Federal Register Vol. 81, No.61,

Federal Register Volume 81, Issue 61 (March 30, 2016)

Page Range17601-18445
FR Document

81_FR_61
Current View
Page and SubjectPDF
81 FR 17689 - Sunshine Act NoticePDF
81 FR 17767 - Notice of order soliciting community proposalsPDF
81 FR 17752 - Sunshine Act Meeting; CorrectionPDF
81 FR 17739 - Request for Comments on Category Management Policy 16-2: Improving the Acquisition and Management of Common Information Technology: Mobile Devices and ServicesPDF
81 FR 17665 - Certain Petroleum Wax Candles From the People's Republic of China: Final Results of Expedited Fourth Sunset Review of the Antidumping Duty OrderPDF
81 FR 17697 - Applicability Determination Index (ADI) Data System Recent Posting: Agency Applicability Determinations, Alternative Monitoring Decisions, and Regulatory Interpretations Pertaining to Standards of Performance for New Stationary Sources, National Emission Standards for Hazardous Air Pollutants, and the Stratospheric Ozone Protection ProgramPDF
81 FR 17755 - 60-Day Notice of Proposed Information Collection: Electronic Diversity Visa Entry FormPDF
81 FR 17754 - 60-Day Notice of Proposed Information Collection: Statement of Consent: Issuance of a U.S. Passport to a Minor Under Age 16PDF
81 FR 17753 - 60-Day Notice of Proposed Information Collection: Statement of Exigent/Special Family Circumstances for Issuance of a U.S. Passport to a Minor Under Age 16PDF
81 FR 17754 - Culturally Significant Objects Imported for Exhibition Determinations: “High Society: The Portraits of Franz X. Winterhalter” ExhibitionPDF
81 FR 17755 - Notice of Public MeetingPDF
81 FR 17694 - Agency Information Collection Activities; Proposed New Collection (EPA ICR No. 2532.01); Comment RequestPDF
81 FR 17696 - Notice of a Public Meeting and Webinar: Managing Cyanotoxins in Drinking WaterPDF
81 FR 17690 - Quadrennial Energy Review: Notice of Public MeetingPDF
81 FR 17758 - Agency Information Collection Activities: Notice of Request for Approval of a New Information CollectionPDF
81 FR 17735 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; National Park Service Institutional Animal Care and Use Committee (NPS IACUC) Amendment, Annual Review, Exhibition, and General Submission FormsPDF
81 FR 17619 - Proposed Establishment of Temporary Restricted Areas R-2509E, R-2509W, and R-2509N; Twentynine Palms, CAPDF
81 FR 17756 - Guidance on the Procedures and Process To Petition the Secretary Under the Airport and Airway Improvement ActPDF
81 FR 17729 - Renewal of Approved Information Collection; OMB Control No. 1004-0121PDF
81 FR 17732 - Renewal of Approved Information CollectionPDF
81 FR 17687 - Proposed Collection; Comment RequestPDF
81 FR 17686 - Proposed Information Collection; Comment RequestPDF
81 FR 17693 - Application To Export Electric Energy; Intercom Energy, Inc.PDF
81 FR 17693 - Application To Export Electric Energy; Cargill Power Markets, LLCPDF
81 FR 17692 - Application To Export Electric Energy; Cargill Power Markets, LLCPDF
81 FR 17689 - Notice of Public Meeting To Inform the Design of a Consent-Based Siting Process for Nuclear Waste Storage and Disposal FacilitiesPDF
81 FR 17690 - Notice of Public Meeting To Inform the Design of a Consent-Based Siting Process for Nuclear Waste Storage and Disposal FacilitiesPDF
81 FR 17694 - Notice of Public Meeting To Inform the Design of a Consent-Based Siting Process for Nuclear Waste Storage and Disposal FacilitiesPDF
81 FR 17601 - Investment and Deposit Activities-Bank NotesPDF
81 FR 17610 - FeesPDF
81 FR 17712 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
81 FR 17617 - Technology Transitions, Policies and Rules Governing Retirement of Copper Loops by Incumbent Local Exchange Carriers and Special Access for Price Cap Local Exchange Carriers; CorrectionPDF
81 FR 17739 - National Industrial Security Program Policy Advisory Committee (NISPPAC)PDF
81 FR 17739 - Freedom of Information Act (FOIA) Advisory Committee; MeetingPDF
81 FR 17760 - Decision That Nonconforming Model Year 2014 Mercedes-Benz SLK Class Passenger Cars Are Eligible for ImportationPDF
81 FR 17763 - Chrysler Group LLC, Grant of Petition for Decision of Inconsequential NoncompliancePDF
81 FR 17764 - Nitto Tire U.S.A, Inc., Grant of Petition for Decision of Inconsequential NoncompliancePDF
81 FR 17688 - Notice of Public Meetings for the Draft Environmental Impact Statement for the Disposal and Reuse of Surplus Property at Naval Station Newport, Rhode IslandPDF
81 FR 17786 - Agency Information Collection Activities; Revision of an Approved Information Collection; Submission for OMB Review; Annual Company-Run Stress Test Reporting Template and Documentation for Covered Institutions With Total Consolidated Assets of $10 Billion to $50 Billion Under the Dodd-Frank Wall Street Reform and Consumer Protection ActPDF
81 FR 17766 - Transportation Research and Development Strategic PlanPDF
81 FR 17720 - Notice of Intent To Prepare a Programmatic Environmental Impact Statement To Review the Federal Coal Program and To Conduct Public Scoping MeetingsPDF
81 FR 17663 - Pacific Northwest National Scenic Trail Advisory CouncilPDF
81 FR 17663 - Shasta County Resource Advisory CommitteePDF
81 FR 17604 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of SponsorshipPDF
81 FR 17716 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial ReviewPDF
81 FR 17718 - Sport Fishing and Boating Partnership CouncilPDF
81 FR 17782 - Request for CommentsPDF
81 FR 17682 - Market Risk Advisory CommitteePDF
81 FR 17617 - Fisheries of the Exclusive Economic Zone Off Alaska; Pollock in Statistical Area 610 in the Gulf of AlaskaPDF
81 FR 17639 - Medication Assisted Treatment for Opioid Use DisordersPDF
81 FR 17713 - FDIC Systemic Resolution Advisory Committee; Notice of MeetingPDF
81 FR 17664 - Notice of Public Meeting of the Oklahoma Advisory Committee To Discuss a Draft Report Regarding the Civil Rights Impact of School Disciplinary Policies That May Contribute to High Rates of Juvenile Incarceration in OklahomaPDF
81 FR 17664 - Notice of Public Meeting of the Kansas Advisory Committee To Review Testimony Regarding Civil Rights and Voting Requirements in the StatePDF
81 FR 17683 - Gree Electric Appliances, Inc. of Zhuhai, Hong Kong Gree Electric Appliances Sales Co., Ltd., and Gree USA Sales, Ltd., Provisional Acceptance of a Settlement Agreement and OrderPDF
81 FR 17740 - Agency Information Collection Activities: Proposed Collection; Comment Request; Investment and Deposit ActivitiesPDF
81 FR 17756 - Notice of Rail Energy Transportation Advisory Committee MeetingPDF
81 FR 17710 - Information Collections Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
81 FR 17716 - National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public MembersPDF
81 FR 17714 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 17708 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
81 FR 17709 - Information Collection Being Reviewed by the Federal Communications CommissionPDF
81 FR 17719 - Advisory Council on Wildlife TraffickingPDF
81 FR 17740 - Integrated Action Plan To Modernize Digital Instrumentation and Controls Regulatory InfrastructurePDF
81 FR 17738 - Avi Weisfogel, D.D.S.; Decision and OrderPDF
81 FR 17734 - Notice of Inventory Completion: University of South Alabama, Center for Archaeological Studies, Mobile, ALPDF
81 FR 17666 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Subsea Cable-Laying Operations in the Bering, Chukchi, and Beaufort SeasPDF
81 FR 17736 - Notice of Inventory Completion: Kamehameha Schools and University of Hawai'i at Hilo, Hilo, HIPDF
81 FR 17736 - Notice of Inventory Completion: Sheriff's Office, Berrien County, Saint Joseph, MIPDF
81 FR 17714 - Notice of Filing of Complaint and AssignmentPDF
81 FR 17637 - Procedures Relating to the Disposition of Property Acquired by the United States Postal Service Office of Inspector General for Use as EvidencePDF
81 FR 17717 - Louisiana; Amendment No. 2 to Notice of a Major Disaster DeclarationPDF
81 FR 17741 - NexPoint Capital, Inc., et al.; Notice of ApplicationPDF
81 FR 17749 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change Amending NYSE Arca Equities Rule 7.31P(h) To Add a New Discretionary Pegged OrderPDF
81 FR 17746 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Rule 6.2 To Create a Reserve Market Maker Options Trading PermitPDF
81 FR 17752 - Self-Regulatory Organizations; New York Stock Exchange LLC; NYSE MKT LLC; Order Granting an Extension to Limited Exemptions From Rule 612(c) of Regulation NMS in Connection With the Exchanges' Retail Liquidity Programs Until August 31, 2016PDF
81 FR 17752 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Granting an Extension to Limited Exemption From Rule 612(c) of Regulation NMS in Connection With the Exchange's Retail Liquidity Program Until August 31, 2016PDF
81 FR 17765 - Oil Spill Response Planning WorkshopPDF
81 FR 17717 - Louisiana; Amendment No. 1 to Notice of a Major Disaster DeclarationPDF
81 FR 17717 - Louisiana; Major Disaster and Related DeterminationsPDF
81 FR 17615 - Suspension of Community EligibilityPDF
81 FR 17761 - General Motors, LLC, Grant of Petition for Decision of Inconsequential NoncompliancePDF
81 FR 17728 - Renewal of Approved Information CollectionPDF
81 FR 17732 - Renewal of Approved Information Collection; Control No. 1004-0001PDF
81 FR 17733 - Notice of Availability and Request for Comments on Draft Director's Order #21 Concerning National Park Service Policies and Procedures Governing Philanthropic PartnershipsPDF
81 FR 17730 - Renewal of Approved Information Collection; Control No. 1004-0114PDF
81 FR 17696 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Regional Haze Regulations (Renewal)PDF
81 FR 17611 - Salicylaldehyde; Exemption From the Requirement of a TolerancePDF
81 FR 17603 - Amendment of Class D Airspace and Class E Airspace; Lynchburg, VAPDF
81 FR 17602 - Amendment of Class D Airspace and Class E Airspace for the Following New York Towns; Ithaca, NY; Poughkeepsie, NYPDF
81 FR 17635 - Safety Zone; Louisiana Dragon Boat Race, Red River Mile Marker, (MM) 88.0 to (MM) 88.5PDF
81 FR 17621 - Administrative ClaimsPDF
81 FR 18389 - Medicaid and Children's Health Insurance Programs; Mental Health Parity and Addiction Equity Act of 2008; the Application of Mental Health Parity Requirements to Coverage Offered by Medicaid Managed Care Organizations, the Children's Health Insurance Program (CHIP), and Alternative Benefit PlansPDF
81 FR 18111 - Leasing of Sulfur or Oil and Gas in the Outer Continental ShelfPDF
81 FR 17789 - Endangered and Threatened Wildlife and Plants; Designation and Nondesignation of Critical Habitat on Molokai, Lanai, Maui, and Kahoolawe for 135 SpeciesPDF
81 FR 18177 - Flight Simulation Training Device Qualification Standards for Extended Envelope and Adverse Weather Event Training TasksPDF

Issue

81 61 Wednesday, March 30, 2016 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 17714-17715 2016-07118 Requests for Nominations: National Advisory Council for Healthcare Research and Quality, 17716 2016-07119 Agriculture Agriculture Department See

Forest Service

AIRFORCE Air Force Department PROPOSED RULES Administrative Claims, 17621-17635 2016-06896 Centers Disease Centers for Disease Control and Prevention NOTICES Meetings: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel, 17716-17717 2016-07134 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicaid and Children's Health Insurance Programs: Mental Health Parity and Addiction Equity Act of 2008; the Application of Mental Health Parity Requirements to Coverage Offered by Medicaid Managed Care Organizations, the Children's Health Insurance Program (CHIP), and Alternative Benefit Plans, 18390-18445 2016-06876 Civil Rights Civil Rights Commission NOTICES Meetings: Kansas Advisory Committee, 17664 2016-07125 Oklahoma Advisory Committee, 17664-17665 2016-07126 Coast Guard Coast Guard PROPOSED RULES Safety Zones: Louisiana Dragon Boat Race, Red River Mile Marker, 17635-17637 2016-06909 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Commodity Futures Commodity Futures Trading Commission NOTICES Meetings: Market Risk Advisory Committee, 17682-17683 2016-07131 Comptroller Comptroller of the Currency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Annual Company-Run Stress Test Reporting Template and Documentation for Covered Institutions with Total Consolidated Assets of $10 Billion to $50 Billion under the Dodd-Frank Wall Street Reform and Consumer Protection Act, 17786-17787 2016-07140 Consumer Product Consumer Product Safety Commission NOTICES Settlement Agreements and Orders: Gree Electric Appliances, Inc. of Zhuhai, Hong Kong Gree Electric Appliances Sales Co., Ltd., and Gree USA Sales, Ltd., 17683-17686 2016-07124 Corporation Corporation for National and Community Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 17686-17687 2016-07160 Defense Department Defense Department See

Air Force Department

See

Navy Department

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 17687 2016-07162
Drug Drug Enforcement Administration NOTICES Decisions and Orders: Avi Weisfogel, D.D.S., 17738-17739 2016-07111 Election Election Assistance Commission NOTICES Meetings; Sunshine Act, 17689 2016-07287 Energy Department Energy Department NOTICES Applications to Export Electric Energy: Cargill Power Markets, LLC, 17692-17693 2016-07156 2016-07157 Intercom Energy, Inc., 17693-17694 2016-07159 Meetings: Inform the Design of a Consent-Based Siting Process for Nuclear Waste Storage and Disposal Facilities, 2016-07152 17689-17690, 17694 2016-07153 2016-07154 2016-07155 Quadrennial Energy Review, 17690-17692 2016-07170 Environmental Protection Environmental Protection Agency RULES Exemption from the Requirement of a Tolerance: Salicylaldehyde, 17611-17615 2016-07085 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 17694-17696 2016-07174 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Regional Haze Regulations, 17696 2016-07087 Guidance: Agency Applicability Determinations, Alternative Monitoring Decisions, and Regulatory Interpretations, etc., 17697-17708 2016-07185 Meetings: Managing Cyanotoxins in Drinking Water, 17696-17697 2016-07173 Federal Aviation Federal Aviation Administration RULES Class D Airspace and Class E Airspace; Amendments: Ithaca, NY; Poughkeepsie, NY, 17602-17603 2016-07077 Lynchburg, VA, 17603-17604 2016-07079 Flight Simulation Training Device Qualification Standards for Extended Envelope and Adverse Weather Event Training Tasks, 18178-18388 2016-05860 PROPOSED RULES Proposed Establishment of Temporary Restricted Areas R-2509E, R-2509W, and R-2509N; Twentynine Palms, CA, 17619-17621 2016-07166 NOTICES Guidance: Procedures and Process to Petition the Secretary under the Airport and Airway Improvement Act, 17756-17758 2016-07165 Federal Communications Federal Communications Commission RULES Technology Transitions, Policies, and Rules Governing Retirement of Copper Loops by Incumbent Local Exchange Carriers and Special Access for Price Cap Local Exchange Carriers; Correction, 17617 2016-07147 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 17708-17713 2016-07115 2016-07116 2016-07117 2016-07121 2016-07148 Federal Deposit Federal Deposit Insurance Corporation NOTICES Meetings: Systemic Resolution Advisory Committee, 17713-17714 2016-07127 Federal Emergency Federal Emergency Management Agency RULES Suspension of Community Eligibility, 17615-17617 2016-07093 NOTICES Major Disaster Declarations: Louisiana; Amendment No. 1, 17717 2016-07095 Louisiana; Amendment No. 2, 17717 2016-07102 Major Disasters and Related Determinations: Louisiana, 17717-17718 2016-07094 Federal Highway Federal Highway Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 17758-17760 2016-07169 Federal Maritime Federal Maritime Commission NOTICES Complaints: Jill M. Alban, et al. v. Nippon Yusen Kabushiki Kaisha, et al., 17714 2016-07105 Fish Fish and Wildlife Service RULES Endangered and Threatened Wildlife and Plants: Designation and Nondesignation of Critical Habitat on Molokai, Lanai, Maui, and Kahoolawe for 135 Species, 17790-18110 2016-06069 NOTICES Meetings: Advisory Council on Wildlife Trafficking, 17719-17720 2016-07113 Sport Fishing and Boating Partnership Council, 17718-17719 2016-07133 Food and Drug Food and Drug Administration RULES New Animal Drugs: Approval of New Animal Drug Applications; Changes of Sponsorship, 17604-17610 2016-07135 Forest Forest Service NOTICES Meetings: Pacific Northwest National Scenic Trail Advisory Council, 17663 2016-07137 Shasta County Resource Advisory Committee, 17663-17664 2016-07136 Health and Human Health and Human Services Department See

Agency for Healthcare Research and Quality

See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

PROPOSED RULES Medication Assisted Treatment for Opioid Use Disorders, 17639-17662 2016-07128
Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

Information Information Security Oversight Office NOTICES Meetings: National Industrial Security Program Policy Advisory Committee, 17739 2016-07146 Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

See

National Park Service

See

Ocean Energy Management Bureau

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Petroleum Wax Candles from the People's Republic of China, 17665-17666 2016-07186 Justice Department Justice Department See

Drug Enforcement Administration

Land Land Management Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 17728-17733 2016-07088 2016-07090 2016-07091 2016-07163 2016-07164 Environmental Impact Statements; Availability, etc.: Federal Coal Program; Public Scoping Meetings, 17720-17728 2016-07138 Management Management and Budget Office NOTICES Category Management Policy 16-2—Improving the Acquisition and Management of Common Information Technology—Mobile Devices and Services, 17739 2016-07192 National Archives National Archives and Records Administration See

Information Security Oversight Office

See

Office of Government Information Services

RULES Fees, 17610-17611 2016-07149
National Credit National Credit Union Administration RULES Investment and Deposit Activities: Bank Notes, 17601-17602 2016-07151 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Investment and Deposit Activities, 17740 2016-07123 National Highway National Highway Traffic Safety Administration NOTICES Importation Eligibility; Petitions: Model Year 2014 Mercedes-Benz SLK Class Passenger Cars, 17760-17761 2016-07144 Petitions for Decisions of Inconsequential Noncompliance: Chrysler Group, LLC, 17763-17764 2016-07143 General Motors, LLC, 17761-17763 2016-07092 Nitto Tire U.S.A, Inc., 17764-17765 2016-07142 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Pollock in Statistical Area 610 in the Gulf of Alaska; Closure, 17617-17618 2016-07129 NOTICES Takes of Marine Mammals Incidental to Specified Activities: Subsea Cable-laying Operations in the Bering, Chukchi, and Beaufort Seas, 17666-17682 2016-07109 National Park National Park Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 17735 2016-07167 Inventory Completions: Kamehameha Schools and University of Hawai'i at Hilo, Hilo, HI, 17736 2016-07107 Sheriff's Office, Berrien County, Saint Joseph, MI, 17736-17737 2016-07106 University of South Alabama, Center for Archaeological Studies, Mobile, AL, 17734-17735 2016-07110 Policies and Procedures Governing Philanthropic Partnerships, 17733-17734 2016-07089 Navy Navy Department NOTICES Meetings: Draft Environmental Impact Statement for the Disposal and Reuse of Surplus Property at Naval Station Newport, Rhode Island, 17688-17689 2016-07141 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Integrated Action Plan to Modernize Digital Instrumentation and Controls Regulatory Infrastructure, 17740-17741 2016-07112 Ocean Energy Management Ocean Energy Management Bureau RULES Leasing of Sulfur or Oil and Gas in the Outer Continental Shelf, 18112-18176 2016-06513 OGIS Office of Government Information Services NOTICES Meetings: Freedom of Information Act Advisory Committee, 17739-17740 2016-07145 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Meetings: Oil Spill Response Planning Workshop, 17765-17766 2016-07096 Postal Service Postal Service PROPOSED RULES Procedures Relating to the Disposition of Property Acquired by the United States Postal Service Office of Inspector General for Use as Evidence, 17637-17639 2016-07103 Securities Securities and Exchange Commission NOTICES Applications: NexPoint Capital, Inc., et al., 17741-17746 2016-07101 Meetings; Sunshine Act, 17752 2016-07224 Self-Regulatory Organizations; Proposed Rule Changes: New York Stock Exchange, LLC, 17752-17753 2016-07098 NYSE Arca, Inc., 2016-07097 2016-07099 17746-17752 2016-07100 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Electronic Diversity Visa Entry Form, 17755 2016-07184 Statement of Consent—Issuance of a U.S. Passport to a Minor Under Age 16, 17754-17755 2016-07183 Statement of Exigent/Special Family Circumstances for Issuance of a U.S. Passport to a Minor under Age 16, 17753-17754 2016-07182 Culturally Significant Objects Imported for Exhibition: High Society—The Portraits of Franz X. Winterhalter, 17754 2016-07180 Meetings: Advisory Panel to the U.S. Section of the North Pacific Anadromous Fish Commission, 17755-17756 2016-07178 Surface Transportation Surface Transportation Board NOTICES Meetings: Rail Energy Transportation Advisory Committee, 17756 2016-07122 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

National Highway Traffic Safety Administration

See

Pipeline and Hazardous Materials Safety Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 17782-17786 2016-07132 Order Soliciting Community Proposals, 17767-17782 2016-07286 Transportation Research and Development Strategic Plan; Requests for Information, 17766-17767 2016-07139
Treasury Treasury Department See

Comptroller of the Currency

Separate Parts In This Issue Part II Interior Department, Fish and Wildlife Service, 17790-18110 2016-06069 Part III Interior Department, Ocean Energy Management Bureau, 18112-18176 2016-06513 Part IV Transportation Department, Federal Aviation Administration, 18178-18388 2016-05860 Part V Health and Human Services Department, Centers for Medicare & Medicaid Services, 18390-18445 2016-06876 Reader Aids

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

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

81 61 Wednesday, March 30, 2016 Rules and Regulations NATIONAL CREDIT UNION ADMINISTRATION 12 CFR Part 703 RIN 3133-AE55 Investment and Deposit Activities—Bank Notes AGENCY:

National Credit Union Administration (NCUA).

ACTION:

Final rule.

SUMMARY:

The NCUA Board (Board) is finalizing a rule that amends the maturity requirement for bank notes to be permissible investments for federal credit unions (FCUs) by removing the word “original” from the current requirement that bank notes have “original weighted average maturities of less than 5 years.”

DATES:

This rule is effective April 29, 2016.

FOR FURTHER INFORMATION CONTACT:

John Nilles, Senior Capital Markets Specialist, Office of Examination and Insurance, at the above address or telephone (703) 518-6360; or Justin M. Anderson, Senior Staff Attorney, Office of General Counsel, at the above address or telephone (703) 518-6540.

SUPPLEMENTARY INFORMATION:

Table of Contents I. Background II. Comments on the October 2015 Proposal III. Final Rule IV. Regulatory Procedures I. Background

In October 2015, the Board issued a proposed rule to amend the maturity requirement for bank notes to be permissible investments for FCUs by removing the word “original” from the requirement that bank notes have “original weighted average maturities of less than 5 years.” 1 As the Board noted in the proposal, the authority for FCUs to invest in bank notes is derived from the provision in the Federal Credit Union Act (the Act) that permits FCUs to make deposits in, among other things, national and state banks.

1 80 FR 63932 (Oct. 22, 2015).

The Act does not provide authority for FCUs to purchase bank notes that are not deposits. The Act, however, does not define “deposit.” NCUA's long-standing policy has been to use the definition of deposit in the Federal Reserve Board's Regulation D. Regulation D provides, in relevant part, that a liability of a depository institution can be a “deposit” if, among other things: (1) It is insured; (2) it is not subordinated to the claims of depositors; and (3) it has a weighted average maturity of less than five years.2

2 NCUA's regulations do not require that all of these criteria be met for bank notes to be permissible investments.

The Board stated in the proposal that removing the word “original” would better align NCUA's requirements for bank notes with the Regulation D definition of a deposit. Further, the Board noted that this amendment would also provide FCUs with some measure of regulatory relief. By removing the word “original,” which ties the bank note's maturity to its original date of issuance, FCUs will be permitted to select from a much larger pool of possible bank note offerings. Specifically, FCUs will be permitted to purchase bank notes that had original maturities of greater than five years but have remaining maturities of less than five years. Expanding the list of permissible offerings for FCUs will result in: (1) Cheaper execution prices; (2) flexibility for FCUs; and (3) greater efficiency for FCUs in finding suitable offerings. The weighted average maturity of less than five years will also maintain safety and soundness by avoiding excessive interest rate risk.

II. Comments on the October 2015 Proposal

The Board received eight comment letters in response to the October 2015 proposal. Generally, all of the commenters supported the rule as proposed. Several of those commenters, however, suggested ways to improve the rule.

One commenter suggested the Board eliminate the maturity requirement for bank notes completely. This commenter suggested that, because there is no statutory requirement for the Board to align the definition of deposit with Regulation D, the Board should define deposit in a way that would allow FCUs to invest in bank notes with any maturities. However, the Federal Reserve Board's Regulation D definition provides sufficient flexibility for FCUs, and maintains safety and soundness in this context. The Board, therefore, will continue to follow NCUA's long-standing policy to use the definition of deposit in Regulation D to determine permissible bank notes that may be purchased by FCUs under the Act.

Another commenter requested the Board issue guidance on concentration limits for FCUs investing in bank notes. The Board notes that there are no regulatory concentration limits on bank notes due to the limited exposure to FCUs that the asset class currently represents.

A final commenter suggested the Board authorize additional investments for FCUs under part 703. This comment raises an issue that is outside the scope of this rulemaking. However, part 703 was included in the Office of General Counsel's review of one-third of NCUA's regulations in 2015. As a result, the Board is considering whether additional amendments to part 703 are warranted. If the Board determines to promulgate such amendments, it will do so in a separate rulemaking.

III. Final Rule

For the reasons stated above, the Board is adopting as final the proposed amendment without change.

IV. Regulatory Procedures 1. Regulatory Flexibility Act

The Regulatory Flexibility Act requires NCUA to prepare an analysis of any significant economic impact a regulation may have on a substantial number of small entities (primarily those under $100 million in assets).3 This final rule will have a minimal economic impact on small credit unions as bank notes are just one small fraction of a typical investment portfolio. Accordingly, NCUA certifies the rule will not have a significant economic impact on a substantial number of small credit unions.

3 5 U.S.C. 603(a); 12 U.S.C. 1787(c)(1).

2. Paperwork Reduction Act

The Paperwork Reduction Act of 1995 (PRA) applies to rulemakings in which an agency by rule creates a new paperwork burden or increases an existing burden.4 For purposes of the PRA, a paperwork burden may take the form of a reporting or recordkeeping requirement, both referred to as information collections. This final rule creates new investment options for FCUs but will not create any new burdens or increase any existing burdens. Therefore, a PRA analysis is not required.

4 44 U.S.C. 3507(d); 5 CFR part 1320.

3. Executive Order 13132

Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order to adhere to fundamental federalism principles. The final rule does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. NCUA has, therefore, determined that this final rule does not constitute a policy that has federalism implications for purposes of the executive order.

4. Assessment of Federal Regulations and Policies on Families

NCUA has determined that this final rule will not affect family well-being within the meaning of section 654 of the Treasury and General Government Appropriations Act, 1999, Public Law 105-277, 112 Stat. 2681 (1998).

List of Subjects 12 CFR Part 703

Credit unions, Investments.

By the National Credit Union Administration Board on March 24, 2016. Gerard Poliquin, Secretary of the Board.

