceed the rebate amount on that next computation date. The Proposed Regulations proposed to make a technical amendment to this example to conform this example to the intended scope of recovery of an overpayment of arbitrage rebate.

    Commenters recommended broadening the scope of recovery of overpayments of arbitrage rebate to permit future valuing of the amount actually paid in computing the amount of the overpayment. Because the Treasury Department and the IRS have concluded that they lack the statutory authority to pay interest on overpayments of arbitrage rebate, the Final Regulations adopt this change as proposed.

    4. Section 1.148-4 Yield on an Issue of Bonds A. Joint Bond Yield Authority

    The 2007 Proposed Regulations proposed to eliminate a provision in the Existing Regulations that permits computation of a single joint bond yield for two or more issues of qualified mortgage bonds or qualified student loan bonds. The 2007 Proposed Regulations solicited public comments on the feasibility of establishing generally applicable, objective standards for joint bond yield computations. Two commenters representing student loan lenders sought to retain this provision and described certain facts on which they believed that the joint computation of yield on student loan bonds might be based. However, in 2010, Congress terminated the Federal Family Education Loan Program (FFELP), effectively eliminating the program for which most student loan bonds were issued yet not affecting State supplemental student loan bond programs. Health Care and Education Reconciliation Act of 2010, Public Law 111-152, section 2201, 124 Stat 1029, 1074 (2010). Given the elimination of the FFELP and the highly factual nature of the requests for joint bond yield computations, the Final Regulations adopt the proposed elimination of the joint bond yield authority provision. In addition, however, in recognition of the administrative challenges for loan yield calculations in these portfolio loan programs, the Final Regulations extend the availability of yield reduction payments to include qualified student loans and qualified mortgage loans generally (see section 5.A. of this preamble).

    B. Modification of Yield Computation for Yield-to-Call Premium Bonds

    The 2007 Proposed Regulations proposed to simplify the yield calculations for certain callable bonds issued with significant amounts of bond premium (sometimes called yield-to-call bonds) to focus on the redemption date that results in the lowest yield on the particular premium bond (rather than the more complex existing focus on the lowest yield on the issue). The Treasury Department and the IRS did not receive any adverse comments regarding this proposed change, received one question that raised issues beyond the scope of this project (see section 12 of this preamble), and received a favorable comment regarding this proposed change. The Final Regulations adopt this change as proposed.

    C. Integration of Hedges

    The Existing Regulations permit issuers to compute the yield on an issue by taking into account payments under “qualified hedges.” Generally, under the Existing Regulations, to be a qualified hedge, the hedge must be interest based, the terms of the hedge must correspond closely with the terms of the hedged bonds, the issuer must duly identify the hedge, and the hedge must contain no significant investment element. The Existing Regulations provide two ways in which a qualified hedge may be taken into account in computing yield on the issue, known commonly as “simple integration” and “super integration.” In the case of simple integration all net payments and receipts on the qualified hedge and the hedged bonds are taken into account in determining the yield on the bonds, such that generally these hedged bonds are treated as variable yield bonds for arbitrage purposes. In the case of super integration, certain hedged bonds are treated as fixed yield bonds, and the qualified hedge must meet additional eligibility requirements beyond those for simple integration. These additional eligibility requirements focus on assuring that the terms of the hedge and the hedged bonds sufficiently correspond so as to warrant treating the hedged bonds as fixed yield bonds for arbitrage purposes.

    i. Cost-of-Funds Hedges

    The 2007 Proposed Regulations proposed to clarify that for purposes of applying the definition of periodic payment to determine whether a hedge has a significant investment element, a “specified index” (upon which periodic payments are based) is deemed to include payments under a cost-of-funds swap, thereby eliminating any doubt that cost-of-funds swaps can be qualified hedges. One commenter supported this clarification and none opposed it. One commenter proposed an amendment that is beyond the scope of this project (see section 12 of this preamble). The Final Regulations adopt this clarification as proposed.

    ii. Taxable Index Hedges

    One of the eligibility requirements for a qualified hedge under the Existing Regulations is that the hedge be interest based. For simple integration, one of the factors used in determining whether a variable-to-fixed interest rate hedge is interest based focuses on whether the variable interest rate on the hedged bonds and the floating interest rate on the hedge are “substantially the same, but not identical to” one another. For super integration purposes, such rates must be “reasonably expected to be substantially the same throughout the term of the hedge.” Issuers have raised interpretative questions about how to apply these rules to hedges based on taxable interest rate indices (taxable indices) because interest rates on taxable indices generally do not correspond as closely as interest rates on tax-exempt market indices to actual market interest rates on tax-exempt, variable-rate bonds. These interpretative questions are particularly important for hedges based on taxable indices (taxable index hedges) used with advance refunding bond issues because issuers generally need to use the qualified hedge rules or some other regime to determine with certainty the yield on the tax-exempt advance refunding bonds to comply with the applicable arbitrage yield restrictions on investments in defeasance escrows.

    The 2007 Proposed Regulations proposed to clarify that taxable index hedges are eligible for simple integration but also included detailed provisions that prescribed the correlation of interest rates needed for taxable index hedges to qualify for simple integration. Commenters generally criticized the proposed interest rate correlation test for simple integration of taxable index hedges as excessively complex or unworkable in various respects. One commenter urged elimination of this rate correlation test as unnecessary on the grounds that other proposed changes in the 2007 Proposed Regulations, including particularly the provision limiting the size and scope of hedges (described in section 4.C.iii of this preamble), were sufficient to control the parameters of taxable index hedges for purposes of simple integration. The Final Regulations clarify that a taxable index hedge is an interest based contract and adopt the comment to eliminate the interest rate correlation test for taxable index hedges. The Final Regulations also clarify that the difference between the interest rate used on the hedged bonds and that used to compute payments on the hedge will not prevent the hedge from being an interest based contract if the two interest rates are substantially similar.

    The 2007 Proposed Regulations proposed to treat taxable index hedges as ineligible for super integration (except in the case of certain anticipatory hedges). Commenters requested an exception to this general prohibition on super integration for instances in which the variable rate on hedged bonds and the variable rate used to determine the hedge provider's payments to the issuer under the hedge are both based on a taxable index and are identical (or nearly so) to one another. The Final Regulations generally adopt the proposed rule that taxable index hedges are ineligible for super integration but, in response to the comments, add an exception for hedges in which the hedge provider's payments are based on an interest rate identical to that on the hedged bonds, because these hedges are perfect hedges that clearly result in a fixed yield. The Treasury Department and the IRS do not adopt commenters' request to permit super integration when the taxable-index-based interest rates for both the hedge and the hedged bonds are nearly identical but not perfectly so. The Treasury Department and the IRS have concluded that such a rule would add unnecessary complexity to the Final Regulations and that commenters' concerns are largely resolved by the extension in the Final Regulations of yield reduction payments to address basis differences between indexes used in hedges and underlying interest rates on hedged bonds in advance refundings (discussed elsewhere in this section of the preamble). The Final Regulations remove references to the particular taxable index called “LIBOR,” without inference.

    Commenters also sought other specific exceptions to the prohibition on super integration. One commenter noted that taxable index hedges cost less than hedges based on a tax-exempt index and recommended allowing super integration of taxable index hedges with mortgage revenue bonds to facilitate compliance with arbitrage restrictions on the yield of the financed mortgages. The Treasury Department and the IRS have concluded that the Final Regulations adequately address the commenter's concerns by permitting simple integration of taxable index hedges and by allowing yield reduction payments for qualified mortgage loans to facilitate compliance with the arbitrage investment restrictions (see section 5.A. of this preamble).

    Other commenters suggested that the proposed prohibition on super integration of taxable index hedges should be prospective. This provision in the Final Regulations applies to bonds sold on or after the date that is 90 days after publication of the Final Regulations in the Federal Register, and does not apply to bonds sold prior to that date or to hedges on those bonds, regardless of when the issuer enters into such a hedge, unless the issuer avails itself of permissive application under § 1.148-11(l)(1) of these Final Regulations.

    The 2007 Proposed Regulations also proposed to modify the yield reduction payment rules to permit issuers to make yield reduction payments on certain hedged advance refunding issues. This proposed provision effectively would allow yield reduction payments to cover the basis differences between the hedge and the hedged bonds in certain circumstances in which super integration was unavailable to address those basis differences, such as when taxable index swaps hedge the interest rate on advance refunding bonds. Commenters requested clarification of which bonds in the issue must be hedged for the issuer to be eligible to make yield reduction payments under the proposed provision. The Final Regulations eliminate the term “hedged bond issue” to clarify that the yield reduction payment is narrowly targeted to the portion of the issue that funds the defeasance escrow and otherwise adopt this change as proposed.

    iii. Size and Scope of a Qualified Hedge

    The 2007 Proposed Regulations proposed to add an express requirement that limits the size and scope of a qualified hedge to a level that is reasonably necessary to hedge the issuer's risk with respect to interest rate changes on the hedged bonds. Generally, the purpose of this proposed limitation is to clarify that certain leveraged hedges are not qualified hedges.

    The 2007 Proposed Regulations proposed an example of a hedge of the appropriate size and scope, based on the principal amount and the reasonably expected interest requirements of the hedged bonds. One commenter suggested clarifying this size and scope limitation to provide more flexibility for anticipatory hedges that are entered into before the issuance of the hedged bonds. The Final Regulations adopt the size and scope limitation as proposed and clarify that this limitation applies to anticipatory hedges based on the reasonably expected terms of the hedged bonds to be issued.

    iv. Correspondence of Payments for Simple Integration

    The Existing Regulations require that, for a hedge to be a qualified hedge, the payments received by the issuer from the hedge provider under the contract correspond closely in time to either the specific payments being hedged on the hedged bonds or specific payments required to be made pursuant to the bond documents, regardless of the hedge, to a sinking fund, debt service fund, or similar fund maintained for the issue of which the hedged bond is a part. The 2007 Proposed Regulations proposed to treat payments as corresponding closely in time for this purpose if the payments were made within 60 calendar days of each other.

    One commenter recommended increasing the permitted period for corresponding payments from 60 days to 90 days to accommodate a range of conventions used in the swap market. The Final Regulations adopt this comment.

    v. Identification of Qualified Hedges

    The 2007 Proposed Regulations proposed to extend the time for an issuer to identify a qualified hedge from three days to 15 days and to clarify that these are calendar days. The 2013 Proposed Regulations proposed to add a requirement that the identification of a qualified hedge include a certificate from the hedge provider containing certain information. Under the 2013 Proposed Regulations, one element required to be certified by the hedge provider is that the rate being paid by the bonds' issuer on the hedge is comparable to the rate that would be paid by a similarly situated issuer of taxable debt.

    Several commenters recommended clarifying the date on which the 15-day period for identification of a hedge commences. The Final Regulations clarify that the date on which the 15-day period begins is the date on which the parties enter into a binding agreement to enter into the hedge (as distinguished from the closing date of the hedge or start date for payments on the hedge, if different).

    Several commenters suggested permitting a party other than the issuer to identify the hedge on its books and records, but such changes are beyond the scope of this project (see section 12 of this preamble).

    One commenter supported the requirement of a hedge provider's certificate. Two other commenters recommended eliminating this requirement as both unnecessary and burdensome in that it exceeds the requirements for other financial contracts related to tax-exempt bond yield. These commenters recommended that, if the pricing of the hedge is a concern, the regulations should provide other methods for establishing fair pricing. These commenters, however, acknowledged that many issuers already use some form of hedge provider's certificate and that the provisions in the Proposed Regulations reflect to some degree the standard provisions of such certificates. In the alternative, these commenters recommended that the hedge provider's certificate should focus on factual aspects of establishing a qualified hedge, rather than on legal conclusions, and offered specific suggestions to that effect. For example, these commenters suggested that issuers also should be required to demonstrate their efforts to establish that the hedge pricing does not include compensation for underwriting or other services, rather than to obtain a certification to that effect. These commenters further suggested that the representation in the Proposed Regulations that the terms of the hedge were agreed to between a willing buyer and a willing seller in a bona fide, arm's length transaction was unnecessary and required a legal conclusion outside the hedge provider's knowledge. Further, the commenters noted that comparable hedges on taxable debt with counterparties similar to State and local government issuers may be rare and recommended that issuers be required to establish that the rate on the hedge is comparable to the rate that the hedge provider would charge for a similar hedge with a counterparty similar to the issuer, but without a reference to debt obligations other than tax-exempt bonds.

    The Final Regulations retain the requirement for a hedge provider's certificate because the hedge provider is uniquely positioned to validate pricing information needed to determine whether a hedge meets the requirements for being a qualified hedge. The Final Regulations retain the certification regarding an arm's length transaction between a willing buyer and a willing seller as one primarily based on fact and commonly obtained by issuers under current practices. In response to public comments, the Final Regulations amend the other required certifications to focus on factual aspects of the hedging transaction. In light of the evolving regulatory environment for swaps, however, the Final Regulations omit the certification that the issuer's rate on the hedge is comparable to the rate that would be paid by a similarly situated issuer of taxable debt. The Final Regulations reserve the authority for the Commissioner to add additional certifications in guidance published in the Internal Revenue Bulletin. In developing any future guidance, the Treasury Department and the IRS may look to the market for swaps on taxable debt and consider the availability of appropriate comparable rates.

    vi. Accounting for Modifications and Terminations a. Modifications and Terminations of Qualified Hedges

    The Existing Regulations provide that a termination of a qualified hedge includes any sale or other disposition of the hedge by the issuer or the acquisition by the issuer of an offsetting hedge. The Existing Regulations further provide that a deemed termination of a qualified hedge occurs when the hedged bonds are redeemed, when the hedge ceases to be a qualified hedge, or when the modification or assignment of the hedge results in a deemed exchange under section 1001. The issuer takes termination payments resulting from a deemed or actual termination of an integrated hedge into account in computing yield on the bonds.

    The 2013 Proposed Regulations proposed guidance on the treatment of modifications and terminations of qualified hedges. The 2013 Proposed Regulations also proposed to eliminate the ambiguous existing standard that triggered terminations for offsetting hedges. The 2013 Proposed Regulations proposed that a modification, including an actual modification, an acquisition of another hedge, or an assignment, results in a deemed termination of a hedge if the modification is material and results in a deemed disposition under section 1001.

    The 2013 Proposed Regulations proposed to simplify the treatment of deemed terminations to provide that a material modification of a qualified hedge (that otherwise would result in a deemed termination) does not result in such a termination if the modified hedge is a qualified hedge. For this purpose, the 2013 Proposed Regulations proposed to require re-testing of the modified hedge for compliance with the requirements for a qualified hedge at the time of the modification, with adjustments. In doing this re-testing, the 2013 Proposed Regulations proposed to disregard any off-market value of the existing hedge at the time of modification. In addition, the 2013 Proposed Regulations proposed to measure the time period for identification of the modified hedge from the date of the modification. Finally, the 2013 Proposed Regulations proposed to omit the requirement for a hedge provider's certificate for the modified hedge. Commenters supported these changes. The Final Regulations adopt these proposed changes with one modification: Assignment of a hedge is no longer given as an example of a modification. The Final Regulations remove this example not because an assignment is not a modification, but because under the regulations under section 1001 an assignment generally does not result in a deemed exchange.

    Commenters sought confirmation that the proposed rules for modifications of qualified hedges in the 2013 Proposed Regulations would replace an existing rule regarding such modifications that is set forth in the first sentence of section 5.1 of Notice 2008-41, 2008-1 CB 742. That sentence generally provides that a modification of a qualified hedge does not result in a deemed termination if the issuer does not expect the modification to change the yield on the hedged bonds over their remaining term by more than 0.25% and the modified hedge is integrated with the bonds. The Final Regulations provide comprehensive rules for determining when a modification of a qualified hedge results in a termination and, therefore, supersede the first sentence of section 5.1 of Notice 2008-41. The Final Regulations have no effect on the remainder of Notice 2008-41. See the section in this preamble entitled “Effect on Other Documents.”

    b. Continuations of Qualified Hedges in Refundings

    The 2013 Proposed Regulations similarly proposed to simplify the treatment of a qualified hedge upon a refunding of the hedged bonds when no actual termination of the associated hedge occurs. If the hedge meets the requirements for a qualified hedge of the refunding bonds as of the issue date of the refunding bonds, with certain exceptions, the 2013 Proposed Regulations proposed to treat the hedge as continuing as a qualified hedge of the refunding bonds instead of being terminated. The Treasury Department and the IRS received favorable comments regarding this proposed change and one comment beyond the scope of this project (see section 12 of this preamble). The Final Regulations adopt this change as proposed.

    The Existing Regulations provide special rules for terminations of super-integrated qualified hedges. A termination is disregarded and these special rules do not apply if, based on the facts and circumstances, the yield will not change. The 2013 Proposed Regulations proposed to apply these special rules to a modified super-integrated qualified hedge that is eligible for continued simple integration. Commenters sought clarification of the effect of this rule on super integration treatment. The purpose of this rule is to determine whether a modified super-integrated qualified hedge that continues to qualify for simple integration also would continue to qualify for super integration. The Final Regulations clarify that the applicable test is the test under the Existing Regulations for determining when to disregard terminations of super-integrated qualified hedges.

    c. Terminations of Hedges at Fair Market Value

    The Proposed Regulations proposed to modify the amounts taken into account for a deemed termination or actual termination of a qualified hedge. For an actual termination of a qualified hedge, the 2013 Proposed Regulations proposed to limit the amount of the hedge termination payment treated as made or received on the hedged bonds to an amount that is (i) no greater than the fair market value of the qualified hedge if paid by the issuer, and (ii) no less than the fair market value of the qualified hedge if received by the issuer. For a deemed termination of a qualified hedge, the 2013 Proposed Regulations proposed that the amount of the deemed termination payment is equal to the fair market value of the qualified hedge on the termination date.

    Commenters recommended that, for an actual termination, the amount actually paid or received by the issuer in connection with the termination should be considered the fair market value of the qualified hedge. The commenters further recommended that, for a deemed termination, the issuer should be able to rely on bid-side quotations from the hedge provider and other providers for purposes of determining the fair market value of the qualified hedge on the termination date. The commenters indicated that, in all cases, the termination amounts, whether actual or deemed, reflect the “bid side” of the hedge market. Because of concerns about the pricing of a hedge in determining the amount to be paid as a termination payment, the Final Regulations retain the rule that the amount of a termination payment that may be taken into account for arbitrage purposes is the fair market value of the qualified hedge on the termination date. The Final Regulations simplify the Proposed Regulations by providing a uniform fair market value standard for both actual and deemed terminations. Although the Treasury Department and the IRS have concluded that bona fide market quotations may be used to support fair market value determinations, the Treasury Department and the IRS have concerns about further specification of particular types of market quotations for purposes of proper reflection of fair market value in various circumstances. Accordingly, the Final Regulations provide that the fair market value of a qualified hedge upon termination is based on all of the facts and circumstances.

    5. Section 1.148-5 Yield and Valuation of Investments A. Yield Reduction Payment Rules

    For certain limited situations, the Existing Regulations permit payment of yield reduction payments to the United States to satisfy yield restriction requirements on certain investments. The 2007 Proposed Regulations proposed to expand these situations to permit issuers to make yield reduction payments to cover nonpurpose investments that an issuer purchases on a date when the issuer is unable to purchase SLGS because the Treasury Department has suspended sales of SLGS.

    Three commenters favored the proposed expansion of the availability of yield reduction payments when SLGS are unavailable. One commenter expressed concern that the proposed provision may not address the circumstance in which a SLGS sale suspension is in effect when an issuer commits to purchase investments, but SLGS sales resume before settlement on that purchase. The Final Regulations clarify that an issuer is permitted to make yield reduction payments if it enters into an agreement to purchase investments on a date when SLGS sales are suspended.

    The commenter also recommended extending the availability of yield reduction payments to cover the circumstance in which an issuer is uncertain whether the Treasury Department may suspend SLGS sales in the future after an issuer has subscribed to purchase SLGS and before the issuance of those SLGS. Although the Treasury Department reserves full discretion to manage its borrowings, including SLGS, it has been the Treasury Department's practice to honor all outstanding SLGS subscriptions received before it suspends SLGS sales. Accordingly, the Treasury Department and the IRS have concluded that yield reduction payments are not needed in this circumstance, and the Final Regulations do not adopt this comment.

    In addition, in comments regarding the proposed elimination of the Commissioner's authority to compute a joint yield for two or more issues of qualified mortgage bonds or qualified student loan bonds, one commenter requested that issuers of qualified student loan bonds be permitted to make yield reduction payments for all qualified student loans, not just those under the FFELP. The Treasury Department and the IRS recognize that the ability to make yield reduction payments for qualified student loans and qualified mortgage loans would provide issuers an administrable alternative to the rarely used authority to compute a joint bond yield on issues of such bonds. The Treasury Department and the IRS also recognize that these portfolio loan programs have particular administrative challenges with loan yield compliance due to the large number of loans. Accordingly, in connection with the elimination of that joint bond yield authority under the Final Regulations, the Treasury Department and the IRS adopt this comment and expand the availability of yield reduction payments to include qualified student loans and qualified mortgage loans generally.

    Commenters requested permission to make yield reduction payments in several other situations not provided in the Proposed Regulations. The Treasury Department and the IRS have concluded these amendments are beyond the scope of this project and, therefore, did not address them in the Final Regulations (see section 12 of this preamble).

    B. Valuation of Investments

    The Existing Regulations provide guidance on how to value investments allocated to an issue but leave some ambiguity about when the present value and the fair market value methods of valuation are permitted or required. The 2013 Proposed Regulations proposed to clarify that the fair market value method of valuation generally is required for any investment on the date the investment is first allocated to an issue or first ceases to be allocated to an issue as a consequence of a deemed acquisition or a deemed disposition.

    The 2013 Proposed Regulations did not propose to distinguish between purpose investments and nonpurpose investments. One commenter urged clarification that purpose investments must be valued at present value at all times. This commenter further suggested that the rules clearly distinguish between purpose and nonpurpose investments. The Treasury Department and the IRS recognize that purpose investments are special investments that are intended to pass on the benefits of the lower borrowing costs of tax-exempt bond financings to eligible beneficiaries of the particular authorized tax-exempt bond program (for example, eligible first-time low and moderate income homebuyers who receive qualified mortgage loans financed with qualified mortgage bonds). Accordingly, the Final Regulations adopt these comments.

    The Existing Regulations include an exception to the mandatory fair market value rule for reallocations of investments between tax-exempt bond issues as a result of the transferred proceeds rule under § 1.148-9(b) or the universal cap rule under § 1.148-6(b)(2). To remove a disincentive against retiring tax-exempt bonds with taxable bonds when the fair market value of the investments allocable to the tax-exempt bonds would cause investment yield to exceed the tax-exempt bond yield, the 2013 Proposed Regulations proposed to change this exception to the fair market value rule to require that only the issue from which the investment is allocated consist of tax-exempt bonds.

    Commenters generally viewed this change favorably. One commenter suggested clarifying an ambiguity in the Existing Regulations regarding when a reallocation from one issue to another occurs “as a result of” the universal cap rule. The Final Regulations clarify that the exception to fair market valuation for investments reallocated as a result of the universal cap rule applies narrowly to circumstances in which investments are deallocated from an issue as a result of the universal cap rule and are reallocated to another issue without further action as a result of an existing pledge of the investment to the other issue (for example, a pledge of investments to multiple bond issues secured by common security under a master indenture). In these circumstances, the issuer has not structured the transaction to benefit from the market valuation of the nonpurpose investments.

    This commenter also suggested providing a safe harbor for when an issuer may liquidate escrow investments after a taxable refunding without concern that the Commissioner would exercise his anti-abuse authority to value the investment at fair market value. This comment is beyond the scope of this project (see section 12 of this preamble).

    Commenters also recommended broad interpretations or expansions of the exception to fair market valuation for investments reallocated as a result of the universal cap rule to cover various types of transactions involving investments that secure a tax-exempt bond issue and that are liquidated at a profit so long as the investment proceeds of the liquidated investments are used to retire tax-exempt bonds early. In one representative scenario, an issuer using funds other than tax-exempt bond proceeds created a yield-restricted escrow fund to defease tax-exempt bonds for which it retained the call rights. If the fair market value of investments in the escrow appreciated, the issuer would issue taxable bonds and use a portion of the proceeds of the taxable bonds to redeem the tax-exempt bonds. Applying universal cap principles, the investments would cease to be allocated to the tax-exempt bonds when the tax-exempt bonds were redeemed and the investments would be allocated to the taxable refunding bonds not as a result of a pre-existing pledge but as replacement proceeds. If the investments were valued at fair market value, the yield on the escrow would exceed the yield on the tax-exempt bonds resulting in arbitrage bonds. The bonds would not be arbitrage bonds if the regulations permitted these escrow investments to be valued at present value at the time of the refunding. Another scenario for which the commenters requested using the present value of investments rather than fair market value involves liquidating the appreciated investments in a defeasance escrow to redeem the tax-exempt issue rather than issuing taxable refunding bonds.

    The Treasury Department and the IRS have concerns about potential unintended consequences and circumvention of arbitrage investment restrictions in these and other similar transactions. In the first scenario, the issuer has structured the transaction specifically to benefit from an appreciation of the escrow investments in a manner inconsistent with the arbitrage restrictions. In the second scenario, the use of present value would allow the issuer to realize the investment return in contravention of the statutory requirements to take into account any gain or loss on the disposition of a nonpurpose investment. Accordingly, except for the technical clarification of the limited application of universal cap deallocations under this rule, the Final Regulations adopt as proposed the revised exception to fair market valuation for investments reallocated as a result of the transferred proceeds rule or the universal cap rule.

    C. Fair Market Value of Treasury Obligations

    The Existing Regulations provide a general rule that the fair market value of an investment is the price at which a willing buyer would purchase the investment from a willing seller in a bona fide, arm's length transaction. For United States Treasury obligations that are traded on the open market, trading values at the time of trades are used to establish fair market values. The Existing Regulations further provide a special rule, aimed primarily at non-transferrable, non-tradable SLGS, that the fair market value of a United States Treasury obligation that is purchased directly from the United States Treasury is its purchase price. This special rule properly indicates that the fair market value of a United States Treasury obligation that is purchased directly from the United States is its purchase price on the original purchase date, but this provision is ambiguous regarding how to determine the fair market value of such an obligation on dates after the original purchase date.

    The 2013 Proposed Regulations proposed to clarify that, on the original purchase date only, the fair market value of such an obligation, including a SLGS security, is its purchase price. The 2013 Proposed Regulations further proposed that, on any date other than the original purchase date, the fair market value of a SLGS security is its redemption price. One commenter objected to the valuation of a SLGS security at other than its purchase price upon a deemed acquisition or deemed disposition. United States Treasury obligations other than SLGS may be purchased and sold on the open market. SLGS, however, are nontransferable obligations that may be purchased or redeemed only from the United States Treasury. For this reason, the 2013 Proposed Regulations proposed that the fair market value of a SLGS security on any date other than its purchase date is the redemption price determined by the United States Treasury under applicable regulations for the SLGS program. The Final Regulations adopt this change as proposed.

    D. Modified Fair Market Value Safe Harbor for Guaranteed Investment Contracts

    The Existing Regulations provide a safe harbor for establishing the fair market value of a guaranteed investment contract. This safe harbor generally relies on a prescribed bidding procedure, including requirements that all bidders be given an equal opportunity to bid with no opportunity to review other bids before providing a bid (that is, the “no last look” rule) and that the bid specifications be provided to prospective bidders “in writing.” The 2007 Proposed Regulations proposed to amend this safe harbor to accommodate electronic bidding procedures by: (1) Permitting bid specifications to be sent electronically over the Internet or by fax; and (2) providing that no impermissible last look occurs if in effect all bidders have an equal opportunity for a last look. One commenter noted an ambiguity in this proposed change. In response to this comment, the Final Regulations clarify that bids must be in writing and timely disseminated and that a writing may be in electronic form and may be disseminated by fax, email, an Internet-based Web site, or other electronic medium that is similar to an Internet-based Web site and regularly used to post bid specifications. The Final Regulations otherwise adopt this change as proposed.

    E. External Commingled Investment Funds

    The Existing Regulations provide certain preferential rules for the treatment of administrative costs of certain widely held external commingled funds. Under the Existing Regulations, a fund is treated as widely held if the fund, on average, has more than 15 unrelated investors and each investor maintains a prescribed minimum average investment in the fund. The 2007 Proposed Regulations proposed to allow additional smaller investors to invest in an external commingled fund without disqualifying the fund so long as at least 16 unrelated investors each maintain the required minimum average investment in the fund.

    One commenter suggested that the regulations should require that a specified percentage of the unrelated investors hold a specified percentage of the daily average value of the fund's assets. The Final Regulations do not adopt this comment, because it is inconsistent with the purpose of the proposed change to enable a fund to become even more widely held by accommodating an unlimited number of small investors without restriction so long as at least 16 unrelated investors each maintain the required minimum average investment in the fund. The commenter also suggested other amendments beyond the scope of this project (see section 12 of this preamble). The Final Regulations adopt this change as proposed.

    6. Section 1.148-8 Small Issuer Exception to Rebate Requirement—Pooled Bonds

    The 2007 Proposed Regulations proposed to amend the Existing Regulations to conform to changes made to section 148(f)(4)(D) by section 508 of the Tax Increase Prevention and Reconciliation Act of 2005, Public Law 109-222, 120 Stat. 345, which eliminated a rule that permitted a pool bond issuer to ignore its pool bond issue in computing whether it had exceeded its $5 million limit for purposes of the small issuer rebate exception. The Treasury Department and the IRS received no comments regarding this proposed change. The Final Regulations adopt this change as proposed.

    7. Section 1.148-10 Anti-Abuse Rules and Authority of Commissioner

    The 2013 Proposed Regulations proposed to amend the Commissioner's authority to depart from the arbitrage regulations when an issuer enters into a transaction for a principal purpose of obtaining a material financial advantage based on the difference between tax-exempt and taxable interest rates in a manner inconsistent with the purposes of section 148, from that “necessary to clearly reflect the economic substance of the transaction” to that “necessary to prevent such financial advantage.” The 2013 Proposed Regulations proposed to remove the references to “economic substance” to prevent confusion of the Commissioner's authority under this arbitrage anti-abuse rule with the economic substance doctrine under general federal tax principles. No substantive change was intended.

    Commenters suggested that this proposed change would give unduly broad discretion to the Commissioner and would reduce certainty of the applicability of published guidance. These commenters recommended limiting the Commissioner's authority to that necessary “to reflect the economics of the transaction to prevent such financial advantage.” The Final Regulations adopt this comment.

    8. Section 1.148-11 Transition Provision for Certain Guarantee Funds

    The Existing Regulations include a transition rule that allows certain State perpetual trust funds (for example, certain State permanent school funds) to pledge funds to guarantee tax-exempt bonds without resulting in arbitrage-restricted replacement proceeds. The 2013 Proposed Regulations proposed to include changes proposed in Notice 2010-5, 2010-2 IRB 256, to increase the amount of tax-exempt bonds that such funds could guarantee under this special rule. Further, in response to comments received on Notice 2010-5, the 2013 Proposed Regulations proposed to extend this special rule to cover certain tax-exempt bonds issued to finance public charter schools, which may be 501(c)(3) organizations. The Treasury Department and the IRS received no comments on these proposed changes. The Final Regulations adopt these changes as proposed.

    9. Section 1.150-1 Definitions A. Definition of Tax-Advantaged Bonds

    The 2013 Proposed Regulations proposed a new definition of tax-advantaged bonds. The Treasury Department and the IRS received no comments regarding this new definition. The Final Regulations substitute “tax benefit” for “subsidy” in describing tax-advantaged bonds but otherwise adopt the definition as proposed.

    B. Definition of Issue

    The Existing Regulations provide that tax-exempt bonds and taxable bonds are not part of the same issue. The 2013 Proposed Regulations proposed to clarify that taxable tax-advantaged bonds and other taxable bonds are part of different issues and that different types of tax-advantaged bonds are parts of different issues. The Treasury Department and IRS received one comment supporting this proposed change and no opposing comments. The Final Regulations adopt this change as proposed.

    C. Definition and Treatment of Grants

    The 2013 Proposed Regulations proposed that the existing definition of grant for arbitrage purposes applies for purposes of other tax-exempt bond provisions. The 2013 Proposed Regulations also proposed to clarify that the character and nature of a grantee's use of proceeds generally is taken into account in determining whether arbitrage and other applicable requirements of the issue are met.

    Commenters requested confirmation that the proposed rule preserves the existing rule that an issuer spends proceeds used for grants for purposes of the arbitrage investment restrictions when the issuer makes the grant to an unrelated third-party. Thus, for example, if the grantee uses the grant to reimburse its expenditures, the reimbursement allocation rules do not apply. The 2013 Proposed Regulations expressly proposed the special grant expenditure rule for arbitrage purposes as an example of a specific exception to the proposed general rule. Commenters also suggested other amendments to the rules for grants that are beyond the scope of this project (see section 12 of this preamble). The Final Regulations adopt these changes as proposed.

    10. Section 1.141-15 Effective Dates

    The Final Regulations include certain technical amendments to final regulations (TD 9741) that were published in the Federal Register on Tuesday, October 27, 2015 (80 FR 65637). Those final regulations provide guidance on allocation and accounting rules and certain remedial actions for purposes of the private activity bond restrictions under section 141 of the Internal Revenue Code that apply to tax-exempt bonds issued by State and local governments.

    The technical amendments amend the applicability dates to include a transition rule for refunding bonds, provided that the weighted average maturity of the refunding bonds is no longer than that of the refunded bonds or, in the case of certain short-term obligations, no longer than 120 percent of the weighted average reasonably expected economic life of the facilities financed. The technical amendments also clarify permissive application of certain provisions to outstanding bonds.

    11. Revenue Procedure 97-15

    Revenue Procedure 97-15, 1997-1 CB 635, provides a program under which an issuer of tax-exempt bonds may request a closing agreement with respect to outstanding bonds to prevent the interest on those bonds from being includible in gross income of the bondholders or being treated as an item of tax preference for purposes of the alternative minimum tax as a result of an action subsequent to the issue date of the bonds that causes the bonds to fail to meet certain requirements relating to the use of proceeds. Notice 2008-31, 2008-1 CB 592, also provides a voluntary closing agreement program for tax-exempt bonds and tax credit bonds. The scope of the violations that can be remedied under Notice 2008-31 is broader than that under Rev. Proc. 97-15. As a result, this Treasury Decision obsoletes Rev. Proc. 97-15.

    12. Comments Beyond the Scope of the Proposed and Final Regulations

    Commenters submitted additional suggestions for revisions to the Existing Regulations. These suggestions include: (1) Adding a new safe harbor to prevent the creation of replacement proceeds specifically for grants and extraordinary working capital financings (and redefining “extraordinary working capital”); (2) adding new rules for using proceeds to fund working capital reserves; (3) providing how an issuer should allocate certain expenses related to yield-to-call premium bonds for computing yield on the issue; (4) revising the rules for determining if an interest rate cap contains a significant investment element; (5) permitting a conduit borrower to identify a qualified hedge on its books and records; (6) providing a safe harbor for when an issuer may liquidate escrow investments for purposes of valuation of investments; (7) revising the proceeds-spent-last expenditure rule to permit financing of certain payments on hedges; (8) permitting yield reduction payments on investments purchased to defease zero-coupon bonds; (9) providing yield reduction payments for a basis difference under circumstances other than those in the Proposed Regulations; (10) exempting external comingled funds that are operated by a government on a not-for-profit basis from the requirements for administrative costs of such funds to be included in qualified administrative costs of investments; (11) establishing an economic life for grants based on the benefit of the grant to the grantor; (12) providing rules for grant repayments; and (13) explaining how certain rules in the Proposed Regulations would apply to very specific facts. These comments identify issues that are beyond the scope of the Proposed Regulations and thus are not addressed in the Final Regulations.

    Applicability Dates

    The Final Regulations generally apply to bonds that are sold on or after October 17, 2016. Certain provisions related to hedges on bonds apply to hedges that are entered into or modified on or after October 17, 2016. The Final Regulations also permit issuers to apply certain of the amended provisions to bonds sold before October 17, 2016. For specific dates of applicability, see §§ 1.141-15, 1.148-11, 1.150-1, and 1.150-2.

    Effect on Other Documents

    As of July 18, 2016, Revenue Procedures 95-47 and 97-15 are obsoleted and Notice 2008-41 is modified.

    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 has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations. It is hereby certified that these regulations will not have a significant economic impact on a substantial number of small entities. This certification is based on the fact that the collection of information in these regulations is required for hedging transactions entered into primarily between larger State and local governments and large counterparties. It is also based on the fact that the estimated recordkeeping burden for all issuers and counterparties is relatively small and the reasonable costs of that burden do not constitute a significant economic impact. Accordingly, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Code, the proposed regulations preceding these final regulations were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business. No comments were received.

    Drafting Information

    The principal authors of these regulations are Johanna Som de Cerff, Spence Hanemann, and Lewis Bell of the Office of Associate Chief Counsel (Financial Institutions and Products), IRS. However, other personnel from the Treasury Department and the IRS participated in their development.

    Availability of IRS Documents

    IRS revenue procedures and notices cited in these final regulations are made available by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402.

    List of Subjects in 26 CFR Part 1

    Income taxes, Reporting and recordkeeping requirements.

    Adoption of Amendments to the Regulations

    Accordingly, 26 CFR part 1 is amended as follows:

    PART 1—INCOME TAXES Paragraph 1. The authority citation for part 1 is amended by removing the entry for § 1.148-6 to read in part as follows: Authority:

    26 U.S.C. 7805 * * *

    Par. 2. Section 1.141-0 is amended by: 1. Revising the entry for § 1.141-15(l)(2). 2. Adding an entry for § 1.141-15(l)(3). 3. Adding an entry for § 1.141-15(n).

    The additions and revisions read as follows:

    § 1.141-0 Table of contents.
    § 1.141-15 Effective/applicability dates.

    (l) * * *

    (2) Refunding bonds.

    (3) Permissive application.

    (n) Effective/applicability dates for certain regulations relating to certain definitions.

    Par. 3. Section 1.141-1 is amended by revising paragraph (a) to read as follows:
    § 1.141-1 Definitions and rules of general application.

    (a) In general. For purposes of §§ 1.141-0 through 1.141-16, the following definitions and rules apply: The definitions in this section, the definitions in § 1.150-1, the definition of placed in service in § 1.150-2(c), the definition of reasonably required reserve or replacement fund in § 1.148-2(f), and the definitions in § 1.148-1 of bond year, commingled fund, fixed yield issue, higher yielding investments, investment, investment proceeds, issue price, issuer, nonpurpose investment, purpose investment, qualified guarantee, qualified hedge, reasonable expectations or reasonableness, rebate amount, replacement proceeds, sale proceeds, variable yield issue and yield.

    Par. 4. Section 1.141-15 is amended by: 1. Redesignating paragraph (l)(2) as (l)(3). 2. Adding new paragraph (l)(2). 3. Amending the first sentence of redesignated paragraph (l)(3) by adding “Except as otherwise provided in this section,” at the beginning of the sentence and removing the word “Issuers” and adding the word “issuers” in its place. 4. Adding paragraph (n).

    The additions and revisions read as follows:

    § 1.141-15 Effective/applicability dates.

    (l) * * *

    (2) Refunding bonds. Except as otherwise provided in this section, §§ 1.141-1(e), 1.141-3(g)(2)(v), 1.141-6, and 1.145-2(b)(4), (5), and (c)(2) do not apply to any bonds sold on or after January 25, 2016, to refund a bond to which these sections do not apply, provided that the weighted average maturity of the refunding bonds is no longer than—

    (i) The remaining weighted average maturity of the refunded bonds; or

    (ii) In the case of a short-term obligation that the issuer reasonably expects to refund with a long-term financing (such as a bond anticipation note), 120 percent of the weighted average reasonably expected economic life of the facilities financed.

    (n) Effective/applicability dates for certain regulations relating to certain definitions. § 1.141-1(a) applies to bonds that are sold on or after October 17, 2016.

    Par. 5. Section 1.148-0(c) is amended by: 1. Revising the entry for § 1.148-2(e)(3). 2. Adding an entry for § 1.148-3(d)(4). 3. Revising the entry for § 1.148-5(d)(2). 4. Revising the entry for § 1.148-8(d). 5. Removing the entries for § 1.148-8(d)(1) and (2). 6. Revising the entry for § 1.148-10(e). 7. Adding entries for § 1.148-11(k). 8. Revising the entries for § 1.148-11(l).

    The revisions and additions read as follows:

    § 1.148-0 Scope and table of contents.

    (c) * * *

    § 1.148-2 General arbitrage yield restriction rules.

    (e) * * *

    (3) Temporary period for working capital expenditures.

    § 1.148-3 General arbitrage rebate rules.

    (d) * * *

    (4) Cost-of-living adjustment.

    § 1.148-5 Yield and valuation of investments.

    (d) * * *

    (2) Mandatory valuation of certain yield restricted investments at present value.

    § 1.148-8 Small issuer exception to rebate requirement.

    (d) Pooled financings—treatment of conduit borrowers.

    § 1.148-10 Anti-abuse rules and authority of Commissioner.

    (e) Authority of the Commissioner to prevent transactions that are inconsistent with the purpose of the arbitrage investment restrictions.

    § 1.148-11 Effective/applicability dates.

    (k) Certain arbitrage guidance updates.

    (1) In general.

    (2) Valuation of investments in refunding transactions.

    (3) Rebate overpayment recovery.

    (4) Hedge identification.

    (5) Hedge modifications and termination.

    (6) Small issuer exception to rebate requirement for conduit borrowers of pooled financings.

    (l) Permissive application of certain arbitrage updates.

    (1) In general.

    (2) Computation credit.

    (3) Yield reduction payments.

    (4) External commingled funds.

    Par. 6. Section 1.148-1 is amended by: 1. Revising paragraph (c)(4)(i)(B)(1). 2. Removing the “or” at the end of paragraph (c)(4)(i)(B)(2). 3. Removing the period at the end of paragraph (c)(4)(i)(B)(3) and adding in its place a semicolon and the word “or”. 4. Adding paragraph (c)(4)(i)(B)(4). 5. Revising paragraph (c)(4)(ii).

    The revisions and additions read as follows:

    § 1.148-1 Definitions and elections.

    (c) * * *

    (4) * * *

    (i) * * *

    (B) * * *

    (1) For the portion of an issue that is to be used to finance working capital expenditures, if that portion is not outstanding longer than the temporary period under § 1.148-2(e)(3) for which the proceeds qualify;

    (4) For the portion of an issue (including a refunding issue) that is to be used to finance working capital expenditures, if that portion satisfies paragraph (c)(4)(ii) of this section.

    (ii) Safe harbor for longer-term working capital financings. A portion of an issue used to finance working capital expenditures satisfies this paragraph (c)(4)(ii) if the issuer meets the requirements of paragraphs (c)(4)(ii)(A) through (E) of this section.

    (A) Determine first testing year. On the issue date, the issuer must determine the first fiscal year following the applicable temporary period under § 1.148-2(e) in which it reasonably expects to have available amounts (first testing year), but in no event can the first day of the first testing year be later than five years after the issue date.

    (B) Application of available amount to reduce burden on tax-exempt bond market. Beginning with the first testing year and for each subsequent fiscal year for which the portion of the issue that is the subject of this safe harbor remains outstanding, the issuer must determine the available amount as of the first day of each fiscal year. Then, except as provided in paragraph (c)(4)(ii)(D) of this section, within the first 90 days of that fiscal year, the issuer must apply that amount (or if less, the available amount on the date of the required redemption or investment) to redeem or to invest in eligible tax-exempt bonds (as defined in paragraph (c)(4)(ii)(E) of this section). For this purpose, available amounts in a bona fide debt service fund are not treated as available amounts.

    (C) Continuous investment requirement. Except as provided in this paragraph (c)(4)(ii)(C), any amounts invested in eligible tax-exempt bonds under paragraph (c)(4)(ii)(B) of this section must be invested continuously in such tax-exempt bonds to the extent provided in paragraph (c)(4)(ii)(D) of this section.

    (1) Exception for reinvestment period. Amounts previously invested in eligible tax-exempt bonds under paragraph (c)(4)(ii)(B) of this section that are held for not more than 30 days in a fiscal year pending reinvestment in eligible tax-exempt bonds are treated as invested in eligible tax-exempt bonds.

    (2) Limited use of invested amounts. An issuer may spend amounts previously invested in eligible tax-exempt bonds under paragraph (c)(4)(ii)(B) of this section within 30 days of the date on which they cease to be so invested to make expenditures for a governmental purpose on any date on which the issuer has no other available amounts for such purpose, or to redeem eligible tax-exempt bonds.

    (D) Cap on applied or invested amounts. The maximum amount that an issuer is required to apply under paragraph (c)(4)(ii)(B) of this section or to invest continuously under paragraph (c)(4)(ii)(C) of this section with respect to the portion of an issue that is the subject of this safe harbor is the outstanding principal amount of such portion. For purposes of this cap, an issuer receives credit towards its requirement to invest available amounts in eligible tax-exempt bonds for amounts previously invested under paragraph (c)(4)(ii)(B) of this section that remain continuously invested under paragraph (c)(4)(ii)(C) of this section.

    (E) Definition of eligible tax-exempt bonds. For purposes of paragraph (c)(4)(ii) of this section, eligible tax-exempt bonds means any of the following:

    (1) A bond the interest on which is excludable from gross income under section 103 and that is not a specified private activity bond (as defined in section 57(a)(5)(C)) subject to the alternative minimum tax;

    (2) An interest in a regulated investment company to the extent that at least 95 percent of the income to the holder of the interest is interest on a bond that is excludable from gross income under section 103 and that is not interest on a specified private activity bond (as defined in section 57(a)(5)(C)) subject to the alternative minimum tax; or

    (3) A certificate of indebtedness issued by the United States Treasury pursuant to the Demand Deposit State and Local Government Series program described in 31 CFR part 344.

    Par. 7. Section 1.148-2 is amended by revising the heading of paragraph (e)(3) and revising paragraph (e)(3)(i) to read as follows:
    § 1.148-2 General arbitrage yield restriction rules.

    (e) * * *

    (3) Temporary period for working capital expenditures—(i) General rule. The proceeds of an issue that are reasonably expected to be allocated to working capital expenditures within 13 months after the issue date qualify for a temporary period of 13 months beginning on the issue date. Paragraph (e)(2) of this section contains additional temporary period rules for certain working capital expenditures that are treated as part of a capital project.

    Par. 8. Section 1.148-3 is amended by: 1. Revising paragraph (d)(1)(iv). 2. Adding paragraph (d)(4). 3. Revising Example 2(iii)(D) of paragraph (j).

    The revisions and addition read as follows:

    § 1.148-3 General arbitrage rebate rules.

    (d) * * *

    (1) * * *

    (iv) On the last day of each bond year during which there are amounts allocated to gross proceeds of an issue that are subject to the rebate requirement, and on the final maturity date, a computation credit of $1,400 for any bond year ending in 2007 and, for bond years ending after 2007, a computation credit in the amount determined under paragraph (d)(4) of this section; and

    (4) Cost-of-living adjustment. For any calendar year after 2007, the $1,400 computation credit set forth in paragraph (d)(1)(iv) of this section shall be increased by an amount equal to such dollar amount multiplied by the cost-of-living adjustment determined under section 1(f)(3) for such year, as modified by this paragraph (d)(4). In applying section 1(f)(3) to determine this cost-of-living adjustment, the reference to “calendar year 1992” in section 1(f)(3)(B) shall be changed to “calendar year 2006.” If any such increase determined under this paragraph (d)(4) is not a multiple of $10, such increase shall be rounded to the nearest multiple thereof.

    (j) * * *

    Example 2.

    * * *

    (iii) * * *

    (D) If the yield during the second computation period were, instead, 7.0000 percent, the rebate amount computed as of July 1, 2004, would be $1,320,891. The future value of the payment made on July 1, 1999, would be $1,471,007. Although the future value of the payment made on July 1, 1999 ($1,471,007), exceeds the rebate amount computed as of July 1, 2004 ($1,320,891), § 1.148-3(i) limits the amount recoverable as a defined overpayment of rebate under section 148 to the excess of the total “amount paid” over the sum of the amount determined under the future value method to be the “rebate amount” as of the most recent computation date and all other amounts that are otherwise required to be paid under section 148 as of the date the recovery is requested. Because the total amount that the issuer paid on July 1, 1999 ($1,042,824.60), does not exceed the rebate amount as of July 1, 2004 ($1,320,891), the issuer would not be entitled to recover any overpayment of rebate in this case.

    Par. 9. Section 1.148-4 is amended by: 1. Revising paragraph (a). 2. Revising paragraph (b)(3)(i). 3. Adding two sentences at the end of paragraph (h)(2)(ii)(A). 4. Revising the heading and introductory text of paragraph (h)(2)(v). 5. Revising the last sentence of paragraph (h)(2)(v)(B). 6. Adding a sentence at the end of paragraph (h)(2)(vi). 7. Revising paragraph (h)(2)(viii). 8. Revising paragraph (h)(3)(iv)(A). 9. Redesignating paragraphs (h)(3)(iv)(B) through (E) as paragraphs (h)(3)(iv)(E) through (H) respectively. 10. Adding new paragraphs (h)(3)(iv)(B), (C), and (D). 11. Revising newly redesignated paragraph (h)(3)(iv)(E). 12. Revising the first sentence in newly redesignated paragraph (h)(3)(iv)(F). 13. Revising newly redesignated paragraph (h)(3)(iv)(G). 14. Revising the first sentence in newly redesignated paragraph (h)(3)(iv)(H). 15. Adding a sentence at the end of paragraph (h)(4)(i)(C). 16. Adding paragraphs (h)(4)(i)(C)(1) and (2). 17. Adding paragraph (h)(4)(iv).

    The revisions and additions read as follows:

    § 1.148-4 Yield on an issue of bonds.

    (a) In general. The yield on an issue of bonds is used to apply investment yield restrictions under section 148(a) and to compute rebate liability under section 148(f). Yield is computed under the economic accrual method using any consistently applied compounding interval of not more than one year. A short first compounding interval and a short last compounding interval may be used. Yield is expressed as an annual percentage rate that is calculated to at least four decimal places (for example, 5.2525 percent). Other reasonable, standard financial conventions, such as the 30 days per month/360 days per year convention, may be used in computing yield but must be consistently applied. The yield on an issue that would be a purpose investment (absent section 148(b)(3)(A)) is equal to the yield on the conduit financing issue that financed that purpose investment.

    (b) * * *

    (3) Yield on certain fixed yield bonds subject to optional early redemption—(i) In general. If a fixed yield bond is subject to optional early redemption and is described in paragraph (b)(3)(ii) of this section, the yield on the issue containing the bond is computed by treating the bond as redeemed at its stated redemption price on the optional redemption date that would produce the lowest yield on that bond.

    (h) * * *

    (2) * * *

    (ii) * * *

    (A) * * * Solely for purposes of determining if a hedge is a qualified hedge under this section, payments that an issuer receives pursuant to the terms of a hedge that are equal to the issuer's cost of funds are treated as periodic payments under § 1.446-3 without regard to whether the payments are calculated by reference to a “specified index” described in § 1.446-3(c)(2). Accordingly, a hedge does not have a significant investment element under this paragraph (h)(2)(ii)(A) solely because an issuer receives payments pursuant to the terms of a hedge that are computed to be equal to the issuer's cost of funds, such as the issuer's actual market-based tax-exempt variable interest rate on its bonds.

    (v) Interest-based contract and size and scope of hedge. The contract is primarily interest-based (for example, a hedge based on a debt index, including a tax-exempt debt index or a taxable debt index, rather than an equity index). In addition, the size and scope of the hedge under the contract is limited to that which is reasonably necessary to hedge the issuer's risk with respect to interest rate changes on the hedged bonds. For example, a contract is limited to hedging an issuer's risk with respect to interest rate changes on the hedged bonds if the hedge is based on the principal amount and the reasonably expected interest payments of the hedged bonds. For anticipatory hedges under paragraph (h)(5) of this section, the size and scope limitation applies based on the reasonably expected terms of the hedged bonds to be issued. A contract is not primarily interest based unless—

    (B) * * * For this purpose, differences that would not prevent the resulting bond from being substantially similar to another type of bond include: a difference between the interest rate used to compute payments on the hedged bond and the interest rate used to compute payments on the hedge where one interest rate is substantially similar to the other; the difference resulting from the payment of a fixed premium for a cap (for example, payments for a cap that are made in other than level installments); and the difference resulting from the allocation of a termination payment where the termination was not expected as of the date the contract was entered into.

    (vi) * * * For this purpose, such payments will be treated as corresponding closely in time under this paragraph (h)(2)(vi) if they are made within 90 calendar days of each other.

    (viii) Identification—(A) In general. The actual issuer must identify the contract on its books and records maintained for the hedged bonds not later than 15 calendar days after the date on which there is a binding agreement to enter into a hedge contract (for example, the date of a hedge pricing confirmation, as distinguished from the closing date for the hedge or start date for payments on the hedge, if different). The identification must specify the name of the hedge provider, the terms of the contract, the hedged bonds, and include a hedge provider's certification as described in paragraph (h)(2)(viii)(B) of this section. The identification must contain sufficient detail to establish that the requirements of this paragraph (h)(2) and, if applicable, paragraph (h)(4) of this section are satisfied. In addition, the existence of the hedge must be noted on the first form relating to the issue of which the hedged bonds are a part that is filed with the Internal Revenue Service on or after the date on which the contract is identified pursuant to this paragraph (h)(2)(viii).

    (B) Hedge provider's certification. The hedge provider's certification must—

    (1) Provide that the terms of the hedge were agreed to between a willing buyer and willing seller in a bona fide, arm's-length transaction;

    (2) Provide that the hedge provider has not made, and does not expect to make, any payment to any third party for the benefit of the issuer in connection with the hedge, except for any such third-party payment that the hedge provider expressly identifies in the documents for the hedge;

    (3) Provide that the amounts payable to the hedge provider pursuant to the hedge do not include any payments for underwriting or other services unrelated to the hedge provider's obligations under the hedge, except for any such payment that the hedge provider expressly identifies in the documents for the hedge; and

    (4) Contain any other statements that the Commissioner may provide in guidance published in the Internal Revenue Bulletin. See § 601.601(d)(2)(ii) of this chapter.

    (3) * * *

    (iv) Accounting for modifications and terminations—(A) Modification defined. A modification of a qualified hedge includes, without limitation, a change in the terms of the hedge or an issuer's acquisition of another hedge with terms that have the effect of modifying an issuer's risk of interest rate changes or other terms of an existing qualified hedge. For example, if the issuer enters into a qualified hedge that is an interest rate swap under which it receives payments based on the Securities Industry and Financial Market Association (SIFMA) Municipal Swap Index and subsequently enters a second hedge (with the same or different provider) that limits the issuer's exposure under the existing qualified hedge to variations in the SIFMA Municipal Swap Index, the new hedge modifies the qualified hedge.

    (B) Termination defined. A termination means either an actual termination or a deemed termination of a qualified hedge. Except as otherwise provided, an actual termination of a qualified hedge occurs to the extent that the issuer sells, disposes of, or otherwise actually terminates all or a portion of the hedge. A deemed termination of a qualified hedge occurs if the hedge ceases to meet the requirements for a qualified hedge; the issuer makes a modification (as defined in paragraph (h)(3)(iv)(A) of this section) that is material either in kind or in extent and, therefore, results in a deemed exchange of the hedge and a realization event to the issuer under section 1001; or the issuer redeems all or a portion of the hedged bonds.

    (C) Special rules for certain modifications when the hedge remains qualified. A modification of a qualified hedge that otherwise would result in a deemed termination under paragraph (h)(3)(iv)(B) of this section does not result in such a termination if the modified hedge is re-tested for qualification as a qualified hedge as of the date of the modification, the modified hedge meets the requirements for a qualified hedge as of such date, and the modified hedge is treated as a qualified hedge prospectively in determining the yield on the hedged bonds. For purposes of this paragraph (h)(3)(iv)(C), when determining whether the modified hedge is qualified, the fact that the existing qualified hedge is off-market as of the date of the modification is disregarded and the identification requirement in paragraph (h)(2)(viii) of this section applies by measuring the time period for identification from the date of the modification and without regard to the requirement for a hedge provider's certification.

    (D) Continuations of certain qualified hedges in refundings. If hedged bonds are redeemed using proceeds of a refunding issue, the qualified hedge for the refunded bonds is not actually terminated, and the hedge meets the requirements for a qualified hedge for the refunding bonds as of the issue date of the refunding bonds, then no termination of the hedge occurs and the hedge instead is treated as a qualified hedge for the refunding bonds. For purposes of this paragraph (h)(3)(iv)(D), when determining whether the hedge is a qualified hedge for the refunding bonds, the fact that the hedge is off-market with respect to the refunding bonds as of the issue date of the refunding bonds is disregarded and the identification requirement in paragraph (h)(2)(viii) of this section applies by measuring the time period for identification from the issue date of the refunding bonds and without regard to the requirement for a hedge provider's certification.

    (E) General allocation rules for hedge termination payments. Except as otherwise provided in paragraphs (h)(3)(iv)(F), (G), and (H) of this section, a payment made or received by an issuer to terminate a qualified hedge, or a payment deemed made or received for a deemed termination, is treated as a payment made or received, as appropriate, on the hedged bonds. Upon an actual termination or a deemed termination of a qualified hedge, the amount that an issuer may treat as a termination payment made or received on the hedged bonds is the fair market value of the qualified hedge on its termination date, based on all of the facts and circumstances. Except as otherwise provided, a termination payment is reasonably allocated to the remaining periods originally covered by the terminated hedge in a manner that reflects the economic substance of the hedge.

    (F) Special rule for terminations when bonds are redeemed. Except as otherwise provided in this paragraph (h)(3)(iv)(F) and in paragraph (h)(3)(iv)(G) of this section, when a qualified hedge is deemed terminated because the hedged bonds are redeemed, the termination payment as determined under paragraph (h)(3)(iv)(E) of this section is treated as made or received on that date. * * *

    (G) Special rules for refundings. When there is a termination of a qualified hedge because there is a refunding of the hedged bonds, to the extent that the hedged bonds are redeemed using the proceeds of a refunding issue, the termination payment is accounted for under paragraph (h)(3)(iv)(E) of this section by treating it as a payment on the refunding issue, rather than the hedged bonds. In addition, to the extent that the refunding issue is redeemed during the period to which the termination payment has been allocated to that issue, paragraph (h)(3)(iv)(F) of this section applies to the termination payment by treating it as a payment on the redeemed refunding issue.

    (H) Safe harbor for allocation of certain termination payments. A payment to terminate a qualified hedge does not result in that hedge failing to satisfy the applicable provisions of paragraph (h)(3)(iv)(E) of this section if that payment is allocated in accordance with this paragraph (h)(3)(iv)(H). * * *

    (4) * * *

    (i) * * *

    (C) * * * A hedge based on a taxable interest rate or taxable interest index cannot meet the requirements of this paragraph (h)(4)(i)(C) unless either—

    (1) The hedge is an anticipatory hedge that is terminated or otherwise closed substantially contemporaneously with the issuance of the hedged bond in accordance with paragraph (h)(5)(ii) or (iii) of this section; or

    (2) The issuer's payments on the hedged bonds and the hedge provider's payments on the hedge are based on identical interest rates.

    (iv) Consequences of certain modifications. The special rules under paragraph (h)(4)(iii) of this section regarding the effects of termination of a qualified hedge of fixed yield hedged bonds apply to a modification described in paragraph (h)(3)(iv)(C) of this section. Thus, such a modification is treated as a termination for purposes of paragraph (h)(4)(iii) of this section unless the rule in paragraph (h)(4)(iii)(C) applies.

    Par. 10. Section 1.148-5 is amended by: 1. Revising paragraph (c)(3). 2. Revising paragraphs (d)(2) and (3). 3. Revising the last sentence in paragraph (d)(6)(i) and adding a sentence at the end of the paragraph. 4. Revising paragraphs (d)(6)(iii)(A)(1) and (6). 5. Revising the second sentence of paragraph (e)(2)(ii)(B).

    The revisions and additions read as follows:

    § 1.148-5 Yield and valuation of investments.

    (c) * * *

    (3) Applicability of special yield reduction rule. Paragraph (c) applies only to investments that are described in at least one of paragraphs (c)(3)(i) through (ix) of this section and, except as otherwise expressly provided in paragraphs (c)(3)(i) through (ix) of this section, that are allocated to proceeds of an issue other than gross proceeds of an advance refunding issue.

    (i) Nonpurpose investments allocated to proceeds of an issue that qualified for certain temporary periods. Nonpurpose investments allocable to proceeds of an issue that qualified for one of the temporary periods available for capital projects, working capital expenditures, pooled financings, or investment proceeds under § 1.148-2(e)(2), (3), (4), or (6), respectively.

    (ii) Investments allocable to certain variable yield issues. Investments allocable to a variable yield issue during any computation period in which at least 5 percent of the value of the issue is represented by variable yield bonds, unless the issue is an issue of hedge bonds (as defined in section 149(g)(3)(A)).

    (iii) Nonpurpose investments allocable to certain transferred proceeds. Nonpurpose investments allocable to transferred proceeds of—

    (A) A current refunding issue to the extent necessary to reduce the yield on those investments to satisfy yield restrictions under section 148(a); or

    (B) An advance refunding issue to the extent that investment of the refunding escrows allocable to the proceeds, other than transferred proceeds, of the refunding issue in zero-yielding nonpurpose investments is insufficient to satisfy yield restrictions under section 148(a).

    (iv) Purpose investments allocable to qualified student loans and qualified mortgage loans. Purpose investments allocable to qualified student loans and qualified mortgage loans.

    (v) Nonpurpose investments allocable to gross proceeds in certain reserve funds. Nonpurpose investments allocable to gross proceeds of an issue in a reasonably required reserve or replacement fund or a fund that, except for its failure to satisfy the size limitation in § 1.148-2(f)(2)(ii), would qualify as a reasonably required reserve or replacement fund, but only to the extent the requirements in paragraphs (c)(3)(v)(A) or (B) of this section are met. This paragraph (c)(3)(v) includes nonpurpose investments described in this paragraph that are allocable to transferred proceeds of an advance refunding issue, but only to the extent necessary to satisfy yield restriction under section 148(a) on those proceeds treating all investments allocable to those proceeds as a separate class.

    (A) The value of the nonpurpose investments in the fund is not greater than 15 percent of the stated principal amount of the issue, as computed under § 1.148-2(f)(2)(ii).

    (B) The amounts in the fund (other than investment earnings) are not reasonably expected to be used to pay debt service on the issue other than in connection with reductions in the amount required to be in that fund (for example, a reserve fund for a revolving fund loan program).

    (vi) Nonpurpose investments allocable to certain replacement proceeds of refunded issues. Nonpurpose investments allocated to replacement proceeds of a refunded issue, including a refunded issue that is an advance refunding issue, as a result of the application of the universal cap to amounts in a refunding escrow.

    (vii) Investments allocable to replacement proceeds under a certain transition rule. Investments described in § 1.148-11(f).

    (viii) Nonpurpose investments allocable to proceeds when State and Local Government Series Securities are unavailable. Nonpurpose investments allocable to proceeds of an issue, including an advance refunding issue, that an issuer purchases if, on the date the issuer enters into the agreement to purchase such investments, the issuer is unable to subscribe for State and Local Government Series Securities because the U.S. Department of the Treasury, Bureau of the Fiscal Service, has suspended sales of those securities.

    (ix) Nonpurpose investments allocable to proceeds of certain variable yield advance refunding issues. Nonpurpose investments allocable to proceeds of the portion of a variable yield issue used for advance refunding purposes that are deposited in a yield restricted defeasance escrow if—

    (A) The issuer has entered into a qualified hedge under § 1.148-4(h)(2) with respect to all of the variable yield bonds of the issue allocable to the yield restricted defeasance escrow and that hedge is in the form of a variable-to-fixed interest rate swap under which the issuer pays the hedge provider a fixed interest rate and receives from the hedge provider a floating interest rate;

    (B) Such qualified hedge covers a period beginning on the issue date of the hedged bonds and ending on or after the date on which the final payment is to be made from the yield restricted defeasance escrow; and

    (C) The issuer restricts the yield on the yield restricted defeasance escrow to a yield that is not greater than the yield on the issue, determined by taking into account the issuer's fixed payments to be made under the hedge and by assuming that the issuer's variable yield payments to be paid on the hedged bonds are equal to the floating payments to be received by the issuer under the qualified hedge and are paid on the same dates (that is, such yield reduction payments can only be made to address basis risk differences between the variable yield payments on the hedged bonds and the floating payments received on the hedge).

    (d) * * *

    (2) Mandatory valuation of certain yield restricted investments at present value. A purpose investment must be valued at present value, and except as otherwise provided in paragraphs (b)(3) and (d)(3) of this section, a yield restricted nonpurpose investment must be valued at present value.

    (3) Mandatory valuation of certain investments at fair market value—(i) In general. Except as otherwise provided in paragraphs (d)(3)(ii) and (d)(4) of this section, a nonpurpose investment must be valued at fair market value on the date that it is first allocated to an issue or first ceases to be allocated to an issue as a consequence of a deemed acquisition or deemed disposition. For example, if an issuer deposits existing nonpurpose investments into a sinking fund for an issue, those investments must be valued at fair market value as of the date first deposited into the fund.