For the reasons discussed above, the National Credit Union Administration amends 12 CFR part 703 as follows:

PART 703—INVESTMENT AND DEPOSIT ACTIVITIES 1. The authority citation for part 703 continues to read as follows: Authority:

12 U.S.C. 1757(7), 1757(8), and 1757(15).

§ 703.14 [Amended]
2. Amend § 703.14(f)(5) by removing the word “original”.
[FR Doc. 2016-07151 Filed 3-29-16; 8:45 am] BILLING CODE 7535-01-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2015-4532; Airspace Docket No. 15-AEA-10] Amendment of Class D Airspace and Class E Airspace for the Following New York Towns; Ithaca, NY; Poughkeepsie, NY AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule; delay of effective date, correction.

SUMMARY:

This action changes the effective date of a final rule published in the Federal Register of February 4, 2016, amending Class E Airspace designated as an extension at Ithaca Tompkins Regional Airport, Ithaca, NY; and the Kingston VORTAC, Poughkeepsie, NY. This correction updates the geographic coordinates of each navigation aid and Ithaca Tompkins Regional Airport (formerly Tompkins County Airport), under Class D airspace and Class E surface area airspace to coincide with the FAA's aeronautical database. Also, Dutchess County Airport is added to the Kingston VORTAC, Poughkeepsie, NY, designation in Class E airspace designated as an extension. The Kingston VORTAC reference is removed from the Class D airspace designation. This action also adds Class D airspace to the title of this rulemaking.

DATES:

This correction is effective 0901 UTC, May 26, 2016, and the effective date of the rule amending 14 CFR part 71, published on February 4, 2016 (81 FR 5902), is delayed to 0901 UTC May 26, 2016. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking History

The Federal Register published a final rule amending Class E Airspace Designated as an Extension at Ithaca Tompkins Regional Airport, Ithaca, NY, (formerly Tompkins County Airport), and the Kingston VORTAC, Poughkeepsie, NY (81 FR 5902, February 4, 2016) Docket No. FAA-2015-4532. Further review revealed the geographic coordinates for the airport and navaids needed to be amended in Class D airspace and Class E surface area airspace. It is also noted that the Kingston VORTAC is erroneously listed in Class D airspace for Poughkeepsie, NY, and is removed. Also, Class D Airspace is added to the title.

Class D and Class E airspace designations are published in paragraphs 5000, 6002, and 6004, respectively, of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in the Order. These are administrative corrections and do not affect the controlled airspace boundaries or operating requirements supporting operations in the Ithaca and Poughkeepsie, NY areas.

Availability and Summary of Documents for Incorporation by Reference

This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

Correction to Final Rule

Accordingly, pursuant to the authority delegated to me, in the Federal Register of February 4, 2016 (81 FR 5902) FR Doc. FAA-2016-02040, Amendment of Class E Airspace for the following NY Towns; Ithaca, NY; Poughkeepsie, NY, is corrected as follows:

On page 5902, column 2, beginning on line 6, remove the following text: “Amendment of Class E Airspace for the following New York Towns; Ithaca, NY; Poughkeepsie, NY” and add in its place “Amendment of Class D and E Airspace for the following New York Towns; Ithaca, NY, Poughkeepsie, NY

On page 5903, column 2, after line 23, add the following text:

Paragraph 5000 Class D Airspace. AEA NY D Ithaca, NY [Corrected] Ithaca Tompkins Regional Airport, Ithaca, NY (Lat. 42°29′29″ N., long. 76°27′31″ W.)

That airspace extending upward from the surface to and including 3,600 feet MSL within a 4-mile radius of Ithaca Tompkins Regional Airport. This Class D airspace area is effective during specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be published continuously in the Airport/Facility Directory.

AEA NY D Poughkeepsie, NY [Corrected] Dutchess County Airport, Poughkeepsie, NY (Lat. 41°37′36″ N., long. 73°53′03″ W.)

That airspace extending upward from the surface to and including 2,700 feet MSL within a 4-mile radius of Dutchess County Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.

Paragraph 6002 Class E Surface Area Airspace AEA NY E2 Ithaca, NY [Corrected] Ithaca Tompkins Regional Airport, Ithaca, NY (Lat. 42°29′29″ N., long. 76°27′31″ W.) Ithaca VOR/DME (Lat. 42°29′42″ N., long. 76°27′35″ W.)

Within a 4-mile radius of Ithaca Tompkins Regional Airport and that airspace extending upward from the surface from the 4-mile radius of the airport to the 5.7-mile radius of the airport clockwise from the 329° bearing to the 081° bearing from the airport; that airspace from the 4-mile radius of the airport to the 8.7-mile radius of the airport extending clockwise from the 081° bearing to the 137° bearing from the airport; that airspace from the 4-mile radius of the airport to the 6.6-mile radius of the airport extending clockwise from the 137° bearing to the 170° bearing from the airport; that airspace from the 4-mile radius to the 5.7-mile radius of the airport extending clockwise from the 170° bearing to the 196° bearing from the airport, and that airspace within 2.7 miles each side of the Ithaca VOR/DME 305° radial extending from the 4-mile radius of the airport to 7.4 miles northwest of the Ithaca VOR/DME. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.

AEA NY E2 Poughkeepsie, NY [Corrected] Dutchess County Airport, Poughkeepsie, NY (Lat. 41°37′36″ N., long. 73°53′03″ W.) Kingston VORTAC (Lat. 41°39′56″ N., long. 73°49′20″ W.)

Within a 4-mile radius of the Dutchess County Airport; and that airspace extending upward from the surface within 3.1 miles each side of the Kingston VORTAC 025° radial extending from the VORTAC to 8.3 miles northeast of the VORTAC, and within 1.8 miles each side of the Kingston VORTAC 231° radial extending from the 4-mile radius to 9.2 miles southwest of the VORTAC and within 3.1 miles each side of the Kingston VORTAC 050° radial extending from the VORTAC to 9.2 miles northeast of the VORTAC. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.

Issued in College Park, Georgia, on March 23, 2016. Jim Dickinson, Acting Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
[FR Doc. 2016-07077 Filed 3-29-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2015-6231; Airspace Docket No. 15-AEA-12] Amendment of Class D Airspace and Class E Airspace; Lynchburg, VA AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule; delay of effective date, correction.

SUMMARY:

This action changes the effective date of a final rule published in the Federal Register of February 4, 2016, amending Class E surface area airspace at Lynchburg, VA, by adjusting the geographic coordinates at Lynchburg Regional-Preston Glenn Field Airport, and Falwell Airport. This correction updates the geographic coordinates of the above airports in Class D airspace, Class E airspace designated as an extension, and Class E airspace extending upward from 700 feet above the surface, and adds Class D Airspace to the title.

DATES:

This correction is effective 0901 UTC, May 26, 2016, and the effective date of the rule amending 14 CFR part 71, published on February 4, 2016 (81 FR 5901), is delayed to 0901 UTC May 26, 2016. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

History

The Federal Register published a final rule amending the geographic coordinates of Lynchburg Regional-Preston Glenn Field Airport and Falwell Airport, Class E surface airspace, Lynchburg, VA. (81 FR 5901, February 4, 2016) Docket No. FAA-2015-6231. Subsequent to publication, the FAA discovered the geographic coordinates of both airports in Class D Airspace, Class E airspace designated as an extension, and Class E airspace extending upward from 700 feet above the surface required an adjustment as well.

Class D and Class E airspace designations are published in paragraphs 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in the Order. These are administrative corrections and do not affect the controlled airspace boundaries or operating requirements supporting operations in the Lynchburg, VA area.

Availability and Summary of Documents for Incorporation by Reference

This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

Correction to Final Rule

Accordingly, pursuant to the authority delegated to me, in the Federal Register of February 4, 2016 (81 FR 5901) FR Doc. FAA-206-02033, Amendment of Class E Airspace; Lynchburg, VA, is corrected as follows:

§ 71.1 [Amended]

On page 5901, column 1, line 22, remove the following text: “Amendment of Class E Airspace for Lynchburg, VA” and add in its place: “Amendment of Class D and Class E Airspace; Lynchburg, VA”. On page 5902, column 1, after line 51, add the following text:

Paragraph 5000 Class D Airspace. AEA VA D Lynchburg, VA [Corrected] Lynchburg Regional-Preston Glenn Field Airport, Lynchburg, VA (Lat. 37°19′31″ N., long. 79°12′04″ W.) Falwell Airport, VA (Lat. 37°22′41″ N., long. 79°07′20″ W.)

That airspace extending upward from the surface to and including 3,400 feet MSL within a 4.5-mile radius of Lynchburg Municipal-Preston Glenn Field Airport, excluding the portion within a .5-mile radius of Falwell Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be published continuously in the Airport/Facility Directory.

Paragraph 6004 Class E Airspace Designated as an Extension to a Class D Surface Area. AEA VA E4 Lynchburg, VA [Corrected] Lynchburg Regional-Preston Glenn Field Airport, Lynchburg, VA (Lat. 37°19′31″ N., long. 79°12′04″ W.) Lynchburg VORTAC (Lat. 37°15′17″ N., long. 79°14′11″ W.)

That airspace extending upward from the surface within 2.7 miles each side of the Lynchburg VORTAC 020° and 200° radials extending from the 4.5-mile radius of Lynchburg Municipal-Preston Glenn Field Airport to 1 mile south of the VORTAC, and within 1.8 miles each side of the Lynchburg VORTAC 022° radial extending from the 4.5-mile radius of the airport to 11.3 miles northeast of the VORTAC. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be published continuously in the Airport/Facility Directory.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. AEA VA E5 Lynchburg, VA [Corrected] Lynchburg Regional-Preston Glenn Field Airport, Lynchburg, VA (Lat. 37°19′31″ N., long. 79°12′04″ W.) Lynchburg VORTAC (Lat. 37°15′17″ N., long. 79°14′11″ W.) Falwell Airport, VA (Lat. 37°22′41″ N., long. 79°07′20″ W.)

That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Lynchburg Regional-Preston Glenn Field, and within 2.7 miles each side of the Lynchburg VORTAC 200° radial extending from the 6.5-mile radius to 7.4 miles south of the VORTAC, and within 3.1 miles each side of the Lynchburg VORTAC 022° radial extending from the 6.5-mile radius to 21.3 miles northeast of the VORTAC, and within a 6.5-mile radius of Falwell Airport.

Issued in College Park, Georgia, on March 23, 2016. Jim Dickinson, Acting Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
[FR Doc. 2016-07079 Filed 3-29-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 528, 529, 556, and 558 [Docket No. FDA-2015-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in November and December 2015.

DATES:

This rule is effective March 30, 2016.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected]

SUPPLEMENTARY INFORMATION:

I. Approval Actions

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during November and December 2015, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

Table 1—Original and Supplemental NADAs and ANADAs Approved During November and December 2015 File No. Sponsor Product name Action 21 CFR
  • Section
  • FOIA
  • Summary
  • NEPA
  • Review
  • 141-453 Alexion Pharmaceuticals, Inc., 33 Hayden Ave., Lexington, MA 02421 hLAL rDNA construct in SBC LAL-C chickens Original approval for expression of a human gene for recombinant human lysosomal acid lipase (rhLAL) protein in chicken egg whites 528.2010 yes EA/
  • FONSI 1
  • 141-456 Orion Corp., Orionintie 1, 02200 Espoo, Finland SILEO (dexmedetomidine oromucosal gel) Original approval for the treatment of noise aversion in dogs 529.539 yes CE 23 141-246 Intervet, Inc., 556 Morris Ave., Summit, NJ 07901 AQUAFLOR (florfenicol) Type A medicated article Supplemental approval of revised representative labeling for Type C medicated feeds; technical amendments revising the expiration of veterinary feed directives (VFDs) and the description of tolerances for fish 556.283,
  • 558.261
  • no CE 24
    141-258 Intervet, Inc., 556 Morris Ave., Summit, NJ 07901 ZILMAX (zilpaterol hydrochloride) Type A medicated article Supplemental approval of a cattle muscle tolerance and of new determinative and confirmatory procedures for residues of zilpaterol in cattle liver and muscle 556.765 yes CE 24 141-361 Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 PULMOTIL AC (tilmicosin phosphate) Concentrate Solution Supplemental approval for the control of swine respiratory disease associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) 520.2471 yes EA/
  • FONSI 1
  • 1 The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of no significant impact (FONSI). 2 The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not have a significant effect on the human environment. 3 CE granted under 21 CFR 25.33(d)(1). 4 CE granted under 21 CFR 25.33(a)(1).
    II. Changes of Sponsorship

    Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201 (Bayer) has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816:

    File No. Product name 21 CFR
  • section
  • 055-002 TEVCOSIN (chloramphenicol) Injectable Solution 522.390 094-170 Phenylbutazone Tablets, USP 100 mg and 200 mg 520.1720a 123-815 Dexamethasone Sodium Phosphate Injection 522.540 141-245 TRIBUTAME (chloroquine phosphate, embutramid, lidocaine) Euthanasia Solution 522.810 200-178 Amikacin Sulfate Injection, 50 mg/mL 522.56 200-193 Clindamycin Hydrochloride Oral Liquid 520.447 200-248 Pyrantel Pamoate Suspension; 2.27 and 4.54 mg 520.2043 200-265 Praziquantel Tablets 520.1870 200-287 GBC (Gentamicin Sulfate Betamethasone Valerate Clotrimazole) Ointment 524.1044g 200-297 Ivermectin Chewable Tablets 520.1193 200-298 Clindamycin Hydrochloride Capsules 520.446 200-365 ROBINUL-V (glycopyrrolate) Injectable Solution 522.1066 200-382 Furosemide Syrup 1% 520.1010

    Bayer has also informed FDA that it has transferred ownership of, and all rights and interest in, approved ANADA 200-342 for Pyrantel Pamoate Paste to Farnam Companies, Inc., 301 West Osborn Rd., Phoenix, AZ 85013-3928.

    Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Hwy., St. Joseph, MO 64506-2002 has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:

    File No. Product name 21 CFR section 006-084 1 SULMET (sulfamethazine) Drinking Water Solution 520.2261a 008-774 SULMET (sulfamethazine) Injectable Solution 522.2260 033-373 1 VETSULID (sulfachlorpyridazine) 520.2200 040-181 1 VETSULID (sulfachlorpyridazine) Oral Suspension 520.2200 055-012 1 CHLORONEX SULMET (chlortetracycline bisulfate/sulfamethazine bisulfate) Soluble Powder 520.445 055-018 1 AUREOMYCIN (chlortetracycline HCl) Tablets 25 mg 520.443 055-039 1 AUREOMYCIN (chlortetracycline HCl) Soluble Oblets 520.443 065-071 1 AUREOMYCIN (chlortetracycline HCl) Soluble Powder 520.441 065-269 1 POLYOTIC (tetracycline hydrochloride) Soluble Powder 520.2345d 065-440 1 CHLORONEX (chlortetracycline HCl or chlortetracycline bisulfate) Soluble Powder 520.441 122-271 1 SULMET (sulfamethazine) Oblets 520.2260a 122-272 1 SULMET (sulfamethazine sodium) Soluble Powder 520.2261b 1 These NADAs were identified as being affected by guidance for industry #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,” December 2013.

    In addition, Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408 (Novartis) has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140.

    File No. Product name 134-644 DENAGARD (tiamulin) Soluble Powder. 139-472 DENAGARD (tiamulin) Type B Medicated Feed. 140-915 INTERCEPTOR (milbemycin oxime) Tablets. 140-916 DENAGARD (tiamulin) Liquid Concentrate. 141-011 DENAGARD (tiamulin) plus CTC (chlortetracycline). 141-026 PROGRAM (lufenuron) Suspension. 141-029 PERCORTEN-V (desoxycorticosterone pivalate) Injectable Suspension. 141-035 PROGRAM (lufenuron). 141-062 PROGRAM (lufenuron) Cat Flavor Tabs. 141-084 SENTINEL (lufenuron and milbemycin oxime) Flavor Tabs. 141-105 PROGRAM (lufenuron) 6-Month Injectable for Cats. 141-120 CLOMICALM (clomipramine) Tablets. 141-163 MILBEMITE (milbemycin oxime) Otic Solution. 141-175 CAPSTAR (nitenpyram) Tablets. 141-203 DERAMAXX (deracoxib) Chewable Tablets. 141-204 SENTINEL Flavor Tabs and CAPSTAR Flea Management System. 141-205 PROGRAM Flavor Tabs and CAPSTAR Flea Management System. 141-218 ATOPICA (cyclosporine) Capsules. 141-320 ONSIOR (robenacoxib) Tablets. 141-329 ATOPICA (cyclosporine) Oral Solution for Cats. 141-333 SENTINEL SPECTRUM (milbemycin oxime, lufenuron, praziquantel) Chewable Tablets. 141-338 INTERCEPTOR SPECTRUM (milbemycin oxime and praziquantel) Chewable Tablets. 141-437 OSURNIA (florfenicol, betamethasone acetate, and terbinafine) Otic Gel. 141-443 ONSIOR (robenacoxib) Injection. 200-517 ZOBUXA (enrofloxacin) Tablets. 200-519 FLORVIO (florfenicol) 2.3% Concentrate Solution.

    As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship. Elanco US, Inc., is retaining Novartis' drug labeler code (058198). Accordingly, the animal drug regulations need only be amended in § 510.600(c) to add Elanco US, Inc., who previously was not the sponsor of an approved application. Cronus Pharma LLC will also be added as a new listing. Following these changes of sponsorship, Novartis is no longer the sponsor of an approved application and will be removed from § 510.600(c).

    III. Technical Amendments

    FDA has noticed the animal drug regulations in 21 CFR part 556 contain tolerances for residues in edible tissues for sulfathiazole, which is no longer the subject of an approved application (79 FR 15540, March 20, 2014). Accordingly, § 556.690 is being removed. FDA has also noticed that the animal drug regulations in 21 CFR 558.4 (§ 558.4) contain assay limits for ronnel and sulfaethoxypyridazine in medicated feed. As there is no longer an approved application for use of either of these drugs in medicated feed, the table for Category II drugs in § 558.4 is being amended to remove assay limits in medicated feed for both drugs. These actions are being taken to improve the accuracy of the regulations.

    In addition, FDA is taking this opportunity to revise the spelling of a bacitracin salt to a preferred form, bacitracin methylenedisalicylate, and to correct the spelling of a genus of pathogenic bacteria, Haemophilus. These actions are being taken to improve the accuracy of the regulations.

    This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

    List of Subjects 21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.

    21 CFR Parts 520, 522, 524, 528, and 529

    Animal drugs.

    21 CFR Part 556

    Animal drugs, Foods.

    21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 520, 522, 524, 528, 529, 556, and 558 are amended as follows:

    PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: Authority:

    21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

    § 510.600 [Amended]
    2. In § 510.600, in the table in paragraph (c)(1), remove the entry for “Novartis Animal Health US, Inc.” and add entries for “Cronus Pharma LLC” and “Elanco US, Inc.” in alphabetical order; and in the table in paragraph (c)(2), revise the entry for “058198” and add an entry for “069043” in numerical order to read as follows:
    § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.

    (c) * * *

    (1) * * *

    Firm name and address Drug labeler code *         *         *         *         *         *         * Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816 069043 *         *         *         *         *         *         * Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140 058198 *         *         *         *         *         *         *

    (2) * * *

    Drug labeler code Firm name and address *         *         *         *         *         *         * 058198 Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140 *         *         *         *         *         *         * 069043 Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816 *         *         *         *         *         *         *
    PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 520 continues to read as follows: Authority:

    21 U.S.C. 360b.

    § 520.88b [Amended]
    4. In § 520.88b, in paragraph (b)(1)(ii)(B), remove “Hemophilus” and in its place add “Haemophilus”. 5. In § 520.154b: a. Revise the section heading. b. In paragraph (a), remove “methylene disalicylate” and in its place add “methylenedisalicylate”.

    The revision reads as follows:

    § 520.154b Bacitracin methylenedisalicylate and streptomycin sulfate powder.
    § 520.441 [Amended]
    6. In § 520.441, in paragraphs (b)(2) and (d)(4)(iii)(C), remove “000010” and in its place add “016592”; and in in paragraphs (d)(1)(i)(A)(1), (d)(2)(i)(A)(1), (d)(4)(iii)(B), and (d)(4)(iv)(B), remove “Hemophilus” and in its place add “Haemophilus”.
    § 520.443 [Amended]
    7. In § 520.443, in paragraph (b), remove “No. 054628” and in its place add “Nos. 016592 and 054628”; and in paragraphs (d)(1)(i), (d)(2)(i), and (d)(3)(i), remove “Hemophilus” and in its place add “Haemophilus”.
    § 520.445 [Amended]
    8. In § 520.445, in paragraph (b), remove “000010” and in its place add “016592”.
    § 520.446 [Amended]
    9. In § 520.446, in paragraph (b)(1), remove “No. 054771” and in its place add “Nos. 054771 and 069043”.
    § 520.447 [Amended]
    10. In § 520.447, in paragraph (b), remove “Nos. 000859, 051311, 054771, 058829, and 061623” and in its place add “Nos. 051311, 054771, 058829, 061623, and 069043”.
    § 520.823 [Amended]
    11. In § 520.823, in paragraph (d)(2)(ii), remove “Hemophilus” and in its place add “Haemophilus”.
    § 520.1010 [Amended]
    12. In § 520.1010, in paragraph (b)(3), remove “Nos. 000859 and 058829” and in its place add “Nos. 058829 and 069043”.
    § 520.1193 [Amended]
    13. In § 520.1193, in paragraph (b)(2), remove “Nos. 000859 and 051311” and in its place add “Nos. 051311 and 069043”.
    § 520.1720a [Amended]
    14. In § 520.1720a, in paragraph (b)(2), remove “Nos. 000859 and 054628” and in its place add “Nos. 054628 and 069043”. 15. In § 520.1870, revise paragraph (b) to read as follows:
    § 520.1870 Praziquantel tablets.

    (b) Sponsor. See No. 069043 in § 510.600(c) of this chapter for use of the product described in paragraph (a)(1) of this section as in paragraph (c)(1) of this section; and for use of the product described in paragraph (a)(2) of this section as in paragraph (c)(2) of this section.

    § 520.2043 [Amended]
    16. In § 520.2043, in paragraph (b)(1), remove “Nos. 000859, 054771, and 058829” and in its place add “Nos. 054771, 058829, and 069043”.
    § 520.2044 [Amended]
    17. In § 520.2044, in paragraph (b)(2), remove “000859” and in its place add “017135”.
    § 520.2200 [Amended]
    18. In § 520.2200, in paragraph (b), remove “000010” and in its place add “016592”.
    § 520.2260a [Amended]
    19. In § 520.2260a, in paragraph (a)(1), remove “000010” and in its place add “016592”.
    § 520.2261a [Amended]
    20. In § 520.2261a, in paragraph (b), remove “000010” and in its place add “016592”.
    § 520.2261b [Amended]
    21. In § 520.2261b, in paragraph (b), remove “000010” and in its place add “016592”.
    § 520.2345d [Amended]
    22. In § 520.2345d, in paragraphs (b)(5), (d)(1)(iii), and (d)(2)(iii), remove “000010” and in its place add “016592”; and in paragraphs (d)(1)(ii) and (d)(2)(ii), remove “Hemophilus” and in its place add “Haemophilus”. 23. In § 520.2471, revise paragraph (d)(2) to read as follows:
    § 520.2471 Tilmicosin.

    (d) * * *

    (2) Indications for use—(i) For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

    (ii) For the control of swine respiratory disease associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

    PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 24. The authority citation for 21 CFR part 522 continues to read as follows: Authority:

    21 U.S.C. 360b.

    § 522.56 [Amended]
    25. In § 522.56, in paragraph (b), remove “000859” and in its place add “069043”.
    § 522.390 [Amended]
    26. In § 522.390, in paragraph (b), remove “Nos. 000859 and 054771” and in its place add “Nos. 054771 and 069043”.
    § 522.540 [Amended]
    27. In § 522.540, in paragraph (e)(2), remove “000859” and in its place add “069043”.
    § 522.810 [Amended]
    28. In § 522.810, in paragraph (b), remove “000859” and in its place add “069043”.
    § 522.1066 [Amended]
    29. In § 522.1066, in paragraph (b), remove “Nos. 000859 and 054771” and in its place add “Nos. 054771 and 069043”.
    § 522.1662a [Amended]
    30. In § 520.1662a, in paragraphs (b)(3)(i)(b), (c)(3)(i), (d)(3)(i)(a), (e)(3)(i)(b), (g)(3)(i)(b), and (k)(3)(ii), remove “Hemophilus” and in its place add “Haemophilus”.
    § 522.2260 [Amended]
    31. In § 522.2260, in paragraph (b), remove “000010” and in its place add “016592”.
    PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 32. The authority citation for 21 CFR part 524 continues to read as follows: Authority:

    21 U.S.C. 360b.

    § 524.1044g [Amended]
    33. In § 522.1044g, in paragraph (b)(3), remove “000859” and in its place add “069043”.
    PART 528—NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS 34. The authority citation for 21 CFR part 528 continues to read as follows: Authority:

    21 U.S.C. 360b.

    35. Add § 528.2010 to read as follows:
    § 528.2010 Human lysosomal acid lipase recombinant deoxyribonucleic acid construct.

    (a) Specifications. A single copy of a human lysosomal acid lipase (hLAL) recombinant deoxyribonucleic acid (rDNA) gene construct located at the SYN LAL-C site in chromosome 6 in a specific, diploid line (SBC LAL-C) of hemizygous and homozygous domestic chickens (Gallus gallus), derived from the lineage progenitor XLL 109.

    (b) Sponsor. See No. 069334 in § 510.600 of this chapter.

    (c) Conditions of use—(1) Intended use. The gene construct directs the expression of that encoding gene such that recombinant, human lysosomal acid lipase (rhLAL) protein intended for the treatment of human disease is present in SBC LAL-C chicken egg whites.

    (2) Limitations. Food or feed from XLL 109 chickens is not permitted in the food or feed supply.

    PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 36. The authority citation for 21 CFR part 529 continues to read as follows: Authority:

    21 U.S.C. 360b.

    37. Add § 529.539 to read as follows:
    § 529.539 Dexmedetomidine.

    (a) Specifications. Each milliliter of gel contains 0.09 milligrams (mg) dexmedetomidine (equivalent to 0.1 mg dexmedetomidine hydrochloride).

    (b) Sponsor. See No. 052483 in § 510.600(c) of this chapter.

    (c) Conditions of use—(1) Amount. Administer onto the oral mucosa between the dog's cheek and gum at a dose of 125 micrograms per square meter.

    (2) Indications for use. For the treatment of noise aversion in dogs.

    (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 38. The authority citation for 21 CFR part 556 continues to read as follows: Authority:

    21 U.S.C. 342, 360b, 371.

    39. In § 556.70, in paragraph (b), remove “methylene disalicylate” and in its place add “methylenedisalicylate”; and add paragraph (c) to read as follows:
    § 556.70 Bacitracin.

    (c) Related conditions of use. See §§ 520.154a, 520.154c, 558.76, and 558.78 of this chapter.

    40. In § 556.283, revise paragraphs (b)(3) and (4) to read as follows:
    § 556.283 Florfenicol.

    (b) * * *

    (3) Freshwater-reared finfish (other than catfish) and salmonids. The tolerance for florfenicol amine (the marker residue) in muscle/skin (the target tissues) is 1 ppm.

    (4) Catfish. The tolerance for florfenicol amine (the marker residue) in muscle (the target tissues) is 1 ppm.

    § 556.690 [Removed]
    41. Remove § 556.690. 42. In § 556.765, revise paragraph (b)(1)(i) and add paragraphs (b)(1)(ii) and (c) to read as follows:
    § 556.765 Zilpaterol.

    (b) * * *

    (1) * * *

    (i) Liver (the target tissue). The tolerance for zilpaterol (the marker residue) is 12 parts per billion (ppb).

    (ii) Muscle. The tolerance for zilpaterol (the marker residue) is 10 ppb.

    (c) Related conditions of use. See § 558.665 of this chapter.

    PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 43. The authority citation for 21 CFR part 558 continues to read as follows: Authority:

    21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

    § 558.4 [Amended]
    44. In § 558.4, in paragraph (d), in the “Category I” table, in the “Drug” column, remove “Bacitracin methylene disalicylate” and in its place add ” Bacitracin methylenedisalicylate”; and in the “Category II” table, remove the entries for “Ronnel” and “Sulfaethoxypyridazine”.
    § 558.55 [Amended]
    45. In § 558.55, in paragraph (d)(2)(ii), in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.
    § 558.58 [Amended]
    46. In § 558.58, in paragraph (e)(4), in the “Limitations” column, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.
    § 558.68 [Amended]
    47. In § 558.68, remove paragraph (e)(3). 48. In § 558.76, remove paragraph (e)(2), redesignate paragraph (e)(3) as paragraph (e)(2), and revise redesignated paragraph (e)(2) to read as follows:
    § 558.76 Bacitracin methylenedisalicylate.

    (e) * * *

    (2) Bacitracin methylenedisalicylate may also be used in combination with:

    (i) Amprolium as in § 558.55.

    (ii) Amprolium and ethopabate as in § 558.58.

    (iii) Clopidol as in § 558.175.

    (iv) Decoquinate as in § 558.195.

    (v) Diclazuril as in § 558.198.

    (vi) Fenbendazole as in § 588.258.

    (vii) Halofuginone hydrobromide as in § 558.265.

    (viii) Ivermectin as in § 558.300.

    (ix) Lasalocid as in § 558.311.

    (x) Monensin as in § 588.355.

    (xi) Narasin as in § 558.363.

    (xii) Nicarbazin alone and with narasin as in § 558.366.

    (xiii) Robenidine as in § 558.515.

    (xiv) Salinomycin as in § 558.550.

    (xv) Semduramicin as in § 558.555.

    (xvi) Zoalene as in § 558.680.

    § 558.128 [Amended]
    49. In § 558.128, in paragraph (e)(7)(ii), remove “methylene disalicylate” and in its place add “methylenedisalicylate”.
    § 558.175 [Amended]
    50. In § 558.175, in paragraph (d)(2), in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.
    § 558.195 [Amended]
    51. In § 558.195, in paragraph (e)(1)(ii), in the “Combination in grams/ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.
    § 558.198 [Amended]
    52. In § 558.198, in paragraphs (d)(1)(ii) and (d)(2)(ii), in the “Combination grams/ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.
    § 558.258 [Amended]
    53. In § 588.258, in paragraphs (e)(2)(vi) and (vii), in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”. 54. In § 558.261, redesignate paragraphs (c)(2)(i) and (ii) as paragraphs (c)(2)(ii) and (i), respectively, revise redesignated paragraph (c)(2)(ii), and add paragraph (c)(4) to read as follows:
    § 558.261 Florfenicol.

    (c) * * *

    (2) * * *

    (ii) For fish must not exceed 6 months from the date of issuance.

    (4) Type A medicated articles and medicated feeds intended for use in fish shall bear the following: “Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy.”

    § 558.265 [Amended]
    55. In § 558.265, in paragraphs (d)(1)(vi) and (d)(2)(ii), remove “methylene disalicylate” and in its place add “methylenedisalicylate”.
    § 558.300 [Amended]
    56. In § 558.300, in paragraphs (e)(2) and (3), in the “Combination in g/ton of feed” column, remove “methylene disalicylate” and in its place add “methylenedisalicylate”; and in paragraph (e)(9), in the “Combination in g/ton of feed ” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.
    § 558.311 [Amended]
    57. In § 558.311, in paragraphs (e)(1)(iv) and (x), in the “Limitations” column, remove “methylene disalicylate” and in its place add “methylenedisalicylate”; and in paragraph (e)(1)(xv), in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.
    § 558.355 [Amended]
    58. In § 558.355, in paragraphs (f)(1)(iii)(b), (f)(1)(xxiv), (f)(1)(xxix) introductory text, (f)(1)(xxix)(b), (f)(1)(xxx) introductory text, (f)(1)(xxx)(b), (f)(2)(ii) introductory text, (f)(2)(ii)(b), (f)(2)(iii) introductory text, (f)(2)(iii)(a), (f)(2)(iii)(b), (f)(4)(ii) introductory text, (f)(4)(ii)(b), (f)(4)(iii) introductory text, (f)(4)(iii)(b), (f)(4)(v) introductory text, and (f)(4)(v)(b), remove “methylene disalicylate” and in its place add “methylenedisalicylate”.
    § 558.363 [Amended]
    59. In § 558.363, in paragraphs (d)(1)(iv) introductory text, (d)(1)(iv)(B), and (d)(3)(ii), remove “methylene disalicylate” and in its place add “methylenedisalicylate”.
    § 558.366 [Amended]
    60. In § 558.366, in paragraph (d), in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” wherever it occurs and in its place add “methylenedisalicylate”.
    § 558.450 [Amended]
    61. In § 558.450, in paragraph (d)(5)(v), in the “Indications for Use” column, remove “Hemophilus” and in its place add “Haemophilus”.
    § 558.515 [Amended]
    62. In § 558.515, in paragraph (d), in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” wherever it occurs and in its place add “methylenedisalicylate”.
    § 558.550 [Amended]
    63. In § 558.550, in paragraphs (d)(1)(iii)(a), (d)(1)(iii)(c), (d)(1)(vi)(a), (d)(1)(xx)(A), (d)(1)(xx)(C), (d)(1)(xxi)(A), (d)(1)(xxi)(C), (d)(3)(ii) introductory text, (d)(3)(ii)(B), (d)(3)(iii) introductory text, (d)(3)(iii)(B), (d)(3)(v) introductory text, and (d)(3)(v)(B), remove “methylene disalicylate” and in its place add “methylenedisalicylate”; and in paragraph (d)(1)(vi)(c), remove “Bacitracin MD” and in its place add “Bacitracin methylenedisalicylate”.
    § 558.555 [Amended]
    64. In § 558.555, in paragraph (d)(2), in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.
    § 558.680 [Amended]
    65. In § 558.680, in paragraphs (d)(1)(ii), (iii), (iv), (vi), (vii), and (viii) in the “Combination in grams per ton” and “Limitations” columns, remove “methylene disalicylate” and in its place add “methylenedisalicylate”; and in paragraph (d)(2)(ii), in the “Combination in grams per ton” column, remove “methylene disalicylate” and in its place add “methylenedisalicylate”.
    Dated: March 25, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine.
    [FR Doc. 2016-07135 Filed 3-29-16; 8:45 am] BILLING CODE 4161-01-P
    NATIONAL ARCHIVES AND RECORDS ADMINISTRATION 36 CFR Part 1258 [FDMS No. NARA-16-0003; NARA-2016-018] RIN 3095-AB90 Fees AGENCY:

    National Archives and Records Administration (NARA).

    ACTION:

    Direct final rule.

    SUMMARY:

    The National Archives and Records Administration (NARA) is making a minor administrative revision to its fees regulation to set a time limit for requesting refunds of reproduction fees.

    DATES:

    This rule is effective April 29, 2016, without further action, unless NARA receives adverse comments by April 19, 2016. If NARA receives an adverse comment, it will publish a timely withdrawal of the rule in the Federal Register.

    ADDRESSES:

    You may submit comments, identified by RIN 3095-AB90, by any of the following methods:

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

    Email: [email protected] Include RIN 3095-AB90 in the subject line of the message.

    Fax: 301-837-0319. Include RIN 3095-AB90 in the subject line of the fax cover sheet.

    Mail (for paper, disk, or CD-ROM submissions. Include RIN 3095-AB90 on the submission): Regulations Comment Desk (External Policy Program, Strategy & Performance Division (SP)); Suite 4100; National Archives and Records Administration; 8601 Adelphi Road; College Park, MD 20740-6001

    Hand delivery or courier: Deliver comments to front desk at the address above.

    Instructions: All submissions must include NARA's name and the regulatory information number for this rulemaking (RIN 3095-AB90). We may publish any comments we receive without changes, including any personal information you include.

    FOR FURTHER INFORMATION CONTACT:

    Kimberly Keravuori, by email at [email protected], or by telephone at 301-837-3151.

    SUPPLEMENTARY INFORMATION:

    Background

    NARA is authorized by 44 U.S.C. 2116(c) to charge reproduction fees when it reproduces documents for non-Federal individuals or entities. This includes official reproductions with the Archives seal, reproductions of archival holdings, and reproductions of operational records. The statute authorizes NARA to recoup its costs, equipment fees, and similar expenses, and to retain the fees as part of the National Archives Trust Fund. NARA promulgated regulations at 36 CFR 1258 to notify users of the fee structure and processes. Among these regulations is a section addressing refunds of these fees (36 CFR 1258.16). It is this provision that we are revising with this rulemaking.

    Due to various factors, it is occasionally difficult for us to make a legible reproduction, particularly of old documents. We notify customers if we anticipate the reproduction will have questionable legibility, and request the customer's approval to proceed with the reproduction—and the fee charges. As a result, we do not provide refunds except in special cases; primarily if we have somehow processed an order incorrectly or it contains errors. However, the regulation's refund provision did not include a refund cut-off period after which a person who ordered a reproduction could no longer request a refund. Customers could request refunds for orders that were years old, which has occurred in several instances. We had no recourse but to process the refunds, which is not a reasonable business practice for orders that are multiple years old. This also caused a significant administrative burden, as NARA had discarded records for some of these orders at the end of their routine business life, in accord with our agency's official records schedule. For example, under records schedule 1807-2, orders made on our online ordering system (SOFA) are destroyed once they are one year old. A refund request five years after the customer received the reproduction not only is not reasonable, but occurs four years after we destroyed records of the order, making it impossible for us to determine if the customer was notified and approved the reproduction, whether there really was an error or something incorrect about the order, and similar issues.

    As a result of these difficulties with refund requests on old orders, we are now revising 36 CFR 1258.16 to set a refund time limit. Customers will have four months from the order date in which to request a refund.

    Regulatory Analysis Review Under Executive Orders 12866 and 13563

    Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (September 30, 1993), and Executive Order 13563, Improving Regulation and Regulation Review, 76 FR 23821 (January 18, 2011), 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). This proposed rule is not “significant” under section 3(f) of Executive Order 12866 because it merely modifies the window of opportunity in which customers may request refunds of reproduction fees. The Office of Management and Budget (OMB) has reviewed this regulation.

    Review Under the Regulatory Flexibility Act (5 U.S.C. 601, et seq.)

    This review requires an agency to prepare an initial regulatory flexibility analysis and publish it when the agency publishes the proposed rule. This requirement does not apply if the agency certifies that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities (5 U.S.C. 603). NARA certifies, after review and analysis, that this proposed rule will not have a significant adverse economic impact on small entities because it merely modifies the window of opportunity in which customers may request refunds of reproduction fees.

    Review Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.)

    This proposed rule does not contain any information collection requirements subject to the Paperwork Reduction Act.

    Review Under Executive Order 13132, Federalism, 64 FR 43255 (August 4, 1999)

    Review under Executive Order 13132 requires that agencies review regulations for federalism effects on the institutional interest of states and local governments, and, if the effects are sufficiently substantial, prepare a Federal assessment to assist senior policy makers. This proposed rule will not have any direct effects on State and local governments within the meaning of the Executive Order. Therefore, the regulation requires no federalism assessment.

    List of Subjects in 36 CFR Part 1258

    Archives and records.

    For the reasons stated in the preamble, NARA amends 36 CFR part 1258 as follows:

    PART 1258—FEES 1. The authority citation for part 1258 remains as follows: Authority:

    44 U.S.C. 2116(c) and 2307.

    2. Revise § 1258.16 to read as follows:
    § 1258.16 What is NARA's refund policy?

    Due to various factors, it is occasionally difficult for NARA to make a legible reproduction. NARA will notify customers and ask for approval to proceed if we anticipate a reproduction of questionable legibility. As a result, NARA does not provide refunds except in special cases. If a customer requests a refund, we review the order to determine if we properly notified the customer of the questionable nature of the original and if the product is a true representation of the original. If the product is a true representation of the original, we will not issue a refund. If you feel we processed your order incorrectly or it contains errors, please contact us within 120 days of your order date to have your issue verified. Once we verify the issue, we will correct the error and resend the documents. If we cannot correct the error, you will receive a refund.

    Dated: March 20, 2016. David S. Ferriero, Archivist of the United States.
    [FR Doc. 2016-07149 Filed 3-29-16; 8:45 am] BILLING CODE 7515-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0019; FRL-9944-12] Salicylaldehyde; Exemption From the Requirement of a Tolerance AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    This regulation establishes an exemption from the requirement of a tolerance for residues of salicylaldehyde (2-hydroxybenzaldehyde, CAS Reg. No. 90-02-8) when used as an inert ingredient (penetration aid) in pesticide formulations applied to growing crops and raw agricultural commodities under 40 CFR 180.910 at a concentration not to exceed 14% by weight of the pesticide formulation. Ag-Chem Consulting LLC, on behalf of Omex Agrifluids submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of salicylaldehyde.

    DATES:

    This regulation is effective March 30, 2016. Objections and requests for hearings must be received on or before May 31, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

    ADDRESSES:

    The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0019, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

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

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

    • Crop production (NAICS code 111).

    • Animal production (NAICS code 112).

    • Food manufacturing (NAICS code 311).

    • Pesticide manufacturing (NAICS code 32532).

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0019 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before May 31, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

    In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0019, by one of the following methods:

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

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

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

    II. Petition for Exemption

    In the Federal Register of April 6, 2015 (80 FR 18327) (FRL-9924-00), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-10777) by Ag-Chem Consulting LLC, 12208 Quinque Lane, Clifton, VA 20124 on behalf of Omex Agrifluids, 24730 Avenue 13, Madera, CA 93637. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of salicylaldehyde (CAS Reg. No. 90-02-8) when used as an inert ingredient (penetration aid) in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest at a concentration not to exceed 14% by weight of the pesticide formulation. That document referenced a summary of the petition prepared by Ag-Chem Consulting LLC, on behalf of Omex Agrifluids, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

    III. Inert Ingredient Definition

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

    IV. Aggregate Risk Assessment and Determination of Safety

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

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

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

    A. Toxicological Profile

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

    The acute oral toxicity of salicylaldehyde was examined in male rats and mice. The general oral lethal amount of salicylaldehyde is estimated to be 500 mg/kg in mice. The dermal LD50 for salicylaldehyde was determined to be greater than 23,000 mg/kg. Dermal irritation studies found salicylaldehyde to be irritating, with eschar formation and scarring 14 days after administration.

    No adverse effects attributable to a single exposure to salicylaldehyde were seen in the toxicity databases. In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, toxicity was not observed in parental animals nor in reproductive parameters at doses up to 160 mg/kg/day, the highest dose tested. Fetal susceptibility was observed. Reduced bodyweight and offspring mortality after 4 days of nursing were observed at 160 mg/kg/day. The NOAEL was 40 mg/kg/day. There was no evidence of neurotoxicity or immunotoxicity in the combined repeated dose toxicity with the reproduction/developmental toxicity screening test.

    Salicylaldehyde was negative for mutagenicity in the Ames test and gave a positive response in the chromosome aberrations test using Chinese hamster cells (in vitro). An in vivo micronucleus assay was negative. Since the in vivo study is more reliable than the in vitro assays, the weight of evidence suggests that salicylaldehyde is unlikely to be mutagenic.

    There are no cancer studies available for salicylaldehyde. According to a DEREK (Nexus) (structural activity relationship) report, there are no structural alerts for carcinogenicity. Based on predicted rapid metabolism and excretion, lack of specific target organ toxicity in the repeat dose toxicity study, lack of mutagenicity concerns, and lack of any structural alerts for carcinogenicity, salicylaldehyde is not expected to be carcinogenic to humans at anticipated dietary concentrations.

    The metabolism of salicylaldehyde in rabbits demonstrated that 75% of single dose of salicylaldehyde was excreted in the urine as glucuronic acid and sulfate conjugates of vanillic acid.

    B. Toxicological Points of Departure/Levels of Concern

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

    No acute toxicological endpoint of concern has been identified for salicylaldehyde. On the basis of the repeated dose and reproductive/developmental toxicity screening study, a no observed adverse effect level (NOAEL) for offspring toxicity for salicylaldehyde was 40 mg/kg bw/day based on reduced body weight and increased mortality in pups at 160 mg/kg/day. The standard 10X factors for intra- and inter-species were applied in establishing he chronic reference dose (cRfD) of 0.4 mg/kg/day (40 mg/kg/day/100). Based on the reduced FQPA Safety Factor for salicylaldehyde of 1X, the chronic population adjusted dose (cPAD) is equivalent to the chronic reference dose (cRfD) at 0.4 mg/kg//day. The chronic oral NOAEL is also applicable to the short- and intermediate-term dermal and inhalation exposure routes.

    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to salicylaldehyde, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from salicylaldehyde in food as follows:

    Acute dietary assessments take into account exposure estimates from dietary consumption of food and drinking water. Chronic dietary assessments take into account dietary food and drinking water. The Agency assessed the dietary exposures to salicylaldehyde as an inert ingredient used in pesticide formulations applied to growing crops and livestock.

    No adverse effects attributable to a single exposure to salicylaldehyde were seen in the toxicity databases; therefore, an acute dietary risk assessment is not appropriate.

    In conducting the chronic dietary exposure assessment to salicylaldehyde an inert ingredient used in pesticide formulations applied to growing crops, raw agricultural commodities, and livestock, the Dietary Exposure Evaluation Model/Food Commodity Intake Database (DEEM-FCID) TM, Version 3.16 was used. EPA used food consumption information from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America, (USDA/NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. As to residue levels in food, no residue data were submitted for salicylaldehyde. In the absence of specific residue data, EPA has developed an approach that uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

    2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for salicylaldehyde, a conservative drinking water concentration value of 100 ppb based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

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

    There are no current or proposed residential uses for salicylaldehyde; however, it is possible that salicylaldehyde may be used as an inert ingredient in pesticide products. A highly conservative residential exposure assessment was performed in which it was assumed that all residential use pesticide products would contain salicylaldehyde as an inert ingredient. A complete description of the approach used to assess possible residential exposures from salicylaldehyde can be found in http://www.regulations.gov in document “Salicylaldehyde; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations,” pp. 15 in docket ID number EPA-HQ-OPP-2015-0019.

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

    EPA has not found salicylaldehyde to share a common mechanism of toxicity with any other substances, and salicylaldehyde does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that salicylaldehyde does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

    D. Safety Factor for Infants and Children

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

    2. Prenatal and postnatal sensitivity. There is evidence of increased susceptibility of infants and children due to exposure to salicylaldehyde. In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, offspring toxicity was manifested as decreased body weights and increased mortality in the absence of maternal toxicity at doses up to 160 mg/kg/day. The offspring toxicity NOAEL was 40 mg/kg/day. However, there are no to low concerns for this susceptibility since there is a clear, well defined offspring toxicity NOAEL and this study is being used to establish the cRfD.

    3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

    i. The toxicity database for salicylaldehyde includes the battery of acute studies, mutagenicity studies and a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test.

    ii. There is no evidence of neurotoxicity in the available studies, therefore there is no need for a developmental neurotoxicity study.

    iii. There is no evidence of immunotoxicity in the available database, therefore there is no need for an immunotoxicity study.

    iv. There are low to no concerns for the increased susceptibility seen in the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test.

    v. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 14% by weight in the formulation (the maximum allowable use rate) and tolerance-level residues.

    EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to salicylaldehyde in drinking water. EPA used similarly conservative assumptions to assess post application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by salicylaldehyde.

    E. Aggregate Risks and Determination of Safety

    1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, salicylaldehyde is not expected to pose an acute risk.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to salicylaldehyde from food and water will utilize 13% of the cPAD for the U.S. population and 49% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

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

    Salicylaldehyde may be used as inert ingredients in pesticide products that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to salicylaldehyde. Using the exposure assumptions described in this unit, EPA has concluded the combined short- and intermediate-term food, water, and residential exposures result in short- and intermediate-term aggregate MOEs of 430 for adults and 170 for children (1-2 years old). Because EPA's level of concern for salicylaldehyde is a MOE of 100 or below, these MOEs are not of concern.

    4. Aggregate cancer risk for U.S. population. Based on a DEREK structural alert analysis and the lack of mutagenicity, salicylaldehyde not expected to pose a cancer risk to humans.

    5. Determination of safety section. Based on these risk assessments, EPA concludes that there is reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to salicylaldehyde residues.

    V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. EPA is establishing a limitation on the amount of salicylaldehyde that may be used in pesticide formulations applied to growing crops. That limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for use on growing crops for sale or distribution that exceed 14% of salicylaldehyde.

    VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for residues salicylaldehyde (CAS Reg. No. 90-02-8) when used as an inert ingredient (penetration aid) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest at a concentration not to exceed crops at no more than 14% by weight of the pesticide formulation.

    VII. Statutory and Executive Order Reviews

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

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

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

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

    VIII. Congressional Review Act

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

    List of Subjects in 40 CFR Part 180

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

    Dated: March 22, 2016. Susan Lewis, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

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

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

    2. In § 180.910, add alphabetically the inert ingredient “Salicylaldehyde” to the table to read as follows:
    § 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. Inert ingredients Limits Uses *         *         *         *         *         *         * Salicylaldehyde (CAS Reg. No. 90-02-8) Not to exceed 14% by weight of pesticide formulation Penetration aid *         *         *         *         *         *         *
    [FR Doc. 2016-07085 Filed 3-29-16; 8:45 a.m.] BILLING CODE 6560-50-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket ID FEMA-2016-0002; Internal Agency Docket No. FEMA-8429] Suspension of Community Eligibility AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Final rule.

    SUMMARY:

    This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at http://www.fema.gov/fema/csb.shtm.

    DATES:

    The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables.

    FOR FURTHER INFORMATION CONTACT:

    If you want to determine whether a particular community was suspended on the suspension date or for further information, contact Patricia Suber, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-4149.

    SUPPLEMENTARY INFORMATION:

    The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register.

    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

    Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

    National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

    Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

    Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

    Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

    Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

    Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

    List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

    PART 64—[AMENDED] 1. The authority citation for part 64 continues to read as follows: Authority:

    42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp.; p. 376.

    § 64.6 [Amended]
    2. The tables published under the authority of § 64.6 are amended as follows:
    State and location Community No. Effective date authorization/cancellation of sale of flood insurance in community Current effective map date Date certain federal assistance no longer available in SFHAs Region III Virginia: Albemarle County, Unincorporated Areas 510006 May 9, 1973, Emerg; December 16, 1980, Reg; May 16, 2016, Susp. May 16, 2016 May 16, 2016 Hampton, City of, Independent City 515527 March 27, 1970, Emerg; January 15, 1971, Reg; May 16, 2016, Susp. ......* do   Do. King and Queen County, Unincorporated Areas 510082 June 20, 1974, Emerg; September 5, 1990, Reg; May 16, 2016, Susp. ......do   Do. Scottsville, Town of, Albemarle and Fluvanna Counties 510007 April 12, 1973, Emerg; September 5, 1979, Reg; May 16, 2016, Susp. .....do   Do. Region V Wisconsin: Cambria, Village of, Columbia County 550057 June 11, 1975, Emerg; September 18, 1985, Reg; May 16, 2016, Susp. ......do   Do. Columbia County, Unincorporated Areas 550581 July 31, 1975, Emerg; April 15, 1980, Reg; May 16, 2016, Susp. ......do   Do. Columbus, City of, Columbia and Dodge Counties 550058 October 7, 1974, Emerg; December 1, 1981, Reg; May 16, 2016, Susp. ......do   Do. Doylestown, Village of, Columbia County 550059 April 30, 1976, Emerg; September 18, 1985, Reg; May 16, 2016, Susp. ......do   Do. Fall River, Village of, Columbia County 550060 April 17, 1975, Emerg; September 4, 1985, Reg; May 16, 2016, Susp. ......do   Do. Lodi, City of, Columbia County 550061 June 13, 1974, Emerg; November 15, 1984, Reg; May 16, 2016, Susp. ......do   Do. Pardeeville, Village of, Columbia County 550062 August 19, 1976, Emerg; August 15, 1983, Reg; May 16, 2016, Susp. ......do   Do. Portage, City of, Columbia County 550063 June 11, 1974, Emerg; August 15, 1983, Reg; May 16, 2016, Susp. ......do   Do. Poynette, Village of, Columbia County 550064 July 29, 1975, Emerg; September 18, 1985, Reg; May 16, 2016, Susp. ......do   Do. Wisconsin Dells, City of, Adams, Columbia, Juneau and Sauk Counties 550065 July 17, 1975, Emerg; December 18, 1984, Reg; May 16, 2016, Susp. ......do   Do. Wyocena, Village of, Columbia County 550066 May 22, 1975, Emerg; January 18, 1984, Reg; May 16, 2016, Susp. ......do   Do. Region VIII Colorado: Crook, Town of, Logan County 080311 May 6, 1977, Emerg; February 5, 1986, Reg; May 16, 2016, Susp. ......do   Do. Iliff, Town of, Logan County 080207 March 20, 1984, Emerg; August 4, 1987, Reg; May 16, 2016, Susp. ......do   Do. Logan County, Unincorporated Areas 080310 January 3, 1977, Emerg; September 29, 1989, Reg; May 16, 2016, Susp. ......do   Do. Sterling, City of, Logan County 080294 August 4, 1977, Emerg; September 29, 1989, Reg; May 16, 2016, Susp. ......do   Do. * .....do = Ditto. Code for reading third column: Emerg.—Emergency; Reg.—Regular; Susp.—Suspension. Dated: March 16, 2016. Roy E. Wright, Deputy Associate Administrator, Federal Insurance and Mitigation Administration, Department of Homeland Security, Federal Emergency Management Agency.
    [FR Doc. 2016-07093 Filed 3-29-16; 8:45 am] BILLING CODE 9110-12-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 51 [GN Docket No. 13-5, RM-11358; WC Docket No. 05-25, RM-10593; FCC 15-97] Technology Transitions, Policies and Rules Governing Retirement of Copper Loops by Incumbent Local Exchange Carriers and Special Access for Price Cap Local Exchange Carriers; Correction AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule, announcement of effective date; correction.

    SUMMARY:

    The Federal Communications Commission published a document in the Federal Register of March 24, 2016 announcing that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection requirements. This document corrections the DATES section.

    DATES:

    The amendments to 47 CFR 51.325(a)(4) and (e), 51.332, and 51.333(b) and (c) published at 80 FR 63322, October 19, 2015, are effective on March 24, 2016. The removal of 47 CFR 51.331(c) and 51.333(f) is effective on March 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Michele Levy Berlove, Attorney Advisor, Wireline Competition Bureau, at 202-418-1477, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    The Federal Communications Commission published a document in the Federal Register of March 24, 2016 (81 FR 15647) announcing that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection associated with the Commission's network change disclosure rules pertaining to copper retirement notices. That document omitted the removal of 47 CFR 51.331(c) and 51.333(f) as effective rules.

    In FR Doc. 2016-06683, published on March 24, 2016 on pages 15647-48, in the third and first columns respectively of those pages, correct the DATES caption to read:

    DATES: The amendments to 47 CFR 51.325(a)(4) and (e), 51.332, and 51.333(b) and (c) published at 80 FR 63322, October 19, 2015, are effective on March 24, 2016. The removal of 47 CFR 51.331(c) and 51.333(f) is effective on March 30, 2016. Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer. Office of the Secretary.
    [FR Doc. 2016-07147 Filed 3-29-16; 8:45 am] BILLING CODE 6712-01-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150818742-6210-02] RIN 0648-XE543 Fisheries of the Exclusive Economic Zone Off Alaska; Pollock in Statistical Area 610 in the Gulf of Alaska AGENCY:

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

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS is prohibiting directed fishing for pollock in Statistical Area 610 in the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the B season allowance of the 2016 total allowable catch of pollock for Statistical Area 610 in the GOA.