    (ii) Exception to fair market value requirement for transferred proceeds allocations, certain universal cap allocations, and commingled funds. Paragraph (d)(3)(i) of this section does not apply if the investment is allocated from one issue to another as a result of the transferred proceeds allocation rule under § 1.148-9(b) or is deallocated from one issue as a result of the universal cap rule under § 1.148-6(b)(2) and reallocated to another issue as a result of a preexisting pledge of the investment to secure that other issue, provided that, in either circumstance (that is, transferred proceeds allocations or universal cap deallocations), the issue from which the investment is allocated (that is, the first issue in an allocation from one issue to another issue) consists of tax-exempt bonds. In addition, paragraph (d)(3)(i) of this section does not apply to investments in a commingled fund (other than a bona fide debt service fund) unless it is an investment being initially deposited in or withdrawn from a commingled fund described in § 1.148-6(e)(5)(iii).

    (6) * * *

    (i) * * * On the purchase date, the fair market value of a United States Treasury obligation that is purchased directly from the United States Treasury, including a State and Local Government Series Security, is its purchase price. The fair market value of a State and Local Government Series Security on any date other than the purchase date is the redemption price for redemption on that date.

    (iii) * * *

    (A) * * *

    (1) The bid specifications are in writing and are timely disseminated to potential providers. For purposes of this paragraph (d)(6)(iii)(A)(1), a writing may be in electronic form and may be disseminated by fax, email, an internet-based Web site, or other electronic medium that is similar to an internet-based Web site and regularly used to post bid specifications.

    (6) All potential providers have an equal opportunity to bid. If the bidding process affords any opportunity for a potential provider to review other bids before providing a bid, then providers have an equal opportunity to bid only if all potential providers have an equal opportunity to review other bids. Thus, no potential provider may be given an opportunity to review other bids that is not equally given to all potential providers (that is, no exclusive “last look”).

    (e) * * *

    (2) * * *

    (ii) * * *

    (B) * * * For purposes of this paragraph (e)(2)(ii)(B), a fund is treated as widely held only if, during the immediately preceding fixed, semiannual period chosen by the fund (for example, semiannual periods ending June 30 and December 31), the fund had a daily average of more than 15 investors that were not related parties, and at least 16 of the unrelated investors each maintained a daily average amount invested in the fund that was not less than the lesser of $500,000 and one percent (1%) of the daily average of the total amount invested in the fund (with it being understood that additional smaller investors will not disqualify the fund). * * *

    Par. 11. Section 1.148-6 is amended by: 1. Revising the second sentence of paragraph (d)(3)(iii)(A). 2. Removing paragraph (d)(4)(iii).

    The revision reads as follows:

    § 1.148-6 General allocation and accounting rules.

    (d) * * *

    (3) * * *

    (iii) * * *

    (A) * * * Except as otherwise provided, available amount excludes proceeds of any issue but includes cash, investments, and other amounts held in accounts or otherwise by the issuer or a related party if those amounts may be used by the issuer for working capital expenditures of the type being financed by an issue without legislative or judicial action and without a legislative, judicial, or contractual requirement that those amounts be reimbursed.

    Par. 12. Section 1.148-7 is revised by: 1. Revising paragraph (c)(3)(v). 2. Revising paragraph (i)(6)(ii).

    The revisions read as follows:

    § 1.148-7 Spending exceptions to the rebate requirement.

    (c) * * *

    (3) * * *

    (v) Representing repayments of grants (as defined in § 1.150-1(f)) financed by the issue.

    (i) * * *

    (6) * * *

    (ii) Repayments of grants (as defined in § 1.150-1(f)) financed by the issue.

    Par. 13. Section 1.148-8(d) is revised to read as follows:
    § 1.148-8 Small issuer exception to rebate requirement.

    (d) Pooled financings—treatment of conduit borrowers. A loan to a conduit borrower in a pooled financing qualifies for the small issuer exception, regardless of the size of either the pooled financing or of any loan to other conduit borrowers, only if—

    (1) The bonds of the pooled financing are not private activity bonds;

    (2) None of the loans to conduit borrowers are private activity bonds; and

    (3) The loan to the conduit borrower meets all the requirements of the small issuer exception.

    Par. 14. Section 1.148-10 is amended by: 1. Revising the last sentence of paragraph (a)(4). 2. Revising the heading and first sentence of paragraph (e).

    The revisions read as follows:

    § 1.148-10 Anti-abuse rules and authority of Commissioner.

    (a) * * *

    (4) * * * These factors may be outweighed by other factors, such as bona fide cost underruns, an issuer's bona fide need to finance extraordinary working capital items, or an issuer's long-term financial distress.

    (e) Authority of the Commissioner to prevent transactions that are inconsistent with the purpose of the arbitrage investment restrictions. If an issuer enters into a transaction for a principal purpose of obtaining a material financial advantage based on the difference between tax-exempt and taxable interest rates in a manner that is inconsistent with the purposes of section 148, the Commissioner may exercise the Commissioner's discretion to depart from the rules of § 1.148-1 through § 1.148-11 as necessary to reflect the economics of the transaction to prevent such financial advantage. * * *

    Par. 15. Section 1.148-11 is amended by: 1. Redesignating paragraphs (d)(1)(i), (ii), (iii), (iv), (v), and (vi) as paragraphs (d)(1)(i)(A), (B), (C), (D), (E), and (F), respectively. 2. Revising the heading of paragraph (d)(1) and adding introductory text to paragraph (d)(1)(i). 3. Revising newly redesignated paragraphs (d)(1)(i)(B), (D), and (F). 4. Adding new paragraph (d)(1)(ii). 5. Adding paragraph (k). 6. Revising paragraph (l).

    The revisions and additions read as follows:

    § 1.148-11 Effective/applicability dates.

    (d) * * *

    (1) Certain perpetual trust funds—(i) A guarantee by a fund created and controlled by a State and established pursuant to its constitution does not cause the amounts in the fund to be pledged funds treated as replacement proceeds if—

    (B) The corpus of the guarantee fund may be invaded only to support specifically designated essential governmental functions (designated functions) carried on by political subdivisions with general taxing powers or public elementary and public secondary schools;

    (D) The issue guaranteed consists of obligations that are not private activity bonds (other than qualified 501(c)(3) bonds) substantially all of the proceeds of which are to be used for designated functions;

    (F) As of the sale date of the bonds to be guaranteed, the amount of the bonds to be guaranteed by the fund plus the then-outstanding amount of bonds previously guaranteed by the fund does not exceed a total amount equal to 500 percent of the total costs of the assets held by the fund as of December 16, 2009.

    (ii) The Commissioner may, by published guidance, set forth additional circumstances under which guarantees by certain perpetual trust funds will not cause amounts in the fund to be treated as replacement proceeds.

    (k) Certain arbitrage guidance updates—(1) In general. Sections 1.148-1(c)(4)(i)(B)(1); 1.148-1(c)(4)(i)(B)(4); 1.148-1(c)(4)(ii); 1.148-2(e)(3)(i); 1.148-3(d)(1)(iv); 1.148-3(d)(4); 1.148-4(a); 1.148-4(b)(3)(i); 1.148-4(h)(2)(ii)(A); 1.148-4(h)(2)(v); 1.148-4(h)(2)(vi); 1.148(h)(4)(i)(C); 1.148-5(c)(3); 1.148-5(d)(2); 1.148-5(d)(3); 1.148-5(d)(6)(i); 1.148-5(d)(6)(iii)(A); 1.148-5(e)(2)(ii)(B); 1.148-6(d)(4); 1.148-7(c)(3)(v); 1.148-7(i)(6)(ii); 1.148-10(a)(4); 1.148-10(e); 1.148-11(d)(1)(i)(B); 1.148-11(d)(1)(i)(D); 1.148-11(d)(1)(i)(F); and 1.148-11(d)(1)(ii) apply to bonds sold on or after October 17, 2016.

    (2) Valuation of investments in refunding transactions. Section 1.148-5(d)(3) also applies to bonds refunded by bonds sold on or after October 17, 2016.

    (3) Rebate overpayment recovery. (i) Section 1.148-3(i)(3)(i) applies to claims arising from an issue of bonds to which § 1.148-3(i) applies and for which the final computation date is after June 24, 2008. For purposes of this paragraph (k)(3)(i), issues for which the actual final computation date is on or before June 24, 2008, are deemed to have a final computation date of July 1, 2008, for purposes of applying § 1.148-3(i)(3)(i).

    (ii) Section 1.148-3(i)(3)(ii) and (iii) apply to claims arising from an issue of bonds to which § 1.148-3(i) applies and for which the final computation date is after September 16, 2013.

    (iii) Section 1.148-3(j) applies to bonds subject to § 1.148-3(i).

    (4) Hedge identification. Section 1.148-4(h)(2)(viii) applies to hedges that are entered into on or after October 17, 2016.

    (5) Hedge modifications and termination. Section 1.148-4(h)(3)(iv)(A) through (H) and (h)(4)(iv) apply to—

    (i) Hedges that are entered into on or after October 17, 2016;

    (ii) Qualified hedges that are modified on or after October 17, 2016 with respect to modifications on or after such date; and

    (iii) Qualified hedges on bonds that are refunded on or after October 17, 2016 with respect to the refunding on or after such date.

    (6) Small issuer exception to rebate requirement for conduit borrowers of pooled financings. Section 1.148-8(d) applies to bonds issued after May 17, 2006.

    (l) Permissive application of certain arbitrage updates—(1) In general. Except as otherwise provided in this paragraph (l), issuers may apply the provisions described in paragraph (k)(1), (2), and (5) in whole, but not in part, to bonds sold before October 17, 2016.

    (2) Computation credit. Issuers may apply § 1.148-3(d)(1)(iv) and (d)(4) for bond years ending on or after October 17, 2016.

    (3) Yield reduction payments. Issuers may apply § 1.148-5(c)(3) for investments purchased on or after October 17, 2016.

    (4) External commingled funds. Issuers may apply § 1.148-5(e)(2)(ii)(B) with respect to costs incurred on or after July 18, 2016.

    Par. 16. Section 1.150-1 is amended by: 1. Adding paragraph (a)(2)(iii). 2. Adding a definition for “tax-advantaged bond” in alphabetical order to paragraph (b). 3. Revising paragraph (c)(2). 4. Adding paragraph (f).

    The revisions and additions read as follows:

    § 1.150-1 Definitions.

    (a) * * *

    (2) * * *

    (iii) Special effective date for definitions of tax-advantaged bond, issue, and grant. The definition of tax-advantaged bond in paragraph (b) of this section, the revisions to the definition of issue in paragraph (c)(2) of this section, and the definition and rules regarding the treatment of grants in paragraph (f) of this section apply to bonds that are sold on or after October 17, 2016.

    (b) * * *

    Tax-advantaged bond means a tax-exempt bond, a taxable bond that provides a federal tax credit to the investor with respect to the issuer's borrowing costs, a taxable bond that provides a refundable federal tax credit payable directly to the issuer of the bond for its borrowing costs under section 6431, or any future similar bond that provides a federal tax benefit that reduces an issuer's borrowing costs. Examples of tax-advantaged bonds include qualified tax credit bonds under section 54A(d)(1) and build America bonds under section 54AA.

    (c) * * *

    (2) Exceptions for different types of tax-advantaged bonds and taxable bonds. Each type of tax-advantaged bond that has a different structure for delivery of the tax benefit that reduces the issuer's borrowing costs or different program eligibility requirements is treated as part of a different issue under this paragraph (c). Further, tax-advantaged bonds and bonds that are not tax-advantaged bonds are treated as part of different issues under this paragraph (c). The issuance of tax-advantaged bonds in a transaction with other bonds that are not tax-advantaged bonds must be tested under the arbitrage anti-abuse rules under § 1.148-10(a) and other applicable anti-abuse rules (for example, limitations against window maturity structures or unreasonable allocations of bonds).

    (f) Definition and treatment of grants—(1) Definition. Grant means a transfer for a governmental purpose of money or property to a transferee that is not a related party to or an agent of the transferor. The transfer must not impose any obligation or condition to directly or indirectly repay any amount to the transferor or a related party. Obligations or conditions intended solely to assure expenditure of the transferred moneys in accordance with the governmental purpose of the transfer do not prevent a transfer from being a grant.

    (2) Treatment. Except as otherwise provided (for example, § 1.148-6(d)(4), which treats proceeds used for grants as spent for arbitrage purposes when the grant is made), the character and nature of a grantee's use of proceeds are taken into account in determining which rules are applicable to the bond issue and whether the applicable requirements for the bond issue are met. For example, a grantee's use of proceeds generally determines whether the proceeds are used for capital projects or working capital expenditures under section 148 and whether the qualified purposes for the specific type of bond issue are met.

    Par. 17. Section 1.150-2(d)(3) is amended by: 1. Amending paragraph (a) by adding an entry for § 1.150-2(j)(3). 2. Revising paragraphs (d)(3) and (j)(1). 3. Adding paragraph (j)(3).

    The revisions and additions read as follows:

    § 1.150-2 Proceeds of bonds used for reimbursement.

    (a) * * *

    (j) * * *

    (3) Nature of expenditure.

    (d) * * *

    (3) Nature of expenditure. The original expenditure is a capital expenditure, a cost of issuance for a bond, an expenditure described in § 1.148-6(d)(3)(ii)(B) (relating to certain extraordinary working capital items), a grant (as defined in § 1.150-1(f)), a qualified student loan, a qualified mortgage loan, or a qualified veterans' mortgage loan.

    (j) * * *

    (1) In general. Except as otherwise provided, the provisions of this section apply to all allocations of proceeds of reimbursement bonds issued after June 30, 1993.

    (3) Nature of expenditure. Paragraph (d)(3) of this section applies to bonds that are sold on or after October 17, 2016.

    John Dalrymple, Deputy Commissioner for Services and Enforcement. Approved: June 28, 2016. Mark J. Mazur, Assistant Secretary of the Treasury.
    [FR Doc. 2016-16558 Filed 7-15-16; 8:45 am] BILLING CODE 4830-01-P
    DEPARTMENT OF THE INTERIOR Bureau of Ocean Energy Management 30 CFR Parts 550 and 556 [MMAA104000] Notice of Availability of Notice to Lessees and Operators of Federal Oil and Gas, and Sulfur Leases, and Holders of Pipeline Right-of-Way and Right-of-Use and Easement Grants in the Outer Continental Shelf—Requiring Additional Security AGENCY:

    Bureau of Ocean Energy Management (BOEM), Interior.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Bureau of Ocean Energy Management (BOEM) is announcing the availability of a guidance document entitled, “Notice to Lessees and Operators of Federal Oil and Gas, and Sulfur Leases, and Holders of Pipeline Right-of-Way and Right-of-Use and Easement Grants in the Outer Continental Shelf—Requiring Additional Security” (NTL No. 2016-N01).

    DATES:

    This guidance document will become effective on September 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Robert Sebastian, Office of Policy, Regulation and Analysis at (504) 736-2761 or email at [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    The Bureau of Ocean Energy Management (BOEM) issues Notices to Lessees (NTL) as guidance documents in accordance with 30 CFR 550.103 to clarify and provide more detail about certain BOEM regulatory requirements, and to outline the information to be provided in various submittals. Under that authority, NTL No. 2016-N01, Requiring Additional Security, sets forth a policy on, and an interpretation of, regulatory requirements to provide a clear and consistent approach for complying with those requirements.

    BOEM is issuing this NTL to clarify the procedures and criteria that BOEM Regional Directors use to determine if and when additional security, pursuant to 30 CFR 556.901(d)-(f), may be required for Outer Continental Shelf (OCS) leases, pipeline rights-of-way (ROW), and rights-of-use and easement (RUE). The guidance and clarification of requirements described in this NTL apply to all BOEM regions. This NTL has also been reformatted, revised, and updated to include correct Bureau names, citations, and web addresses. This NTL supersedes and replaces NTL No. 2008-N07, Supplemental Bond Procedures.

    This NTL details several changes in policy that are within the scope of the existing regulations and the discretion vested in the BOEM Regional Directors. First, BOEM has determined that its previously utilized formulas for determining financial strength and reliability are outdated and no longer provide sufficient protection for liabilities incurred during OCS operations. Therefore, this NTL describes new criteria that will be used to determine the financial ability of a lessee, ROW holder, or RUE holder to carry out its obligations, and addresses the possibility of individually tailoring a plan to enable the lessee, ROW holder, or RUE holder to use one or more forms of security other than surety bonds and pledges of Treasury securities and/or to phase-in compliance with the additional security requirement pursuant to such a plan. In addition, the current self-insurance upper limit of 50% of a lessee's net worth is being reduced and will range from 0% to no more than 10% of a lessee's “tangible net worth” as defined in the NTL.

    Second, this NTL discontinues two policies under NTL No. 2008-N07: (1) If BOEM determined that one or more co-lessees or co-owners had sufficient financial strength and reliability, it was not necessary to provide additional security; and (2) for the purpose of determining the requirement for additional security, BOEM excluded from its decommissioning liability calculation the full amount of the decommissioning liability on leases, ROWs, and RUEs for which there was at least one financially strong co-lessee or co-owner. Thus lessees will no longer be granted waivers from the additional security obligations, and BOEM is discontinuing the policy of considering the combined strength and reliability of co-lessees when determining a lessee's additional security requirements. Now, when determining the amount of additional security that may be required, the Regional Director will consider whether each lessee, ROW holder, or RUE holder is capable of addressing the responsibility for 100 percent of the cost of decommissioning and other liability for every lease, ROW, and RUE in which the lessee, ROW holder, or RUE holder holds an ownership interest or for which they provide a guarantee. In order to meet all or a portion of the additional security required for any one lease, ROW, or RUE, BOEM will take into account enforceable agreements that lessees, ROW holders or RUE holders have made with their co-lessees or co-owners regarding the allocation of security obligations to such lease, ROW, or RUE.

    II. Electronic Access

    NTL No. 2016-N01 is available on BOEM's Web site at: http://www.boem.gov/Notices-to-Lessees-and-Operators/.

    Authority:

    This document is published pursuant to the Outer Continental Shelf Lands Act of August 7, 1953; 43 U.S.C. 1331 et seq., as amended, and the implementing regulations at 30 CFR 550.103.

    Date: July 12, 2016. Abigail Ross Hopper, Director, Bureau of Ocean Energy Management.
    [FR Doc. 2016-16846 Filed 7-15-16; 8:45 am] BILLING CODE 4310-MR-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0682] Drawbridge Operation Regulation; Black Warrior River, Eutaw, Alabama AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulations.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Norfolk Southern Railroad vertical lift span bridge across the Black Warrior River, mile 267.8, at Eutaw, Greene County, Alabama. This deviation is necessary to install drive motors necessary for the continued safe operation of the bridge. This deviation allows the bridge to remain closed for two (2) three-hour periods daily, Monday through Thursday for three consecutive weeks.

    DATES:

    This deviation is effective from August 1, 2016 through August 18, 2016.

    ADDRESSES:

    The docket for this deviation, [USCG-2016-0682] is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email David Frank, Bridge Administration Branch, Coast Guard; telephone 504-671-2128, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Norfolk Southern Corporation requested a temporary deviation in order to perform maintenance on the Norfolk Southern Railroad vertical lift span bridge across the Black Warrior River, mile 267.8, at Eutaw, Greene County, Alabama. This deviation allows the bridge owner to install drive motors necessary to improve reliability and safe operation of the movable bridge. This temporary deviation allows the bridge to remain closed to navigation from 8 a.m. until 11 a.m. and from 1 p.m. until 4 p.m. daily, Monday through Thursday, August 1, 2016 through August 18, 2016.

    The Norfolk Southern Railroad vertical lift span drawbridge currently operates in accordance with 33 CFR 117.5, which states the general requirement that the drawbridge shall open on signal. The bridge has a vertical clearance of 18.3 feet above Bridge Reference Elevation for Navigation Clearance (BRENC), elevation 99.2 feet, in the closed-to-navigation position and 72 feet above BRENC in the open-to-navigation position. Navigation on the waterway consists primarily of tugs with tows and occasional recreational craft. The Coast Guard has coordinated this temporary deviation with the Warrior-Tombigbee Waterway Association (WTWA). The WTWA representative indicated that the vessel operators will be able to schedule transits through the bridge such that operations will not significantly be hindered. Thus, it has been determined that this temporary deviation will not have a significant effect on these vessels.

    Vessels able to pass through the bridge in the closed position may do so at any time and should pass at the slowest safe speed. The bridge will be able to open for emergencies and there are no immediate alternate routes for vessels to pass.

    The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge.

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

    Dated: July 12, 2016. David M. Frank, Bridge Administrator, Eighth Coast Guard District.
    [FR Doc. 2016-16864 Filed 7-15-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2011-1126] Security Zones; Seattle's Seafair Fleet Week Moving Vessels, 2016, Puget Sound, WA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of enforcement of regulation.

    SUMMARY:

    The Coast Guard will enforce Seattle's Seafair Fleet Week Moving Vessels security zones from 10 a.m. on August 2, 2016, through 6 p.m. on August 8, 2016. These security zones are necessary to help ensure the security of the vessels from sabotage or other subversive acts during Seafair Fleet Week Parade of Ships. The designated participating vessels are: HMCS SASKATOON (MM 709) and USCGC ACTIVE (WMEC 618). During the enforcement period, no person or vessel may enter or remain in the security zones without the permission of the Captain of the Port (COTP), Puget Sound or his designated representative. The COTP has granted general permission for vessels to enter the outer 400 yards of the security zones as long as those vessels within the outer 400 yards of the security zones operate at the minimum speed necessary to maintain course unless required to maintain speed by the navigation rules.

    DATES:

    The regulations in 33 CFR 165.1333 will be enforced from 10 a.m. on August 2, 2016 through 6 p.m. on August 8, 2016, unless canceled sooner by the Captain of the Port, Puget Sound or his designated representative.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this notice, call or email LT Kate Haseley, Sector Puget Sound Waterways Management, Coast Guard; telephone (206) 217-6051, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Coast Guard will enforce the security zones for Seattle's Seafair Fleet Week Moving Vessels in 33 CFR 165.1333 from 10 a.m. on August 2, 2016, through 6 p.m. on August 8, 2016.

    In accordance with the general regulations in 33 CFR part 165, subpart D, no person or vessel may enter or remain in the security zones without the permission of the Captain of the Port, Puget Sound or his designated representative. For the purposes of this rule, the following areas are security zones: All navigable waters within 500 yards of HMCS SASKATOON (MM 709) and USCGC ACTIVE (WMEC 618) while each such vessel is in the Sector Puget Sound COTP Zone.

    The COTP has granted general permission for vessels to enter the outer 400 yards of the security zones as long as those vessels within the outer 400 yards of the security zones operate at the minimum speed necessary to maintain course unless required to maintain speed by the navigation rules. The COTP may be assisted by other federal, state or local agencies with the enforcement of the security zones.

    All vessel operators who desire to enter the inner 100 yards of the security zones or transit the outer 400 yards at greater than minimum speed necessary to maintain course must obtain permission from the COTP or his designated representative by contacting the on-scene patrol craft on VHF 13 or Ch 16. Requests must include the reason why movement within this area is necessary. Vessel operators granted permission to enter the security zones will be escorted by the on-scene patrol craft until they are outside of the security zones.

    This notice is issued under authority of 33 CFR 165.1333 and 5 U.S.C. 552(a). In addition to this notice of enforcement, the Coast Guard will provide the maritime community with advanced notification of the security zones via the Local Notice to Mariners and marine information broadcasts on the day of the event.

    Dated: July 11, 2016. M.W. Raymond, Captain, U.S. Coast Guard, Captain of the Port, Puget Sound.
    [FR Doc. 2016-16871 Filed 7-15-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket No. USCG-2011-0451] Safety Zone, Seafair Air Show Performance, 2016, Seattle, WA AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of enforcement of regulation.

    SUMMARY:

    The Coast Guard will enforce the annual Seafair Air Show Performance safety zone on Lake Washington, Seattle, WA daily, from 8 a.m. until 4 p.m., from August 4, 2016, through August 7, 2016. This action is necessary to ensure the safety of the public from inherent dangers associated with these annual aerial displays. During the enforcement period, no person or vessel may enter or transit this safety zone unless authorized by the Captain of the Port or his designated representative.

    DATES:

    The regulations in 33 CFR 165.1319 will be enforced daily, from 8 a.m. until 4 p.m., from August 4, 2016, through August 7, 2016.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this notice of enforcement, call or email LT Kate Haseley, Sector Puget Sound Waterways Management Division, Coast Guard; telephone (206) 217-6051, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Coast Guard will enforce the Seafair Air Show Performance safety zone in 33 CFR 165.1319 daily, from 8 a.m. until 4 p.m., from August 4, 2016, through August 7, 2016 unless canceled sooner by the Captain of the Port.

    Under the provisions of 33 CFR 165.1319, the following area is designated as a safety zone: All waters of Lake Washington, Washington State, south of the Interstate 90 bridge, west of Mercer Island, and north of Seward Park. The specific boundaries of the safety zone are listed in 33 CFR 165.1319(b).

    In accordance with the general regulations in 33 CFR part 165, subpart C, no person or vessel may enter or remain in the zone except for support vessels and support personnel, vessels registered with the event organizer, or other vessels authorized by the Captain of the Port or Designated Representatives. Vessels and persons granted authorization to enter the safety zone must obey all lawful orders or directions made by the Captain of the Port or his designated representative.

    The Captain of the Port may be assisted by other federal, state and local law enforcement agencies in enforcing this regulation.

    This document is issued under authority of 33 CFR 165.1319 and 5 U.S.C. 552(a). In addition to this notice of enforcement in the Federal Register, the Coast Guard will provide the maritime community with advanced notification of the safety zone via the Local Notice to Mariners and marine information broadcasts on the day of the event. If the COTP determines that the safety zone need not be enforced for the full duration stated in this notice of enforcement, he may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area.

    Dated: July 11, 2016. M.W. Raymond, Captain, U.S. Coast Guard, Captain of the Port, Puget Sound.
    [FR Doc. 2016-16870 Filed 7-15-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 17 RIN 2900-AP42 Prescriptions in Alaska and U.S. Territories and Possessions AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Final rule.

    SUMMARY:

    The Department of Veterans Affairs (VA) is removing its medical regulation that governs medications provided in Alaska and territories and possessions of the United States because this regulation is otherwise subsumed by another VA medical regulation related to provision of medications that are prescribed by non-VA providers.

    DATES:

    This final rule is effective August 17, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Kristin J. Cunningham, Director, Business Policy, Chief Business Office (10D), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Ave. NW., Washington, DC 20420; (202) 382-2508. (This is not a toll-free number.)

    SUPPLEMENTARY INFORMATION:

    In a document published in the Federal Register on February 8, 2016 (81 FR 6479), VA proposed to amend part 17 of 38 CFR by amending the regulations that govern medication provided in Alaska and territories and possessions of the United States. We provided a 60-day comment period, which ended on April 8, 2016. We received no comments on the proposed rule. Under section 1712(d) of title 38 United States Code (U.S.C.), VA must furnish medications to veterans who receive increased compensation or pension benefits by reason of being permanently housebound or in need of regular aid and attendance, if such medications are prescribed for the treatment of any injury or illness suffered by such veteran. VA originally promulgated two regulations on October 4, 1967, to implement section 1712(d), in title 38 Code of Federal Regulations (CFR) 17.60d and 17.60e. See 32 FR 13816. Section 1712(d) does not require these certain veterans to be receiving VA hospital care or medical services as a condition of receiving medications from VA and § 17.60d provided that VA pharmacies would fill prescriptions for these veterans when they were receiving care from a non-VA provider to treat any of the veteran's illnesses or injuries. See 32 FR 13816 (October 4, 1967). Section 17.60e, in turn, addressed geographic areas that, at the time, did not have VA pharmacies—§ 17.60e provided that in those areas without VA pharmacies, VA may reimburse the cost of prescriptions that otherwise would have been filled under § 17.60d. See 32 CFR 13816 (October 4, 1967).

    Sections 17.60d and 17.60e were renumbered as §§ 17.96 and 17.97, respectively, and relate to the same cohort of veterans for whom VA is authorized to provide prescription medication under section 1712(d). Because the same cohort of veterans is at issue in §§ 17.96 and 17.97, and because § 17.96 already provides for the filling of prescriptions in non-VA pharmacies, a separate § 17.97 to address prescriptions in non-VA pharmacies (pharmacies in areas without VA pharmacies) is no longer necessary. We are, therefore, removing § 17.97 and marking it as reserved for future use, and are also revising § 17.96 to clarify that any non-VA pharmacy under contract with VA may be used, not just those non-VA pharmacies in a state home under contract with VA for filling prescriptions for patients in state homes.

    We are making one edit to the proposed revision of the introductory paragraph in § 17.96 for grammatical accuracy. No change to the meaning of the proposed regulation text is intended by this edit.

    Based on the rationale set forth in the Supplementary Information to the proposed rule and in this final rule, VA is adopting the proposed rule as a final rule with the edit discussed in this final rule.

    Effect of Rulemaking

    Title 38 of the Code of Federal Regulations, as revised by this final rulemaking, represents VA's implementation of its legal authority on this subject. Other than future amendments to this regulation or governing statutes, no contrary guidance or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible or, if not possible, such guidance is superseded by this rulemaking.

    Paperwork Reduction Act

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

    Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule directly affects only individuals and would not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this amendment is exempt from the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604.

    Executive Order 12866 and 13563

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

    The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's Web site at http://www.va.gov/orpm/, by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year to Date.”

    Unfunded Mandates

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

    Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans Dental Care; 64.012, Veterans Prescription Service; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 64.022, Veterans Home Based Primary Care; and 64.024, VA Homeless Providers Grant and Per Diem Program.

    Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on June 30, 2016, for publication.

    List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Health care, Health facilities, Health professions, Health records, Homeless, Mental health programs, Nursing homes, Veterans.

    Dated: June 30, 2016. Jeffrey Martin, Office Program Manager, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.

    For the reasons set forth in the preamble, we amend 38 CFR part 17 as follows:

    PART 17—MEDICAL 1. The authority citation for part 17 continues to read as follows: Authority:

    38 U.S.C. 501, and as noted in specific sections.

    2. Amend § 17.96 by revising the introductory text to read as follows:
    § 17.96 Medication prescribed by non-VA physicians.

    Any prescription, which is not part of authorized Department of Veterans Affairs hospital or outpatient care, for drugs and medicines ordered by a private or non-Department of Veterans Affairs doctor of medicine or doctor of osteopathy duly licensed to practice in the jurisdiction where the prescription is written, shall be filled by a Department of Veterans Affairs pharmacy or a non-VA pharmacy under contract with VA, including non-VA pharmacy in a state home under contract with VA for filling prescriptions for patients in state homes, provided:

    § 17.97 [Removed and reserved]
    3. Remove and reserve § 17.97.
    [FR Doc. 2016-16908 Filed 7-15-16; 8:45 am] BILLING CODE 8320-01-P
    DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 17 RIN 2900-AP59 Hospital Care and Medical Services for Camp Lejeune Veterans AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Final rule.

    SUMMARY:

    This document amends Department of Veterans Affairs (VA) regulations to reflect a statutory mandate that VA provide health care to certain veterans who served at Camp Lejeune, North Carolina, for at least 30 days during the period beginning on August 1, 1953, and ending on December 31, 1956. The law requires VA to furnish hospital care and medical services for these veterans for certain illnesses and conditions that may be attributed to exposure to toxins in the water system at Camp Lejeune. This rule does not address the statutory provision requiring VA to provide health care to these veterans' family members; regulations applicable to such family members will be promulgated through a separate final rule.

    DATES:

    Effective Date: This rule is effective July 18, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Bridget Souza, Deputy Director, Business Policy, VHA Office of Community Care (10D), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Ave. NW., Washington, DC 20420, (202) 382-2537. (This is not a toll-free number.)

    SUPPLEMENTARY INFORMATION:

    On August 6, 2012, the President signed into law the Honoring America's Veterans and Caring for Camp Lejeune Families Act of 2012, Public Law 112-154 (“the Act”). Among other things, section 102 of the Act amended section 1710 of title 38, United States Code (U.S.C.), to require VA to provide hospital care and medical services, for certain specified illnesses and conditions, to veterans who served at the Marine Corps base at Camp Lejeune, North Carolina (hereinafter referred to as Camp Lejeune), while on active duty in the Armed Forces for at least 30 days during the period beginning on January 1, 1957, and ending on December 31, 1987.

    On September 11, 2013, VA published a notice of proposed rulemaking setting forth proposed regulations to provide hospital care and medical services to certain veterans who served at Camp Lejeune for at least 30 days from January 1, 1957, to December 31, 1987 (“the 1957 cohort”). 78 FR 55671-55675, Sept. 11, 2013. A final rule issuing those regulations was published on September 24, 2014, at 79 FR 57409-57415. In addition to various other provisions, the rule promulgated 38 CFR 17.400, Hospital care and medical services for Camp Lejeune veterans.

    Subsequently, Congress passed the Consolidated and Further Continuing Appropriations Act, 2015, Public Law 113-235 (“the Consolidated Act”), which President Obama signed into law on December 16, 2014. Division I, Title II, § 243 of the law amended 38 U.S.C. 1710(e)(1)(F) by striking “January 1, 1957,” and inserting “August 1, 1953.” This added a new cohort of veterans to the group who are eligible for care pursuant to 38 U.S.C. 1710(e)(1)(F), namely, veterans who served on active duty in the Armed Forces at Camp Lejeune, North Carolina, for not fewer than 30 days during the period from August 1, 1953, to December 31, 1956 (the “1953 cohort”). Although this rulemaking revises regulations to reflect this statutory amendment, we note that VA is currently providing health care to veterans in the 1953 cohort under section 1710(e)(1)(F), as amended.

    Pursuant to the Consolidated Act, VA amends § 17.400 to account for the change in the date that begins the period of eligibility for Camp Lejeune veterans to receive VA hospital care and medical services. Specifically, we amend the definition of “Camp Lejeune veteran” in § 17.400(b) by deleting “January 1, 1957” and adding in its place “August 1, 1953.”

    Currently, § 17.400(d)(2) establishes a right to retroactive reimbursement for the 1957 cohort for any copayments paid to VA for VA care provided to the veteran on and after August 6, 2012, so long as the veteran requests Camp Lejeune status no later than September 24, 2016. We previously noted in a Notice of Proposed Rulemaking that the basis for limiting beginning of this retroactivity period to August 6, 2012, was that the law authorizing Camp Lejeune benefits became effective on that date. We also explained in the proposed and final rules that the basis for the end date of September 24, 2016, was that it provided veterans with sufficient time (ultimately two years from the date that the regulation took effect) to file for retroactive benefits. 79 FR 57410. In this rulemaking, we are providing a similar retroactivity provision in § 17.400(d)(2) for the new 1953 cohort.

    We further amend § 17.400(b) by adding a definition for “covered illness or condition.” This definition is comprised of the 15 illnesses and conditions for which VA is required to provide hospital care and medical services to veterans under 38 U.S.C. 1710(e)(1)(F). These illnesses and conditions are currently listed in § 17.400(d)(1), which addresses exemptions from copayments. We remove the list of these illnesses and conditions from § 17.400(d)(1) and add it as part of the newly-added definition of “covered illness or condition” in § 17.400(b) for the purpose of improving the overall clarity of § 17.400. This is not a substantive change. We also amend § 17.400(b) to correct the spelling of the condition “Myelodysplastic syndromes,” which is misspelled in current § 17.400. Similarly, we amend § 17.400(b) to make the word “lymphoma” lower case.

    We make one technical change to § 17.400(c) to remove the reference to “illnesses or conditions listed in paragraph (d)(1)(i) through (xv) of this section,” and add in its place a reference to “covered illness or condition,” because this term is now defined in § 17.400(b), as explained above. We make one clarifying change to § 17.400(c). Current § 17.400(c) refers to “the veteran's active duty in the Armed Forces” and “the veteran's service,” but does not specifically reference the veteran's active duty service at Camp Lejeune. We revise § 17.400(c) to state “VA will assume that a covered illness or condition is attributable to the veteran's active duty service at Camp Lejeune unless it is clinically determined, under VA clinical practice guidelines, that such an illness or condition resulted from a cause other than such service.” This is not a substantive change. As we stated in the preamble to the proposed rule, “[i]n § 17.400(c), we would explain that VA would assume that a veteran who has been diagnosed with one of the 15 illnesses or conditions listed in § 17.400(d)(1)(A)-(O) has that specific condition or illness due to his or her exposure to contaminated water during service at Camp Lejeune.” 78 FR 55671, 55673.

    We make several amendments to § 17.400(d). First, we amend paragraph (d)(1) by removing the current list of covered illnesses and conditions and adding them to the definitions in § 17.400(b), as noted above.

    We further amend § 17.400(d)(1) to specify the dates for each cohort for the exemption from copayments for hospital care and medical services provided for a covered illness or condition. Specifically, paragraph (d)(1)(i) provides that members of the 1957 cohort are not subject to such copayments for hospital care and medical services provided on or after August 6, 2012, the date that the Act was signed by the President and became effective. This provision is unchanged from the exemption provision for these veterans in former § 17.400(d)(1). Paragraph (d)(1)(ii) provides that members of the 1953 cohort are not subject to such copayments for hospital care and medical services provided on or after December 16, 2014, the date that the Consolidated Act was signed by the President and became effective. This distinction is required because the Consolidated Act's amendment to 38 U.S.C. 1710(e)(1)(F) changed the date of active duty service at Camp Lejeune that would qualify a veteran for hospital care and medical services based on such service; but it did not make such eligibility retroactive to the date on which the Act became effective. Accordingly, VA must limit the 1953 cohort's eligibility for exemption from copayments to the effective date of the Consolidated Act.

    We also revise § 17.400(d)(2) to provide the criteria for eligibility for the 1953 and 1957 cohorts' retroactive exemption from copayments, i.e., reimbursement of copayments previously paid to VA for hospital care and medical services for a covered illness or condition. Under paragraph (d)(2)(i), a Camp Lejeune veteran in the 1957 cohort will be reimbursed for copayments if VA provided the hospital care or medical services to the veteran on or after August 6, 2012, the date the veteran became eligible for hospital care and medical services under the Act, and the veteran requested Camp Lejeune veteran status no later than September 24, 2016, two years after the date on which § 17.400 was initially promulgated. This is not a substantive change from the retroactive exemption for these veterans in former § 17.400(d)(2).

    Under paragraph (d)(2)(ii), a Camp Lejeune veteran in the 1953 cohort will be reimbursed for copayments if VA provided the hospital care or medical services to the veteran on or after December 16, 2014, the date the veteran became eligible for hospital care and medical services by virtue of the Consolidated Act, and the veteran requested Camp Lejeune veteran status no later than July 18, 2018, two years after the effective date of this rule. We believe that two years will provide veterans sufficient time to learn about their new status and notify VA that they meet the requirements to be a Camp Lejeune veteran; this is the same look-back period provided to veterans in the 1957 cohort in paragraph (d)(2)(i). As in the case of exemptions from copayments, discussed above, we note that veterans in the 1953 cohort are not eligible for reimbursement for copayments made before December 16, 2014, because the Consolidated Act's amendment to 38 U.S.C. 1710(e)(1)(F) changed only the date of active duty service at Camp Lejeune that would qualify a veteran for Camp Lejeune status; it did not make such eligibility retroactive to the date of the Act. Accordingly, VA must limit the 1953 cohort's eligibility for reimbursement of copayments to the effective date of the Consolidated Act.

    Effect of Rulemaking

    Title 38 of the Code of Federal Regulations, as revised by this final rulemaking, represents VA's implementation of its legal authority on this subject. Other than future amendments to this regulation or governing statutes, no contrary guidance or procedures are authorized. All existing or subsequent VA guidance must be read to conform with this rulemaking if possible or, if not possible, such guidance is superseded by this rulemaking.

    Administrative Procedure Act

    The Secretary of Veterans Affairs finds under 5 U.S.C. 553(b)(B) that there is good cause to publish this rule without prior opportunity for public comment, and under 5 U.S.C. 553(d)(3) that there is good cause to publish this rule with an immediate effective date. This rulemaking makes clarifying, non-substantive changes to § 17.400 in addition to amending that regulation to incorporate a provision mandated by Congress. See Public Law 113-235. Notice and public comment is unnecessary because it could not result in any change to this provision. Further, since the public law became effective on its date of enactment, VA believes it is impracticable and contrary to law and the public interest to delay this rule for the purpose of soliciting advance public comment or to have a delayed effective date.

    Unfunded Mandates

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

    Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (at 44 U.S.C. 3501-3507) requires that VA consider the impact of paperwork and other information collection burdens imposed on the public. Under 44 U.S.C. 3507(a), an agency may not collect or sponsor the collection of information, nor may it impose an information collection requirement unless it displays a currently valid Office of Management and Budget (OMB) control number. See also 5 CFR 1320.8(b)(3)(vi).

    This final rule will impose the following amended information collection requirements. Veterans will apply for hospital care and medical services as a Camp Lejeune veteran under § 17.400 by completing VA Form 10-10EZ, “Application for Health Benefits,” which is required under 38 CFR 17.36(d) for all hospital care and medical services. OMB previously approved the collection of information for VA Form 10-10EZ and an amendment to that information collection, inclusion of a specific checkbox for individuals to identify themselves as meeting the requirements of being a Camp Lejeune veteran based on the required service at Camp Lejeune between 1957 and 1987, and assigned OMB control number 2900-0091. An amendment to the checkbox is needed so that veterans can identify themselves as meeting the requirements for being a Camp Lejeune veteran based on the required service at Camp Lejeune between August 1, 1953, and December 31, 1987. As required by the Paperwork Reduction Act of 1995 (at 44 U.S.C. 3507(d)), VA submitted this information collection amendment to OMB for its review. OMB approved the amended information collection requirements under existing control number 2900-0091.

    Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-12). This final rule will directly affect only individuals and will not affect any small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final flexibility analysis requirements of sections 603 and 604.

    Executive Order 12866 and Executive Order 13563

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

    The economic, interagency, budgetary, legal, and policy implications of this final rule have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's Web site at http://www.va.gov/orpm/, by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year to Date.”

    Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this rule are 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.012, Veterans Prescription Service; 64.013, Veterans Prosthetic Appliances; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; and 64.022, Veterans Home Based Primary Care.

    Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on June 30, 2016, for publication.

    List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Health care, Health facilities, Health professions, Health records, Homeless, Medical devices, Medical research, Mental health programs, Nursing homes, Veterans.

    Dated: June 30, 2016. Jeffrey Martin, Office Program Manager, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.

    For the reasons set forth in the supplementary information of this rulemaking, the Department of Veterans Affairs amends 38 CFR part 17 as follows:

    PART 17—MEDICAL 1. The authority citation for part 17 continues to read as follows: Authority:

    38 U.S.C. 501, and as noted in specific sections.

    2. Revise § 17.400 to read as follows:
    § 17.400 Hospital care and medical services for Camp Lejeune veterans.

    (a) General. In accordance with this section, VA will provide hospital care and medical services to Camp Lejeune veterans. Camp Lejeune veterans will be enrolled pursuant to § 17.36(b)(6).

    (b) Definitions. For the purposes of this section:

    Camp Lejeune means any area within the borders of the U.S. Marine Corps Base Camp Lejeune or Marine Corps Air Station New River, North Carolina.

    Camp Lejeune veteran means any veteran who served at Camp Lejeune on active duty, as defined in 38 U.S.C. 101(21), in the Armed Forces for at least 30 (consecutive or nonconsecutive) days during the period beginning on August 1, 1953, and ending on December 31, 1987. A veteran served at Camp Lejeune if he or she was stationed at Camp Lejeune, or traveled to Camp Lejeune as part of his or her professional duties.

    Covered illness or condition means any of the following illnesses and conditions:

    (i) Esophageal cancer;

    (ii) Lung cancer;

    (iii) Breast cancer;

    (iv) Bladder cancer;

    (v) Kidney cancer;

    (vi) Leukemia;

    (vii) Multiple myeloma;

    (viii) Myelodysplastic syndromes;

    (ix) Renal toxicity;

    (x) Hepatic steatosis;

    (xi) Female infertility;

    (xii) Miscarriage;

    (xiii) Scleroderma;

    (xiv) Neurobehavioral effects; and

    (xv) Non-Hodgkin's lymphoma.

    (c) Limitations. For a Camp Lejeune veteran, VA will assume that a covered illness or condition is attributable to the veteran's active duty service at Camp Lejeune unless it is clinically determined, under VA clinical practice guidelines, that such an illness or condition resulted from a cause other than such service.

    (d) Copayments—(1) Exemption. (i) Camp Lejeune veterans who served at Camp Lejeune between January 1, 1957, and December 31, 1987, are not subject to copayment requirements for hospital care and medical services provided for a covered illness or condition on or after August 6, 2012.

    (ii) Camp Lejeune veterans who served at Camp Lejeune between August 1, 1953, and December 31, 1956, are not subject to copayment requirements for hospital care and medical services provided for a covered illness or condition on or after December 16, 2014.

    (2) Retroactive exemption. VA will reimburse Camp Lejeune veterans for any copayments paid to VA for hospital care and medical services provided for a covered illness or condition if either of the following is true:

    (i) For Camp Lejeune veterans who served at Camp Lejeune between January 1, 1957, and December 31, 1987, VA provided the hospital care or medical services to the Camp Lejeune veteran on or after August 6, 2012, and the veteran requested Camp Lejeune veteran status no later than September 24, 2016; or

    (ii) For Camp Lejeune veterans who served at Camp Lejeune between August 1, 1953, and December 31, 1956, VA provided the hospital care or medical services to the Camp Lejeune veteran on or after December 16, 2014, and the veteran requested Camp Lejeune veteran status no later than July 18, 2018.

    (The Office of Management and Budget has approved the information collection requirement in this section under control number 2900-0091.)

    (Authority: 38 U.S.C. 1710)
    [FR Doc. 2016-16917 Filed 7-15-16; 8:45 am] BILLING CODE 8320-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2012-0022; FRL-9949-09-Region 6] Approval and Promulgation of Implementation Plans; Louisiana; Permitting of Greenhouse Gases AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is partially approving and partially disapproving a revision to the Louisiana State Implementation Plan (SIP) submitted on December 21, 2011. This revision outlines the State's program to regulate and permit emissions of greenhouse gases (GHGs) in the Louisiana Prevention of Significant Deterioration (PSD) program. We are approving these provisions to the extent that they address the GHG permitting requirements for sources already subject to PSD for pollutants other than GHGs. We are disapproving these provisions to the extent they require PSD permitting for sources that emit only GHGs above the thresholds triggering the requirement to obtain a PSD permit since that is no longer consistent with federal law. The EPA is taking this action under section 110 and part C of the Clean Air Act (CAA or Act).

    DATES:

    This rule is effective on August 17, 2016.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2012-0022. All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Adina Wiley, [email protected], (214) 665-2115.

    SUPPLEMENTARY INFORMATION:

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

    I. Background

    The background for this action is discussed in detail in our May 6, 2016 proposal. See 81 FR 27382. In that document we proposed to approve as revisions to the Louisiana SIP, the revisions to the Louisiana PSD permitting program submitted on December 21, 2011, that provide the State the authority to regulate and permit emissions of GHGs from Step 1 sources in the Louisiana PSD program. We also proposed to disapprove the provisions submitted on December 21, 2011, that would enable the State of Louisiana to regulate and permit Step 2 sources under the Louisiana PSD program because the submitted provisions were no longer consistent with federal laws.

    Our proposed action also corrected an omission in the EPA's August 19, 2015, proposed approval of the Louisiana Major New Source Review program, where we did not explicitly propose approval of a portion of the definition of “major stationary source.” To correct this omission, we provided an additional opportunity for the public to comment on the revisions to the definition of “major stationary source” at LAC 33:III.509(B) submitted on December 20, 2005 as subparagraph (e), but was moved to subparagraph (f) in the December 21, 2011 submittal.

    II. Response to Comments

    We received comments from the Louisiana Department of Environmental Quality (LDEQ). Our responses are provided below.

    Comment 1: The LDEQ commented that the State initiated rulemaking AQ358 on January 20, 2016, to remove the PSD GHG Step 2 permitting provisions. The rulemaking was promulgated on April 20, 2016, after no comments were received during the public comment period. Therefore, LDEQ's PSD program no longer contains permitting requirements for Step 2 sources. The LDEQ also submitted copies of the AQ358 rulemaking for reference.

    Response 1: We recognize that the LDEQ has completed a rulemaking to remove the Step 2 GHG permitting provisions from the LDEQ PSD program consistent with our proposed partial disapproval. Today's final action disapproves the Step 2 provisions that were submitted for the EPA's consideration as a revision to the Louisiana SIP. No further actions are necessary on the part of the LDEQ to remove the Step 2 provisions adopted by the LDEQ on April 20, 2011 and submitted December 21, 2011, from our consideration. Further, today's final action also removes the portion of the Louisiana SIP at 40 CFR 52.986(c) where the EPA narrowed our approval of the Louisiana PSD SIP to apply to Step 2 permitting. See 75 FR 82536, December 30, 2010.

    Comment 2: The LDEQ provided comment on the EPA's interpretation of the “automatic rescission provisions” under LAC 33:III.501(C)(14). Specifically, the LDEQ commented that “In the event of a “change in federal law” or a Supreme Court or D.C. Circuit “order which limits or renders ineffective the regulation” of GHGs under Part C of Title I of the Clean Air Act, LDEQ will provide notice to the general public and regulated community if such law or order will impact how LDEQ's [sic] administers its PSD program under LAC 33:III.509. In addition, LDEQ will ensure that any such changes are consistent with EPA's interpretation of the law or order.”

    Response 2: The EPA appreciates the comment from the LDEQ and the affirmation that the LDEQ will provide notice to the general public and community in the event of a change in federal law or a court decision that limits or renders ineffective the regulation of GHGs under the PSD program. We note that the LDEQ stated public notice would likely be through the LDEQ Web site; we find this method to be sufficient to satisfy the requirements of section 110(l) of the CAA.

    III. Final Action

    We are approving the following revisions to the Louisiana SIP submitted on December 21, 2011. The revisions were adopted and submitted in accordance with the CAA and are consistent with the laws and regulations for PSD permitting of GHGs; therefore we are taking final action to approve these revisions under section 110 and part C of the Act.

    • New provisions as LAC 33:III.501(C)(14) adopted on April 20, 2011 and submitted December 21, 2011;

    • New definitions of “carbon dioxide equivalent” and “greenhouse gases” at LAC 33:III.509(B) adopted on April 20, 2011 and submitted December 21, 2011;

    • Revisions to the definitions of “major stationary source” paragraphs (a) and (b) and “significant” at LAC 33:III.509(B) adopted on April 20, 2011 and submitted on December 21, 2011; and

    • Revisions to the definition of “major stationary source” paragraph (e) as submitted on December 20, 2005, and renumbered to paragraph (f) in the April 20, 2011 adoption submitted on December 21, 2011.

    As a result of our final approval of the above revisions, the EPA is also removing the existing provisions at 40 CFR 52.986(c) under which the EPA narrowed the applicability of the Louisiana PSD program to regulate sources consistent with federal PSD permitting requirements.

    We are disapproving the following severable portions of the December 21, 2011 Louisiana SIP submittal that establish GHG permitting requirements for Step 2 sources:

    • Revisions to the definitions of “major stationary source” paragraph (c) and “significant” as it pertains to Step 2 sources, adopted on April 20, 2011 and submitted on December 21, 2011.

    As a result of our final disapproval of the above revisions, the EPA is adding a new entry at 40 CFR 52.986(c) to reflect the disapproval of the PSD GHG Step 2 provisions. We are taking this final action under section 110 and part C of the Act; as such, we are not imposing sanctions as a result of this final disapproval. This final disapproval does not require the EPA to promulgate a Federal Implementation Plan because we are finding that the submitted provisions are inconsistent with federal laws for the regulation and permitting of GHG emissions.

    IV. Incorporation by Reference

    In this rule, we are finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, we are finalizing the incorporation by reference of the revisions to the Louisiana regulations as described in the Final Action section above. We have made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the EPA Region 6 office.

    V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 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 CAA. Accordingly, this action proposes approval of the portions of the submitted revisions to State law for the regulation and permitting of GHG emissions consistent with federal requirements and proposes disapproval of the portions of the state laws that do not meet Federal requirements for the regulation and permitting of GHG emissions.

    A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

    B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under the PRA. There is no burden imposed under the PRA because this action proposes to disapprove submitted revisions that are no longer consistent with federal laws for the regulation and permitting of GHG emissions.

    C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This action proposes to disapprove submitted revisions that are no longer consistent with federal laws for the regulation and permitting of GHG emissions, and therefore will have no impact on small entities.

    D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector. This action proposes to disapprove submitted revisions that are no longer consistent with federal laws for the regulation and permitting of GHG emissions, and therefore will have no impact on small governments.

    E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

    F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

    This action does not have tribal implications as specified in Executive Order 13175. This action proposes to disapprove provisions of state law that are no longer consistent with federal laws for the regulation and permitting of GHG emissions; there are no requirements or responsibilities added or removed from Indian Tribal Governments. Thus, Executive Order 13175 does not apply to this action.

    G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it disapproves state permitting provisions that are inconsistent with federal laws for the regulation and permitting of GHG emissions.

    H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

    I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

    J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

    The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. This action is not subject to Executive Order 12898 because it disapproves state permitting provisions that are inconsistent with federal laws for the regulation and permitting of GHG emissions.

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this 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 September 16, 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, Incorporation by reference, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: July 7, 2016. Ron Curry, Regional Administrator, Region 6.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart T—Louisiana 2. In § 52.970(c), the table titled “EPA Approved Louisiana Regulations in the Louisiana SIP” is amended by revising the entries for “Section 501” and “Section 509” under Chapter 5—Permit Procedures to read as follows:
    § 52.970 Identification of plan.

    (c) * * *

    EPA Approved Louisiana Regulations in the Louisiana SIP State citation Title/Subject State approval date EPA approval date Comments *         *         *         *         *         *         * Chapter 5—Permit Procedures Section 501 Scope and Applicability 4/20/2011 7/18/2016, [Insert Federal Register citation] *         *         *         *         *         *         * Section 509 Prevention of Significant Deterioration 12/20/2012 7/18/2016, [Insert Federal Register citation] SIP does not include the provisions for Step 2 GHG permitting at “major stationary source” paragraph (c) or “significant” as adopted on April 20, 2011.
  • SIP does not include the PM2.5 SMC at LAC 33:III.509(I)(5)(a) from the 12/20/2012 adoption. LAC 33:III.509(I)(5)(a) is SIP-approved as of 10/20/2007 adoption.
  • *         *         *         *         *         *         *
    3. Section 52.986 is amended by revising paragraph (c) to read as follows:
    § 52.986 Significant deterioration of air quality.

    (c) The revisions to the Louisiana SIP adopted on April 20, 2011, and submitted on December 21, 2011, establishing PSD permitting requirements for sources that are classified as major and thus required to obtain a PSD permit based solely on their potential GHG emissions (“Step 2” sources) at the definition of “major stationary source” paragraph (c) and the definition of “significant” at LAC 33:III.509(B), are disapproved as inconsistent with federal law for the regulation and permitting of GHGs.

    [FR Doc. 2016-16791 Filed 7-15-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2016-0164; FRL-9949-07-Region 9] Determination of Attainment of the 1-Hour Ozone National Ambient Air Quality Standard in the San Joaquin Valley Nonattainment Area in California AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is determining that the San Joaquin Valley nonattainment area has attained the 1-hour ozone National Ambient Air Quality Standard. This determination is based on sufficient, quality-assured, and certified data for the 2012-2014 period. Ozone data collected in 2015 show continued attainment of the standard in the San Joaquin Valley.

    DATES:

    This final rule is effective on August 17, 2016.

    ADDRESSES:

    The EPA has established a docket for this action, identified by Docket ID Number EPA-R09-OAR-2016-0164. The index to the docket is available electronically at http://www.regulations.gov or in hard copy at the EPA Region IX office, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., confidential business information). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed below.

    FOR FURTHER INFORMATION CONTACT:

    Anita Lee, (415) 972-3958, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document whenever “we,” “us,” or “our” is used, we mean the EPA.

    Table of Contents I. Background II. Public Comments III. The EPA's Responses to Comments IV. Final Action V. Statutory and Executive Order Reviews I. Background

    On May 18, 2016, the EPA proposed to determine that the San Joaquin Valley (“Valley”) 1-hour ozone nonattainment area had attained the 1-hour ozone National Ambient Air Quality Standard (NAAQS or “standard”) based on sufficient, quality-assured, and certified data from the most recent three-year period (2012-2014).1 We noted that preliminary data for 2015 were consistent with continued attainment in the San Joaquin Valley. The Valley covers approximately 23,000 square miles and includes all of Fresno, Kings, Madera, Merced, San Joaquin, Stanislaus, and Tulare counties, as well as the western half of Kern County.2

    1 See 81 FR 31206 (May 18, 2016).

    2 See 40 CFR 81.305.

    In our proposed rule, we provided background information on the 1-hour ozone standard, the designations and classifications of the San Joaquin Valley under the Clean Air Act (CAA or “Act”) for the 1-hour ozone standard, and the EPA's prior actions related to the 1-hour ozone standard in the Valley.3 We also described how we determine whether an area's air quality meets the 1-hour ozone standard, and identified the relevant air monitoring agencies in the San Joaquin Valley and their respective ozone monitoring networks, network plans, and annual certifications of ambient air monitoring data.4 In our proposed rule, we also discussed the requests, and associated analyses, submitted by the California Air Resources Board (CARB) and the San Joaquin Valley Air Pollution Control District (“District”), that the EPA find that the Valley has attained the 1-hour ozone standard.5

    3 See 81 FR 31206 at 31207 (May 18, 2016).

    4Id. at 31208-31210.

    5Id. at 31208.

    As discussed in our proposed rule, an area attains the 1-hour ozone standard if the highest three-year average of expected exceedances is less than or equal to 1 expected exceedance. Table 1 in our proposed rule summarized the expected 1-hour ozone exceedances, per year and as an average over the 2012-2014 period, at the regulatory monitoring sites in the San Joaquin Valley. During the 2012-2014 period, the highest three-year average of expected exceedances at any site in the Valley was 0.7 expected exceedances at Fresno—Sierra Skypark in Fresno County. At the time of our proposed determination, preliminary data for 2015 was available but not yet certified. We provided preliminary data for 2015 that showed continued attainment of the 1-hour ozone standard.6 All three agencies operating regulatory monitoring sites in the San Joaquin Valley submitted their 2015 data certifications to the EPA by May 10, 2016, shortly following the release of our proposed rule.7

    6Id. at 31209, Table 1, footnote 1 citing to Quicklook Reports providing ambient air quality data from 2012-2015 in the docket for this action.

    7 The Regional Administrator for the EPA Region 9 office signed the proposed rule on May 3, 2016, and it was published in the Federal Register on May 18, 2016. The California Air Resources Board, the District, and the National Park Service all submitted their 2015 data certifications by May 10, 2016. See (1) letter from Ravi Ramalingam, Chief, Consumer Products and Air Quality Assessment Branch, Air Quality Planning and Science Division, CARB, to Elizabeth Adams, Acting Director, Air Division, EPA Region IX, certifying calendar year 2015 ambient air quality data and quality assurance data, dated May 10, 2016; (2) letter from Jon Klassen, Program Manager, SJVAPCD, to Deborah Jordan, Director, Air Division, EPA Region IX, certifying calendar year 2015 ambient air quality data and quality assurance data, dated May 9, 2016; and (3) letter from Barkley Sive, Program Manager, NPS, to Lew Weinstock, EPA, certifying 2015 ozone data, dated April 27, 2016.

    For this final action, we have repeated our review of the 2015 data now that the data have been certified to confirm that the data are consistent with continued attainment of the 1-hour ozone standard in the San Joaquin Valley. In Table 1 below, we supplement the corresponding table from our proposed rule with 2015 data. As shown in Table 1 below, the highest three-year average of expected exceedances at any site in the Valley for 2013-2015 was 0.4, at Fresno—Sierra Skypark in Fresno County. Based on complete, quality-assured, and certified data, the expected exceedances in Table 1 indicate continued attainment of the 1-hour ozone standard in the SJV over 2013-2015.8

    8 As discussed in our proposed rule, a “complete” data set for determining attainment of the ozone standard is generally one that includes three years of data with an average percent of days with valid monitoring data greater than 90 percent with no single year less than 75 percent. The 2013-2015 data summarized in Table 1 from all of the regulatory sites meet this criterion. See June 20, 2016 spreadsheet titled “20160620_QLRpt_SJV_1hrO3_2012-2015.xlsx,” in the docket for this final action.

    Table 1—One-Hour Ozone Data for the San Joaquin Valley One-Hour Ozone Nonattainment Area1 Site (AQS ID) Expected exceedances
  • by year
  • 2012 2013 2014 2015 Expected exceedances
  • 3-yr average
  • 2012-2014 2013-2015
    FRESNO COUNTY: Clovis—Villa (06-019-5001) 0.0 0.0 0.0 0.0 0.0 0.0 Fresno—Drummond Street (06-019-0007) 1.0 0.0 0.0 1.0 0.3 0.3 Fresno—Garland (06-019-0011) 1.0 0.0 0.0 0.0 0.3 0.0 Fresno—Sierra Skypark (06-019-0242) 1.0 0.0 1.1 0.0 0.7 0.4 Parlier (06-019-4001) 1.0 0.0 0.0 0.0 0.3 0.0 Tranquility (06-019-2009) 0.0 0.0 0.0 0.0 0.0 0.0 KERN COUNTY: Arvin—Di Giorgio (06-029-5002) 0.0 0.0 0.0 0.0 0.0 0.0 Bakersfield—Muni (06-029-2012) 0.0 0.0 0.0 0.0 2 0.0 0.0 Bakersfield—California (06-029-0014) 0.0 0.0 0.0 0.0 0.0 0.0 Edison (06-029-0007) 0.0 0.0 0.0 0.0 0.0 0.0 Maricopa (06-029-0008) 0.0 0.0 0.0 0.0 0.0 0.0 Oildale (06-029-0232) 0.0 0.0 0.0 0.0 0.0 0.0 Shafter (06-029-6001) 0.0 0.0 0.0 0.0 0.0 0.0 KINGS COUNTY: Hanford—Irwin (06-031-1004) 0.0 0.0 0.0 0.0 0.0 0.0 MADERA COUNTY: Madera—Pump Yard (06-039-0004) 0.0 0.0 0.0 0.0 0.0 0.0 Madera—City (06-039-2010) 0.0 0.0 0.0 0.0 0.0 0.0 MERCED COUNTY: Merced—Coffee (06-047-0003) 0.0 0.0 0.0 0.0 0.0 0.0 SAN JOAQUIN COUNTY: Stockton—Hazelton (06-077-1002) 0.0 0.0 0.0 0.0 0.0 0.0 Tracy—Airport (06-077-3005) 0.0 0.0 0.0 0.0 0.0 0.0 STANISLAUS COUNTY: Modesto—14th Street (06-099-0005) 0.0 0.0 0.0 0.0 0.0 0.0 Turlock (06-099-0006) 0.0 0.0 0.0 0.0 0.0 0.0 TULARE COUNTY: Porterville (06-107-2010) 0.0 0.0 0.0 0.0 0.0 0.0 Sequoia National Park—Ash Mountain (06-107-0009) 0.0 0.0 0.0 0.0 0.0 0.0 Visalia—Church Street (06-107-2002) 0.0 0.0 0.0 0.0 0.0 0.0 1 Source: Quicklook Report, “20160620_QLRpt_SJV_1hrO3_2012-2015.pdf,” June 20, 2016; and “20160620_QLRpt_SJV_1hrO3_2012-2015.xlsx,” June 20, 2016 (in the docket for this final action). 2 Based on CARB's missing data analysis for this site, at most one exceedance could have been recorded during the first half of 2012 if the site had been operational during that period. Assuming such an exceedance had occurred, the 3-year average of expected exceedances for the 2012-2014 period at the Bakersfield-Municipal Airport site would have been 0.3, which is less than the corresponding value at Fresno—Sierra Skypark (0.7) and less than the NAAQS.

    We proposed to determine that the San Joaquin Valley has attained the 1-hour ozone standard based on our analysis of the ambient air quality data, as well as our review of 1-hour ozone trends in the Valley, data completeness, and the adequacy of the ozone monitoring network.9 We noted that if we finalize the proposed determination, to the extent not already fulfilled, the requirements for the state to submit attainment demonstrations and associated reasonably available control measures, reasonable further progress plans, contingency measures for failure to attain or make reasonable progress and other plans related to attainment of the 1-hour ozone standard for San Joaquin Valley shall be suspended until such time as the area is redesignated as attainment for the current ozone NAAQS or a redesignation substitute for the 1-hour ozone standard is approved, at which time the requirements no longer apply.10 If, however, prior to such redesignation or approval of such redesignation substitute, the EPA determines that San Joaquin Valley has violated the 1-hour ozone NAAQS, then the area is again required to submit such attainment-related plans.11

    9 See 81 FR 31206, at 31208-31211 (May 18, 2016).

    10 See 40 CFR 51.1118.

    11Id.