    DATES:

    Effective 1200 hours, Alaska local time (A.l.t.), March 28, 2016, through 1200 hours, A.l.t., May 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Josh Keaton, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

    The B season allowance of the 2016 total allowable catch (TAC) of pollock in Statistical Area 610 of the GOA is 4,591 metric tons (mt) as established by the final 2016 and 2017 harvest specifications for groundfish of the GOA (81 FR 14740, March 18, 2016) and inseason adjustment (81 FR 15650, March 24, 2016).

    In accordance with § 679.20(d)(1)(i), the Regional Administrator has determined that the B season allowance of the 2016 TAC of pollock in Statistical Area 610 of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 4,391 mt and is setting aside the remaining 200 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for pollock in Statistical Area 610 of the GOA.

    After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of directed fishing for pollock in Statistical Area 610 of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 24, 2016.

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

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

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: March 25, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-07129 Filed 3-25-16; 4:15 pm] BILLING CODE 3510-22-P
    81 61 Wednesday, March 30, 2016 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 73 [Docket No. FAA-2016-4282; Airspace Docket No. 16-AWP-3] RIN 2120-AA66 Proposed Establishment of Temporary Restricted Areas R-2509E, R-2509W, and R-2509N; Twentynine Palms, CA AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to establish temporary restricted areas R-2509E, R-2509W, and R-2509N, Twentynine Palms, CA, to support a Marine Expeditionary Brigade level Large Scale Exercise (LSE) planned for existing and newly acquired training lands at Marine Corps Air Ground Combat Center (MCAGCC), Twentynine Palms from August 1 to August 18, 2016.

    DATES:

    Comments must be received on or before May 16, 2016.

    ADDRESSES:

    Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001; telephone: (202) 366-9826. You must identify FAA Docket No. FAA-2016-4282 and Airspace Docket No. 16-AWP-3, at the beginning of your comments. You may also submit comments through the Internet at www.regulations.gov. You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone 1-800-647-5527), is on the ground floor of the building at the above address.

    Comments on environmental and land use aspects to should be directed to: Mr. Chris Proudfoot, Proposed 29 Palms Land Acquisition/Airspace Establishment Project MAGTFTC, MCAGCC, Bldg. 1554, Box 788104 Twentynine Palms, CA 92278-8104; phone: (760) 830-7926.

    FOR FURTHER INFORMATION CONTACT:

    Jason Stahl, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783.

    SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish the temporary restricted area airspace at Twentynine Palms, CA, to enhance aviation safety and accommodate essential United States Marine Corps training requirements.

    Comments Invited

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

    Communications should identify both docket numbers (FAA Docket No. FAA-2016-4282 and Airspace Docket No. 16-AWP-3) and be submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number). You may also submit comments through the Internet at www.regulations.gov.

    Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2016-4282 and Airspace Docket No. 16-AWP-3.” The postcard will be date/time stamped and returned to the commenter.

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

    Availability of NPRMs

    An electronic copy of this document may be downloaded through the Internet at www.regulations.gov.

    You may review the public docket containing the proposal, any comments received and any final disposition in person at the Dockets Office (see ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. An informal docket may also be examined during normal business hours at the office of the Operations Support Group, Western Service Center, Federal Aviation Administration, 1601 Lind Ave. SW., Renton, WA 98057.

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

    Background

    Marine Corps combat readiness depends on the continued availability of ranges and training areas that provide realistic, mission-oriented training and exercises. Marine Corps training proceeds on a continuum, from entry-level training of individual Marines in basic military skills to large-scale exercises involving a Marine Air Ground Task Force (MAGTF). Currently, the Marine Corps does not have sufficient range space to conduct a Marine Expeditionary Brigade (MEB) level live fire exercise. Through careful analysis and a series of studies, MCAGCC Twentynine Palms was identified as the only Marine Corps installation capable of expansion to the dimensions required to support this level of exercise. Acquisition of new lands without the requisite special use airspace (SUA) would not allow for the training events required to successfully execute this essential exercise. Consequently, a new restricted area, military operations areas (MOA) and air traffic control-assigned airspace are being developed as a critical element of the required expansion to support large scale MEB level exercises and those supporting building block training events. A prior proposal for permanent SUA received a non-concurrence from LA Center and will not be available to support the first Large Scale Exercise on new Twentynine Palms lands planned for August 1 to August 18, 2016. The establishment of temporary restricted area R-2509E, W, and N, will substantially enhance both the capability and capacity of the MCAGCC Twentynine Palms Range and Training Areas (RTA) to conduct required training for a MEB large scale exercise.

    The Proposal

    This proposal would establish new temporary restricted areas R-2509E, R-2509W, and R-2509N for the period from August 1 to August 18, 2016, to accommodate live fire from pistols, rifles, machine guns, anti-tank weapons, mortars, artillery, Unmanned Aircraft Systems, fixed wing, and rotary wing training activities including close air support and live ordnance delivery. This proposed temporary restricted area is required to effectively deconflict Department of Defense and civilian air traffic from hazards associated with live fire training.

    Maximum altitudes within the R-2509E would be Flight Level (FL) 400, however, impacts mitigation were coordinated with Los Angeles Air Route Traffic Control Center and will be implemented to include limiting higher airspace activations above FL220 to only 2 hours for 2 days of the exercise. R-2509W would have a ceiling of 8,000 feet MSL and R-2509N would have a ceiling of 16,000 feet MSL. Supersonic flight will not be conducted as part of the above aviation training activities.

    The times of use would be by NOTAM, and activations of R-2509E above FL220 would have the NOTAM issued 48 hours in advance. Expected usage would be 12 hours per day for 10 days up to 16,000 feet and 16 hours per day for 6 days up to FL220.

    The lateral boundaries of the proposed areas would be as follows:

    Temporary R-2509E—Beginning at lat. 34°40′30″ N., long. 116°29′43″ W.; to lat. 34°39′24″ N., long. 116°29′19″ W.; to lat. 34°36′00″ N., long. 116°28′03″ W.; to lat. 34°31′30″ N., long. 116°26′48″ W.; to lat. 34°30′00″ N., long. 116°26′23″ W.; to lat. 34°21′35″ N., long. 116°21′38″ W.; to lat. 34°19′30″ N., long. 116°20′29″ W.; to lat. 34°17′38″ N., long. 116°19′19″ W.; to lat. 34°22′25″ N., long. 116°31′10″ W.; to lat. 34°34′17″ N., long. 116°35′52″ W.; to the point of beginning.

    Temporary R-2509W—Beginning at lat. 34°35′03″ N., long. 116°36′10″ W.; to lat. 34°34′17″ N., long. 116°35′52″ W.; to lat. 34°22′25″ N., long. 116°31′10″ W.; to lat. 34°26′57″ N., long. 116°42′51″ W.; to lat. 34°29′44″ N., long. 116°42′51″ W.; to the point of beginning.

    Temporary R-2509N—Beginning at lat. 34°35′03″ N., long. 116°36′10″ W.; to lat. 34°40′30″ N., long. 116°29′43″ W.; to lat. 34°34′17″ N., long. 116°35′52″ W.; to the point of beginning.

    These temporary restricted areas would automatically expire on August 18, 2016.

    Regulatory Notices and Analyses

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

    Environmental Review

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

    List of Subjects in 14 CFR Part 73

    Airspace, Prohibited areas, Restricted areas.

    The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 73 as follows:

    PART 73—SPECIAL USE AIRSPACE 1. The authority citation for part 73 continues to read as follows: Authority:

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

    § 73.25 California (Amended)
    2. § 73.25 is amended as follows: R-2509E Twentynine Palms, CA [New]

    Boundaries. Beginning at lat. 34°40′30″ N; long. 116°29′43″ W; to lat. 34°39′24″ N; long. 116°29′19″ W; to lat. 34°36′00″ N; long. 116°28′03″ W; to lat. 34°31′30″ N; long. 116°26′48″ W; to lat. 34°30′00″ N; long. 116°26′23″ W; to lat. 34°21′35″ N; long. 116°21′38″ W; to lat. 34°19′30″ N; long. 116°20′29″ W; to lat. 34°17′38″ N; long. 116°19′19″ W; to lat. 34°22′25″ N; long. 116°31′10″ W; to lat. 34°34′17″ N; long. 116°35′52″ W; to the point of beginning.

    Designated altitudes. Surface to FL 400.

    Time of designation. Intermittent by NOTAM during the period from August 1 to August 18, 2016.

    Controlling agency. FAA, Los Angeles Air Route Traffic Control Center (ARTCC).

    Using agency. Commanding General, Marine Corps Air Ground Combat Center (MCAGCC), Twentynine Palms, CA.

    R-2509W Twentynine Palms, CA [New]

    Boundaries. Beginning at lat. 34°35′03″ N., long. 116°36′10″ W.; to lat. 34°34′17″ N., long. 116°35′52″ W.; to lat. 34°22′25″ N., long. 116°31′10″ W.; to lat. 34°26′57″ N., long. 116°42′51″ W.; to lat. 34°29′44″ N., long. 116°42′51″ W.; to the point of beginning.

    Designated altitudes. Surface to 8,000 feet MSL.

    Time of designation. Intermittent by NOTAM during the period from August 1 to August 18, 2016.

    Controlling agency. FAA, Los Angeles Air Route Traffic Control Center (ARTCC).

    Using agency. Commanding General, Marine Corps Air Ground Combat Center (MCAGCC), Twentynine Palms, CA.

    R-2509N Twentynine Palms, CA [New]

    Boundaries. Beginning at lat. 34°35′03″ N., long. 116°36′10″ W.; to lat. 34°40′30″ N., long. 116°29′43″ W.; to lat. 34°34′17″ N., long. 116°35′52″ W.; to the point of beginning.

    Designated altitudes. Surface to 16,000 feet MSL.

    Time of designation. Intermittent by NOTAM during the period from August 1 to August 18, 2016.

    Controlling agency. FAA, Los Angeles Air Route Traffic Control Center (ARTCC).

    Using agency. Commanding General, Marine Corps Air Ground Combat Center (MCAGCC), Twentynine Palms, CA.

    Issued in Washington, DC, on March 24, 2016. Gemechu Gelgelu, Acting Manager, Airspace Policy Group.
    [FR Doc. 2016-07166 Filed 3-29-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF DEFENSE Department of the Air Force 32 CFR Part 842 [Docket ID: USAF-2015-0003] RIN 0701-AA79 Administrative Claims AGENCY:

    Department of the Air Force, DoD.

    ACTION:

    Proposed rule.

    SUMMARY:

    This rule contains amendments for policy changes and clarification and deletions for the Air Force guidance on Administrative claims and Personnel and Carrier Recovery Claims. The rule relates to the Air Force processes for claims filed for and against the Air Force as well as Air Force processes for filing personnel and carrier recovery claims.

    DATES:

    Comments must be received by May 31, 2016.

    ADDRESSES:

    You may submit comments, identified by docket number and/or Regulatory Information Number (RIN) and title, by any of the following methods:

    Federal Rulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.

    Instructions: All submissions received must include the agency name and docket number or RIN for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Daniel Lemieux (AFLOA/JACC), 1500 West Perimeter Rd, Ste 1700, Joint Base Andrews, MD 20762, (240) 612-4646, [email protected]

    SUPPLEMENTARY INFORMATION: Executive Summary I. Purpose of This Regulatory Action

    The purpose of this rule is to provide the public with information necessary to file a claim against the United States Air Force for money damages and to notify the public of the procedures used to collect money from the public for damages to property under the control of the United States Air Force. Additionally, it is to provide the public with information about proposed changes and deletions concerning the settlement and payment of claims under the Military Personnel and Civilian Employee's Claims Act for incident to service loss and damage to personal property.

    II. Summary of the Major Provisions of This Regulatory Action

    This part describes the process and procedures by which claims against the Air Force will be addressed, including who are proper claimants, how, where and when to file a claim, what claims are payable, how the Air Force will adjudicate claims and how to appeal unfavorable decisions. It also describes the process the Air Force will use for asserting claims against persons who damage Air Force property.

    Changes: This part has been substantially revised and should be reviewed in its entirety to determine the changes made.

    Deletions: This part has been substantially revised and should be reviewed in its entirety to determine the deletions made.

    III. Costs and Benefits

    The regulations contained herein require the public who wish to file a claim against the Air Force to substantiate their loss, which may result in minor or incidental costs to the claimant. Revised regulations pertaining to how the Air Force asserts claims for damage to Air Force property may result in increased costs to those who cause said damage. The benefits of these regulations include increased safeguards to ensure public funds are not expended for fraudulent claims and to ensure the U.S. government receives adequate compensation for damages to its property wrongfully caused by others.

    Retrospective Review

    This rule is part of DoD's retrospective plan, completed in August 2011, under Executive Order 13563, “Improving Regulation and Regulatory Review,” DoD's full plan and updates can be accessed at: http://www.regulations.gov/#!docketDetail;dct=FR+PR+N+O+SR;rpp=10;po=0;D=DOD-2011-OS-0036.

    Administrative Procedure Act: The Air Force has determined that the Administrative Procedure Act, 5 U.S.C. 553, requires notice of proposed rulemaking and an opportunity for public participation in connection with these correction amendments and deletions. In this regard, the Air Force notes that such notice and opportunity for comment is necessary because these correction amendments and deletions are not related solely to interpretative rules, general statements of policy, rules of agency organization, procedure, or practice, nor is there good cause to find that notice and public procedure thereon are impracticable, unnecessary or contrary to the public interest.

    Regulatory Procedures Executive Order 12866, “Regulatory Planning and Review” and Executive Order 13563, “Improving Regulation and Regulatory Review”

    Executive Orders 13563 and 12866 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, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The Department of Air Force has assessed this rule and determined this rule to be a “non-significant regulatory action.”

    Unfunded Mandates Reform Act (Sec. 202, Pub. L. 104-4)

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4) requires agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2014, that threshold is approximately $141 million. This rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.

    Public Law 96-354, “Regulatory Flexibility Act” (5 U.S.C. 601)

    It has been certified that this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

    Public Law 96-511, “Paperwork Reduction Act” (44 U.S.C. Chapter 35)

    This rule does not impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995.

    Executive Order 13132, “Federalism”

    Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This rule will not have a substantial effect on State and local governments.

    List of Subjects in 32 CFR Part 842

    Administrative claims.

    Accordingly, 32 CFR part 842 is proposed to be amended as follows:

    PART 842—[AMENDED] 1. The authority citation for 32 CFR part 842 continues to read as follows: Authority:

    Sec. 8013, 100 Stat. 1053, as amended; 10 U.S.C. 8013, except as otherwise noted; 28 CFR 14.11, except as otherwise noted.

    2. The Note for part 842 is revised to read as follows: Note:

    Air Force Regulations are available on the e-Publishing Web site at http://www.e-publishing.af.mil/ for downloading. This part is derived from Air Force Instruction 51-501, Tort Claims, and Air Force Instruction 51-502, Personnel and Carrier Recovery Claims.

    3. Amend part 842 by: a. Revising all references to “HQ USAF/JACC” to read “AFLOA/JACC.” b. Revising all references to “USAF/JACC” to read “AFLOA/JACC.” 4. Revise § 842.0 to read as follows:
    § 842.0 Scope.

    This part establishes standard policies and procedures for all administrative claims resulting from Air Force activities and for which the Air Force has assigned responsibility.

    5. Amend § 842.2 by: a. Revising paragraph (f). b. Removing paragraph (g). c. Redesignating paragraphs (h) through (o) as (g) through (n). d. Revising newly redesignated paragraph (g).

    The revisions read as follows:

    § 842.2 Definitions.

    (f) AFLOA/JACC. Claims and Tort Litigation Division, 1500 West Perimeter Road, Suite 1700, Joint Base Andrews, MD 20762.

    (g) Owner. A holder of a legal title or an equitable interest in certain property. Specific examples include:

    (1) For real property. The mortgagor, and the mortgagee if that individual can maintain a cause of action in the local courts involving a tort to that specific property.

    (2) For personal property. A bailee, lessee, mortgagee and a conditional vendee. A mortgagor, conditional vendor, title loan company or someone else other than the owner, who has the title for purposes of security are not owners.

    6. Revise § 842.4 to read as follows:
    § 842.4 Where to file a claim.

    File a claim at the base legal office of the unit or installation at or nearest to where the accident or incident occurred. If the accident or incident occurred in a foreign country where no Air Force unit is located, file the claim with the Defense Attache (DATT) or Military Assistance Advisory Group (MAAG) personnel authorized to receive claims (DIAM 100-1 and AFR 400-45). In a foreign country where a claimant is unable to obtain adequate assistance in filing a claim, the claimant may contact the nearest Air Force SJA. The SJA then advises AFLOA/JACC through claims channels of action taken and states why the DATT or MAAG was unable to adequately assist the claimant.

    § 842.9 [Removed]
    7. Remove § 842.9. Subpart B—[Removed] 8. Remove Subpart B, consisting of §§ 842.10 through 842.14. Subpart C—[Redesignated as Subpart B] 9. Redesignate subpart C, consisting of §§ 842.15 through 842.20, as subpart B, consisting of §§ 842.9 through 842.14, respectively. 10. Amend newly redesignated § 842.10 by revising paragraphs (a), (b), and (d) to read as follows:
    § 842.10 Definitions.

    (a) Appointing commander. The commander exercising special court-martial jurisdiction over the offender.

    (b) Board of officers. One to three commissioned officers appointed to investigate a complaint of willful property damage or wrongful taking by Air Force personnel.

    (d) Willful damage. Damage or destruction caused intentionally, knowingly, and purposely, without justifiable excuse.

    11. Amend newly redesignated § 842.12 by adding paragraphs (g) through (i) to read as follows:
    § 842.12 Claims not payable.

    (g) Claims involving wrongful taking stemming from larceny, forgery or deceit, which are not accompanied by riotous or violent action.

    (h) Claims against Air National Guard members unless they are performing duty under Title 10 U.S.C.

    (i) Claims for indirect, consequential or remote damages.

    12. Revise newly redesignated § 842.13 to read as follows:
    § 842.13 Limiting provisions.

    (a) A complaint must be submitted within 90 days of the date of the incident. The appointing commander may find good cause for the delay and accept a late claim. The appointing commander's determination of good cause is final and not reviewable.

    (b) Assessment of damages in excess of $5,000 against an offender's pay for a single incident requires AFLOA/JACC approval.

    13. Revise newly redesignated § 842.14 to read as follows:
    § 842.14 Filing a claim.

    Claimant complains (orally or in writing) to the commander of a military organization or unit of the alleged offending member or members or to the commander of the nearest military installation. If the claim is made orally, the individual must assist the commander to reduce the complaint to writing within a reasonable time. The complainant need not request a sum certain in writing at the time the complaint is filed, but they must present such value and evidence before settlement is made.

    Subpart D—[Redesignated as Subpart C] 14. Redesignate subpart D, consisting of §§ 842.21 through 842.35, as subpart C, consisting of §§ 842.15 through 842.29.
    § 842.16 [Amended]
    15. Amend newly redesignated § 842.16 by: a. Removing paragraphs (a), (c), (e), and (g). b. Redesignating paragraphs (b), (d), (f), and (h) as paragraphs (a), (b), (c), and (d). 16. Revise newly designated § 842.17 to read as follows:
    § 842.17 Delegations of authority.

    (a) Settlement authority. The Secretary of the Air Force has delegated the authority to assign areas of responsibility and designate functional responsibility for claims under the Military Personnel and Civilian Employees' Claims Act to The Judge Advocate General (TJAG).

    (b) Reconsideration authority. A settlement authority has the same authority specified in paragraph (a) of this section. However, with the exception of TJAG, a settlement authority may not deny a claim on reconsideration that it, or its delegate, had previously denied.

    (c) Authority to reduce, withdraw and restore delegated settlement authority. Any superior settlement authority may reduce, withdraw, or restore delegated authority.

    17. Amend newly designated § 842.18 by revising paragraph (a) to read as follows:
    § 842.18 Filing a claim.

    (a) How and when to file a claim. A claim is filed when a federal military agency receives from a claimant or duly authorized agent a properly completed AF Form 180, DD Form 1842 or other written and signed demand for a determinable sum of money.

    (1) A claim is also filed when a federal military agency receives from a claimant or duly authorized agent an electronic submission, through a Department of Defense claims Web site, indicating that the claimant intends for the appropriate military branch to consider a digitally signed demand for a determinable sum of money.

    (2) A claim is also filed when the Air Force receives from a claimant or duly authorized agent an electronic submission, through the Air Force claims Web site, a digitally signed demand for a determinable sum of money.

    18. Revise newly designated § 842.19 introductory text to read as follows:
    § 842.19 Partial payments.

    Upon request of a claimant, a settlement authority may make a partial payment in advance of final settlement when a claimant experiences personal hardship due to extensive property damage or loss. Partial payments are made if a claim for only part of the loss is submitted and is readily provable, up to the amount of the settlement authority. (The claimant may later amend the claim for the remainder of the loss.) If the total payable amount of the claim exceeds the payment limits of the settlement authority, send it with recommendations to the proper settlement authority.

    19. Revise newly designated § 842.21 to read as follows:
    § 842.21 Who may file a claim.

    A claim may be filed by:

    (a) A proper claimant,

    (b) An authorized agent or legal representative of a proper claimant,

    (c) A survivor of a deceased proper claimant in this order:

    (1) Spouse.

    (2) Children.

    (3) Father or mother.

    (4) Brothers or sisters.

    20. Amend newly designated § 842.24 by revising paragraph (d) to read as follows:
    § 842.24 General provisions.

    (d) Property that is owned by the claimants, or their immediate families, or borrowed for their use, or in which the claimants or their immediate families has an enforceable ownership interest.

    21. Amend newly designated § 842.25 by revising introductory text and paragraphs (a) and (b) to read as follows:
    § 842.25 Claims payable.

    Claims may be payable for loss of or damage to tangible personal property when the damage occurs incident to service. For loss of or damage to property to be incident to service, it must occur at a place and time that is connected to the service of an active duty military member or employment of a civilian employee.

    (a) Authorized Location. Claims are only payable when the claimed property is located in an authorized location. There must be some connection between the claimant's service and the location of the claimed property. Duty locations where personal property is used, stored or held because of official duties are authorized places. Other authorized places may include:

    (1) Any location on a military installation not otherwise excluded.

    (2) Any office, building, recreation area, or real estate the Air Force or any other DoD element uses or controls.

    (3) Any place a military member is required or ordered to be pursuant to their duties and while performing those duties.

    (4) Assigned Government Housing or Quarters in the United States or provided in kind. The Military Personnel and Civilian Employees' Claims Act specifically prohibits payment for loss of or damage to property in quarters within the US unless the housing or quarters are assigned or otherwise provided in kind. Base housing that has not been privatized is generally considered assigned or provided in kind wherever it is located.

    (i) Privatized Housing or Quarters within the United States subject to the Military

    Housing Privatization Initiative located within the fence line of a military installation or on federal land in which the DoD has an interest is considered assigned or otherwise provided in kind for the purposes of the Military Personnel and Civilian Employees' Claims Act.

    (ii) Reserved.

    (5) Housing or Quarters outside the United States. Outside the US, authorized off-base quarters, as well as assigned quarters, including quarters in US territories and possessions, are authorized places. The residence of a civilian employee is not an authorized location if the employee is a local inhabitant.

    (6) Temporary Duty Quarters (TDY) and locations en route to the TDY destination.

    Significant deviations from the direct travel route are not authorized locations.

    (7) Permanent Change of Station (PCS) temporary quarters and locations enroute to the PCS destination. Significant deviations from the direct travel route are not authorized locations.

    (8) Entitlement and Benefit Locations. For these locations to be authorized, the claimant must be using them for the intended purpose and the property must be reasonably linked to that purpose.

    (9) Locations where Personal Property shipped or stored at government expense are found. Government facilities where property is stored at the claimant's expense or for their convenience without an entitlement are not authorized places.

    (b) Payable Causes of Loss Incident to Service. Because the PCA is not a substitute for private insurance, loss or damage at quarters or other authorized locations may only be paid if caused by:

    (1) An unusual occurrence;

    (2) Theft, vandalism or other malfeasance;

    (3) Hostile action;

    (4) A carrier, contractor, warehouseman or other transportation service provider storing or moving goods or privately owned vehicles at government expense;

    (5) An agent of the US; or

    (6) A permanent seizure of a witness' property by the Air Force.

    22. Amend newly designated § 842.26 by: a. Revising paragraphs (d), (j), (m), (n), (u), (y), and (z). b. Remove paragraphs (aa), (bb), (cc), and (dd).
    § 842.26 Claims not payable.

    (d) The loss is recovered or recoverable from an insurer or other source unless the settlement authority determines there is good cause for not claiming against the insurer.

    (j) It is an appraisal fee, unless the settlement authority requires one to adjudicate the claim.

    (m) It is an item acquired, possessed, shipped, or stored in violation of any U.S. Armed Force directive or regulation.

    (n) It is an item fraudulently claimed.

    (u) It is an inconvenience expense.

    (y) It is damage to, or loss of a rental vehicle which TDY or PCS orders authorized.

    (z) It is a cost to relocate a telephone or mobile or manufactured home due to a government ordered quarters move.

    Subpart E—[Removed] 23. Remove subpart E. Subpart F—[Redesignated as Subpart D] 24. Redesignate subpart F, consisting of §§ 842.40 through 842.54, as subpart D consisting of §§ 842.30 through 842.44. 25. Revise newly redesignated § 842.30 to read as follows:
    § 842.30 Scope of this subpart.

    This subpart establishes policies and procedures for all administrative claims under the Military Claims Act for which the Air Force has assigned responsibility.

    26. Amend newly redesignated § 842.31, by revising paragraph (b) to read as follows:
    § 842.31 Definitions.

    (b) Final denial. A letter mailed from the settlement authority to the claimant or authorized agent advising the claimant that the Air Force denies the claim. Final denial letters mailed from within the United States shall be sent by U.S. Mail, certified mail, return receipt requested.

    27. Amend newly redesignated § 842.32 by: a. Revising paragraphs (a)(1) introductory text, (a)(3) introductory text, (a)(3)(ii) and (iii), (a)(4) and (5), (b), and (f) introductory text: b. Removing paragraph (f)(8) and redesignating paragraphs (f)(9) through (11) as paragraphs (f)(8) through (10).

    The revisions read as follows:

    § 842.32 Delegations of authority.

    (a) Settlement authority:

    (1) The Secretary of the Air Force has authority to:

    (3) The following individuals have delegated authority to settle claims for $25,000 or less and to deny claims in any amount:

    (ii) The Director, Civil Law and Litigation.

    (iii) The Chief, Associate Chief and Branch Chiefs, Claims and Tort Litigation Division.

    (4) SJAs of the Air Force component commander of the US Geographic combatant commands for claims arising within their respective combatant command areas of responsibility have delegated authority to settle claims payable or deny claims filed for $25,000 or less.

    (5) SJAs of GCMs in PACAF and USAFE have delegated authority to settle claims payable, or deny claims filed for $15,000 or less.

    (b) Redelegation of authority. The Chief, Claims and Tort Litigation Division may redelegate his or her authority to Staff Judge Advocates. A settlement authority may redelegate his or her authority for claims not exceeding $25,000, to a subordinate judge advocate or civilian attorney in writing. The Chief, AFLOA/JACC may redelegate up to $25,000, in writing, to paralegals assigned to AFLOA/JACC and, upon request, may authorize installation Staff Judge Advocates to redelegate their settlement authority to paralegals under their supervision.