    II. Public Comments

    We solicited comment on the proposed determination of attainment and opened a 30-day public comment period. The comment period closed on June 17, 2016. During the comment period, we received a comment from a member of the public in support of the proposal, and a comment letter from the Western States Petroleum Association (WSPA). WSPA also expressed support for the proposed attainment determination but recommended concurrent revocation of the District's penalty fee rule based on the District's demonstration that the attainment of the 1-hour ozone standard is due to permanent and enforceable emissions reductions and based on the sunset clause in the penalty fee rule itself. We respond to WSPA's comment in the following section of this document.

    III. The EPA's Responses to Public Comments

    In our proposed rule, we noted that in addition to the request for a clean data determination, the District provided documentation in its staff report intending to support a finding that attainment of the 1-hour ozone standard is due to permanent and enforceable emission reductions. As discussed in our proposed rule, the EPA's final implementation rule for the 2008 ozone standard established a mechanism, referred to as a “redesignation substitute,” through which an area may shift to contingency status those requirements, such as penalty fee program requirements under CAA section 185, to which an area had remained subject under the EPA's anti-backsliding regulations governing the transition from revoked ozone standards (such as the 1-hour ozone standard) to current ozone standards.

    To invoke the redesignation substitute, a state must submit two things: (1) A demonstration that the area has attained the revoked ozone NAAQS due to permanent and enforceable emission reductions, and (2) a demonstration that the area will maintain the revoked NAAQS for 10 years from the date of the EPA's approval of this showing.12 The District submitted the first required demonstration to the EPA but did not submit the second required component of the redesignation substitute mechanism, i.e., the demonstration that the area will maintain the 1-hour ozone standard for 10 years. Because neither the state nor the District has submitted a complete demonstration required to invoke the redesignation substitute mechanism, we stated in our proposed rule that action on a single element (i.e., the demonstration of attainment due to permanent and enforceable emissions reductions) was not appropriate without the second required element (i.e., the 10-year maintenance demonstration). When the state submits a demonstration that the San Joaquin Valley will maintain the 1-hour ozone standard for 10 years, we will review and consider whether both demonstrations together meet the requirements of the redesignation substitute mechanism for the 1-hour ozone standard.

    12 40 CFR 51.1105(b).

    Moreover, we note that the District's penalty fee rule does not automatically sunset upon the EPA's final determination of attainment for the 1-hour ozone standard. The penalty fee rule (i.e., District Rule 3170 (“Federally Mandated Ozone Nonattainment Fee”) provides, in relevant part:

    “The fees established by this rule shall cease to be applicable when the San Joaquin Valley Air Basin (SJVAB) has met the revoked federal one-hour ambient air quality standard for ozone.

    For the purposes of this rule, the San Joaquin Valley Air Basin shall have met the revoked federal one-hour ambient air quality standard for ozone upon EPA's determination, through notice-and-comment rulemaking, of concurrence with a demonstration by the APCO and the California Air Resources Board that the average number of days per calendar year with maximum hourly average concentration above 0.12 ppm is less than or equal to one (1), for each monitor. To make this demonstration, the APCO will, using all available quality assured monitoring data, calculate at each monitor the average number of days over the standard per year during a three-year period according to the procedures found in 40 CFR part 50 Appendix H, and show that the improvement in air quality is due to permanent and enforceable emissions reductions.”

    Thus, under the terms of the penalty fee rule, the fee provisions do not sunset simply upon the EPA's determination of attainment of the 1-hour ozone standard. The EPA's concurrence on the demonstration that attainment of the standard is due to permanent and enforceable emissions reductions is also a prerequisite to triggering the sunset clause. While the District has submitted such a demonstration, we indicated in our proposed rule and reiterate above that we are taking no action on the District's demonstration at this time. We will consider the District's demonstration in a separate rulemaking if and when it is supplemented with the 10-year maintenance demonstration element also needed to invoke the redesignation substitute mechanism in 40 CFR 51.1105(b).

    IV. Final Action

    Based on the analyses in our proposed rule of ambient air quality data, 1-hour ozone trends in the Valley, and the adequacy of the monitoring network in the Valley, as well as our review of 2015 data in this final rule indicating continued attainment of the standard, we are taking final action to determine that the San Joaquin Valley nonattainment area has attained the 1-hour ozone standard. This determination is based on sufficient, quality-assured, and certified data for the period 2012-2014.

    V. Statutory and Executive Order Reviews

    This action finalizes a determination based on air quality data and does not impose additional requirements beyond those imposed by state law. For that reason, this final action:

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

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

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

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

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

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

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

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

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

    In addition, this final clean data determination does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000) because the SIP obligations discussed herein do not apply to Indian Tribes, and thus will not impose substantial direct costs on tribal governments or preempt tribal law.

    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 September 16, 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, Incorporation by reference, Intergovernmental relations, Oxides of nitrogen, Ozone, Volatile organic compounds.

    Dated: June 30, 2016. Deborah Jordan, Acting Regional Administrator, Region IX.

    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 F—California 2. Section 52.282 is amended by adding paragraph (h) to read as follows:
    § 52.282 Control strategy and regulations: Ozone

    (h) Determination of attainment. EPA has determined that, as of August 17, 2016, the San Joaquin Valley 1-hour ozone nonattainment area has attained the 1-hour ozone standard, based upon sufficient, quality-assured and certified ambient air quality monitoring data for 2012-2014.

    [FR Doc. 2016-16792 Filed 7-15-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R10-OAR-2016-0051; FRL—9949-18-Region 10] Extension of the Attainment Date for the Oakridge, Oregon 24-hour PM2.5 Nonattainment Area AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is finalizing its decision to grant a 1-year extension of the attainment date for the Oakridge, Oregon nonattainment area to meet the 2006 24-hour PM2.5 NAAQS from December 31, 2015 to December 31, 2016, on the basis that the State has met the criteria for such an extension under the Clean Air Act (CAA).

    DATES:

    This final rule is effective August 17, 2016.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R10-OAR-2016-0051. All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information the disclosure of which is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the Air Planning Unit, Office of Air and Waste, EPA Region 10, 1200 Sixth Avenue, Seattle, WA 98101. The EPA requests that if at all possible, you contact the individual listed in the FOR FURTHER INFORMATION CONTACT section to view the hard copy of the docket. You may view the hard copy of the docket Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    For information please contact Justin Spenillo at (206) 553-6125, [email protected] or by using the above EPA, Region 10 address.

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Background Information II. Final Action III. Statutory and Executive Orders Review I. Background Information

    On May 18, 2016, the EPA proposed to grant a 1-year extension of the attainment date for the Oakridge, Oregon nonattainment area to meet the 2006 24-hour PM2.5 NAAQS from December 31, 2015 to December 31, 2016, on the basis that the State has met the criteria for such an extension under the CAA (81 FR 31202). An explanation of the CAA requirements, a detailed analysis of the submittal, and the EPA's reasons for proposing approval were provided in the notice of proposed rulemaking, and will not be restated here. The public comment period for this proposed rule ended on June 17, 2016. The EPA received no comments on the proposal.

    II. Final Action

    The EPA finds that the State has met the criteria for receiving a 1-year extension to the Moderate area attainment date for the 2006 PM2.5 NAAQS for the Oakridge NAA as provided in section 188(d) of the Act. The State is implementing the requirements and commitments in the applicable attainment plan for the PM2.5 NAAQS in the area, and the 98th percentile 24-hour PM2.5 air quality value for 2015 is below 35 μg/m3. Accordingly, the State has established that it meets the criteria of section 188(d) as the EPA interprets those requirements for purposes of the 2006 PM2.5 NAAQS. The EPA therefore exercises the discretion granted to the Administrator by section 188(d) of the CAA to extend the Moderate area attainment date for the Oakridge NAA from December 31, 2015 to December 31, 2016.

    III. Statutory and Executive Orders Review

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

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

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

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

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

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

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

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

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

    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 it 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 September 16, 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, Incorporation by reference, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: July 7, 2016. Michelle L. Pirzadeh, Acting Regional Administrator, Region 10.
    [FR Doc. 2016-16789 Filed 7-15-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary 45 CFR Part 92 [HHS-OCR-2015-0006] RIN 0945-AA02 Nondiscrimination in Health Programs and Activities; Correction AGENCY:

    Office of the Secretary (OS), HHS.

    ACTION:

    Final rule; correction.

    SUMMARY:

    This document corrects a typographical error that appeared in the final rule published in the Federal Register on May 18, 2016, entitled “Nondiscrimination in Health Programs and Activities.”

    DATES:

    This correction is effective on July 18, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Section 1557 mailbox at [email protected] Eileen Hanrahan, (800) 368-1019 or (800) 537-7697 (TDD).

    SUPPLEMENTARY INFORMATION:

    I. Background

    In FR Doc. 2016-11458 of May 18, 2016 (81 FR 31375) (hereinafter referred to as the Section 1557 final rule) there is a typographical error that is discussed in the “Summary of Error,” and further identified and corrected in the “Correction of Error” section below. The provision in this correction document is effective as if it had been included in the Section 1557 final rule published in the Federal Register on May 18, 2016.

    II. Summary of Error

    On page 31473, in Appendix A to Part 92—Sample Notice Informing Individuals About Nondiscrimination and Accessibility Requirements and Sample Nondiscrimination Statement: Discrimination is Against the Law, the telephone number provided for assistance with filing a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights was incorrect. The correct telephone number is 800-368-1019.

    III. Correction of Error

    In FR Doc. 2016-11458 of May 18, 2016 (81 FR 31375), make the following correction:

    1. On page 31473, first column, first full paragraph, line 22, “1-800-868-1019” is corrected to read “1-800-368-1019”.

    Dated: July 8, 2016. Madhura C. Valverde, Executive Secretary to the Department, Department of Health and Human Services.
    [FR Doc. 2016-16680 Filed 7-15-16; 8:45 am] BILLING CODE 4153-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 300 [Docket No. 130717632-4285-02] RIN 0648-XE729 International Fisheries; Pacific Tuna Fisheries; 2016 Bigeye Tuna Longline Fishery Closure in the Eastern Pacific Ocean AGENCY:

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

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS is temporarily closing the U.S. pelagic longline fishery for bigeye tuna for vessels over 24 meters in overall length in the eastern Pacific Ocean (EPO) through December 31, 2016, because the 2016 catch limit of 500 metric tons is expected to be reached. This action is necessary to prevent the fishery from exceeding the applicable catch limit established by the Inter-American Tropical Tuna Commission (IATTC) in Resolution C-13-01 (Multiannual Program for the Conservation of Tuna in the Eastern Pacific Ocean During 2014-2016).

    DATES:

    The rule is effective 12 a.m. local time July 25, 2016, through 11:59 p.m. local time December 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Taylor Debevec, NMFS West Coast Region, 562-980-4066.

    SUPPLEMENTARY INFORMATION:

    The United States is a member of the IATTC, which was established under the Convention for the Establishment of an Inter-American Tropical Tuna Commission signed in 1949 (Convention). The Convention provides an international agreement to ensure the effective international conservation and management of highly migratory species of fish in the IATTC Convention Area. The IATTC Convention Area, as amended by the Antigua Convention, includes the waters of the EPO bounded by the coast of the Americas, the 50° N. and 50° S. parallels, and the 150° W. meridian.

    Pelagic longline fishing in the EPO is managed, in part, under the Tuna Conventions Act as amended (Act), 16 U.S.C. 951-962. Under the Act, NMFS must publish regulations to carry out recommendations of the IATTC that have been approved by the Department of State (DOS). Regulations governing fishing by U.S. vessels in accordance with the Act appear at 50 CFR part 300, subpart C. These regulations implement IATTC recommendations for the conservation and management of highly migratory fish resources in the EPO.

    In 2013, the IATTC adopted Resolution C-13-01, which establishes an annual catch limit of bigeye tuna for longline vessels over 24 meters. For calendar years 2014, 2015, and 2016, the catch of bigeye tuna by longline gear in the IATTC Convention Area by fishing vessels of the United States that are over 24 meters in overall length is limited to 500 metric tons per year. With the approval of the DOS, NMFS implemented this catch limit by notice-and-comment rulemaking under the Act (79 FR 19487, April 9, 2014, and codified at 50 CFR 300.25).

    NMFS, through monitoring the retained catches of bigeye tuna using logbook data submitted by vessel captains and other available information from the longline fisheries in the IATTC Convention Area, has determined that the 2016 catch limit is expected to be reached by July 25, 2016. In accordance with 50 CFR 300.25(b), this Federal Register notice announces that the U.S. longline fishery for bigeye tuna in the IATTC Convention Area will be closed for vessels over 24 meters in overall length starting on July 25, 2016, through the end of the 2016 calendar year. The 2017 fishing year is scheduled to open on January 1, 2017; the bigeye tuna catch limit for longline vessels over 24 meters in overall length has yet to be determined for 2017. The IATTC will meet in October 2016 and is scheduled to address tropical tuna conservation and management, including the catch limit for large longline vessels. Any measures adopted by the IATTC in October 2016 would subsequently be implemented by NMFS via rulemaking.

    During the closure, a U.S. fishing vessel over 24 meters in overall length may not be used to retain on board, transship, or land bigeye tuna captured by longline gear in the IATTC Convention Area, except as follows:

    • Any bigeye tuna already on board a fishing vessel on July 25, 2016, may be retained on board, transshipped, and/or landed, to the extent authorized by applicable laws and regulations, provided all bigeye tuna are landed within 14 days after the effective date of this rule, that is, no later than August 8, 2016.

    • In the case of a vessel that has declared to NMFS that the current trip type is shallow-set longlining, the 14-day limit to land all bigeye in the previous paragraph is waived. However, the prohibition on any additional retention of bigeye tuna still applies as of July 25, 2016.

    Other prohibitions during the closure include the following:

    • Bigeye tuna caught by a United States vessel over 24 meters in overall length with longline gear in the IATTC Convention Area may not be transshipped to a fishing vessel unless that fishing vessel is operated in compliance with a valid permit issued under 50 CFR 660.707 or 665.801.1

    1 In 50 CFR 300.25(b)(4)(ii), the reference to § 665.21 is outdated. The former 50 CFR 665.21 has been recodifed to § 665.801.

    • A U.S. fishing vessel over 24 meters in overall length that is not on a declared shallow-set longline trip may not be used to fish in the Pacific Ocean using longline gear both inside and outside the IATTC Convention Area during the same fishing trip, with the exception of a fishing trip that was already in progress when the prohibitions were put into effect.

    • If a vessel over 24 meters in overall length not on a declared shallow-set longline trip is used to fish in the Pacific Ocean using longline gear outside the IATTC Convention Area, and the vessel enters the IATTC Convention Area at any time during the same fishing trip, the longline gear on the fishing vessel must be stowed in a manner so as not to be readily available for fishing. Specifically, the hooks, branch lines, and floats must be stowed and not available for immediate use, and any power-operated mainline hauler on deck must be covered in such a manner that it is not readily available for use.

    Classification

    NMFS has determined there is good cause to waive prior notice and opportunity for public comment pursuant to 5 U.S.C. 553(b)(B). This action is based on the best available information and is necessary for the conservation and management of bigeye tuna. Compliance with the notice and comment requirement would be impracticable and contrary to the public interest because NMFS would be unable to ensure that the 2016 bigeye tuna catch limit applicable to longline vessels over 24 meters is not exceeded. The annual catch limit is an important mechanism to ensure that the United States complies with its international obligations in preventing overfishing and managing the fishery at optimum yield. Moreover, NMFS previously solicited, and considered, public comments on the rule that established the catch limit (79 FR 19487, April 9, 2014), including a provision for issuing a notice to close the fishery, if necessary, to prevent exceeding the catch limit. For the same reasons, NMFS has also determined there is good cause to waive the requirement for a 30-day delay in effectiveness under 5 U.S.C. 553(d)(3).

    This action is required by § 300.25(b) and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 951 et seq.

    Dated: July 13, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-16893 Filed 7-13-16; 4:15 pm] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 151211999-6343-02] RIN 0648-XE720 Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Georges Bank Cod Trimester Total Allowable Catch Area Closure for the Common Pool Fishery AGENCY:

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

    ACTION:

    Temporary rule; area closure.

    SUMMARY:

    This action closes the Georges Bank Cod Trimester Total Allowable Catch Area to Northeast multispecies common pool vessels fishing with trawl gear, sink gillnet gear, and longline/hook gear for the remainder of Trimester 1, through August 31, 2016. The closure is required by regulation because the common pool fishery has caught 90 percent of its Trimester 1 quota for Georges Bank cod. This closure is intended to prevent an overage of the common pool's quota for this stock.This action is effective July 13, 2016, through August 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Liz Sullivan, Fishery Management Specialist, (978) 282-8493.

    SUPPLEMENTARY INFORMATION:

    Federal regulations at § 648.82(n)(2)(ii) require the Regional Administrator to close a common pool Trimester Total Allowable Catch (TAC) Area for a stock when 90 percent of the Trimester TAC is projected to be caught. The closure applies to all common pool vessels fishing with gear capable of catching that stock for the remainder of the trimester.

    As of July 11, 2016, the common pool fishery caught between 79 and 89 percent of the Trimester 1 TAC (3.3 mt) for Georges Bank (GB) cod. We project that 90 percent of the Trimester 1 TAC will be caught within a few days. The fishing year 2016 common pool sub-annual catch limit (sub-ACL) for GB cod is 13.2 mt.

    Effective July 13, 2016, the GB Cod Trimester TAC Area is closed for the remainder of Trimester 1, through August 31, 2016, to all common pool vessels fishing with trawl gear, sink gillnet gear, and longline/hook gear. The GB Cod Trimester TAC Area consists of statistical areas 521, 522, 525, and 561. The area reopens at the beginning of Trimester 2 on September 1, 2016.

    If a vessel declared its trip through the Vessel Monitoring System (VMS) or the interactive voice response system, and crossed the VMS demarcation line prior to July 13, 2016, it may complete its trip within the Trimester TAC Area.

    Any overage of the Trimester 1 or 2 TACs must be deducted from the Trimester 3 TAC. If the common pool fishery exceeds its sub-ACL for the 2016 fishing year, the overage must be deducted from the common pool's sub-ACL for fishing year 2017. Any uncaught portion of the Trimester 1 and Trimester 2 TACs is carried over into the next trimester. However, any uncaught portion of the common pool's sub-ACL may not be carried over into the following fishing year.

    Weekly quota monitoring reports for the common pool fishery are on our Web site at: http://www.greateratlantic.fisheries.noaa.gov/ro/fso/MultiMonReports.htm. We will continue to monitor common pool catch through vessel trip reports, dealer-reported landings, VMS catch reports, and other available information, and, if necessary, we will make additional adjustments to common pool management measures.

    Classification

    This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.

    The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) and 5 U.S.C. 553(d)(3) to waive prior notice and the opportunity for public comment and the 30-day delayed effectiveness period because it would be impracticable and contrary to the public interest.

    Regulations require the Regional Administrator to close a trimester TAC area to the common pool fishery when 90 percent of the Trimester TAC for a stock has been caught. Updated catch information only recently became available indicating that the common pool fishery will catch 90 percent of its Trimester 1 TAC for GB cod in the week of July 11, 2016. The time necessary to provide for prior notice and comment, and a 30-day delay in effectiveness, prevents the immediate closure of the GB Cod Trimester 1 TAC Area. Delaying the effective date of a closure increases the likelihood that the common pool fishery will exceed its quota of GB cod to the detriment of this stock, which could undermine management objectives of the Northeast Multispecies Fishery Management Plan. Additionally, an overage of the common pool quota could cause negative economic impacts to the common pool fishery as a result of overage paybacks in a future trimester or fishing year.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: July 13, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-16891 Filed 7-13-16; 4:15 pm] BILLING CODE 3510-22-P
    81 137 Monday, July 18, 2016 Proposed Rules DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 981 [Doc. No. AMS-SC-16-0045; SC16-981-2 PR] Almonds Grown in California; Increased Assessment Rate AGENCY:

    Agricultural Marketing Service, USDA.

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule would implement a recommendation from the Almond Board of California (Board) to increase the assessment rate established for the 2016-17 through the 2018-19 crop years from $0.03 to $0.04 per pound of almonds handled under the marketing order (order). Of the $0.04 per pound assessment, 60 percent (or $0.024 per pound) would be available as credit-back for handlers who conduct their own promotional activities. The assessment rate would return to $0.03 for the 2019-20 and subsequent crop years, and the amount available for handler credit-back would return to $0.018 per pound (60 percent). The Board locally administers the order and is comprised of growers and handlers of almonds grown in California. Assessments upon almond handlers are used by the Board to fund reasonable and necessary expenses of the program. The crop year begins August 1 and ends July 31. The $0.04 assessment rate would remain in effect until July 31, 2019. Beginning August 1, 2019, the assessment rate would return to $0.03 and would remain in effect indefinitely unless modified, suspended, or terminated.

    DATES:

    Comments must be received by August 2, 2016.

    ADDRESSES:

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

    FOR FURTHER INFORMATION CONTACT:

    Andrea Ricci, Marketing Specialist or Jeffery Smutny, Regional Director, California Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (559) 487-5901, Fax: (559) 487-5906, or Email: with [email protected] or [email protected]

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

    SUPPLEMENTARY INFORMATION:

    This proposed rule is issued under Marketing Order No. 981, as amended (7 CFR part 981), regulating the handling of almonds grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

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

    This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, California almond handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as proposed herein would be applicable to all assessable almonds beginning on August 1, 2016, through July 31, 2019. Beginning August 1, 2019, the assessment rate would return to the current $0.03 and would remain in effect indefinitely unless modified, suspended, or terminated.

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

    This proposed rule would increase the assessment rate for the 2016-17 through 2018-19 crop years from $0.03 to $0.04 per pound of almonds received. Of the $0.04 per pound assessment, 60 percent (or $0.024 per pound) would be available as credit-back for handlers who conduct their own promotional activities. The assessment rate would return to $0.03 for the 2019-20 and subsequent crop years, and the amount available for handler credit-back would return to $0.018 per pound (60 percent).

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

    For the 2005-06 and subsequent crop years, the Board recommended, and USDA approved, an assessment rate of $0.03 per pound that would continue in effect from crop year to crop year unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Board or other information available to USDA. Of the $0.03 per pound assessment, 60 percent ($0.018) per pound was made available as credit-back for handlers who conducted their own promotional activities.

    The Board met on April 12, 2016, and unanimously recommended 2016-17 expenditures of $69,897,626 and an assessment rate of $0.04 per pound of almonds received. In comparison, last year's budgeted expenditures were $58,998,976. The proposed assessment rate of $0.04 is $0.01 higher than the rate currently in effect, and the credit-back portion of the assessment rate ($0.024 per pound) would be $0.006 more than the credit-back portion currently in effect.

    The Board estimates a production increase of thirty percent, or 600 million pounds, by the 2019-20 crop year. This increase is nearly as much as their largest market currently consumes. Due to the size of the increase in forecasted production, the Board anticipates that increased market development projects and new marketing programs are required to successfully market the additional supply. Accordingly, the Board has recommended a new “Nut of Choice” marketing program.

    The Board also anticipates needing additional funding for the industry's new “Crop of Choice” research program, as well as additional research to address concerns such as: Changing water supply and quality systems; air quality and how it relates to harvesting, pesticide, and energy use; and bee health.

    The three-year higher assessment rate is needed to fund the increase in marketing and research activities. The Board anticipates that by the 2019-20 crop year, the increase in production assessed at the reinstated $0.03 per pound rate should generate sufficient revenue to cover the anticipated expenditures at that time. Therefore, beginning August 1, 2019, the assessment rate would return to $0.03 per pound.

    The following table compares major budget expenditures recommended by the Board for the 2015-16 and 2016-17 crop years:

    Budget expense categories 2015-16 2016-17 Operations Expenses $7,904,000 $8,404,000 Board Accelerated Innovation Management (AIM) Initiatives 1,500,000 1,000,000 Crop of Choice Initiatives 0 5,625,000 Reputation Management 1,826,350 2,000,000 Production Research 1,843,331 1,843,331 Environmental Research 1,039,790 1,039,790 Scientific Affairs/Nutrition 1,640,000 1,640,000 Global Market Development 38,583,756 38,583,756 Nut of Choice Initiatives 0 5,100,000 Technical & Regulatory Affairs 1,045,500 1,045,500 Industry Services 2,436,220 2,436,220 Almond Quality & Food Safety 790,800 790,800 Corporate Technology 389,229 389,229

    The assessment rate recommended by the Board was derived by considering the anticipated 30 percent production increase in the next three years, anticipated expenditures plus additional program expenses, current production level, and maintaining adequate operating reserve funds. In its recommendation, the Board utilized an estimate of 1,835,290,000 pounds of assessable almonds for the 2016-17 crop year. If realized, this would provide estimated assessment revenue of $62,262,213, which reflects credit-back reimbursements and organic exemptions. In addition, it is anticipated that $20,907,722 will be provided by other sources, including interest income, Market Access Program (MAP) funds, and operating reserve funds. When combined, revenue from these sources would be adequate to cover budgeted expenses.

    Section 981.81 of the order authorizes the Board to maintain operating reserve funds consisting of an administrative-research portion and a marketing promotion portion, and states that the amount allocated to each portion shall not exceed six months' budgeted expenses for that activity area. Funds in the reserve at the end of the 2016-17 crop year are estimated to be approximately $16,581,222, well within the amount permitted by the order.

    The proposed assessment rate would continue in effect until July 31, 2019. Beginning August 1, 2019, the assessment rate would return to $0.03 and would continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Board or other available information.

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

    Initial Regulatory Flexibility Analysis

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

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

    There are approximately 6,800 almond growers in the production area and approximately 100 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).

    The National Agricultural Statistics Service (NASS) reported in its 2012 Agricultural Census that there were 6,841 almond farms in the production area (California), of which 6,204 had bearing acres. The following computation provides an estimate of the proportion of producers (farms) and agricultural service firms (handlers) that would be considered small under the SBA definitions.

    The NASS Census data indicates that out of the 6,204 California farms with bearing acres of almonds, 4,471 (72 percent) have fewer than 100-bearing acres.

    In its most recently reported crop year (2014), NASS reported an average yield of 2,150 pounds per acre, and a season average grower price of $3.19 per pound. A 100-acre farm with an average yield of 2,150 pounds per acre would produce about 215,000 pounds of almonds. At $3.19 per pound, that farm's production would be valued at $685,850.

    Since Census of Agriculture indicates that the majority of California's almond farms are smaller than 100 acres, it could be concluded that the majority of growers had annual receipts from the sale of almonds in 2014-15 of less than $685,850, well below the SBA threshold of $750,000. Thus, over 70 percent of California's almond growers would be considered small growers according to SBA's definition.

    According to information supplied by the Board, approximately 30 percent of California's almond handlers shipped almonds valued under $7,500,000 during the 2014-15 crop year, and would therefore be considered small handlers according to the SBA definition.

    This proposal would increase the assessment rate collected from handlers for the 2016-17 through the 2018-19 crop years from $0.03 to $0.04 per pound of almonds received. Of the $0.04 per pound assessment, 60 percent (or $0.024 per pound) would be available as credit-back for handlers who conduct their own promotional activities, consistent with § 981.441 of the order's regulations and subject to Board approval. The Board unanimously recommended 2016-17 expenditures of $69,897,626 and an assessment rate of $0.04 per pound of almonds received. The proposed assessment rate of $0.04 is $0.01 higher than the 2015-16 rate, and the credit-back portion of $0.024 per pound would be $0.006 higher than the current credit-back portion of $0.018. The quantity of assessable almonds for the 2016-17 crop year is estimated at 1,835,290,000 pounds.

    This would provide estimated assessment revenue of $62,262,213, which reflects credit-back reimbursements and organic exemptions. In addition, it is anticipated that $20,907,722 will be provided by other sources, including interest income, MAP funds, and operating reserve funds. When combined, revenue from these sources would be adequate to cover budgeted expenses.

    The major expenditures recommended by the Board for the 2016-17 crop year include $8,404,000 for Operations Expenses, $1,000,000 for Board AIM Initiatives, $5,625,000 for Crop of Choice Initiatives, $2,000,000 for Reputation Management, $1,843,331 for Production Research, $1,039,790 for Environmental Research, $1,640,000 for Scientific Affairs/Nutrition, $38,583,756 for Global Market Development, $5,100,000 for Nut of Choice Initiatives, $1,045,500 for Technical & Regulatory Affairs, $2,436,220 for Industry Services, $790,800 for Almond Quality & Food Safety, and $389,229 for Corporate Technology.

    Budgeted expenses for these items in 2015-16 were $7,904,000 for Operations Expenses, $1,500,000 for Board AIM Initiatives, $0 for Crop of Choice Initiatives, $1,826,350 for Reputation Management, $1,843,331 for Production Research, $1,039,790 for Environmental Research, $1,640,000 for Scientific Affairs/Nutrition, $38,583,756 for Global Market Development, $0 for Nut of Choice Initiatives, $1,045,500 for Technical & Regulatory Affairs, $2,436,220 for Industry Services, $790,800 for Almond Quality & Food Safety, and $389,229 for Corporate Technology.

    The Board estimates a production increase of thirty percent, or 600 million pounds, by the 2019-20 crop year. This increase is nearly as much as their largest market currently consumes. Increased market development investment, as well as new marketing programs will be required to successfully market the additional supply. Additional investment in research is also needed to address concerns such as: Changing water supply and quality systems; air quality and how it relates to harvesting, pesticide, and energy use; and bee health. Accordingly, the three-year higher assessment rate is needed to fund the Board's new Nut of Choice marketing program and Crop of Choice research activities. The Board anticipates that by the 2019-20 crop year, the increased production assessed at the reinstated $0.03 per pound rate should generate sufficient revenue to cover the anticipated expenditures at that time.

    Prior to arriving at this budget and assessment rate, the Board held a strategic planning session in February 2016. The Board also considered recommendations made from its various committees including the Global Market Development Committee, Production Research Committee, and Environmental Committee. Alternative expenditure levels were discussed, based upon the relative value of various activities to the almond industry. The Board ultimately determined that 2016-17 expenditures of $69,897,626 were appropriate, and the recommended assessment rate plus, income from other sources and operation reverse funds, would generate sufficient revenue to meet its expenses.

    A review of historical information and preliminary information pertaining to the upcoming crop year indicates that the grower price for the 2016-17 season could range between $3.21 and $3.19 per pound of almonds. Therefore, the estimated assessment revenue for the 2016-17 crop year (disregarding any amounts credited pursuant to § 981.41 and § 981.441) as a percentage of total grower revenue could range between 1.24 and 1.25 percent, respectively.

    This action would increase the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. Some of the additional costs may be passed on to growers. However, these costs would be offset by the benefits derived by the operation of the marketing order. In addition, the Board's meeting was widely publicized throughout the California almond industry and all interested persons were invited to attend the meeting and participate in Board deliberations on all issues. Like all Board meetings, the April 12, 2016, meeting was a public meeting and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and informational impacts of this action on small businesses.

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

    This proposed rule would impose no additional reporting or recordkeeping requirements on either small or large California almond handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

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

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

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

    A 15-day comment period is provided to allow interested persons to respond to this proposed rule. Fifteen days is deemed appropriate because: (1) The 2016-17 crop year begins on August 1, 2016, and the marketing order requires that the rate of assessment for each crop year apply to all assessable almonds handled during such crop year; (2) the Board needs to have sufficient funds to pay its expenses which are incurred on a continuous basis; and (3) handlers are aware of this action which was unanimously recommended by the Board at a public meeting.

    List of Subjects in 7 CFR Part 981

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

    For the reasons set forth in the preamble, 7 CFR part 981 is proposed to be amended as follows:

    PART 981—ALMONDS GROWN IN CALIFORNIA 1. The authority citation for 7 CFR part 981 continues to read as follows: Authority:

    7 U.S.C. 601-674.

    2. Section 981.343 is revised to read as follows:
    § 981.343 Assessment rate.

    For the period August 1, 2016, through July 31, 2019, the assessment rate shall be $0.04 per pound for California almonds. Of the $0.04 assessment rate, 60 percent per assessable pound is available for handler credit-back. On and after August 1, 2019, an assessment rate of $0.03 per pound is established for California almonds. Of the $0.03 assessment rate, 60 percent per assessable pound is available for handler credit-back.

    Dated: July 12, 2016. Elanor Starmer, Administrator, Agricultural Marketing Service.
    [FR Doc. 2016-16814 Filed 7-15-16; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Parts 93, 94, 95, 96, and 98 [Docket No. APHIS-2009-0095] RIN 0579-AD10 Importation of Sheep, Goats, and Certain Other Ruminants AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Proposed rule.

    SUMMARY:

    We are proposing to amend the regulations that govern the importation of animals and animal products to revise the conditions for the importation of live sheep, goats, and certain other non-bovine ruminants, and products derived from sheep and goats, with regard to transmissible spongiform encephalopathies such as bovine spongiform encephalopathy (BSE) and scrapie. We are proposing to remove BSE-related import restrictions on sheep and goats and most of their products, and to add import restrictions related to transmissible spongiform encephalopathies for certain wild, zoological, or other non-bovine ruminant species. The conditions we are proposing for the importation of specified commodities are based on internationally accepted scientific literature and will in general align our regulations with guidelines set out in the World Organization for Animal Health's Terrestrial Animal Health Code.

    DATES:

    We will consider all comments that we receive on or before September 16, 2016.

    ADDRESSES:

    You may submit comments by either of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2009-0095.

    Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2009-0095, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238.

    Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2009-0095 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call (202) 799-7039 before coming.

    FOR FURTHER INFORMATION CONTACT:

    For information concerning live animals, contact Dr. Oriana Beemer, Veterinary Medical Officer, Animal Permitting and Negotiating Services, National Import Export Services, VS, APHIS, 4700 River Road, Unit 39, Riverdale, MD 20737-1231; (301) 851-3300.

    For information regarding ruminant products and for other information regarding this proposed rule, contact Dr. Christopher Robinson, Director, Animal Products Permitting and Negotiation Services, National Import Export Services, VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737-1231; (301) 851-3300.

    SUPPLEMENTARY INFORMATION: I. Executive Summary Need for the Regulatory Action

    The current bovine spongiform encephalopathy (BSE)-related import regulations prohibit the importation of most live sheep and goats and most sheep and goat products from countries that are considered a risk for BSE. The current regulations allow the importation of non-pregnant slaughter or feeder sheep that are under 12 months old from Canada, certain products from sheep and goats, and sheep and goat semen. The conditions we are proposing for the importation of sheep and goats and their products are based on internationally accepted scientific literature and are consistent with World Organization for Animal Health (OIE) guidelines. We are proposing these amendments after conducting a thorough review of relevant scientific literature and a comprehensive evaluation of the issues and concluding that the proposed changes to the regulations will continue to guard against the introduction of transmissible spongiform encephalopathies (TSEs) such as BSE and scrapie into the United States, while allowing the importation of additional animals and animal products into this country.

    Legal Authority for the Regulatory Action

    Under the Animal Health Protection Act (AHPA, 7 U.S.C. 8301 et seq.), the Secretary of Agriculture has the authority to issue orders and promulgate regulations to prevent the introduction into the United States and the dissemination within the United States of any pest or disease of livestock. The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA or Department) administers regulations in 9 CFR subchapter D that govern the exportation and importation of animals (including poultry) and animal products.

    Summary of the Major Provisions of the Regulatory Action

    We are proposing to remove BSE-related import restrictions on sheep and goats and the products derived from them. We are also proposing to add import restrictions related to TSEs for certain wild, zoological, or other non-bovine ruminant species. The existing BSE-related import restrictions also function as protection against the introduction of other TSEs, such as scrapie. While the BSE-related restrictions are no longer warranted for non-bovine ruminant products, it is necessary for us to add appropriate safeguards against the introduction of other TSEs for non-bovine ruminants.

    Costs and Benefits

    This proposed rule's impact would stem from its effect on U.S. imports of the affected commodities. Assuming an increase in imports of 1,966 metric tons (MT) in a net trade welfare model, we project a decrease in wholesale prices of a little more than 1 percent and a fall in domestic production of 615 MT. We estimate consumption would increase by 1,351 MT. As a result, producer welfare would decline by about $6.3 million and consumer welfare would increase by about $14.4 million, yielding an annual net welfare benefit of about $8.1 million. USDA does not have an estimate of the costs or benefits of the change in import restrictions for certain wild, zoological, or other non-bovine ruminant species, and we request comment on such an estimate.

    II. Background

    In order to guard against the introduction and spread of livestock pests and diseases, APHIS regulates the importation of animals and animal products into the United States. The regulations in 9 CFR parts 92, 93, 94, 95, 96, and 98 (referred to below as the regulations) govern the importation of certain animals, meat, other animal products and byproducts, hay and straw, embryos, and semen into the United States in order to prevent the introduction of various livestock pests and diseases.

    Two of the diseases addressed by the current regulations regarding sheep and goats are scrapie and BSE. Scrapie and BSE belong to the family of diseases known as TSEs. In addition to scrapie and BSE, TSEs include, among other diseases, chronic wasting disease in deer and elk, and variant Creutzfeldt-Jakob disease in humans.

    The current BSE-related import regulations restrict the importation of most live ruminants and ruminant-derived products and by-products. The regulations in § 94.18 provide for the importation of meat, meat products, and other edible products derived from bovines (Bos indicus, Bos taurus and Bison bison). The current regulations in § 93.419 allow only the importation of sheep and goats for immediate slaughter or restricted feeding for slaughter from Canada, provided that the sheep and goats are under 12 months of age and are not pregnant.

    In a final rule published on December 4, 2013 (78 FR 72979-73008, Docket No. APHIS-2008-0010), we amended the BSE-related import requirements for B. indicus, B. taurus, B. bison, and removed the BSE-related import restrictions on camelids and cervids from any region.1 However, that rule did not address BSE-related restrictions on domesticated sheep and goats or other non-bovine ruminant species. We believe that further refinement of the regulations is in order given the latest scientific information regarding BSE and scrapie. In this proposed rule, therefore, we are proposing to amend the regulations regarding BSE and scrapie as they apply to the importation of sheep and goats and products derived from sheep and goats, as well as to other ruminant species that are not bovines, cervids, and camelids. We first discuss the changes we are proposing regarding BSE and sheep and goats, then the changes we are proposing regarding scrapie. Lastly, we address the changes we are proposing for other non-bovine ruminants with respect to TSEs generally.

    1 To view the rule, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0010.

    In addition to these changes, we are also proposing to establish provisions that would allow the importation, in specific cases, of other ruminants that would not otherwise be eligible for importation due to TSEs, if the Administrator determines that the disease risk posed by the animals can be adequately mitigated through pre-entry and post-entry mitigation measures. Conversely, we are proposing that certain ruminants whose importation is not currently restricted due to TSEs would, in specific cases, be subject to specified pre-entry and post-entry requirements, if the Administrator determines that the measures are necessary to guard against the transmission of TSEs to livestock in the United States. These provisions are discussed in more detail in this document under the heading “Zoological Ruminants.”

    Nature of BSE

    As noted, BSE belongs to the family of diseases known as TSEs. All TSEs affect the central nervous systems of the infected animals. However, the distribution of infectivity in the body of the animal and mode of transmission differ according to the species and the TSE agent.

    The agent that causes BSE has yet to be fully characterized. The theory that is most accepted in the international scientific community is that the agent is an abnormal form of a normal protein known as cellular prion protein. The BSE agent does not evoke a traditional immune response or inflammatory reaction in host animals. BSE is confirmed by post-mortem examination of an animal's brain tissue, which may include detection of the abnormal form of the prion protein in the brain tissues. The pathogenic form of the protein is both less soluble and more resistant to degradation than the normal form. The BSE agent is resistant to heat and to normal sterilization processes.

    BSE is not a contagious disease, and therefore is not spread through casual contact between animals. Scientists believe that the primary route of transmission is through ingestion of feed that has been contaminated with a sufficient amount of tissue from an infected animal. This route of transmission can be prevented by excluding potentially contaminated materials from ruminant feed.

    Current Regulations Regarding BSE

    The protective measures APHIS has taken against BSE have evolved over the years, as scientific understanding of the disease has increased. From 1997 until 2005, the only two categories of regions listed in the CFR with regard to BSE were regions in which BSE was known to exist, and those regions that presented an undue risk of introducing BSE into the United States because their import requirements were less restrictive than those that would be acceptable for import into the United States and/or because the regions had inadequate surveillance. In a January 2005 final rule (70 FR 460-553, Docket No. 03-080-3), APHIS amended its regulations to recognize a category of regions that present a minimal risk of introducing BSE into the United States, even though BSE may have been diagnosed in the region. The December 4, 2013, final rule amended the BSE regulations to change the categories of regions in which BSE is known to exist. Formerly, we had used the following classifications: Regions of undue risk for BSE and BSE minimal-risk regions. In the final rule, we adopted the system used by the OIE of classifying areas as being either of negligible risk, controlled risk, or undetermined risk for BSE. Whether live bovines and bovine-derived products are eligible for importation into the United States, and under what conditions, is in many cases determined by the BSE category of the region from which the animal or product originates.

    The prohibitions on the importation of animals, meat, and other animal products into the United States are set forth in 9 CFR parts 93, 94, 95, and 96. Section 93.401 prohibits the importation of any non-bovine ruminant that has been in a region listed in § 94.24(a). Section 94.24 restricts the importation of meat and edible products from ovines and caprines due to BSE. Section 94.25 restricts the importation from Canada of meat and edible products other than gelatin from sheep and goats, and § 94.26 provides for the importation of gelatin derived from horses or swine, or from sheep and goats that have not been in a region restricted because of BSE. Section 94.27 provides for the transit shipment of meat, meat products, and other edible products derived from bovines, ovines, or caprines that are otherwise prohibited importation into the United States in accordance with § 94.18 through § 94.26. Section 96.2 prohibits the importation of casings, except stomach casings, from ovines or caprines that originated in or were processed in any region listed in § 95.4(a)(4), unless certain conditions are met.

    When the BSE regulations were codified in 1991 (56 FR 19794-19796, Docket No. 90-252), they applied to all ruminants. Over the past two decades, however, extensive research has been conducted regarding BSE. Based on the information now available, it does not appear to be necessary to continue to prohibit or restrict the importation of sheep and goats and their products with regard to BSE, except in certain limited situations. Therefore, we are proposing to amend the BSE regulations to remove the current prohibitions and restrictions regarding such commodities, except as noted. We discuss below the scientific literature regarding BSE and sheep and goats and the rationale for our proposed changes to the regulations.

    Experiments dating back to the 1990s have demonstrated the ability of BSE to be transmitted to domestic sheep and goats via oral challenge and other routes of inoculation, and, in one study, for inoculated sheep to transmit BSE laterally (Foster, Hope et al. 1993; Foster, Parnham et al. 2001; Foster, Parnham et al. 2001; Jeffrey, Ryder et al. 2001; Bellworthy, Hawkins et al. 2005; Andreoletti, Morel et al. 2006; Bellworthy, Dexter et al. 2008; Konold, Bone et al. 2008). However, information on BSE transmission in sheep and goats that were not experimentally inoculated or exposed to experimentally inoculated sheep or goats is extremely limited. There have been only two retroactively diagnosed cases of naturally occurring BSE in goats. In these two cases there was no evidence of lateral spread.

    In 2005, BSE in a goat was confirmed at the Community Reference Laboratory in Weybridge, United Kingdom. The goat was slaughtered in 2002 in France and was tested as part of a slaughter surveillance program. An epidemiologic investigation conducted at the time of the initial TSE diagnosis did not detect any additional cases in the herd. The goat and its entire herd were destroyed at the time the initial test results were received, and no additional TSE cases were detected. It is not known how the goat acquired BSE; however, because the goat was born prior to the enactment of a ruminant-to-ruminant feed ban, it is possible that consumption of infected ruminant protein was the route of inoculation (Eloit, Adjou et al. 2005; ProMED 2005).

    A second naturally occurring case of BSE in a goat was confirmed in 2011 in the United Kingdom (U.K.) in a goat born in 1990 and evaluated as part of a retrospective study. This goat was also born prior to the enactment of strict BSE control measures in feed (Spiropoulos, Lockey, et al. 2011). There have been no other naturally occurring cases of BSE reported in sheep or goats. Based on the absence of detection of BSE in sheep and goats born after the effective implementation of feed bans, APHIS believes it is unlikely that BSE is being laterally transmitted within domestic sheep or goat populations.

    Because of concerns that BSE may be present in sheep and goats, some countries have embarked on testing programs to detect BSE in these animals. Due to the clinical similarities between BSE and scrapie, surveillance programs for BSE in sheep and goats often target animals that have tested positive to TSE screening tests (sometimes using archived samples of animals that were presumed to have had scrapie) in order to increase the likelihood of finding a BSE-positive animal. Because the United Kingdom was the epicenter of the bovine BSE epizootic in the 1990s, most experts believe that if BSE were to exist within domestic sheep or goat populations, it would most likely occur and be detectable in the United Kingdom. To date, studies conducted in the United Kingdom have not detected any cases of BSE in domestic sheep (Gravenor, Ryder et al. 2003; Stack, Jeffrey et al. 2006) and only one case in a goat (Spiropoulos, Lockey, et al. 2011), despite the testing of thousands of animals, and have concluded that BSE does not appear to be amplifying through lateral transmission in these populations.

    Additional estimates show that if BSE were present in U.K. domestic sheep populations, it would exist at an extremely low level. Two recent studies evaluated the potential prevalence of BSE in the domestic sheep population of the United Kingdom. In order to maximize efficiency, both studies used historical samples in which a TSE, presumably scrapie, had been detected. Additional testing was performed on these samples to determine if BSE, rather than scrapie, was responsible for the initial positive results. Neither study identified any cases of BSE, but both were able to determine that the highest likely prevalence of BSE in the U.K. sheep population was extremely low (Gravenor, Ryder et al. 2003; Stack, Jeffrey et al. 2006).

    Since 2005, the European Commission has required that each index case of a TSE in a flock receive additional testing to determine if BSE is the diagnosis. Estimates of the likely prevalence of BSE in sheep have been made based on data collected during 2005 and 2006. With over 1.5 million sheep tested, it was calculated with 95 percent confidence that there were at most 0.3-0.5 cases (depending on the model used) of BSE per 10,000 healthy slaughter sheep in the European Union (EU) countries at highest risk for BSE (United Kingdom, Ireland, France, and Portugal) (EFSA 2007). No cases of BSE in sheep have been reported since this study was published, so we would expect the risk to be lower if the calculation was repeated to include data from subsequent years.

    Based on the evidence discussed above, we believe it is not warranted to continue to prohibit or restrict trade of live sheep and goats and the products of sheep and goats due to BSE, other than processed animal protein. We continue to consider processed animal protein containing materials derived from sheep and goats to be a BSE risk due to the possibility that such material has been commingled with bovine materials, and because one significant use of these materials is in animal feed. For these reasons, we would continue to restrict the importation of these commodities.

    The changes we are proposing with regard to sheep and goats and BSE are consistent with the approach taken by the OIE. The OIE, of which the United States is a Member country, is the internationally recognized standard-setting body that develops science-based recommendations for the safe trade of animals and animal products. The World Trade Organization has recognized the OIE as the international forum for setting animal health standards, reporting global animal disease events, and presenting guidelines and recommendations on sanitary measures relating to animal health.

    The OIE facilitates intergovernmental cooperation to prevent the spread of contagious diseases in animals by sharing scientific research among its members. The major functions of the OIE are to collect and disseminate information on the distribution and occurrence of animal diseases and to ensure that science-based standards govern international trade in animals and animal products. The OIE carries out its function through the development and revision of international standards for diagnostic tests, vaccines, and the safe international trade of animals and animal products.

    The OIE develops risk-based standards, which are published in the OIE Terrestrial Animal Health Code (Code). As an OIE Member country, the United States reviews and, where appropriate, comments on all draft OIE chapters and revisions. As part of the U.S. consideration of OIE drafts, APHIS distributes these drafts to the U.S. livestock and aquaculture industries, veterinary experts in various U.S. academic institutions, and other interested persons for review and comment.

    In addition, each year, prior to formulating its comments for the OIE annual meeting, APHIS makes available on its Web site those potential changes to the Code that the OIE has submitted to Member countries for comment, and accepts information and recommendations from the public regarding those proposed changes. Through its OIE Reference Laboratories and Collaborating Centers, APHIS also provides OIE Member countries with technical assistance and expert advice on disease surveillance and control and risk analysis, as well as diagnostic assistance, evaluation, and consultation.

    Over the years, the OIE Member countries, including the United States, have agreed to amend the OIE guidelines for BSE based on increased scientific evidence regarding the disease. Current OIE recommendations regarding BSE in ruminants do not include any BSE-related measures for sheep and goats other than the general requirements applied to all ruminant meat and bone meal (processed animal proteins).

    Importation of Live Ruminants

    In this proposed rule, we would amend the regulations to remove most of the current BSE provisions regarding sheep and goats. Below, we identify specific sections and paragraphs in the regulations from which regulatory text relating to BSE and sheep and goats would be removed or revised.

    § 93.400 Definitions: We would remove the definition of suspect for a transmissible spongiform encephalopathy because this term would no longer appear in the regulations. We would also revise the definitions for designated feedlot and flock. The definition of designated feedlot is being changed to reference scrapie-related restrictions rather than BSE-related restrictions. The current definition of flock is being expanded to include goats as well as sheep. We would add definitions for certified status, classical scrapie, country mark, flock of birth, flock of residence, goat, killed and completely destroyed, non-classical scrapie, sheep, transmissible spongiform encephalopathies (TSEs), and TSE-affected sheep or goat, since these terms are currently not defined.

    Specifically, we propose to define certified status as “a flock that has met the requirements equivalent to the Export Certified status of the U.S. Scrapie Flock Certification Program while participating in a program under the supervision of the national veterinary authority of the region of origin, as determined by an evaluation conducted by APHIS of the program.” In the U.S. Scrapie Flock Certification Program, Export Certified flocks receive a high level of monitoring, including annual inspections and inspection of all cull animals, and are subject to official identification and recordkeeping requirements, among other things. Export Certified flocks in the United States are considered scrapie free. These requirements are consistent with OIE recommendations in Article 14.8.5 of the OIE Terrestrial Health Code.

    We would define classical scrapie as “any form of scrapie that the Administrator has determined poses a significant risk of natural transmission” and non-classical scrapie as “any form of scrapie that the Administrator has determined poses a low risk of natural transmission.” We are proposing these definitions to distinguish between strains of the disease that pose a significant risk of natural transmission and thus present a significant livestock disease risk, and those strains that pose a low risk of natural transmission and do not present a significant livestock disease risk.

    We would define country mark as “a permanent mark approved by the Administrator for identifying a sheep or goat to its country of origin.” We are proposing this definition to distinguish this mark from other forms of identification, such as eartags or backtags, that might be used on an animal. We are proposing to require the use of country marks for sheep and goats because this permanent identification allows APHIS to trace an animal back to the country of origin in the event that the animal shows symptoms of a TSE.

    We would define flock of birth as “the flock into which a sheep or goat is born” and flock of residence as “the flock (1) within which an individual sheep or goat was born, raised, and resided until exported to the United States; or (2) in which the sheep or goat resided for breeding purposes for 60 days or more until exported to the United States; or (3) in which sheep and goats for export were assembled for export to the United States and maintained for at least 60 days immediately prior to export, without any addition of animals or contact with animals other than through birth, on a single premises, or on more than one premises under the same ownership and between which unrestricted movement occurred.” We are proposing to add these two definitions to clarify to which flocks certain requirements pertain.

    We would define goat as “any animal of the genus Capra” and sheep as “any animal of the genus Ovis” to clarify that the requirements for sheep and goats apply not only to domesticated sheep and goats, but also to wild animals of those genera which are also susceptible to scrapie.

    We are proposing to define killed and completely destroyed as “killed, or maintained under quarantine in a manner that will prevent disease spread until the animal is no longer living; and the remains have been disposed of in a way that prevents disease spread” to clarify that sheep and goats known to be affected by TSEs are not to enter slaughter channels.

    We are proposing to define transmissible spongiform encephalopathies (TSEs) as “A family of progressive and generally fatal neurodegenerative disorders thought to be caused by abnormal proteins, called prions, that typically produce characteristic microscopic changes, including but not limited to non-inflammatory neuronal loss, giving a spongiform appearance to tissues in the brains and central nervous systems of affected animals.” The Administrator may make a determination that a disease meeting these general criteria is not a TSE of whose introduction or dissemination would cause adverse animal health or disease concerns and that animals affected by it would not be subject to the regulations if the disease presents a low risk of transmission.

    We are proposing to define TSE-affected sheep or goat as “A sheep or goat suspected or known by the national veterinary authority of the region of origin to be infected with a transmissible spongiform encephalopathy prior to the disposal of the animal” in order to clarify to which animals the provisions would apply.

    § 93.404 Import Permits for Ruminants: We are proposing to add a new paragraph (a)(2) to this section to specify additional information that an importer would have to submit with the application for an import permit for sheep and goats. Specifically, we would require that, for sheep and goats imported for immediate slaughter or restricted feeding for slaughter, the slaughter establishment to which the animals will be imported, or the designated feedlot in which the animals will be maintained until moved to slaughter be specified. We need this information to validate that the animals are slaughtered and to rapidly locate the animals should the country of origin report a disease outbreak. It will also clarify that these animals are in, and are not to be removed from, slaughter channels.

    For sheep and goats imported for purposes other than immediate slaughter or restricted feeding for slaughter, we would require that the importer provide the flock identification number if imported to a flock, and the premises or location identification number of the flock or other premises to which the animals are imported, as listed in the Scrapie National Database. If the sheep and goats originate in regions not free of classical scrapie, the importer would have to provide documentation showing that the animals have reached and maintained certified status in a scrapie flock certification program that has been evaluated and approved by the Administrator. The documentation would have to specify the address, or other means of identification, of the premises and flock of birth, and any other flocks in which the animal has resided. We need this information to ensure that a continuous previous health history is available for animals that may be considered for importation into the United States.

    We are also proposing to add a new paragraph (a)(5) to this section to address mitigation measures to allow the importation of zoological ruminants. This change is discussed below under the heading “Zoological Ruminants.”

    Last, we would add a new paragraph (a)(6) which would provide for permits to be issued by the Administrator for sheep of certain classical scrapie-resistant genotypes, as determined by testing at the National Veterinary Services Laboratories (NVSL) or another laboratory approved by the Administrator. This would reduce import restrictions on animals found to be genetically resistant to scrapie.

    Current paragraphs (a)(2), (a)(3),and (a)(4) would be redesignated as paragraphs (a)(3), (a)(4) and (a)(7), respectively.

    § 93.405 Health Certificate for Ruminants: Paragraph (a)(4) describes the information that must be included on a health certificate accompanying sheep or goats from Canada. We are proposing to remove this paragraph because paragraph (b), which contains additional requirements for health certificates for goats, would be revised to incorporate requirements for health certificates for sheep. These additional requirements would include some of the information currently required under paragraph (a)(4), because that information is relevant to animal diseases other than BSE. Paragraph (c), which currently contains additional requirements for health certificates for sheep, would be removed, and paragraph (d) would be redesignated as paragraph (c).

    § 93.419 Sheep and goats from Canada: This section would be removed and reserved. Provisions for the importation of sheep and goats from Canada would be moved to § 93.435.

    § 93.420 Ruminants from Canada for immediate slaughter other than sheep and goats: The reference in paragraph (a) to the provisions regarding sheep and goats for immediate slaughter in § 93.419 would be replaced by a reference to the provisions in § 93.435.

    § 93.424 Import permits and applications for inspection of ruminants (from Mexico): Paragraphs (a)(1) and (2) would be removed, and paragraph (a) would be revised to state that sheep and goats for immediate slaughter do not need to be accompanied by an import permit if entering the United States through a port on the U.S./Mexico border. Currently the regulations provide that wethers (castrated male sheep or goats) do not need to be accompanied by an import permit if they enter the United States from Mexico through land border ports, even if they are not being imported for immediate slaughter. We are proposing to remove this exemption because we need the information from the import permit to conduct a traceback investigation in the event of a disease outbreak.

    § 93.428 Sheep and goats and wild ruminants from Mexico: This section would be revised to refer to the scrapie provisions in § 93.435 which would also apply to sheep and goats from Mexico.

    § 93.435 Sheep and goats: This section would be revised to contain provisions for importing sheep and goats from anywhere in the world. The provisions for sheep and goats imported for immediate slaughter and restricted feeding for slaughter would be similar to the existing requirements for sheep and goats imported for those purposes from Canada, currently contained in § 93.419. The requirements for importing sheep and goats for other purposes, currently contained in § 93.435, would be updated to make them in general consistent with international standards, by limiting imports for these purposes to animals from classical scrapie-free countries or flocks, except as permitted by the Administrator under paragraph (a)(5) of § 93.404. This would allow for the importation of animals that are very low risk due to their genotype or other factors. We would also revise this section to establish a notice-based approach for recognizing regions as free of classical scrapie. The regulations would provide the Web address and a contact for requesting copies of the list of classical scrapie-free regions by mail, fax, or email. The regulations also would explain APHIS' process for adding or removing a region to or from the list.

    This proposed action would allow more timely changes to the list than if we had to do it through rulemaking, as we do now. APHIS considers a disease to exist in a region when we receive reports of an outbreak of the disease in the region from veterinary officials of the national government of the region and/or the OIE, or from another source that the Administrator determines to be reliable, e.g., APHIS inspectors based in foreign countries.

    As it is now, when APHIS determines that a disease is present in a region and presents a potential threat to animal health in the United States, we would take immediate action to restrict imports from that region. We would no longer need to follow that action with an interim rule in the Federal Register to change text in the regulations. Instead, we would immediately list the region on the APHIS Web site and announce the listing through a notice, rather than a rule, in the Federal Register. The notice would provide an opportunity for public comment.

    We would add a region to a list of regions we recognize as free of classical scrapie only after completing an evaluation and making it available for public comment. We would do this through a notice in the Federal Register. Following the close of the comment period, we would publish another notice responding to comments and announcing APHIS' decision. The criteria we are proposing for evaluating a region's classical scrapie disease status would be consistent with current scientific understanding, international standards, and 9 CFR part 92, “Importation of Animals and Animal Products: Procedures for Requesting Recognition of Regions.” Additional details about the factors APHIS reviews to determine a region's status may be found on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/reg_request.shtml.

    Zoological Ruminants

    Section 93.404 of the regulations contains provisions regarding permits for the importation of ruminants into the United States. With several exceptions, ruminants are not eligible for importation if the importer has not first applied for and obtained an import permit from APHIS. Part 93 subpart D contains a number of provisions that specifically prohibit or restrict the importation of ruminants into the United States with regard to specified diseases, or that set forth risk mitigation measures that must be taken or agreed to before an import permit will be issued. Among the specific prohibitions and restrictions in current part 93 subpart D are those, discussed above, that prohibit the importation of live non-bovine ruminants from regions listed in § 94.24(a).

    Currently, non-bovine ruminants other than sheep and goats from regions not listed in § 94.24(a) are not subject to any import restrictions with regard to BSE. We believe, however, that there is a certain category of ruminants that present enough of a potential risk of spreading TSEs that their importation should be prohibited unless certain risk mitigation measures are in place. This category of ruminants includes certain ruminants held in zoological facilities and certain wild ruminants. For the purposes of discussion, we will refer to such animals as zoological ruminants to distinguish them from domesticated sheep, goats, and bovines.

    Scientific literature indicates that at least certain zoological ruminants are susceptible to TSEs caused by the BSE agent. In association with the BSE epidemic in domestic cattle in Europe, TSEs have been diagnosed in several species of zoo animals, all from the families Bovidae and Felidae. Sixteen cases of TSEs have been recorded from antelope in U.K. zoos including one nyala (Tragelaphus angasi), six eland (Taurotragus oryx), six greater kudu (Tragelaphus strepsiceros), one gemsbok (Oryx gazelle), one Arabian oryx (Oryx leucoryx), and one scimitar-horned oryx (Oryx dammah) (Travis and Miller 2003). The first recorded case was a nyala euthanized at a wildlife park in England in 1986, the same year that the first BSE cases in cattle were recognized (Wells, Scott et al. 1987; Jeffrey and Wells 1988). Reported cases of TSEs in zoo bovids peaked around 1991, and no additional cases in zoo antelope have been reported since 1996 (Kirkwood 2000).

    Several lines of evidence support the hypothesis that at least some, if not all, of the spongiform encephalopathy cases diagnosed in zoo bovids were caused by the BSE agent. First, the cases in zoos coincide geographically and temporally with the BSE epidemic in Great Britain. Second, epidemiologic investigations indicated that all affected animals, or the herds into which they were born or moved, could have been exposed to feeds containing ruminant-derived protein or other potentially contaminated material (Kirkwood and Cunningham 1994). Finally, comparable patterns of incubation periods and pathologic effects were seen in mice inoculated with brain tissue homogenate from the affected nyala, an affected kudu, and BSE-affected cattle (Jeffrey, Scott et al. 1992).

    The greater kudu, a non-domestic African antelope, appears to be particularly susceptible to BSE. Six of eight kudu that died in a small herd at the London Zoo from 1989 through 1992 were diagnosed with spongiform encephalopathy (Kirkwood and Cunningham 1994). The disease is presumed to have been introduced to the kudu herd through feeds containing ruminant-derived protein around the time of the BSE epidemic in U.K. cattle. However, some of the affected kudu were born after the elimination of the potentially contaminated feed from the premises, and one case occurred in a kudu born at another zoo and introduced to the affected herd (Kirkwood, Cunningham et al. 1994). Because most of the affected kudu did not consume feed containing ruminant-derived protein, it was postulated that the disease may have spread naturally in the herd, either by transmission between individuals or through contamination of the environment (Kirkwood, Cunningham et al. 1993).

    The epidemiology of the TSE cases in kudu contrasts with BSE in cattle in several respects. The attack rate in the London Zoo kudu herd is notably higher than the attack rate seen in BSE affected cattle herds. The pattern of disease in antelope also differs from cattle affected with BSE, characterized by a younger average age of onset and a shortened clinical course (Kirkwood and Cunningham 1999). Additionally, infectivity in greater kudu with TSE is distributed in a wider range of tissues than in cattle with BSE (Cunningham, Kirkwood et al. 2004).

    Information about the infectivity of tissues from TSE-affected zoological ruminants is limited to studies of tissue from four London Zoo kudus with spongiform encephalopathy. Fifteen of 32 kudu tissue homogenates transmitted BSE to mice. Of these, fresh central nervous, lymphoreticular, and distal ileum tissue indicated moderate or high levels of spongiform encephalopathy infectivity. Traces of infectivity were demonstrated in kudu spleen, lung, skin, conjunctiva, and salivary gland (Cunningham, Kirkwood et al. 2004).

    A wide range of species in zoological collections were probably exposed to BSE-contaminated feed; new cases in other captive zoological species may emerge, or it is possible that some species may carry and transmit the disease without showing clinical signs. The possibility of transmission of BSE-related encephalopathy between members, or from mother to offspring, within herds of zoological ruminants, as suspected with the London Zoo kudus, cannot be ruled out. Although there is currently no evidence that TSEs exist in free-living zoological ruminants (veterinary authorities in southern African countries conducting passive surveillance in wildlife have not encountered any clinical cases or histopathological lesions compatible with TSEs (Horn, Bobrow et al.), active surveillance has not been implemented in any region of the world for TSEs in antelope or free-living Caprinae.

    Many of the non-domestic ruminants are endangered species. The scimitar-horned oryx, for example, is listed as “Extinct in the Wild” on the International Union for Conservation of Nature Red List (http://www.iucnredlist.org/), and 13 species of the Caprinae subfamily are listed as threatened on the Red List. In order to maintain genetic diversity in these very small populations, animals must be moved between zoological collections, both domestically and internationally (Shackleton 1997). Movement of animals may also be a goal of conservation programs seeking to reintroduce captive-bred endangered species into the wild. Both types of movement carry the risk of inadvertent introduction of infectious diseases that may have serious consequences for conservation efforts. The management of animal genetic resources must include a consideration of the potential risk of importing undetected prion diseases with rare breeding stock.

    Although each of the cases to date of ruminant TSEs possibly connected to BSE in zoo animals was diagnosed in a region known to be affected with BSE, we believe that even zoological ruminants in regions not categorized as BSE-affected or as posing undue risk of BSE could be at risk for BSE-related TSEs, due to possible origin in a BSE-affected region or feeding with BSE-contaminated protein. Even in countries that have enforced a ban on the feeding of ruminant protein to domestic ruminants for an identifiable period of time, it can be difficult in some cases to determine when and if a country ceased feeding ruminant protein to zoo ruminants.

    Because of the potential variety of practices in the feeding of zoo ruminants, as well as the potential that certain zoo ruminants may have originated in BSE-affected countries, we believe it is necessary to consider on a case-by-case basis the potential spongiform encephalopathy risk of zoological ruminants. As noted above, a ruminant may not be imported into the United States unless the importer has first applied for and obtained a permit from APHIS for such importation. In the case of zoological ruminants, the Administrator will consider the disease risk of each animal and the ability of the receiving zoo to manage the risks before deciding whether to issue an import permit.

    Paragraph (a)(3) of § 93.404 currently provides that an application for a permit to import ruminants may be denied due to, among other reasons, the lack of satisfactory information necessary to determine that the importation will not be likely to transmit any communicable disease to livestock or poultry of the United States.

    Even with zoological ruminants that would otherwise be denied importation into the United States, however, we believe that, in most cases, adequate mitigation measures with respect to potential TSE risks can be taken to allow the animal to be safely imported into the United States. Although the precise measures APHIS considers necessary could vary on a case-by-case basis, such measures could include the following:

    • That the animal be held at approved permanent post-entry quarantine facilities;

    • That any movement of the animal out of or among such facilities occur only in accordance with a compliance agreement between APHIS and the owners of approved facilities; and

    • That, upon the death of the animal, the APHIS Service Center Director be notified, and the carcass be tested for TSEs and be completely destroyed in a manner acceptable to the Administrator.

    Any conditions for the importation of a zoological ruminant would be spelled out in the import permit for that animal. Any such conditions could also be applied to any progeny of the animal, as well to as any ruminants housed with either the animal or its progeny. In the event that the conditions of importation of a zoological ruminant were applied to its progeny or contact animals, the Administrator could require that a zoo enter into a cooperative, compliance, or other agreement that sets out specific requirements for releasing the progeny or contact animals based on postmortem testing of the imported animal with negative results.

    Ruminants From Regions Where BSE Exists

    As noted above, the current regulations contain broad prohibitions and restrictions regarding the importation of non-bovine ruminants other than sheep and goats from regions listed in § 94.24(a). The prohibitions apply to zoological ruminants as well as to domesticated ruminants. However, the regionally based prohibitions do not address individual situations where a ruminant that would otherwise be denied entry from a region listed in § 94.24(a) could be safely entered into the United States, provided certain risk mitigation measures are taken.

    Section 93.401 of the regulations contains general prohibitions on the importation of ruminants. We would amend paragraph (a) of this section by revising the second sentence to remove the reference to § 94.24(a). That section contains a list of regions in which BSE is known to exist, but is no longer needed since we have changed the way we recognize regions for BSE risk. We are proposing to amend the second sentence to read “Notwithstanding any other provision of this subpart, the importation of any ruminant that is not a bovine, camelid, cervid, sheep, or goat is prohibited.” This change would remove BSE restrictions on the importation of many non-bovine ruminants, but would continue to protect against the introduction of TSEs into the United States.

    Currently § 93.401(a) also provides that the Administrator may, upon request in specific cases, allow ruminants or products to be brought into or through the United States under such conditions as he or she may prescribe, when he or she determines in the specific case that such action will not endanger the livestock or poultry of the United States. Providing for the importation of specific animals in individual cases has great value for conservation efforts. In order to maintain genetic diversity in species with very small populations, animals must be moved between zoological collections, both domestically and internationally.

    In the preceding section of this document, we discussed the type of mitigation measures that could be used to adequately mitigate TSE risk from zoo ruminants from regions other than those listed in § 94.24(a). We believe that the same types of mitigation measures can be employed to safely import zoological ruminants from regions listed in § 94.24(a).

    In this document, therefore, we are proposing to add a new paragraph (a)(5) to the import permit provisions in § 93.404 to address such situations. The new paragraph would provide that, in specific cases, a permit may be issued for ruminants that would otherwise be prohibited importation due to TSEs pursuant to part 93 subpart D if the Administrator determines that the disease risk posed by the animals can be adequately mitigated through pre-entry or post-entry mitigation measures, or through combinations of such measures. Such measures would be specified in the permit. If it is determined prior to or after importation that any pre-entry or post-entry requirements were not met, or that the ruminants are affected with or have been exposed to TSEs, the ruminants, their progeny, and any other ruminants that have been housed with or exposed to the ruminants will be disposed of or otherwise handled as directed by the Administrator.

    We would also provide that importers seeking a permit pursuant to the paragraph must send their request by postal mail to the Administrator, c/o National Import Export Services, VS, APHIS, 4700 River Road, Unit 39, Riverdale, MD 20737-1231, or make their request online via APHIS' electronic permitting system, by email or by fax. Information about using these methods to request a permit can be found on the APHIS Web site at http://www.aphis.usda.gov/animal_health/permits/.

    Sheep and Goat Products

    The regulations in 9 CFR parts 94, 95, and 96 prohibit or restrict the importation of certain animals and animal products, byproducts, and foreign animal casings into the United States to prevent the introduction of communicable diseases of livestock and poultry. We are also proposing to amend part 94, part 95, and part 96 of the regulations to remove the current BSE provisions regarding sheep and goats. In the following sections, we identify those CFR sections and paragraphs from which regulatory text relating to BSE and sheep and goats would be removed.

    Transit Shipment of Articles

    The regulations in §§ 94.15, 94.27, and 95.15 currently provide requirements for the transit shipment of animal products and materials. Section 94.15 provides general requirements for the movement and handling of animal products and materials through the United States for immediate export. Section 94.27 provides requirements for transit shipment of meat, meat products, and other edible products derived from bovines, ovines, or caprines through air or ocean ports or by overland transport. Section 95.15 provides requirements for transit shipment of animal byproducts through air or ocean ports or by overland transport.

    We are proposing to revise § 94.15 to consolidate the requirements for transit shipment of all these products into one section and to eliminate some BSE-related restrictions that are no longer warranted. The new requirements would be similar to those that already exist in § 94.15. Paragraphs (b) and (c) of § 94.15 would be redesignated as (c) and (d), respectively. The specific requirements for meat, meat products, and other edible products derived from bovines, ovines, or caprines in § 94.27 would be removed because they are no longer warranted. Section 95.15 would also be removed.

    Restrictions on the Importation of Meat and Edible Products Due to BSE

    The regulations in § 94.24 restrict the importation of meat and edible products, including gelatin, from ovines and caprines due to BSE, those in § 94.25 restrict the importation from Canada of meat and edible products from ovines and caprines other than gelatin, and those in § 94.26 apply to gelatin derived from horses or swine or from ovines or caprines that have not been in a region restricted because of BSE. While there is no BSE risk associated with gelatin or meat and other edible products derived from sheep and goats, these restrictions also function as protection against the introduction of other TSEs, such as scrapie.

    We are proposing to remove §§ 94.24 and 94.25. This will remove both the prohibition on the importation of meat and other edible products ovines and caprines from regions in which BSE is known to exist, and the requirement that meat and edible products from sheep and goats from Canada, other than gelatin, be derived only from animals less than 12 months of age. These restrictions were related to concerns about BSE risk and are no longer warranted since there is no scientific evidence that BSE is circulating in sheep or goats.

    We are proposing to amend § 94.26 by removing the references to ovines and caprines that have not been in a region restricted because of BSE from the section heading and the regulatory text. In place of those references we would add a reference to non-bovine ruminants. Gelatin derived from non-bovine ruminants, like gelatin derived from horses and swine, does not present a risk for BSE since there is no scientific evidence that BSE is circulating in sheep or goats.

    Restrictions on Importation of Byproducts Derived From Ruminants Due to BSE

    Part 95 of the regulations prohibits or restricts the importation of products other than meat and other edible products to prevent the introduction of certain animal diseases. We are proposing to amend § 95.1 by removing the definitions for positive for a transmissible spongiform encephalopathy and suspect for a transmissible spongiform encephalopathy because those terms no longer appear in the regulations.

    Section 95.4 contains restrictions on the importation of processed animal protein, offal, tankage, fat, glands, certain tallow other than tallow derivatives, and serum due to bovine spongiform encephalopathy. We are proposing to amend this section first by revising the section heading to remove the exception for certain tallow derivatives. We would also revise paragraph (b)(1) to remove the exception for tallow derivatives from that paragraph. We are making these changes in order to be consistent with our requirements for bovine-derived tallow derivatives, which are subject to restrictions set out in § 95.9.

    Paragraph (a) contains a list of regions in which BSE is known to exist. We would revise the paragraph to remove this list, which is no longer needed since we have changed the way we recognize regions for BSE risk.

    In paragraph (c), we would remove the reference to paragraph (a)(4) from paragraph (c)(1)(iv), and remove paragraphs (c)(2) and (c)(3). These revisions would remove BSE-related restrictions from these products when derived from sheep and goats. We would also amend paragraphs (c)(1)(ii) and (iv) to add the words “and the material is not ineligible for importation under the conditions of § 95.5” after the words “cervids and camelids” and “ovines and caprines,” respectively. These would not be new requirements; the regulations in § 95.5 have always applied to products derived from all ruminant species, due to concerns about commingling or cross-contamination. However, this change would clarify that the restrictions in that section continue to apply to products derived from cervids, camelids, ovines, and caprines. Paragraphs (c)(4) through (c)(8) would be redesignated as paragraphs (c)(2) through (c)(6), respectively.

    In newly redesignated paragraph (c)(3), we would amend the first sentence to remove the requirement that facilities that process or handle any material derived from mammals be inspected at least annually for compliance with the provisions of this section, either by a representative of the government agency responsible for animal health in the region, or by APHIS. Instead, we would require only facilities that process or handle processed animal protein be inspected at least annually. The rendering process used to make processed animal protein creates a material that cannot be differentiated by species without a polymerase chain reaction test, and much rendering is performed involving multiple species. As a result, there is a risk of cross-contamination with processed animal protein that does not exist with the other products. For this reason we would continue to require inspections for facilities that process or handle processed animal proteins.

    Paragraphs (d) and (e) contain restrictions on serum, serum albumin, serocolostrum, amniotic liquids or extracts, and placental liquids derived from ovines and caprines due to BSE. We are proposing to remove both of these paragraphs because BSE-related restrictions on these products are no longer warranted. These products present a risk of introducing other diseases, however, and would continue to be prohibited importation into the United States, except for scientific, educational, or research purposes if the Administrator determines that the importation can be made under conditions that will prevent the introduction of animal diseases into the United States.

    Paragraph (g) contains restrictions on offal derived from ovines and caprines. These restrictions are no longer warranted and paragraph (g) would be removed.

    Section 95.40 contains additional certification requirements for certain materials derived from sheep and goats, including processed animal protein, tankage, offal, glands and unprocessed fat tissue, and derivatives of those products. These additional certification requirements were established due to BSE concerns and are no longer warranted; therefore, we are proposing to remove § 95.40.

    Restrictions on the Importation of Foreign Animal Casings

    Part 96 of the current regulations includes provisions regarding the importation of animal casings into the United States. The regulations in § 96.2 prohibit the importation of ruminant casings into the United States to prevent the introduction of BSE. We would remove the restrictions on casings derived from sheep and goats by removing paragraph (b)(1), which pertains to casings derived from sheep slaughtered in Canada. We would also redesignate paragraph (b)(2) as (b)(1).

    Sheep and Goat Germ Plasm

    The regulations in 9 CFR part 98 govern the importation into the United States of germ plasm (embryos and semen), including germ plasm from sheep and goats. Subpart A sets forth requirements for ruminant and swine embryos from regions free of rinderpest and foot-and-mouth disease (FMD), and for embryos of horses and asses. Subpart B sets forth requirements for ruminant and swine embryos from regions where rinderpest and FMD exist. Subpart C sets forth the requirements for the importation of animal semen from species regulated by APHIS.

    Currently, the regulations in § 98.10a provide that embryos from sheep in regions other than Australia, Canada, and New Zealand may be imported only if the embryos are transferred to females in a flock that participates in the Voluntary Scrapie Flock Certification Program (9 CFR part 54, subpart B) and qualifies as a “Certified” flock, or:

    • The embryos are transferred to females in a flock that participates in the Voluntary Scrapie Flock Certification Program and the flock owner has agreed, in writing, to maintain the flock, and all first generation (F1) progeny resulting from the embryos in accordance with all requirements of the Voluntary Scrapie Flock Certification Program; and

    • The importer provides the Voluntary Scrapie Flock Certification Program identification number as part of the application for an import permit; and

    • The embryos are the progeny of a dam and sire that are part of flocks in the region of origin that participate in a program that has been determined by the Administrator to be equivalent to the Voluntary Scrapie Flock Certification Program, and those flocks have been determined to be at a level equivalent to “Certified.”

    In addition, the flock to which the embryos are transferred must also be monitored for scrapie until the flock, and all first generation progeny resulting from the embryos qualifies as a “Certified” flock.

    Because sheep and goat embryos and oocytes present similar disease risks, those risks can be addressed by the same mitigations, and also because we anticipate that use of oocytes will increase as reproductive technology continues to improve, we are proposing to add provisions for goat embryos and both sheep and goat oocytes to the regulations in § 98.10a. Specifically, we would revise the section heading to read “Sheep and goat embryos and oocytes.” We would also add a definition of oocyte to read “the first and second maturation stages of a female reproductive cell prior to fertilization” to § 98.2 of the regulations. This definition is consistent with international standards.

    We are proposing to allow the importation of in vivo-derived sheep and goat embryos and oocytes with the requirement that, if these embryos and oocytes are collected from donors in, or originating from, regions not free of classical scrapie, the health certificate required under § 98.5 must include additional declarations stating that the embryos or oocytes were collected, processed, and stored in accordance with the requirements in § 98.3, and, for in vivo-derived sheep embryos only, that the embryo is of either of the scrapie-resistant genotypes, AARR or AAQR, based on official testing of the parents or the embryo. The testing may be performed at the NVSL or at another laboratory approved by the Administrator.

    The certificate that would accompany sheep embryos that are not of either of these genotypes, sheep embryos that are in vitro-derived or processed, and all goat embryos, would also have to include statements that in the region where the embryos originate:

    • TSEs of sheep and goats are compulsorily notifiable;

    • A classical scrapie awareness, surveillance, monitoring, and control system is in place;

    • TSE-affected sheep and goats are killed and completely destroyed; and

    • The feeding of meat-and-bone meal of ruminant origin has been banned and effectively enforced in the whole country.

    The certificate would also have to state that the donor animals:

    • Have been kept since birth in flocks in which no case of classical scrapie had been confirmed during their residency;

    • Are permanently identified to enable traceback to their flock of birth or herd of origin, and the identification is recorded on the certificate accompanying the embryos and linked to the embryo container identification;

    • Showed no clinical sign of classical scrapie at the time of embryo or oocyte collection; and

    • Have not tested positive for, and are not suspect for, a transmissible spongiform encephalopathy.

    We are adding these certification requirements for embryo genotypes that are not scrapie resistant, but which originate from regions not considered by APHIS as free of classical scrapie, to ensure that mitigations are in place to detect classical scrapie if it is present in sheep or goat populations.

    We are also proposing to remove the existing requirement that sheep embryos from regions other than Australia, New Zealand, or Canada be transferred only to flocks in the Voluntary Scrapie Flock Certification program (SFCP). Enrollment in this program requires an annual inspection with inventory reconciliation and submission of tissues from certain animals for scrapie testing. We are making this change because the scientific literature demonstrates that embryos are low risk for scrapie transmission. APHIS has determined that requiring all F1 offspring to be maintained in an SFCP flock is unnecessary as well as overly burdensome on importers.

    Instead, we would require that sheep and goat embryos or oocytes from regions that are not free of classical scrapie be imported only for transfer to females in flocks listed in the National Scrapie Database, or to an APHIS-approved storage facility where they may be kept and later transferred to recipient females in a flock that is listed in the National Scrapie Database. We would also allow imported embryos or oocytes that are not otherwise restricted by the conditions of an import permit to be transferred from a listed flock to any other listed flock with written notification to the responsible APHIS Veterinary Services (VS) National Import Export Services (NIES) Service Center. To be listed in the National Scrapie Database, a flock owner must contact the local VS Surveillance, Preparedness and Response (SPRS) field office or a cooperating State Veterinarian's office and request to be listed; and provide the location of the flock and the owner's contact information. The VS SPRS field office or State Veterinarian's Office will enter the information in the database, and will issue the flock identification and the premises identification number that are required to be submitted on the permit application. To find the nearest VS NIES Service Center or SPRS field office, contact the State or Territory Point of Contact (POC). A list of POCs can be found on the APHIS Web site at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/contact-us.

    Finally, we would require the importer, owner of a recipient flock, or the owner of an APHIS-approved embryo or oocyte storage facility to maintain records of the disposition (including destruction) of imported or stored embryos or oocytes for 5 years after the embryo or oocyte is transferred or destroyed. These records would have to be made available during normal business hours to APHIS representatives on request for review and copying. This recordkeeping requirement is consistent with the recordkeeping requirements for imported semen that already exist, and would allow us to conduct traceback investigations in the event of a disease introduction.

    The regulations in § 98.3(h) currently require that ruminant and swine embryos have an intact zona pellucida, which effectively prohibits the importation of in vitro-derived and processed embryos except as provided under § 98.10. We intend to continue to allow such importations on a case-by-case basis, if the Administrator determines that any disease risk posed by the embryos can be adequately mitigated through pre-entry or post-entry mitigation measures, or through combinations of such measures.

    The regulations in 98.13 provide requirements for import permits for ruminant and swine embryos from regions where rinderpest or FMD exist. We are proposing to add a new paragraph (c) to this section specifying that applications for a permit to import sheep and goat embryos and oocytes must include the flock identification number of the receiving flock and the premises or location identification number assigned in the APHIS National Scrapie Database; or, in the case of embryos or oocytes moving to a storage facility, the premises or location identification number must be included. We are proposing this change to ensure that the permit requirements for sheep and goat embryos and oocytes from regions where rinderpest or FMD exist are consistent with the requirements for sheep and goat embryos and oocytes from regions that are free of those diseases.

    The regulations in § 98.15 set forth the requirements for ruminant and swine embryos from regions where foot-and-mouth disease or rinderpest exist. Currently, § 98.15(a)(1) and (2) require that, for ruminants, no case of BSE (among other diseases) occurred (1) during the year before collection in the embryo collection unit or in any herd in which the donor dam was present, or (2) in or within 5 kilometers of the embryo collection unit, or in any herd in which the donor dam was present. We are proposing to remove these requirements because we believe the proposed requirements for sheep and goat embryos in § 98.10a will provide adequate protection against a TSE introduction via embryo or oocyte transfer.

    Section 98.15(a)(7)(i)(A) currently requires that, for ruminants, not less than 30 days, nor more than 120 days after embryo collection, the donor dam must be examined and found free of BSE (among other diseases). We are proposing to amend this requirement by removing the requirement that sheep and goats be found free of clinical signs of BSE because sheep and goat embryos do not present a risk for transmitting BSE since BSE is not circulating in the sheep and goat populations.

    Currently § 98.15(a)(8)(i)(A) requires that, for ruminants, between the time of embryo collection and all required examinations and tests are completed, no animals in the embryo collection unit with the donor dam, or in the donor dam's herd of origin, exhibited clinical evidence of BSE (among other diseases). We are proposing to remove BSE from the list of diseases in this paragraph because we believe the proposed requirements for sheep and goat embryos in § 98.10a will provide adequate protection against a TSE introduction through embryo or oocyte transfer.

    Currently, the regulations in § 98.35(e) require that, for sheep and goat semen from any part of the world to be imported into the United States:

    • The donor animals must be permanently identified to enable traceback to their establishment of origin;

    • They have been kept since birth in establishments in which no case of scrapie has been confirmed during their residency;

    • They neither showed clinical signs of scrapie at the time of semen collection nor developed scrapie between the time of semen collection and the export of semen to the United States; and

    • The dam of the semen donor is not, or was not, affected with scrapie.

    The regulations also require that in the region where the semen originates, scrapie is a compulsorily notifiable disease, an effective surveillance and monitoring program for scrapie is in place, affected sheep and goats are slaughtered and completely destroyed, and the feeding of meat and bone meal or greaves derived from ruminants has been banned and the ban effectively enforced for the whole region.

    At the time the regulations were established, they were consistent with the then current scientific understanding of scrapie and existing international standards. However, advances in scientific understanding of the disease now allow us to relieve some restrictions on the importation of sheep and goat semen. Epidemiological evidence from natural cases in the field suggests that classical scrapie is unlikely to be transmitted via semen (Wrathall 1997). In addition, studies to date have failed to detect PrPSc in components of semen (Gatti, Meyer et al. 2002).

    As part of a study to investigate transmission of classical scrapie through embryo transfer, Wang, et al., used a classical scrapie-positive ram to mate with two donor ewes, one scrapie positive, the other negative (Wang, Foote et al. 2001). None of the lambs resulting from embryos of either ewe developed classical scrapie, nor did the uninfected ewe that was bred to the infected ram. The study did not provide information about the scrapie strain or the genotypes of the rams, donor ewes, and recipient ewes.

    A more recent study evaluated the infectivity of semen from infected rams by injecting it via intracerebral inoculation into classical scrapie-susceptible transgenic mice overexpressing the VRQ allele. Semen from three classical scrapie-positive VRQ homozygous sheep was injected into a total of 40 transgenic mice, with none subsequently developing classical scrapie. One of the infected sheep was exhibiting clinical signs of classical scrapie and the other two were asymptomatic at the time of collection. In comparison, the injection of brain homogenate from 4 scrapie-infected sheep intracerebrally into 23 transgenic mice resulted in infection of 100 percent of the mice (Sarradin, Melo et al. 2008).

    Recently, 8 ewes in a historically scrapie-negative sentinel flock of 24 sheep were discovered to be scrapie-positive 4 months after having been bred to scrapie-positive rams from an adjacent highly infected flock. The flock had also been bred in previous years by other rams from the infected flock and had fence line contact with rams from the infected flock. The ewes had been bred to these rams in order to increase the scrapie-susceptibility of the sentinel flock to the `Caine' strain of scrapie (i.e., to increase the proportion of sheep with at least one valine insertion at codon 136). This strain has a relatively short incubation period, particularly in sheep that are homozygous for valine at codon 136. The discovery of the infected ewes led to an investigation by Rubenstein et al. (2012) to determine whether it was possible that scrapie could have been transmitted to the ewes through exposure to the semen of infected rams (Rubenstein, Bulgin et al. 2012).

    Using newly developed detection techniques such as serial protein misfolding cyclic amplification, combined with an optical fiber immunoassay, the investigators detected prion disease-associated-seeding activity, which is assumed to imply the presence of PrPSc in semen samples from the rams in the affected flock described above. In addition, intracerebral inoculation of a newly-generated sheep scrapie-susceptible transgenic mouse line with semen from both infected and uninfected rams from the flock resulted in the detection of PrPSc in all of the mice inoculated with semen from scrapie-positive rams, but in none of the mice inoculated with semen from scrapie-negative rams.

    These experiments suggest that semen from scrapie-infected rams could harbor infectious PrPSc; however, additional studies are necessary to determine whether the level of infectivity in semen is sufficient to transmit scrapie laterally to ewes or to embryos resulting from the use of scrapie-infected semen donors.

    To date, there has been no direct evidence to support the transmission of TSE infectivity through semen of sheep and goats to other sheep or goats; however, the studies conducted have been somewhat limited.

    Based on the findings of these studies, we have determined that the previous restrictions in our regulations are no longer consistent with APHIS' assessment of the scrapie transmission risks associated with sheep or goat semen, or with international standards. We are therefore proposing to amend § 98.35 to remove paragraph (e)(1)(ii) to eliminate the requirement that donor animals have been kept since birth in establishments in which no case of scrapie has been confirmed during their residency, and redesignate paragraphs (e)(1)(iii) and (e)(1)(iv) as (e)(1)(ii) and (e)(1)(iii), respectively. We would also amend newly redesignated paragraph (e)(1)(iii) to require that the donor animals were not, and are not, restricted in the country of origin or destroyed due to exposure to a TSE, and will add a new paragraph (e)(1)(iv) to allow APHIS to establish testing requirements for semen and/or semen donors.

    We are also proposing to revise paragraph (e)(3) to include semen from all countries, and to allow semen to be imported to an APHIS-approved semen storage facility prior to being transferred to females in a flock listed in the National Scrapie Database. This change will provide an additional option for producers and importers. Further, we are proposing to add new paragraphs (e)(4) and (5) to describe recordkeeping requirements for APHIS-approved semen storage facilities, including a requirement that progeny of imported semen be officially identified and records maintained of their disposition in order to allow these animals to be traced if a need arises.

    Executive Orders 12866 and 13563 and Regulatory Flexibility Act

    This proposed rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.

    We have prepared an economic analysis for this rule. The economic analysis provides a cost-benefit analysis, as required by Executive Orders 12866 and 13563, which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The economic analysis also provides an initial regulatory flexibility analysis that examines the potential economic effects of this rule on small entities, as required by the Regulatory Flexibility Act. The economic analysis is summarized below. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov).

    Based on the information we have, there is no reason to conclude that adoption of this proposed rule would result in any significant economic effect on a substantial number of small entities. However, we do not currently have all of the data necessary for a comprehensive analysis of the effects of this proposed rule on small entities. Therefore, we are inviting comments on potential effects. In particular, we are interested in determining the number and kind of small entities that may incur benefits or costs from the implementation of this proposed rule.

    This analysis examines impacts on U.S. entities of a rule that would remove BSE restrictions on the importation of live sheep and goats and most of their products. The rule also would align our scrapie regulations generally with OIE guidelines and establish a notice-based approach for recognizing regions as free of scrapie. We are also proposing to amend the BSE and scrapie regulations as they apply to other ruminant species that are not bovines, cervids, camelids, sheep or goats. The rule is part of a continuing program to allow the importation of agricultural products that APHIS has determined are without significant risk of introducing exotic animal diseases into the United States.

    This proposed rule's impact would stem from its effect on U.S. imports of the affected commodities. Consumer welfare gains from the potential increase in imports are expected to exceed producer welfare losses. While the rule could affect U.S. imports of a wide range of commodities, we focus our attention on the production and trade of live sheep and goats and their meat. This rule may affect imports of other ruminants such as animals received by zoos, but APHIS does not have information that would allow us to evaluate such impacts. Estimated net benefits of the rule are demonstrated in terms of increased imports of lamb, mutton, and goat meat.

    U.S. imports of sheep and goat meat come almost entirely from Australia and New Zealand, with chilled or frozen lamb the main product. To evaluate potential effects of the rule, we estimate impacts for U.S. production, consumption, and prices of sheep and goat meat imports using a net trade welfare model. The imports are expected to be small in comparison to an already large import base. We model three levels of additional sheep and goat meat imports into the United States: 983 MT, 1,966 MT, and 3,932 MT. These quantities are equal to approximately 5, 10, and 20 percent of the sum of (i) average EU sheep and goat meat exports to non-EU markets, 2010-2014, excluding Australia and New Zealand and (ii) average sheep and goat meat exports to EU countries by 21 other countries, 2010-2014. The largest assumed quantity is equivalent to less than 3 percent of average annual U.S. sheep and goat meat consumption during this same period.

    The medium level of assumed additional imports, 1,966 MT, would cause a decrease in wholesale prices of a little more than 1 percent and a fall in domestic production of 615 MT. Consumption would increase by 1,351255 MT. Producer welfare would decline by about $6.3 million and consumer welfare would increase by about $14.4 million, yielding an annual net welfare benefit of about $8.1 million. Similarly, the other two assumed import levels yield positive net benefits. To the extent that sheep and goat meat imported as a result of this rule may displace imports from existing sources, the price and welfare effects would be smaller than indicated; we note that over one half of the current U.S. market is imported.

    The majority of establishments that may be affected by the proposed rule are small, and the economic impacts are likely to be small as well. If an additional 1,966 MT of sheep and goat meat were to be imported by the United States because of this rule, the annual decrease in producer welfare per small entity would be about $48, or the equivalent of about 1 percent of average annual sales by small entities. We welcome public comment that would allow us to better understand likely economic effects of the rule.

    Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this proposed rule will be preempted; (2) no retroactive effect will be given to this proposed rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this proposed rule.

    Executive Order 13175

    This proposed rule has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects 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.

    The Animal and Plant Health Inspection Service has assessed the impact of this rule on Indian tribes and determined that this rule does not, to our knowledge, have tribal implications that require tribal consultation under E.O. 13175. If a Tribe requests consultation, the Animal and Plant Health Inspection Service will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified herein are not expressly mandated by Congress.

    National Environmental Policy Act

    To provide the public with documentation of APHIS' review and analysis of any potential environmental impacts associated with changes to the import regulations pertaining to sheep, goats, and certain other non-bovine ruminants, and products derived from sheep and goats, we have prepared an environmental assessment. The environmental assessment was prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

    The environmental assessment may be viewed on the Regulations.gov Web site or in our reading room. (A link to Regulations.gov and information on the location and hours of the reading room are provided under the heading ADDRESSES at the beginning of this proposed rule.) In addition, copies may be obtained by calling or writing to the individual listed under FOR FURTHER INFORMATION CONTACT.

    Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), some of the reporting and recordkeeping requirements included in this proposed rule have been approved under Office of Management and Budget (OMB) control numbers 0579-0040 and 0579-0101. The new reporting and recordkeeping requirements included in this proposed rule have been submitted as a new information collection for approval to OMB. Please send comments on the information collection request (ICR) to OMB's Office of Information and Regulatory Affairs via email to [email protected], Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS-2009-0095. Please send a copy of your comments to USDA using one of the methods described under ADDRESSES at the beginning of this document, preferably the use of the Federal eRulemaking Portal.

    APHIS uses a variety of information collection procedures and forms to gather data in its effort to prevent the introduction or spread of disease. Information collected via these procedures and forms includes, but is not limited to, the names of the exporter and importer of the animal commodities; the origins of the animals or animal products to be imported; the health status of the animals or the processing methods used to produce animal products to be imported; the destination of delivery in the United States; and whether the animals or animal products were temporarily offloaded in another country during transit to the United States.

    We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:

    (1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;

    (2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

    (3) Enhance the quality, utility, and clarity of the information to be collected; and

    (4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses).

    Estimate of burden: Public reporting burden for this collection of information is estimated to average 0.531 hours per response.

    Respondents: State representatives; Foreign governments/veterinary officials; accredited veterinarians; importers and owners of sheep, goats, and certain other small ruminants; slaughter plant personnel; and feedlot personnel.

    Estimated annual number of respondents: 7,423.

    Estimated annual number of responses per respondent: 8.73.

    Estimated annual number of responses: 64,771.

    Estimated total annual burden on respondents: 34,408 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

    Copies of this new information collection are located at http://www.regulations.gov/#!docketDetail;D=APHIS-2009-0095 and can be obtained from Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

    USDA will respond to any ICR-related comments in the final rule. All comments will also become a matter of public record.

    E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

    List of Subjects 9 CFR Part 93

    Animal diseases, Imports, Livestock, Poultry and poultry products, Quarantine, Reporting and recordkeeping requirements.

    9 CFR Part 94

    Animal diseases, Imports, Livestock, Meat and meat products, Milk, Poultry and poultry products, Reporting and recordkeeping requirements.

    9 CFR Part 95

    Animal feeds, Hay, Imports, Livestock, Reporting and recordkeeping requirements, Straw, Transportation.

    9 CFR Part 96

    Imports, Livestock, Reporting and recordkeeping requirements.

    9 CFR Part 98

    Animal diseases, Imports.

    Accordingly, we are proposing to amend 9 CFR parts 93, 94, 95, 96, and 98 as follows:

    PART 93—IMPORTATION OF CERTAIN ANIMALS, BIRDS, FISH, AND POULTRY, AND CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS OF CONVEYANCE AND SHIPPING CONTAINERS 1. The authority citation for part 93 continues to read as follows: Authority:

    7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

    2. Section 93.400 is amended as follows: a. By adding, in alphabetical order, definitions for “Certified status”, “Classical scrapie”, and “Country mark”; b. By revising the definitions for “Designated feedlot” and “Flock”; c. By adding, in alphabetical order, definitions for “Flock of birth”, “Flock of residence”, “Goat”, “Killed and completely destroyed”, “Non-classical scrapie”, and “Sheep”; d. By removing the definition of “Suspect for a transmissible spongiform encephalopathy”; and e. By adding, in alphabetical order, definitions for “Transmissible spongiform encephalopathies (TSEs)”, and “TSE-affected sheep or goat”.

    The additions and revisions read as follows:

    § 93.400 Definitions.

    Certified status. A flock that has met requirements equivalent to the Export Certified status of the U.S. Scrapie Flock Certification Program while participating in a program under the supervision of the national veterinary authority of the region of origin, as determined by an evaluation conducted by APHIS of the program.

    Classical scrapie. Any form of scrapie that the Administrator has determined poses a significant risk of natural transmission.

    Country mark. A permanent mark approved by the Administrator for identifying a sheep or goat to its country of origin.

    Designated feedlot. A feedlot that has been designated by the Administrator as one that is eligible to receive sheep and goats from regions that are not free of classical scrapie, and whose owner or legally responsible representative has signed an agreement as specified in § 93.435(c)(11) and is in full compliance with all the provisions of the agreement.

    Flock. Any group of one or more sheep or goats maintained on a single premises, or on more than one premises under the same ownership and between which unrestricted movement is allowed; or two or more groups of sheep or goats under common ownership or supervision on two or more premises that are geographically separated, but among which there is an interchange or movement of animals.

    Flock of birth. The flock into which a sheep or goat is born.

    Flock of residence. The flock:

    (1) Within which an individual sheep or goat was born, raised, and resided until exported to the United States; or

    (2) In which the sheep or goat resided for breeding purposes for 60 days or more until exported to the United States; or

    (3) In which sheep and goats for export were assembled for export to the United States and maintained for at least 60 days immediately prior to export, without any addition of animals or contact with animals other than through birth, on a single premises, or on more than one premises under the same ownership and between which unrestricted movement occurred.

    Goat. Any animal of the genus Capra.

    Killed and completely destroyed. Killed, or maintained under quarantine in a manner that will prevent disease spread until the animal is no longer living; and the remains have been disposed of in a way that prevents disease spread.

    Non-classical scrapie. Any form of scrapie that the Administrator has determined poses a low risk of natural transmission.

    Sheep. Any animal of the genus Ovis.

    Transmissible spongiform encephalopathies (TSEs). A family of progressive and generally fatal neurodegenerative disorders thought to be caused by abnormal proteins, called prions, that typically produce characteristic microscopic changes, including, but not limited to, non-inflammatory neuronal loss, giving a spongiform appearance to tissues in the brains and central nervous systems of affected animals.

    TSE-affected sheep or goat. A sheep or goat suspected or known by the national veterinary authority of the region of origin to be infected with a transmissible spongiform encephalopathy prior to the disposal of the animal.

    3. In § 93.401, paragraph (a) is revised to read as follows:
    § 93.401 General prohibitions; exceptions.

    (a) No ruminant or product subject to the provisions of this part shall be brought into the United States except in accordance with the regulations in this part and part 94 of this subchapter; 3 nor shall any such ruminant or product be handled or moved after physical entry into the United States before final release from quarantine or any other form of governmental detention except in compliance with such regulations. Notwithstanding any other provision of this subpart, the importation of any ruminant that is not a bovine, camelid, cervid, sheep, or goat is prohibited. Provided, however, the Administrator may upon request in specific cases permit ruminants or products of such to be brought into or through the United States under such conditions as he or she may prescribe, when he or she determines in the specific case that such action will not endanger the livestock of the United States.

    3 Importations of certain animals from various regions are absolutely prohibited under part 94 because of specified diseases.

    4. Section 93.404 is amended as follows: a. Paragraphs (a)(2), (a)(3), and (a)(4) are redesignated as paragraphs (a)(3), (a)(4), and (a)(7), respectively; b. By adding new paragraph (a)(2) and paragraphs (a)(5), and (6); c. In newly redesignated paragraph (a)(7)(v), the reference to “paragraph (a)(4)(iv)” is removed and a reference to “paragraph (a)(7)(iv)” is added in its place; and d. In newly redesignated paragraph (a)(7)(vi), the references to “paragraph (a)(4)(iv)(A)” and “paragraph (a)(4)(iv)(B)” are removed and references to “paragraph (a)(7)(iv)(A)” and “paragraph (a)(7)(iv)(B)”, respectively, are added in their place.

    The additions read as follows:

    § 93.404 Import permits for ruminants and for ruminant test specimens for diagnostic purposes; and reservation fees for space at quarantine facilities maintained by APHIS.

    (a) * * *

    (2) In addition to the requirements in paragraph (a)(1) of this section, the importer must submit the following information along with the application for an import permit:

    (i) For sheep or goats imported for immediate slaughter, or for restricted feeding for slaughter:

    (A) The slaughter establishment to which the animals will be imported; or

    (B) The designated feedlot in which sheep and goats imported for restricted feeding for slaughter will be maintained until moved to slaughter.

    (ii) For sheep and goats imported for purposes other than immediate slaughter or restricted feeding for slaughter:

    (A) The flock identification number, if imported to a flock, and the premises or location identification number, of the flock or other premises to which the animals are imported as listed in the Scrapie National Database.

    (B) For sheep and goats from regions not free from classical scrapie, the importer must provide documentation that the animal has reached and maintained certified status in a Scrapie Flock Certification program that has been determined by the Administrator to provide equivalent risk reduction as the Export Category of the U.S. Scrapie Flock Certification Program. The documentation must specify the address, or other means of identification, of the premises and flock of birth, and any other flock(s) in which the animals have resided.

    (5) In specific cases, a permit may be issued for ruminants that would otherwise be prohibited importation due to TSEs pursuant to this subpart, if the Administrator determines that the disease risk posed by the animals can be adequately mitigated through pre-entry or post-entry mitigation measures, or through combinations of such measures. These measures will be specified in the permit. If it is determined prior to or after importation that any pre-entry or post-entry requirements were not met, or that the ruminants are affected with or have been exposed to TSEs, the ruminants, their progeny, and any other ruminants that have been housed with or exposed to the ruminants will be disposed of or otherwise handled as directed by the Administrator. Importers seeking a permit pursuant to this paragraph must send their request to the Administrator, c/o National Import Export Services, VS, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737-1231, or via the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/live_animals.shtml.

    (6) The Administrator may issue permits under paragraph (a)(5) of this section for male sheep that are determined to be AA at codon 136 and either RR, HR, KR or QR at codon 171 and for female sheep that are AA at codon 136 and RR at codon 171 by the National Veterinary Services Laboratories or another laboratory approved by the Administrator. Such sheep must meet all requirements for import other than the requirement that they originate in a flock or region that is free of classical scrapie. The permit will provide for post entry confirmation of the animal's scrapie susceptibility genotype and/or genetic testing for identity.

    5. Section 93.405 is amended as follows: a. Paragraph (a)(4) is removed; b. Paragraph (b) is revised; c. Paragraph (c) is removed; and d. Paragraph (d) is redesignated as paragraph (c) and revised.

    The revisions read as follows:

    § 93.405 Health certificate for ruminants.

    (b) Sheep and goats. (1) In addition to the statements required by paragraph (a) of this section, the certificate accompanying sheep or goats from any part of the world must also include the name and address of the importer; the number or quantity of sheep or goats to be imported; the purpose of the importation; the official individual sheep or goat identification applied to the animals; and, when required by § 93.435, the permanent country mark and other identification present on the animal, including registration number, if any; a description of each sheep or goat linked to the official identification number, including age, sex, breed, color, and markings, if any; the flock of residence; the address (including street, city, State, and ZIP Code) of the destination where the sheep or goats are to be physically located after importation, including the premises or location identification number assigned in the APHIS National Scrapie Database and when applicable the flock identification number; the name and address of the exporter; the port of embarkation in the region of export; the mode of transportation, route of travel and port of entry in the United States; and, for sheep or goats imported for purposes other than immediate slaughter or restricted feeding for slaughter, the certificate must specify the region of origin and, for regions not free of scrapie, the address or other identification of the premises and flock of birth, and any other flock in which the animals have resided.

    (2) The certificate accompanying sheep or goats from any part of the world, except as provided in paragraph (b)(4) of this section for sheep or goats imported for immediate slaughter, and in paragraph (b)(5) of this section for sheep or goats for restricted feeding for slaughter, must also state:

    (i) That the sheep or goats originated from a region recognized as free of classical scrapie by APHIS; or that the animals have reached and maintained certified status in a scrapie flock certification program approved by APHIS;

    (ii) That the sheep or goats have not commingled with sheep or goats of a lower health status, or resided on the premises of a flock or herd of lower health status, after leaving the flock of residence and prior to arrival in the United States;

    (iii) That any enclosure, container or conveyance in which the sheep or goats had been placed during the export process, and which had previously held sheep or goats, was cleaned and disinfected in accordance with § 54.7(e)(2) of this chapter prior to being used for the sheep or goats;

    (iv) That none of the female sheep or goats is carrying an implanted embryo from a lower health status flock; or that any implanted embryo met the requirements for import into the United States when implanted and documentation as required in part 98 of this subchapter is attached;

    (v) That the veterinarian issuing the certificate has inspected the sheep or goats, and their flock(s) of residence, within 30 days of consignment for import to the United States, and found the animals and the flock(s) of residence to be free of any evidence of infectious or contagious disease;

    (vi) That as far as it is possible for the veterinarian who inspects the animals to determine, none of the sheep or goats in the flock(s) of residence has been exposed to any infectious or contagious disease during the 60 days immediately preceding shipment to the United States; and

    (vii) The animals' movement is not restricted within the country of origin due to animal health reasons.

    (3) The certificate accompanying sheep or goats from any part of the world, except as provided in paragraph (b)(4) of this section for sheep or goats imported for immediate slaughter, or in paragraph (b)(5) of this section for sheep or goats for restricted feeding for slaughter, must also include:

    (i) The results of any testing required in the import permit; and

    (ii) Any other information required in the import permit.

    (4) For sheep or goats imported for immediate slaughter, in addition to the statements required under paragraph (a) of this section, the certificate must include statements that:

    (i) The region is recognized as free of classical scrapie by APHIS; or

    (ii) The region has not been recognized as free of classical scrapie by APHIS but the following criteria have been met:

    (A) TSEs in sheep and goats are compulsorily notifiable;

    (B) An effective classical scrapie awareness, surveillance, monitoring, and control system is in place;

    (C) TSE-affected sheep and goats are killed and completely destroyed;

    (D) The sheep and goats selected for export showed no clinical sign of scrapie on the day of shipment and are fit for travel;

    (E) The sheep and goats have not tested positive for, and are not suspect for, a transmissible spongiform encephalopathy; and

    (F) The animals' movement is not restricted within the country of origin due to animal health reasons.

    (5) Sheep or goats for restricted feeding for slaughter. For sheep or goats imported for restricted feeding for slaughter, in addition to the statements required under paragraph (a) of this section, the certificate must include statements that:

    (i) The region is recognized as free of classical scrapie by APHIS; or

    (ii) The region has not been recognized as free of classical scrapie by APHIS but the following criteria have been met:

    (A) TSEs in sheep and goats are compulsorily notifiable;

    (B) An effective classical scrapie awareness, surveillance, monitoring and control system is in place;

    (C) TSE-affected sheep and goats are killed and completely destroyed;

    (D) The sheep or goats showed no clinical sign of scrapie or any other infectious disease on the day of shipment and are fit for travel;

    (E) The sheep or goats have not tested positive for, and are not suspect for, a transmissible spongiform encephalopathy;

    (F) The animals' movement is not restricted within the country of origin due to animal health concerns;

    (G) Female sheep and goats are not known to be pregnant, are not visibly pregnant, and female animals have not been exposed:

    (1) To a sexually intact male at over 5 months of age; or

    (2) To a sexually intact male within 5 months of shipment;

    (H) That the veterinarian issuing the certificate has inspected the sheep or goats for export, and their flock(s) of residence, within 30 days of consignment for shipment to the United States, and found the animals and the flock(s) of residence to be free of any evidence of infectious or contagious disease; and

    (I) That as far as it is possible for the veterinarian who inspects the animals to determine, none of the sheep or goats has been exposed to any infectious or contagious disease during the 60 days immediately preceding shipment to the United States.

    (c) If ruminants are unaccompanied by the certificate as required by paragraphs (a) and (b) of this section, or if such ruminants are found upon inspection at the port of entry to be affected with a communicable disease or to have been exposed thereto, they shall be refused entry and shall be handled or quarantined, or otherwise disposed of as the Administrator may direct.

    § 93.406 [Amended]
    6. Amend § 93.406(b) by removing the references “§§ 93.419 and 93.428(b)” and adding “§§ 93.428(b) and 93.435” in their place.
    § 93.419 [Removed and Reserved]
    7. Section 93.419 is removed and reserved. 8. In § 93.420, paragraph (a) introductory text is amended by adding a sentence after the paragraph heading to read as follows:
    § 93.420 Ruminants from Canada for immediate slaughter other than sheep and goats.

    (a) * * *. The requirements for the importation of sheep and goats from Canada for immediate slaughter are contained in § 93.435. * * *

    9. Section 93.424 is amended by revising paragraph (a) to read as follows:
    § 93.424 Import permits and applications for inspection of ruminants.

    (a) For ruminants intended for importation from Mexico, the importer shall first apply for and obtain from APHIS an import permit as provided in § 93.404: Provided, that: An import permit is not required for sheep or goats imported for immediate slaughter if the animal is offered for entry at a land border port designated in § 93.403(c).

    10. Section 93.428 is amended by revising paragraph (a) to read as follows:
    § 93.428 Sheep and goats and wild ruminants from Mexico.

    (a) Sheep and goats intended for import from Mexico must be imported in accordance with § 93.435, and shall be accompanied by a certificate issued in accordance with § 93.405 and stating, if such sheep and goats are shipped by rail or truck, that such animals were loaded into cleaned and disinfected cars or trucks for transportation direct to the port of entry. Notwithstanding such certificate, such sheep and goats shall be detained as provided in § 93.427(a) and shall be dipped at least once in a permitted scabies dip under supervision of an inspector.

    11. Section 93.435 is revised to read as follows:
    § 93.435 Sheep and goats.

    (a) General provisions. (1) Sheep and goats imported from anywhere in the world shall be accompanied by a certificate issued in accordance with § 93.405. If the sheep or goats are not accompanied by the certificate, or if they are found upon inspection at the port of entry to be affected with or exposed to a communicable disease, they shall be refused entry and shall be handled or quarantined, or otherwise disposed of, as the Administrator may direct.

    (2) All imported sheep and goats must be officially identified at the time of presentation for entry into the United States with unique identification numbers using official identification devices, or by other means that have been approved by the Administrator, and which will allow the animals that are not imported for immediate slaughter or for feeding for slaughter to be traced at any time to the farm or premises of birth, and for animals imported for immediate slaughter or for feeding for slaughter to the flock of residence. Official identification may not be removed or altered at any time after entry into the United States, except by an authorized USDA representative at the time of slaughter. A list of the acceptable types of official identification may be found on the APHIS Web site at [ADDRESS TO BE ADDED IN FINAL RULE].

    (3) All imported sheep and goats other than for immediate slaughter or as provided in paragraph (c) of this section for restricted feeding for slaughter must be identified at the time of presentation for entry into the United States with a country mark using a means and in a location on the animal that has been approved by the Administrator for this use. A list of the acceptable country marks may be found on the APHIS Web site at [ADDRESS TO BE ADDED IN FINAL RULE]

    (4) Except as provided in paragraph (b) of this section for sheep or goats imported for immediate slaughter, and in paragraph (c) of this section for sheep or goats for restricted feeding for slaughter, the importer shall maintain records of the sale, death or other disposition of all imported animals which include the official identification number(s) and country marks on the animals at the time of import; a record of the replacement of any lost identification devices linking the new official identification number to the lost device number; the date and manner of disposition; and the name and address of the new owner. Such records must be maintained for a period of 5 years after the sale or death of the animal. The records must be available for APHIS to view and copy during normal business hours.

    (b) Sheep and goats imported for immediate slaughter from anywhere in the world. (1) Sheep and goats imported for immediate slaughter must be imported only through a port of entry allowed in § 93.403, in a means of conveyance sealed in the country of origin with seals of the national government, and must be moved directly as a group from the port of entry to a recognized slaughtering establishment for slaughter as a group; and

    (2) The sheep and goats shall be inspected by the port veterinarian or other designated APHIS representative at the port of entry to determine that the animals are free from evidence of communicable disease and are considered fit for further travel; and

    (3) The seals on the means of conveyance must be broken only at the port of entry by the APHIS port veterinarian or at the recognized slaughtering establishment by an authorized USDA representative. If the seals are broken by the APHIS port veterinarian at the port of entry, the means of conveyance must be resealed with seals of the U.S. Government before being moved to the recognized slaughtering establishment; and

    (4) The shipment must be accompanied from the port of entry to the recognized slaughtering establishment by APHIS Form VS 17-33.

    (c) Sheep and goats imported for restricted feeding for slaughter. (1) Sheep and goats for restricted feeding for slaughter purposes may only be imported into the United States from countries or regions that are have been determined to be free of classical scrapie by APHIS, or that have scrapie awareness, surveillance, and control programs that have been evaluated and determined by APHIS to be effective.

    (2) The sheep and goats must be imported only through a port of entry allowed in § 93.403 in a means of conveyance sealed in the region of origin with seals of the national government of the region of origin. The seals may be broken either by an APHIS representative at the port of entry, or at the designated feedlot by an authorized APHIS representative. If the seals are broken by an APHIS representative, the means of conveyance must be resealed with seals of the U.S. Government before being moved to the designated feedlot; and

    (3) The sheep and goats shall be inspected by the port veterinarian or other designated representative at the port of entry to determine that the animals are free from evidence of communicable disease and are considered fit for further travel; and

    (4) The sheep and goats must be moved directly as a group from the port of entry to a designated feedlot; and

    (5) The sheep and goats may not be commingled with any sheep or goats that are not being moved directly to slaughter from the designated feedlot; and

    (6) The sheep and goats may be moved from the port of entry only to a feedlot designated in accordance with paragraph (c)(11) of this section and must be accompanied from the port of entry to the designated feedlot by APHIS Form VS 17-130 or other movement documentation stipulated in the import permit; and

    (7) Upon arrival at the designated feedlot, the official identification for each animal must be reconciled by an APHIS veterinarian, or other official designated by APHIS, with the accompanying documentation; and

    (8) The sheep and goats must remain at the designated feedlot until transported to a recognized slaughtering establishment. The sheep and goats must be moved directly to the recognized slaughtering establishment in a means of conveyance sealed by an accredited veterinarian, a State representative, or an APHIS representative with seals of the U.S. Government. The seals must be broken at the recognized slaughtering establishment only by an authorized USDA representative; and

    (9) The sheep and goats must be accompanied to the recognized slaughtering establishments by APHIS Form VS 1-27 or other documentation stipulated in the import permits; and

    (10) The sheep and goats must be slaughtered within 12 months of importation.

    (11) To be eligible as a designated feedlot to receive sheep and goats imported for feeding, a feedlot must be approved by APHIS. To be approved by APHIS, the feedlot operator or his or her agent must enter into a compliance agreement with the Administrator. The compliance agreement must provide that the operator:

    (i) Will monitor all imported feeder animals to ensure that they have the required official identification at the time of arrival to the feedlot; and will not remove official identification from animals unless medically necessary, in which case new official identification will be applied and cross referenced in the records. Any lost official identification will be replaced with eartags provided by APHIS for the purpose and will be linked the new official identification with the lost identification. If more than one animal loses their official identification at the same time, the new official identification will be linked with all possible original identification numbers;

    (ii) Will monitor all incoming imported feeder animals to ensure that they have the required country mark, or will maintain all imported animals in separate pens from U.S. origin animals, and that all sheep and goats that enter the feedlot are moved only for slaughter;

    (iii) Will maintain records of the acquisition and disposition of all imported sheep and goats entering the feed lot, including the official identification number and all other identifying information, the age of each animal, the date each animal was acquired and the date each animal was shipped to slaughter, and the name and location of the plant where each animal was slaughtered. For imported animals that die in the feedlot, the feedlot will remove the official identification device if affixed to the animal, or will record any other official identification on the animal and place the official identification device or record of official identification in a file with a record of the disposition of the carcass;

    (iv) Will maintain copies of the APHIS Forms VS 17-130 and VS 1-27 or other movement documentation deemed acceptable by the Administrator that have been issued for incoming animals and for animals moved to slaughter and that list the official identification of each animal;

    (v) Will allow State and Federal animal health officials access to inspect its premises and animals and to review inventory records and other required files upon request;

    (vi) Will keep required records for at least 5 years;

    (vii) Will designate either the entire feedlot or pens within the feedlot as terminal for sheep and goats to be moved only directly to slaughter;

    (viii) Agrees that if inventory cannot be reconciled or if animals are not moved to slaughter as required, the approval of the feedlot to receive additional animals will be immediately withdrawn and any imported animals remaining in the feedlot will be disposed of as directed by the Administrator;

    (ix) Agrees that if an imported animal gives birth in the feedlot, the offspring will be humanely euthanized and the birth tissues and soiled bedding disposed of in a sanitary landfill or by another means approved by the Administrator; and

    (x) Agrees to maintain sexually intact animals of different genders over 5 months of age in separate enclosures.

    (xi) For a feedlot to be approved to receive sheep or goats imported for feeding under this section, but which do not have a country mark, the compliance agreement must also provide that the feedlot will maintain all imported animals in separate pens from U.S. origin animals and that all sheep and goats that enter the feedlot are moved only for slaughter.

    (d) Sheep or goats imported other than as provided in paragraph (b) of this section for immediate slaughter or as provided in paragraph (c) of this section for sheep and goats imported for restricted feeding for slaughter must originate from a region recognized as free of classical scrapie by APHIS or from a flock that has certified status in a scrapie flock certification program recognized by APHIS as acceptable for this purpose, or as provided in § 93.404(a)(5) or (6).

    (e) Sheep and goats transiting the United States. Sheep or goats that meet the entry requirements for immediate slaughter in § 93.405 may transit the United States in accordance with § 93.401 regardless of their intended use in the receiving country.

    (f) Classical scrapie status of foreign regions. APHIS considers classical scrapie to exist in all regions of the world except those declared free of this disease by APHIS.

    (1) A list of regions that APHIS has declared free of classical scrapie is maintained on the APHIS Web site at http://www.aphis.usda.gov/import_export/animals/animal_disease_status.shtml. Copies of the list are also available via postal mail, fax, or email upon request to Regionalization Evaluation Services, National Import Export Services, Veterinary Services, Animal and Plant Health Inspection Service, 4700 River Road, Unit 38, Riverdale, Maryland 20737.

    (2) APHIS will add a region to this list only after it conducts an evaluation of the region in accordance with § 92.2 of this subchapter and finds that classical scrapie is not likely to be present in its sheep or goat populations. In the case of a region formerly on this list that is removed due to an outbreak, the region may be returned to the list in accordance with the procedures for reestablishment of a region's disease-free status in § 92.4 of this subchapter. APHIS will remove a region from the list of those it has declared free of classical scrapie upon determining that classical scrapie exists there based on reports APHIS receives of outbreaks of the disease in sheep or goats from veterinary officials of the exporting country, from the World Organization for Animal Health (OIE), from other sources the Administrator determines to be reliable, or upon determining that the region's animal health infrastructure, regulations, or policy no longer qualifies the region for such status.

    (Approved by the Office of Management and Budget under control numbers 0579-0040 and 0579-0101)
    § 93.505 [Amended]
    12. Amend § 93.505(a), by removing the citation “§ 94.24(b)(6)” and replacing it with the citation “§ 94.31(b)(6)”. PART 94—RINDERPEST, FOOT-AND-MOUTH DISEASE, NEWCASTLE DISEASE, HIGHLY PATHOGENIC AVIAN INFLUENZA, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, SWINE VESICULAR DISEASE, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND RESTRICTED IMPORTATIONS 13. The authority citation for part 94 continues to read as follows: Authority:

    7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

    14. Section § 94.15 is revised to read as follows:
    § 94.15 Transit shipment of articles.

    (a) Any meat or other animal product or material (excluding materials that are required to be consigned to USDA-approved establishments for further processing) that is eligible for entry into the United States, as provided in this part or in part 95 of this subchapter, may transit the United States by air and ocean ports and overland transportation if the articles are accompanied by the required documentation specified in this part and in part 95.

    (b) Any meat or other animal product or material that is not eligible for entry into the United States, as provided in this part or in part 95 of this subchapter, may transit air and ocean ports only, with no overland movement outside the airport terminal area or dock area of the maritime port, in the United States for immediate export if the conditions of paragraphs (b)(1) through (4) of this section are met.

    (1) The articles must be sealed in leakproof containers bearing serial numbers during transit. Each container must remain under either Customs seal or Foreign Government seal during the entire time that it is in the United States.

    (2) Before transit, the person moving the articles must notify, in writing, the authorized Customs inspector at both the place in the United States where the articles will arrive and the port of export. The notification must include the:

    (i) Times and dates of arrival in the United States;

    (ii) Times and dates of exportation from the United States;

    (iii) Mode of transportation; and

    (iv) Serial numbers of the sealed containers.

    (3) The articles must transit the United States under Customs bond.

    (4) The shipment is exported from the United States within 7 days of its entry.

    (c) Pork and pork products from Baja California, Baja California Sur, Campeche, Chihuahua, Coahuila, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, and Yucatan, Mexico, that are not eligible for entry into the United States in accordance with this part may transit the United States via land border ports for immediate export if the following conditions of paragraphs (c)(1) through (4) of this section are met:

    (1) The person moving the pork and pork products must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3 (available from APHIS, Veterinary Services, National Import Export Services, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/).

    (2) The pork or pork products are packaged at a Tipo Inspección Federal plant in Baja California, Baja California Sur, Campeche, Chihuahua, Coahuila, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, or Yucatan, Mexico, in leakproof containers and sealed with serially numbered seals of the Government of Mexico, and the containers remain sealed during the entire time they are in transit across Mexico and the United States.

    (3) The person moving the pork and pork products through the United States notifies, in writing, the authorized Customs inspector at the United States port of arrival prior to such transiting. The notification must include the following information regarding the pork and pork products:

    (i) Permit number;

    (ii) Times and dates of arrival in the United States;

    (iii) Time schedule and route to be followed through the United States; and

    (iv) Serial numbers of the seals on the containers.

    (4) The pork and pork products must transit the United States under Customs bond and must be exported from the United States within the time limit specified on the permit. Any pork or pork products that have not been exported within the time limit specified on the permit or that have not been transited in accordance with the permit or applicable requirements of this part will be destroyed or otherwise disposed of as the Administrator may direct pursuant to the Animal Health Protection Act (7 U.S.C. 8301 et seq.).

    (d) Poultry carcasses, parts, or products (except eggs and egg products) from Baja California, Baja California Sur, Campeche, Chihuahua, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, Tamaulipas, or Yucatan, Mexico, that are not eligible for entry into the United States in accordance with the regulations in this part may transit the United States via land ports for immediate export if the following conditions of paragraphs (d)(1) through (4) of this section are met:

    (1) The person moving the poultry carcasses, parts, or products through the United States must obtain a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16-3 (available from APHIS, Veterinary Services, National Import Export Services, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal_health/permits/).

    (2) The poultry carcasses, parts, or products are packaged at a Tipo Inspección Federal plant in Baja California, Baja California Sur, Campeche, Chihuahua, Nuevo Leon, Quintana Roo, Sinaloa, Sonora, Tamaulipas, or Yucatan, Mexico, in leakproof containers with serially numbered seals of the Government of Mexico, and the containers remain sealed during the entire time they are in transit through Mexico and the United States.

    (3) The person moving the poultry carcasses, parts, or products through the United States must notify, in writing, the authorized CBP inspector at the United States port of arrival prior to such transiting. The notification must include the following information regarding the poultry to transit the United States:

    (i) Permit number;

    (ii) Times and dates of arrival in the United States;

    (iii) Time schedule and route to be followed through the United States; and

    (iv) Serial numbers of the seals on the containers.

    (4) The poultry carcasses, parts, or products must transit the United States under U.S. Customs bond and must be exported from the United States within the time limit specified on the permit. Any poultry carcasses, parts, or products that have not been exported within the time limit specified on the permit or that have not transited in accordance with the permit or applicable requirements of this part will be destroyed or otherwise disposed of as the Administrator may direct pursuant to the Animal Health Protection Act (7 U.S.C. 8301 et seq.).

    (e) Meat and other products of ruminants or swine from regions listed in § 94.11(a) and pork and pork products from regions listed in § 94.13 that do not meet the requirements of § 94.11(b) or § 94.13(a) may transit through the United States for immediate export, provided the provisions of paragraph (b) of this section are met, and provided all other applicable provisions of this part are met.

    (Approved by the Office of Management and Budget under control numbers 0579-0040 and 0579-0145)
    § 94.18 [Amended]
    15. In paragraph (a), by adding the word “and” before the citation “94.23” and removing the words “, and § 94.27”.
    § 94.24 [Removed and Reserved]
    16. Section 94.24 is removed and reserved.
    § 94.25 [Removed and reserved]
    17. Section 94.25 is removed and reserved. 18. Section 94.26 is revised to read as follows:
    § 94.26 Gelatin derived from horses, swine, or non-bovine ruminants.

    Gelatin derived from horses, swine, or non-bovine ruminants must be accompanied at the time of importation into the United States by an official certificate issued by a veterinarian employed by the national government of the region of origin. The official certificate must state the species of animal from which the gelatin is derived.

    § 94.27 [Removed and reserved]
    19. Section 94.27 is removed and reserved. PART 95—SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS), AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES 20. The authority citation for part 95 continues to read as follows: Authority:

    7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

    § 95.1 [Amended]
    21. Section 95.1 is amended by removing the definitions of “Positive for a transmissible spongiform encephalopathy” and “Suspect for a transmissible spongiform encephalopathy”. 22. Section 95.4 is amended as follows: a. The section heading is revised; b. Paragraph (a) is revised; c. Paragraph (b)(1) is revised; d. Paragraphs (c)(1)(ii) and (iv) are revised; e. Paragraphs (c)(2) and (c)(3) are removed, and paragraphs (c)(4) through (c)(8) are redesignated as paragraphs (c)(2) through (c)(6), respectively; f. In newly redesignated paragraph (c)(3), the first sentence is revised; g. In newly redesignated paragraph (c)(5), the reference “(c)(5)” is removed and the reference “(c)(3)” is added in its place; h. In newly redesignated paragraph (c)(6), the words “National Center for Import and Export” are removed and the words “National Import Export Services” are added in their place; i. Paragraphs (d) and (e) are removed; j. Paragraph (f) and the Note to paragraph (f) are redesignated as paragraph (d) and the Note to paragraph (d), respectively; and k. Paragraph (g) is removed.

    The revisions read as follows:

    § 95.4 Restrictions on the importation of processed animal protein, offal, tankage, fat, glands, tallow, tallow derivatives, and serum due to bovine spongiform encephalopathy.

    (a) Except as provided in this section, or in § 94.15, any of the materials listed in paragraph (b) in this section derived from animals, or products containing such materials, are prohibited importation into the United States.

    (b) * * * (1) Processed animal protein, tankage, offal, tallow, and tallow derivatives, unless in the opinion of the Administrator, the tallow cannot be used in feed;

    (c) * * *

    (1) * * *

    (ii) Cervids and camelids, and the material is not ineligible for importation under the conditions of § 95.5.

    (iv) Ovines and caprines, and the material is not ineligible for importation under the conditions of § 95.5.

    (3) If the facility processes or handles any processed animal protein, inspection of the facility for compliance with the provisions of this section is conducted at least annually by a representative of the government agency responsible for animal health in the region, unless the region chooses to have such inspection conducted by APHIS. * * *

    § 95.15 [Removed and reserved]
    23. Section 95.15 is removed and reserved.
    § 95.40 [Removed and reserved]
    24. Section 95.40 is removed and reserved. PART 96—RESTRICTION OF IMPORTATIONS OF FOREIGN ANIMAL CASINGS OFFERED FOR ENTRY INTO THE UNITED STATES 25. The authority citation for part 96 continues to read as follows: Authority:

    7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.4.

    § 96.2 [Amended]
    26. Section 96.2 is amended as follows: a. Paragraph (b)(1) is removed. b. Paragraph (b)(2) is redesignated as paragraph (b)(1). c. A new paragraph (b)(2) is added and reserved. d. In paragraph (c)(3), by removing the words “paragraphs (b)(2)(i) through (b)(3)(iv)” and replacing them with the words “paragraph (b)(1).” PART 98—IMPORTATION OF CERTAIN ANIMAL EMBRYOS AND ANIMAL SEMEN 27. The authority citation for part 98 continues to read as follows: Authority:

    7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

    28. Section 98.2 is amended by adding, in alphabetical order, definitions for “Oocyte” and “Transmissible spongiform encephalopathies (TSEs)” to read as follows.
    § 98.2 Definitions.

    Oocyte. The first and second maturation stages of a female reproductive cell prior to fertilization.

    Transmissible spongiform encephalopathies (TSEs). A family of progressive and generally fatal neurodegenerative disorders thought to be caused by abnormal proteins, called prions, that typically produce characteristic microscopic changes, including, but not limited to, non-inflammatory neuronal loss, giving a spongiform appearance to tissues in the brains and nervous systems of affected animals.