    (f) Special exceptions. Do not settle or deny claims for the following reasons without AFLOA/JACC approval:

    28. Amend newly redesignated § 842.33, by revising paragraph (a) to read as follows:
    § 842.33 Filing a claim.

    (a) Elements of a proper claim. A claim is must be filed on a Standard Form 95 or other written document. It must be signed by the Claimant or authorized agent, be for money damages in a sum certain, and lay out a basic statement as to the nature of the claim that will allow the Air Force to investigate the allegations contained therein.

    29. Revise newly redesignated § 842.34 to read as follows:
    § 842.34 Advance payments.

    Subpart P sets forth procedures for advance payments.

    30. Amend newly redesignated § 842.35 by revising paragraphs (a) and (c) to read as follows:
    § 842.35 Statute of limitations.

    (a) A claim must be filed in writing within 2 years after it accrues. It is deemed to be filed upon receipt by The Judge Advocate General, AFLOA/JACC, or a Staff Judge Advocate of the Air Force. A claim accrues when the claimant discovers or reasonably should have discovered the existence of the act that resulted in the claimed loss. The same rules governing accrual pursuant to the Federal Tort Claims Act should be applied with respect to the Military Claims Act. Upon receipt of a claim that properly belongs with another military department, the claim is promptly transferred to that department.

    (c) A claim filed after the statute of limitations has run is considered if the U.S. is at war or in an armed conflict when the claim accrues or if the U.S. enters a war or armed conflict after the claim accrues, and if good causes shows how the war or armed conflict prevented the claimant from diligently filing the claim within the statute of limitations. But in no case will a claim be considered if filed more than two years after the war or armed conflict ends.

    31. Revise newly redesignated § 842.37 to read as follows:
    § 842.37 Who are proper claimants.

    (a) Citizens and inhabitants of the United States. U.S. inhabitants includes dependents of the U.S. military personnel and federal civilian employees temporarily outside the U.S. for purposes of U.S. government service.

    (b) U.S. military personnel and civilian employees. NOTE: These personnel are not proper claimants for claims for personal injury or death that occurred incident to their service.

    (c) Foreign military personnel when the damage or injury occurs in the U.S. Do not pay for claims under the MCA for personal injury or death of a foreign military personnel that occurred incident to their service.

    (d) States, state agencies, counties, or municipalities, or their political subdivisions.

    (e) Subrogees of proper claimants to the extent they have paid for the claim in question.

    32. Revise newly redesignated § 842.38 to read as follows:
    § 842.38 Who are not proper claimants.

    (a) Governments of foreign nations, their agencies, political subdivisions, or municipalities.

    (b) Agencies and NAFIs of the U.S. Government.

    (c) Subrogees of § 842.42(a) and (b) of this part.

    (d) Inhabitants of foreign countries.

    33. Amend newly redesignated § 842.39 by: a. Revising paragraph (a). b. Removing paragraphs (c), (d) and (f). c. Redesignating paragraph (e) as paragraph (c).

    The revision reads as follows

    § 842.39 Claims payable.

    (a) Claims arising from negligent or wrongful acts or omissions committed by United States military or civilian personnel while acting in the scope of their employment, subject to the exceptions listed in this subpart.

    34. Revise newly redesignated § 842.40 to read as follows:
    § 842.40 Claims not payable.

    (a) Is covered by the FTCA, FCA, IACA, 10 U.S.C. 2734a and 2734b, Air Force Admiralty Claims Act (AFACA), 10 U.S.C. 9801-9804, 9806, NGCA, 32 U.S.C. 715, or covered under the Military Personnel and Civilian Employees' Claims Act (MPCECA), 31 U.S.C. 3701, 3721. (1) MCA claims arising from noncombat activities in the U.S. are not covered by the FTCA because more elements are needed to state an FTCA claim than are needed to state a claim under the MCA for noncombat activities. All FTCA claims are based on elements of traditional tort liability (i.e., duty, breach, causation, and damages); that is, they are fault based. Noncombat activity claims under the MCA are based solely on causation and damages. Because MCA claims for noncombat activities are not fault based, they are not covered by the FTCA.

    (2) Claims for incident-to-service damage to vehicles caused by the negligence of a member or employee of the armed forces acting in the scope of employment are paid under the MCA, instead of the Military Personnel and Civilian Employees' Claims Act.

    (b) Arises with respect to the assessment or collection of any customs duty, or the detention of any goods or merchandise by any U.S. officer of customs or excise, or any other U.S. law enforcement officer. NOTE: This includes loss or damage to property detained by members of the Security Forces or Office of Special Investigation (OSI).

    (c) Is cognizable under U.S. admiralty and maritime law, to include:

    (1) The Suits in Admiralty Act, 46 U.S.C. 30901 and following.

    (2) The Death on the High Seas Act, 46 U.S.C. 30301 and following.

    (3) The Public Vessels Act, 46 U.S.C. 31101 and following.

    (4) EXCEPTION: Claims arising from noncombat activities may be paid under the MCA, even if they are also cognizable under paragraphs (c)(1) through (c)(3), of this section.

    (d) Arises out of assault, battery, false imprisonment, false arrest, malicious prosecution, or abuse of process. EXCEPTION: Unless such actions were committed by an investigative or law enforcement officer of the U.S. who is empowered by law to conduct searches, seize evidence, or make arrests for violations of federal law.

    (e) Arises out of libel, slander, misrepresentation, or deceit.

    (f) Arises out of an interference with contract rights.

    (g) Arises out of the combat activities of U.S. military forces.

    (h) Is for the personal injury or death of a member of the Armed Forces of the U.S. incident to the member's service.

    (i) Is for the personal injury or death of any person for workplace injuries covered by the Federal Employees' Compensation Act, 5 U.S.C. 8101, and following.

    (j) Is for the personal injury or death of any employee of the U.S., including nonappropriated fund employees, for workplace injuries covered by the Longshore and Harbor Workers' Compensation Act, 33 U.S.C. 901, and following.

    (k) Is for a taking of property, e.g., by technical trespass or over flight of aircraft.

    (l) Is for patent or copyright infringement.

    (m) Results wholly from the negligent or wrongful act of the claimant.

    (n) Is for the reimbursement of medical, hospital, or burial expenses furnished at the expense of the U.S., either directly or through contractual payments.

    (o) Arises from contractual transactions, express or implied (including rental agreements, sales agreements, leases, and easements), that:

    (1) Are payable or enforceable under oral or written contracts; or

    (2) Arise out of an irregular procurement or implied contract.

    (p) Is for the personal injury or death of military or civilian personnel of a foreign government incident to their service.

    (q) Is based on an act or omission of an employee of the government, exercising due care, in the execution of a statute or regulation, whether or not such statute or regulation is valid. Do not deny claims solely on this exception without the prior approval of USAF/JACC. Claims under the noncombat activities provision of this subpart may be paid even if this paragraph applies. Is based on the exercise or performance of, or the failure to exercise or perform, a discretionary function or duty on the part of a federal agency or a federal government employee, whether or not the discretion involved is abused. Do not deny claims solely on this exception without the prior approval of USAF/JACC. EXCEPTION: Claims under the noncombat activities provision may be paid even if this paragraph applies.

    (r) Is not in the best interests of the U.S., is contrary to public policy, or is otherwise contrary to the basic intent of the MCA. Examples include, but are not limited to, when a claimant's criminal conduct or failure to comply with a nonpunitive regulation is a proximate cause of the loss. Prior approval must be obtained from USAF/JACC before denying claims solely on this exception.

    (s) Arises out of an act or omission of any employee of the government in administering the provisions of the Trading With the Enemy Act, 50 U.S.C. app. 1-44.

    (t) Is for damages caused by the imposition or establishment of a quarantine by the U.S.

    (u) Arises from the fiscal operations of the Department of the Treasury or from the regulation of the monetary system.

    (v) Arises from the activities of the Tennessee Valley Authority.

    (w) Arises from the activities of a federal land bank, a federal intermediate credit bank, or a bank for cooperatives.

    (x) Is for the personal injury or death of any government contractor employee for whom benefits are available under any worker's compensation law, or under any contract or agreement providing employee benefits through insurance, local law, or custom when the U.S. pays insurance either directly or as part of the consideration under the contract. Only USAF/JACC may act on these claims.

    (y) Is for damage, injury or death from or by flood or flood waters at any place.

    (z) Is for damage to property or other losses of a state, commonwealth, territory, or the District of Columbia caused by Air National Guard personnel engaged in training or duty under 32 U.S.C. 316, 502, 503, 504, or 505 who are assigned to a unit maintained by that state, commonwealth, territory, or the District of Columbia.

    (aa) Is for damage to property or for any death or personal injury arising out of activities of any federal agency or employee of the government in carrying out the provisions of the Disaster Relief Act of 1974 (42 U.S.C. 5121, et seq.), as amended.

    (bb) Arises from activities that present a political question.

    (cc) Arises from private, as distinguished from government, transactions.

    (dd) Is based solely on compassionate grounds.

    (ee) Is for rent, damage, or other expenses or payments involving the regular acquisition, use, possession, or disposition of real property or interests therein by and for the U.S.

    (ff) Is presented by a national, or a corporation controlled by a national, of a country at war or engaged in armed conflict with the U.S., or any country allied with such enemy country unless the appropriate settlement authority determines that the claimant is, and at the time of the incident was, friendly to the U.S. A prisoner of war or an interned enemy alien is not excluded as to a claim for damage, loss, or destruction of personal property in the custody of the U.S. otherwise payable. Forward claims considered not payable under this paragraph, with recommendations for disposition, to USAF/JACC.

    (gg) Arises out of the loss, miscarriage, or negligent transmission of letters or postal matter by the U.S. Postal Service or its agents or employees.

    (hh) Is for damage to or loss of bailed property when the bailor specifically assumes such risk.

    (ii) Is for property damage, personal injury, or death occurring in a foreign country to an inhabitant of a foreign country.

    (jj) Is for interest incurred prior to the payment of a claim.

    (kk) Arises out of matters which are in litigation against the U.S.

    (ll) Is for attorney fees or costs in connection with pursuing an administrative or judicial remedy against the U.S. or any of its agencies.

    (mm) Is for bail, interest or inconvenience expenses incurred in connection with the preparation and presentation of the claim.

    (nn) Is for a failure to use a duty of care to keep premises owned or under the control of the U.S. safe for use for any recreational purpose, or for a failure by the U.S. to give any warning of hazardous conditions on such premises to persons entering for a recreational purpose unless there is a willful or malicious failure to guard or warn against a dangerous condition, or unless consideration was paid to the U.S. (including a nonappropriated fund instrumentality) to use the premises.

    35. Revise newly redesignated § 842.41 to read as follows:
    § 842.41 Applicable law.

    This paragraph provides the existing law governing liability, measurement of liability and the effects of settlement upon awards.

    (a) Many of the exclusions in this subpart are based upon the wording of 28 U.S.C. 2680 or other federal statutes or court decisions interpreting the Federal Tort Claims Act. Federal case law interpreting the same exclusions under the Federal Tort Claims Act is applied to the Military Claims Act. Where state law differs with federal law, federal law prevails.

    (b) Extent of liability. Where the claim arises is important in determining the extent of liability.

    (1) When a claim arises in the United States, its territories or possessions, the same law as if the claim was cognizable under the FTCA will be applied.

    (2) Claims in foreign countries. In claims arising in a foreign country, where the claim is for personal injury, death, or damage to or loss of real or personal property caused by an act or omission alleged to be negligent, wrongful, or otherwise involving fault of military personnel or civilian officers or employees of the United States acting within the scope of their employment, liability or the United States is determined according federal case law interpreting the FTCA. Where the FTCA requires application of the law of the place where the act or omission occurred, settlement authorities will use the rules set forth in the currently adopted edition of the Restatement of the Law, published by the American Law Institute, to evaluate the liability of the Air Force, subject to the following rules:

    (i) Foreign rules and regulations governing the operation of motor vehicles (rules of the road) are applied to the extent those rules are not specifically superseded or preempted by United States military traffic regulations.

    (ii) Absolute or strict liability will not apply for claims not arising from noncombat activities.

    (iii) Hedonic damages are not payable.

    (iv) The collateral source doctrine does not apply.

    (v) Joint and several liability does not apply. Payment will be made only upon the portion of loss, damage, injury or death attributable to the Armed Forces of the United States.

    (vi) Future economic loss will be discounted to present value after deducting for federal income taxes and, in cases of wrongful death, personal consumption.

    (c) Do not approve payment for:

    (i) Punitive damages.

    (ii) Cost of medical or hospital services furnished at the expense of the United States.

    (iii) Cost of burial expenses paid by the United States.

    (d) Settlement by insurer or joint tortfeasor. When settlement is made by an insurer or joint tortfeasor and an additional award is warranted, an award may be made if both of the following are present:

    (1) The United States is not protected by the release executed by the claimant.

    (2) The total amount received from such source is first deducted.

    36. Amend newly redesignated § 842.42, by revising paragraphs (a) and (c) to read as follows:
    § 842.42 Appeal of final denials.

    (a) A claimant may appeal the final denial of the claim. The claimant sends the request, in writing, to the settlement authority that issued the denial letter within 60 days of the date the denial letter was mailed. The settlement authority may waive the 60 day time limit for good cause.

    (c) Where the settlement authority does not reach a final agreement on an appealed claim, he or she sends the entire claim file to the next higher settlement authority, who is the appellate authority for that claim. Any higher settlement authority may act upon an appeal.

    Subpart G—[Redesignated as Subpart E] 37. Redesignate subpart G, consisting of §§ 842.55 through 842.68, as subpart E, consisting of §§ 842.45 through 842.58, respectively. 38. Revise newly redesignated § 842.47 to read as follows:
    § 842.47 Delegations of authority.

    (a) Settlement authority. (1) The Secretary of the Air Force has the authority to:

    (i) Settle claims for payment of $100,000 or less.

    (ii) Settle claims for more than $100,000, pay the first $100,000, and report the excess to the Department of the Treasury for payment.

    (iii) Deny claims in any amount.

    (2) The Judge Advocate General, Deputy Judge Advocate General, Director of Civil Law, and the Chief, Deputy Chief and Branch Chiefs, Claims and Tort Litigation Staff are FCCs and have delegated authority to:

    (i) Settle claims for payment of $100,000 or less.

    (ii) Deny claims in any amount.

    (3) The SJAs of the Air Force component commander of the U.S. geographic combatant commands are FCC for claims arising in their respective combatant command AORs and may deny claims of $50,000 or less and will pay claims filed in any amount when payment is for $50,000 or less.

    (b) Redelegating settlement authority. A settlement authority appointed as a FCC in paragraph (a) of this section may appoint one or more subordinate judge advocates or civilian attorneys to act as FCC, and redelegate all or part of that settlement authority to such persons.

    (c) Settlement negotiations. A settlement authority may settle a claim in any sum within its settlement authority, regardless of the amount claimed. Send uncompromised claims in excess of the delegated authority through claims channels to the level with settlement authority. Unsuccessful negotiations at one level do not bind higher authority.

    (d) Special exceptions. Do not settle claims for medical malpractice without HQ USAF/JACC approval.

    39. Amend newly redesignated § 842.48, by revising paragraph (a) to read as follows:
    § 842.48 Filing a claim.

    (a) How and when filed. A claim is filed when the Air Force receives from a claimant or authorized agent a properly completed SF 95 or other signed and written demand for money damages in a sum certain. A claim may be presented orally only if oral claims are the custom in the country where the incident occurred and the claimant is functionally illiterate. In any case where an oral claim is made, claims personnel must promptly reduce the claim to writing with all particulars carefully noted. A claim belonging to another agency is promptly transferred to the appropriate agency.

    40. Revise newly redesignated § 842.49 to read as follows:
    § 842.49 Advance payments.

    Subpart P outlines procedures for advance payments.

    41. Amend newly redesignated § 842.50, by revising paragraph (a) to read as follows:
    § 842.50 Statute of limitations.

    (a) A claim must be presented to the Air Force within 2 years after it accrues. It accrues when the claimant discovers or reasonably should have discovered the existence of the act that resulted in the claimed loss or injury.

    42. Amend newly redesignated § 842.52, by revising paragraphs (a) and (b) to read as follows:
    § 842.52 Who are proper claimants.

    (a) Foreign nationals. In a wrongful death case, if the decedent is an inhabitant of a foreign country, even though his or her survivors are U.S. inhabitants, the FCA will apply.

    (b) U.S. nationals residing abroad, unless the claim arises from a benefit, privilege or service provided to them by the U.S. Government, or they reside in the foreign country primarily because they are employed directly by the United States, or sponsored by or accompanying such a person, or employed by a U.S. civilian contractor in furtherance of a contract with the U.S. Government, or sponsored by or accompanying such a person.

    43. Amend newly redesignated § 842.53 by revising paragraphs (b), (c), and (e) to read as follows:
    § 842.53 Who are not proper claimants.

    (b) Persons determined to be U.S. inhabitants. U.S. inhabitants include dependents of U.S. military personnel and U.S. Government civilian employees.

    (c) Foreign military personnel suffering personal injury, or death arising incident to service or pursuant to combined and/or joint military operations. Such operations include, but are not limited to, military exercises and United Nations, NATO, and other regional peacekeeping and humanitarian missions.

    (e) National governments and their political subdivisions engaging in war or armed conflict with the United States or its allies. This includes factions that have not necessarily been recognized by the international community as a legitimate nation state.

    44. Amend newly redesignated § 842.54 by: a. Revising paragraph (a). b. Removing paragraph (b). c. Redesignating paragraph (c) as paragraph (b).

    The revision reads as follows:

    § 842.54 Payment criteria.

    The following criteria is considered before determining liability.

    (a) The incident causing the damage or injury must arise in a foreign country and be caused by noncombatant activities of the U.S. Armed Forces or by the negligent or wrongful acts of civilian employees or military members of the Armed Forces.

    (1) It is a prerequisite to U.S. responsibility if the employee causing the damage or injury is a local inhabitant, a prisoner of war, or an interned enemy alien. These persons are “employees” within the meaning of the Foreign Claims Act (FCA) only when in the service of the United States. Ordinarily, a slight deviation as to time or place does not constitute a departure from the scope of employment. The purpose of the activity and whether it furthers the general interest of the United States is considered. If the claim arose from the operation or use of a U.S. Armed Forces vehicle or other equipment by such a person, pay it provided local law imposes liability on the owner of the vehicle or other equipment in the circumstances involved.

    (2) It is immaterial when the claim arises from the acts or omissions of any U.S. Armed Forces member or employee not listed in § 842.64(c)(1) of this part. The Act imposes responsibility on the United States when it places a US citizen or non-U.S. citizen employee in a position to cause the injury or damage. If the cause is a criminal act clearly outside the scope of employment, ordinarily pay the claim and consider disciplinary action against the offender.

    45. Amend newly redesignated § 842.55 by: a. Revising paragraphs (a), (c), (f), (h), (m), (o) and (q). b. Adding paragraphs (s) and (t).

    The revisions and additions read as follows:

    § 842.55 Claims not payable.

    A claim is not payable when it:

    (a) Is waived under an applicable international agreement, or pursuant to an applicable international agreement, a receiving state should adjudicate and pay the claim. However, if a foreign government subject to such an international agreement disputes its legal responsibilities under the agreement, and the claimant has no other means of compensation, USAF/JACC may authorize payment.

    (c) Is for attorney fees, punitive damages, a judgment or interest on a judgment, bail, or court costs. FCC should consider providing early notice to claimants that attorney fees are not payable as an item of damage under the FCA.

    (f) Is a paternity claim.

    (h) Results wholly from the negligent or wrongful act of the claimant or agent.

    (m) Results from an action by an enemy, or directly or indirectly from an act of the U.S. armed forces in combat, except that a claim may be allowed if it arises from an accident or malfunction incident to the operation of an aircraft of the U.S. armed forces, including its airborne ordnance, indirectly related to combat, and occurring while preparing for or going to, or returning from a combat mission.

    (o) Arises out of personal activities of family members, guests, servants, or activities of the pets of members and employees of the U.S. Armed Forces.

    (q) Is covered under U..S admiralty or maritime laws, unless authorized by The Judge Advocate General or Chief, Claims and Tort Litigation Staff.

    (s) Is not in the best interest of the United States, is contrary to public policy, or otherwise contrary to the basic intent of the FCA. Claims considered not payable on this basis will be forwarded to USAF/JACC for final decision.

    (t) Is presented by a national, or a corporation controlled by a national, of a country at war or engaged in armed conflict with the United States, or any country allied with such enemy country unless the settlement authority determines the claimant is, and at the time of the incident was, friendly to the United States. EXCEPTION: A prisoner of war or interned enemy alien is not excluded from filing a claim for damage, loss, or destruction of personal property within the U.S. Armed Forces' custody if the claim is otherwise payable.

    46. Revise newly redesignated § 842.56 to read as follows:
    § 842.56 Applicable law.

    This section provides guidance to determine the applicable law for assessment of liability.

    (a) In adjudicating FCA claims, settlement authorities will follow the law, customs, and standards of the country where the claim arose, except:

    (1) Causation is determined based upon general principles of U.S. tort law found in federal case law and standard legal publications.

    (2) Joint and several liability does not apply. Payment is based solely on the portion of loss, damage, injury or death attributable to the U.S. Armed Forces.

    (3) If lost income or lost profits is recoverable under the law where the claim arose, they shall be limited to net lost income or net lost profits, taking into account appropriate deductions for taxes, regular business expenditures, and in the case of wrongful death, personal consumption during the loss period.

    (b) Settlement authorities will not deduct compensation from collateral sources except for:

    (1) Direct payments by a member or civilian employee of the U.S. Armed Forces for damages (not solatia).

    (2) Any payments recovered or recoverable from an insurance policy when premiums were paid, directly or indirectly, by the United States, or a member or civilian employee of the U.S. Armed Forces; or when the member or employee has the benefit of the insurance (such as when a U.S. member or employee borrows a vehicle of a local national, and the vehicle carries insurance for the benefit of any driver with permission to drive the vehicle).

    47. Revise newly redesignated § 842.57 to read as follows:
    § 842.57 Reconsideration of final denials.

    This section provides the procedures used to reconsider a final denial.

    (a) An FCC has the inherent authority to reconsider a final decision. The mere fact that a request for reconsideration is received does not obligate the settlement authority to reopen the claim.

    (b) The FCC does not mention a reconsideration right in the original denial letter.

    (c) A settlement authority must reconsider the final action when there is:

    (1) New and material evidence concerning the claim or,

    (2) Obvious errors in the original decision.

    (d) The FCC must document in the claim file the reason for reconsideration.

    (e) A FCC above the original settlement authority may direct a claim be forwarded to a higher FCC for reconsideration.

    48. Revise newly redesignated § 842.58 to read as follows:
    § 842.58 Right of subrogation, indemnity, and contribution.

    The Air Force has all the rights of subrogation, indemnity and contribution, as local law permits. However, settlement authorities will not seek contribution or indemnity from U.S. military members or civilian employees whose conduct gave rise to U.S. government liability, or whenever it would be harmful to international relations.

    Subpart H—[Redesignated as Subpart F] 49. Redesignate subpart H, consisting of §§ 842.69 through 842.72, as subpart F, consisting of §§ 842.59 through 842.62, respectively. 50. Revise newly redesignated § 842.59 to read as follows:
    § 842.59 Scope of this subpart.

    This subpart governs Air Force actions in investigating, processing, and settling claims under the International Agreement Claims Act.

    51. Amend newly redesignated § 842.60 by revising paragraphs (a), (d), (e), (f) and (g) to read as follows:
    § 842.60 Definitions.

    (a) Civilian component. Civilian personnel accompanying and employed by an international agreement contracting force. Local employees, contractor employees, or members of the American Red Cross are not a part of the civilian component unless specifically included in the agreement.

    (d) Legally responsible. A term of art providing for settlement of claims under cost sharing international agreements in accordance with the law of the receiving state. Often, employees who are local inhabitants, not part of the civilian component of the force, could cause the sending state to be legally responsible under a respondeat superior theory.

    (e) Receiving state. The country where the force or civilian component of another contracting party is temporarily located. It is often thought of as the “host nation.”

    (f) Sending state. The country sending the force or civilian component to the receiving State. In cases where U.S. personnel are stationed in a foreign country, the U.S. is the sending state.

    (g) Third parties. A term of art used in International Agreements. Parties other than members of the force and civilian component of the sending or receiving States. Dependents, tourists, and other noninhabitants of a foreign country are third parties (and therefore can generally make a claim under a SOFA) unless the international agreement, or an understanding between the countries involved, specifically excludes them.

    52. Revise newly redesignated § 842.61 to read as follows:
    § 842.61 Delegations of authority.

    (a) Staff Judge Advocates of the Air Force component commands of the U.S. geographic combatant commands will, within their combatant command AORs, fulfill U.S. obligations concerning claims abroad subject to 10 U.S.C. 2734a for which the Air Force has settlement authority. Consistent with 10 U.S.C. 2734a and the international agreement, they may reimburse or pay the pro rata share of a claim as agreed, or if inconsistent with the IACA or the international agreement, they may object to a bill presented,

    (b) The Secretary of the Air Force, The Judge Advocate General, the Deputy Judge Advocate General, The Director of Civil Law and Chief of the Claims and Tort Litigation Division may also exercise settlement authority under 10 U.S.C. 2734a.

    (c) Redelegation of authority. A settlement authority may redelegate his or her authority to a subordinate judge advocate or civilian attorney in writing.

    (d) Authority to reduce, withdraw, and restore settlement authority. Any superior settlement authority may reduce, withdraw, or restore delegated authority.

    53. Amend newly redesignated § 842.62 by revising paragraph (b) to read as follows:
    § 842.62 Filing a claim.

    (b) Claims arising in the United States. The claimant files tort claims arising from the act or omission of military or civilian personnel of another contracting party at any U.S. military installation. The Staff Judge Advocate for the installation where such military or civilian personnel is assigned or attached will promptly notify the Foreign Claims Branch of USAF/JACC as well as the Commander, U.S. Army Claims Service. If the files said claim at an installation other than the location where said military or civilian personnel is assigned, the Staff Judge Advocate for that installation will promptly forward the claim to the appropriate installation Staff Judge Advocate.

    Subpart I—[Redesignated as Subpart G] 54. Redesignate subpart I, consisting of §§ 842.73 through 842.81 as subpart G, consisting of §§ 842.63 through 842.71, respectively. 55. Revise newly redesignated § 842.63 to read as follows:
    § 842.63 Scope of this subpart.

    This subpart explains how to settle and pay claims against the United States, for property damage, personal injury, or death incident to the use of a government vehicle or any other government property on a government installation which are not payable under any other statute.

    56. Amend newly redesignated § 842.65 by revising paragraph (a)(5) to read as follows:
    § 842.65 Delegations of authority.

    (a) * * *

    (5) SJA of the Air Force component commands of the U.S. geographic combatant commands.

    57. Amend newly redesignated § 842.68 by: a. Removing the brackets in the second sentence of paragraph (a). b. Revising paragraph (c).

    The revision reads as follows:

    § 842.68 Claims payable.

    (c) Arose from the use of a government vehicle at any place or from the use of other government property on a government installation, and

    58. Amend newly redesignated § 842.69 by adding paragraph (e) to read as follows:
    § 842.69 Claims not payable.

    (e) For pain and suffering or other general damages.

    59. Revise newly redesignated § 842.71 to read as follows:
    § 842.71 Settlement agreement.

    Do not pay a claim unless the claimant accepts the amount offered in full satisfaction of the claim and signs a settlement agreement to that effect, in which the claimant agrees to release any and all claims against the United States, its employees and agents arising from the incident in question. Use the settlement agreement approved for use by the Department of Justice for the settlement of FTCA claims, tailored to this claim.

    Subpart J—[Redesignated as Subpart H] 60. Redesignate subpart J, consisting of §§ 842.82 through 842.85, as subpart H, consisting of §§ 842.72 through 842.75, respectively. 61. Amend newly redesignated § 842.74 by: a. Revising paragraph (a)(1)(i). b. Removing and reserving paragraph (a)(1)(ii) and removing paragraph (a)(1)(iii). c. Revising paragraph (b)(3)(iv).

    The revisions read as follows:

    § 842.74 Delegations of authority.

    (a) * * *

    (1) * * *

    (i) Settle or deny a claim in any amount. Settlements for payment of more than $500,000 are certified to Congress for payment.

    (b) * * *

    (3) * * *

    (iv) The Chief and Deputy Chief, Claims and Tort Litigation Division.

    62. In newly redesignated § 842.75, add paragraph (c) to read as follows:
    § 842.75 Reconsidering claims against the United States.

    (c) There is no time limit for submitting a request for reconsideration, but it is within the discretion of the settlement authority to decline to reconsider a claim based on the amount of time passed since the claim was originally denied.

    Subpart K—[Removed] 63. Remove subpart K, consisting of §§ 842.86 through 842.91. 64. Add new subpart I, consisting of §§ 842.76 through 842.79. Subpart I—Claims Under the Federal Tort Claims Act (28 U.S.C. 1346(b), 2402, 2671, 2672, 2674-2680) Sec. 842.76 Scope of this subpart. 842.77 Delegations of authority. 842.78 Settlement agreements. 842.79 Administrative claim; when presented. Subpart I—Claims Under the Federal Tort Claims Act (28 U.S.C. 1346(b), 2402, 2671, 2672, 2674-2680)
    § 842.76 Scope of this subpart.

    This subpart, promulgated under the authority of 28 CFR 14.11, governs claims against the United States for property damage, personal injury, or death, from the negligent or wrongful acts or omission of Air Force military or civilian personnel while acting within the scope of their employment.

    § 842.77 Delegations of authority.

    (a) Settlement authority. (1) The following individuals are delegated the full authority of the Secretary of the Air Force to settle and deny claims:

    (i) The Judge Advocate General.

    (ii) The Deputy Judge Advocate General.

    (iii) The Director of Civil Law.

    (iv) The Division Chief of Claims and Tort Litigation.

    (v) The Division Chief of Environmental Law and Litigation.

    (b) Redelegation of authority. A settlement authority may be redelegated, in writing, to a subordinate judge advocate or civilian attorney. The Chief, AFLOA/JACC may redelegate up to $25,000, in writing, to paralegals assigned to AFLOA/JACC and, upon request, may authorize installation Staff Judge Advocates to redelegate their settlement authority to paralegals under their supervision.

    (c) Authority to reduce, withdraw, and restore settlement authority. Any superior settlement authority may reduce, withdraw, or restore delegated authority.

    (d) Settlement negotiations. A settlement authority may settle a claim filed in any amount for a sum within the delegated authority. Unsettled claims in excess of the delegated authority will be sent to the next highest level with settlement authority. Unsuccessful negotiations at one level do not bind higher authority.

    § 842.78 Settlement agreements.

    The claimant must sign a settlement agreement and general release before any payment is made.

    § 842.79 Administrative claim; when presented.

    When the Air Force is the proper agency to receive a claim pursuant to 28 CFR 14.2(b), for purposes of the provisions of 28 U.S.C. 2401(b), 2672 and 2675, a claim shall be deemed to have been presented when it is received by:

    (a) The office of the Staff Judge Advocate of the Air Force installation nearest the location of the incident; or

    (b) The Claims and Tort Litigation Division, 1500 West Perimeter Road, Suite 1700, Joint Base Andrews, MD 20762.

    Subpart L—[Redesignated as Subpart J] 65. Redesignate subpart L, consisting of §§ 842.92 through 842.99, as subpart J, consisting of §§ 842.80 through 842.87, respectively. 66. Revise newly redesigated § 842.80 to read as follows:
    § 842.80 Scope of this subpart.

    This subpart describes how to assert, administer, and collect claims for damage to or loss or destruction of government property and lost wages of Air Force servicemembers through negligent or wrongful acts. It does not cover admiralty, hospital recovery, or nonappropriated fund claims.

    67. Amend newly redesignated § 842.81 by revising paragraph (a) to read as follows:
    § 842.81 Delegations of authority.

    (a) Settlement authority. (1) The following individuals have delegated authority to settle, compromise, suspend, or terminate action on claims asserted for $100,000 or less and to accept full payment on any claim:

    (i) The Judge Advocate General.

    (ii) The Deputy Judge Advocate General.

    (iii) The Director of Civil Law.

    (iv) Chief, Deputy Chief, and Branch Chiefs, Claims and Tort Litigation Staff.

    (2) Installation staff judge advocates have authority to assert claims in any amount, accept full payment on any claim and to compromise, suspend or terminate action on claims asserted for $25,000 or less.

    68. Amend newly redesignated § 842.82 by revising paragraphs (a)(2), (c), and (e) to read as follows:
    § 842.82 Assertable claims.

    (a) * * *

    (2) Less than $100 but collection is practicable and economical.

    (c) The claim is for property damage arising from the same incident as a hospital recovery claim.

    (e) The claim is assertable as a counterclaim under an international agreement. (The claim should be processed under subpart G of this part).

    69. Amend newly redesignated § 842.83 by revising paragraph (b)(2) and adding paragraph (f) to read as follows:
    § 842.83 Non-assertable claims.

    (b) * * *

    (2) Caused by a person who has accountability and responsibility for the damaged property under the Report of Survey system.

    (f) Loss or damage caused by an employee of another federal agency while the employee was acting in the scope of his employment.

    70. Revise newly redesignated § 842.85 to read as follows:
    § 842.85 Referring a claim to the U.S. Attorney or the Department of Justice.

    If collection efforts are unsuccessful, AFLOA/JACC may refer a claim to the appropriate U.S. Attorney's Office or the Department of Justice for initiation of a lawsuit.

    Subpart M—[Redesignated as Subpart K] 71. Redesignate subpart M, consisting of §§ 842.100 through 842.114, as subpart K, consisting of §§ 842.88 through 842.102, respectively 72. Revise newly redesignated § 842.88 to read as follows:
    § 842.88 Scope of this subpart.

    This subpart establishes policies and procedures for all administrative claims under the National Guard Claims Act for which the Air Force has assigned responsibility. Unless otherwise outlined in this subpart, follow procedures as outlined in Subpart E for claims arising out of noncombat activities.

    73. Revise newly redesignated § 842.89 to read as follows:
    § 842.89 Definitions.

    (a) Air National Guard (ANG). The federally recognized Air National Guard of each state, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, and Guam.

    (b) ANG member. An ANG member is one who is performing duty under 32 U.S.C., section 316, 502, 503, 504, or 505 for which the member is entitled to pay from the United States or for which the member has waived pay from the United States.

    (c) ANG duty status—(1) Active federal service. ANG members may serve on active Federal duty under 10 U.S.C. to augment the active Air Force under certain circumstances or for certain types of duty or training (e.g., overseas training exercises and ANG alert duty). Duty under 10 U.S.C. does not fall under this subpart.

    (2) Federally funded duty. ANG members perform specified federally funded duty or training under 32 U.S.C. such as weekend drills, annual training, field exercises, range firing, military schooling, full time unit support, or recruiting duties. Duty under 32 U.S.C. falls under this subpart for noncombat activities.

    (3) State duty. State duty is duty not authorized by federal law but required by the governor of the state and paid for from state funds. Such duty includes civil emergencies (natural or other disasters), civil disturbances (riots and strikes), and transportation requirements for official state functions, public health, or safety. State duty does not fall under this subpart.

    (d) ANG technicians. An ANG technician is a Federal employee employed under 32 U.S.C. 709. Tort claims arising out of his or her activity are settled under the Federal Tort Claims Act (FTCA).

    74. Amend newly redesignated § 842.90 by: a. Removing the introductory text; b. Revising paragraphs (a)(4) and (5) and (b). c. Removing paragraph (f)(1) and redesignating paragraphs (f)(2) and (3) as (f)(1) and (2), respectively.

    The revisions read as follows:

    § 842.90 Delegations of authority.

    (a) * * *

    (4) The SJAs of the Air Force component commander of the U.S. Geographic combatant commands for claims arising within their respective combatant command areas of responsibility have delegated authority to settle claims payable or to deny claims filed for $25,000 or less.

    (5) SJAs of GCMs in PACAF and USAFE have delegated authority to settle claims payable, and deny claims filed, for $15,000 or less.

    (b) Redelegation of authority. A settlement authority may redelegate up to $25,000 of settlement authority to a subordinate judge advocate or civilian attorney. This redelegation must be in writing and can be for all claims or limited to a single claim. The Chief, AFLOA/JACC may redelegate up to $25,000, in writing, to paralegals assigned to AFLOA/JACC and, upon request, may authorize installation Staff Judge Advocates to redelegate their settlement authority to paralegals under their supervision.

    75. Revise newly redesignated § 842.91 to read as follows:
    § 842.91 Filing a claim.

    (a) Elements of a proper claim. A claim is must be filed on a Standard Form 95 or other written document. It must be signed by the Claimant or authorized agent, be for money damages in a sum certain, and lay out a basic statement as to the nature of the claim that will allow the Air Force to investigate the allegations contained therein.

    (b) Amending a claim. A claimant may amend a claim at any time prior to final action. To amend a claim the claimant or his or her authorized agent must submit a written, signed demand.

    76. Revise newly redesignated § 842.92 to read as follows:
    § 842.92 Advance payments.

    Subpart P of this part sets forth procedures for such payments.

    77. Revise newly redesignated § 842.93 to read as follows:
    § 842.93 Statute of limitations.

    (a) A claim must be filed in writing within 2 years after it accrues. It is deemed to be filed upon receipt by The Judge Advocate General, USAF/JACC, or a Staff Judge Advocate of the Air Force. A claim accrues when the claimant discovers or reasonably should have discovered the existence of the act that resulted in the claimed loss. The same rules governing accrual pursuant to the Federal Tort Claims Act should be applied with respect to the National Guard Claims Act. Upon receipt of a claim that properly belongs with another military department, the claim is promptly transferred to that department.

    (b) The statutory time period excludes the day of the incident and includes the day the claim was filed.

    (c) A claim filed after the statute of limitations has run is considered if the U.S. is at war or in an armed conflict when the claim accrues or if the U.S. enters a war or armed conflict after the claim accrues, and if good causes shows how the war or armed conflict prevented the claimant from diligently filing the claim within the statute of limitations. But in no case will a claim be considered if filed more than two years after the war or armed conflict ends.

    78. Revise newly redesignated § 842.94 to read as follows:
    § 842.94 Who may file a claim.

    The following individuals may file a claim under this subpart.

    (a) Owners of the property or their authorized agents may file claims for property damage.

    (b) Injured persons or their duly authorized agents may file claims for personal injury.

    (c) Duly appointed guardians of minor children or any other persons legally entitled to do so under applicable local law may file claims for minors' personal injuries.

    (d) Executors or administrators of a decedent's estate or another person legally entitled to do so under applicable local law, may file claims based on:

    (1) An individual's death.

    (2) A cause of action surviving an individual's death.

    (e) Insurers with subrogation rights may file claims for losses paid in full by them. The parties may file claims jointly or individually, to the extent of each party's interest, for losses partially paid by insurers with subrogation rights.

    (f) Authorized agents signing claims show their title or legal capacity and present evidence of authority to present the claims.

    79. Revise newly redesignated § 842.95 to read as follows:
    § 842.95 Who are proper claimants.

    (a) Citizens and inhabitants of the United States. U.S. inhabitants includes dependents of the U.S. military personnel and federal civilian employees temporarily outside the U.S. for purposes of U.S. government service.

    (b) U.S. military personnel and civilian employees. NOTE: These personnel are not proper claimants for claims for personal injury or death that occurred incident to their service.

    (c) Foreign military personnel when the damage or injury occurs in the U.S. Do not pay for claims under the MCA for personal injury or death of a foreign military personnel that occurred incident to their service.

    (d) States, state agencies, counties, or municipalities, or their political subdivisions.

    (e) Subrogees of proper claimants to the extent they have paid for the claim in question.

    80. Revise newly redesignated § 842.96 to read as follows:
    § 842.96 Who are not proper claimants.

    (a) Governments of foreign nations, their agencies, political subdivisions, or municipalities.

    (b) Agencies and Nonappropriated fund instrumentalities of the U.S. Government including the District of Columbia government.

    (c) Inhabitants of foreign countries.

    (d) The state, territory and its political subdivisions whose Air National Guard member caused the loss.

    (e) Subrogees of the claimants in paragraphs (a) through (d) of this section.

    81. Revise newly redesignated § 842.97 to read as follows:
    § 842.97 Claims payable.

    Claims arising from noncombat activities of the United States when caused by ANG members performing duty under 32 U.S.C. and acting within the scope of their employment, whether or not such injuries or damages arose out of their negligent or wrongful acts or omissions.

    82. In newly redesignated § 842.98, revise paragraphs (a), (b), and (c) to read as follows:
    § 842.98 Claims not payable.

    (a) Is covered by the FTCA, FCA, IACA, 10 U.S.C. 2734a and 2734b, Air Force Admiralty Claims Act (AFACA), 10 U.S.C. 9801-9804, 9806, MCA, 10 U.S.C. 2733, or covered under the Military Personnel and Civilian Employees' Claims Act (MPCECA), 31 U.S.C. 3701, 3721.

    (b) NGCA claims arising from noncombat activities in the U.S. are not covered by the FTCA because more elements are needed to state an FTCA claim than are needed to state a claim under the NGCA for noncombat activities. All FTCA claims are based on elements of traditional tort liability (i.e., duty, breach, causation, and damages); that is, they are fault based. Noncombat activity claims under the NGCA are based solely on causation and damages. Because NGCA claims for noncombat activities are not fault based, they are not covered by the FTCA.

    (c) See subpart E for other claims not payable.

    83. Revise newly redesignated § 842.99 to read as follows:
    § 842.99 Applicable law.

    (a) Many of the exclusions in this subpart are based upon the wording of 28 U.S.C. 2680 or other federal statutes or court decisions interpreting the Federal Tort Claims Act. Federal case law interpreting the same exclusions under the Federal Tort Claims Act is applied to the National Guard Claims Act. Where state law differs with federal law, federal law prevails.

    (b) Extent of liability. Where the claim arises is important in determining the extent of liability.

    (1) When a claim arises in the United States, its territories or possessions, the same law as if the claim was cognizable under the FTCA will be applied.

    (2) Claims in foreign countries. In claims arising in a foreign country, where the claim is for personal injury, death, or damage to or loss of real or personal property caused by an act or omission alleged to be negligent, wrongful, or otherwise involving fault of military personnel or civilian officers or employees of the United States acting within the scope of their employment, liability or the United States is determined according federal case law interpreting the FTCA. Where the FTCA requires application of the law of the place where the act or omission occurred, settlement authorities will use the rules set forth in the currently adopted edition of the Restatement of the Law, published by the American Law Institute, to evaluate the liability of the Air Force, subject to the following rules:

    (i) Absolute or strict liability will not apply for claims not arising from noncombat activities.

    (ii) Hedonic damages are not payable

    (iii) The collateral source doctrine will not apply

    (iv) Joint and several liability does not apply. Payment will be made only upon the portion of loss, damage, injury or death attributable to the Armed Forces of the United States.

    (v) Future economic loss will be discounted to present value after deducting for federal income taxes and, in cases of wrongful death, personal consumption.

    (c) Do not approve payment for:

    (1) Punitive damages.

    (2) Cost of medical or hospital services furnished at U.S. expense.

    (3) Cost of burial expenses paid by the United States.

    (d) Settlement by insurer or joint tortfeasor. When settlement is made by an insurer or joint tortfeasor and an additional award is warranted, an award may be made if both of the following are present:

    (1) The United States is not protected by the release executed by the claimant.

    (2) The total amount received from such source is first deducted.

    84. In newly redesignated § 842.100, revise paragraphs (a), (b), (c), and (d) to read as follows:
    § 842.100 Appeal of final denials.

    (a) A claimant may appeal the final denial of the claim. The claimant sends the request, in writing, to the settlement authority that issued the denial letter within 60 days of the date the denial letter was mailed. The settlement authority may waive the 60 day time limit for good cause.

    (b) Upon receipt of the appeal, the original settlement authority reviews the appeal.

    (c) Where the settlement authority does not reach a final agreement on an appealed claim, he or she sends the entire claim file to the next higher settlement authority, who is the appellate authority for that claim. Any higher settlement authority may act upon an appeal.

    (d) The decision of the appellate authority is the final administrative action on the claim.

    85. Revise newly redesignated § 842.101 to read as follows:
    § 842.101 Government's right of subrogation, indemnity, and contribution.

    The Air Force becomes subrogated to the rights of the claimant upon settling a claim. The Air Force has the rights of contribution and indemnity permitted by the law of the situs or under contract. Do not seek contribution or indemnity from ANG members whose conduct gave rise to Government liability.

    86. Revise newly redesignated § 842.102 to read as follows:
    § 842.102 Attorney fees.

    In the settlement of any claim pursuant to 32 U.S.C. 715 and this subpart, attorney fees will not exceed 20 percent of any award provided that when a claim involves payment of an award over $1,000,000, attorney fees on that part of the award exceeding $1,000,000 may be determined by the Secretary of the Air Force. For the purposes of this paragraph, an award is deemed to be the cost to the United States at the time of purchase of a structured settlement, and not its future value.

    Subpart N—[Redesignated as Subpart L] 87. Redesignate subpart N, consisting of §§ 842.115 through §§ 842.125 as subpart L, consisting of §§ 842.103 through §§ 842.113, respectively. 88. Revise newly redesignated § 842.103 to read as follows:
    § 842.103 Scope of this subpart.

    This subpart explains how the United States asserts and settles claims for costs of medical care, against third parties under the Federal Medical Care Recovery Act (FMCRA) (10 U.S.C. 1095) and various other laws.

    89. Amend newly redesignated § 842.104 by revising paragraph (a) and adding paragraphs (h) and (i) to read as follows:
    § 842.104 Definitions.

    (a) Medical Cost Reimbursement Program Regional Field Offices. The Chief of the Medical Cost Reimbursement Program (MCRP) Branch determines and assigns geographic responsibility for all regional field offices. Each field office is responsible for investigating all potential claims and asserting claims within their jurisdiction for the cost of medical care provided by either a Medical Treatment Facility or at a civilian facility through Tricare.

    (h) Accrued pay. The total of all pay accrued to the account of an active duty member during a period when the member is unable to perform military duties. It does not include allowances.

    (i) Future care. Medical care reasonably expected to be provided or paid for in the future treatment of an injured party as determined during the investigative process.

    90. Revise newly redesignated § 842.105 to read as follows:
    § 842.105 Delegations of authority.

    (a) Settlement authority. The following individuals have delegated authority to settle, compromise, or waive MCRP claims for $300,000 or less and to accept full payment on any claim:

    (1) The Judge Advocate General.

    (2) The Deputy Judge Advocate General.

    (3) The Director of Civil Law.

    (4) Chief, Claims and Tort Litigation Staff and the Chief, MCRP.

    (b) Redelegation of authority. The individuals described in paragraph (a) of this section may re-delegate a portion or all of their authority to subordinates, subject to the following limitations:

    (1) SJAs, when given Medical Cost Reimbursement (MCR) claims jurisdiction, are granted authority to waive, compromise, or settle claims in amounts of $25,000 or less. This authority may be re-delegated in writing with authority to re-delegate to subordinates.

    (2) SJAs of numbered Air Forces, when given MCR claims jurisdiction, are granted authority to waive, compromise, or settle claims in amounts of $40,000 or less. This authority may be re-delegated in writing with authority to re-delegate to subordinates.

    (3) SJAs of single base GCMs, the SJAs of GMCs in PACAF and USAFE, and the SJAs of each Air Force base, station, or fixed installation have delegated authority to compromise or waive claims for $15,000 or less and to accept full payment on any claim

    (c) Authority to assert a claim. Each settlement authority has authority to assert a claim in any amount for the reasonable value of medical care.

    (d) Authority to reduce, withdraw, and restore settlement authority. Any superior settlement authority may reduce, withdraw, or restore delegated authority.

    (e) Settlement negotiations. A settlement authority may settle a claim filed for an amount within the delegated settlement authority. Claims in excess of the delegated authority must be approved by the next higher settlement authority. Unsuccessful negotiations at one level do not bind higher authority.

    Note: Telephonic approvals, in the discretion of the higher settlement authority, are authorized.

    (f) Special exceptions. Only the Department of Justice (DOJ) may approve claims involving:

    (1) Compromise or waiver of a claim for more than $300,000.

    (2) Settlement previously referred to DOJ.

    (3) Settlement where a third party files suit against the U.S. or the injured party arising out of the same incident.

    91. Revise newly redesignated § 842.107 to read as follows:
    § 842.107 Nonassertable claims.

    The following are considered nonassertable claims and should not be asserted:

    (a) Claims against any department, agency, or instrumentality of the United States. “Agency or instrumentality” includes any self-insured nonappropriated fund activity whether revenue producing, welfare, or sundry. The term does not include private associations.

    (b) Claims for care furnished a veteran by the Department of Veterans Affairs (VA) for service connected disability. However, claims may be asserted for the reasonable value of medical care an Air Force member receives prior to his or her discharge and transfer to the VA facility or when the Air Force has reimbursed the VA facility for the care.

    (c) Claims for care furnished a merchant seaman under 42 U.S.C. 249. A claim against the seaman's employer should not be filed.

    (d) Government contractors. In claims in which the United States must reimburse the contractor for a claim according to the terms of the contract, settlement authorities investigate the circumstances surrounding the incident to determine if assertion is appropriate. If the U.S. is not required to reimburse the contractor, the MCR authority may assert a claim against the contractor.

    (e) Foreign governments. Settlement authorities investigate any claims that might be made against foreign governments, their political subdivisions, armed forces members or civilian employees.

    (f) U.S. personnel. Claims are not asserted against members of the uniformed services; employees of the U.S., its agencies or instrumentalities; or an individual who is a dependent of a service member or employee at the time of assertion unless they have insurance to pay the claim, they were required by law or regulation to have insurance which would have covered the Air Force, or their actions, which necessitated the medical treatment provided at government expense, constituted willful misconduct or gross negligence.

    92. Amend newly redesignated § 842.108 by revising paragraphs (a) and (b) to read as follows:
    § 842.108 Asserting the claim.

    (a) MCR personnel assert a claim against a tortfeasor or other third party using a formal letter on Air Force stationery. The assertion is made against all potential payers, including insurers. The demand letter should state the legal basis for recovery and sufficiently describe the facts and circumstances surrounding the incident giving rise to medical care. Applicable bases of recovery include U.S. status as a third-party beneficiary under various types of insurance policies, workers' compensation laws, no-fault laws, or other Federal statutes, including COB or FMCRA.

    (b) The MCR authority must promptly notify the injured parties or their legal representatives, in writing, that the United States will attempt to recover from the third parties the reasonable value of medical care furnished or to be furnished and that they:

    (1) Should seek advice from a legal assistance officer or civilian counsel.

    (2) Must cooperate in the prosecution of all actions of the United States against third parties.

    (3) Must furnish a complete statement regarding the facts and circumstances surrounding the incident which caused the injury.

    (4) Must not execute a release or settle any claim which exists as a result of the injury without prior notice to the MCR authority.

    93. Revise newly redesignated § 842.109 to read as follows:
    § 842.109 Referring a claim to the US Attorney.

    (a) All cases that require forwarding to the DoJ must be routed through the Chief, MCRP. The MCR authority ensures that personnel review all claims for possible referral not later than two years after the date of the incident for tort based cases.

    (b) The United States or the injured party on behalf of the United States must file suit within 3 years after an action accrues. This is usually 3 years after the initial treatment is provided in a federal medical facility or after the initial payment is made by Tricare, whichever is first.

    94. Revise newly redesignated § 842.111 to read as follows:
    § 842.111 Recovery rates in government facilities.

    The Federal Register contains the rates set by the Office of Management and Budget, of which judges take judicial notice. Apply the rates in effect at the time of care to claims.

    95. Revise newly redesignated § 842.112 to read as follows:
    § 842.112 Waiver and compromise of United States interest.

    Waivers and compromises of government claims can be made. This paragraph lists the basic guidance for each action. (See this subpart for claims involving waiver and compromise of amounts in excess of settlement authorities' delegated amounts.)

    (a) Convenience of the Government. When compromising or waiving a claim for convenience of the Government, settlement authorities should consider the following factors:

    (1) Risks of litigation.

    (2) Questionable liability of the third party.

    (3) Costs of litigation.

    (4) Insurance (Uninsured or Underinsured Motorist and Medical Payment Coverage) or other assets of the tortfeasor available to satisfy a judgment for the entire claim.

    (5) Potential counterclaim against the U.S.

    (6) Jury verdict expectancy amount.

    (7) Amount of settlement with proposed distribution.

    (8) Cost of any future care.

    (9) Tortfeasor cannot be located.

    (10) Tortfeasor is judgment proof.

    (11) Tortfeasor has refused to pay and the case is too weak for litigation.

    (b) Hardship on the injured party. When compromising or waiving a claim to avoid undue hardship on the injured party, settlement authorities should consider the following factors:

    (1) Permanent disability or disfigurement of the injured party.

    (2) Decreased earning power of the injured party.

    (3) Out of pocket losses to the injured party.

    (4) Financial status of the injured party.

    (5) Pension rights of the injured party.

    (6) Other government benefits available to the injured party.

    (7) An offer of settlement from a third party which includes virtually all of the thirty party's assets, although the amount is considerably less than the calculation of the injured party's damages.

    (8) Whether the injured party received excessive treatment.

    (9) Amount of settlement with proposed distribution, including reductions in fees or damages by other parties, medical providers, or attorneys in order to reduce the hardship on the injured party.

    (c) Compromise or waiver. A compromise or waiver can be made upon written request from the injured party or the injured party's legal representative.

    96. Revise newly redesignated § 842.113 to read as follows:
    § 842.113 Reconsideration of a waiver for undue hardship.

    A settlement authority may reconsider its previous action on a request for waiver or compromise whether requested or not. Reconsideration is normally on the basis of new evidence or discovery of errors in the waiver submission or settlement, but can be based upon a re-evaluation of the claim by the settlement authority.

    Subpart O—[Removed] 97. Remove subpart O, consisting of §§ 842.126 through 842.136. 98. Add new subpart M, consisting of §§ 842.114 through 842.117. Subpart M—Nonappropriated Fund Claims
    § 842.114 Scope of this subpart.

    This subpart describes how to settle claims for and against the United States for property damage, personal injury, or death arising out of the operation of Nonappropriated Fund Instrumentalities (NAFIs). Unless stated below, such claims will follow procedures outlined in other subparts of this part for the substantive law applicable to the particular claim. For example, a NAFI claim adjudicated under the Federal Tort Claims Act will follow procedures in this subpart as well as subpart K.

    § 842.115 Definitions.

    (a) Army and Air Force Exchange Service (AAFES). The Army and Air Force Exchange Service is a joint command of the Army and Air Force, under the jurisdiction of the Chiefs of Staff of the Army and Air Force, which provides exchange and motion picture services to authorized patrons.

    (b) Morale, welfare, and recreation (MWR) activities. Air Force MWR activities are activities operated directly or by contract which provide programs to promote morale and well-being of the Air Force's military and civilian personnel and their dependents. They may be funded wholly with appropriated funds, primarily with nonappropriated funds (NAF), or with a combination of appropriated funds and NAFs.

    (c) Nonappropriated funds. Nonappropriated funds are funds generated by Department of Defense military and civilian personnel and their dependents and used to augment funds appropriated by the Congress to provide a comprehensive morale-building, welfare, religious, educational, and recreational program, designed to improve the well-being of military and civilian personnel and their dependents.

    (d) Nonappropriated funds instrumentality. A nonappropriated fund instrumentality is a Federal government instrumentality established to generate and administer nonappropriated funds for programs and services contributing to the mental and physical well-being of personnel.

    § 842.116 Payment of claims against NAFIs.