    § 98.3 [Amended]
    29. Section 98.3 is amended as follows: a. In paragraph (d), by adding the words “except that, for sheep and goats only, the donor sire must meet the scrapie requirements in § 98.35 instead of the requirements in § 93.435 of this chapter;” after the words “United States;”; b. In paragraph (e), by removing the citation “part 92” and adding the citation “part 93” in its place, and by adding the words “except that, for sheep and goats only, the donor dam must meet the requirements for embryo donors in § 98.10(a) instead of the requirements in § 93.435 of this chapter;” after the words “United States;”; and c. In paragraph (f), by removing the words “§ 93.404(a)(2) or (3)” and adding the words “§ 93.404(a)(3) or (4)” in their place. 30. Section 98.4 is amended by adding paragraph (e) to read as follows:
    § 98.4 Import permit.

    (e) Applications for a permit to import sheep and goat embryos and oocytes must include the flock identification number of the receiving flock and the premises or location identification number assigned in the APHIS National Scrapie Database; or, in the case of embryos or oocytes moving to a storage facility, the premises or location identification number must be included.

    § 98.5 [Amended]
    31. In § 98.5, paragraph (b) is removed and reserved. 32. Section 98.10a is revised to read as follows:
    § 98.10a Sheep and goat embryos and oocytes.

    (a) Sheep and goat embryos or oocytes collected from donors located in, or originating from, regions recognized by APHIS as free of classical scrapie, or which are from a flock or herd that has certified status in a scrapie flock certification program recognized by APHIS as acceptable, may be imported in accordance with §§ 98.3 through 98.8. In addition to the requirements of § 98.5, the health certificate must indicate that the embryos or oocytes were collected, processed, and stored in conformity with the requirements in § 98.3(g).

    (b) In vivo-derived sheep and goat embryos or oocytes collected from donors located in, or originating from, regions or flocks not recognized by APHIS as free of classical scrapie, may be imported in accordance with §§ 98.3 through 98.8 and the following conditions:

    (1) The embryos or oocytes must be accompanied by a health certificate meeting the requirements listed in § 98.5, and with the following additional certifications:

    (i) The embryos or oocytes were collected, processed and stored in conformity with the requirements in § 98.3(g).

    (ii) For in vivo-derived sheep embryos only: The embryo is of the genotype AAQR or AARR based on official testing of the parents or the embryo.

    (iii) Certificates for sheep embryos that are not of the genotype AAQR or AARR, and for all goat embryos, must contain these additional certifications:

    (A) In the country or zone:

    (1) TSEs of sheep and goats are compulsorily notifiable;

    (2) A scrapie awareness, surveillance, monitoring, and control system is in place;

    (3) TSE-affected sheep and goats are killed and completely destroyed;

    (4) The feeding to sheep and goats of meat-and-bone meal of ruminant origin has been banned and the ban is effectively enforced in the whole country.

    (B) The donor animals:

    (1) Have been kept since birth in flocks or herds in which no case of scrapie had been confirmed during their residency; and

    (2) Are permanently identified to enable a traceback to their flock or herd of origin, and this identification is recorded on the certificate accompanying the embryo(s) and linked to the embryo container identification; and

    (3) Showed no clinical sign of scrapie at the time of embryo/oocyte collection; and

    (4) Have not tested positive for, and are not suspect for, a transmissible spongiform encephalopathy; and

    (5) Are not under movement restrictions within the country or region of origin as a result of exposure to a transmissible spongiform encephalopathy.

    (c) Any additional certifications or testing requirements established by APHIS, based on genetic susceptibility of the embryo or embryo parents, and/or on scrapie testing of the embryo donor, will be listed in the APHIS import permit. Such certifications or required test results must also be recorded on the health certificate accompanying the embryo(s).

    (d) Sheep and goat embryos or oocytes may only be imported for transfer to recipient females in the United States if the flock or herd in which the recipients reside is listed in the National Scrapie Database; except that APHIS may permit importation of sheep and goat embryos or oocytes to an APHIS-approved storage facility where they may be kept until later transferred to recipient females in a flock or herd in the United States that is listed in the APHIS National Scrapie Database, and under such conditions as the Administrator deems necessary to trace the movement of the imported embryos or oocytes. Imported sheep or goat embryos or oocytes that are not otherwise restricted by the conditions of an import permit may be transferred from a listed flock or herd to any other listed flock or herd or from an embryo storage facility to a listed flock or herd with written notification to the responsible APHIS Veterinary Services Service Center.

    (e) The importer, the owner of a recipient flock or herd to which delivery of the embryos or oocytes is made, or the owner of an APHIS-approved embryo or oocyte storage facility must maintain records of the disposition (including destruction) of imported or stored embryos or oocytes for 5 years after the embryo or oocyte is transferred or destroyed. These records must be made available during normal business hours to APHIS representatives on request for review and copying.

    (f) In vitro-derived or manipulated sheep or goat embryos and oocytes. As provided in § 98.10, APHIS will make a case-by-case determination or establish conditions in an import permit that includes any additional mitigations deemed necessary to prevent the introduction of disease.

    (g) The owner of all sheep or goats resulting from embryos or oocytes imported under this section shall:

    (1) Identify them at birth with a permanent official identification number consistent with the provisions of § 79.2 of this chapter; such identification may not be removed except at slaughter and must be replaced if lost;

    (2) Maintain a record linking the official identification number to the imported embryo or oocyte including a record of the replacement of lost tags;

    (3) Maintain records of any sale or disposition of such animals, including the date of sale or disposition, the name and address of the buyer, and the animal's official identification number; and

    (4) Keep the required records for a period of 5 years after the sale or death of the animal. APHIS may view and copy these records during normal business hours.

    (Approved by the Office of Management and Budget under control numbers 0579-0040 and 0579-0101)

    33. Section 98.13 is amended by adding paragraph (c) to read as follows:
    § 98.13 Import permit.

    (c) Applications for a permit to import sheep and goat embryos and oocytes must include the flock identification number of the receiving flock and the premises or location identification number assigned in the APHIS National Scrapie Database; or, in the case of embryos or oocytes moving to a storage facility, the premises or location identification number must be included.

    § 98.15 [Amended]
    34. Section 98.15 is amended as follows: a. In paragraph (a), introductory text, by removing the words “follows, except that, with regard to bovine spongiform encephalopathy, the following does not apply to bovines, cervids, or camelids” and adding the word “follows:” in their place. b. In paragraph (a)(1)(i), by removing the words “Bovine spongiform encephalopathy, contagious” and adding the word “Contagious” in their place. c. In paragraph (a)(2)(i), by removing the words “Bovine spongiform encephalopathy, contagious” and adding the word “Contagious” in their place. d. In paragraph (a)(7)(i)(A), by removing the words “Bovine spongiform encephalopathy, brucellosis” and adding the word “Brucellosis” in their place. e. In paragraph (a)(8)(i)(A), by removing the words “Bovine spongiform encephalopathy, brucellosis” and adding the word “Brucellosis” in their place. 35. Section 98.30 is amended by adding, in alphabetical order, a definition for “Establishment” to read as follows.
    § 98.30 Definitions.

    Establishment. The premises in which animals are kept.

    36. Section 98.35 is amended as follows: a. Paragraph (e)(1)(ii) is removed and paragraphs (e)(1)(iii) and (e)(1)(iv) are redesignated as paragraphs (e)(1)(ii) and (e)(1)(iii), respectively; b. Newly redesignated (e)(1)(iii) is revised; c. New paragraph (e)(1)(iv) is added; d. Paragraph (e)(3) is revised; and e. Paragraphs (e)(4) and (5) are added.

    The revisions and additions read as follows:

    § 98.35 Declaration, health certificate, and other documents for animal semen.

    (e) * * *

    (1) * * *

    (iii) The donor animal is not, nor was not, restricted in the country of origin, or destroyed, due to exposure to a TSE.

    (iv) Any additional certifications or testing requirements established by APHIS, based on genetic susceptibility of the semen donor, and/or on scrapie testing of the donor or semen, will be listed in the APHIS import permit. Such certifications or required test results must also be recorded on the health certificate accompanying the semen.

    (3) Sheep and goat semen may only be imported for transfer to recipient females in the United States if the flock or herd in which recipients reside is listed in the National Scrapie Database; except that APHIS may permit importation of sheep and goat semen to an APHIS-approved storage facility where they may be kept until later transferred to recipient females in a flock or herd in the United States that is listed in the APHIS National Scrapie Database, and under such conditions as the Administrator deems necessary to trace the movement of the imported semen. Imported sheep or goat semen that is not otherwise restricted by the conditions of an import permit may be transferred from a listed flock or herd to any other listed flock or herd or from an approved semen storage facility to a listed flock or herd or another approved semen storage facility with written notification to the responsible APHIS Veterinary Services Service Center.

    (4) The importer, the owner of a recipient flock or herd to which delivery of the semen is made, or the owner of an APHIS-approved semen storage facility must maintain records of the disposition (including destruction) of imported or stored semen for 5 years after the semen is transferred or destroyed. These records must be made available during normal business hours to APHIS representatives on request for review and copying.

    (5) The owner of all sheep or goats resulting from semen imported under this section shall:

    (i) Identify them at birth with a permanent official identification number consistent with the provisions of § 79.2 of this chapter; such identification may not be removed except at slaughter and must be replaced if lost;

    (ii) Maintain a record linking the official identification number to the imported semen, including a record of the replacement of lost tags;

    (iii) Maintain records of any sale or disposition of such animals, including the date of sale or disposition, the name and address of the buyer, and the animal's official identification number; and

    (iv) Keep the required records for a period of 5 years after the sale or death of the animal. APHIS may view and copy these records during normal business hours.

    Done in Washington, DC, this 12th day of July 2016. Edward Avalos, Under Secretary for Marketing and Regulatory Programs.
    [FR Doc. 2016-16816 Filed 7-15-16; 8:45 am] BILLING CODE 3410-34-P
    81 137 Monday, July 18, 2016 Notices DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2015-0063] International Trade Data System Test Concerning the Electronic Submission to the Automated Commercial Environment of Data Using the Partner Government Agency Message Set AGENCY:

    Animal and Plant Health Inspection Service, USDA.

    ACTION:

    Notice.

    SUMMARY:

    The Animal and Plant Health Inspection Service (APHIS), in coordination with U.S. Customs and Border Protection (CBP), is advising the public that a pilot plan to test and assess the International Trade Data System for the electronic submission of data required by APHIS Animal Care, Biotechnology Regulatory Services, Plant Protection and Quarantine, and Veterinary Services for processing in the Automated Commercial Environment has proven successful and will end on August 15, 2016. After this date, all submissions of APHIS-required data must be submitted in accordance with the procedures on the CBP Web site.

    DATES:

    The test will end August 15, 2016.

    FOR FURTHER INFORMATION CONTACT:

    For technical questions related to the Automated Commercial Environment or Automated Broker Interface transmissions, contact your assigned CBP client representative. Interested parties without an assigned client representative should direct their questions to Mr. Steven Zaccaro, U.S. Customs and Border Protection, DHS, 1400 L Street NW., 2nd floor, Washington, DC 20229-1225; [email protected]

    For PGA-related questions, contact Ms. Emi Wallace, U.S. Customs and Border Protection, DHS, 1400 L Street NW., 2nd floor, Washington, DC 20229-1225; [email protected]

    For APHIS program-related questions, contact Ms. Cindy Walters, APHIS Liaison for Automated Commercial Environment, International Trade Data System, Management and Program Analyst, Quarantine Policy and Analysis Staff, PPQ, APHIS, 4700 River Road Unit 60, Riverdale, MD 20720; 301-851-2273; [email protected]

    SUPPLEMENTARY INFORMATION:

    The National Customs Automation Program (NCAP) was established in Subtitle B of Title VI—Customs Modernization, in the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057, 2170, December 8, 1993; see 19 U.S.C. 1411). Through NCAP, the initial thrust of customs modernization was on trade compliance and the development of the Automated Commercial Environment (ACE), the planned successor to the Automated Commercial System (ACS). ACE is an automated and electronic system for commercial trade processing intended to streamline business processes, facilitate growth in trade, ensure cargo security, and foster participation in global commerce, while ensuring compliance with U.S. laws and regulations and reducing costs for U.S. Customs and Border Protection (CBP) and all of its communities of interest. The ability to meet these objectives depends on successfully modernizing CBP's business functions and the information technology that supports those functions.

    CBP's modernization efforts are accomplished through phased releases of ACE component functionality designed to replace specific legacy ACS functions or test new automated procedures. The Automated Broker Interface (ABI) allows participants to electronically file required import data with CBP and transfers that data into ACE.

    On October 2, 2015, the Animal and Plant Health Inspection Service (APHIS) published a notice in the Federal Register (80 FR 59721, Docket No. APHIS-2015-0063) 1 announcing a pilot test in furtherance of the International Trade Data System (ITDS). The purpose of ITDS is to eliminate redundant information filing requirements, efficiently regulate the flow of commerce, and effectively enforce laws and regulations relating to international trade, by establishing a single portal system, operated by CBP, for the collection and distribution of standard electronic import and export data required by all participating Federal agencies. As part of this test, APHIS-required data was transmitted electronically to operational ports using either ACE, ABI, or the Document Image System.2

    1 To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0063.

    2 CBP announced changes to the Document Image System test in a notice published in the Federal Register on October 15, 2015 (80 FR 62082, Docket No. USCP-2015-0046). To view this notice, go to http://www.regulations.gov/#!docketDetail;D=USCBP-2015-0046.

    APHIS is announcing that the APHIS core pilot has proven successful and, as a result, will end August 15, 2016. After this date, entry filers will be required to file electronic entries in ACE with APHIS data and some or all APHIS forms using the method designated on the CBP Web site for the submission of the APHIS data and forms. APHIS will still collect some paper documentation, such as phytosanitary certificates and health certificates for live animals and animal products, due to an Office of Management and Budget waiver. Information regarding methods of submission is available on the CBP Web site at https://www.cbp.gov/sites/default/files/assets/documents/2016-Mar/PGA%20Forms%20Document%20March%2030%202016.pdf.

    Done in Washington, DC, this 13th day of July 2016. Jere L. Dick, Acting Administrator, Animal and Plant Health Inspection Service.
    [FR Doc. 2016-16932 Filed 7-15-16; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Forest Service Notice of New Fee Site AGENCY:

    Carson National Forest, USDA Forest Service.

    ACTION:

    Notice of new fee site.

    SUMMARY:

    The Carson National Forest is proposing to charge a $100 fee for the overnight rental of the Amole Canyon Group Shelter. This facility has been recently constructed and has not been available for recreation use prior to this date. Rentals of other shelters in the Taos and Santa Fe area have shown that people appreciate and enjoy the availability of group meeting places for events and for family gatherings. Funds from the shelter reservation will be used for the continued operation and maintenance of the facility. These fees are only proposed and will be determined upon further analysis and public comment.

    DATES:

    Send any comments about these fee proposals by October 2016 so comments can be compiled, analyzed and shared with a Recreation Resource Advisory Committee. Should the fee proposal move forward, the site will likely be available for reservation May 2017.

    ADDRESSES:

    Forest Supervisor, Carson National Forest, 208 Cruz Alta Road, Taos, NM 87557.

    FOR FURTHER INFORMATION CONTACT:

    Sharon Cuevas, Recreation Fee Coordinator, (505) 842-3235.

    SUPPLEMENTARY INFORMATION:

    The Federal Recreation Lands Enhancement Act (Title VII, Pub. L. 108-447) directed the Secretary of Agriculture to publish a six month advance notice in the Federal Register whenever new recreation fee areas are established.

    This new fee will be reviewed by a Recreation Resource Advisory Committee prior to a final decision and implementation.

    Currently Federal and State agencies in the state of New Mexico offer group shelter rentals of this type as part of a successful program. These sites receive a high level of use and handle the large group sizes common in the area.

    The site consists of a large log-built canopy shelter on a concrete pad with two vault toilets, a pedestal grill, accessible parking, and many paved parking spurs to accommodate several camper trailers. The Amole Canyon Group Shelter is located 15 miles from the community of Taos New Mexico adjacent to the High Road to Taos Scenic Byway.

    A business analysis of the Amole Canyon Group Shelter has shown that people desire having this sort of recreation experience on the Carson National Forest. A market analysis indicates that the $100/per night fee is both reasonable and acceptable for this sort of unique recreation experience.

    People wanting to rent this facility will need to do so through the National Recreation Reservation Service, at www.recreation.gov or by calling 1-877-444-6777. The National Recreation Reservation Service charges a $9 fee for reservations.

    Dated: July 8, 2016. James Duran, Carson National Forest Supervisor.
    [FR Doc. 2016-16750 Filed 7-15-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Rural Business-Cooperative Service Rural Business Lending National Stakeholder Forum 2016—Business and Industry Guaranteed Loan Program AGENCY:

    Rural Business-Cooperative Service, USDA.

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The Rural Business-Cooperative Service (RBS), an Agency within USDA Rural Development, is holding a forum to introduce the updated Business and Industry (B&I) Guaranteed Loanmaking and Servicing Regulations, as published in the Federal Register Friday, June 3, 2016. Major changes to the program include strengthened criteria for non-regulated lender participation, provisions for New Markets Tax Credit and Cooperative Stock Purchase Program, and modified loan scoring criteria.

    Speakers from the Agency will discuss the new rule to educate lenders and borrowers on changes to program eligibility and servicing. The National Stakeholder Forum can be attended via webinar or in person.

    DATES:

    National Stakeholder Forum: The National Stakeholder Forum will be held on Friday, July 29, 2016, from 1:00 p.m. to 3:00 p.m. Eastern Daylight Time.

    Registration: It is requested that you register by 12 p.m. Eastern Daylight Time Wednesday, July 27, 2016, to attend the forum in person. See the Instructions for Attending the Meeting section of this notice for additional information. If you wish to participate via webinar, you must register for the webinar at https://cc.readytalk.com/r/njphkhxlsyvr&eom prior to or during the webinar.

    ADDRESSES:

    The National Stakeholder Forum will take place in Room 107-A of the Whitten Building on 1400 Jefferson Drive SW., located between 12th and 14th Streets SW., in Washington DC 20250.

    FOR FURTHER INFORMATION CONTACT:

    Janna Bruce, Rural Business-Cooperative Service, Room 6858, 1400 Independence Avenue SW., Washington, DC 20250, Telephone: (202)401-0081. Email: [email protected] Persons with disabilities who require alternative means for communication of program information (Braille, large print, audiotape, etc.) should contact Janna Bruce using the information above.

    SUPPLEMENTARY INFORMATION:

    The B&I Guaranteed Loan Program is authorized by the Consolidated Farm and Rural Development Act and provides loan guarantees to banks and other approved lenders to finance private businesses located in rural areas. The Rural Business-Cooperative Service (Agency) is the agency within the Rural Development mission area of the United States Department of Agriculture (USDA) responsible for administering the B&I Guaranteed Loan Program. The Agency published a proposed rule on September 15, 2014, that proposed changes to refine the regulations for the B&I Guaranteed Loan Program in an effort to improve program delivery, clarify the regulations to make them easier to understand, and reduce delinquencies. The final rule was published in the Federal Register on June 3, 2016 (https://federalregister.gov/a/2016-12945).

    In order to familiarize the public with the new rule, representatives from the U.S. Department of Agriculture (USDA) are conducting this National Stakeholder Forum. Discussion points will include the new criteria for non-regulated lender participation, expanded program eligibility, and changes to loan servicing requirements. Participants will be afforded the opportunity to ask questions on the material in the presentation through the webinar software or in person.

    Date: July 29, 2016.

    Time: 1:00 p.m.-3:00 p.m., Eastern Daylight Time.

    Location information: USDA Whitten Building, 1400 Jefferson Drive SW., Room 107-A, Washington, DC 20250.

    Instructions for Attending the Meeting

    Space for attendance at the meeting is limited. Due to USDA headquarters security and space requirements, all persons wishing to attend the forum in person must send an email to [email protected] with “RBS Stakeholder Forum” in the subject line by 12 p.m. Eastern Daylight Time Wednesday, July 27, 2016. Registrations will be accepted until maximum room capacity is reached. Seating will be available on a first come, first serve basis.

    To register, provide the following information:

    • First and Last Names • Organization • Title • Email • City, State

    Upon arrival at the USDA Whitten Building, registered persons must provide valid photo identification in order to enter the building; visitors need to enter the Whitten Building on the mall side. Please allow extra time to get through security.

    USDA Non-Discrimination Statement

    In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

    Persons with disabilities who require alternative means of communication for program information (e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

    To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at https://www.ascr.usda.gov/filing-program-discrimination-complaint-usda-customer and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by:

    (1) Mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW., Washington, DC 20250-9410;

    (2) fax: (202) 690-7442; or

    (3) email: [email protected]

    USDA is an equal opportunity provider, employer, and lender. Dated: July 8, 2016. Samuel H. Rikkers, Administrator, Rural Business-Cooperative Service.
    [FR Doc. 2016-16921 Filed 7-15-16; 8:45 am] BILLING CODE 3410-XY-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Illinois Advisory Committee To Discuss Voting Rights in the State AGENCY:

    U.S. Commission on Civil Rights.

    ACTION:

    Announcement of meeting.

    SUMMARY:

    Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Illinois Advisory Committee (Committee) will hold a meeting on Tuesday, August 23, 2016, at 12:00 p.m. CDT. The purpose of this meeting is to discuss voting rights in the state, and to identify the scope of study for the next Committee inquiry on the topic.

    This meeting is available to the public through the following toll-free call-in number: 888-427-9419, conference ID: 4580773. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement at the end of the meeting. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.

    Member of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Regional Programs Unit, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at [email protected] Persons who desire additional information may contact the Regional Programs Unit at (312) 353-8311.

    Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at https://database.faca.gov/committee/meetings.aspx?cid=246. Click on the “Meeting Details” and “Documents” links to download. Records generated from this meeting may also be inspected and reproduced at the Regional Programs Unit, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Regional Programs Unit at the above email or street address.

    Agenda
    Welcome and Introductions Discussion: Voting Rights in Illinois Public Comment Future plans and actions Adjournment DATES:

    The meeting will be held on Tuesday, August 23, 2016, at 12:00 p.m. CDT.

    Public Call Information:

    Dial: 888-427-9419.

    Conference ID: 4580773.

    FOR FURTHER INFORMATION CONTACT:

    Melissa Wojnaroski at [email protected]v or 312-353-8311.

    Dated: July 13, 2016. David Mussatt, Chief, Regional Programs Unit.
    [FR Doc. 2016-16902 Filed 7-15-16; 8:45 am] BILLING CODE 6335-01-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-12-2016] Foreign-Trade Zone (FTZ) 168—Dallas/Fort Worth, Texas, Authorization of Limited Production Activity, Gulfstream Aerospace Corporation, (Passenger Jet Aircraft), Dallas, Texas

    On March 8, 2016, the Metroplex International Trade Development Corporation, grantee of FTZ 168, submitted a notification of proposed production activity to the FTZ Board on behalf of Gulfstream Aerospace Corporation, within Site 10, in Dallas, 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 (81 FR 14834, March 18, 2016). The FTZ Board has determined that further review of part of the proposed activity is warranted at this time. The production activity described in the notification is authorized on a limited basis, subject to the FTZ Act and the Board's regulations, including Section 400.14, and further subject to a restriction requiring admission of foreign-status upholstery leather in privileged foreign status (19 CFR 146.41).

    Dated: July 5, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-16371 Filed 7-15-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-570-043] Countervailing Duty Investigation of Stainless Steel Sheet and Strip From the People's Republic of China: Preliminary Affirmative Determination and Alignment of Final Determination With Final Antidumping Duty Determination AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) preliminarily determines that countervailable subsidies are being provided to producers and exporters of stainless steel sheet and strip (stainless sheet and strip) from the People's Republic of China (PRC). The period of investigation is January 1, 2015, through December 31, 2015. We invite interested parties to comment on this preliminary determination.

    DATES:

    Effective July 18, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Emily Halle, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-0176.

    SUPPLEMENTARY INFORMATION: Scope of the Investigation

    The products covered by this investigation are stainless sheet and strip from the PRC. For a complete description of the scope of this investigation, see Appendix II.

    Methodology

    The Department is conducting this countervailing duty (CVD) investigation in accordance with section 701 of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found countervailable, we preliminarily determine that there is a subsidy, i.e., a financial contribution by an “authority” that gives rise to a benefit to the recipient, and that the subsidy is specific.1 For a full description of the methodology underlying our preliminary conclusions, see the Preliminary Decision Memorandum.2 A list of topics discussed in the Preliminary Decision Memorandum is included as Appendix I to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/. The signed Preliminary Decision Memorandum and the electronic version are identical in content.

    1See sections 771(5)(B) and (D) of the Act regarding financial contribution; section 771(5)(E) of the Act regarding benefit; and section 771(5A) of the Act regarding specificity.

    2See Memorandum, “Decision Memorandum for the Preliminary Affirmative Determination: Countervailing Duty Investigation of Stainless Steel Sheet and Strip From the People's Republic of China,” dated concurrently with, and hereby adopted by, this notice (Preliminary Decision Memorandum).

    The Department notes that, in making these findings, we relied, in part, on facts available and, because we find that one or more respondents did not act to the best of their ability to respond to the Department's requests for information, we drew an adverse inference where appropriate in selecting from among the facts otherwise available.3 For further information, see “Use of Facts Otherwise Available and Adverse Inferences” in the Preliminary Decision Memorandum.

    3See sections 776(a) and (b) of the Act.

    Alignment

    As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), we are aligning the final CVD determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of stainless sheet and strip from the PRC based on a request made by Petitioners.4 Consequently, the final CVD determination will be issued on the same date as the final AD determination, which is currently scheduled to be issued no later than November 23, 2016, unless postponed.

    4See Letter from Petitioners, “Countervailing Duty Investigation of Stainless Steel Sheet and Strip from the People's Republic of China—Petitioners' Request to Align the Countervailing Duty Final Determination with the Companion Antidumping Duty Final Determination,” June 24, 2016.

    Preliminary Determination and Suspension of Liquidation

    In accordance with section 703(d)(1)(A)(i) of the Act, we calculated an individual estimated countervailable subsidy rate for Shanxi Taigang Stainless Steel Co. Ltd. (Taigang), the only cooperating, individually-investigated exporter/producer. Additionally, in accordance with sections 703(d) and 705(c)(5)(A) of the Act, for companies not individually investigated, we apply an “all-others” rate, which is normally calculated by weight averaging the subsidy rates of the companies selected for individual investigation by those companies' exports of the subject merchandise to the United States. However, under section 705(c)(5)(A)(i) of the Act, the all-others rate excludes zero and de minimis rates calculated for the exporters and producers individually investigated, as well as rates based entirely on facts otherwise available. Therefore, we have excluded the rates based entirely on facts otherwise available assigned to Ningbo Baoxin Stainless Steel Co., Ltd. (Ningbo Baoxin) and Daming International Import Export Co. Ltd. (Daming) from the all-others rate. Because the only individually calculated rate that is not zero, de minimis, or based on facts otherwise available is the rate calculated for Taigang, in accordance with section 705(c)(5)(A)(i) of the Act, the rate calculated for Taigang is preliminarily assigned as the all-others rate. The preliminary estimated countervailable subsidy rates are summarized in the table below.

    Company Subsidy rate
  • (percent)
  • Shanxi Taigang Stainless Steel Co. Ltd 57.30 Ningbo Baoxin Stainless Steel Co., Ltd., Baosteel Stainless Steel Co. Ltd., Baoshan Iron & Steel Co., Ltd., Baosteel Desheng Stainless Steel Co., Ltd., Baosteel Co., Ltd., Bayi Iron & Steel Co., Ltd., Ningbo Iron & Steel Co., Ltd., Shaoguan Iron & Steel Co., Ltd., Guangdong Shaoguan Iron & Steel Co., Ltd., and Zhanjiang Iron & Steel Co., Ltd 193.12 Daming International Import Export Co. Ltd. and Tianjin Taigang Daming Metal Product Co., Ltd 193.12 All-Others 57.30

    In accordance with section 703(d)(2) of the Act, we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of all entries of stainless sheet and strip from the PRC as described in the “Scope of the Investigation. Pursuant to 19 CFR 351.205(d), the Department will instruct CBP to require a cash deposit equal to the rests indicated above. Section 703(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of the investigation was published. On June 27, 2016, we preliminarily found that critical circumstances exist for imports produced or exported by Taigang, Ningbo Baoxin, Daming, and all-other exporters or producers.5 Accordingly, for these companies, in accordance with section 703(e)(2)(A) of the Act, suspension of liquidation of stainless sheet and strip from the PRC, as described in the “Scope of the Investigation,” shall apply to unliquidated entries of merchandise entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice, the date suspension of liquidation is first ordered.

    5See Countervailing Duty Investigation of Stainless Steel Sheet and Strip From the People's Republic of China: Preliminary Determination of Critical Circumstances, 81 FR 41519 (June 27, 2016).

    Verification

    As provided in section 782(i)(1) of the Act, we intend to verify the information submitted by the respondents prior to making our final determination.

    International Trade Commission Notification

    In accordance with section 703(f) of the Act, we will notify the International Trade Commission (ITC) of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information relating to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order, without the written consent of the Assistant Secretary for Enforcement and Compliance.

    In accordance with section 705(b)(2) of the Act, if our final determination is affirmative, the ITC will make its final determination within 45 days after the Department makes its final determination.

    Disclosure and Public Comment

    The Department intends to disclose to interested parties the calculations performed in connection with this preliminary determination within five days of its public announcement.6 Interested parties may submit case and rebuttal briefs, as well as request a hearing.7 For a schedule of the deadlines for filing case briefs, rebuttal briefs, and hearing requests, see the Preliminary Decision Memorandum.

    6See 19 CFR 351.224(b).

    7See 19 CFR 351.309(c)-(d), 19 CFR 351.310(c).

    This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).

    Dated: July 11, 2016. Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance. Appendix I List of Topics Discussed in the Preliminary Decision Memorandum I. Summary II. Background III. Scope Comments IV. Scope of the Investigation V. Preliminary Determination of Critical Circumstances VI. Injury Test VII. Application of the CVD Law to Imports From the PRC VIII. Alignment IX. Use of Facts Otherwise Available and Adverse Inferences X. Subsidies Valuation XI. Benchmarks and Interest Rates XII. Analysis of Programs XIII. Disclosure and Public Comment XIV. Conclusion Appendix II Scope of the Investigation

    The merchandise covered by this investigation is stainless steel sheet and strip, whether in coils or straight lengths. Stainless steel is an alloy steel containing, by weight, 1.2 percent or less of carbon and 10.5 percent or more of chromium, with or without other elements. The subject sheet and strip is a flat-rolled product with a width that is greater than 9.5 mm and with a thickness of 0.3048 mm and greater but less than 4.75 mm, and that is annealed or otherwise heat treated, and pickled or otherwise descaled. The subject sheet and strip may also be further processed (e.g., cold-rolled, annealed, tempered, polished, aluminized, coated, painted, varnished, trimmed, cut, punched, or slit, etc.) provided that it maintains the specific dimensions of sheet and strip set forth above following such processing. The products described include products regardless of shape, and include products of either rectangular or non-rectangular cross-section where such cross-section is achieved subsequent to the rolling process, i.e., products which have been “worked after rolling” (e.g., products which have been beveled or rounded at the edges).

    For purposes of the width and thickness requirements referenced above: (1) Where the nominal and actual measurements vary, a product is within the scope if application of either the nominal or actual measurement would place it within the scope based on the definitions set forth above; and (2) where the width and thickness vary for a specific product (e.g., the thickness of certain products with non-rectangular cross-section, the width of certain products with non-rectangular shape, etc.), the measurement at its greatest width or thickness applies.

    All products that meet the written physical description, and in which the chemistry quantities do not exceed any one of the noted element levels listed above, are within the scope of this investigation unless specifically excluded.

    Subject merchandise includes stainless steel sheet and strip that has been further processed in a third country, including but not limited to cold-rolling, annealing, tempering, polishing, aluminizing, coating, painting, varnishing, trimming, cutting, punching, and/or slitting, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the stainless steel sheet and strip.

    Excluded from the scope of this investigation are the following: (1) Sheet and strip that is not annealed or otherwise heat treated and not pickled or otherwise descaled; (2) plate (i.e., flat-rolled stainless steel products of a thickness of 4.75 mm or more); and (3) flat wire (i.e., cold-rolled sections, with a mill edge, rectangular in shape, of a width of not more than 9.5 mm).

    The products under investigation are currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7219.13.0031, 7219.13.0051, 7219.13.0071, 7219.13.0081, 7219.14.0030, 7219.14.0065, 7219.14.0090, 7219.23.0030, 7219.23.0060, 7219.24.0030, 7219.24.0060, 7219.32.0005, 7219.32.0020, 7219.32.0025, 7219.32.0035, 7219.32.0036, 7219.32.0038, 7219.32.0042, 7219.32.0044, 7219.32.0045, 7219.32.0060, 7219.33.0005, 7219.33.0020, 7219.33.0025, 7219.33.0035, 7219.33.0036, 7219.33.0038, 7219.33.0042, 7219.33.0044, 7219.33.0045, 7219.33.0070, 7219.33.0080, 7219.34.0005, 7219.34.0020, 7219.34.0025, 7219.34.0030, 7219.34.0035, 7219.34.0050, 7219.35.0005, 7219.35.0015, 7219.35.0030, 7219.35.0035, 7219.35.0050, 7219.90.0010, 7219.90.0020, 7219.90.0025, 7219.90.0060, 7219.90.0080, 7220.12.1000, 7220.12.5000, 7220.20.1010, 7220.20.1015, 7220.20.1060, 7220.20.1080, 7220.20.6005, 7220.20.6010, 7220.20.6015, 7220.20.6060, 7220.20.6080, 7220.20.7005, 7220.20.7010, 7220.20.7015, 7220.20.7060, 7220.20.7080, 7220.90.0010, 7220.90.0015, 7220.90.0060, and 7220.90.0080. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this proceeding is dispositive.

    [FR Doc. 2016-16947 Filed 7-15-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-580-870] Certain Oil Country Tubular Goods From the Republic of Korea: Initiation and Expedited Preliminary Results of Changed Circumstances Review AGENCY:

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

    DATES:

    Effective Date: July 18, 2016.

    SUMMARY:

    In response to a request from Hyundai Steel Co. Ltd. (Hyundai Steel), a producer/exporter of certain oil country tubular goods (OCTG) from the Republic of Korea (Korea), and pursuant to section 751(b) of the Tariff Act of 1930, as amended (the Act), 19 CFR 351.216 and 351.221(c)(3)(ii), the Department is initiating a changed circumstances review (CCR) and issuing this notice of preliminary results. We have preliminarily determined that Hyundai Steel is the successor-in-interest to the former Hyundai HYSCO and, as such, if the Department upholds these preliminary results in the final results, Hyundai Steel will be entitled to the antidumping duty deposit rate currently assigned to Hyundai HYSCO with respect to the subject merchandise.

    FOR FURTHER INFORMATION CONTACT:

    Victoria Cho, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5075.

    SUPPLEMENTARY INFORMATION: Background

    On September 10, 2014, the Department published an antidumping duty order on OCTG from Korea.1

    1See Certain Oil Country Tubular Goods From India, the Republic of Korea, Taiwan, the Republic of Turkey, and the Socialist Republic of Vietnam: Antidumping Duty Orders; and Certain Oil Country Tubular Goods From the Socialist Republic of Vietnam: Amended Final Determination of Sales at Less Than Fair Value, 74 FR 53691 (September 10, 2014).

    On February 24, 2016,2 Hyundai Steel informed the Department that effective July 1, 2015, it had merged with Hyundai HYSCO,3 and requested that: (1) The Department conduct a CCR under 19 CFR 351.216(b) to determine that it is the successor-in-interest to Hyundai HYSCO for purposes of determining Hyundai Steel's antidumping duty cash deposits and liabilities; (2) the Department's successor-in-interest determination be effective as of July 1, 2015, the date on which the merger was completed; and (3) on an expedited basis under 19 CFR 351.221(c)(3)(ii).

    2See the February 24, 2016, letter from Hyundai Steel, “Oil Country Tubular Goods from the Republic of Korea: Request for a Changed Circumstances Review,” (CCR Request).

    3 Hyundai HYSCO was a respondent in the investigation of OCTG from Korea covering the period July 1, 2012-June 30, 2013. Hyundai HYSCO received a 15.75 percent dumping margin. See Certain Oil Country Tubular Goods From the Republic of Korea: Final Determination of Sales at Less Than Fair Value and Negative Final Determination of Critical Circumstances, 79 FR 41983 (July 18, 2014).

    On May 18, 2016,4 the Department declined to initiate the CCR that Hyundai Steel requested in its February 24, 2016, CCR Request. The Department determined that it would not conduct a CCR of a final determination in an investigation less than 24 months after the publication of the final determination absent showing of good cause.5 The Department further found that Hyundai Steel “did not reference or attempt to show good cause” in its February 24, 2016, request.6 On May 31, 2016,7 Hyundai Steel filed its second request for a CCR, in which it alleged that that good cause exists in this case and requested that the Department initiate a CCR.

    4See the Department's May 18, 2016, letter to Hyundai Steel.

    5See the Department's May 18, 2016, letter to Hyundai Steel (the Department's Rejection Letter); 19 CFR 351.216(c); and section 751(b)(4) of the Act.

    6See the CCR Request; and also see the Department's Rejection Letter.

    7See the May 31, 2016, letter from Hyundai Steel to the Department.

    We received no comments from any other interested party.

    Scope of the Review

    The merchandise covered by this review is certain oil country tubular goods (OCTG), which are hollow steel products of circular cross-section, including oil well casing and tubing, of iron (other than cast iron) or steel (both carbon and alloy), whether seamless or welded, regardless of end finish (e.g., whether or not plain end, threaded, or threaded and coupled) whether or not conforming to American Petroleum Institute (API) or non-API specifications, whether finished (including limited service OCTG products) or unfinished (including green tubes and limited service OCTG products), whether or not thread protectors are attached. The scope of the investigation also covers OCTG coupling stock. For a complete description of the scope of the investigation, see Appendix I to this notice.

    Initiation and Preliminary Results

    Pursuant to section 751(b)(1) of the Act, the Department will conduct a CCR 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.8 In addition, because the final determination was published less than 24 months prior to the date on which Hyundai Steel submitted its request for a CCR (i.e., May 31, 2016), and pursuant to section 351.216(c) of the Department's regulations, a CCR will not be initiated unless good cause exists. We find that good cause exists in the instant CCR request to initiate this CCR before the 24 month anniversary of the final determination, as demonstrated by Hyundai Steel.9 Moreover, as noted above in the “Background” section, we have received information indicating that on July 1, 2015, Hyundai HYSCO merged with Hyundai Steel, with the latter assuming all operations for the production and sale of the subject merchandise.10 This constitutes changed circumstances warranting a review of this order.11

    8See 19 CFR 351.216(c); section 735(a) of the Act.

    9See the May 31, 2016, letter from Hyundai Steel to the Department.

    10See the CCR request.

    11See 19 CFR 351.216(d).

    Section 351.221(c)(3)(ii) of the Department's regulations permits the Department to combine the notice of initiation of a CCR and the notice of preliminary results if the Department concludes that expedited action is warranted. In this instance, because we have on the record the information necessary to make a preliminary finding and no party has opposed expedited action, we find that expedited action is warranted, and have combined the notice of initiation and the notice of preliminary results.

    In making a successor-in-interest determination, the Department examines several factors, including but not limited to, changes in: (1) Management; (2) production facilities; (3) supplier relationships; and (4) customer base.12 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 resulting operation is not materially dissimilar to that of its predecessor.13 Thus, if the evidence demonstrates that, with respect to the production and sale 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.

    12See, e.g., Preliminary Results of Antidumping Duty Changed Circumstances Review: Carbon and Certain Alloy Steel Wire Rod from Canada, 71 FR 75229 (December 14, 2009) and unchanged in Notice of Final Results of Antidumping Duty Changed Circumstances Review: Carbon and Certain Alloy Steel Wire Rod from Canada, 72 FR 15102 (March 30, 2007) (Carbon and Certain Alloy Steel from Canada); Certain Lined Paper Products From India: Preliminary Results of Changed Circumstances Review, 79 FR 21897 (April 18, 2014) and unchanged in Certain Lined Paper Products From India: Final Results of Changed Circumstances Review, 79 FR 35726 (June 24, 2014).

    13See, e.g., Notice of Initiation and Preliminary Results of Antidumping Duty Changed Circumstances Review: Carbon and Certain Alloy Steel Wire Rod From Mexico, 75 FR 67685 (November 3, 2010) and unchanged in Final Results of Antidumping Duty Changed Circumstances Review: Carbon and Certain Alloy Steel Wire Rod From Mexico, 76 FR 45509 (July 29, 2011); Carbon and Certain Alloy Steel from Canada.

    In its CCR Request, Hyundai Steel explained that effective July 1, 2015, Hyundai HYSCO merged with Hyundai Steel,14 with Hyundai Steel effectively absorbing Hyundai HYSCO. On April 28, 2015, the board of directors of Hyundai Steel and Hyundai HYSCO, both members of the Hyundai Motor Group, decided to merge the two companies. The absorption-type merger was conducted, through which Hyundai Steel became the surviving company.15 Hyundai Steel claimed that since the merger took effect, it is operating essentially the same business as the former Hyundai HYSCO, and there has been no significant change in management, production facilities, supplier relationships, or customer base with respect to the production and sale of the subject merchandise.16 Hyundai Steel submitted detailed documentation relating to the merger of the two companies (e.g., major shareholders' lists, board of directors' lists, executives' lists, meeting minutes regarding the merger, business registration certificates, and a copy of the merger corporate registration and announcement of the merger).17

    14See the CCR Request.

    15Id., at 3.

    16Id., at 4.

    17Id., at 3 and Exhibits 1 through 8.

    With respect to management, Hyundai Steel asserts that the management structure of the former Hyundai HYSCO has also remained largely unchanged. Hyundai Steel retained most of its board of directors. Mr. Heon-seok Lee, who was a board member and executive of Hyundai HYSCO, remained as an executive of Hyundai Steel.18 In addition, Hyundai Steel states that of the 17 executives of Hyundai HYSCO, 12 have remained at Hyundai Steel after the merger, excluding only four non-executive directors. Nine out of the 12 executives that remained at Hyundai Steel have been assigned to departments and divisions within Hyundai Steel.19

    18Id., at 8 and exhibit 2.

    19Id., at 8-9 and exhibit 3.

    Hyundai Steel further explained that its current organizational structure is substantially similar to that of Hyundai HYSCO. The only change to the organizational structure is that HYSCO's Business Management Division and Overseas Business Division in its Sales Division were divided and integrated into Hyundai Steel's Business Planning Department, Administrative Service Department, Accounting/Monetary Department, Sales Department and R&D Center, according to the function of each team. The other three divisions (i.e., the Sales Division (excluding the Overseas Business sub-division), Pipe Plant, and Automotive Parts Plant) were simply transferred over to Hyundai Steel.20 Moreover, Hyundai Steel claims that the merger did not affect the overall organizational structure in the production and sale of OCTG.21

    20Id., at 7.

    21Id., at 7 and exhibit 9.

    Based on this information, and in particular, based on the fact that Hyundai Steel's management team continues to include the majority of the former HYSCO managers, we preliminarily find that the reorganization resulting from the merger of the two companies did not result in management that was materially dissimilar with respect to the subject merchandise.

    With respect to production facilities, Hyundai Steel asserts that all of the production facilities for Hyundai HYSCO and Hyundai Steel have remained the same, after Hyundai Steel absorbed Hyundai HYSCO due to the merger.22 Hyundai Steel provided copies of HYSCO's company brochure and a screenshot of Hyundai Steel's official Web site, which identifies the addresses and telephone numbers of the offices, production facilities, and branch offices of Hyundai HYSCO and Hyundai Steel.23 Hyundai Steel contends that none of these locations have changed as a result of the merger, including the location of the production facility for OCTG and the Steel Pipe Plant located in Ulsan, South Korea. Based on this information, we preliminarily find that the merger did not result in material changes to the production of the subject merchandise.

    22See, e.g., Carbon and Certain Alloy Steel from Canada.

    23See the CCR Request at 9 and exhibit 10.

    With respect to suppliers and customers, all of the supplier relationships related to OCTG for Hyundai HYSCO and Hyundai Steel have remained the same. Specifically, Hyundai Steel states that is was Hyundai HYSCO's sole supplier of hot-rolled coil for OCTG production in June 2015.24 After the merger, although the level of integration may have changed, the coil used in the production of OCTG continues to be supplied by Hyundai Steel.25 Hyundai Steel contends that it has also maintained Hyundai HYSCO's OCTG customer base.26 Hyundai Steel asserts that Hyundai HYSCO USA (HHU) was Hyundai HYSCO's sole U.S. customer in June 2015, while Hyundai Steel America (HSA) was Hyundai Steel's sole U.S. customer in July 2015.27 Hyundai Steel asserts that its U.S. subsidiary, HSA, is the same company as Hyundai HYSCO's U.S. subsidiary, HHU, which was renamed pursuant to the merger.28

    24Id., at 9 and exhibit 11.

    25Id., Hyundai Steel states that due to the time required to integrate the systems of the two companies, the internal systems relating to pipe products continued to operate separately after the merger while Hyundai Steel worked to merge the two systems into a single system. Therefore, during July 2015, Hyundai Steel is recognized in the system as the hot-rolled supplier.

    26See the CCR Request at 9 and exhibit 12.

    27Id., at 9 and 10 and exhibit 12.

    28Id.

    Based on the evidence reviewed, we preliminarily find that Hyundai Steel is the successor-in-interest to the merger of Hyundai Steel and Hyundai HYSCO. Specifically, we preliminarily find that the merger of these two companies resulted in no significant changes to management, production facilities, supplier relationships, and customers with respect to the production and sale of the subject merchandise. Thus, Hyundai Steel operates as the same business entity as Hyundai HYSCO with respect to the subject merchandise. If the Department upholds these preliminary results in the final results, Hyundai Steel will be entitled to the antidumping duty deposit rate currently assigned to Hyundai HYSCO with respect to the subject merchandise (i.e., 15.75 percent). If these preliminary results are adopted in the final results of this CCR, we will instruct U.S. Customs and Border Protection to suspend liquidation of entries of OCTG made by Hyundai Steel, effective on the publication date of the final results.

    Public Comment

    Interested parties may submit case briefs and/or written comments not later than 14 days after the date of publication of this notice. Rebuttal briefs and rebuttals to written comments, which must be limited to issues raised in such briefs or comments, may be filed not later than 21 days after the date of publication of this notice. Parties who submit case or rebuttal briefs are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities. All comments are to be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS) available to registered users at http://iaaccess.trade.gov and in the Central Records Unit, Room B8024 of the main Department of Commerce building, and must also be served on interested parties.29 An electronically filed document must be received successfully in its entirety by ACCESS by 5:00 p.m. Eastern Time on the day it is due.30

    29See 19 CFR 351.303(f).

    30See 19 CFR 351.303(b).

    Consistent with 19 CFR 351.216(e), we will issue the final results of this CCR no later than 270 days after the date on which this review was initiated, or within 45 days if all parties agree to our preliminary finding. We are issuing and publishing this finding and notice in accordance with sections 751(b)(1) and 777(i)(l) of the Act and 19 CFR 351.216.

    Dated: July 8, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance. Appendix I—Scope of the Review

    The merchandise covered by the investigation is certain oil country tubular goods (OCTG), which are hollow steel products of circular cross-section, including oil well casing and tubing, of iron (other than cast iron) or steel (both carbon and alloy), whether seamless or welded, regardless of end finish (e.g., whether or not plain end, threaded, or threaded and coupled) whether or not conforming to American Petroleum Institute (API) or non-API specifications, whether finished (including limited service OCTG products) or unfinished (including green tubes and limited service OCTG products), whether or not thread protectors are attached. The scope of the investigation also covers OCTG coupling stock.

    Excluded from the scope of the investigation are: Casing or tubing containing 10.5 percent or more by weight of chromium; drill pipe; unattached couplings; and unattached thread protectors.

    The merchandise subject to the investigation is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under item numbers: 7304.29.10.10, 7304.29.10.20, 7304.29.10.30, 7304.29.10.40, 7304.29.10.50, 7304.29.10.60, 7304.29.10.80, 7304.29.20.10, 7304.29.20.20, 7304.29.20.30, 7304.29.20.40, 7304.29.20.50, 7304.29.20.60, 7304.29.20.80, 7304.29.31.10, 7304.29.31.20, 7304.29.31.30, 7304.29.31.40, 7304.29.31.50, 7304.29.31.60, 7304.29.31.80, 7304.29.41.10, 7304.29.41.20, 7304.29.41.30, 7304.29.41.40, 7304.29.41.50, 7304.29.41.60, 7304.29.41.80, 7304.29.50.15, 7304.29.50.30, 7304.29.50.45, 7304.29.50.60, 7304.29.50.75, 7304.29.61.15, 7304.29.61.30, 7304.29.61.45, 7304.29.61.60, 7304.29.61.75, 7305.20.20.00, 7305.20.40.00, 7305.20.60.00, 7305.20.80.00, 7306.29.10.30, 7306.29.10.90, 7306.29.20.00, 7306.29.31.00, 7306.29.41.00, 7306.29.60.10, 7306.29.60.50, 7306.29.81.10, and 7306.29.81.50.

    The merchandise subject to the investigation may also enter under the following HTSUS item numbers: 7304.39.00.24, 7304.39.00.28, 7304.39.00.32, 7304.39.00.36, 7304.39.00.40, 7304.39.00.44, 7304.39.00.48, 7304.39.00.52, 7304.39.00.56, 7304.39.00.62, 7304.39.00.68, 7304.39.00.72, 7304.39.00.76, 7304.39.00.80, 7304.59.60.00, 7304.59.80.15, 7304.59.80.20, 7304.59.80.25, 7304.59.80.30, 7304.59.80.35, 7304.59.80.40, 7304.59.80.45, 7304.59.80.50, 7304.59.80.55, 7304.59.80.60, 7304.59.80.65, 7304.59.80.70, 7304.59.80.80, 7305.31.40.00, 7305.31.60.90, 7306.30.50.55, 7306.30.50.90, 7306.50.50.50, and 7306.50.50.70.

    The HTSUS subheadings above are provided for convenience and customs purposes only. The written description of the scope of the investigation is dispositive.

    [FR Doc. 2016-16923 Filed 7-15-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration North American Free Trade Agreement (NAFTA), Article 1904; Notice of Completion of Panel Review AGENCY:

    United States Section, NAFTA Secretariat, International Trade Administration, Department of Commerce.

    ACTION:

    Notice of Completion of Panel Review of the United States International Trade Commission's final determination of Polyethylene Terephthalate Resin from Canada, Secretariat File No. USA-CDA-2016-1904-01.

    SUMMARY:

    A Request for Panel Review was filed on behalf of Selenis Canada, Inc. with the United States Section of the NAFTA Secretariat for the International Trade Commission's final determination regarding Polyethylene Terephthalate Resin from Canada on June 6, 2016. Pursuant to Rule 39(1) of the to the Article 1904 Panel Rules, the interested person shall file a Complaint within 30 days after filing a Request for Panel Review. No Complaint was filed on July 6, 2016. Therefore, pursuant to Rule 71(3), the panel review is deemed terminated the day after the expiration of the limitation period established in Rule 39(1), effectively July 7, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Paul E. Morris, United States Secretary, NAFTA Secretariat, Room 2061, 1401 Constitution Avenue NW., Washington, DC 20230, (202) 482-5438.

    Dated: July 12, 2016. Paul E. Morris, United States Secretary, NAFTA Secretariat.
    [FR Doc. 2016-16844 Filed 7-15-16; 8:45 am] BILLING CODE 3510-GT-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-580-810] Welded ASTM A-312 Stainless Steel Pipe From the Republic of Korea: Final Results of Antidumping Duty Administrative Review; 2013-2014 AGENCY:

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

    SUMMARY:

    For the final results of the administrative review of the antidumping duty (AD) order on Welded ASTM A-312 Stainless Steel Pipe from the Republic of Korea (Korea), we find that SeAH Steel Corporation (SeAH) and LS Metal Co., Ltd. (LS Metal) made sales of subject merchandise at less than normal value. The period of review is December 1, 2013, through November 30, 2014.

    DATES:

    Effective July 18, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Lingjun Wang, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-2316.

    SUPPLEMENTARY INFORMATION: Background

    On January 7, 2016, the Department of Commerce (Department) published in the Federal Register the preliminary results.1 For a history of events that have occurred since the Preliminary Results, see the Issues and Decision Memorandum.2 The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov, and is available to all parties in the Central Records Unit, Room B8024 of the main Department of Commerce building. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly on the Internet at http://trade.gov/login.aspx. The signed Issues and Decision Memorandum and the electronic versions of the Issues and Decision Memorandum are identical in content.

    1See Welded ASTM A-312 Stainless Steel Pipe from the Republic of Korea: Preliminary Results of Antidumping Duty Administrative Review; 2013-2014, 81 FR 742 (January 7, 2016) (Preliminary Results).

    2See “Issues and Decision Memorandum for the Final Results of Antidumping Duty Administrative Review: Welded ASTM A-312 Stainless Steel Pipe from the Republic of Korea; 2013-2014” (Issues and Decision Memorandum), dated concurrently with and hereby adopted by this notice.

    We tolled the deadline for issuing final results by four business days to May 13, 2016,3 to which we extended to July 11, 2016. The revised deadline for the final results of this review is now July 11, 2016.4

    3 As explained in the memorandum from the Acting Assistant Secretary for Enforcement & Compliance, the Department has exercised its discretion to toll all administrative deadlines due to the recent closure of the Federal Government. See Memorandum to the Record from Ron Lorentzen, Acting A/S for Enforcement & Compliance, regarding “Tolling of Administrative Deadlines as a Result of the Government Closure During Snowstorm Jonas,” dated January 27, 2016. All deadlines in this segment of the proceeding have been extended by four business days.

    4See the Department's April 27, 2016 and July 1, 2016 memorandums.

    Scope of the Order

    The merchandise subject to the antidumping duty order is welded austenitic stainless steel pipe that meets the standards and specifications set forth by the American Society for Testing and Materials (ASTM) for the welded form of chromium-nickel pipe designated ASTM A-312. The merchandise covered by the scope of the orders also includes austenitic welded stainless steel pipes made according to the standards of other nations which are comparable to ASTM A-312.

    Imports of welded ASTM A-312 stainless steel pipe are currently classifiable under the following Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 7306.40.5005, 7306.40.5015, 7306.40.5040, 7306.40.5062, 7306.40.5064, and 7306.40.5085. Although these subheadings include both pipes and tubes, the scope of the antidumping duty order is limited to welded austenitic stainless steel pipes. The HTSUS subheadings are provided for convenience and customs purposes. However, the written description of the scope of the orders is dispositive.5

    5See Issues and Decision Memorandum for a full description of the scope of order.

    Analysis of Comments Received

    All issues raised in the case and rebuttal briefs are addressed in the Issues and Decision Memorandum. A list of issues raised and to which we responded in the Issues and Decision Memorandum is attached to this notice as an Appendix.

    Changes Since the Preliminary Results

    Based on a review of the record and comments received from interested parties regarding our Preliminary Results, we have made a change to SeAH's margin calculation.6

    6See Issues and Decision Memorandum at Comment 3, and “Calculation for the Final Results of SeAH Steel Corporation in the Antidumping Duty Administrative Review of Welded ASTM A-312 Stainless Steel Pipe from the Republic of Korea” (Final Calculation Memorandum).

    Final Results of Review

    As a result of our review, we determine the following weighted-average dumping margins exist for the period December 1, 2013, through November 30, 2014.

    Producer or exporter Weighted-
  • average
  • dumping
  • margin
  • SeAH Steel Corporation 2.58 LS Metal Co., Ltd 31.70
    Disclosure

    We intend to disclose the calculation performed in connection with these final results within five days of the publication date of this notice pursuant to 19 CFR 351.224(b).

    Assessment Rates

    Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(1), the Department determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise, in accordance with the final results of this review. The Department intends to issue assessment instructions to CBP 15 days after the date of publication of the final results of review. We will instruct CBP to liquidate entries of merchandise produced and/or exported by the aforementioned companies. The Department will calculate importer-specific assessment rates for SeAH. Where the respondent reported the entered value for its sales, the Department calculates importer-specific ad valorem assessment rates based on the ratio of the total amount of dumping calculated for the examined sales to the total entered value of those same sales.7 However, where the respondent did not report the entered value for its sales, the Department calculates importer-specific per-unit duty assessment rates. We will instruct CBP to apply an ad valorem assessment rate as indicated above to all entries of subject merchandise during the POR which were produced and/or exported by LS Metal and the all other companies.

    7See 19 CFR 351.212(b).

    Cash Deposit Requirements

    The following deposit requirements will be effective for all shipments of Welded ASTM A-312 Stainless Steel Pipe from Korea entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review, as provided for by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for the company under review will be equal to the weighted-average dumping margin established in the final results of this review (except, if the rate is de minimis, i.e., less than 0.5 percent, then the cash deposit rate will be zero); (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published in the completed segment for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the less-than-fair-value investigation (LTFV), but the manufacturer is, the cash deposit rate will be the rate established in the completed segment for the most recent period for the manufacturer of the merchandise; and (4) if neither the exporter nor the manufacturer is a firm covered in this or any other completed segment of this proceeding, then the cash deposit rate will continue to be 7.00 pecent, the “all others” rate made effective by the LTFV investigation.8 These deposit requirements, when imposed, shall remain in effect until further notice.

    8See Notice of Amended Final Determination and Antidumping Duty Order: Certain Welded Stainless Steel Pipe From the Republic of Korea, 60 FR 10064 (February 23, 1995).

    Notification to Importers

    This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

    Notifications to Interested Parties

    This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

    The Department is issuing and publishing these final results of administrative review in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(5).

    Dated: July 11, 2016. Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance. Appendix Summary Background Scope of the Order Affiliation Based on Close Supplier Relationship Use of Adverse Facts Available Changes Since the Preliminary Results Discussion of the Issues 1. Alignment of Product Characteristics—End Finish to Those From Recent Investigations 2. Applicability of Cost of Production Methodology From Line Pipe9

    9See Welded Line Pipe from the Republic of Korea: Final Determination of Sales at Less Than Fair Value, 80 FR 61366 (October 13, 2015) (Line Pipe) and accompanying Issues and Decision Memorandum (IDM) at Comment 5.

    3. Applicability U.S. Indirect Selling Expenses Methodology From Line Pipe10

    10Id. at Comment 20.

    4. Differential Pricing Analysis Is Not Consistent With the Requirements of the Statute or With Basic Principles of Statistical Analysis
    [FR Doc. 2016-16945 Filed 7-15-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE740 Western Pacific Fishery Management Council; Public Meetings AGENCY:

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

    ACTION:

    Notice of public meetings.

    SUMMARY:

    The Western Pacific Fishery Management Council (Council) will hold its 167th meeting by teleconference and webinar to discuss and make recommendations on fishery management issues in the Western Pacific Region.

    DATES:

    The Council will meet on August 3, 2016, between 1 p.m. and 3 p.m. (Hawaii Standard Time (HST)); 12 noon and 2 p.m. (American Samoa Standard Time (ASST)); and August 4, 2016, between 9 a.m. and 11 a.m. (Marianas Standard Time (MST)). All times listed are local island times.

    ADDRESSES:

    The meeting will be held by teleconference and webinar. The following venues will also be host sites for the teleconference: Council Conference Room, 1164 Bishop Street, Suite 1400, Honolulu, HI; Land Grant Conference Room, American Samoa Community College, Agriculture, Community and Natural Resources, Mapusaga Road, Malaeimi Village, American Samoa; Guam Hilton Resort and SPA, 202 Hilton Road, Tumon Bay, Guam; Department of Land and Natural Resources Conference Room, Santa Remedio Drive, Lower Base, Saipan, MP. For specific time and agenda, see SUPPLEMENTARY INFORMATION.

    The teleconference will be conducted by telephone and by web. The teleconference numbers are: U.S. toll-free: 1 (888) 482-3560 or International Access: +1 (647) 723-3959, and Access Code: 5228220; The webinar can be accessed at: https://wprfmc.webex.com/join/info.wpcouncilnoaa.gov.

    FOR FURTHER INFORMATION CONTACT:

    Kitty M. Simonds, Executive Director; telephone: (808) 522-8220.

    SUPPLEMENTARY INFORMATION:

    Public comment periods will be provided throughout the agenda. The order in which agenda items are addressed may change. The meetings will run as late as necessary to complete scheduled business. Written comments must be received by July 29, 2016. Oral testimony may be provided during designated periods during the meeting at the host sites or by teleconference. Background documents will be available from, and written comments should be sent to, Kitty M. Simonds, Executive Director; Western Pacific Fishery Management Council, 1164 Bishop Street, Suite 1400, Honolulu, HI 96813, phone: (808) 522-8220 or fax: (808) 522-8226.

    Schedule and Agenda for the 167th Council Meeting

    1 p.m.-3 p.m., Wednesday, August 3, 2016 (HST); 12 noon-2 p.m., Wednesday, August 3, 2016 (ASST); 9 a.m.-11 a.m., Thursday, August 4, 2016 (MST).

    1. Welcome and Introductions 2. Review and Approval of the 167th Agenda 3. Expansion of the Papahanaumokuakea Marine National Monument a. Report on status of the potential President proposal b. Report on Council actions and activities c. Public Comment d. Discussion and recommendations 4. U.S. Territory Bigeye Tuna Limit Options 5. Council Family Changes a. Scientific and Statistical Committee Member Appointments b. Advisory Panel Changes 6. International Union for Conservation of Nature Resolutions 7. Public Comment 8. Other Business 9. Council Discussion and Recommendations

    Non-Emergency issues not contained in this agenda may come before the Council for discussion and formal Council action during its 167th meeting. However, Council action on regulatory issues will be restricted to those issues specifically listed in this document and any regulatory issue arising after publication of this document that requires emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take action to address the emergency.

    Special Accommodations

    The host sites are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: July 13, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries National Marine Fisheries Service.
    [FR Doc. 2016-16914 Filed 7-15-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE738 New England Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice; public meeting.

    SUMMARY:

    The New England Fishery Management Council (Council) is scheduling a public meeting of its Recreational Advisory Panel to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

    DATES:

    This meeting will be held on Tuesday, August 2, 2016 at 10 a.m.

    ADDRESSES:

    The meeting will be held at the DoubleTree by Hilton, 363 Maine Mall Road, South Portland, ME 04106; phone: (207) 775-6161; fax: (207) 756-6622.

    Council address: New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950.

    FOR FURTHER INFORMATION CONTACT:

    Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.

    SUPPLEMENTARY INFORMATION:

    Agenda

    The Advisory Panel will receive an overview of the Council staff white paper on the recreational management measures process. They will also develop recommendations to the Groundfish Committee regarding improving the recreational management measures process. They panel will also receive an overview of the Marine Recreational Information Program (MRIP) by NOAA staff. The panel also plans to discuss recommendations to the Groundfish Committee regarding 2017 Council priorities. Other business will be discussed as necessary.

    Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: July 13, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-16910 Filed 7-15-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: NOAA Teacher At Sea Program.

    OMB Control Number: 0648-0283.

    Form Number(s): None.

    Type of Request: Regular (extension of a currently approved information collection).

    Number of Respondents: 1,125.

    Average Hours per Response: 45 minutes to read and complete application, 15 minutes to complete a Health Services Questionnaire, 15 minutes to deliver and discuss recommendation forms to persons from whom recommendations are being requested, 15 minutes for those persons to complete a recommendation form, and 2 hours for a follow-up report.

    Burden Hours: 758.

    Needs and Uses: This request is for extension of a currently approved collection.

    NOAA provides educators an opportunity to gain first-hand experience with field research activities through the NOAA Teacher at Sea Program. Through this program, educators spend up to 4 weeks at sea on a NOAA research vessel, participating in an on-going research project with NOAA scientists. The application solicits information from interested educators: Basic personal information, teaching experience and ideas for applying program experience in their classrooms, plus two recommendations and a NOAA Health Services Questionnaire required of anyone selected to participate in the program. Once educators are selected and participate on a cruise, they write a report detailing the events of the cruise and ideas for classroom activities based on what they learned while at sea. These materials are then made available to other educators so they may benefit from the experience, without actually going to sea themselves. NOAA does not collect information from this universe of respondents for any other purpose.

    Affected Public: Individuals or households.

    Frequency: One time for applicants and those providing recommendations; for participants, a total of three times in one year.

    Respondent's Obligation: Required to obtain or retain benefits.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: July 13, 2016. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2016-16903 Filed 7-15-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE735 Pacific Fishery Management Council; Webinar AGENCY:

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

    ACTION:

    Notice of webinar.

    SUMMARY:

    The Pacific Fishery Management Council's (Pacific Council's) Scientific and Statistical Committee (SSC) will hold a webinar to approve new overfishing limit (OFL) estimates for Pacific ocean perch and to discuss plans for two upcoming workshops. The webinar is open to the public.

    DATES:

    The SSC webinar will commence at 2 p.m. PST, Tuesday, August 2, 2016 and continue until 4 p.m. or as necessary to complete business for the day.