    Substantiated claims against NAFIs must not be paid solely from appropriated funds. Claims are sent for payment as set out in this subpart. Do not delay paying a claimant because doubt exists whether to use appropriated funds or NAFs. Pay the claim initially from appropriated funds and decide the correct funding source later.

    § 842.117 Claims by customers, members, participants, or authorized users.

    (a) Customer complaints. Do not adjudicate claims complaints or claims for property loss or damage under this subpart that the local NAFI activity can satisfactorily resolve.

    (b) Claims generated by concessionaires. Most concessionaires must have commercial insurance. Any unresolved claims or complaints against concessionaires or their insurers are sent to the appropriate contracting officers.

    Subpart P—[Redesignated as Subpart N] 99. Redesignate subpart P, consisting of §§ 842.137 through 842.143, as subpart N, consisting of §§ 842.118 through 842.124. 100. Revise newly redesignated § 842.118 to read as follows:
    § 842.118 Scope of this subpart.

    (a) This subpart explains how to process certain administrative claims:

    (1) Against the United States for property damage, personal injury, or death, arising out of Air Force assigned noncombat missions performed by the Civil Air Patrol (CAP), as well as certain other Air Force authorized missions performed by the CAP in support of the Federal government.

    (2) In favor of the United States for damage to US Government property caused by CAP members or third parties.

    (b) Unless stated below, such claims will follow procedures outlined in other subparts of this part for the substantive law applicable to the particular claim. For example, a CAP claim adjudicated under the Military Claims Act will follow procedures in this subpart as well as subpart E.

    §§ 842.120 and 842.121 [Removed]
    101. Remove newly-redesignated §§ 842.120 and 842.121.
    §§ 842.122 through 842.124 [Redesignated as §§ 842.120 through 842.122]
    102. Newly redesignated §§ 842.122 through 842.124 are further redesignated as §§ 842.120 through 842.122, respectively. Subpart Q—[Redesignated as Subpart O] 103. Redesignate subpart Q, consisting of §§ 842.144 through 842.150, as subpart O, consisting of §§ 842.123 through 842.129. 104. Revise newly redesignated § 842.123 to read as follows:
    § 842.123 Scope of this subpart.

    This subpart tells how to make an advance payment before a claim is filed or finalized under the Military Claims, Foreign Claims and National Guard Claims Acts.

    105. In newly redesignated § 842.124, revise paragraph (c)(4) to read as follows:
    § 842.124 Delegation of authority.

    (c) * * *

    (4) SJAs of the Air Force component commander of the US Geographic combatant commands for claims arising within their respective combatant command areas of responsibility.

    106. In newly redesignated § 842.126, revise paragraph (b) to read as follows:
    § 842.126 When authorized.

    (b) The potential claimant has an immediate need amounting to a hardship for food, shelter, medical or burial expenses, or other necessities. In the case of a commercial enterprise, severe financial loss or bankruptcy will result if the Air Force does not make an advance payment.

    Henry Williams, Acting Air Force Federal Liaison Officer.
    [FR Doc. 2016-06896 Filed 3-29-16; 8:45 am] BILLING CODE 5001-10-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2016-0171] RIN 1625-AA00 Safety Zone; Louisiana Dragon Boat Race, Red River Mile Marker, (MM) 88.0 to (MM) 88.5 AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of Proposed Rulemaking.

    SUMMARY:

    The Coast Guard proposes to establish a permanent safety zone for an annually recurring marine event in the Red River, from MM 88.0 to MM 88.5. This action is necessary to protect persons and vessels from the potential safety hazards associated with a dragon boat race taking place in early May, 2016 and recurring annually thereafter. This proposed rulemaking would prohibit persons and vessels from being in the safety zone unless specifically authorized by the Captain of the Port (COTP), Lower Mississippi River or a designated representative. We invite your comments on this proposed rulemaking.

    DATES:

    Comments and related material must be received by the Coast Guard on or before April 14, 2016.

    ADDRESSES:

    You may submit comments identified by docket number USCG-2016-0171 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions about this proposed rulemaking, call or email LT Tyrone Conner, Sector Lower Mississippi River Waterways Management Division, U.S. Coast Guard; telephone (901)521-4725, email [email protected]

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

    This is the sixth annual Louisiana Dragon Boat Race, occurring each year on the Red River during the first few weeks in May. We have established a safety zone for the race event in past years through a temporary final rulemaking each year. For this year and subsequent years, we propose to establish the safety zone as a permanent annually recurring regulation to safeguard against the hazards associated with a race event on the Red River, near Alexandria, Louisiana.

    The legal basis and authorities for this rule are found in 33 U.S.C. 1231. The purpose of this proposed safety zone is to protect both spectators and participants from the hazards associated with the race event.

    III. Discussion of Proposed Rule

    The COTP Lower Mississippi River proposes to establish a safety zone approximately 7:00 a.m. to 5:00 p.m. for approximately 10 hours on the first or second Saturday in May, recurring annually. The proposed safety zone would encompass all waters of the Red River from Mile Marker (MM) 88.0 to (MM) 88.5. All persons and vessels, except those persons and vessels participating in the dragon boat race and those vessels enforcing the areas, would be prohibited from entering, transiting through, anchoring in, or remaining within the safety zone. No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. The regulatory text we are proposing appears at the end of this document.

    IV. Regulatory Analyses

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

    A. Regulatory Planning and Review

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

    This regulatory action determination is based on the time, location and duration of the safety zone. Vessel traffic would be restricted from entering, transiting, or anchoring within a small portion of the Red River during one day each May. Vessels may request permission from the COTP to deviate from the restriction and transit through the safety zone and notifications to the marine community will be made through local notice to mariners (LNM) and broadcast notice to mariners (BNM). Therefore, those operating on the waterway will be able to plan operations around the proposed safety zone and its enforcement times.

    B. Impact on Small Entities

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

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

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

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

    C. Collection of Information

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

    D. Federalism and Indian Tribal Governments

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

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

    E. Unfunded Mandates Reform Act

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

    F. Environment

    We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves establishing a temporary safety zone for approximately 10 hours on one day in May each year on the Red River from (MM) 88.0 to (MM) 88.5. Normally such actions are categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. A preliminary environmental analysis checklist and Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

    G. Protest Activities

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

    V. Public Participation and Request for Comments

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

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

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

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

    List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:

    PART 165— REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority:

    33 U.S.C. 1231; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Department of Homeland Security Delegation No. 0170.1

    2. In § 165.801, amend Table 6 by adding line 13 to read as follows:
    § 165.801 Annual fireworks displays and other events in the Eighth Coast Guard District requiring safety zones. Table 6 of § 165.801—Sector Lower Mississippi River Annual and Recurring Safety Zones Date Sponsor/name Sector lower MS river
  • location
  • Safety zone
    *         *         *         *         *         *         * 13. First or Second Saturday in May Louisiana Dragon Boat Race Red River, Alexandria, LA Regulated Area: Red River mile marker 88.0 to 88.5, Alexandria, LA. *         *         *         *         *         *         *
    Dated: March 16, 2016. T.J. Wendt, Captain, U.S. Coast Guard, Captain of the Port, Lower Mississippi River.
    [FR Doc. 2016-06909 Filed 3-29-16; 8:45 am] BILLING CODE 9110-04-P
    POSTAL SERVICE 39 CFR Part 230 Procedures Relating to the Disposition of Property Acquired by the United States Postal Service Office of Inspector General for Use as Evidence AGENCY:

    Postal Service.

    ACTION:

    Proposed rule.

    SUMMARY:

    This proposed rule establishes procedures for the disposition of abandoned property held by the United States Postal Service Office of Inspector General. The rule establishes procedures for determining the ownership of abandoned property, the advertisement of abandoned items with no apparent owner held by the Office of Inspector General, and the disposal of items declared abandoned.

    DATES:

    Comments must be received on or before April 29, 2016.

    ADDRESSES:

    Written comments should be directed to the Office of Inspector General, Office of General Counsel, 1735 North Lynn Street, Arlington, Virginia 22209-2013. Copies of all written comments will be available at that address for inspection and copying between 9 a.m. and 4 p.m., Monday through Friday.

    FOR FURTHER INFORMATION CONTACT:

    Gladis Griffith, Office of General Counsel, (703) 248-4683.

    SUPPLEMENTARY INFORMATION:

    In the course of conducting official investigations, Special Agents of the United States Postal Service Office of Inspector General frequently recover property lost or stolen from the mail and obtain custody of property needed for use as evidence in proceedings to enforce various provisions of the United States Code. In most cases, such property is returned to the owner at the conclusion of the investigation or any resulting administrative or judicial proceedings. In some cases, however, the owners fail to claim property, and it therefore remains in the custody of the Office of Inspector General after it is no longer needed. The proposed rule would establish a fair and uniform procedure to identify the owners of such property, afford them an opportunity to claim its return, and in the event a valid claim is not received, treat such property as abandoned and direct that it be sold or put to official use. Apparent owners would be notified of their right to claim property, and where no apparent owner is known and the value of the property in question exceeds $200, notice would be published on the Office of Inspector General's Web site inviting the owner to submit a claim for its return.

    List of Subjects in 39 CFR Part 230

    Administrative practice and procedure, Claims, Law enforcement, Property (abandoned).

    For the reasons stated in the preamble, the Postal Service proposes to amend 39 CFR part 230 as follows:

    PART 230—OFFICE OF INSPECTOR GENERAL 1. The authority citation for part 230 continues to read as follows: Authority:

    5 U.S.C. App.3; 39 U.S.C. 401(2) and 1001.

    2. Add the subpart C to read as follows: Subpart C—Rules of Procedure Relating to the Disposition of Stolen Mail Matter and Property Acquired by the Office of Inspector General for Use as Evidence Sec. 230.30 Scope. 230.31 Definitions. 230.32 Disposition of property of apparent owners where property is valued over $200. 230.33 Disposition of property of apparent owners where property is valued at $200 or less. 230.34 Disposition of property of unknown owners where property is valued over $200. 230.35 Disposition of property of unknown owners where property is valued at $200 or less. 230.36 Contraband and property subject to court order. 230.37 Determination of type of property. 230.38 Disposition of abandoned property; additional period for filing claims. 230.39 Submission of claims. 230.40 Determination of claims. 230.41 Reconsideration of claims. 230.42 Disposition of property declared abandoned where title vests in the government.
    § 230.30 Scope.

    This subpart prescribes procedures governing the disposition of any property (real, personal, tangible, or intangible) obtained by the United States Postal Service Office of Inspector General (Office of Inspector General) for possible use as evidence after the need to retain such property no longer exists.

    § 230.31 Definitions.

    The following definitions apply to this subpart:

    (a) Apparent. That which is clear, plain, and evident.

    (b) Owner. The person recognized by the law as having the ultimate control over and right to use the property.

    (c) Ruling official. The official who has the authority to grant or deny the claim for the abandoned or other unclaimed property where the property is located, typically the Executive Special Agent in Charge, or a designee. If, however, the property is a firearm or contraband, the Executive Special Agent in Charge should consult with the Office of Inspector General, Office of General Counsel prior to commencing the abandonment action.

    (d) Claimant. The person who submitted the claim for the abandoned or other unclaimed property.

    (e) Owner. The person recognized by the law as having the ultimate control over and right to use the property.

    § 230.32 Disposition of property of apparent owners where property is valued over $200.

    Where an apparent owner of property subject to this subpart is known, and the estimated value of the property exceeds $200, the owner shall be notified by certified mail at his last known address. The written notice shall describe the property and the procedure for filing a claim for its return (see, §§ 230.36 and 230.39). Such claims must be filed within 30 days from the date the written notice is postmarked. If the apparent owner of the property fails to file a timely claim, the property is considered abandoned and must be disposed of as provided in § 230.38.

    § 230.33 Disposition of property of apparent owners where property is valued at $200 or less.

    Where an apparent owner of property subject to this subpart is known, and the estimated value of the property is $200 or less, the Executive Special Agent in Charge, or a designee, should attempt to return the property to the owner. If successful, the Executive Special Agent in Charge shall request the owner sign a Hold Harmless Agreement. If not, the Executive Special Agent in Charge shall vest title in the Government.

    § 230.34 Disposition of property of unknown owners where property is valued over $200.

    (a) Where no apparent owner of property subject to this subpart is known, except property described in § 230.36, and the estimated value of the property exceeds $200, the Executive Special Agent in Charge, or a designee, must publish notice providing the following information:

    (1) A description of the property, including model or serial numbers, if known;

    (2) A statement of the location where the property was found;

    (3) The name, address, and telephone number of the Executive Special Agent in Charge who has custody of the property; and

    (4) A statement inviting any person who believes he or she is fully entitled to the property to submit a claim for its return with the Executive Special Agent in Charge identified in the notice. Such claim must be submitted within 30 days from the date of first publication of the notice.

    (b) The notice under paragraph (a) of this section must be published for three consecutive weeks on the Office of Inspector General's Web site.

    § 230.35 Disposition of property of unknown owners where property is valued at $200 or less.

    Where the owner of property subject to this subpart is unknown and the estimated value of the property is $200 or less, no notice is required, and the Executive Special Agent in Charge, or a designee, should vest title in the Government, subject to the rights of the owner to submit a valid claim as provided in § 230.38.

    § 230.36 Contraband and property subject to court order.

    Claims submitted with respect to property subject to this subpart, possession of which is unlawful, must be denied, in writing, by certified mail, and the person submitting the claim must be accorded 45 days from the postmarked date to institute judicial proceedings to challenge the denial. If judicial proceedings are not instituted within 45 days, or any extension of time for good cause shown, the contraband property must be destroyed unless the Executive Special Agent in Charge, or a designee, determines that it should be placed in official use by the Office of Inspector General. Property subject to this part, the disposition of which is involved in litigation or is subject to an order of court, must be disposed of as determined by the court.

    § 230.37 Determination of type of property.

    If the Office of Inspector General is unable to determine whether the personal property in its custody is abandoned or voluntarily abandoned, it shall contact the Office of Inspector General, Office of General Counsel for such a determination.

    § 230.38 Disposition of abandoned property; additional period for filing claims.

    (a) Upon expiration of the time provided in §§ 230.32 and 230.34 for the filing of claims or any extension thereof, and without the receipt of a timely claim, the property described in the notice is considered abandoned and becomes the property of the Government. However, if the owner satisfies the requirements of paragraph (b) of this section, except for property described in § 230.36, such abandoned property must be returned to the owner if a valid claim is filed within three years from the date the property became abandoned, with the following qualifications:

    (1) Where property has been placed in official use by the Office of Inspector General, a person submitting a valid claim under this section must be reimbursed the fair market value of the property at the time title vested in the Office of Inspector General, less costs incurred in returning or attempting to return such property to the owner; or

    (2) Where property has been sold, a person submitting a valid claim under this section must be reimbursed the same amount as the last appraised value of the property prior to the sale of such property.

    (b) In order to present a valid claim under paragraph (a) of this section, the claimant must establish he or she had no actual or constructive notice that he or she was entitled to file a claim pursuant to § 230.32 or § 230.34 prior to the date the property became abandoned. Publication of a notice pursuant to § 230.34 provides constructive notice, unless a claimant can demonstrate circumstances that reasonably precluded his or her access to the published notice.

    § 230.39 Submission of claims.

    Claims submitted pursuant to this subpart must be submitted on Postal Service Form 1503, which may be obtained from the Executive Special Agent in Charge who has custody of the property.

    § 230.40 Determination of claims.

    Upon receipt of a claim under this subpart, the Office of Inspector General must conduct an investigation to determine the merits of the claim. The results of the investigation must be submitted to the ruling official, who must approve or deny the claim by written decision, a copy of which must be forwarded to the claimant by certified mail. If the claim is granted, the conditions of relief and the procedures to be followed to obtain the relief shall be set forth. If the claim is denied, the claimant shall be advised of the reason for such denial.

    § 230.41 Reconsideration of claims.

    A written request for reconsideration of denied claims must be based on evidence recently developed or not previously presented. It must be submitted within 10 days of the postmarked date of the letter denying the claim. The ruling official shall advise the Asset Forfeiture Coordinator if a timely reconsideration of the denial is made. The Office of Inspector General, Office of General Counsel shall rule on the reconsideration request.

    § 230.42 Disposition of property declared abandoned where title vests in the government.

    Property declared abandoned, including cash and proceeds from the sale of property subject to this part, may be shared with federal, state, or local agencies. Abandoned property may also be destroyed, sold, or placed into official use. However, before abandoned property can be shared with another agency, sold, or placed into official use, the Executive Special Agent in Charge must confer with the Office of Inspector General, Office of General Counsel. Unless the Executive Special Agent in Charge determines the cash or proceeds of the sale of the abandoned property are to be shared with other law enforcement agencies, such cash or proceeds shall be converted to money orders and transmitted to: United States Postal Service, Disbursing Officer, 2825 Lone Oak Parkway, Eagan, MN 55121-9640.

    Stanley F. Mires, Attorney, Federal Compliance.
    [FR Doc. 2016-07103 Filed 3-29-16; 8:45 am] BILLING CODE 7710-12-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 8 RIN 0930-AA22 Medication Assisted Treatment for Opioid Use Disorders AGENCY:

    Substance Abuse and Mental Health Services Administration (SAMHSA), HHS.

    ACTION:

    Proposed rule.

    SUMMARY:

    The Secretary of the Department of Health and Human Services (the Secretary) (HHS) proposes a rule to increase the highest patient limit for qualified physicians to treat opioid use disorder under section 303(g)(2) of the Controlled Substances Act (CSA) from 100 to 200. The purpose of the proposed rule is to increase access to treatment for opioid use disorder while reducing the opportunity for diversion of the medication to unlawful use.

    DATES:

    To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on May 31, 2016.

    ADDRESSES:

    You may submit comments, identified by Regulatory Information Number (RIN) 0930-AA22, by any of the following methods:

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

    Regular Mail or Hand Delivery or Courier: Written comments mailed by regular mail must be sent to the following address only: The Substance Abuse and Mental Health Services Administration, Department of Health and Human Services, Attn: Jinhee Lee, SAMHSA, 5600 Fishers Lane, Room 13E21C, Rockville, Maryland 20857. Please allow sufficient time for mailed comments to be received before the close of the comment period.

    Express or Overnight Mail: Written comments sent by hand delivery, or regular, express or overnight mail must be sent to the following address only: The Substance Abuse and Mental Health Services Administration, Department of Health and Human Services, Attn: Jinhee Lee, SAMHSA, 5600 Fishers Lane, Room 13E21C, Rockville, Maryland 20857.

    Instructions: To avoid duplication, please submit only one copy of your comments by only one method. All submissions received must include the agency name and docket number or RIN for this rulemaking. All comments received will become a matter of public record and will be posted without change to http://www.regulations.gov, including any personal information provided. For detailed instructions on submitting comments and additional information on the rulemaking process and viewing public comments, see the “Public Participation” heading of the SUPPLEMENTARY INFORMATION section of this document.

    Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Jinhee Lee, Pharm.D., Public Health Advisor, Center for Substance Abuse Treatment, 240-276-0545, Email address: [email protected]

    SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose B. Summary of Major Provisions C. Summary of Impacts II. Public Participation III. Background A. Opioid Use Disorder B. Medication-Assisted Treatment C. Statutory and Rulemaking History D. Current Process for Obtaining a Practitioner Waiver Under 21 U.S.C. 823(g)(2) E. Evaluations of the Current System F. Need for Rulemaking IV. Summary of Proposed Rule A. General B. Scope (§ 8.1) C. Definitions (§ 8.2) D. Opioid Treatment Programs (§§ 8.3-8.4) E. Which practitioners are eligible for a patient limit of 200? (§ 8.610) F. What constitutes a qualified practice setting? (§ 8.615) G. What is the process to request a patient limit of 200? (§ 8.620) H. How will a request for patient limit increase be processed? (§ 8.625) I. What must practitioners do in order to maintain their approval to treat up to 200 patients under § 8.625? (§ 8.630) J. What are the reporting requirements for practitioners whose request for patient limit increase is approved under § 8.625? (§ 8.635) K. What is the process for renewing a practitioner's request for patient limit increase approval? (§ 8.640) L. What are the responsibilities of practitioners who do not submit a renewal request for patient limit increase or whose request is denied? (§ 8.645) M. Can SAMHSA suspend or revoke a practitioner's patient limit increase approval? (§ 8.650) N. Can a practitioner request to temporarily treat up to 200 patients in emergency situations? (§ 8.655) V. Collection of information requirements VI. Regulatory Impact Analysis A. Introduction B. Summary of the Proposed Rule C. Need for the Proposed Rule D. Analysis of Benefits and Costs E. Sensitivity Analysis F. Analysis of Regulatory Alternatives G. Regulatory Flexibility Analysis VII. Agency Questions for Comment Acronyms ASAM American Society of Addiction Medicine CFR Code of Federal Regulations CSA Controlled Substances Act DEA Drug Enforcement Administration FDA Food and Drug Administration FR Federal Register HHS Department of Health and Human Services HIV Human Immunodeficiency Virus MAT Medication-Assisted Treatment NOI Notification of Intent NPRM Notice of Proposed Rulemaking OTP Opioid Treatment Program QA Quality Assurance QI Quality Improvement RFA Regulatory Flexibility Act SAMHSA Substance Abuse and Mental Health Services Administration U.S.C. United States Code I. Executive Summary A. Purpose

    The purpose of this proposed rule is to expand access to medication-assisted treatment (MAT) by allowing eligible practitioners to request approval to treat up to 200 patients under section 303(g)(2) of the Controlled Substances Act (CSA). The rulemaking also includes requirements to ensure that patients receive the full array of services that comprise evidence-based MAT and minimize the risk that the medications provided for treatment are misused or diverted. We hope that this proposed rule will stimulate broader availability of high-quality MAT both in specialized addiction treatment settings and throughout more mainstream health care delivery systems.

    Section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)) allows individual practitioners to dispense or prescribe Schedule III, IV, or V controlled substances that have been approved by the Food and Drug Administration (FDA) for use in maintenance and detoxification treatment without registering as an opioid treatment program (OTP). Currently, the only FDA-approved medications that meet this standard are buprenorphine and the combination buprenorphine/naloxone (hereinafter referred to as buprenorphine). Buprenorphine is a schedule III controlled substance under the CSA. The CSA also imposes a limit on the number of patients a practitioner may treat with certain types of FDA-approved narcotic drugs, such as buprenorphine, at any one time. Pursuant to 21 U.S.C. 823(g)(2)(B)(iii), the Secretary is authorized to change this patient limit by regulation at any one time.

    Section 303(g)(2)(B)(iii) of the CSA allows qualified practitioners who file an initial notification of intent (NOI) to treat a maximum of 30 patients at a time. After 1 year, the practitioner may file a second NOI indicating his/her intent to treat up to 100 patients at a time. To qualify to treat any patients with buprenorphine, the practitioner must be a physician, possess a valid license to practice medicine, be a registrant of the Drug Enforcement Administration (DEA), have the capacity to refer patients for appropriate counseling and other necessary ancillary services, and have completed required training. As specified in the statute, the training requirement may be satisfied in several ways: One may hold subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties or addiction medicine from the American Osteopathic Association; hold an addiction certification from the American Society of Addiction Medicine (ASAM); complete an 8-hour training provided by an approved organization; have participated as an investigator in one or more clinical trials leading to the approval of a medication that qualifies to be prescribed under 21 U.S.C. 823(g)(2); or complete other training or have such other experience as the State medical licensing board or the Secretary considers to demonstrate the ability of the physician to treat and manage persons with opioid use disorder.

    Access to MAT has been subject to patient limits via the provisions contained in the CSA and enforced by DEA. Since 21 U.S.C. 823(g)(2) was originally modified by legislation in 2000 to allow the provision of MAT without registering as an OTP, additional modifications have been made to address the application of the patient limit in group medical practices and to create a higher patient limit for practitioners with 1 year of experience. These changes, while important, have not proven sufficient to support the development of adequate treatment capacity to keep pace with the growth of the national crisis of opioid misuse and overdose. To the extent that the current patient limit contributes to this access challenge, this proposed rule seeks to make a useful change in an effort to improve access.

    B. Summary of Major Provisions

    The proposed rule would revise the highest patient limit from 100 patients per practitioner with an existing waiver (waivered practitioner) to 200 patients for practitioners who meet certain criteria. Practitioners who have a waiver to treat 100 patients for at least 1 year would be eligible to apply for a waiver to treat up to 200 patients if they possess a subspecialty board certification in addiction medicine or addiction psychiatry or practice in a qualified practice setting as defined in this proposed rule. In either case, practitioners with the higher limit of 200 would also be required to accept greater responsibility for ensuring behavioral health services and care coordination are received and for ensuring quality assurance and improvement practices, diversion control, and continuity of care in emergencies. The higher limit would also carry with it the duty to regularly reaffirm the practitioner's ongoing eligibility and to participate in data reporting and monitoring as required by SAMHSA. In addition, practitioners in good standing with a current waiver to prescribe to up to 100 patients (i.e., the practitioner has filed an NOI and satisfied all required criteria) could request the higher limit in emergency situations for a limited time period. SAMHSA would review all emergency situation requests in consultation, to the extent practicable, with appropriate governmental authorities before such requests would be granted.

    C. Summary of Impacts

    The proposed rule is intended to increase access to MAT for some patients with an opioid use disorder, providing them with a path to recovery; reduce costs across different sectors (e.g. health care, criminal justice, and social service); and, ultimately, reduce the number of opioid-related overdose deaths. From 2016-2020, present value benefits of $11,019 million and annualized benefits of $2,336 million are estimated using a 3 percent discount rate; present value benefits of $10,148 million and annualized benefits of $2,313 million are estimated using a 7 percent discount rate. Present value costs of $955 million and annualized costs of $202 million are estimated using a 3 percent discount rate; present value costs of $880 million and annualized costs of $201 million are estimated using a 7 percent discount rate.

    II. Public Participation Comments Invited

    HHS invites interested parties to submit comments on all aspects of the proposed rule. When submitting comments, please reference a specific portion of the proposed rule, provide an explanation for any recommended change, and include supporting data. Specific agency questions for comment are listed in section VII. Comments responding to these questions should reference them by number.

    All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable and/or confidential information that is included in a comment. We post all comments received as soon as possible after they have been received on the following Web site: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.

    Comments received before the close of the comment period will also be available for public inspection, generally beginning approximately 3 weeks after publication of the proposed rule, at the headquarters of the Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Rockville, Maryland 20857, Monday through Friday of each week from 8:30 a.m. to 4:00 p.m. To schedule an appointment to view public comments, call 240-276-1660.

    We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and will respond to the comments in the preamble of the final rule. Please allow sufficient time for mailed comments to be received before the close of the comment period.

    III. Background A. Opioid Use Disorder

    Substance use disorder is a treatable chronic disease caused by changes to the structure and function of the brain due to exposure to intoxicating substances.1 Most of these substances alter the brain by increasing the release of the neurotransmitter dopamine, which plays an important role in the brain's reward system.2 Chronic exposure to drugs disrupts the way the brain controls both life-sustaining behaviors and those related to drug use.3 Opioid use disorder is a type of substance use disorder that has the added complexity of disrupting the naturally occurring function of endorphins throughout the body.4 This is what underlies the rapid formation of dependence and tolerance, and the withdrawal syndrome typically observed when opioid use is discontinued.5 The cycle of tolerance and withdrawal leads persons dependent on opioids to take larger doses, seek more potent opioids, or adopt methods of administration, such as injection, to intensify the opioid's effects.6 7 The possibility of experiencing euphoria, while an element of drug initiation, becomes more and more remote as the euphoric feelings experienced become less pleasurable and use of the drug becomes necessary for the user to feel “normal”.8 As a result, most opioid dependent persons must continue to use opioids in order to maintain function and to forestall the painful symptoms of withdrawal.9

    1 The Science of Drug Abuse and Addiction: The Basics. (2014, September 1). Retrieved from: http://www.drugabuse.gov/publications/media-guide/science-drug-abuse-addiction-basics.