    ADDRESSES:

    To attend the SSC webinar, please join online at http://www.gotomeeting.com/online/webinar/join-webinar and enter the webinar ID: 120-344-715, as well as your name and email address. After logging in to the webinar, please call the toll number 1 (562) 247-8321 and enter 348-717-205 when prompted for the audio access code. Participants are encouraged to use their telephone, as this is the best practice to avoid technical issues and excessive feedback. (See the PFMC GoToMeeting Audio Diagram for best practices). A public listening station will also be provided at the Council office.

    Council address: Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384; telephone: 503-820-2280.

    FOR FURTHER INFORMATION CONTACT:

    Mr. John DeVore, Pacific Council; telephone: (503) 820-2280.

    SUPPLEMENTARY INFORMATION:

    The specific objectives of the SSC webinar are to approve new OFL estimates for Pacific ocean perch for use in establishing 2017-18 specifications and management measures, and to advance plans for two upcoming workshops (historical catch reconstruction workshop and a stock productivity workshop) sponsored by the Pacific Council and NMFS. Public comments during the webinar will be received from attendees at the discretion of the SSC chair.

    Although non-emergency issues not identified in the webinar agenda may come before the webinar participants for discussion, those issues may not be the subject of formal action during this webinar. Formal action at the webinar will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the webinar participants' intent to take final action to address the emergency.

    Technical Information and System Requirements

    PC-based attendees: Required: Windows® 7, Vista, or XP. Mac®-based attendees: Required: Mac OS® X 10.5 or newer. Mobile attendees: Required: iPhone®, iPad®, AndroidTM phone or Android tablet GoToMeeting Webinar Apps). You may send an email to Mr. Kris Kleinschmidt or contact him at (503) 820-2280, extension 425 for technical assistance.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for auxiliary aids should be directed to Mr. Kris Kleinschmidt at (503) 820-2425 at least 5 days prior to the webinar date.

    Dated: July 13, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-16909 Filed 7-15-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE737 Gulf of Mexico Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The Gulf of Mexico Fishery Management Council will hold a joint meeting of its Shrimp Advisory Panel (AP), Coral Advisory Panel, and Coral Statistical and Scientific Committee (SSC).

    DATES:

    The meeting will convene Wednesday, August 3, 2016, from 8 a.m. to 5 p.m. and Thursday, August 4, 2016, from 8 a.m. to 12 p.m. (EDT)

    ADDRESSES:

    The meeting will take place at the Council's office.

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

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    The items of discussion on the agenda are as follows:

    The Shrimp AP, Coral AP and Coral SSC will meet jointly to review the coral data portal; discuss the proposed Flower Garden Banks National Marine Sanctuary and the Florida Keys National Marine Sanctuary expansions; discuss potential Habitat Areas of Particular Concern (HAPC) in the Gulf of Mexico; and provide recommendations to the Council for the August 2016 Council meeting.

    —Meeting Adjourns—

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

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

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

    Special Accommodations

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

    Dated: July 13, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-16915 Filed 7-15-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE739 New England Fishery Management Council; Public Meeting AGENCY:

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

    ACTION:

    Notice; public meeting.

    SUMMARY:

    The New England Fishery Management Council (Council) is scheduling a public meeting of its Groundfish Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

    DATES:

    This meeting will be held on Wednesday, August 3, 2016 at 9 a.m.

    ADDRESSES:

    Meeting address: The meeting will be held at the DoubleTree by Hilton, 363 Maine Mall Road, South Portland, ME 04106; phone: (207) 775-6161; fax: (207) 756-6622.

    Council address: New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950.

    FOR FURTHER INFORMATION CONTACT:

    Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.

    SUPPLEMENTARY INFORMATION: Agenda

    The committee will receive a summary of the recommendations from the Recreational Advisory Panel meeting on August 2. The panel will discuss specifications and management measures of Framework Adjustment 56 as well as (1) receive an overview of the Council staff white paper on the recreational management measures process, (2) develop recommendations to the Council regarding improving the recreational management measures process, (3) receive a Plan Development Team (PDT) report that summarizes Atlantic halibut management and recent catch and effort for the directed fishery in the State of Maine, and (4) discuss draft alternatives and make recommendations to the Council. They will also receive a progress report from the PDT on the white paper on monitoring strategies, and develop recommendations to the Council. Other business will be discussed as necessary.

    Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

    Special Accommodations

    This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: July 13, 2016. Tracey L. Thompson, Acting Deputy Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-16913 Filed 7-15-16; 8:45 am] BILLING CODE 3510-22-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION Supervisory Highlights: Summer 2016 AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Supervisory Highlights; notice.

    SUMMARY:

    The Bureau of Consumer Financial Protection (CFPB) is issuing its twelfth edition of its Supervisory Highlights. In this issue of Supervisory Highlights, we report examination findings in the areas of auto originations, debt collection, mortgage origination, small-dollar lending, and fair lending. As in past editions, this report includes information about a recent public enforcement action that was a result, at least in part, of our supervisory work. The report also includes information on our coordination with state and federal regulators on supervisory matters, as well as information on recently released guidance.

    DATES:

    The Bureau released this edition of the Supervisory Highlights on its Web site on June 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Adetola Adenuga, Consumer Financial Protection Analyst, Office of Supervision Policy, 1700 G Street NW., 20552, (202) 435-9373.

    SUPPLEMENTARY INFORMATION: 1. Introduction

    As the Consumer Financial Protection Bureau (CFPB or Bureau) enters its fifth year, it continues to examine bank and nonbank providers of consumer financial products and services under the Bureau's jurisdiction.1 In this twelfth edition of Supervisory Highlights, the CFPB shares recent supervisory observations in the areas of auto origination, debt collection, mortgage origination, small-dollar lending and fair lending. The findings reported here reflect information obtained from supervisory activities completed during the period under review. In some instances, not all corrective actions, including through enforcement, have been completed at the time of this report's publication.

    1 The CFPB supervises depository institutions and credit unions with total assets of more than $10 billion, and their affiliates. In addition, the CFPB has authority under the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) to supervise nonbanks, regardless of size, in certain specific markets: Mortgage companies (originators, brokers, servicers, and providers of loan modification or foreclosure relief services); payday lenders; and private education lenders.

    The CFPB may also supervise “larger participants” in other nonbank markets as the CFPB defines by rule. To date, the CFPB has issued five rules defining larger participants in the following markets: Consumer reporting (effective September 2012), consumer debt collection (effective January 2013), student loan servicing (effective March 2014), international money transfers (effective December 2014) and automobile financing (effective August 2015).

    The CFPB's supervisory activities have either led to or supported a recent public enforcement action, requiring nearly $5 million in consumer remediation and an additional $3 million in civil money penalties.2 In addition to these public enforcement actions, Supervision continues to resolve violations using non-public supervisory actions. When Supervision examinations determine that a supervised entity has violated a statute or regulation, Supervision directs the entity to implement appropriate corrective measures, including remediation of consumer harm when appropriate.

    2 The CFPB Office of Enforcement also brought other actions unrelated to supervisory activities.

    Recent supervisory resolutions resulted in restitution 3 of approximately $24.5 million to more than 257,000 consumers. Other corrective actions included, for example, developing improved policies and procedures, building enhanced monitoring systems to ensure compliance, and improving training for employees.

    3 The term “restitution” as used in this report refers specifically to monetary relief (or redress) to consumers, whereas remediation includes both monetary and non-monetary forms of relief.

    This report highlights supervision work generally completed between January 2016 and April 2016 (unless otherwise stated), though some completion dates may vary. Any questions or comments from supervised entities can be directed to [email protected]

    2. Supervisory Observations

    Below are some of Supervision's recent examination observations in automobile origination, debt collection, mortgage origination, small-dollar lending and fair lending.

    2.1 Automobile Origination

    The Dodd-Frank Act 4 gave the CFPB supervisory authority over “larger participants” of certain markets for consumer financial products or services as the Bureau defines by rulemaking. In June 2015, the CFPB finalized its automobile finance market larger participant regulation.5 In this market, automobile loans can be made through direct or indirect lending channels. For direct lending, consumers go directly to a bank, credit union, or other lender and apply for and obtain a loan. Consumers will commonly get an interest rate quote or a conditional commitment letter from the bank or credit union before going to the dealership to buy an automobile. In indirect lending, also called dealer-arranged financing, consumers obtain auto financing from a lender through a dealership.

    4 12 U.S.C. 5514(a)(1)(B).

    5 12 CFR 1090.108.

    The CFPB conducted examinations focused on assessing compliance management systems (CMS) and automobile financing practices to determine whether entities are complying with applicable Federal consumer financial laws.

    2.1.1 Deceptive Practice in Advertising Add-On Gap Coverage Products and Disclosure of Payment Deferral Terms

    Examiners determined that one or more auto lenders deceptively advertised the benefits of their gap coverage products, leaving the impression that these products would fully cover the remaining balance of a consumer's loan in the event of vehicle loss.6 In fact, the product only covered amounts below a certain loan to value ratio. Bureau examiners further found that one or more auto lenders engaged in a deceptive practice by using a telephone script that created the false overall net impression that the only effects of taking advantage of a loan deferral would be to extend the maturity of the loan and to accrue interest during the deferral, but omitted informing consumers that the subsequent payment would be applied to the interest earned on the unpaid amount financed from the date of the last payment received from the consumer. This way of applying the payment could result in the consumer paying more finance charges than originally disclosed. These violations are under review by the Bureau to determine what, if any, remedial and corrective actions should be undertaken by the relevant financial institutions.

    6 An act or practice is deceptive when there is a material representation, omission, act or practice that misleads or is likely to mislead the consumer and the consumer has a reasonable interpretation of the representation, omission, act or practice. 12 U.S.C. 5536(a)(1)(B) prohibits deceptive acts or practices.

    2.1.2 CMS Deficiencies

    At one or more institutions, examiners determined that an overall weak CMS allowed violations of Federal consumer financial law during the review period. Weaknesses included the failure to raise compliance-related issues to the institution's board of directors or other principal (Board); failure to follow institution's policies and procedures in daily practices; failure to properly monitor and correct business line practices to align with Federal consumer financial law; failure to adequately track training completed by employees and the Board; and failure to adequately follow up on consumer complaints with a corresponding failure of compliance audit to highlight deficiencies in the consumer complaint response process. The relevant financial institutions have undertaken remedial and corrective actions regarding these violations, which are under review by the Bureau.

    2.2 Debt Collection

    The Supervision program covers certain bank and nonbank creditors who originate and collect their own debt, as well as the larger nonbank third-party debt collectors. During recent examinations, examiners identified an unfair practice and violations of the Fair Debt Collection Practices Act (FDCPA).7

    7 15 U.S.C. 1692-1692p.

    2.2.1 Miscoding of Accounts Unsuitable for Sale by Debt Sellers

    During one or more examinations, examiners determined that debt sellers, as a result of widespread coding errors, sold thousands of debts that did not properly reflect that: (1) The accounts were in bankruptcy, (2) the debt sellers had concluded the debts were products of fraud, or (3) the accounts had been settled in full. The relevant accounts sold were in, or likely to be subject to, collections. Supervision concluded that this practice was unfair.8

    8 12 U.S.C. 5531(c); 5536(a)(1)(B).

    In some cases, coding failed to reflect a pending bankruptcy proceeding when the debt seller had received notice that the consumer had filed for bankruptcy. In other instances, one or more debt sellers either failed to code accounts to indicate that a fraud claim was pending or failed to code accounts to indicate that fraud had occurred. In other cases, one or more debt sellers failed to include codes indicating that the debt seller(s) had settled the relevant accounts in full. These errors caused or were likely to cause substantial injury in the form of subjecting consumers to debt collection efforts either: (1) Prohibited by the automatic stay provisions of the Bankruptcy Code,9 or (2) on debts for which the consumer was not responsible because the relevant accounts were impacted by fraud or were settled in full. Supervision directed one or more debt sellers to redress consumers impacted by each category of the three coding errors and to enhance service provider oversight to include critical vendors performing collections and processes relating to debt sale arrangements, such as suppliers providing coding services.

    9 11 U.S.C. 362.

    2.2.2 Use of Misleading Statements Regarding Repayment Options

    Section 807(10) of the FDCPA prohibits a debt collector from using any false representation or deceptive means to collect any debt.10 Examiners determined that one or more collectors falsely represented to consumers that a down payment was necessary in order to establish a repayment arrangement, when the collectors' policies and procedures included no such requirement. In other cases, one or more collectors falsely represented that the only option for repayment was using a checking account, when the debt collectors' policies and procedures did not limit repayment to checking accounts. Supervision directed one or more debt collectors to analyze their process to determine why the collectors made false representations to consumers regarding payment options and based on such analysis, to determine the appropriate corrective action to ensure future compliance.

    10 15 U.S.C. 1692e(10).

    2.3 Mortgage Origination

    During the review period covered by this report, several mortgage origination examinations focused upon reviewing compliance with provisions of CFPB's Title XIV rules,11 existing Truth in Lending Act (TILA) and Real Estate Settlement Procedures Act (RESPA) 12 disclosure provisions,13 and other applicable Federal consumer financial laws. Examiners also evaluated entities' CMS. Examiners found general compliance with the reviewed Federal consumer financial laws, though many entities continue to have CMS deficiencies.

    11 These Title XIV rules include the Loan Originator Rule (12 CFR 1026.36), the Ability to Repay Rule (12 CFR 1026.43), and rules reflecting amendments to the Equal Credit Opportunity Act and Truth in Lending Act regarding appraisals and valuations (12 CFR 1002.14 and 12 CFR 1026.35).

    12 TILA is implemented by Regulation Z and RESPA by Regulation X.

    13 These mortgage origination examination findings cover a period preceding the effective date of the Know Before You Owe Integrated Disclosure Rule. The disclosures reviewed in these exams are the Good Faith Estimate (GFE), the Truth in Lending disclosure, and the HUD-1 form.

    2.3.1 Incorrect Calculation of the Amount Financed on Loans With Discount Credits

    Regulation Z requires the amount financed to be calculated by determining the principal loan amount or the cash price (minus any down payment), adding any other amounts that are financed by the creditor and that are not part of the finance charge, and subtracting any prepaid finance charge.14 Regulation Z also provides that finance charges disclosed are treated as accurate if they are understated by no more than $100 or are greater than the amount required to be disclosed.15 One or more institutions incorrectly calculated the amount financed on loans with discount credits, and subsequently incorrectly calculated the finance charge on the same loans. The calculation method used to determine the amount financed for these loans resulted in a negative finance charge and an amount financed that exceeded the stated loan amount, resulting in a violation of Regulation Z. Supervision directed that the practice cease and that training and revised policies and procedures be provided to ensure that disclosures were calculated accurately.

    14 12 CFR 1026.18(b).

    15 12 CFR 1026.18(d)(1).

    2.3.2 Failure To Comply With RESPA Section 8

    RESPA Section 8 and its implementing Regulation X generally prohibit the acceptance of any fee, kickback or other thing of value in exchange for a referral.16 An affiliated business arrangement (ABA) is permitted so long as it meets the requirements of RESPA by not offering anything of value in exchange for a referral.17 Bureau examiners found that one or more institutions had ABAs that did not fully meet the requirements of a compliant ABA under RESPA. One or more institutions provided a referral and required the use of an affiliated provider of flood determination and tax services, a settlement service that is not among the prescribed settlement services (attorney, credit reporting agency or real estate appraiser chosen by the lender) that may be required by a lender who makes a referral and has a compliant ABA.18 The majority of consumers who received the incorrect ABA disclosure did not pay the fees charged by the affiliated service provider as these fees were lender paid. Supervision directed the institutions to revise the affiliated business disclosures to avoid improper referrals.

    16 12 U.S.C. 2607(a); 12 CFR 1024.14(b).

    17 12 U.S.C. 2607(c)(4); 12 CFR 1024.15.

    18 12 CFR 1024.15(b)(2).

    2.3.3 Failure To Provide Fair Credit Reporting Act Adverse Action Notices

    Section 615(a) of the Fair Credit Reporting Act (FCRA) 19 requires that if any person takes any adverse action with respect to any consumer that is based on information contained in a consumer report, the person must provide the consumer with notice of the adverse action (e.g., a denial of credit) including: (1) The name, address, and telephone number of the consumer reporting agency that furnished the report to the person; (2) a statement that the consumer reporting agency did not make the decision to take the adverse action; (3) the consumer's right to obtain a free copy of a consumer report from that consumer reporting agency; and (4) the consumer's right to dispute with the furnishing consumer reporting agency the accuracy or completeness of information contained the consumer report.20 One or more institutions took adverse action based on information in consumer reports 21 but failed to make the required disclosures. Examiners found these actions to be violations caused by a lack of both appropriate training and adequate policies and procedures. Supervision directed the institutions to revise their training and policies and procedures mechanisms to ensure that employees provide FCRA-required information on adverse action notices.

    19 15 U.S.C. 1681m(a).

    20 15 U.S.C. 1681m(a)(3)-(4). If a numerical credit score is used in taking the adverse action, the credit score and other score-related information is also required. See 15 U.S.C. 1681m(a)(2).

    21 The credit score was not a factor in these decisions.

    2.3.4 Failure To Properly Disclose Interest on Interest-Only Loans

    Regulation Z requires that creditors disclose interest-only loan payment amounts that will be applied to interest and principal. These amounts must be itemized and labeled as “interest payment” and “principal payment.” 22 One or more institutions offering interest-only bridge loans 23 failed to accurately disclose the interest payment because it erroneously included a portion of the monthly payment amount that was to be applied to fees financed into the principal balance. This failure, due to a software error to separately itemize and properly disclose the correct interest and principal payment, violated Regulation Z. Supervision directed the institutions to examine and assess whether the monthly payment amounts of the affected loans were correctly applied to accrued interest and the principal amount. Institutions were also directed to ensure that the final balloon payment was assessed in accordance with the mortgage note.

    22 12 CFR 1026.18(s)(3)(ii)(B).

    23 A bridge loan is a short term loan with a term of 12 months or less, such as a loan to finance the purchase of a new dwelling, or connected with the acquisition or construction of a dwelling intended to become the consumer's principal dwelling. See 12 CFR 1026.32(d)(1)(ii)(B), 1026.35(b)(2)(i)(C) and 1026.43(a)(3)(ii).

    2.3.5 CMS Deficiencies

    At one or more institutions, examiners concluded that a weak CMS allowed violations of Regulations V, X, and Z to occur. For example, one or more supervised institutions had weak oversight of automated systems, including inadequate testing of codes that calculate the finance charge and the amount financed when originating residential loans to consumers. In addition, one or more supervised entities failed to monitor for changes that would require updated disclosures to comply with applicable Federal consumer financial laws.

    To address the above findings, Supervision directed entities to enhance their monitoring and corrective action and compliance audit practices prior to using revised disclosures, and to revise training, policies and procedures, monitoring and corrective action, and compliance audit practices to ensure that adverse action notices were properly completed. After Supervision notified the entities' management of these findings, the entities took corrective action to improve their CMS.

    2.4 Small-Dollar Lending

    The Dodd-Frank Act gave the CFPB supervisory and enforcement authority over payday lenders, who generally provide small-dollar loans directly to consumers. Since launching its payday lending supervisory program in January 2012, the Bureau has conducted multiple examinations for compliance with Federal consumer laws. During the review period, examiners evaluated lenders' compliance with Regulation E,24 which implements the Electronic Fund Transfer Act.25 Among other things, these reviews assessed compliance with requirements related to preauthorized electronic fund transfers (EFTs).

    24 12 CFR part 1005.

    25 15 U.S.C. 1693 et seq.

    Regulation E provides that when the amount of a preauthorized EFT differs from the preceding EFT, the designated payee must provide notice in advance of the transfer. It also provides an optional, alternative approach whereby the payee may give the consumer the option of receiving notice only when the amount of a payment either falls outside a specified range, or only when the transfer differs from the most recent transfer by more than the agreed upon amount. The Rule commentary provides that the specified range must be one that could be anticipated by the consumer.

    Examiners found that the installment loan agreements of one or more entities failed to set out an acceptable range of amounts to be debited, in lieu of providing individual notice of transfers of varying amounts. These ranges could not be anticipated by the consumer because they contained ambiguous or undefined terms in their descriptions of the upper and lower limits of the range. When examiners found such violations, Supervision directed that entities take the following steps:

    For new loans, revise loan agreements to specify a range of amounts that consumers can reasonably anticipate if the firms elect to continue to give the consumer the option of receiving notice of a range of transfers instead of providing advance notice of each preauthorized EFT that varies in amount.

    For existing loans not governed by a revised agreement, notify borrowers of the amount of any new transfer that will vary from the amount of the previous transfer or from the preauthorized amount before initiating the new transfer.

    2.5 Fair Lending 2.5.1 Reporting Actions Taken for Conditionally-Approved Applications With Unmet Underwriting Conditions

    Compliance with the Home Mortgage Disclosure Act (HMDA) and Regulation C remains a top priority in the Bureau's fair lending examinations.26 Among other things, Regulation C requires covered depository and non-depository institutions to submit to the appropriate Federal agency data they collect and record pursuant to Regulation C, including the type of action taken on reportable transactions.27 Financial institutions use the codes listed in Appendix A of Regulation C when reporting the type of action taken on an application or loan.28 Under Regulation C, when an institution issues a loan approval subject to the applicant's meeting underwriting conditions and the application does not result in an origination, the reported “action taken” code varies according to the following circumstances: 29

    26See CFPB Bulletin 2013-11, Home Mortgage Disclosure Act (HMDA) and Regulation C—Compliance Management; CFPB HMDA Resubmission Schedule and Guidelines; and HMDA Enforcement, available at http://files.consumerfinance.gov/f/201310_cfpb_hmda_compliance-bulletin_fair-lending.pdf.

    27 12 CFR 1003.4(a), (a)(8); 12 CFR 1003.5(a)(1).

    28See 12 CFR 1003, app. A, I.B.

    29 Underwriting conditions here do not include “customary loan commitment or loan-closing conditions, such as a clear-title requirement or an acceptable property survey.” 12 CFR part 1003, Supp. I, 1003.4, comment 4(a)(8)-4.

    If the institution sent the applicant a written notice of incompleteness pursuant to Regulation B,30 and the applicant responded to the request for additional information within the period of time specified in the notice but the applicant did not meet the underwriting conditions, then the action taken is reported as “Application denied” (Code 3).31

    30See 12 CFR 1002.9(c)(2).

    31See 12 CFR part 1003, Supp. I, 1003.4, comment 4(a)(8)-4 (financial institutions report Code 3, “Application denied,” “[i]f an institution issues a loan approval subject to the applicant's meeting underwriting conditions (other than customary loan commitment or loan-closing conditions, such as a clear-title requirement or an acceptable property survey) and the applicant does not meet them”).

    If the institution sent the applicant a written notice of incompleteness pursuant to Regulation B, and the applicant did not respond to the request for additional information within the period of time specified in the notice, then the action taken is reported as “File closed for incompleteness” (Code 5).32

    32 12 CFR 1003 app. A, I.B.1.e (“Use Code 5 if you sent a written notice of incompleteness under 1002.9(c)(2) of Regulation B (Equal Credit Opportunity) and the applicant did not respond to your request for additional information within the period of time specified in your notice.”).

    If the institution did not send the applicant a written notice of incompleteness pursuant to Regulation B, and the applicant did not meet the underwriting conditions, then the action taken is reported as “Application denied” (Code 3).33

    33See 12 CFR part 1003, Supp. I, 1003.4, comment 4(a)(8)-4.

    If the applicant expressly withdrew the application before a credit decision was made, then the action taken is reported as “Application withdrawn” (Code 4).34

    34 12 CFR 1003, app. A, I.B.1.d (“Use Code 4 only when the application is expressly withdrawn by the applicant before a credit decision is made.”).

    During one or more HMDA data integrity reviews conducted substantially within the last year, examiners found that after issuing a conditional approval subject to underwriting conditions, the institutions did not accurately report the action taken on the loans or applications. For example, examiners found where one or more institutions issued a conditional approval subject to the applicants meeting underwriting conditions, and then the applicants withdrew their applications before the institutions made a credit decision, the institutions incorrectly coded the action taken as “Application denied” (Code 3) or “File closed for incompleteness” (Code 5) instead of “Application withdrawn” (Code 4). In other instances, examiners found that one or more institutions incorrectly coded the action taken as “Application approved but not accepted” (Code 2) instead of “Application denied” (Code 3) after the applicants failed to respond to a conditional approval subject to the applicants meeting underwriting conditions, and did not send the applicants either a written notice of incompleteness or an adverse action notice as required by Regulation B.35

    35 12 CFR 1002.9(a)(1)(ii).

    Supervision directed one or more institutions to enhance their policies and procedures regarding their HMDA reporting of the actions taken on loans and applications and, where necessary, provide adverse action notices. Supervision also required one or more institutions to resubmit their HMDA Loan Application Register (LAR) where the number of errors exceeded the CFPB's HMDA resubmission thresholds.

    2.5.2 Equal Credit Opportunity Act Special Purpose Credit Programs

    The Equal Credit Opportunity Act (ECOA) 36 and Regulation B 37 permit a creditor to extend special purpose credit to applicants who meet eligibility requirements for certain types of credit programs.38 Regulation B specifically confers special purpose credit program status upon:

    36 15 U.S.C. 1601 et seq.

    37 12 CFR part 1002.

    38 15 U.S.C. 1691(c)(3) (providing that ECOA's prohibitions against discrimination are not violated when a creditor refuses to extend credit offered pursuant to certain special purpose credit programs satisfying Regulation B-prescribed standards); 12 CFR 1002.8 (special purpose credit program standards).

    Any special purpose credit program offered by a for-profit organization, or in which such an organization participates to meet special social needs, if:

    (i) The program is established and administered pursuant to a written plan that identifies the class of persons that the program is designed to benefit and sets forth the procedures and standards for extending credit pursuant to the program; and

    (ii) The program is established and administered to extend credit to a class of persons who, under the organization's customary standards of creditworthiness, probably would not receive such credit or would receive it on less favorable terms than are ordinarily available to other applicants applying to the organization for a similar type and amount of credit.39

    39 12 CFR 1002.8(a)(3).

    The commentary to Regulation B clarifies that, in order to satisfy these requirements, “a for-profit organization must determine that the program will benefit a class of people who would otherwise be denied credit or would receive it on less favorable terms. This determination can be based on a broad analysis using the organization's own research or data from outside sources, including governmental reports and studies.” 40

    40 12 CFR part 1002, Supp. I, 1002.8, comment 8(a)-5.

    During the course of the Bureau's supervisory activity, examination teams have observed credit decisions made pursuant to the terms of programs that for-profit institutions have described as special purpose credit programs. Examination teams have reviewed the terms of the programs, including the written plan required by Regulation B, and the institution's determination that the program would benefit a class of people who would otherwise be denied credit or would receive it on less favorable terms.

    In one or more reviews, examiners observed programs that were established pursuant to these provisions of ECOA and Regulation B. For example, in one or more reviews, examiners observed a small business lending program providing credit to minority-owned businesses. The program was established and administered pursuant to a written plan and was based on a determination that minority-owned firms were otherwise more likely to be denied credit than non-minority owned firms.

    In addition, in one or more reviews, examiners observed a mortgage lending program with special rates and terms for individuals with income below certain thresholds or buying property in areas where the median income was below certain thresholds. The program was established and administered pursuant to a written plan and was based on a determination that applicants meeting one or both of the aforementioned criteria had credit characteristics that otherwise would result either in denial of mortgage credit or in higher-priced mortgage credit.

    In every case, special purpose credit program status depends upon adherence to the ECOA and Regulation B requirements for special purpose credit programs. A program, for example, offering more favorable pricing or products exclusively to a particular class of persons without evidence that such individuals would otherwise be denied credit or would receive it on less favorable terms would not satisfy the ECOA and Regulation B requirements for a special purpose credit program. With that in mind, however, the Bureau generally takes a favorable view of conscientious efforts that institutions may undertake to develop special purpose credit programs to promote extensions of credit to any class of persons who would otherwise be denied credit or would receive it on less favorable terms.

    2.6 Remedial Actions

    The public enforcement actions listed below resulted, at least in part, from recent supervisory work. As described above, Supervision also continues to resolve matters using non-public supervisory tools, where appropriate.

    2.6.1 Public Enforcement Actions

    The Bureau's supervisory activities resulted in or supported the following public enforcement action.

    Citibank, N.A.

    On February 23, 2016, the CFPB took action 41 against Citibank, N.A. (Citibank) for illegal debt sales practices. Citibank, from February 2010 until June 2013, provided inaccurate and inflated annual percentage rate (APR) information for almost 130,000 credit card accounts it sold to debt buyers. These buyers then used the exaggerated APR in debt collection attempts. Citibank also failed to promptly forward to debt buyers approximately 14,000 customer payments totaling almost $1 million. This delayed the updating of account balances and subjected consumers to collection efforts from debt buyers after they had already, in reality, paid off their account. The CFPB ordered Citibank to provide nearly $5 million in consumer relief and pay a $3 million penalty for selling credit card debt with inflated interest rates and for failing to forward consumer payments promptly to debt buyers.

    41See Press Release at http://www.consumerfinance.gov/about-us/newsroom/cfpb-orders-citibank-to-provide-relief-to-consumers-for-illegal-debt-sales-and-collection-practices/.

    2.6.2 Non-Public Supervisory Actions

    In addition to the public enforcement actions above, recent supervisory activities have resulted in approximately $24.5 million in restitution to more than 257,000 consumers. These non-public supervisory actions generally have been the product of CFPB ongoing supervision and/or targeted examinations, involving either examiner findings or self-reported violations of Federal consumer financial law. Recent non-public resolutions were reached in the areas of automobile finance and remittances.

    3. Examination Procedures 3.1 Coordination With State and Federal Regulators on Supervisory Matters

    The CFPB coordinates certain supervisory activities with appropriate Federal and State bank and nonbank regulators.

    At the State level, coordinated supervision helps maximize the agencies' collective effectiveness at protecting consumers, increasing efficiency, avoiding supervisory duplication, and minimizing burden on supervised entities. The CFPB, the Conference of State Bank Supervisors (CSBS), other State agency associations, and 62 agencies in all fifty states, the District of Columbia, Puerto Rico, and Guam have joined a cooperative Memorandum of Understanding (MOU) to facilitate coordinated activities.

    In addition, the Bureau and State regulatory agencies (through CSBS) have established a Framework 42 for cooperation and coordination on State bank and nonbank examinations. The Bureau works with State regulators and other State regulatory associations on nonbank supervisory matters through the State Coordinating Committee (SCC) referenced under the Framework to facilitate scheduling of and participation in coordinated examinations. The Bureau and the SCC have conducted multiple coordinated examinations during the review period and are currently preparing the 2017 nonbank coordinated examination schedule. The Bureau has also implemented processes to share its examination schedules, examination reports, and supervisory letters with its State counterparts.

    42 For more on the framework, see http://files.consumerfinance.gov/f/201305_cfpb_state-supervisory-coordination-framework.pdf.

    At the Federal level, the Bureau coordinates with the prudential regulators, including the Office of the Comptroller of the Currency (OCC), the Federal Reserve Banks and the Board of Governors of the Federal Reserve System (Federal Reserve), the National Credit Union Administration (NCUA), and the Federal Deposit Insurance Corporation (FDIC), regarding various supervisory matters. In connection with very large State-chartered banks and credit unions and certain nonbanks under the CFPB's supervisory authority, the CFPB may coordinate with both the appropriate State and Federal agencies. Representatives of the Bureau and the Federal prudential regulators meet regularly to coordinate supervisory and other activities, and supervisory staff at the Bureau and the Federal prudential regulators confer on a routine basis to discuss examinations and other supervisory matters regarding particular institutions.

    3.2 Recent CFPB Guidance

    The CFPB is committed to providing guidance on its supervisory priorities to industry and members of the public.

    3.2.1 Expiration of the Suspension of Credit Card Agreement Submission Under TILA (Regulation Z)

    Regulation Z requires credit card issuers to submit their currently-offered credit card agreements to the Bureau, to be posted on the Bureau's Web site. In April 2015, the Bureau suspended that submission obligation for a period of one year. That suspension has expired, and a submission was due on the first business day on or after April 30, 2016 (i.e., May 2, 2016).43

    43 Submission instructions can be found on the Bureau's Web site at http://www.consumerfinance.gov/credit-cards/agreements/.

    3.2.2 Interagency Guidance Regarding Deposit Reconciliation Practices

    On May 18, 2016, the CFPB jointly released guidance with the Federal Reserve, the FDIC, the NCUA, and the OCC regarding deposit account reconciliation practices. This guidance informs financial institutions about supervisory expectations regarding customer account deposit reconciliation practices.

    The guidance establishes the supervisory expectation that financial institutions will adopt deposit reconciliation policies and practices that are designed to avoid or reconcile discrepancies, or designed to resolve discrepancies so that customers are not disadvantaged. In addition, the guidance affirms the expectation that financial institutions will effectively manage their deposit reconciliation practices to comply with applicable laws and regulations and to prevent potential harm to customers. The guidance also notes that financial institutions should implement effective CMS to ensure compliance with applicable laws and regulations, and fair treatment of customers. The guidance notes that a financial institution's deposit reconciliation practices may, depending on the facts and circumstances, violate the prohibition against unfair, deceptive, and abusive acts or practices found in Section 5 of the Federal Trade Commission Act and sections 1031 and 1036 of the Dodd-Frank Act.44

    44See, for example, the CFPB's action against Citizens Bank, summarized in the Fall 2015 edition of Supervisory Highlights, available at http://files.consumerfinance.gov/f/201510_cfpb_supervisory-highlights.pdf and the Order issued on August 12, 2015, available at http://files.consumerfinance.gov/f/201408_cfpb_consent-order-rbs-citizens.pdf.

    The Bureau expects to continue coordinating with other agencies on these issues, and will consider appropriate action if law violations are identified at institutions or their service providers, consistent with the Bureau's authority.

    4. Conclusion

    One of the Bureau's goals is to provide information that enables industry participants to ensure their operations remain in compliance with Federal consumer financial law. The CFPB recognizes the value of communicating program findings to CFPB-supervised entities to aid their efforts to comply with Federal consumer financial law, and to other stakeholders to foster better understanding of the CFPB's work.

    To this end, the Bureau remains committed to publishing its Supervisory Highlights report periodically in order to share information regarding general supervisory and examination findings (without identifying specific institutions, except in the case of public enforcement actions), to communicate operational changes to the program, and to provide a convenient and easily accessible resource for information on the CFPB's guidance documents.

    Dated: June 29, 2016. Richard Cordray, Director, Bureau of Consumer Financial Protection.
    [FR Doc. 2016-16787 Filed 7-15-16; 8:45 am] BILLING CODE 4810-AM-P
    DEPARTMENT OF DEFENSE Office of the Secretary Government-Industry Advisory Panel; Notice of Federal Advisory Committee Meeting AGENCY:

    Office of the Under Secretary of Defense (Acquisition, Technology, and Logistics), Department of Defense (DoD).

    ACTION:

    Federal advisory committee meeting notice.

    SUMMARY:

    The Department of Defense is publishing this notice to announce the following Federal advisory committee meeting of the Government-Industry Advisory Panel. This meeting is open to the public.

    DATES:

    The meeting will be held from 1:00 p.m. to 5:00 p.m. on Tuesday, August 2, 2016. Public registration will begin at 12:45 p.m. For entrance into the meeting, you must meet the necessary requirements for entrance into the Pentagon. For more detailed information, please see the following link: http://www.pfpa.mil/access.html.

    ADDRESSES:

    Pentagon Library, Washington Headquarters Services, 1155 Defense Pentagon, Washington, DC 20301-1155. The meeting will be held in Room M2. The Pentagon Library is located in the Pentagon Library and Conference Center (PLC2) across the Corridor 8 bridge.

    FOR FURTHER INFORMATION CONTACT:

    LTC Andrew Lunoff, Office of the Assistant Secretary of Defense (Acquisition), 3090 Defense Pentagon, Washington, DC 20301-3090, email: [email protected], phone: 571-256-9004.

    SUPPLEMENTARY INFORMATION:

    Purpose of the Meeting: This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (FACA) (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150. The Government-Industry Advisory Panel will review sections 2320 and 2321 of title 10, United States Code (U.S.C.), regarding rights in technical data and the validation of proprietary data restrictions and the regulations implementing such sections, for the purpose of ensuring that such statutory and regulatory requirements are best structured to serve the interest of the taxpayers and the national defense. The scope of the panel is as follows: (1) Ensuring that the Department of Defense (DoD) does not pay more than once for the same work, (2) Ensuring that the DoD contractors are appropriately rewarded for their innovation and invention, (3) Providing for cost-effective reprocurement, sustainment, modification, and upgrades to the DoD systems, (4) Encouraging the private sector to invest in new products, technologies, and processes relevant to the missions of the DoD, and (5) Ensuring that the DoD has appropriate access to innovative products, technologies, and processes developed by the private sector for commercial use.

    Agenda: This will be the fourth meeting of the Government-Industry Advisory Panel with a series of meetings planned through October 1, 2016. The panel will cover details of 10 U.S.C. 2320 and 2321, begin understanding the implementing regulations and detail the necessary groups within the private sector and government to provide supporting documentation for their review of these codes and regulations during follow-on meetings. Agenda items for this meeting will include the following: (1) Briefing from Office of the Secretary of Defense Research & Engineering on current Modular Open Systems Approach (MOSA); (2) Briefing from Joint PEO on current challenges with Intellectual Property regulations, strategies and guidance; (3) Briefing from industry program managers on experiences in development of new products, selling commercial products to government and challenges associated to intellectual property regulations strategies used by the government; (4) Public Comments; (5) Comment Adjudication & Planning for follow-on meeting.

    Availability of Materials for the Meeting: A copy of the agenda or any updates to the agenda for the August 2, 2016 meeting will be available as requested or at the following site: http://www.facadatabase.gov/committee/meetings.aspx?cid=2561.

    Minor changes to the agenda will be announced at the meeting. All materials will be posted to the FACA database after the meeting.

    Public Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b, as amended, and 41 CFR 102-3.140 through 102-3.165, and subject to the availability of space, this meeting is open to the public. Registration of members of the public who wish to attend the meeting will begin upon publication of this meeting notice and end three business days (July 28) prior to the start of the meeting. All members of the public must contact LTC Lunoff at the phone number or email listed in the FOR FURTHER INFORMATION CONTACT section to make arrangements for Pentagon escort, if necessary. Public attendees should arrive at the Pentagon's Visitor's Center, located near the Pentagon Metro Station's south exit and adjacent to the Pentagon Transit Center bus terminal with sufficient time to complete security screening no later than 12:30 p.m. on August 2. To complete security screening, please come prepared to present two forms of identification of which one must be a pictured identification card. Government and military DoD CAC holders are not required to have an escort, but are still required to pass through the Visitor's Center to gain access to the Building. Seating is limited and is on a first-to-arrive basis. Attendees will be asked to provide their name, title, affiliation, and contact information to include email address and daytime telephone number to the Designated Federal Officer (DFO) listed in the FOR FURTHER INFORMATION CONTACT section. Any interested person may attend the meeting, file written comments or statements with the committee, or make verbal comments from the floor during the public meeting, at the times, and in the manner, permitted by the committee.

    Special Accommodations: The meeting venue is fully handicap accessible, with wheelchair access.

    Individuals requiring special accommodations to access the public meeting or seeking additional information about public access procedures, should contact LTC Lunoff, the committee DFO, at the email address or telephone number listed in the FOR FURTHER INFORMATION CONTACT section, at least five (5) business days prior to the meeting so that appropriate arrangements can be made.

    Written Comments or Statements: Pursuant to 41 CFR 102-3.105(j) and 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act, the public or interested organizations may submit written comments or statements to the Government-Industry Advisory Panel about its mission and/or the topics to be addressed in this public meeting. Written comments or statements should be submitted to LTC Lunoff, the committee DFO, via electronic mail, the preferred mode of submission, at the email address listed in the FOR FURTHER INFORMATION CONTACT section in the following formats: Adobe Acrobat or Microsoft Word. The comment or statement must include the author's name, title, affiliation, address, and daytime telephone number. Written comments or statements being submitted in response to the agenda set forth in this notice must be received by the committee DFO at least five (5) business days prior to the meeting so that they may be made available to the Government-Industry Advisory Panel for its consideration prior to the meeting. Written comments or statements received after this date may not be provided to the panel until its next meeting. Please note that because the panel operates under the provisions of the Federal Advisory Committee Act, as amended, all written comments will be treated as public documents and will be made available for public inspection.

    Verbal Comments: Members of the public will be permitted to make verbal comments during the meeting only at the time and in the manner allowed herein. If a member of the public is interested in making a verbal comment at the open meeting, that individual must submit a request, with a brief statement of the subject matter to be addressed by the comment, at least three (3) business days in advance to the committee DFO, via electronic mail, the preferred mode of submission, at the email address listed in the FOR FURTHER INFORMATION CONTACT section. The committee DFO will log each request to make a comment, in the order received, and determine whether the subject matter of each comment is relevant to the panel's mission and/or the topics to be addressed in this public meeting. A 15-minute period near the end of the meeting will be available for verbal public comments. Members of the public who have requested to make a verbal comment and whose comments have been deemed relevant under the process described in this paragraph, will be allotted no more than three (3) minutes during this period, and will be invited to speak in the order in which their requests were received by the DFO.

    Dated: July 13, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-16931 Filed 7-15-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Army, Corps of Engineers Intent To Prepare an Environmental Impact Statement for the Lake Okeechobee Watershed Project, Okeechobee, Highlands, Charlotte, Glades, Martin and St. Lucie Counties, Florida AGENCY:

    Department of the Army, U.S. Army Corps of Engineers, DOD.

    ACTION:

    Notice of intent.

    SUMMARY:

    The Jacksonville District, U.S. Army Corps of Engineers (Corps) is beginning preparation of a National Environmental Policy Act assessment for the Lake Okeechobee Watershed Project (LOWP). The Everglades ecosystem, including Lake Okeechobee, encompasses a system of diverse wetland landscapes that are hydrologically and ecologically connected across more than 200 miles from north to south and across 18,000 square miles of southern Florida. In 2000, the U.S. Congress authorized the Federal government, in partnership with the State of Florida, to embark upon a multi-decade, multi-billion dollar Comprehensive Everglades Restoration Plan (CERP) to further protect and restore the remaining Everglades ecosystem while providing for other water-related needs of the region. CERP involves modification of the existing network of drainage canals and levees that make up the Central and Southern Florida Flood Control Project. One of the next steps for implementation of CERP is to identify opportunities to restore the quantity, quality, timing and distribution of flows into Lake Okeechobee. The LOW Project preliminary project area, where placement of features will be considered, covers a large portion of the Lake Okeechobee Watershed north of the lake. Water inflows into Lake Okeechobee greatly exceed outflow capacity, thus many times there is too much water within Lake Okeechobee that needs to be released in order to ensure integrity of the Herbert Hoover Dike. At other times, there may be too little water within Lake Okeechobee. Lake levels that are too high or too low, and inappropriate recession and ascension rates, can adversely affect native vegetation, and fish and wildlife species that depend upon the lake for foraging and reproduction. The volume and frequency of undesirable freshwater releases to the east and west lowers salinity in the estuaries, severely impacting oysters, sea grasses, and fish. Additionally, high nutrient levels adversely affect in-lake water quality, estuary habitat, and habitat throughout the Greater Everglades. The objectives of the LOW Project are to improve the quality, quantity, timing and distribution of water entering Lake Okeechobee, provide for better management of lake water levels, reduce damaging releases to the Caloosahatchee and St. Lucie estuaries downstream of the lake and improve system-wide operational flexibility.

    ADDRESSES:

    U.S. Army Corps of Engineers, Planning and Policy Division, Environmental Branch, P.O. Box 4970, Jacksonville, FL 32232-0019.

    FOR FURTHER INFORMATION CONTACT:

    Gretchen Ehlinger at 904-232-1682 or email at [email protected] Additional information is also available at http://bit.ly/LakeOWatershed.

    SUPPLEMENTARY INFORMATION:

    a. Since 2000, much progress has been made on CERP projects. Construction has begun on the first generation of CERP project modifications already authorized by Congress. These include the Picayune Strand Restoration, the Indian River Lagoon South and Site 1 Impoundment Projects. Congressional authorization has been received for the second generation of CERP projects, including Biscayne Bay Coastal Wetlands-Phase 1, the Broward County Water Preserve Areas, the Caloosahatchee River (C-43) West Basin Storage Reservoir, and the C-111 Spreader Canal Western Project which are already under construction or are operational, and the Broward County Water Preserve Areas which is currently being designed. The Central Everglades Planning Project is currently awaiting congressional authorization. All of these CERP projects contribute significant ecological benefits to the system and the specific regional habitats in which they are located.

    b. The objectives of the LOWP are to improve the quality, quantity, timing and distribution of water entering Lake Okeechobee, provide for better management of lake water levels, reduce damaging releases to the Caloosahatchee and St. Lucie estuaries downstream of the lake and improve system-wide operational flexibility.

    c. A scoping letter will be used to invite comments from Federal, State, and local agencies, affected Indian Tribes, and other interested private organizations and individuals.

    d. A scoping meeting will be held July 26th, 2016 from 6:00 to 8:00 p.m. at the Okeechobee Auditorium, 3800 NW., 16th Boulevard, Suite A, Okeechobee, FL 34972.

    e. All alternative plans will be reviewed under provisions of appropriate laws and regulations, including the Endangered Species Act, Fish and Wildlife Coordination Act, Clean Water Act, and Farmland Protection Policy Act.

    f. The Draft Environmental Impact Assessment is expected to be available for public review in late 2017.

    Dated: July 7, 2016. Eric P. Summa, Chief, Planning and Policy Division.
    [FR Doc. 2016-16920 Filed 7-15-16; 8:45 am] BILLING CODE 3720-58-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0036] Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 2017-2018 Free Application for Federal Student Aid (FAFSA) AGENCY:

    Department of Education (ED), Federal Student Aid (FSA).

    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 August 17, 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-0036. 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-343, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Misty Parkinson, 202-377-3749.

    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: 2017-2018 Free Application for Federal Student Aid (FAFSA).

    OMB Control Number: 1845-0001.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 38,669,924.

    Total Estimated Number of Annual Burden Hours: 20,036,012.

    Abstract: Section 483 of the Higher Education Act of 1965, as amended (HEA), mandates that the Secretary of Education “. . . shall produce, distribute, and process free of charge common financial reporting forms as described in this subsection to be used for application and reapplication to determine the need and eligibility of a student for financial assistance. . . ”.

    The determination of need and eligibility are for the following title IV, HEA, federal student financial assistance programs: The Federal Pell Grant Program; the Campus-Based programs (Federal Supplemental Educational Opportunity Grant (FSEOG), Federal Work-Study (FWS), and the Federal Perkins Loan Program); the William D. Ford Federal Direct Loan Program; the Teacher Education Assistance for College and Higher Education (TEACH) Grant; and the Iraq and Afghanistan Service Grant.

    Federal Student Aid, an office of the U.S. Department of Education (hereafter “the Department”), subsequently developed an application process to collect and process the data necessary to determine a student's eligibility to receive title IV, HEA program assistance. The application process involves an applicant's submission of the Free Application for Federal Student Aid (FAFSA®). After submission of the FAFSA, an applicant receives a Student Aid Report (SAR), which is a summary of the data they submitted on the FAFSA. The applicant reviews the SAR, and, if necessary, will make corrections or updates to their submitted FAFSA data. Institutions of higher education listed by the applicant on the FAFSA also receive a summary of processed data submitted on the FAFSA which is called the Institutional Student Information Record (ISIR).

    The Department seeks OMB approval of all application components as a single “collection of information”. The aggregate burden will be accounted for under OMB Control Number 1845-0001. The specific application components, descriptions and submission methods for each are listed in Table one.

    Table 1—Federal Student Aid Application Components Component Description Submission method Initial Submission of FAFSA FAFSA on the Web (FOTW) Online FAFSA that offers applicants a customized experience Submitted by the applicant via fafsa.gov. FOTW—Renewal Online FAFSA for applicants who have previously completed the FAFSA FOTW—EZ Online FAFSA for applicants who qualify for the Simplified Needs Test (SNT) or Automatic Zero (Auto Zero) needs analysis formulas FOTW—EZ Renewal Online FAFSA for applicants who have previously completed the FAFSA and who qualify for the SNT or Auto Zero needs analysis formulas FAFSA on the Phone (FOTP) The Federal Student Aid Information Center (FSAIC) representatives assist applicants by filing the FAFSA on their behalf through FOTW Submitted through fafsa.gov for applicants who call 1-800-4-FED-AID. FOTP—EZ FSAIC representatives assist applicants who qualify for the SNT or Auto Zero needs analysis formulas by filing the FAFSA on their behalf through FOTW FAA Access Online tool that a financial aid administrator (FAA) utilizes to submit a FAFSA Submitted through faaaccess.ed.gov by an FAA on behalf of an applicant. FAA Access—Renewal Online tool that an FAA can utilize to submit a Renewal FAFSA FAA Access—EZ Online tool that an FAA can utilize to submit a FAFSA for applicants who qualify for the SNT or Auto Zero needs analysis formulas FAA Access—EZ Renewal Online tool that an FAA can utilize to submit a FAFSA for applicants who have previously completed the FAFSA and who qualify for the SNT or Auto Zero needs analysis formulas Electronic Other This is a submission done by an FAA, on behalf of the applicant, using the Electronic Data Exchange (EDE) The FAA may be using their mainframe computer or software to facilitate the EDE process. Printed FAFSA The printed version of the PDF FAFSA for applicants who are unable to access the Internet or complete the form using FOTW Mailed by the applicant. Correcting Submitted FAFSA Information and Reviewing FAFSA Information FOTW—Corrections Any applicant who has a Federal Student Aid ID (FSA ID)—regardless of how they originally applied—may make corrections using FOTW Corrections Submitted by the applicant via fafsa.gov. Electronic Other—Corrections With the applicant's permission, corrections can be made by an FAA using the EDE The FAA may be using their mainframe computer or software to facilitate the EDE process. Paper SAR—This is a SAR and an option for corrections. The full paper summary that is mailed to paper applicants who did not provide an e-mail address and to applicants whose records were rejected due to critical errors during processing. Applicants can write corrections directly on the paper SAR and mail for processing Mailed by the applicant. FAA Access—Corrections An institution can use FAA Access to correct the FAFSA Submitted through faaaccess.ed.gov by an FAA on behalf of an applicant. Internal Department Corrections The Department will submit an applicant's record for system-generated corrections There is no burden to the applicants under this correction type as these are system-based corrections. FSAIC Corrections Any applicant, with their Data Release Number (DRN), can change the postsecondary institutions listed on their FAFSA or change their address by calling FSAIC These changes are made directly in the CPS system by a FSAIC representative. SAR Electronic (eSAR) The eSAR is an online version of the SAR that is available on FOTW to all applicants with an FSA ID. Notifications for the eSAR are sent to students who applied electronically or by paper and provided an e-mail address. These notifications are sent by e-mail and include a secure hyperlink that takes the user to the FOTW site Cannot be submitted for processing.

    This information collection also documents an estimate of the annual public burden as it relates to the application process for federal student aid. The Applicant Burden Model (ABM) measures applicant burden through an assessment of the activities each applicant conducts in conjunction with other applicant characteristics and in terms of burden, the average applicant's experience. Key determinants of the ABM include:

    ☐ The total number of applicants that will potentially apply for federal student aid;

    ☐ How the applicant chooses to complete and submit the FAFSA (e.g., by paper or electronically via FOTW®);

    ☐ How the applicant chooses to submit any corrections and/or updates (e.g., the paper SAR or electronically via FOTW Corrections);

    ☐ The type of SAR document the applicant receives (eSAR, SAR acknowledgment, or paper SAR);

    ☐ The formula applied to determine the applicant's expected family contribution (EFC) (full need analysis formula, Simplified Needs Test or Automatic Zero); and

    ☐ The average amount of time involved in preparing to complete the application.

    The ABM is largely driven by the number of potential applicants for the application cycle. The total application projection for 2017-2018 is based upon two factors—estimating the growth rate of the total enrollment into post-secondary education and applying the growth rate to the FAFSA submissions. The ABM is also based on the application options available to students and parents. The Department accounts for each application component based on web trending tools, survey information, and other Department data sources.

    For this 2017-2018 Free Application for Federal Student Aid (FAFSA) collection, the Department is reporting a net burden decrease of −524,469 hours.

    The reporting hour burden calculations in this notice reflect the Department's best estimates using data from the 2015-16 FAFSA application cycle in which Federal Student Aid traditionally has estimated reporting burden. However, in order to reflect a change in which prior tax year's information will be utilized in the application, a conservative estimate has been reflected as part of the reporting hour burden calculation. As such, we will continuously monitor and capture statistical information in order to reflect more accurate calculations in future cycles.

    Dated: July 13, 2016. Stephanie Valentine, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-16930 Filed 7-15-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM98-1-000] Records Governing Off-the-Record Communications; Public Notice

    This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications.

    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication.

    Prohibited communications are included in a public, non-decisional file associated with, but not a part of, the decisional record of the proceeding. Unless the Commission determines that the prohibited communication and any responses thereto should become a part of the decisional record, the prohibited off-the-record communication will not be considered by the Commission in reaching its decision. Parties to a proceeding may seek the opportunity to respond to any facts or contentions made in a prohibited off-the-record communication, and may request that the Commission place the prohibited communication and responses thereto in the decisional record. The Commission will grant such a request only when it determines that fairness so requires. Any person identified below as having made a prohibited off-the-record communication shall serve the document on all parties listed on the official service list for the applicable proceeding in accordance with Rule 2010, 18 CFR 385.2010.

    Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v).

    The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These filings are available for electronic review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the eLibrary link. Enter the docket number, excluding the last three digits, in the docket number field to access the document. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or for TTY, contact (202) 502-8659.

    Docket No. File date Presenter or requester Prohibited: 1. CP15-138-000 6-27-2016 Sharon and Russell Olt. 2. P-2082-027 6-28-2016 Siskiyou County Water Users Association. 3. CP15-500-000 7-8-2016 Luc Novovitch. Exempt: 1. P-2464-000, P-2484-000 6-27-2016 FERC Staff.1 2. CP16-10-000 6-27-2016 U.S. House Representative H. Morgan Griffith. 3. CP16-38-000 6-28-2016 FERC Staff.2 4. CP16-10-000 6-29-2016 Franklin County, Virginia County Administrator W. Brent Robertson. 5. CP15-514-000 6-29-2016 State of Pennsylvania Senator Camera Bartolotta. 6. P-2485-000, P-1889-000 7-1-2016 FERC Staff.3 7. EL15-95-000 7-5-2016 State of Maryland Governor Larry Hogan. 8. CP15-138-000 7-5-2016 State of Pennsylvania House Representative Bryan Cutler. 9. CP15-115-000, CP15-115-001 7-8-2016 FERC Staff.4 10. CP15-539-000 7-11-2016 FERC Staff.5 11. CP15-514-000 7-11-2016 FERC Staff.6 1 Email dated June 23, 2016 with Grace Schwefel from Village of Gresham. 2 Memo dated June 28, 2016 reporting email with Columbia Gas Transmission, LLC. 3 Email dated May 12, 2016 between Paul Richmond and John Bullard from National Marine Fisheries Services. 4 Email dated July 7, 2016 between Bruce Clark from Natfuel and Jeff Thommes from ERM. 5 Memo dated July 8, 2016 forwarding emails with Columbia Pipeline Group. 6 Memo dated July 8, 2016 forwarding emails with Columbia Pipeline Group. Dated: July 12, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-16881 Filed 7-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP16-1086-000.

    Applicants: Questar Overthrust Pipeline Company.

    Description: Annual Fuel Reimbursement Report of Questar Overthrust Pipeline Company.

    Filed Date: 7/11/16.

    Accession Number: 20160711-5096.

    Comments Due: 5 p.m. ET 7/25/16.

    Docket Numbers: RP16-1087-000.

    Applicants: High Island Offshore System, L.L.C.

    Description: § 4(d) Rate Filing: Revise NGL Bank BTU Calculation to be effective 12/1/2015.

    Filed Date: 7/11/16.

    Accession Number: 20160711-5169.

    Comments Due: 5 p.m. ET 7/25/16.

    Docket Numbers: RP16-1088-000.

    Applicants: Trailblazer Pipeline Company LLC.

    Description: § 4(d) Rate Filing: PALS Service to be effective 9/1/2016.

    Filed Date: 7/12/16.

    Accession Number: 20160712-5000.

    Comments Due: 5 p.m. ET 7/25/16.

    Docket Numbers: RP16-1089-000.

    Applicants: Tennessee Gas Pipeline Company, L.L.C.

    Description: § 4(d) Rate Filing: Volume No. 2—Neg. Rate Agmts Enerplus Resources SP319104 and SP319105 to be effective 8/1/2016.

    Filed Date: 7/12/16.

    Accession Number: 20160712-5029.

    Comments Due: 5 p.m. ET 7/25/16.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    Filings in Existing Proceedings

    Docket Numbers: RP16-329-001.

    Applicants: Transwestern Pipeline Company, LLC.

    Description: Compliance filing RP16-329 Compliance Filing to be effective 7/1/2016.

    Filed Date: 7/12/16.

    Accession Number: 20160712-5019.

    Comments Due: 5 p.m. ET 7/25/16.

    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: July 12, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-16880 Filed 7-15-16; 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: EC16-146-000.

    Applicants: Great Plains Energy, Westar Energy, Inc.

    Description: Joint Application of Great Plains Energy Incorporated and Westar Energy, Inc. for Authorization of Disposition of Jurisdictional Assets and Merger.

    Filed Date: 7/11/16.

    Accession Number: 20160711-5204.

    Comments Due: 5 p.m. ET 9/9/16.

    Take notice that the Commission received the following exempt wholesale generator filings:

    Docket Numbers: EG16-127-000.

    Applicants: East Pecos Solar, LLC.

    Description: Self-Certification of EG or FC of East Pecos Solar, LLC.

    Filed Date: 7/12/16.

    Accession Number: 20160712-5045.

    Comments Due: 5 p.m. ET 8/2/16.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-2507-008.

    Applicants: Westar Energy, Inc.

    Description: Notice of Non-Material Change in Status of Westar Energy, Inc.

    Filed Date: 7/11/16.

    Accession Number: 20160711-5205.

    Comments Due: 5 p.m. ET 8/1/16.

    Docket Numbers: ER10-2633-025; ER10-2570-025; ER10-2717-025; ER10-3140-025; ER13-55-015.

    Applicants: Birchwood Power Partners, L.P., Shady Hills Power Company, L.L.C., EFS Parlin Holdings, LLC, Inland Empire Energy Center, LLC, Homer City Generation, L.P.

    Description: Supplement to July 7, 2016 Notice of Non-Material Change in Status of the GE Companies under ER10-2633, et al.

    Filed Date: 7/7/16.

    Accession Number: 20160708-5080.

    Comments Due: 5 p.m. ET 7/28/16.

    Docket Numbers: ER16-1882-000.

    Applicants: Boulder Solar Power, LLC.

    Description: Supplement to June 3, 2016 Boulder Solar Power, LLC tariff filing.

    Filed Date: 7/11/16.

    Accession Number: 20160711-5201.

    Comments Due: 5 p.m. ET 8/1/16.

    Docket Numbers: ER16-2176-000.

    Applicants: Pacific Gas and Electric Company.

    Description: Application of Pacific Gas and Electric Company for a One-Time Waiver of a Generator Interconnection Procedures requirement in its Wholesale Distribution Tariff (FERC Electric Tariff Volume No. 4).

    Filed Date: 7/11/16.

    Accession Number: 20160711-5200.

    Comments Due: 5 p.m. ET 8/1/16.

    Docket Numbers: ER16-2177-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Cancellation: Notice of Cancellation of WMPA SA No. 4461, Queue No. W4-027 to be effective 7/19/2016.

    Filed Date: 7/12/16.

    Accession Number: 20160712-5025.

    Comments Due: 5 p.m. ET 8/2/16.

    Docket Numbers: ER16-2178-000.

    Applicants: NorthWestern Corporation.

    Description: § 205(d) Rate Filing: SA 781—Agreement with Montana DOT re Whitehall-South Project to be effective 7/13/2016.

    Filed Date: 7/12/16.

    Accession Number: 20160712-5032.

    Comments Due: 5 p.m. ET 8/2/16.

    Docket Numbers: ER16-2179-000.

    Applicants: Duke Energy Progress, LLC, Duke Energy Florida, LLC, Duke Energy Carolinas, LLC.

    Description: § 205(d) Rate Filing: Order No. 827 Compliance Filing to be effective 9/21/2016.

    Filed Date: 7/12/16.

    Accession Number: 20160712-5038.

    Comments Due: 5 p.m. ET 8/2/16.

    Docket Numbers: ER16-2180-000.

    Applicants: NorthWestern Corporation.

    Description: § 205(d) Rate Filing: SA 782—Agreement with City of Bozeman re Story Mill Park to be effective 7/13/2016.

    Filed Date: 7/12/16.

    Accession Number: 20160712-5070.

    Comments Due: 5 p.m. ET 8/2/16.

    Docket Numbers: ER16-2182-000.

    Applicants: International Transmission Company, Michigan Electric Transmission Company, LLC, ITC Midwest LLC, ITC Great Plains, LLC.

    Description: International Transmission Company, et al. submits Compliance Refund Report per 35.19a(b): [4/19/2016 Letter Order in FA14-15].

    Filed Date: 7/7/16.

    Accession Number: 20160707-5237.

    Comments Due: 5 p.m. ET 7/28/16.

    Docket Numbers: ER16-2183-000.

    Applicants: New York Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: NYISO filing of LGIA (SA 2276) among NYISO, NYPA and Jericho Rise Wind Farm to be effective 6/29/2016.

    Filed Date: 7/12/16.

    Accession Number: 20160712-5129.

    Comments Due: 5 p.m. ET 8/2/16.

    Docket Numbers: ER16-2184-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) Rate Filing: Amended Letter Agreement City of Pasadena to be effective 9/11/2016.

    Filed Date: 7/12/16.

    Accession Number: 20160712-5134.

    Comments Due: 5 p.m. ET 8/2/16.

    Docket Numbers: ER16-2185-000.

    Applicants: Westar Energy, Inc.

    Description: § 205(d) Rate Filing: Cost-Based Tariff Vol. No. 20 to be effective 8/31/2010.

    Filed Date: 7/12/16.

    Accession Number: 20160712-5138.

    Comments Due: 5 p.m. ET 8/2/16.

    Take notice that the Commission received the following electric securities filings:

    Docket Numbers: ES16-42-000.

    Applicants: Trans Bay Cable LLC.

    Description: Application under Section 204 of the Federal Power Act for Authority to Issue Securities of Trans Bay Cable LLC.

    Filed Date: 7/12/16.

    Accession Number: 20160712-5087.

    Comments Due: 5 p.m. ET 8/2/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: July 12, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-16878 Filed 7-15-16; 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: CP16-469-000.

    Applicants: ANR Storage Company.

    Description: Abbreviated Application of ANR Storage Company for Approval to Abandon Individually Certificated Part 157 Service and Provide Part 284 Service.

    Filed Date: 6/16/16.

    Accession Number: 20160616-5109.

    Comments Due: 5 p.m. ET 7/15/16.

    Docket Numbers: RP16-1082-000.

    Applicants: Columbia Gas Transmission, LLC.

    Description: Petition for Approval of Settlement of Columbia Gas Transmission, LLC.

    Filed Date: 6/30/16.

    Accession Number: 20160630-5425.

    Comments Due: 5 p.m. ET 7/12/16.

    Docket Numbers: RP16-1083-000.

    Applicants: MIGC LLC.

    Description: Annual Fuel Retention Percentage Tracker of MIGC LLC.

    Filed Date: 7/1/16.

    Accession Number: 20160701-5344.

    Comments Due: 5 p.m. ET 7/13/16.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    Filings in Existing Proceedings

    Docket Numbers: RP01-382-026.

    Applicants: Northern Natural Gas Company.

    Description: Northern Natural Gas Company submits Carlton Reimbursement Report.

    Filed Date: 6/1/16.

    Accession Number: 20160601-5395.

    Comments Due: 5 p.m. ET 6/18/16.

    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: July 11, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-16879 Filed 7-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL16-90-000] Panda Liberty LLC; Notice of Institution of Section 206 Proceeding and Refund Effective Date

    On July 12, 2016, the Commission issued an order in Docket No. EL16-90-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into the justness and reasonableness of Panda Liberty LLC's proposed reactive power rate schedule. Panda Liberty LLC, 156 FERC ¶ 61,033 (2016).

    The refund effective date in Docket No. EL16-90-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the Federal Register.

    Dated: July 12, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-16894 Filed 7-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL16-96-000] PJM Interconnection, L.L.C.; Notice of Institution of Section 206 Proceeding and Refund Effective Date

    On July 11, 2016, the Commission issued an order in Docket No. EL16-96-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into the justness and reasonableness of certain aspects of PJM Interconnection, L.L.C.'s Amended and Restated Operating Agreement. PJM Interconnection, L.L.C., 156 FERC ¶ 61,030 (2016).

    The refund effective date in Docket No. EL16-96-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the Federal Register.

    Dated: July 12, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-16895 Filed 7-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RD16-4-000] Proposed Agency Information Collection AGENCY:

    Federal Energy Regulatory Commission, DOE.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    The Federal Energy Regulatory Commission (Commission) invites public comment in Docket No. RD16-4-000 on a proposed change to a collection of information (FERC-725M, Mandatory Reliability Standards: Generator Requirements at the Transmission Interface) that the Commission is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995. The Commission previously issued a Notice in the Federal Register (81 FR 26543, May 3, 2016) requesting public comments. The Commission received no comments and is making this notation in the submittals to OMB.

    DATES:

    Comments regarding the proposed information collections must be received on or before August 17, 2016.

    ADDRESSES:

    Comments filed with OMB, identified by the OMB Control No. 1902-0263, should be sent via email to the Office of Information and Regulatory Affairs at: [email protected], Attention: Federal Energy Regulatory Commission Desk Officer.

    A copy of the comments should also be sent to the Commission, in Docket No. RD16-4-000, by either of the following methods:

    eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.

    Mail/Hand Delivery/Courier: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street NE., Washington, DC 20426.

    Instructions: All submissions must be formatted and filed in accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance, contact FERC Online Support by email at [email protected], or by phone at: (866) 208-3676 (toll-free), or (202) 502-8659 for TTY.

    Docket: Users interested in receiving automatic notification of activity in this docket or in viewing/downloading comments and issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

    FOR FURTHER INFORMATION CONTACT:

    Ellen Brown may be reached by email at [email protected], telephone at (202) 502-8663, and fax at (202) 273-0873.

    SUPPLEMENTARY INFORMATION:

    The Commission will submit the reporting and recordkeeping requirements of proposed Reliability Standard FAC-003-4 (Transmission Vegetation Management) to OMB for review. Proposed Reliability Standard FAC-003-4 1 replaces the requirements from the previous version of the Reliability Standard (FAC-003-3 2 ), which is approved under FERC-725M (Mandatory Reliability Standards: Generator Requirements at the Transmission Interface, OMB Control No. 1902-0263).

    1 The Reliability Standard was approved in a Delegated Order issued on 4/26/2016 (posted at http://elibrary-backup.ferc.gov/idmws/common/opennat.asp?fileID=14218839).

    2 Reliability Standard FAC-003-3 was approved in Order No. 785 in Docket No. RM12-16-000. Revisions to Reliability Standard for Transmission Vegetation Management, Order No. 777, 142 FERC ¶ 61,208 (2013). The associated reporting and recordkeeping requirements in FAC-003-3 were approved by OMB on Dec. 17, 2013, under FERC-725M.

    Type of Request: Three-year approval of the revised FERC-725M information collection requirements with the stated changes to the current reporting and record retention requirements.

    Abstract: The Commission requires the information collected by the FERC-725M to implement the statutory provisions of section 215 of the Federal Power Act (FPA).3 On August 8, 2005, Congress enacted into law the Electricity Modernization Act of 2005, which is title XII, subtitle A, of the Energy Policy Act of 2005 (EPAct 2005).4 EPAct 2005 added a new section 215 to the FPA, which requires a Commission-certified Electric Reliability Organization (ERO) to develop mandatory and enforceable Reliability Standards, which are subject to Commission review and approval. Once approved, the Reliability Standards may be enforced by the ERO subject to Commission oversight, or the Commission can independently enforce Reliability Standards.5

    3 16 U.S.C. 824o (2012).

    4 Energy Policy Act of 2005, Public Law 109-58, title XII, subtitle A, 119 Stat. 594, 941 (codified at 16 U.S.C. 824o).

    5 16 U.S.C. 824o(e)(3).

    On February 3, 2006, the Commission issued Order No. 672, implementing section 215 of the FPA.6 Pursuant to Order No. 672, the Commission certified one organization, the North American Electric Reliability Corporation (NERC), as the ERO.7 The Reliability Standards developed by the ERO and approved by the Commission apply to users, owners and operators of the Bulk-Power System as set forth in each Reliability Standard.

    6Rules Concerning Certification of the Electric Reliability Organization; and Procedures for the Establishment, Approval, and Enforcement of Electric Reliability Standards, Order No. 672, FERC Stats. & Regs. ¶ 31,204, order on reh'g, Order No. 672-A, FERC Stats. & Regs. ¶ 31,212 (2006).

    7North American Electric Reliability Corp., 116 FERC ¶ 61,062, order on reh'g and compliance, 117 FERC ¶ 61,126 (2006), order on compliance, 118 FERC ¶ 61,190, order on reh'g, 119 FERC ¶ 61,046 (2007), aff'd sub nom. Alcoa Inc. v. FERC, 564 F.3d 1342 (D.C. Cir. 2009).

    On March 14, 2016, NERC filed a petition for Commission approval of proposed Reliability Standard FAC-003-4 (Transmission Vegetation Management). NERC states in its petition that proposed Reliability Standard FAC-003-4 reflects revisions to the current Minimum Vegetation Clearance Distances (MVCDs) in Reliability Standard FAC-003-3 based on additional testing regarding the appropriate gap factor to be used to calculate clearance distances for vegetation. NERC explains that in response to the Commission's directive as part of its approval of an earlier version of the Reliability Standard, FAC-003-2, NERC contracted with the Electric Power Research Institute (EPRI) to conduct this testing.8 As NERC notes, when the Commission approved Reliability Standard FAC-003-2, the Commission stated that “it is important that NERC develop empirical evidence that either confirms assumptions used in calculating the MVCD values based on the Gallet equation, or gives reason to revisit the Reliability Standard.” 9

    8 NERC Petition at 7 (citing Order No. 777, 142 FERC ¶ 61,208 (2013)).

    9 Order No. 777, 142 FERC ¶ 61,208 at P 3.

    NERC states in its petition that preliminary testing conducted by EPRI indicated that the gap factor used to calculate MVCDs should be adjusted. NERC further explains that proposed Reliability Standard FAC-003-4 proposes higher and more conservative MVCD values, and therefore maintains that these revisions will “enhance reliability and provide additional confidence by applying a more conservative approach to determining the vegetation clearing distances.” 10 NERC states that the revised clearances as reflected in Table 2 were moved into the text of the proposed Reliability Standard, and that MVCD values were added for elevations up to 15,000 feet, but that no other substantive changes were made to the currently-effective Reliability Standard FAC-003-3.11

    10 NERC Petition at 3.

    11Id. at 12, and n. 37 (describing certain non-substantive edits to the standard and implementation plan as compared to the currently-effective version of the standard).

    Type of Respondents: Transmission Owner (TO) and Generator Owner (GO)

    Estimate of Annual Burden:12 The burden and cost estimates below are based on the number of transmission owners and generator owners as reflected in NERC's registry (i.e., updated since the Commission's approval of earlier versions of FAC-003). Transmission owners and applicable generator owners have a one-time burden to review and modify existing documentation, plans and procedures, as well as an ongoing burden to retain records. Our estimate of the number of respondents affected is based on the NERC Compliance Registry as of February 25, 2016. According to the Compliance Registry, NERC has registered 320 transmission owners and 940 generator owners within the United States, and we estimate that approximately 10 percent (or 94) of the registered generator owners have interconnection facilities that meet the requirements for applicability under the new standard. The estimated annual burden and cost of the new standard follow.13

    12 The Commission defines “burden” as the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a federal agency. For further information, refer to 5 CFR 1320.3.

    13 The estimates for cost per hour (for salary plus benefits) are derived from the Bureau of Labor and Statistics' figures for May 2015 (at http://www.bls.gov/oes/current/naics2_22.htm#11-0000 and benefits [updated March 10, 2016] at http://www.bls.gov/news.release/ecec.nr0.htm), as follows:

    • $62.16/hour for salary plus benefits [based on the average for an electrical engineer (code 17-2071, at $64.20/hour), a first-line supervisor of forestry workers (code 45-1011, at $33.34/hour), and a manager (code 11-0000, at $88.94/hour)]

    • $31.76/hour, salary plus benefits for an information and record clerk (code 43-4000).

    FERC-725M—Changes Due to FAC-003-4 in Docket No. RD16-4-000 Requirements/measures 14 Number of
  • respondents 15
  • Number of
  • responses per
  • respondent
  • Total number
  • of responses
  • Average burden hours and
  • cost per response
  • Total annual burden hours and cost Total annual
  • cost per
  • respondent
  • ($)
  • (1) (2) (1)*(2)=(3) (4) (3)*(4)=(5) Strategies, documentation, processes, & procedures (M3) [one-time] 414 1 414 4 hrs.; $248.64 1,656 hrs.; $102,936.96 [@$62.16/hr.] $248.64 Record Retention (Compliance 1.2) [ongoing] 414 1 414 1 hr.; $31.76 414 hrs.; $13,148.64 [@$31.76/hr.] 31.76 Total Net Change, due to RD16-4 2,070 hrs.; $116,085.60 16

    Comments: Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collections of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

    14 The Order in Docket No. RD16-4 does not modify the following requirements. However, due to normal fluctuations in industry, the number of respondents (TOs and GOs), in the submittal to OMB will be updated as follows.

    • The Quarterly Reporting (Compliance 1.4) is required of 102 respondents (94 GOs and 8 Regional Entities), rather than 96 respondents.

    • The requirements for Annual Vegetation Inspection Document (M6), annual vegetation work plan (M7), evidence of management of vegetation (M1 and M2), confirmed vegetation condition (M4), and corrective action (M5) are required of 94 respondents (rather than 88).

    15 We estimate a total of 414 respondents (320 TOs and 94 GOs) are affected.

    16 This is the estimate for Year 1 (including one-time implementation cost plus ongoing record retention costs). In subsequent years, only the record retention costs ($13,148.64, annual total for all respondents) will continue.

    For the submittal to OMB (available in reginfo.gov), the one-time implementation burden and cost (which will be completed in Year 1) will be averaged over Years 1-3.

    Dated: July 11, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-16899 Filed 7-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12965-002] Wickiup Hydro Group, LLC; Notice of Schedule Change

    On June 27, 2016, the Commission issued a “Notice of Teleconference to Discuss Endangered Species Act Consultation” for the Wickiup Dam Hydroelectric Project, FERC Project No. 12965. This teleconference has been rescheduled due to unforeseen scheduling conflicts to August 1, 2016 at 1:00 p.m. Pacific Daylight Time (4:00 p.m. Eastern Daylight Time). Please email Karen Sughrue at [email protected] to RSVP.

    Dated: July 11, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-16898 Filed 7-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. CP16-3-000 and CP16-3-001] Texas Eastern Transmission, LP; Notice of Schedule for Environmental Review of the Access South, Adair Southwest, and Lebanon Extension Projects

    On October 8, 2015, Texas Eastern Transmission, LP (Texas Eastern) filed an application requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) of the Natural Gas Act to construct, operate, and maintain pipeline loops, install additional compression, and allow for reverse flow capabilities. The proposed projects, known as Access South, Adair Southwest, and the Lebanon Extension Projects would enable Texas Eastern to transport up to an additional 622,000 dekatherms per day of natural gas on its mainline system from Uniontown, Pennsylvania to points in Ohio, Kentucky, and Mississippi.

    On October 22, 2015, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the projects. Among other things, the Notice of Application alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization within 90 days of the date of issuance of the Commission staff's Environmental Assessment (EA) for the projects. This instant notice identifies the FERC staff's planned schedule for the completion of the EA for the projects.

    Schedule for Environmental Review

    Issuance of EA—August 8, 2016

    90-day Federal Authorization Decision Deadline—November 6, 2016

    If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the projects' progress.

    Project Description

    The projects would include (1) construction and maintenance of approximately 15.8 miles of 36-inch-diameter pipeline at three locations in Meigs and Monroe Counties, Ohio and 0.5 mile of 16-inch-diameter replacement pipeline within its existing right-of-way in Attala County, Mississippi; (2) installation of a new 16,875 horsepower compressor unit at an existing compressor station in Tompkinsville, Kentucky; and (3) modification of 12 existing compressor stations to allow for reverse flow capabilities in Pennsylvania, Ohio, Kentucky, Tennessee, Alabama, and Mississippi.

    Background

    On August 11, 2015, the Commission issued a Notice of Intent to Prepare an Environmental Assessment for the Planned Access South, Adair Southwest, and the Lebanon Extension Projects and Request for Comments on Environmental Issues (NOI). The NOI was issued during the pre-filing review of the projects in Docket No. PF15-17-000 and was sent to affected landowners; federal, state, and local government agencies; elected officials; environmental and public interest groups; Native American tribes; other interested parties; and local libraries and newspapers.

    In response to the NOI, the Commission received environmental comments from the Ohio Department of Natural Resources, the U.S. Fish and Wildlife Service, the U.S. Army Corps of Engineers, a landowner, and combined comments from the Allegheny Defense Project, Buckeye Forest Council, Center for Biological Diversity, Freshwater Accountability Project, Heartwood, Kentucky Heartwood, and the Ohio Valley Environmental Coalition. The primary issues raised by the commentors included location of pipeline on an affected landowner's property; federally-listed threatened and endangered species; state-listed endangered species; migratory birds; permitting requirements; minimization and avoidance of impacts on streams and wetlands; direct, indirect and cumulative project impacts; connected actions; forest fragmentation; and noise.

    On May 17, 2016, the Commission issued a Supplemental Notice of Intent to Prepare an Environmental Assessment for the Proposed Access South, Adair Southwest, and the Lebanon Extension Projects and Request for Comments on Environmental Issues (Supplemental NOI). The Supplemental NOI was sent to landowners within one half mile of the compressor stations who had not been included in Texas Eastern's original landowner list. In response to the Supplemental NOI, we received one comment from the U.S. Fish and Wildlife Service stating that it had no comments on the projects.

    Additional Information

    In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Additional information about the project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC Web site (www.ferc.gov). Using the “eLibrary” link, select “General Search” from the eLibrary menu, enter the selected date range and “Docket Number” excluding the last three digits (i.e., CP16-3), and follow the instructions. For assistance with access to eLibrary, the helpline can be reached at (866) 208-3676, TTY (202) 502-8659, or at [email protected] The eLibrary link on the FERC Web site also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rule makings.

    Dated: July 12, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-16900 Filed 7-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Staff Attendance at the Southwest Power Pool Regional Entity Trustee, Members' Committee and Board of Directors' Meetings

    The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of its staff may attend the meetings of the Southwest Power Pool, Inc. Regional Entity Trustee (RE), Members' Committee and Board of Directors as noted below. Their attendance is part of the Commission's ongoing outreach efforts.

    All meetings will be held at the Rushmore Plaza Holiday Inn, 505 North Fifth St., Rapid City, SD 57701. The hotel phone number is (605) 348-4000. All meetings are Mountain Time.

    SPP RE July 25, 2016 (7:30 a.m.-12:00 p.m.) SPP Members/Board of Directors July 25, 2016 (12:00 p.m.-5:00 p.m.) July 26, 2016 (8:00 a.m.-12:00 p.m.)

    The discussions may address matters at issue in the following proceedings:

    Docket No. ER11-1844, Midcontinent Independent System Operator, Inc. Docket No. EL12-60, Southwest Power Pool, Inc., et al. Docket No. ER12-959, Southwest Power Pool, Inc. Docket No. ER12-1179, Southwest Power Pool, Inc. Docket No. ER12-1586, Southwest Power Pool, Inc. Docket No. EL15-66, Southern Company Services, et al. v. Midcontinent Independent System Operator, Inc. Docket No. EL15-77, Morgan Stanley Capital Group Inc. v. Midcontinent Independent System Operator, Inc. Docket No. ER14-1183, Southwestern Electric Power Company Docket No. ER14-2445, Midcontinent Independent System Operator, Inc. Docket No. ER14-2850, Southwest Power Pool, Inc. Docket No. ER15-1499, Southwest Power Pool, Inc. Docket No. ER15-1775, Southwest Power Pool, Inc. Docket No. ER15-1777, Southwest Power Pool, Inc. Docket No. ER15-1943, Southwest Power Pool, Inc. Docket No. ER15-1976, Southwest Power Pool, Inc. Docket No. ER15-2028, Southwest Power Pool, Inc. Docket No. ER15-2069, Northwestern Corporation Docket No. ER15-2115, Southwest Power Pool, Inc. Docket No. ER15-2265, Southwest Power Pool, Inc. Docket No. ER15-2324, Southwest Power Pool, Inc. Docket No. ER15-2347, Southwest Power Pool, Inc. Docket No. ER15-2351, Southwest Power Pool, Inc. Docket No. ER15-2356, Southwest Power Pool, Inc. Docket No. EC16-53, South Central MCN, LLC Docket No. EL16-20, Grid Assurance LLC Docket No. EL16-70, Cottonwood Wind Project, LLC v. Nebraska Public Power District Docket No. ER16-13, Southwest Power Pool, Inc. Docket No. ER16-204, Southwest Power Pool, Inc. Docket No. ER16-209, Southwest Power Pool, Inc. Docket No. ER16-228, Southwest Power Pool, Inc. Docket No. ER16-791, Southwest Power Pool, Inc. Docket No. ER16-829, Southwest Power Pool, Inc. Docket No. ER16-846, Southwest Power Pool, Inc. Docket No. ER16-862, Southwest Power Pool, Inc. Docket No. ER16-863, Southwest Power Pool, Inc. Docket No. ER16-932, Southwest Power Pool, Inc. Docket No. ER16-1086, Southwest Power Pool, Inc. Docket No. ER16-1211, Midcontinent Independent System Operator, Inc. Docket No. ER16-1286, Southwest Power Pool, Inc. Docket No. ER16-1305, Southwest Power Pool, Inc. Docket No. ER16-1351, Westar Energy, Inc. Docket No. ER16-1355, Westar Energy, Inc. Docket No. ER16-1314, Southwest Power Pool, Inc. Docket No. ER16-1341, Southwest Power Pool, Inc. Docket No. ER16-1544, Southwest Power Pool, Inc. Docket No. ER16-1546, Southwest Power Pool, Inc. Docket No. ER16-1605, Southwestern Electric Power Company Docket No. ER16-1618, Southwest Power Pool, Inc. Docket No. ER16-1676, Southwest Power Pool, Inc. Docket No. ER16-1709, Southwest Power Pool, Inc. Docket No. ER16-1710, Southwest Power Pool, Inc. Docket No. ER16-1711, Southwest Power Pool, Inc. Docket No. ER16-1712, Southwest Power Pool, Inc. Docket No. ER16-1713, Southwest Power Pool, Inc. Docket No. ER16-1715, Southwest Power Pool, Inc. Docket No. ER16-1772, Public Service Company of Colorado Docket No. ER16-1774, Southwest Power Pool, Inc. Docket No. ER16-1797, Midcontinent Independent System Operator, Inc. Docket No. ER16-1799, Southwest Power Pool, Inc. Docket No. ER16-1812, Southwestern Electric Power Company Docket No. ER16-1814, Southwest Power Pool, Inc. Docket No. ER16-1826, Southwest Power Pool, Inc. Docket No. ER16-1905, Southwest Power Pool, Inc. Docket No. ER16-1912, Southwest Power Pool, Inc. Docket No. ER16-1945, Southwest Power Pool, Inc. Docket No. ER16-1951, Southwest Power Pool, Inc. Docket No. ER16-1959, Southwest Power Pool, Inc. Docket No. ER16-1989, Southwest Power Pool, Inc. These meetings are open to the public.

    For more information, contact Patrick Clarey, Office of Energy Market Regulation, Federal Energy Regulatory Commission at (317) 249-5937 or [email protected]

    Dated: July 11, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-16897 Filed 7-15-16; 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 exempt wholesale generator filings:

    Docket Numbers: EG16-126-000.

    Applicants: McHenry Battery Storage, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of McHenry Battery Storage, LLC.

    Filed Date: 7/8/16.

    Accession Number: 20160708-5176.

    Comments Due: 5 p.m. ET 7/29/16.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-2474-014.

    Applicants: Sierra Pacific Power Company.

    Description: Compliance filing: Market-Based Rate Tariff Volume No. 7 SPPC to be effective 6/9/2016.

    Filed Date: 7/8/16.

    Accession Number: 20160708-5185.

    Comments Due: 5 p.m. ET 7/29/16.

    Docket Numbers: ER10-2475-014.

    Applicants: Nevada Power Company.

    Description: Compliance filing: Market-Based Rate Tariff, Volume No. 11 to be effective 6/9/2016..

    Filed Date: 7/8/16.

    Accession Number: 20160708-5184.

    Comments Due: 5 p.m. ET 7/29/16.

    Docket Numbers: ER12-1266-006.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Compliance filing: 2016-07-08 Order 745-719 True-up Filing to be effective 6/1/2012.

    Filed Date: 7/8/16.

    Accession Number: 20160708-5191.

    Comments Due: 5 p.m. ET 7/29/16.

    Docket Numbers: ER12-2261-007.

    Applicants: Russell City Energy Company, LLC.

    Description: Notification of Change in Status of Russell City Energy Company, LLC.

    Filed Date: 7/8/16.

    Accession Number: 20160708-5229.

    Comments Due: 5 p.m. ET 7/29/16.

    Docket Numbers: ER16-1062-001.

    Applicants: MidAmerican Energy Company.

    Description: Compliance filing: MidAmerican Energy Company Offer of Settlement to be effective 5/1/2016.

    Filed Date: 7/11/16.

    Accession Number: 20160711-5000.

    Comments Due: 5 p.m. ET 8/1/16.

    Docket Numbers: ER16-1062-002.

    Applicants: MidAmerican Energy Company.

    Description: Compliance filing: Motion for Interim Rates to be effective 8/1/2016.

    Filed Date: 7/11/16.

    Accession Number: 20160711-5001.

    Comments Due: 5 p.m. ET 8/1/16.

    Docket Numbers: ER16-1301-001.

    Applicants: ISO New England Inc., Emera Maine.

    Description: Compliance filing: Emera Maine Compliance Filing—Docket No. ER16-1301-000 to be effective 6/1/2016.

    Filed Date: 7/11/16.

    Accession Number: 20160711-5162.

    Comments Due: 5 p.m. ET 8/1/16.

    Docket Numbers: ER16-1371-002.

    Applicants: 63SU 8ME LLC.

    Description: Notice of Change in Status of 63SU 8ME LLC.

    Filed Date: 7/11/16.

    Accession Number: 20160711-5149.

    Comments Due: 5 p.m. ET 8/1/16.

    Docket Numbers: ER16-2167-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 2880R1 Rattlesnake Creek Wind Project GIA to be effective 6/10/2016.

    Filed Date: 7/8/16.

    Accession Number: 20160708-5174.

    Comments Due: 5 p.m. ET 7/29/16.

    Docket Numbers: ER16-2168-000.

    Applicants: Pacific Gas and Electric Company.

    Description: § 205(d) Rate Filing: Interim Transmission Access Charge Balancing Account Adjustment (TACBAA) 2016 to be effective 10/1/2016.

    Filed Date: 7/8/16.

    Accession Number: 20160708-5192.

    Comments Due: 5 p.m. ET 7/29/16.

    Docket Numbers: ER16-2169-000.

    Applicants: Algonquin SKIC 20 Solar, LLC.

    Description: Baseline eTariff Filing: Application for Initial Tariff to be effective 7/14/2016.

    Filed Date: 7/8/16.

    Accession Number: 20160708-5193.

    Comments Due: 5 p.m. ET 7/29/16.

    Docket Numbers: ER16-2171-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Cancellation: Notice of Cancellation of WMPA SA No. 3439, Queue No. Y1-027 to be effective 5/26/2016.

    Filed Date: 7/11/16.

    Accession Number: 20160711-5061.

    Comments Due: 5 p.m. ET 8/1/16.

    Docket Numbers: ER16-2172-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2016-07-11_SA 2926 GRE—Oliver Wind III FCA (C023) to be effective 7/12/2016.

    Filed Date: 7/11/16.

    Accession Number: 20160711-5071.

    Comments Due: 5 p.m. ET 8/1/16.

    Docket Numbers: ER16-2173-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2016-07-11_SA 2927 Duke Energy Business Services—Duke Energy Indiana GIA (J453) to be effective 7/12/2016.

    Filed Date: 7/11/16.

    Accession Number: 20160711-5078.

    Comments Due: 5 p.m. ET 8/1/16.

    Docket Numbers: ER16-2174-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Cancellation: Notice of Cancellation of WMPA SA No. 3251, Queue No. W3-025 and X1-077 to be effective 8/22/2016.

    Filed Date: 7/11/16.

    Accession Number: 20160711-5164.

    Comments Due: 5 p.m. ET 8/1/16.

    Docket Numbers: ER16-2175-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2016-07-11_2nd Quarter MISO Tariff Clean-Up Filing to be effective 7/12/2016.

    Filed Date: 7/11/16.

    Accession Number: 20160711-5168.

    Comments Due: 5 p.m. ET 8/1/16.

    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: July 11, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-16877 Filed 7-15-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CD16-15-000] City of Sheridan, WY; Notice of Preliminary Determination of a Qualifying Conduit Hydropower Facility and Soliciting Comments and Motions To Intervene

    On July 6, 2016, the City of Sheridan, WY filed a notice of intent to construct a qualifying conduit hydropower facility, pursuant to section 30 of the Federal Power Act (FPA), as amended by section 4 of the Hydropower Regulatory Efficiency Act of 2013 (HREA). The proposed Beckton Hall Road PRV Vault Project would have an installed capacity of 240 kilowatts (kW) and would be located within the Beckton Hall Road PRV Vault, which is part of the City of Sheridan's existing raw water transmission system. The project would be located near the City of Sheridan in Sheridan County, Wyoming.

    Applicant Contact: Dan Roberts, City of Sheridan, 55 Grinnell Plaza, Sheridan, WY 82801, Phone No. (307) 675-4233.

    FERC Contact: Robert Bell, Phone No. (202) 502-6062, email: [email protected]

    Qualifying Conduit Hydropower Facility Description: The proposed project would consist of: (1) A proposed 240-kW turbine placed inside a 30-inch-diameter pipeline, with the facility entirely housed within the Beckton Hall Road PRV Vault, and (2) appurtenant facilities. The proposed project would have an estimated annual generating capacity of 836.5 megawatt-hours.

    A qualifying conduit hydropower facility is one that is determined or deemed to meet all of the criteria shown in the table below.

    Table 1—Criteria for Qualifying Conduit Hydropower Facility Statutory provision Description Satisfies
  • (Y/N)
  • FPA 30(a)(3)(A), as amended by HREA The conduit is a tunnel, canal, pipeline, aqueduct, flume, ditch, or similar manmade water conveyance that is operated for the distribution of water for agricultural, municipal, or industrial consumption and not primarily for the generation of electricity Y FPA 30(a)(3)(C)(i), as amended by HREA The facility is constructed, operated, or maintained for the generation of electric power and uses for such generation only the hydroelectric potential of a non-federally owned conduit Y FPA 30(a)(3)(C)(ii), as amended by HREA The facility has an installed capacity that does not exceed 5 megawatts Y FPA 30(a)(3)(C)(iii), as amended by HREA On or before August 9, 2013, the facility is not licensed, or exempted from the licensing requirements of Part I of the FPA Y

    Preliminary Determination: Based upon the above criteria, Commission staff has preliminarily determined that the proposal satisfies the requirements for a qualifying conduit hydropower facility under 16 U.S.C. 823a, and is exempted from the licensing requirements of the FPA.

    Comments and Motions to Intervene: The deadline for filing comments contesting whether the facility meets the qualifying criteria is 45 days from the issuance date of this notice.

    The deadline for filing motions to intervene is 30 days from the issuance date of this notice.

    Anyone may submit comments or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210 and 385.214. Any motions to intervene must be received on or before the specified deadline date for the particular proceeding.

    Filing and Service of Responsive Documents: All filings must (1) bear in all capital letters the “COMMENTS CONTESTING QUALIFICATION FOR A CONDUIT HYDROPOWER FACILITY” or “MOTION TO INTERVENE,” as applicable; (2) state in the heading the name of the applicant and the project number of the application to which the filing responds; (3) state the name, address, and telephone number of the person filing; and (4) otherwise comply with the requirements of sections 385.2001 through 385.2005 of the Commission's regulations.1 All comments contesting Commission staff's preliminary determination that the facility meets the qualifying criteria must set forth their evidentiary basis.

    1 18 CFR 385.2001-2005 (2015).

    The Commission strongly encourages electronic filing. Please file motions to intervene and comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

    Locations of Notice of Intent: Copies of the notice of intent can be obtained directly from the applicant or such copies can be viewed and reproduced at the Commission in its Public Reference Room, Room 2A, 888 First Street NE., Washington, DC 20426. The filing may also be viewed on the web at http://www.ferc.gov/docs-filing/elibrary.asp using the “eLibrary” link. Enter the docket number (e.g., CD16-15-000) in the docket number field to access the document. For assistance, call toll-free 1-866-208-3676 or email [email protected]. For TTY, call (202) 502-8659.

    Dated: July 12, 2016. Kimberly Bose, Secretary.
    [FR Doc. 2016-16896 Filed 7-15-16; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2016-0346; FRL-9949-14-OAR] RIN 2060-AS30 Oil and Natural Gas Sector: Request for Information, Emerging Technologies AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice; request for information.

    SUMMARY:

    The Environmental Protection Agency (EPA) is issuing this request for information to the public to obtain information about monitoring, detection of fugitive emissions, and alternative mitigation approaches in the oil and natural gas sector.

    DATES:

    Responses must be received on or before November 15, 2016.

    ADDRESSES:

    Submit your information, identified by Docket ID No. EPA-HQ-OAR-2016-0346, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting responses. Once submitted, responses cannot be edited or withdrawn. The EPA may publish any response received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional information on submission of CBI can be found below in this document. Multimedia submissions (audio, video, etc.) must be accompanied by a written response. The written response is considered the official response and should include discussion of all points you wish to make. The EPA will generally not consider information or content located outside of the primary submission (i.e., on the Web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    Docket. All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically at http://www.regulations.gov or in hard copy at the U.S. Environmental Protection Agency, EPA Docket Center, EPA WJC West Building, Room 3334, 1301 Constitution Ave. NW., Washington, DC. 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 Air Docket is (202) 566-1742.

    FOR FURTHER INFORMATION CONTACT:

    For further information about this action, contact Mr. Matthew Witosky, Sector Policies and Programs Division (E143-05), Office of Air Quality Planning and Standards, Environmental Protection Agency, Research Triangle Park, North Carolina 27711, telephone number: (919) 541-2865; facsimile number: (919) 541-3740; email address: [email protected]. For further information on the EPA's oil and natural gas sector regulatory program, contact Mr. Bruce Moore, Sector Policies and Programs Division (E143-05), Office of Air Quality Planning and Standards, Environmental Protection Agency, Research Triangle Park, North Carolina 27711, telephone number: (919) 541-5460; facsimile number: (919) 541-3470; email address: [email protected]. For additional contact information, see the following SUPPLEMENTARY INFORMATION section.

    SUPPLEMENTARY INFORMATION: I. General Information A. Who may be interested in this request?

    This request may be of interest to the categories and entities listed in Table 1:

    Table 1—Industrial Source Categories Potentially Interested in This Action Category NAICS code 1 Examples of industrial entities Industry 211111 Crude Petroleum and Natural Gas Extraction. 211112 Natural Gas Liquid Extraction. 221210 Natural Gas Distribution. 486110 Pipeline Distribution of Crude Oil. 486210 Pipeline Transportation of Natural Gas. Federal government Not affected. State/local/tribal government Potentially interested. 1 North American Industry Classification System.

    This table is not intended to be exhaustive, but rather is meant to provide a guide for readers regarding entities that may desire to submit information responsive to this request. If you have any questions, consult either the air permitting authority for the entity, your EPA Regional representative as listed in 40 CFR 60.4 (General Provisions), or the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    B. What should I consider as I prepare my information and responses to the EPA?

    Do not submit information containing CBI to the EPA through http://www.regulations.gov or email. Send or deliver information identified as CBI only to the following address: OAQPS Document Control Officer (C404-02), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, Attention: Docket ID No. EPA-HQ-OAR-2016-0346. Clearly mark the part or all of the information that you claim to be CBI. For CBI in a disk or CD-ROM that you mail to the EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the information that includes information claimed as CBI, a copy of the information that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. Send or deliver information identified as CBI only to the following address: OAQPS Document Control Officer (C404-02), U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, Attention Docket ID No. EPA-HQ-2016-0346.

    II. Background

    On June 3, 2016, the EPA published a final rule titled “Oil and Natural Gas Sector: Emission Standards for New, Reconstructed, and Modified Sources,” 81 FR 35824 (June 3, 2016). These new source performance standards (NSPS), at 40 CFR part 60, subpart OOOOa, set standards for both greenhouse gases (GHGs) and volatile organic compounds (VOC).

    While a great deal of information is available on the oil and natural gas industry and has to date provided a strong technical foundation to support the Agency's recent actions, the EPA is seeking additional information now of a broader perspective. This additional information may be key in addressing emissions from existing oil and natural gas sources under section 111(d) of the Clean Air Act (CAA). The EPA has taken the first step toward obtaining such information, issuing the first draft of an Information Collection Request (ICR) requiring owners/operators to provide information that may enable the development of effective standards for this industry under CAA section 111(d). The EPA published the first draft of the ICR June 3, 2016, for public comment (81 FR 35763).

    Recognizing that technology used to detect, measure, and mitigate emissions is rapidly developing, the EPA is issuing this request for information, inviting all parties to provide information on innovative technologies to accurately detect, measure, and mitigate emissions from the oil and natural gas industry.

    For example, the EPA is aware of efforts to foster development and use of advanced monitoring and leak detection equipment, generally similar to optical gas imaging required in the 2016 NSPS. The Agency is requesting information related to these efforts. The EPA seeks to take advantage of the new knowledge being generated by research and focused activities such as the Department of Energy's Advanced Research Projects Agency-Energy (ARPA-E) and other similar programs that are developing innovative monitoring, detection, and mitigation technologies. While final results are not yet available from some projects, such as those funded under ARPA-E, the EPA is interested in learning about works-in-progress that may lead to advanced monitoring techniques, devices or systems appropriate for the dynamic and complex oil and natural gas sector.

    The EPA also is seeking information on how these advanced monitoring technologies would be broadly applicable to existing sources. For example, research may be developing monitoring systems that provide coverage across emission points or equipment in a way that was not previously possible, thus enabling a different approach to setting standards.

    The EPA is also seeking information to advance mitigation opportunities. The EPA is particularly interested in information on technologies that could allow for effective emissions controls at well sites or other co-located facilities.

    Parties may respond to this request for information with published or unpublished papers, technical information, data, or any other information they consider responsive to this request.

    In addition to consideration of the information we hope to receive in response to this request, the EPA intends to provide an opportunity to further engage with stakeholders on these subjects. An event, such as the Natural Gas STAR Annual Implementation Workshop, tentatively scheduled for early 2017, may be a valuable forum for this exchange of information. Specific information regarding an event will be made available in the coming months.

    The EPA is providing a 120-day period for the public to submit the requested information. While the EPA will not respond to all submissions, we may contact respondents for further information or data.

    Dated: July 8, 2016. Janet G. McCabe, Acting Assistant Administrator, Office of Air and Radiation.
    [FR Doc. 2016-16927 Filed 7-15-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9949-20-OA] Notification of a Public Teleconference of a Work Group Under the Auspices of the Chartered Science Advisory Board AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The EPA Science Advisory Board (SAB) Staff Office announces a public teleconference of a Work Group under the auspices of the Chartered Science Advisory Board to gather and review information on shipboard ballast water treatment system efficacy and related conclusions in the 2011 SAB report, Efficacy of Ballast Water Treatment Systems: A Report by the EPA Science Advisory Board.

    DATES:

    The public teleconference for the Work Group of the Chartered SAB will be conducted on Friday, August 12, 2016, from 12:00 p.m. to 4:00 p.m. (Eastern Time).

    Location: The public teleconference will be conducted by telephone only.

    FOR FURTHER INFORMATION CONTACT:

    Any member of the public wishing to obtain information concerning the public teleconference may contact Mr. Thomas Carpenter, Designated Federal Officer (DFO), EPA Science Advisory Board Staff Office (1400R), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; by telephone/voice mail at (202) 564-4885 or at [email protected] General information about the SAB as well as any updates concerning the teleconference announced in this notice may be found on the EPA Web site at http://www.epa.gov/sab.

    SUPPLEMENTARY INFORMATION:

    The SAB was established pursuant to the Environmental Research, Development, and Demonstration Authorization Act (ERDDAA), codified at 42 U.S.C. 4365, to provide independent scientific and technical advice to the Administrator on the technical basis for Agency positions and regulations. The SAB is a federal advisory committee chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2. At the request of the SAB, a Work Group composed of a subset of SAB members will review the underlying data on ballast water treatment efficacy to assist the SAB in considering information regarding conclusions about shipboard treatment efficacy in the SAB report, Efficacy of Ballast Water Treatment Systems: A Report by the Science Advisory Board (EPA-SAB-11-009). The Work Group will gather and review information, analyze the report's underlying data and related conclusions and develop recommendations for deliberation by the Chartered Science Advisory Board at a future meeting. The SAB is not seeking new data regarding ballast water treatment system efficacy and will focus its inquiry on analyzing the data underlying the report and the related conclusions. The SAB Staff Office notes that neither the Federal Advisory Committee Act (FACA) nor EPA policy requires meetings of Work Groups under the auspices of a chartered federal advisory committee to provide notice or conduct public meetings. Public notice of this meeting of the Work Group is being provided to assist the Work Group in obtaining public comment from interested parties on the topic under consideration.

    Availability of Meeting Materials: The agenda and materials in support of this teleconference will be available on the EPA Web site at http://www.epa.gov/sab in advance of the teleconference.

    Procedures for Providing Public Input: Public comment for consideration by EPA's federal advisory committees and panels has a different purpose from public comment provided to EPA program offices. Therefore, the process for submitting comments to a federal advisory committee is different from the process used to submit comments to an EPA program office.

    Federal advisory committees and panels, including scientific advisory committees, provide independent advice to EPA. Members of the public can submit comments for a federal advisory committee to consider as it develops advice for EPA. Input from the public to the SAB will have the most impact if it provides specific scientific or technical information or analysis for SAB panels to consider or if it relates to the clarity or accuracy of the technical information. Oral Statements: In general, individuals or groups requesting an oral presentation at a teleconference will be limited to three minutes. Each person making an oral statement should consider providing written comments as well as their oral statement so that the points presented orally can be expanded upon in writing. Interested parties should contact Mr. Thomas Carpenter, DFO, in writing (preferably via email) at the contact information noted above, by August 4, 2016 to be placed on the list of public speakers. Written Statements: Written statements should be supplied to the DFO, preferably via email, at the contact information noted above one week before the teleconference so that the information may be made available to the Board members for their consideration. It is the SAB Staff Office general policy to post written comments on the Web page for the advisory meeting or teleconference. Submitters are requested to provide an unsigned version of each document because the SAB Staff Office does not publish documents with signatures on its Web sites. Members of the public should be aware that their personal contact information, if included in any written comments, may be posted to the SAB Web site. Copyrighted material will not be posted without explicit permission of the copyright holder.

    Accessibility: For information on access or services for individuals with disabilities, please contact Mr. Thomas Carpenter at (202) 564-4885 or [email protected] To request accommodation of a disability, please contact Mr. Carpenter preferably at least ten days prior to the teleconference to give EPA as much time as possible to process your request.

    Dated: July 11, 2016. Thomas H. Brennan, Deputy Director, EPA Science Advisory Staff Office.
    [FR Doc. 2016-16929 Filed 7-15-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to all Interested Parties of the Termination of the Receivership of 10438, Plantation Federal Bank, Pawleys Island, South Carolina

    Notice is hereby given that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for Plantation Federal Bank, Pawleys Island, South Carolina (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of Plantation Federal Bank on April 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 34.6, 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: July 13, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-16889 Filed 7-15-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination; 10469 1st Regents Bank Andover, Minnesota

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10469 1st Regents Bank, Andover, Minnesota (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of 1st Regents Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective July 01, 2016 the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: July 13, 2016. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-16890 Filed 7-15-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination; 10376 First Peoples Bank, Port Saint Lucie, Florida

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10376 First Peoples Bank, Port Saint Lucie, Florida (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of First Peoples Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective July 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: July 13, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-16888 Filed 7-15-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL ELECTION COMMISSION [NOTICE 2016-05] Filing Dates for the Pennsylvania Special Election in the 2nd Congressional District AGENCY:

    Federal Election Commission.

    ACTION:

    Notice of filing dates for special election.

    SUMMARY:

    Pennsylvania has scheduled a special general election on November 8, 2016, to fill the U.S. House of Representatives seat in the 2nd Congressional District vacated by Representative Chaka Fattah.

    Committees required to file reports in connection with the Special General Election on November 8, 2016, shall file a 12-day Pre-General Report, and a 30-day Post-General Report.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Elizabeth S. Kurland, Information Division, 999 E Street NW., Washington, DC 20463; Telephone: (202) 694-1100; Toll Free (800) 424-9530.

    SUPPLEMENTARY INFORMATION: Principal Campaign Committees

    All principal campaign committees of candidates who participate in the Pennsylvania Special General Election shall file a 12-day Pre-General Report on October 27, 2016; and a Post-General Report on December 8, 2016. (See chart below for the closing date for each report.)

    Note that these reports are in addition to the campaign's committee's regular quarterly filings. (See chart below for the closing date for each report).

    Unauthorized Committees (PACs and Party Committees)

    Political committees filing on a quarterly basis in 2016 are subject to special election reporting if they make previously undisclosed contributions or expenditures in connection with the Pennsylvania Special General Election by the close of books for the applicable report(s). (See chart below for the closing date for each report.)

    Committees filing monthly that make contributions or expenditures in connection with the Pennsylvania Special General Election will continue to file according to the monthly reporting schedule.

    Additional disclosure information in connection with the Pennsylvania Special General Election may be found on the FEC Web site at http://www.fec.gov/info/report_dates.shtml.

    Disclosure of Lobbyist Bundling Activity

    Principal campaign committees, party committees and Leadership PACs that are otherwise required to file reports in connection with the special general election must simultaneously file FEC Form 3L if they receive two or more bundled contributions from lobbyists/registrants or lobbyist/registrant PACs that aggregate in excess of the $17,600 during the special election reporting periods. (See chart below for closing date of each period.) 11 CFR 104.22(a)(5)(v), (b).

    Calendar of Reporting Dates for Pennsylvania Special General Election [Committees involved in the Special General (11/08/16) must file] Report Close of books 1 Reg./cert. & overnight
  • mailing
  • deadline
  • Filing deadline
    Pre-General 10/19/16 10/24/16 10/27/16 Post-General 11/28/16 12/08/16 12/08/16 Year-End 12/31/16 01/31/17 01/31/17 1 The reporting period always begins the day after the closing date of the last report filed. If the committee is new and has not previously filed a report, the first report must cover all activity that occurred before the committee registered as a political committee up through the close of books for the first report due.

    On behalf of the Commission.

    Matthew S. Petersen, Chairman, Federal Election Commission.
    [FR Doc. 2016-16821 Filed 7-15-16; 8:45 am] BILLING CODE 6715-01-P
    FEDERAL MARITIME COMMISSION Sunshine Act Meeting AGENCY HOLDING THE MEETING:

    Federal Maritime Commission.

    TIME AND DATE:

    July 20, 2016—10 a.m.

    PLACE:

    800 North Capitol Street NW., First Floor Hearing Room, Washington, DC.

    STATUS:

    The meeting will be held in Open Session.

    MATTERS TO BE CONSIDERED:

    Open Session 1. International Affairs Briefings: a. Korea/U.S. Bilateral Discussions b. 9th Annual U.S./China Maritime Consultative Meeting c. 8th U.S./China Transportation Forum d. Panama Canal Expansion 2. Supply Chain Innovation Teams Update 3. Docket No. 16-04: Proposed Rule on Ocean Common Carrier and MTO Agreements 4. Docket No. 16-05: Proposed Rule on Service Contracts and NVOCC Service Arrangements CONTACT PERSON FOR MORE INFORMATION:

    Karen V. Gregory, Secretary, (202) 523-5725.

    Karen V. Gregory, Secretary.
    [FR Doc. 2016-16961 Filed 7-14-16; 11:15 am] BILLING CODE 6731-AA-P
    GENERAL SERVICES ADMINISTRATION [Notice-ISP-2016-01; Docket No. 2016-002; Sequence No. 13] Privacy Act of 1974; Notice of an Updated System of Records AGENCY:

    Office of the Chief Information Officer, General Services Administration (GSA).

    ACTION:

    Notice; System name change.

    SUMMARY:

    GSA proposes a new system of records subject to the Privacy Act of 1974, as amended, 5 U.S.C. 552a.

    DATES:

    Effective: August 17, 2016.

    ADDRESSES:

    GSA Privacy Act Officer (ISP), General Services Administration, 1800 and F Street NW., Washington, DC 20405.

    FOR FURTHER INFORMATION CONTACT:

    Call or email the GSA Privacy Act Officer: telephone 571-388-6570; email [email protected]

    SUPPLEMENTARY INFORMATION:

    GSA proposes to establish a system of records subject to the Privacy Act of 1974, 5 U.S.C. 552a. The system provides an account to users that gives them control over how government agencies interact with them and their personal information. Agencies can build applications on top of the USA.gov platform that will streamline and improve citizen interactions with government. Applications will leverage data and resources associated with the user's account, including personal information. The information in the system is contributed voluntarily by the user and cannot be accessed by government without explicit consent of the user, except as provided in this notice. Information is not shared between government agencies, except when the user gives explicit consent to share his or her information, except as provided in this notice.

    Dated: July 7, 2016. Pranjali Desai, Director, Policy and Compliance Division, Office of the Chief Information Security Officer, General Services Administration. GSA/OCSIT-1 SYSTEM NAME:

    USA.gov

    SYSTEM LOCATION:

    The system is maintained for GSA under contract. Contact the System Manager for additional information.

    CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:

    Anyone is able to create an account.

    CATEGORIES OF RECORDS IN THE SYSTEM:

    Records may include, but are not limited to: (1) Biographical data such as name, address, email, phone number, birth date, and basic demographic information such as whether or not the individual is married, a veteran, a small business owner, a parent or a student; (2) information stored by third-party applications that have been authorized by the user to access their account using one or more of USA.gov's programmatic interfaces, such as notifications, tasks, or events; (3) a history of third-party applications interactions with a user's account so the user can monitor how their account is being accessed by third-parties. Use of the system, and contribution of personal information, is completely voluntary.

    AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

    E-Government Act of 2002 (Pub. L. 107-347, 44 U.S.C. 3501 note)

    PURPOSES:

    To enable users to control how government interacts with them and their personal information, and to aid and assist users in interacting with government.

    ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:

    Users interacting with third-party applications, such as those developed by government agencies, may be asked to authorize the third-party application to access their system resources, such as their personal profile information. If a user authorizes use of his or her information, the third-party application will be given programmatic access to the user's account resources. All interactions with a user's account, such as reading personal profile information, are logged and are auditable by the user. Users can revoke a third-party application's authorization to access their account resources at any time. System information may be accessed by system managers, technical support and designated analysts in the course of their official duties. Information from this system also may be disclosed as a routine use:

    a. In any legal proceeding, where pertinent, to which GSA, a GSA employee, or the United States is a party before a court or administrative body.

    b. To a Federal, State, local, or foreign agency responsible for investigating, prosecuting, enforcing, or carrying out a statute, rule, regulation, or order when GSA becomes aware of a violation or potential violation of civil or criminal law or regulation.

    c. To a Member of Congress or his or her staff on behalf of, and at the request of, the individual who is the subject of the record.

    d. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), and the Government Accountability Office (GAO) in accordance with their responsibilities for evaluating Federal programs.

    e. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.

    f. To the National Archives and Records Administration (NARA) for records management purposes.

    g. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.

    h. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) The Agency 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 GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.

    POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING AND DISPOSING OF RECORDS IN THE SYTEM: STORAGE:

    All records are stored electronically in a database. Personally identifiable information is encrypted.

    RETRIEVABILITY:

    Records are retrieved using an authorization protocol. A user of the system grants explicit authorization to an application or government agency to access his or her profile. The system generates a unique token that authorizes only that application or agency to access the user's account. The system correlates the unique token, ensures that both the agency and the user involved are correct, and returns the information to the agency.

    SAFEGUARDS:

    System records are safeguarded in accordance with the requirements of the Privacy Act. Access to physical infrastructure is limited to authorized individuals with passwords; the database is maintained behind a firewall certified in accordance with National Institute of Standards and Technology standards and information in the database is encrypted.

    SAFEGUARDS AGAINIST UNAUTHORIZED ACCESS:

    Records are safeguarded in accordance with Privacy Act requirements. Access is limited to authorized individuals and protected with two-factor authentication, databases are behind a firewall. Personally Identifiable Information is encrypted at rest, and all transmissions of any information over external networks are encrypted. All passwords, encryption algorithms and firewalls are compliant with National Institute of Standards and Technology standards.

    RETENTION AND DISPOSAL:

    System records are retained and disposed of according to GSA records maintenance and disposition schedules and the requirements of the National Archives and Records Administration. Users may delete their own information from the system at any time.

    SYSTEM MANAGER AND ADDRESS:

    Director, USA.gov, General Services Administration, 1800 F Street NW., Washington, DC 20405.

    NOTIFICATION PROCEDURE:

    Individuals or users maintain their own information. Inquires can be made via the Web site at https://www.usa.gov, or at the above address under `System Manager and Address'.

    RECORD ACCESS PROCEDURES:

    Individuals or users wishing to access their own records may do so by password.

    CONTESTING RECORD PROCEDURES:

    Individuals or users of the system may amend or delete their own records online.

    RECORD SOURCE CATEGORIES:

    The sources for information in the system are the individuals (or system users) for whom the records are maintained and third-party applications which the user has authorized to contribute information to his or her account.

    [FR Doc. 2016-16868 Filed 7-15-16; 8:45 am] BILLING CODE 6820-34-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-1011; Docket No. CDC-2016-0061] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a request for extension of an approved information collection entitled Emergency Epidemic Investigation Data Collections (OMB Control No. 0920-1011). CDC will use the information collected to identify prevention and control measures in response to outbreaks and other public health events.

    DATES:

    Written comments must be received on or before September 16, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2016-0061 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

    Please note:

    All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    Proposed Project

    Emergency Epidemic Investigation Data Collections (OMB control number 0920-1011), Expiration 03-31-2017-Extension—Division of Scientific Education and Professional Development, Center for Surveillance, Education, and Laboratory Services, Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    CDC previously conducted Emergency Epidemic Investigations (EEIs) under Office of Management and Budget (OMB) control number 0920-0008. In 2013, CDC received OMB approval (OMB control number 0920-1011) for a new OMB generic clearance for a 3-year period to collect vital information during EEIs in response to urgent outbreaks or events (i.e., natural, biological, chemical, nuclear, radiological) characterized by undetermined agents, undetermined sources, undetermined transmission, or undetermined risk factors. CDC seeks OMB approval for an extension of this generic clearance (OMB control number 0920-1011) for a 3-year period.

    Supporting effective emergency epidemic investigations is one of the most important ways that CDC protects the health of the public. CDC is frequently called upon to conduct EEIs at the request of local, state, or international health authorities seeking support to respond to urgent outbreaks or urgent public health-related events. In response to external partner requests, CDC provides necessary epidemiologic support to identify the agents, sources, modes of transmission, or risk factors to effectively implement rapid prevention and control measures to protect the public's health. Data collection is a critical component of the epidemiologic support provided by CDC; data are analyzed to determine the agents, sources, modes of transmission, or risk factors so that effective prevention and control measures can be implemented. During an unanticipated outbreak or event, immediate action by CDC is necessary to minimize or prevent public harm. The legal justification for EEIs are found in the Public Health Service Act (42 U.S.C. Sec. 301[241](a).

    Successful investigations are dependent on rapid and flexible data collection that evolves during the investigation and is customized to the unique circumstances of each outbreak or event. Data collection elements will be those necessary to identify the agents, sources, mode of transmission, or risk factors. Examples of potential data collection methods include telephone or face-to-face interview; email, web or other type of electronic questionnaire; paper-and-pencil questionnaire; focus groups; medical record review; laboratory record review; collection of clinical samples; and environmental assessment. Respondents will vary depending on the nature of the outbreak or event; examples of potential respondents include health care professionals, patients, laboratorians, and the general public. Participation in EEIs is voluntary and there are no anticipated costs to respondents other than their time. CDC will use the information gathered during EEIs to rapidly identify and effectively implement measures to minimize or prevent public harm.

    CDC projects 60 EEIs in response to outbreaks or events characterized by undetermined agents, undetermined sources, undetermined transmission, or undetermined risk factors annually. The projected average number of respondents is 200 per EEI, for a total of 12,000 respondents. CDC estimates the average burden per response is 0.5 hours and each respondent will be asked to respond once. Therefore, the total estimated annual burden hours are 6,000. These estimates are based on the reported burden for EEIs that have been performed during the previous two years.

    OMB approval is requested for three years. Participation is based on previous Emergency Epidemic Investigations. There are no costs to respondents.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Total
  • number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden hours
  • (in hours)
  • Emergency Epidemic Investigation Participants Emergency Epidemic Investigation Data Collection Instruments 12,000 1 30/60 6,000 Total 6,000
    Jeffrey M. Zirger, Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-16882 Filed 7-15-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Statement of Organization, Functions, and Delegations of Authority

    Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 81 FR 30307-30308, dated May 16, 2016) is amended to reflect the reorganization of the Office of the Director, Centers for Disease Control and Prevention.

    Section C-B, Organization and Functions, is hereby amended as follows:

    After the title and the mission and function statements for the Office of the Associate Director for Laboratory Science and Safety (CAC) insert the following:

    Office of the Director (CAC1). (1) Provides scientific, technical, and managerial expertise and leadership in the development and enhancement of laboratory science and safety programs; (2) oversees and monitors the development, implementation, and evaluation of the laboratory safety and quality management programs across CDC; (3) advises on policy, partnerships, and issues management matters; (4) advises on matters related to internal and external public health communications; (5) provides oversight to ensure CDC compliance with regulations for select agents and toxins, and the safe possession, use and transfer of select agents and toxins; and (6) leads responses to laboratory incidents and emergencies.

    Office of Laboratory Science (CACB). (1) Provides high-level oversight and coordination of laboratory quality and safety training programs at all CDC campuses; (2) develops agency-level plans, policies, procedures and guidelines for implementation of quality management programs within Centers, Institute, and Offices (CIOs); (3) assures regulatory compliance and tracking for CDC's portfolio of laboratory developed tests; and (4) provides oversight of the catalog of laboratory safety training activities and tracking agency-wide progress and compliance with laboratory safety training requirements.

    Office of Laboratory Safety (CACC). (1) Provides high-level oversight and coordination of laboratory safety at all CDC campuses; (2) develops and assures effectiveness of agency-level plans, policies, manuals and tools for implementation of laboratory safety standards; (3) assures regulatory compliance for biological safety, chemical safety, radiation safety and the possession, use and transport of select agents and toxins; and (4) provides expertise and consultation for biological safety, chemical safety and radiation safety.

    Sherri Berger, Chief Operating Officer, Centers for Disease Control and Prevention.
    [FR Doc. 2016-16884 Filed 7-15-16; 8:45 am] BILLING CODE 4160-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30-Day-16-16AVB] Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

    Proposed Project

    US Zika Pregnancy Registry—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    In May 2015, the World Health Organization reported the first local transmission of Zika virus in the Western Hemisphere, with autochthonous cases identified in Brazil. As of March 16, 2016, local transmission has been identified in at least 32 countries or territories in the Americas. Further spread to other countries in the region is likely. Local vectorborne transmission of Zika virus has not been documented in the 50 U.S. states or the District of Columbia, but has occurred in U.S. territories, including in Puerto Rico, the U.S. Virgin Islands, and American Samoa. However, Zika virus infections have been reported in travelers returning to the United States from areas with active Zika virus transmission. Zika virus infection also has occurred through sexual transmission, which may pose an additional risk to non-travelling pregnant women whose partners may have traveled to areas at high risk for Zika virus acquisition. With the ongoing outbreak in the Americas, the number of Zika virus disease cases among travelers returning to the United States likely will increase, and sexual transmission from male travelers to their sex partners in the United States will likely continue to occur. In addition, mosquito-borne local transmission may occur in states where Aedes species mosquitoes are present.

    In some Brazilian states where Zika virus transmission has occurred, there has been an increase in cases of infants born with microcephaly. Zika virus infections have been confirmed in several infants with microcephaly and in fetal losses in women infected during pregnancy. In addition to microcephaly, a range of other problems have been detected among fetuses and infants infected with Zika virus before birth, such as absent or poorly developed brain structures, defects of the eye, hearing deficits, and impaired growth. The Ministry of Health in Brazil, with support from the Pan American Health Organization (PAHO), the U.S. Centers for Disease Control and Prevention (CDC), and other partners, is investigating the association between Zika virus infection and microcephaly, as well as other adverse pregnancy and infant outcomes.

    As part of the public health response to the Zika virus disease outbreak, CDC will conduct supplemental surveillance of antenatal diagnostic testing and clinical outcomes among pregnant women with laboratory evidence of Zika virus or unspecified flavivirus infection and their infants through the U.S. Zika Pregnancy Registry. It is anticipated that the Registry will provide critical information to direct CDC clinical recommendations and public health guidance and messages.

    The objective of this Registry is to monitor the frequency and types of pregnancy and infant outcomes following Zika virus infection during pregnancy, so as to inform ongoing response efforts for this Zika virus disease outbreak, including recommendations for clinical care, planning for services for pregnant women and infants affected by Zika virus, and improved prevention of Zika virus infections during pregnancy.

    There are no costs to the respondents other than their time. The total estimated annual burden hours are 2,167.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hrs.)
  • State, Territorial and Local Health Departments Maternal Health History Form 100 10 30/60 Supplemental Imaging Form 100 10 10/60 Laboratory Results Form 100 10 15/60 Clinicians and Other Providers Assessment at Delivery Form 100 10 30/60 Infant Health Follow-Up Form 100 30 15/60
    Jeffrey M. Zirger, Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-16872 Filed 7-15-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2016-0064; 60 Day-16-0969] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on “Monitoring Changes in Attitudes and Practices among Family Planning Providers and Clinics,” a survey to assess dissemination and use of guidance documents about the use of contraceptives and the delivery of quality family planning services.

    DATES:

    Written comments must be received on or before September 16, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2016-0064 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

    Please note:

    All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    Proposed Project

    Monitoring Changes in Attitudes and Practices among Family Planning Providers and Clinics (OMB No. 0920-0969, exp. 5/31/2014)—Reinstatement with Change—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    The Division of Reproductive Health (DRH) at the Centers for Disease Control and Prevention (CDC) develops and disseminates guidance to improve the use of contraceptives and the delivery of quality family planning services. The U.S. Medical Eligibility Criteria for Contraceptive Use (US MEC), the first national guidance on family planning containing evidence-based recommendations for the safe use of contraceptive methods for women and men with specific characteristics and medical conditions, was published by the CDC in June 2010. The US Selected Practice Recommendations for Contraceptive Use (US SPR), which provides guidance on how to use contraceptive methods safely and effectively once they are deemed to be medically appropriate, was published by the CDC in June 2013. Providing Quality Family Planning Services (QFP), which provides evidence-informed recommendations to improve client care and service delivery infrastructure to support the provision of quality family planning services to women and men of reproductive age in the United States, was published by CDC and the Office of Population Affairs (OPA) in April 2014. The US MEC, US SPR, and QFP have been widely disseminated to health care providers and other constituents via professional organizations, federal program grantees, scientific and programmatic meetings, scientific manuscripts, online resources, and other avenues.

    In 2009-2010, CDC collected baseline information related to diffusion and use of the US MEC (OMB No. 0920-0008). In 2013-2014, CDC collected follow-up information related to the US MEC and baseline information related to the US SPR and QFP (OMB No. 0920-0969). These information collections provided useful knowledge about differences in attitudes and practices of family planning providers based on varying levels of key demographic characteristics (e.g., years since completion of formal health care training), and identification of attitudes not consistent with current scientific evidence (e.g., misconceptions that intrauterine devices are not safe for adolescents or nulliparous women). CDC used findings to develop educational materials and opportunities for health care providers.

    In 2017, in collaboration with the HHS Office of Population Affairs (OPA), CDC plans to request a reinstatement of OMB No. 0920-0969, “Monitoring Changes in Attitudes and Practices among Family Planning Providers and Clinics.” The information collection will allow CDC and OPA to assess changes in attitudes and practices among family planning providers and clinics after the release of these three national guidance documents, and to identify persisting misconceptions and/or gaps in clinic-level practices (e.g., low provision of preconception health services) that may warrant continued and more tailored dissemination and educational activities. Specifically, the survey will allow CDC and OPA to improve family planning-related public health practice by (1) understanding the current use of contraception guidance in practice and valued sources of contraceptive information, including awareness and use of the US MEC, US SPR and QFP; (2) describing current attitudes and practices among family planning providers and clinics related to recommendations included in the US MEC, US SPR, and QFP and assessing changes from baseline; and (3) identifying targeted training needs in use of guidance and family planning service delivery (e.g., provider tools, continuing education modules).

    In 2017-2018, CDC plans to administer a follow-up survey to a sample of 10,000 private- and public-sector family planning providers and clinic administrators in the United States. The design, methodology, and analytic approach are based on methods previously approved for the 2013-2014 survey. Minor changes to survey content will be made to eliminate unnecessary questions, add new questions of interest, and improve formatting, usability, and data quality. As in 2013-2014, different versions of the survey instrument will be administered to providers and clinic administrators. The estimated burden per response for providers is 15 minutes and has not changed since the previous OMB approval. The estimated burden per response for administrators will be reduced from 40 minutes to 25 minutes.

    Private-sector physicians will be randomly selected from sampling frames with individual-level information on physicians. To reach public-sector providers and clinic administrators, publicly funded clinics will be randomly selected; one provider and the clinic administrator will be asked to complete surveys at sampled clinics. Specifically, surveys will be completed by: (a) 2,000 private-sector office-based physicians (i.e., those specializing in obstetrics/gynecology, family medicine, and adolescent medicine), sampled from the American Medical Association Physician Masterfile; (b) 2,000 providers from Title X clinics, sampled from a database of publicly funded family planning clinics; (c) 2,000 providers from non-Title X clinics, sampled from a database of publicly funded family planning clinics; (d) 2,000 clinic administrators from Title X clinics, sampled from a database of publicly funded family planning clinics; and (e) 2,000 clinic administrators from non-Title X clinics, sampled from a database of publicly funded family planning clinics.

    Each sampled provider and clinic will receive a mailed survey package. For private-sector family planning providers, each mailed survey package will include a single survey to be completed by the provider. For public-sector clinics, each mailed survey package will include two surveys—one to be completed by a randomly selected family planning provider at the clinic, and the second to be completed by the clinic administrator. Each mailed survey will be accompanied by a postage-paid return envelope. Individuals will also be given the option to complete the survey online via a password protected web-based data collection system.

    OMB approval is requested for one year. Participation is voluntary and there are no costs to respondents other than their time.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hr)
  • Total burden
  • (in hr)
  • Office-based physicians (private sector) 2017 Survey of Health Care Providers 2,000 1 15/60 500 Title X clinic providers (public sector) 2017 Survey of Health Care Providers 2,000 1 15/60 500 Non-Title X publicly funded clinic providers (public sector) 2017 Survey of Health Care Providers 2,000 1 15/60 500 Title X clinic administrators (public sector) 2017 Survey of Administrators of Publicly-Funded Health Centers that Provide Family Planning 2,000 1 25/60 834 Non-Title X publicly funded clinic administrators (public sector) 2017 Survey of Administrators of Publicly-Funded Health Centers that Provide Family Planning 2,000 1 25/60 834 Total 3,168
    Jeffrey M. Zirger, Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-16874 Filed 7-15-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket No. CDC-2016-0063; 60Day-16-16AVC] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on “Generic Clearance for CDC/ATSDR Formative Research and Tool Development”. This information collection request is designed to allow CDC to conduct formative research information collection activities used to inform aspects of surveillance, communications, health promotion, and research project development.

    DATES:

    Written comments must be received on or before September 16, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2016-0063 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

    Please note:

    All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    Proposed Project Generic Clearance for CDC/ATSDR Formative Research and Tool Development (CDC) Background and Brief Description

    The Centers for Disease Control and Prevention (CDC) requests approval for a new generic clearance for CDC/ATSDR Formative Research and Tool Development. This information collection request is designed to allow CDC to conduct formative research information collection activities used to inform many aspects of surveillance, communications, health promotion, and research project development at CDC. Formative research is the basis for developing effective strategies including communication channels, for influencing behavior change. It helps researchers identify and understand the characteristics—interests, behaviors and needs—of target populations that influence their decisions and actions.

    Formative research is integral in developing programs as well as improving existing and ongoing programs. Formative research looks at the community in which a public health intervention is being or will be implemented and helps the project staff understand the interests, attributes and needs of different populations and persons in that community. Formative research occurs before a program is designed and implemented, or while a program is being conducted.

    At CDC formative research is necessary for developing new programs or adapting programs that deal with the complexity of behaviors, social context, cultural identities, and health care that underlie the epidemiology of diseases and conditions in the U.S. CDC conducts formative research to develop public-sensitive communication messages and user friendly tools prior to developing or recommending interventions, or care. Sometimes these studies are entirely behavioral but most often they are cycles of interviews and focus groups designed to inform the development of a product.

    Products from these formative research studies will be used for prevention of disease. Findings from these studies may also be presented as evidence to disease-specific National Advisory Committees, to support revisions to recommended prevention and intervention methods, as well as new recommendations.

    Much of CDC's health communication takes place within campaigns that have fairly lengthy planning periods—timeframes that accommodate the standard Federal process for approving data collections. Short term qualitative interviewing and cognitive research techniques have previously proven invaluable in the development of scientifically valid and population-appropriate methods, interventions, and instruments.

    This request includes studies investigating the utility and acceptability of proposed sampling and recruitment methods, intervention contents and delivery, questionnaire domains, individual questions, and interactions with project staff or electronic data collection equipment. These activities will also provide information about how respondents answer questions and ways in which question response bias and error can be reduced.

    This request also includes collection of information from public health programs to assess needs related to initiation of a new program activity or expansion or changes in scope or implementation of existing program activities to adapt them to current needs. The information collected will be used to advise programs and provide capacity-building assistance tailored to identify needs.

    Overall, these development activities are intended to provide information that will increase the success of the surveillance or research projects through increasing response rates and decreasing response error, thereby decreasing future data collection burden to the public. The studies that will be covered under this request will include one or more of the following investigational modalities: (1) Structured and qualitative interviewing for surveillance, research, interventions and material development, (2) cognitive interviewing for development of specific data collection instruments, (3) methodological research (4) usability testing of technology-based instruments and materials, (5) field testing of new methodologies and materials, (6) investigation of mental models for health decision-making, to inform health communication messages, and (7) organizational needs assessments to support development of capacity. Respondents who will participate in individual and group interviews (qualitative, cognitive, and computer assisted development activities) are selected purposively from those who respond to recruitment advertisements.

    In addition to utilizing advertisements for recruitment, respondents who will participate in research on survey methods may be selected purposively or systematically from within an ongoing surveillance or research project. Participation of respondents is voluntary.

    There is no cost to participants other than their time. The total estimated annual burden is 8,000 hours.

    Type of respondent Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average hours
  • per response
  • Total response
  • burden
  • (hrs.)
  • General public and health care providers Screener
  • Consent Forms
  • 4,000
  • 2,000
  • 1
  • 1
  • 10/60
  • 10/60
  • 667
  • 333
  • Interview 2,000 1 1 2,000 Focus group interview 2,000 1 2 4,000 Survey 2,000 1 30/60 1,000 Total 8,000
    Jeffrey M. Zirger, Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-16873 Filed 7-15-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Privacy Act of 1974; System of Records Notice AGENCY:

    Department of Health and Human Services (HHS), Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR).

    ACTION:

    Notice to establish five new and delete one Privacy Act systems of records.

    SUMMARY:

    In accordance with the requirements of the Privacy Act of 1974, as amended (5 U.S.C. 552a), the Office of Refugee Resettlement (ORR) within HHS' Administration for Children and Families (ACF) is establishing five new systems of records: 09-80-0321 ORR Division of Children's Services Records; 09-80-0325 ORR Internet Refugee Arrivals Data System (iRADS); 09-80-0327 ORR Repatriation Program Records; 09-80-0329 ORR Unaccompanied Refugee Minors Records; and 09-80-0388 ORR Refugee Suicide Database. ORR is deleting one system of records, 09-60-0217 ORR Cuban Refugee Data System, which is being replaced by the new iRADS system of records.

    Four of the five new systems of records are “mixed,” in that they contain records pertaining to both U.S. persons (i.e., individuals who are citizens of the United States or aliens lawfully admitted for permanent residence in the United States) and non-U.S. persons.

    The Privacy Act applies only to U.S. persons (citizens of the United States or aliens lawfully admitted for permanent residence in the United States). As a matter of discretion, ORR will treat information that it maintains in its mixed systems of records as being subject to the provisions of the Privacy Act, regardless of whether the information relates to U.S. persons covered by the Privacy Act.

    This policy implements a 1975 Office of Management and Budget (OMB) recommendation to apply, as a matter of policy, the administrative provisions of the Privacy Act to records about non-U.S. persons in mixed systems of records (referred to as the non-U.S. persons policy).

    DATES:

    This Notice will become effective 30 days after publication, unless the Office of Refugee Resettlement makes changes based on comments received. Written comments should be submitted on or before the effective date.

    ADDRESSES:

    The public should address written comments to Gary Cochran, Senior Agency Officer for Privacy, by mail at Administration for Children and Families, Mary E. Switzer Building, 330 C Street SW., Washington, DC 20201, or by email at [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Questions should be directed to the contact person for the system in question:

    1. 09-80-0321 ORR Division of Children's Services Records Jallyn Sualog, Administration for Children and Families, ORR, Mary E. Switzer Building, 330 C Street SW., Washington, DC 20201; Email: [email protected] 2. 09-80-0325 ORR Internet Refugee Arrivals Data System (iRADS) Joann Simmons, Administration for Children and Families, ORR, Mary E. Switzer Building, 330 C Street SW., Washington, DC 20201; Email: [email protected] 3. 09-80-0327 ORR Repatriation Program Records Elizabeth Russell, Administration for Children and Families, ORR, Mary E. Switzer Building, 330 C Street SW., Washington, DC 20201; Email: [email protected] 4. 09-80-0329 ORR Unaccompanied Refugee Minors Records Jallyn Sualog, Administration for Children and Families, ORR, Mary E. Switzer Building, 330 C Street SW., Washington, DC 20201; Email: [email protected] 5. 09-80-0388 ORR Refugee Suicide Database Dr. Curi Kim, Administration for Children and Families, ORR, Mary E. Switzer Building, 330 C Street SW., Washington, DC 20201; Email: [email protected]
    SUPPLEMENTARY INFORMATION I. Background on Five New Systems of Records

    The five new systems of records established in this Notice are maintained by the Office of Refugee Resettlement (ORR) within HHS' Administration for Children and Families (ACF); ORR plans, develops, and directs the implementation of a domestic resettlement assistance program for refugees and other eligible populations. ORR provides resources to assist these populations with successful integration into American society. ORR's social services help refugees become self-sufficient as quickly as possible after their arrival in the United States. ORR also provides guidance, resources, and oversight for specific health challenges including medical assistance, initial health screenings, and consultations. ORR also oversees the Unaccompanied Children Program, providing care for unaccompanied children without lawful immigration status, and the U.S. Repatriation Program, providing loans to eligible repatriates referred from the U.S. Department of State.

    One of the five new systems of records, 09-80-0327 ORR Repatriation Program Records, contains information about U.S. persons only (i.e., U.S. citizens and their dependents receiving temporary assistance who have been identified as having returned to the U.S. or been brought from a foreign country to the U.S. because of destitution, illness, war, threat of war, or a similar crisis). The remaining four systems of records are “mixed,” in that they contain, or could contain, records pertaining to both U.S. persons and non-U.S. persons. The System of Records Notices (SORNs) published in this Notice for the four mixed systems include a statement to this effect, in the “Categories of Individuals” section:

    The Privacy Act applies only to U.S. persons (citizens of the United States or aliens lawfully admitted for permanent residence in the United States). As a matter of discretion, ORR will treat information that it maintains in its mixed systems of records as being subject to the provisions of the Privacy Act, regardless of whether or not the information relates to U.S. persons covered by the Privacy Act.

    This statement implements a 1975 Office of Management and Budget (OMB) recommendation to apply, as a matter of discretion, the administrative provisions of the Privacy Act to records about non-U.S. persons in mixed systems of records (referred to as the non-U.S. persons policy).

    II. Deletion of One Existing System of Records

    The existing system of records that is being deleted, 09-60-0217 ORR Cuban Refugee Data System, covered only records pertaining to Cuban refugees. That system has been subsumed into a broader system of records, 09-80-0325 ORR Internet Refugee Arrivals Data System (iRADS), covering refugees from all countries and other individuals eligible for ORR-funded benefits and services.

    III. The Privacy Act

    The Privacy Act (5 U.S.C. 552a) governs the means by which the U.S. Government collects, maintains, and uses information about individuals in a system of records. A “system of records” is a group of any records under the control of a federal agency from which information about an individual is retrieved by the individual's name or other personal identifier. The Privacy Act requires each agency to publish in the Federal Register a system of records notice (SORN) identifying and describing each system of records the agency maintains, including the purposes for which the agency uses information about individuals in the system, the routine uses for which the agency discloses such information outside the agency, and how individual record subjects can exercise their rights under the Privacy Act (e.g., to determine if the system contains information about them).

    As required by the Privacy Act (5 U.S.C. 552a(r)), HHS has sent a report of this new system of records to the Committee on Homeland Security and Governmental Affairs of the Senate, the Committee on Oversight and Government Reform of the House of Representatives, and the Office of Information and Regulatory Affairs of the Office of Management and Budget (OMB).

    Dated: July 11, 2016. Robert Carey, Director, Office of Refugee Resettlement.

    The following system of records is hereby deleted:

    • 09-60-0217 Cuban Refugee Data System.

    System of Records Notices (SORNs) are published below for five new systems of records:

    System Number:

    09-80-0321.

    System Name:

    ORR Division of Children's Services Records.

    Security Classification:

    Unclassified.

    System Location:

    Division of Children's Services (DCS), Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), Department of Health and Human Services (HHS), Mary E. Switzer Building, 330 C Street Washington, DC.

    Categories of Individuals Covered by the System:

    Unaccompanied children under ORR's care, unaccompanied children who receive an adjustment of status or become U.S. citizens, children of unaccompanied children, potential sponsors of the unaccompanied children, and members of potential sponsor's household, including both U.S. and non-U.S. citizens.

    Unaccompanied children (UC) are children who have no lawful immigration status in the United States; have not attained 18 years of age; and with respect to whom (i) there is no parent or legal guardian in the United States; or (ii) no parent or legal guardian in the United States is available to provide care and physical custody.

    The Privacy Act applies only to U.S. persons (citizens of the United States or aliens lawfully admitted for permanent residence in the United States). As a matter of discretion, ORR will treat information that it maintains in its mixed systems of records as being subject to the provisions of the Privacy Act, regardless of whether or not the information relates to U.S. persons covered by the Privacy Act. This implements a 1975 Office of Management and Budget (OMB) recommendation to apply, as a matter of policy, the administrative provisions of the Privacy Act to records about non-U.S. persons in mixed systems of records (referred to as the non-U.S. persons policy).

    Categories of Records in the System:

    Records consist of computerized indexing system data and case files:

    • The computerized indexing system contains personal identification data, such as Alien Registration Number, Fingerprint Identification Number (“FINS” number), and Social Security Number (SSN); date and place of birth; date and port of entry; apprehension date and location; manner of entry; apprehension field office; individual(s) apprehended with the unaccompanied child; attorney of record; juvenile/criminal history records; case disposition; significant incident reports; sponsor's biographical, financial and immigration status information; sponsor's household members' biographical information; and personal identification data of an unaccompanied child's potential sponsor, including the sponsor's biographical information (e.g., name, date of birth, place of birth), financial information, immigration status information, household members' biographical information, SSN, phone number, address, criminal background and case disposition, and results of child abuse and neglect checks.

    • The case file contains information that is pertinent to the care and placement of unaccompanied children, including biographical information on each unaccompanied child, such as birth and marriage certificates; various ORR forms and supporting documents (and attachments, e.g. photographs); incident reports; medical and dental records; mental health evaluations; case notes and records; clinical notes and records; immigration forms and notifications; attorney of record and legal papers; home studies and/or post-release service records on a sponsor of an unaccompanied child; family reunification information including the sponsors' individual and financial data; case disposition; correspondence; and SSN; and juvenile/criminal history records.

    Authority for Maintenance of the System:

    6 U.S.C. 279; 8 U.S.C. 1232.

    Purpose(s):

    Records are used within HHS/ACF/ORR by DCS to provide a safe and appropriate environment for each unaccompanied child placed into ORR custody through his/her release to a family member or sponsor in the U.S., until he/she is removed to his/her home country by DHS immigration officials, until the child turns 18 years of age, or until the minor receives lawful immigration status.

    Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of Such Uses:

    These routine uses specify circumstances, in addition to those provided by statute in the Privacy Act of 1974, 5 U.S.C. 552a(b), under which ACF may release information from this system of records without the consent of the data subject. Each proposed disclosure of information under these routine uses will be evaluated to ensure that the disclosure is legally permissible, including but not limited to ensuring that the purpose of the disclosure is compatible with the purpose for which the information was collected.

    1. Disclosure to an Attorney or Representative. Information may be disclosed to an attorney or representative (as defined in 8 CFR 1.2) who is acting on behalf of an individual covered by this system of records in connection with any proceeding before the Department of Homeland Security or the Executive Office for Immigration Review; an attorney representing an unaccompanied child in a state court in a dependency hearing that may determine or alter the unaccompanied child's custody status or placement; or an attorney representing an unaccompanied child in a juvenile or criminal court in relation to criminal charges.

    2. Disclosure for Health and Safety. Information such as health records related to communicable diseases or other illnesses that have the potential to affect public health and safety may be disclosed to any state or local health authorities, to ensure that all health issues potentially affecting public health and safety in the United States are being or have been, adequately addressed. Private health information not related to illnesses that affect public health and safety will remain confidential. This information may be disclosed for the purposes of coordinating medical and mental health evaluations, services, and care for unaccompanied alien children while in ORR care and custody. Information may be shared with a health provider to make age determinations for unaccompanied children.

    3. Disclosure to Protection and Advocacy Organization. Information may be disclosed to a Protection or Advocacy organization when access is authorized and the request is appropriately made under the Protection and Advocacy for Individuals with Mental Illness Act, 42 U.S.C. 10801 et seq. Information may be disclosed to an HHS-appointed child advocate for the purpose of effectively advocating for the best interest of the child. Child advocates are granted access to this information under the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 section 235(c)(6), 8 U.S.C. 1232(c)(6).

    4. Disclosure to Plaintiffs' Counsel. Information may be disclosed to plaintiffs' counsel as required under the settlement agreement in Flores v. Reno, Case No. CV85-4544-RJK (C.D. Cal. 1996); and Perez-Olano v. Holder, Case No. CV 5-3604 (C.D. Cal. 2010).

    5. Disclosure to Department of Homeland Security. Information may be disclosed to the Department of Homeland Security for the purpose of adjudicating or deciding immigration relief, notification of admission/discharge information and forms, and reported escapes of an unaccompanied child from ORR custody; and for background check purposes to ensure safe releases.

    6. Disclosure for Law Enforcement or Child Welfare Purpose. Information may be disclosed to the appropriate federal, state, local, tribal, or foreign agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, if the information is relevant to a violation or potential violation of civil or criminal law or regulation within the jurisdiction of the receiving entity; and for background check purposes to ensure safe releases. Information may be shared with certain state and local agencies that provide child welfare services such as state licensing agencies, Child Protective Services, and education agencies such as state, county, or municipal schools for the purpose of protecting an unaccompanied child's health and welfare and background check purposes to ensure safe releases, as well as enrollment of an unaccompanied child in a school or educational program.

    7. Disclosure for Private Relief Legislation. Information may be disclosed to the Office of Management and Budget at any stage in the legislative coordination and clearance process in connection with private relief legislation as set forth in OMB Circular No. A 19.

    8. Disclosure to Congressional Office. Information may be disclosed to a congressional office from the record of an individual in response to a written inquiry from the congressional office made at the written request of the individual.

    9. Disclosure to Department of Justice or in Proceedings. Information may be disclosed to the Department of Justice, or in a proceeding before a court, adjudicative body, or other administrative body before which HHS is authorized to appear, when:

    • HHS, or any component thereof; or

    • any employee of HHS in his or her official capacity; or

    • any employee of HHS in his or her individual capacity where the Department of Justice or HHS has agreed to represent the employee; or

    • the United States, if HHS determines that litigation is likely to affect HHS or any of its components,

    is a party to litigation or has an interest in such litigation, and the use of such records by the Department of Justice or HHS is deemed by HHS to be relevant and necessary to the litigation provided, however, that in each case it has been determined that the disclosure is compatible with the purpose for which the records were collected.

    10. Disclosure to Department of Justice for LOPC Facilitation. Information may be disclosed to the Department of Justice, Executive Office for Immigration Review for purposes of collaboration in facilitating sponsors' participation in Legal Orientation Programs for Custodians (LOPCs) under the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 section 235(c)(4), 8 U.S.C. 1232(c)(4).

    11. Disclosure to the National Archives. Information may be disclosed to the National Archives and Records Administration in records management inspections.

    12. Disclosure to Contractors, Grantees, and Others. Information may be disclosed to contractors, grantees, consultants, or volunteers performing or working on a contract, service, grant, cooperative agreement, job, or memorandum of understanding, or other activity for HHS and who have a need to have access to the information in the performance of their duties or activities for HHS.

    13. Disclosure to Office of Personnel Management. Information may be disclosed to the Office of Personnel Management pursuant to that agency's responsibility for evaluation and oversight of federal personnel management.

    14. Disclosure in Connection with Litigation. Information may be disclosed in connection with litigation or settlement discussions regarding claims by or against HHS, including public filing with a court, to the extent that disclosure of the information is relevant and necessary to the litigation or discussions.

    15. Disclosure Incident to Requesting Information. Information may be disclosed (to the extent necessary to identify the individual, inform the source of the purpose of the request, and to identify the type of information requested), to any source from which additional information is requested when necessary to obtain information relevant to an agency decision concerning benefits.

    16. Disclosure for Administrative Claims, Complaints, and Appeals. Information may be disclosed to an authorized appeal grievance examiner, formal complaints examiner, equal employment opportunity investigator, arbitrator or other person properly engaged in investigation or settlement of an administrative grievance, complaint, claim, or appeal filed by an employee, but only to the extent that the information is relevant and necessary to the proceeding. Agencies that may obtain information under this routine use include, but are not limited to, the Office of Personnel Management, Office of Special Counsel, Merit Systems Protection Board, Federal Labor Relations Authority, Equal Employment Opportunity Commission, and Office of Government Ethics.

    17. Disclosure to State Refugee Coordinators. Information may be shared with State Refugee Coordinators for children in ORR care who are being transferred into the ORR's Unaccompanied Refugee Minors program for purposes of coordinating appropriate placement and services for the child. The State Refugee Coordinator refers to the individuals designated by a Governor or a State to be responsible for, and who is authorized to, ensure coordination of public and private resources in refugee resettlement.

    18. Disclosure to other Federal Departments and Nongovernmental Organizations and Foreign Governments for Safe Repatriation of UC. Information may be disclosed to other federal agencies (such as the Department of State, Department of Justice, Department of Homeland Security), nongovernmental organizations and foreign governments as it relates to the safe repatriation of UC to their country of origin as directed under the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 section 235(a)(5), 8 U.S.C. 1232(a)(5).

    19. Disclosure in the Event of a Security Breach. Information may be disclosed to appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in this system of records, provided the information disclosed is relevant and necessary for that assistance.

    20. Disclosure for Cybersecurity Monitoring Purposes. Records may be disclosed to the U.S. Department of Homeland Security (DHS) if captured in an intrusion detection system used by HHS and DHS pursuant to a DHS cybersecurity program that monitors Internet traffic to and from federal government computer networks to prevent a variety of types of cybersecurity incidents.

    Disclosure to Consumer Reporting Agencies:

    None.

    Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System—

    Storage: Computer records are stored on a computer network. Paper records are stored in file folders.

    Retrievability: Records are retrieved by name or Alien Registration Number of the unaccompanied child; records are electronically retrieved from the web-based data management system using name, Alien Registration Number, or SSN of the party involved.

    Safeguards:

    Safeguards conform to the HHS Information Security Program, http://www.hhs.gov/ocio/securityprivacy/index.html.

    Retention and Disposal:

    Computerized indexing system records are retained permanently; they are offered to the National Archives every five years (see N1-292-90-04, item 15). Case files are retained for five years following receipt of the final progress report (see N1-292-90-4, item 34).

    System Manager and Address:

    Director, Division of Children Services, Office of Refugee Resettlement, Administration for Children and Families, Mary E. Switzer Building, 330 C Street SW., Washington, DC 20201.

    Notification Procedures:

    Individuals seeking to determine whether this system of records contains information about themselves should address written inquiries to the System Manager. The request should include the name, telephone number and/or email address, SSN or Alien Registration Number, and address of the individual, and the request must be signed. The requester's letter must provide sufficient particulars to enable the System Manager to distinguish between records on subject individuals with the same name. Verification of identity as described in HHS's Privacy Act regulations may be required. 45 CFR 5b.5

    Record Access Procedures:

    Individuals seeking access to a record about themselves in this system of records should address written inquiries to the System Manager. The request should include the name, telephone number and/or email address, SSN or Alien Registration Number, and address of the individual, and should be signed. The requester's letter must provide sufficient particulars to enable the System Manager to distinguish between records on subject individuals with the same name. Verification of identity as described in HHS's Privacy Act regulations may be required. 45 CFR 5b.5

    Contesting Record Procedures:

    Individuals seeking to amend a record about themselves in this system of records should address the request for amendment to the System Manager. The request should (1) include the name, telephone number and/or email address, SSN or Alien Registration Number, and address of the individual, and should be signed; (2) identify the system of records that the individual believes includes his or her records or otherwise provide enough information to enable the identification of the individual's record; (3) identify the information that the individual believes in not accurate, relevant, timely, or complete; (4) indicate what corrective action is sought; and (5) include supporting justification or documentation for the requested amendment. Verification of identity as described in HHS's Privacy Act regulations may be required. 45 CFR 5b.5

    Record Source Categories:

    Record subjects, family members, private individuals, private and public hospitals, doctors, law enforcement agencies and officials, private attorneys, facilities reports, third parties, foreign governments, other federal agencies, state and local governments, agencies and instrumentalities.

    Exemptions Claimed for the System:

    None.

    System Number:

    09-80-0325.

    System Name:

    ORR Internet Refugee Arrivals Data System (iRADS).

    Security Classification:

    Unclassified.

    System Location:

    Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), Department of Health and Human Services (HHS), Mary E. Switzer Building, 330 C Street SW., Washington, DC. A list of contractor sites where individually identifiable data are currently located is available upon request to the system manager.

    Categories of Individuals Covered by the System:

    Records pertain to the following individuals:

    • Individuals who are paroled as a refugee or asylee under 8 U.S.C. 1182(d)(5) [section 212(d)(5) of the Immigration and Nationality Act (INA)].

    • Individuals admitted as a refugee under 8 U.S.C. 1157 (section 207 of INA).

    • Individuals granted asylum under 8 U.S.C. 1158 (section 208 of INA).

    • Cuban and Haitian entrants, in accordance with requirements in Public Law 97-35, title V, §§ 543(a)(2), 547 [8 U.S.C. 1522 (note)] and 45 CFR part 401.

    • Certain Amerasians from Vietnam who are admitted to the U.S. as immigrants pursuant to 8 U.S.C. 1101 note (Amerasian Immigration).

    • Iraqi or Afghan Special Immigrant Visa-holders admitted under the Consolidated Appropriations Act of 2008 (Pub. L. 110-161, Division G, Title V, Section 525) or the National Defense Authorization Act for FY 2008 (Pub. L. 110-181, Division A, Title XII, Section 1244).

    • Certified victims of a severe form of human trafficking as defined under 22 U.S.C. 7105(b)(1)(c) (Trafficking Victims Protection Act of 2000).

    • Individuals admitted for permanent residence, provided the individual previously held one of the statuses identified above.

    The Privacy Act applies only to U.S. persons (citizens of the United States or aliens lawfully admitted for permanent residence in the United States). As a matter of discretion, ORR will treat information that it maintains in its mixed systems of records as being subject to the provisions of the Privacy Act, regardless of whether or not the information relates to U.S. persons covered by the Privacy Act. This implements a 1975 Office of Management and Budget (OMB) recommendation to apply, as a matter of policy, the administrative provisions of the Privacy Act to records about non-U.S. persons in mixed systems of records (referred to as the non-U.S. persons policy).

    Categories of Records in the System:

    Records consist of automated database records; data elements include but are not limited to: Alien Number, Full Name, Birth Date, Arrival Date or Date of Grant of Asylum, Immigration Status (Refugee, Asylee, etc), Marital Status, Age, Gender, Ethnicity (for populations other than Asylees), Full Address (City, State, Zip Code), County, Birth Country, Citizenship Country, Country of Origin, English Ability, Occupational Skills, Health Status, Administrative Data (e.g., voluntary resettlement agency).

    Authority for Maintenance of the System:

    8 U.S.C. 1521 et seq.

    Purpose(s):

    Records are used by HHS/ACF/ORR to generate data needed to allocate funds for Formula Social Services and Targeted Assistance grants according to statutory formulas established under 8 U.S.C. 1522(c)(1)(B) & (c)(2)(B); extract samples for the Annual Survey of Refugees, which collects information on the economic adjustment of refugees; and support other budget and grant requirements and data requests from within and outside ORR. This system of records does not collect new information but consolidates information on eligible populations obtained from other agencies.

    Routine uses of records maintained in the system, including categories of users and the purposes of such uses:

    These routine uses specify circumstances, in addition to those provided by statute in the Privacy Act of 1974, 5 U.S.C. 552a(b), under which ACF may release information from this system of records without the consent of the data subject. Each proposed disclosure of information under these routine uses will be evaluated to ensure that the disclosure is legally permissible, including but not limited to ensuring that the purpose of the disclosure is compatible with the purpose for which the information was collected.

    1. Disclosure for Law Enforcement Purpose. Information may be disclosed to the appropriate federal, state, local, tribal, or foreign agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, if the information is relevant to a violation or potential violation of civil or criminal law or regulation within the jurisdiction of the receiving entity.

    2. Disclosure for Private Relief Legislation. Information may be disclosed to the Office of Management and Budget at any stage in the legislative coordination and clearance process in connection with private relief legislation as set forth in OMB Circular No. A 19.

    3. Disclosure to Congressional Office. Information may be disclosed to a congressional office from the record of an individual in response to a written inquiry from the congressional office made at the written request of the individual.

    4. Disclosure to Department of Justice or in Proceedings. Information may be disclosed to the Department of Justice, or in a proceeding before a court, adjudicative body, or other administrative body before which HHS is authorized to appear, when:

    • HHS, or any component thereof; or

    • any employee of HHS in his or her official capacity; or

    • any employee of HHS in his or her individual capacity where the Department of Justice or HHS has agreed to represent the employee; or

    • the United States, if HHS determines that litigation is likely to affect HHS or any of its components,

    is a party to litigation or has an interest in such litigation, and the use of such records by the Department of Justice or HHS is deemed by HHS to be relevant and necessary to the litigation provided, however, that in each case it has been determined that the disclosure is compatible with the purpose for which the records were collected.

    5. Disclosure to the National Archives. Information may be disclosed to the National Archives and Records Administration in records management inspections.

    6. Disclosure to Contractor. Information may be disclosed to a contractor performing or working on a contract for HHS and who has a need to have access to the information in the performance of its duties or activities for HHS.

    7. Disclosure for Administrative Claim, Complaint, and Appeal. Information may be disclosed to an authorized appeal grievance examiner, formal complaints examiner, equal employment opportunity investigator, arbitrator or other person properly engaged in investigation or settlement of an administrative grievance, complaint, claim, or appeal filed by an employee, but only to the extent that the information is relevant and necessary to the proceeding. Agencies that may obtain information under this routine use include, but are not limited to, the Office of Personnel Management, Office of Special Counsel, Merit Systems Protection Board, Federal Labor Relations Authority, Equal Employment Opportunity Commission, and Office of Government Ethics.

    8. Disclosure in Connection with Litigation. Information may be disclosed in connection with litigation or settlement discussions regarding claims by or against HHS, including public filing with a court, to the extent that disclosure of the information is relevant and necessary to the litigation or discussions.

    9. Disclosure Incident to Requesting Information. Information may be disclosed (to the extent necessary to identify the individual, inform the source of the purpose of the request, and to identify the type of information requested), to any source from which additional information is requested when necessary to obtain information relevant to an agency decision concerning benefits.

    10. Disclosure in the Event of a Security Breach. Information may be disclosed to appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in this system of records, provided the information disclosed is relevant and necessary for that assistance.

    11. Disclosure for Cybersecurity Monitoring Purposes. Records may be disclosed to the U.S. Department of Homeland Security (DHS) if captured in an intrusion detection system used by HHS and DHS pursuant to a DHS cybersecurity program that monitors Internet traffic to and from federal government computer networks to prevent a variety of types of cybersecurity incidents.

    Information may also be disclosed from this system of records to parties outside HHS for any of the uses authorized directly in the Privacy Act at 5 U.S.C. 552a(b)(2) and (b)(4)-(11).

    Disclosure to Consumer Reporting Agencies:

    None.

    Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System— Storage:

    Records are stored in a computer database operated by a contractor.

    Retrievability:

    Records are retrieved by “A” (alien) number or by name, date of birth, or date of entry.

    Safeguards:

    Safeguards conform to the HHS Information Security Program, http://www.hhs.gov/ocio/securityprivacy/index.html.

    Retention and Disposal:

    Records are retained permanently; they are offered to the National Archives every five years (see N1-292-90-04, item 15).

    System Manager and Address:

    Division Director, Division of Budget Policy and Data Analysis, Office of Refugee Resettlement, Administration for Children and Families, Department of Health and Human Services, Mary E. Switzer Building, 330 C Street SW., Washington, DC 20201.

    Notification Procedures:

    Individuals seeking to determine whether this system of records contains information about themselves should address written inquiries to the System Manager. The request should include the name, telephone number and/or email address, Alien Number, and address of the individual, and the request must be signed. Verification of identity as described in HHS's Privacy Act regulations may be required. 45 CFR 5b.5

    The requestor's letter must also provide sufficient particulars to enable ACF to distinguish between records on subject individuals with the same name.

    Record Access Procedures:

    Individuals seeking access to a record about themselves in this system of records should address written inquiries to the System Manager. The request should include the name, telephone number and/or email address, Alien Number, and address of the individual, and should be signed. Verification of identity as described in HHS's Privacy Act regulations may be required. 45 CFR 5b.5

    The requestor's letter must also provide sufficient particulars to enable ACF to distinguish between records on subject individuals with the same name.

    Contesting Record Procedures:

    Individuals seeking to amend a record about themselves in this system of records should address the request for amendment to the System Manager. The request should (1) include the name, telephone number and/or email address, Alien Number, and address of the individual, and should be signed; (2) provide the name or other information about the project that the individual believes contains his or her records; (3) identify the information that the individual believes is not accurate, relevant, timely, or complete; (4) indicate what corrective action is sought; and (5) include supporting justification or documentation for the requested amendment. Verification of identity as described in HHS's Privacy Act regulations may be required. 45 CFR 5b.5

    Record Source Categories:

    Record subjects, Department grantees, and social service agencies. Refugee arrival data from the Department of State's Worldwide Refugee Arrivals Processing System (WRAPS); legacy refugee arrival data from the Department of State's Refugee Data Center; Department of Homeland Security (DHS) U.S. Citizenship and Immigration Services (USCIS) asylum corps grant data and I-730 asylee derivative data with some data elements provided by Customs and Border Protection; DHS/Customs and Border Protection (CBP) data regarding Cubans and Haitians entering the U.S. at land borders or Ports of Entry other than Miami, FL, as well as Iraqi and Afghan Special Immigrants (starting in FY 2008); the Department of Justice (DOJ) Executive Office of Immigration Review (EOIR) asylum grant data; the United States Conference of Catholic Bishops (USCCB) and Church World Services in Miami, FL data for Cuban and Haitian entrants and Havana parolees (including data on Cuban Medical Parolees) entering the U.S. through the Port of Miami; the I-643 form (OMB No. 1615-0070), completed by refugees and asylees, Cuban and Haitian entrants, and Amerasians and submitted to USCIS or ORR when filing an application for adjustment of status.

    Exemptions Claimed for the System:

    None.

    System Number:

    09-80-0327.

    System Name:

    ORR Repatriation Program Records.

    Security Classification:

    Unclassified.

    System Location:

    Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), Department of Health and Human Services (HHS), Mary E. Switzer Building, 330 C Street SW., Washington, DC.

    Categories of Individuals Covered by the System:

    U.S. citizens and their dependents receiving temporary assistance who have been identified by the Department of State as having returned, or been brought from a foreign country to the U.S. because of destitution, illness, war, threat of war, or a similar crisis.

    Categories of Records in the System:

    Records consist of case files, containing:

    • Identifying information including but not limited to name, date of birth, place of birth, gender, Social Security Number (SSN), passport number, case number, citizenship, address;

    • service information, including but not limited to type of case (settlement or exception), resettlement state, case activity (dates and notes);

    • types of assistance requested, including but not limited to financial, food, travel, clothing, medical, other;

    • types of assistance provided, including but not limited to identification numbers, service providers, cost information;

    • medical information, including but not limited to diagnosis, prognosis, mental health status, hospitalization;

    • next-of-kin information, including next of kin name, identification number, address, relationship, telephone numbers;

    • repayment information, including but not limited to deferrals, extensions, referrals to collection agencies and Internal Revenue Service, payments; and

    • travel plans, including but not limited to name of escort, destinations, flight numbers, dates of travel.

    Authority for Maintenance of the System:

    Section 1113 of the Social Security Act, 42 U.S.C. 1313 (Assistance for U.S. Citizens Returned from Foreign Countries) and 24 U.S.C. 321-329 (Hospitalization of mentally ill nationals returned from foreign countries).

    Purpose(s):

    Records are used by HHS/ACF/ORR to administer the United States Repatriation Program, which provides temporary assistance to U.S. citizens and their dependents who have been identified by the Department of State as having returned, or been brought from a foreign country to the U.S. because of destitution, illness, war, threat of war, or a similar crisis. Temporary assistance may include money payments, medical care, temporary billeting, transportation, and other goods and services necessary for the health or welfare of individuals (including guidance, counseling, and other welfare services), furnished to United States citizens and their dependents who are without available resources in the U.S. upon their arrival from abroad and for up to 90 days after their arrival, not exceeding 90 days as may be provided in regulations of the Secretary of HHS. All temporary assistance provided under the Program and allocable to individual recipients is repayable to the federal government. HHS' Program Support Center administers debt collection for these repayments.

    Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of Such Uses:

    These routine uses specify circumstances, in addition to those provided by statute in the Privacy Act of 1974, 5 U.S.C. 552a(b), under which ACF may release information from this system of records without the consent of the data subject. Each proposed disclosure of information under these routine uses will be evaluated to ensure that the disclosure is legally permissible, including but not limited to ensuring that the purpose of the disclosure is compatible with the purpose for which the information was collected.

    1. Disclosure to Department of State. Information may be disclosed to the Department of State in connection with determinations of eligibility, referral, planning, and provision of temporary assistance of or in cases referred to HHS.

    2. Disclosure to States. Information may be disclosed to the states in connection with coordination and/or provision of temporary services for eligible repatriates.

    3. Disclosure to Service Provider. Information may be disclosed to providers of services (e.g. community-based organizations, hospitals) and to local state institutions (e.g., courts and social service agencies) that assist in coordination and/or the provision of temporary services.

    4. Disclosure to Agency for Temporary Services. Information may be disclosed to other federal agencies and non-governmental agencies for planning or provision of temporary services to eligible repatriates.

    Federal agencies include but are not limited to Department of State, Department of Defense, Department of Justice, Department of Homeland Security, Department of Housing and Urban Development, Federal Emergency Management Agency, Department of Agriculture, and United States Department of Transportation. Non-governmental agencies include but are not limited to American Red Cross and Salvation Army.

    5. Disclosure for Law Enforcement Purpose. Information may be disclosed to the appropriate federal, state, local, tribal, or foreign agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, if the information is relevant to a violation or potential violation of civil or criminal law or regulation within the jurisdiction of the receiving entity.

    6. Disclosure Incident to Requesting Information. Information may be disclosed (to the extent necessary to identify the individual, inform the source of the purpose of the request, and to identify the type of information requested), to any source from which additional information is requested when necessary to obtain information relevant to an agency decision concerning retention of an employee or other personnel action (other than hiring), retention of a security clearance, the letting of a contract, or the issuance or retention of a grant, or other benefit.

    7. Disclosure for Employee Retention, Security Clearance, Contract, or Other Benefit. Disclosure may be made to a federal, state, local, foreign, or tribal or other public authority of the fact that this system of records contains information relevant to the retention of an employee, the retention of a security clearance, the letting of a contract, or the issuance or retention of a license, grant, or other benefit. The other agency or licensing organization may then make a request supported by the written consent of the individual for the entire record if it so chooses. No disclosure will be made unless the information has been determined to be sufficiently reliable to support a referral to another office within HHS or to another federal agency for criminal, civil, administrative, personnel, or regulatory action.

    8. Disclosure for Private Relief Legislation. Information may be disclosed to the Office of Management and Budget at any stage in the legislative coordination and clearance process in connection with private relief legislation as set forth in OMB Circular No. A 19.

    9. Disclosure to Congressional Office. Information may be disclosed to a congressional office from the record of an individual in response to a written inquiry from the congressional office made at the written request of the individual.

    10. Disclosure to Department of Justice or in Proceedings. Information may be disclosed to the Department of Justice, or in a proceeding before a court, adjudicative body, or other administrative body before which HHS is authorized to appear, when:

    • HHS, or any component thereof; or

    • any employee of HHS in his or her official capacity; or

    • any employee of HHS in his or her individual capacity where the Department of Justice or HHS has agreed to represent the employee; or

    • the United States, if HHS determines that litigation is likely to affect HHS or any of its components,

    is a party to litigation or has an interest in such litigation, and the use of such records by the Department of Justice or HHS is deemed by HHS to be relevant and necessary to the litigation provided, however, that in each case it has been determined that the disclosure is compatible with the purpose for which the records were collected.

    11. Disclosure to the National Archives. Information may be disclosed to the National Archives and Records Administration in records management inspections.

    12. Disclosure to Contractors, Grantees, and Others. Information may be disclosed to contractors, grantees, consultants, or volunteers performing or working on a contract, service, grant, cooperative agreement, job, or other activity for HHS and who have a need to have access to the information in the performance of their duties or activities for HHS.

    13. Disclosure for Administrative Claim, Complaint, and Appeal. Information may be disclosed to an authorized appeal grievance examiner, formal complaints examiner, equal employment opportunity investigator, arbitrator or other person properly engaged in investigation or settlement of an administrative grievance, complaint, claim, or appeal filed by an employee, but only to the extent that the information is relevant and necessary to the proceeding. Agencies that may obtain information under this routine use include, but are not limited to, the Office of Personnel Management, Office of Special Counsel, Merit Systems Protection Board, Federal Labor Relations Authority, Equal Employment Opportunity Commission, and Office of Government Ethics.

    14. Disclosure to Office of Personnel Management. Information may be disclosed to the Office of Personnel Management pursuant to that agency's responsibility for evaluation and oversight of federal personnel management.

    15. Disclosure in Connection with Litigation. Information may be disclosed in connection with litigation or settlement discussions regarding claims by or against HHS, including public filing with a court, to the extent that disclosure of the information is relevant and necessary to the litigation or discussions.

    16. Disclosure in the Event of a Security Breach. Information may be disclosed to appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in this system of records, provided the information disclosed is relevant and necessary for that assistance.

    17. Disclosure for Cybersecurity Monitoring Purposes. Records may be disclosed to the U.S. Department of Homeland Security (DHS) if captured in an intrusion detection system used by HHS and DHS pursuant to a DHS cybersecurity program that monitors Internet traffic to and from federal government computer networks to prevent a variety of types of cybersecurity incidents.

    Information may also be disclosed from this system of records to parties outside HHS for any of the uses authorized directly in the Privacy Act at 5 U.S.C. 552a(b)(2) and (b)(4)-(12).

    Disclosure to Consumer Reporting Agencies:

    The HHS Program Support Center may make disclosures to consumer reporting agencies regarding debts referred from repatriation activities. See System of Records 09-40-0012 Debt Management and Collection System.

    Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System— Storage:

    Records are stored on grantee's computer network and safe/file cabinet.

    Retrievability:

    Records are retrieved by name of recipient, case file, or SSN.

    Safeguards:

    Safeguards conform to the HHS Information Security Program, http://www.hhs.gov/ocio/securityprivacy/index.html.

    Retention and Disposal:

    Files are transferred to a Federal Records Center one year after termination of collection efforts, and are destroyed five years after termination of collection efforts (see N1-292-93-1).

    System Manager and Address:

    Manager, Repatriation Program, Office of Refugee Resettlement, Administration for Children and Families, Department of Health and Human Services, Mary E. Switzer Building, 330 C Street SW., Washington, DC 20201.

    Notification Procedures:

    Individuals seeking to determine whether this system of records contains information about themselves should address written inquiries to the System Manager. The request should include the name, telephone number and/or email address, SSN, and address of the individual, and the request must be signed. The requester's letter must provide sufficient particulars to enable the System Manager to distinguish between records on subject individuals with the same name. Verification of identity as described in HHS's Privacy Act regulations may be required. 45 CFR 5b.5

    Record Access Procedures:

    Individuals seeking access to a record about themselves in this system of records should address written inquiries to the System Manager. The request should include the name, telephone number and/or email address, SSN, and address of the individual, and should be signed. The requester's letter must provide sufficient particulars to enable the System Manager to distinguish between records on subject individuals with the same name. Verification of identity as described in HHS's Privacy Act regulations may be required. 45 CFR 5b.5

    Contesting Record Procedures:

    Individuals seeking to amend a record about themselves in this system of records should address the request for amendment to the System Manager. The request should (1) include the name, telephone number and/or email address, SSN, and address of the individual, and should be signed; (2) identify the system of records that the individual believes includes his or her records or otherwise provide enough information to enable the identification of the individual's record; (3) identify the information that the individual believes in not accurate, relevant, timely, or complete; (4) indicate what corrective action is sought; and (5) include supporting justification or documentation for the requested amendment. Verification of identity as described in HHS's Privacy Act regulations may be required. 45 CFR 5b.5.

    Record Source Categories:

    Information may be obtained from a wide variety of institutions and individuals involved who may be in the process or repatriation and/or deportation. Sources include the record subject; representatives and relatives of the record subject; Department of State and other federal agencies; international agencies; foreign governments; social service organizations; employers; state agencies; health care institutions; and other sources including public information.

    Exemptions Claimed for the System:

    None.

    System Number:

    09-80-0329.

    System Name:

    ORR Unaccompanied Refugee Minors Records.

    Security Classification:

    Unclassified.

    System Location:

    Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), Department of Health and Human Services (HHS), Mary E. Switzer Building, 330 C Street SW., Washington, DC.

    Categories of Individuals Covered by the System:

    Refugee unaccompanied children who are admitted from refugee camps overseas or determined eligible after arrival in the United States and do not have a parent or a relative available and committed to providing for their long term care; children eligible for benefits as victims of a severe form of trafficking; entrant children with Cuban-Haitian Entrant designation; and unaccompanied minor children granted asylum in the United States, Special Immigrant Juvenile Status, or U status.

    The Privacy Act applies only to U.S. persons (citizens of the United States or aliens lawfully admitted for permanent residence in the United States). As a matter of discretion, ORR will treat information that it maintains in its mixed systems of records as being subject to the provisions of the Privacy Act, regardless of whether or not the information relates to U.S. persons covered by the Privacy Act. This implements a 1975 Office of Management and Budget (OMB) recommendation to apply, as a matter of policy, the administrative provisions of the Privacy Act to records about non-U.S. persons in mixed systems of records (referred to as the non-U.S. persons policy).

    Categories of Records in the System:

    Records consist of database records and hard copy case files:

    • The database includes information reported on ORR Forms 3 and 4 (name, address, alien number, country of origin, immigration classification, parents' names, national and local refugee resettlement agency, child welfare agency, school progress, English language acquisition, education progress, social adjustment, health conditions, family reunion, emancipation information, etc.), eligibility determinations, identifying information, placement, and progress summaries are recorded.

    • Hard copy case files include letters and forms documenting the reclassification and designation of individuals covered by the systems, tracking documents, and case notes. Electronic files include messages used for determining placements.

    Authority for Maintenance of the System:

    8 U.S.C. 1521, 1522; Title V of the Refugee Education Assistance Act of 1980, 8 U.S.C. 1522 note.

    Purpose(s):

    Records are used by HHS/ACF/ORR to establish legal responsibility, under state law, to ensure that unaccompanied minor refugees and entrants receive the full range of assistance, care, and services which are available to all foster children in the state; a legal authority is designated to act in place of the child's unavailable parent(s). Reunification of children with their parents or other appropriate adult relatives is encouraged, through family tracing and coordination with local refugee resettlement agencies. Additional services provided include: Indirect financial support for housing, food, clothing, medical care and other necessities; intensive case management by social workers; independent living skills training; educational supports; English language training; career/college counseling and training; mental health services; assistance adjusting immigration status; cultural activities; recreational opportunities; support for social integration; and cultural and religious preservation.

    Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of Such Uses:

    These routine uses specify circumstances, in addition to those provided by statute in the Privacy Act of 1974, 5 U.S.C. 552a(b), under which ACF may release information from this system of records without the consent of the data subject. Each proposed disclosure of information under these routine uses will be evaluated to ensure that the disclosure is legally permissible, including but not limited to ensuring that the purpose of the disclosure is compatible with the purpose for which the information was collected.

    1. Disclosure to Attorney. Information may be disclosed to an attorney or representative (as defined in 8 CFR 1.2) who is acting on behalf of an individual covered by this system of records in connection with any proceeding before the Department of Homeland Security or the Executive Office for Immigration Review.

    2. Disclosure to a Protection or Advocacy Organization. Information may be disclosed to a protection or advocacy organization when access is authorized and the request is appropriately made under the Protection and Advocacy for Individuals with Mental Illness Act, 42 U.S.C. 10801 et seq.

    3. Disclosure to Department of Homeland Security for Immigration Relief. Information may be disclosed to the Department of Homeland Security for the purpose of adjudicating or deciding immigration relief.

    4. Disclosure to Service Provider. Information may be disclosed to a provider of services to refugee minors, foster care agency, national voluntary refugee resettlement agency, or to a local, county or State institution (e.g., State refugee coordinator, child welfare agency, court, or social service agency) involved in resettlement activities.

    5. Disclosure for Law Enforcement Purpose. Information may be disclosed to the appropriate federal, state, local, tribal, or foreign agency responsible for investigating, prosecuting, enforcing, or implementing a statute, rule, regulation, or order, if the information is relevant to a violation or potential violation of civil or criminal law or regulation within the jurisdiction of the receiving entity.

    6. Disclosure for Private Relief Legislation. Information may be disclosed to the Office of Management and Budget at any stage in the legislative coordination and clearance process in connection with private relief legislation as set forth in OMB Circular No. A 19.

    7. Disclosure to Congressional Office. Information may be disclosed to a congressional office from the record of an individual in response to a written inquiry from the congressional office made at the written request of the individual.

    8. Disclosure to Department of Justice or in Proceedings. Information may be disclosed to the Department of Justice, or in a proceeding before a court, adjudicative body, or other administrative body before which HHS is authorized to appear, when:

    • HHS, or any component thereof; or

    • any employee of HHS in his or her official capacity; or

    • any employee of HHS in his or her individual capacity where the Department of Justice or HHS has agreed to represent the employee; or

    • the United States, if HHS determines that litigation is likely to affect HHS or any of its components,

    is a party to litigation or has an interest in such litigation, and the use of such records by the Department of Justice or HHS is deemed by HHS to be relevant and necessary to the litigation provided, however, that in each case it has been determined that the disclosure is compatible with the purpose for which the records were collected.

    9. Disclosure to the National Archives. Information may be disclosed to the National Archives and Records Administration in records management inspections.

    10. Disclosure to Contractors, Grantees, and Others. Information may be disclosed to contractors, grantees, consultants, or volunteers performing or working on a contract, service, grant, cooperative agreement, job, or other activity for HHS and who have a need to have access to the information in the performance of their duties or activities for HHS.

    11. Disclosure for Administrative Claim, Complaint, and Appeal. Information from this system of records may be disclosed to an authorized appeal grievance examiner, formal complaints examiner, equal employment opportunity investigator, arbitrator or other person properly engaged in investigation or settlement of an administrative grievance, complaint, claim, or appeal filed by an employee, but only to the extent that the information is relevant and necessary to the proceeding. Agencies that may obtain information under this routine use include, but are not limited to, the Office of Personnel Management, Office of Special Counsel, Merit Systems Protection Board, Federal Labor Relations Authority, Equal Employment Opportunity Commission, and Office of Government Ethics.

    12. Disclosure to Office of Personnel Management. Information from this system of records may be disclosed to the Office of Personnel Management pursuant to that agency's responsibility for evaluation and oversight of federal personnel management.

    13. Disclosure in Connection with Litigation. Information from this system of records may be disclosed in connection with litigation or settlement discussions regarding claims by or against HHS, including public filing with a court, to the extent that disclosure of the information is relevant and necessary to the litigation or discussions.

    14. Disclosure in the Event of a Security Breach. Information may be disclosed to appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in this system of records, provided the information disclosed is relevant and necessary for that assistance.

    15. Disclosure for Cybersecurity Monitoring Purposes. Records may be disclosed to the U.S. Department of Homeland Security (DHS) if captured in an intrusion detection system used by HHS and DHS pursuant to a DHS cybersecurity program that monitors Internet traffic to and from federal government computer networks to prevent a variety of types of cybersecurity incidents.

    Information may also be disclosed from this system of records to parties outside HHS for any of the uses authorized directly in the Privacy Act at 5 U.S.C. 552a(b)(2) and (b)(4)-(11).

    Disclosure to Consumer Reporting Agencies:

    None.

    Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System— Storage:

    Computer records are stored on a computer network. Paper records are stored in file folders.

    Retrievability:

    Records of refugee unaccompanied minors, reclassified refugee unaccompanied minors, children who are eligible for benefits as victims of a severe form of trafficking, entrant minor children of the Cuban-Haitian Entrant programs and minor children granted asylum, Special Immigrant Juvenile Status or U status are retrieved by name and alien numbers from the ORR database.

    Safeguards:

    Safeguards conform to the HHS Information Security Program, http://www.hhs.gov/ocio/securityprivacy/index.html.

    Retention and Disposal:

    Database records are retained permanently; they are offered to the National Archives every five years (see N1-292-90-04, item 15). Case files are retained for five years following receipt of the final progress report (see N1-292-90-4, item 34).

    System Manager and Address:

    Director, Division of Children's Services, Office of Refugee Resettlement, Administration for Children and Families, Department of Health and Human Services, Mary E. Switzer Building, 330 C Street SW., Washington, DC 20201.

    Notification procedures:

    Individuals seeking to determine whether this system of records contains information about themselves should address written inquiries to the System Manager. The request should include the name, telephone number and/or email address, Alien Number, and address of the individual, and the request must be signed. The requester's letter must provide sufficient particulars to enable the System Manager to distinguish between records on subject individuals with the same name. Verification of identity as described in HHS's Privacy Act regulations may be required. 45 CFR 5b.5

    Record Access Procedures:

    Individuals seeking access to a record about themselves in this system of records should address written inquiries to the System Manager. The request should include the name, telephone number and/or email address, Alien Number, and address of the individual, and should be signed. The requester's letter must provide sufficient particulars to enable the System Manager to distinguish between records on subject individuals with the same name. Verification of identity as described in HHS's Privacy Act regulations may be required. 45 CFR 5b.5

    Contesting Record Procedures:

    Individuals seeking to amend a record about themselves in this system of records should address the request for amendment to the System Manager. The request should (1) include the name, telephone number and/or email address, Alien Number, and address of the individual, and should be signed; (2) identify the system of records that the individual believes includes his or her records or otherwise provide enough information to enable the identification of the individual's record; (3) identify the information that the individual believes in not accurate, relevant, timely, or complete; (4) indicate what corrective action is sought; and (5) include supporting justification or documentation for the requested amendment. Verification of identity as described in HHS's Privacy Act regulations may be required. 45 CFR 5b.5

    Record Source Categories:

    Record subject, national and local voluntary refugee resettlement agencies, child welfare agencies, family members, private individuals, private and public hospitals, doctors, law enforcement agencies and officials, private attorneys, facilities reports, third parties, other Federal agencies, State and local governments, agencies and instrumentalities.

    Exemptions Claimed for the System:

    None.

    System Number:

    09-80-0388.

    System Name:

    ORR Refugee Suicide Database.

    Security Classification:

    Unclassified.

    System Location:

    Datacenter for Administration for Children and Families (ACF), Department of Health and Human Services (HHS), Mary E. Switzer Building, 330 C Street SW., Washington, DC

    Categories of Individuals Covered by the System:

    Records pertain to individuals in ORR populations reported as unsuccessfully attempting a suicide in the United States. ORR populations include refugees, asylees, Cuban/Haitian entrants, Afghan and Iraqi Special Immigrants, certain Amerasians, and victims of human trafficking.

    The Privacy Act applies only to U.S. persons (citizens of the United States or aliens lawfully admitted for permanent residence in the United States). As a matter of discretion, ORR will treat information that it maintains in its mixed systems of records as being subject to the provisions of the Privacy Act, regardless of whether or not the information relates to U.S. persons covered by the Privacy Act. This implements a 1975 Office of Management and Budget (OMB) recommendation to apply, as a matter of policy, the administrative provisions of the Privacy Act to records about non-U.S. persons in mixed systems of records (referred to as the non-U.S. persons policy).

    Categories of Records in the System:

    Records consist of data reported by states and other resettlement organizations, using the Refugee Suicide and Self-Harm Report Form, which ORR enters into spreadsheets. The records may include the following information about the individual who attempted suicide: Alien number; country of origin; age; gender; residence (city/county, state); estimated length of time in the U.S.; date of suicide attempt; outcome of suicide attempt; household members (type of relationship); ORR population type; current immigration status; marital/relationship status; employment status at time of suicide attempt; health insurance status; English proficiency; religion; method of suicide attempted; place of occurrence; contributing factors; and mental health concerns.

    Authority of Maintenance of the System:

    Section 412(b)(4) of the Immigration and Nationality Act (8 U.S.C. 1522(b)(4))

    Purpose(s):

    ORR will use records in the Refugee Suicide Database to identify trends and factors related to suicidal behavior among ORR populations. Additionally, ORR will use the records to plan, implement, and evaluate suicide prevention and intervention activities, in collaboration with local, state, and national government agencies and organizations serving the refugee population.

    Routine uses of records maintained in the system, including categories of users and the purposes of such users:

    These routine uses specify circumstances under which ACF may disclose information from this system of records without the prior written consent of the data subject. Each proposed disclosure of information under these routine uses will be evaluated to ensure that the disclosure is legally permissible, including but not limited to ensuring that the purpose of the disclosure is compatible with the purpose for which the information was collected.

    1. Disclosure to Government Agencies and Organizations Assisting the Refugee Population. Information will be shared with local, state, and national government agencies and organizations serving the refugee population, for the purpose of collaborating with them to plan, implement, and evaluate suicide prevention and intervention activities.

    2. Disclosure to Contractors, Grantees, and Others. Information may be disclosed to contractors, grantees, consultants, or volunteers performing or working on a contract, service, grant, cooperative agreement, job, or memorandum of understanding, or other activity for HHS related to the purposes of the system, and who have a need to have access to the information in the performance of their duties or activities for HHS.

    3. Disclosure in the Event of a Security Breach. Records may be disclosed to appropriate federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in this system of records, when the information disclosed is relevant and necessary for that assistance.

    4. Disclosure for Cybersecurity Monitoring Purposes. Records may be disclosed to the U.S. Department of Homeland Security (DHS) if captured in an intrusion detection system used by HHS and DHS pursuant to a DHS cybersecurity program that monitors Internet traffic to and from federal government computer networks to prevent a variety of types of cybersecurity incidents.

    Information may also be disclosed from this system of records to parties outside HHS for any of the uses authorized directly in the Privacy Act at 5 U.S.C. 552a(b)(2) and (b)(4)-(11).

    Disclosures to Consumer Reporting Agencies:

    None.

    Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System— Storage:

    Records are stored in an electronic database on a computer network.

    Retrievability:

    Records are retrieved by alien number.

    Safeguards:

    Information in this system is safeguarded in accordance with applicable laws, rules and policies. Records are protected from unauthorized access through appropriate administrative, physical, and technical safeguards. Access to the records is restricted to authorized personnel (a limited number of employees in ORR with access to the database, and a limited number of employees in other HHS offices, e.g., CDC and SAMHSA, receiving data from ORR) who are advised of the confidentiality of the records and the civil and criminal penalties for misuse. Personnel with authorized access to the system are provided privacy and security training for electronically stored information. The records are processed and stored in a secure environment. All records are stored in an area that is physically safe from access by unauthorized persons at all times. Safeguards conform to the HHS Information Security Program, http://www.hhs.gov/ocio/securityprivacy/index.html.

    Retention and Disposal:

    The records will be retained indefinitely pending scheduling with the National Archives and Records Administration (NARA). Because the records will have continuing value for epidemiological purposes, the retention period proposed to NARA may be 100 years or longer.

    System manager and address:

    Director, Division of Refugee Health, Office of Refugee Resettlement, Administration for Children and Families, Mary E. Switzer Building, 330 C Street SW., Washington, DC 20201.

    Notification procedure:

    Individuals seeking to determine whether this system of records contains information about them should address written inquiries to the System Manager. The request should include the alien number, age, telephone number, and/or email address of the individual data subject. The request must be signed by the requester. Verification of identity as described in the Department's Privacy Act regulations may be required (see 45 CFR 5b.5). If the individual data subject is a minor or is legally incompetent, the individual's legal representative (parent or court-appointed guardian) may request notification on the individual's behalf. The representative must provide verification of identity and competent evidence of the parent or guardian relationship.

    Record access procedures:

    Individuals seeking access to a record about them in this system of records should address written inquiries to the System Manager. The request should include the alien number, age, telephone number, and/or email address of the individual. The request must be signed by the individual to whom such information pertains. Verification of identity as described in the Department's Privacy Act regulations may be required (see 45 CFR 5b.5). If the individual data subject is a minor or is legally incompetent, the individual's legal representative (parent or court-appointed guardian) may request access on the individual's behalf. The representative must provide verification of identity and competent evidence of the parent or guardian relationship.

    Contesting record procedures:

    Individuals seeking to amend a record about them in this system of records should address the request for amendment to the System Manager. The request should:

    • Include the alien number, age, telephone number, and/or email address of the individual, and should be signed by the individual to whom such information pertains;

    • identify the system of records that the individual believes includes his or her records or otherwise provide enough information to enable the identification of the individual's record;

    • identify the information that the individual believes is not accurate, relevant, timely or complete;

    • indicate what corrective action is sought; and

    • include supporting justification or documentation for the requested amendment.

    Verification of identity as described in the Department's Privacy Act regulations may be required (see 45 CFR 5b.5). If the individual data subject is a minor or is legally incompetent, the individual's legal representative (parent or court-appointed guardian) may make an amendment request on the individual's behalf. The representative must provide verification of identity and competent evidence of the parent or guardian relationship.

    Record source categories:

    The information maintained in the system is provided by states and other resettlement organizations when they report a suicide attempt using the Refugee Suicide and Report Form. The State Refugee Coordinator and State Refugee Health Coordinator will be primarily responsible for reporting this information. They will collect the information from various sources within the state including refugee resettlement agencies, public health departments, ethnic-based community organizations, and refugee community leaders.

    Exemptions claimed for the system:

    None.

    [FR Doc. 2016-16812 Filed 7-15-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0031] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Clinical Laboratory Improvement Amendments Act of 1988 Waiver Applications AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by August 17, 2016.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to [email protected] All comments should be identified with the OMB control number 0910-0598. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    CLIA Waiver Applications—OMB Control Number 0910-0598—Extension

    Congress passed the CLIA (Pub. L. 100-578) in 1988 to establish quality standards for all laboratory testing. The purpose was to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test took place. CLIA requires that clinical laboratories obtain a certificate from the Secretary of Health and Human Services (the Secretary), before accepting materials derived from the human body for laboratory tests (42 U.S.C. 263a(b)). Laboratories that perform only tests that are “simple” and that have an “insignificant risk of an erroneous result” may obtain a certificate of waiver (42 U.S.C. 263a(d)(2)). The Secretary has delegated to FDA the authority to determine whether particular tests (waived tests) are “simple” and have “an insignificant risk of an erroneous result” under CLIA (69 FR 22849, April 27, 2004).

    On January 30, 2008, FDA published a guidance document entitled “Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079632.htm). This guidance document describes recommendations for device manufacturers submitting to FDA an application for determination that a cleared or approved device meets this CLIA standard (CLIA waiver application). The guidance recommends that CLIA waiver applications include a description of the features of the device that make it “simple”; a report describing a hazard analysis that identifies potential sources of error, including a summary of the design and results of flex studies and conclusions drawn from the flex studies; a description of fail-safe and failure alert mechanisms and a description of the studies validating these mechanisms; a description of clinical tests that demonstrate the accuracy of the test in the hands of intended operators; and statistical analyses of clinical study results.

    In the Federal Register of April 1, 2016 (81 FR 18858), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Activity Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Average
  • burden per
  • response
  • Total hours Total operating and
  • maintenance
  • costs
  • CLIA waiver application 40 1 40 1,200 48,000 $350,000 1 There are no capital costs associated with this collection of information.
    Table 2—Estimated Annual Recordkeeping Burden 1 Activity Number of
  • recordkeepers
  • Number of
  • records per
  • recordkeeper
  • Total annual records Average
  • burden per
  • recordkeeping
  • Total hours
    CLIA waiver records 40 1 40 2,800 112,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    The total number of reporting and recordkeeping hours is 160,000 hours. FDA bases the burden on an Agency analysis of premarket submissions with clinical trials similar to the waived laboratory tests. Based on previous years' experience with CLIA waiver applications, FDA expects 40 manufacturers to submit one CLIA waiver application per year. The time required to prepare and submit a waiver application, including the time needed to assemble supporting data, averages 1,200 hours per waiver application for a total of 48,000 hours for reporting. Based on previous years' experience with CLIA waiver applications, FDA expects that each manufacturer will spend 2,800 hours creating and maintaining the record for a total of 112,000 hours.

    The total operating and maintenance cost associated with the waiver application is estimated at $350,000. This cost is largely attributed to clinical study costs incurred, which include site selection and qualification, protocol review, and study execution (initiation, monitoring, closeout, and clinical site/subject compensation—including specimen collection for study as well as shipping and supplies).

    Dated: July 13, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-16886 Filed 7-15-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Public Workshop AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshop.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the following public workshop entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers.” The topics to be discussed are the current regulatory environment for these activities, the definitions of the various terms FDA proposed in the prior Federal Register notice on this subject, and whether these activities should appropriately be regulated by FDA or a non-governmental organization.

    DATES:

    The public workshop will be held on October 27, 2016, from 8:30 a.m. to 5 p.m. and October 28, 2016, from 8:30 a.m. to 4 p.m.

    ADDRESSES:

    The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    FOR FURTHER INFORMATION CONTACT:

    Felicia Brayboy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3464, Silver Spring, MD 20993, 301-796-8086, [email protected].

    SUPPLEMENTARY INFORMATION:

    I. Background

    On March 4, 2016, FDA published in the Federal Register a notice (81 FR 11477) requesting comments from interested persons, including those engaged or otherwise interested in the “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices,” including radiation-emitting devices subject to the electronic product radiation control provisions of the Federal Food, Drug, and Cosmetic Act. FDA took this action, in part, because various stakeholders have expressed concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities. This docket asked that interested persons, including Original equipment manufacturers (OEMs), health care establishments, and third-party entities review proposed terms and definitions and provide edits if applicable. The docket also sought insights into basic concepts with regard to these activities. FDA is currently reviewing all of the comments and will use them to inform a set of working questions designed to promote an understanding of challenges and best practices to mitigate risks associated with these activities. These working questions will be addressed in group discussions on both days of the workshop.

    II. Topics for Discussion at the Public Workshop

    The public workshop sessions will incorporate the following general themes pertaining to the refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, and servicing of medical devices:

    • Establish working definitions for third-party and OEM activities.

    • Discuss benefits and challenges that stakeholders encounter, potential benefits and risks to patients/users, and failure modes of devices introduced as a result of performing activities associated with third-party entities.

    • Identify current best practices and discuss alternative methods to mitigate risks associated with performing activities associated with third-party entities.

    • Determine whether specific procedures are necessary for each activity as it relates to third-party services performed.

    Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by September 23, 2016, by 4 p.m. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration on the day of the public workshop; will be provided beginning at 7:30 a.m.

    If you need special accommodations due to a disability, please contact Peggy Roney, Office of Communication, Education, and Radiation Programs, 301-796-5671, email: [email protected], no later than October 13, 2016.

    To register for the public workshop, please visit FDA's Medical Devices News & Events—Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this meeting/public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact Peggy Roney to register (see special accomodations contact). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list.

    Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. The Webcast link will be available on the registration Web page after October 20, 2016. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    Requests for Oral Presentations: This public workshop includes a public comment session and topic-focused sessions. During online registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topics you wish to address. FDA has included general topics in this document. FDA will do its best to accommodate requests to make public comments and participate in the focused sessions. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by September 30, 2016. All r