    2 National Institute on Drug Abuse (2014). Drugs, brains, and behavior: The science of addiction. (NIH Pub No. 14-5605). Retrieved from: https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/soa_2014.pdf.

    3 Id.

    4 National Institute on Drug Abuse. Impacts of Drugs on Neurotransmission. Retrieved from: http://www.drugabuse.gov/news-events/nida-notes/2007/10/impacts-drugs-neurotransmission.

    5 Id.

    6 Kosten, T.R., & George, T.P. (2002). The Neurobiology of Opioid Dependence: Implications for Treatment. Science & Practice Perspectives, 1(1), 13-20.

    7 Peavy, K.M., Banta-Green, C.J., Kingston, S., Hanrahan, M., Merrill, J.O., & Coffin, P.O. (2012). “Hooked on” prescription-type opiates prior to using heroin: Results from a survey of syringe exchange clients. Journal of Psychoactive Drugs, 44(3), 259-265.

    8 National Institute on Drug Abuse, supra note 2.

    9 Id.

    Opioid use disorder is essentially the same phenomenon. The potential for addiction and the symptoms of tolerance and withdrawal are very similar, whether the opioid is heroin or a prescription pain reliever, such as oxycodone or hydrocodone, because the brain responds to all opioids similarly. Untreated opioid dependence is associated with adoption of high-risk opioid use behaviors.10 11 12 A person who is no longer able to avoid withdrawal with the amount of opioid he or she is accustomed to or can afford to buy may transition to using opioids by injection, for example, because this route of administration can more quickly and efficiently deliver the drug to the brain via injection into the bloodstream rather than through the digestive tract.13 14 However, use of opioids by injection carries additional risks of infection with hepatitis C virus and human immunodeficiency virus (HIV), local and systemic infections, cardiovascular and respiratory problems, and higher overdose risk.15 16 17

    10 Peavy, supra note 7.

    11 Jones, C.M. (2013). Heroin use and heroin use risk behaviors among nonmedical users of prescription opioid pain relievers, United States, 2002-2004 and 2008-2010. Drug and Alcohol Dependence, 132(1-2):95-100.

    12 Lankenau, S.E., Teti, M., Silva, K., Bloom, J.J., Harocopos, A., & Treese, M. (2012). Initiation into prescription opioid misuse amongst young injection drug users. International Journal of Drug Policy, 23(1), 37-44.

    13 Peavy, supra note 7.

    14 Drug Delivery Methods (2015). Retrieved from http://learn.genetics.utah.edu/content/addiction/delivery/.

    15 National Institute on Drug Abuse (2014). Heroin (Number 15-0165). Retrieved from: https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/heroinrrs_11_14.pdf.

    16 Bruneau, J., Roy, E., Arrunda, N., Zang, G., & Jutras-Aswad, D. (2012). The rising prevalence of prescription opioid injection and its association with hepatitis C incidence among street-drug users. Addiction, 107(7):1318-27.

    17 Conrad, C., Bradley, H.M., Broz, D., Buddha, S., Chapman, E.L., Galang, R.R., Duwve, J.M. (2015). Community outbreak of HIV infection linked to injection drug use of oxymorphone—Indiana, 2015. Morbidity and Mortality Weekly Report, 64(16): 443-44.

    The majority of these individuals do not recognize that repeated use of opioids, albeit legitimate, may increase the risk of developing an opioid use disorder, which may lead some individuals to switch from prescription drugs to cheaper and more risky substitutes like heroin. Based on combined 2014 National Survey on Drug Use and Health data, there are 1.9 million people aged 12 or older with a past-year pain reliever use disorder and 539,000 people with a past-year heroin use disorder.

    As many as 86 percent of persons who met diagnostic criteria for opioid use disorder in 2014 could be classified as dependent on opioids.18 In addition to changing the structure and function of the brain, when a person has dependence, the whole body has adapted to the presence of the opioid and does not function properly when the substance is absent, thus making it extremely difficult to discontinue use without formal treatment.19 Many people with opioid dependence who undergo detoxification in order to stop using opioids subsequently relapse to opioid use.20 As many as 95 percent of patients who undergo detoxification only, relapse to opioid use within weeks.21 22

    18 Substance Abuse and Mental Health Services Administration (2015). Prescription drug misuse and abuse. Retrieved from: http://www.samhsa.gov/prescription-drug-misuse-abuse.

    19 Definition of dependence. (2007). Retrieved from: http://www.drugabuse.gov/publications/teaching-packets/neurobiology-drug-addiction/section-iii-action-heroin-morphine/8-definition-dependence.

    20 Kleber, H. D. (2007). Pharmacologic treatments for opioid dependence: detoxification and maintenance options. Dialogues in Clinical Neuroscience, 9(4), 455-470. National Institute on Drug Abuse. Patients Addicted to Opioid Painkillers Achieve Good Results With Outpatient Detoxification. Retrieved from: http://www.drugabuse.gov/news-events/nida-notes/2015/02/patients-addicted-to-opioid-painkillers-achieve-good-results-outpatient-detoxification on December 12, 2015.

    21 Ling, W., Amass, L., Shoptaw, S., Annon, J.J., Hillhouse, M., Babcock, D., Brigham, G., Harrer, J., Reid, M., Muir, J., Buchan, B., Orr, D., Woody, G., Krejci, J., Ziedonis, D., Group, the B.S.P. (2005). A multi-center randomized trial of buprenorphine-naloxone versus clonidine for opioid detoxification: findings from the National Institute on Drug Abuse Clinical Trials Network. Addiction (Abingdon, England), 100(8), 1090-1100.

    22 Weiss, R.D., Potter, J.S., Fiellin, D.A., Byrne, M., Connery, H.S., Dickinson, W., Gardin, J., Griffin, L.M., Gourevitch, N.M., Haller, D., Hasson, A., Huang, Z., Jacobs, P., Kosinski, S.A., Lindblad, R., McCance-Katz, F.E., Provost, E.S., Selzer, J., Somoza, C.E., Sonne, C.S., Ling, W. (2011). Adjunctive Counseling During Brief and Extended Buprenorphine-Naloxone Treatment for Prescription Opioid Dependence: A 2-Phase Randomized Controlled Trial. Archives of General Psychiatry, 68(12), 1238-1246.

    Adverse consequences associated with prescription drug misuse have also increased. Prescription drugs, especially opioid analgesics, have increasingly been implicated in drug overdose deaths over the last decade.23 The National Vital Statistics System indicated there were 18,893 opioid analgesics overdose related deaths in 2014, which is nearly 5 times greater than the number of related deaths in 1999.24 Deaths related to heroin have also sharply increased, more than tripling between 2010 and 2014.25 Rates of prescription drug misuse related to emergency department visits and treatment admissions have risen significantly in recent years.26 The Centers for Disease Control and Prevention reports that almost 7,000 people are treated in emergency departments each day for using opioids in a manner other than as directed.27 Opioids, primarily prescription pain relievers and heroin, are the main drugs associated with overdose deaths. In 2014, opioids were involved in 28,647 deaths, or 61 percent of all drug overdose deaths; the rate of opioid overdoses has tripled since 2000.28

    23 Macrae, J. (2015, July 27). HHS Launches Multi-pronged Effort to Combat Opioid Abuse. Retrieved from: http://www.hhs.gov/blog/2015/07/27/hhs-launches-multi-pronged-effort-combat-opioid-abuse.html. Centers for Disease Control and Prevention. Wide-ranging Online Data for Epidemiologic Research (WONDER), Multiple-Cause-of-Death file, 2000-2014. 2015.

    24 CDC/NCHS, National Vital Statistics System, Mortality File. Retrieved from: http://www.cdc.gov/nchs/data/health_policy/AADR_drug_poisoning_involving_OA_Heroin_US_2000-2014.pdf.

    25 HHS takes strong steps to address opioid-drug related overdose, death and dependence. (2015, March 26) Retrieved from: http://www.hhs.gov/about/news/2015/03/26/hhs-takes-strong-steps-to-address-opioid-drug-related-overdose-death-and-dependence.html.

    26 Substance Abuse and Mental Health Services Administration, supra note 18.

    27 Centers for Disease Control and Prevention. Wide-ranging Online Data for Epidemiologic Research (WONDER), Multiple-Cause-of-Death file, (2015, October 28). Understanding the epidemic: When the prescription becomes the problem. Retrieved from: http://www.cdc.gov/drugoverdose/epidemic/.

    28 Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in Drug and Opioid Overdose Deaths—United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2016;64(50):1378-82. Retrieved from: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6450a3.htm.

    The economic costs of illegal drug use, including the use of medications that are prescribed for others, are considerable. According to the Office of National Drug Control Policy, the economic cost of drug addiction in the United States was estimated at $193 billion in 2007, the last available estimate.29 Indeed, opioid use disorders contribute to over $72 billion in medical costs alone each year.30 These costs—costs related to treatment and prevention services; other health care costs, such as those for individuals with co-occurring illnesses that result from or are exacerbated by use and misuse of drugs obtained illicitly; and costs associated with lost productivity, social welfare, and crime—impose burdens on the workplace, healthcare system, and communities.

    29 Study Shows Illicit Drug Use Costs U.S. Economy More Than $193 Billion. (2011, June 1). Retrieved from: https://www.whitehouse.gov/sites/default/files/ondcp/newsletters/ondcp_update_june_2011.pdf.

    30 Coalition Against Insurance Fraud. (2007). Prescription for peril: how insurance fraud finances theft and abuse of addictive prescription drugs. Retrieved from: http://www.insurancefraud.org/downloads/drugDiversion.pdf.

    B. Medication-Assisted Treatment (MAT)

    Opioid use disorder is a treatable medical condition from which it is possible to recover.31 Medication, along with other behavioral therapy, has the potential to play an important role in the successful treatment of opioid use disorder and provide a foundation for recovery.32 Research indicates that medication combined with behavioral health services produces the best outcomes.33 34 Effective treatment is comprehensive and tailored to each patient's drug use patterns; medical and psychiatric co-morbidities, and social corollaries of substance use disorder; and includes consideration of the person's vocational and legal needs.35

    31 Bart, G. (2012). Maintenance Medication for Opiate Addiction: The Foundation of Recovery. Journal of Addictive Diseases, 31(3), 207-225. http://doi.org/10.1080/10550887.2012.694598.

    32 Medication and Counseling Treatment. (2015, September 28). Retrieved from: http://www.samhsa.gov/medication-assisted-treatment/treatment.

    33 National Institute on Drug Abuse, supra note 2.

    34 Buprenorphine. (2015, September 25). Retrieved from: http://www.samhsa.gov/medication-assisted-treatment/treatment/buprenorphine.

    35 National Institute on Drug Abuse, supra note 2.

    MAT is the use of medication in combination with behavioral health services to provide a whole-patient, individualized approach to the treatment of substance use disorder, including opioid use disorder.36 MAT is a safe and effective strategy for decreasing the frequency and quantity of opioid use and reducing the risk of overdose and death.37 Although MAT has significant evidence to support it as an effective treatment, it remains highly underutilized, with only an estimated 1 million out of an estimated 2.5 million who needed treatment actually receiving it in 2012 38 This gap is a function of many factors, including treatment capacity and negative attitudes, prejudice, and discrimination that prevent individuals from seeking services. A full discussion of the barriers to MAT utilization can be found in the regulatory impact analysis of this document.

    36 Medication and Counseling Treatment, supra note 32.

    37 Kresina, T.F., & Lubran, R.L. (2011). Improving public health through access to and utilization of medication assisted treatment. International Journal of Environmental Research and Public Health, 8(10):4102-17.

    38 Volkow, N.D., Frieden, T.R., Hyde, P.S., & Cha, S.S. (2014). Medication-assisted therapies—tackling the opioid-overdose epidemic. New England Journal of Medicine, 370(22):2063-6.

    Methadone, buprenorphine, and naltrexone are the three main types of active ingredients 39 contained in FDA approved products currently used to treat opioid use disorder in the U.S.40 Treatment of opioid use disorder using methadone can only be provided in OTPs regulated by SAMHSA under 42 CFR part 8 and requires patient assessments, on-site counseling, daily monitoring and observation of the medication use, and careful control of any take-home methadone.41 42 Also, methadone for opioid use disorder can only be dispensed in an OTP clinic setting.34 Unlike methadone, medicines containing buprenorphine are permitted to be dispensed in either an office-based setting or in an OTP, significantly increasing treatment access.43 Under 21 U.S.C. 823(g)(2), qualified practitioners can prescribe, administer, or dispense medicines containing buprenorphine for treatment of opioid use disorder in various settings, including in an office, community hospital, health department, or correctional facility. As with all medications used in MAT, buprenorphine is prescribed as part of a comprehensive treatment plan that includes counseling and participation in social support programs.44

    39 Naloxone is an active ingredient in some forms of buprenorphine when used by other than the recommended sublingual (under the tongue) route.

    40 Volkow, supra note 38.

    41 Id.

    42 Methadone. (2015, September 28). Retrieved from: http://www.samhsa.gov/medication-assisted-treatment/treatment/methadone.

    43 Kresina, supra note 37.

    44 Id.

    C. Statutory and Rulemaking History

    There is a long history of laws and rules to protect people from unnecessary or inappropriate exposure to opioids. Two important laws are the CSA and the Controlled Substances Import and Export Act, which became law in 1970. Together, these statutes and their implementing regulations govern the manufacturing and distribution of controlled substances. Controlled substances are those medications or chemical substances that are scheduled I through V under the CSA, with Schedule I having the most relative abuse potential and likelihood of causing dependence when abused, and Schedule V having the least potential for abuse and dependence.45

    45 Controlled Substance Schedules. (2015). Retrieved from: http://www.deadiversion.usdoj.gov/schedules/.

    In 2000, Congress amended the CSA (21 U.S.C. 801 et seq.) to establish “waiver authority for physicians who dispense or prescribe certain narcotic drugs for maintenance treatment or detoxification treatment” (Drug Addiction Treatment Act of 2000, Pub. L. 106-310, Title XXXV, 114 Stat. 1222, codified at 21 U.S.C. 823(g)(2)). This waiver authority established the existing 30 and 100 patient limits. Pursuant to such waiver authority, the statutory and regulatory requirement (21 U.S.C. 823(g)(1) and 21 CFR 1301.13(e)) that a practitioner obtain a separate DEA registration to prescribe buprenorphine for maintenance or detoxification treatment is waived. Prior to this amendment, practitioners who wanted to provide maintenance or detoxification treatment using opioid drugs were required to be registered as Narcotic Treatment Programs, today commonly referred to as OTPs.

    Under the provisions of the CSA implementing regulations (21 CFR 1301.28(b)(1)(iii) and (iv)), the 30-patient limitation applied equally to individual practices and to group practices (i.e., 30 patients per group practice), severely limiting the number of patients who could be treated by physicians in group practices. In 2005, the CSA was amended to lift the patient limitation on prescribing opioid addiction treatment medications by practitioners in group practices (Pub. L. 109-56) so that practitioners could prescribe up to 30 patients individually regardless of whether they are in a group or solo practice.46 In 2006, the CSA was further amended by the Office of National Drug Control Policy Reauthorization Act of 2006 (Pub. L. 109-469) to permit the treatment of up to 100 patients by each qualifying practitioner. As a result, DEA made conforming changes their regulations.47

    46 “A bill to amend the Controlled Substances Act to lift the patient limitation on prescribing drug addiction treatments by medical practitioners in group practices, and for other purposes” (Pub. L. 109-56).

    47 See 21 CFR 1301.28(b)(1)(iii) and (iv).

    D. Current Process for Obtaining a Practitioner Waiver Under 21 U.S.C. 823(g)(2)

    To be able to prescribe buprenorphine for the maintenance or detoxification of opioid use disorder, qualified practitioners must file a Request for Patient Limit Increase with SAMHSA. In accordance with 21 U.S.C. 823(g)(2)(D)(iii), SAMHSA processes the Request for Patient Limit Increase by verifying the practitioner's medical license and qualification to prescribe buprenorphine, and informs the DEA of whether the practitioner meets all of the statutory requirements for a waiver. If the statutory requirements for a waiver are met, the DEA verifies the practitioner's current registration and assigns an identification number to the practitioner. This information is conveyed to the practitioner by a letter issued from SAMHSA. At this point, the practitioner is considered to be a waivered practitioner.

    Waivered practitioners must comply with all sections of the CSA regarding validity of prescriptions, recordkeeping, inventory, and medication administration or dispensing. DEA is authorized to conduct periodic on-site inspections of all registrants. As of 2013, DEA had systematically visited nearly all waivered practitioners. Most inspections were uneventful, and the majority of practitioners were found to be in compliance. Problems encountered typically involved administrative issues and required practitioners to make changes to recordkeeping practices. Should DEA find violations of law, it can revoke a practitioner's right to prescribe buprenorphine and take further legal action, if necessary.

    E. Evaluations of the Current System

    Evaluations of the process for granting waivers under the 21 U.S.C. 823(g)(2) waiver system are limited. In 2006, SAMHSA published the results of an evaluation that examined the availability and effectiveness of treatment as well as adverse consequences.48

    48 Substance Abuse and Mental Health Services Administration. (2006). The SAMHSA Evaluation of the Impact of the DATA Waiver Program. Retrieved from: http://www.buprenorphine.samhsa.gov/FOR_FINAL_summaryreport_colorized.pdf.

    A number of barriers to MAT adoption using buprenorphine in an office-based setting were identified in this evaluation, with three in particular that were consistently identified amongst waivered practitioners as problematic: (1) The 30-patient limit, (2) limited third-party reimbursement, and (3) high medication/treatment costs. Additional barriers identified include a hesitation to initiate buprenorphine prescribing because of (1) a lack of a sufficient number of patients needing MAT for opioid use disorders, (2) difficult initial treatment setup and logistics, and (3) patients' reluctance around counseling as a component of treatment. A number of non-waivered practitioners cited common challenges to obtaining a waiver, including lack of appropriate training or experience, concerns about recordkeeping and potential audits by DEA, and a scarcity of appropriate concomitant counseling resources in their areas.

    More recently, in September 2014, SAMHSA, in partnership with the National Institute on Drug Abuse, convened a meeting of expert professionals for a Buprenorphine Summit to gather the perspectives of leaders from the field regarding the state of practice and their assessment of possible strategies for moving forward. This Summit presented an opportunity for active and collaborative discussion about caring for patients; designing, operating, and sustaining programs; supporting recovery; and training practitioners. The participants explored what is known about the adoption of MAT with buprenorphine-containing products to treat opioid use disorder; reasons why it has not been as widely prescribed as might have been expected; and ways that Federal agencies, health professionals, and concerned individuals might enable buprenorphine treatment to become more accessible.

    Participants from the Summit provided some reasons waivered practitioners were not prescribing buprenorphine, including but not limited to the following: Practitioners do not have practice partners with waivers or practice partners who can provide cross-coverage because of the interpretation of the patient limit; they lack institutional support; their community lacks psychosocial resources for patients; they feel that with current patient limits, they cannot treat a sufficient volume of patients to meet all of the costs of providing buprenorphine given current third-party reimbursement; the regulations and scrutiny particular to prescribing buprenorphine can make them feel as if they are doing something questionable by prescribing it; and current confidentiality rules make it difficult to integrate substance use disorder care with primary care.

    Some of the ideas that came out of the Summit included strategies to expand availability of buprenorphine treatment for opioid use disorders, such as examining the elimination of restrictions on prescribing buprenorphine. Specific ideas included enabling non-physician practitioners to prescribe buprenorphine (which would require a legislative change); raising the cap on how many patients a practitioner can have in treatment at a time; and allowing practitioners to cross-cover one another on a short-term basis, which is a practice standard across medicine, without being in violation of the patient limit. The latter two are addressed in this Notice of Proposed Rulemaking (NPRM).

    F. Need for Rulemaking

    In the intervening 15 years since enactment of 21 U.S.C. 823(g)(2), there have been a number of changes, including the amendment that (1) allowed for practitioners in group practices to prescribe up to 30 patients individually regardless of whether they are in a group or sole practice, and (2) allowed for practitioners who had a waiver for at least 1 year to submit a second NOI to treat up to 100 patients at a time. Other changes include expansion in insurance coverage and parity protections due to passage of the Mental Health Parity and Addiction Equity Act, as well as the Affordable Care Act. Educational and training activities have also expanded, including the FDA Risk Evaluation and Mitigation Strategy (REMS) for buprenorphine and SAMHSA's Provider Clinical Support System for MAT. In addition, a new subspecialty board certification has been developed for allopathic physicians in addiction medicine, creating a pathway for more physicians to obtain broader knowledge of substance use disorders in general.

    Despite this progress, the nation finds itself in the midst of a public health crisis of opioid addiction, misuse, and related morbidity and mortality.49 Each day in the United States, 44 people die from overdose of prescription pain relievers.50 As previously stated, in 2014, opioids were involved in 28,647 deaths, or 61 percent of all drug overdose deaths; the rate of opioid overdoses has tripled since 2000.51

    49 FACT SHEET: Obama Administration Announces Public and Private Sector Efforts to Address Prescription Drug Abuse and Heroin Use. (2015, October 21). Retrieved from: https://www.whitehouse.gov/the-press-office/2015/10/21/fact-sheet-obama-administration-announces-public-and-private-sector.

    50 Centers for Disease Control and Prevention, supra note 27.

    51 Rudd, supra note 28.

    There are approximately 1,400 OTPs and 31,857 practitioners waived to prescribe buprenorphine. The use of extended-release injectable naltrexone has also made an important contribution to increasing access to MAT in the private physician office-based setting, but the number of patients receiving treatment with naltrexone in such settings is not known. Providers wishing to serve more people have the option of both office-based MAT with buprenorphine products as well as specialty addiction treatment programs that include an OTP. However, recent research has also shown that an estimated 1 million people out of 2.3 million individuals in the U.S. with opioid abuse or dependence were untreated.52 This assumes that practitioners were treating patients at maximum capacity. Data from DATA-waived providers in 2008 53 indicate that practitioners are likely only reaching 57 percent of their total patient capacity for buprenorphine treatment. At the State level, an estimated 3 patients per 1,000 people in the U.S. had an unmet need for treatment, assuming that practitioners were treating patients at maximum potential capacity.54

    52 Jones CM, Campopiano M, Baldwin G, McCance-Katz E. National and state treatment need and capacity for opioid agonist medication-assisted treatment. Am J Public Health 2015;105(8):e55-e63.

    53 Arfken CL, Johanson CE, Menza SD, Schuster CR. Expanding treatment capacity for opioid ependence with office-based treatment with buprenorphine: national surveys of physicians. J Subst Abuse Treat. 2010;39(2):96-104.

    54 Jones, supra note 53.

    While the Federal Guidelines for OTPs, published early in 2015, promote the use of both buprenorphine and naltrexone, in addition to methadone, in the approximately 1,400 OTPs, increasing access to MAT through OTPs is limited by several factors. These factors include the fact that the patient capacity of individual OTPs is typically determined by State licensing requirements, building permits, or other State or local regulations. Geography and the daily nature of methadone treatment are other factors that affect the ability to expand access to MAT via OTPs in general, but they do not directly relate to the capacity of an individual OTP to treat patients. Rather they are limitations on the expansion of access to more individuals utilizing methadone specifically.

    HHS is promoting access to all forms of MAT for opioid use disorder through multiple activities included in the Secretary's Opioid Initiative. Given the Secretary's unique authority to increase the patient limit on treatment under 21 U.S.C. 823(g)(2) by rulemaking, the proposed rule is an essential element of a comprehensive approach to increasing access to MAT.

    Increasing the limits on the number of patients per waivered practitioner has been requested by many individuals, organizations, and entities. In a letter to the Secretary, ASAM notes that the prescribing limit is a major barrier to patient access to care and the current limits place arbitrary limits on the number of patients a practitioner can treat. It also notes that no other medications are limited in such a manner.55 The American Psychiatric Association, American Academy of Addiction Psychiatry, and the American Osteopathic Academy of Addiction Medicine also wrote to the Secretary and stated that as “the number of people addicted to these opioids increases, there continues to be a shortage of physicians who are appropriately trained to treat them. The shortage severely complicates and impairs our ability to effectively address the epidemic, particularly in many rural and underserved areas of the nation.” 56

    55 Letter to Secretary Burwell from the American Society for Addiction Medicine, July 31, 2014.

    56 Letter to Secretary Burwell from the American Psychiatric Association, American Academy of Addiction Psychiatry, and the American Osteopathic Academy of Addiction Medicine, July 25, 2014.

    In sum, given the public health crisis of opioid misuse and abuse and the treatment gap between those individuals with an opioid use disorder and those currently receiving treatment, this proposed rule is needed to raise the patient cap in an effort to increase access to MAT with buprenorphine and associated counseling and supports. In keeping with the spirit of mental health parity, we emphasize that competency in addiction care should exist throughout the healthcare continuum. To balance optimal access and safety, we strive to ensure that the credentials needed to prescribe MAT are within reach for interested physicians, programs are practical to implement, and reporting requirements are not perceived as a barrier to participation. We seek comment on whether the proposed rule appropriately strikes this balance.

    IV. Summary of Proposed Rule A. General

    To date, SAMHSA has implemented the provisions of 21 U.S.C. 823(g)(2) without rulemaking due to the clear and specific provisions included in the statute. As authorized by the statute at 21 U.S.C. 823(g)(2)(B)(iii), SAMHSA is initiating rulemaking at this time to increase access to MAT with buprenorphine in the office-based setting as authorized under 21 U.S.C. 823(g)(2). The proposed rule would increase the highest available patient limit for qualified practitioners to receive a waiver from 100 to 200. This new higher patient limit would significantly increase patient capacity for practitioners qualified to prescribe at this level while also ensuring that waivered practitioners would be able to provide the full treatment continuum associated with MAT.

    Practitioners authorized to treat up to 200 patients under 21 U.S.C. 823(g)(2) would be required to meet infrastructure, capacity, and reporting requirements that exceed those required for the lower limits. The incremental increase from 100 to 200 patients and the concomitant reporting requirements would allow the Department to monitor the quality of care being delivered, identify any changes in the rate of diversion, and improvements in health outcomes for opioid-dependent patients. It would attach additional criteria and responsibilities to practitioners who would be able to treat up to 200 patients with the specific aims of ensuring quality of care and minimizing diversion. Importantly, the additional criteria and responsibilities are not intended to be unduly burdensome to the practitioner who wishes to expand his or her MAT treatment practice and we seek comment on the associated burden. Rather, they are intended to reflect the current standard of care for the treatment of opioid use disorder while also recognizing the growing demand for opioid use disorder treatment integrated into the non-specialist practice in more mainstream settings. This proposed rule does not add these additional requirements to practitioners who have a waiver to treat 100 or fewer patients under 21 U.S.C. 823(g)(2). The proposed rule also would create an option for an increased patient limit for practitioners responding to emergency situations that require immediate, increased access to MAT pharmacotherapies. Also included in the proposed rule are key definitions.

    This proposal would add subpart F to 42 CFR part 8. To accomplish this, additional changes would be made to part 8. Proposed changes to part 8 to accommodate the proposed rule include retitling the part to encompass all MAT over which the Secretary has regulatory authority. Consequently, under the proposed rule, subpart A would be entitled General Provisions. Current subparts A, B, and C would change to subparts B, C, and D, respectively. The titles of these subparts would be revised to make it clear that they apply only to OTPs.

    B. Scope (§ 8.1)

    Under the proposed rule, the scope of part 8 would encompass rules that are applicable to OTPs, and to waivered practitioners who seek to provide MAT to more than 100 patients. New subparts B through D under the proposed rule would contain the rules relevant to OTPs. Subpart E would be reserved and Subpart F would contain the proposed new rule. Section 8.1 would also explain that the proposed rules in the new subpart F pertain only to those practitioners using a waiver under 21 U.S.C. 823(g)(2) with a patient limit of 101 to 200.

    C. Definitions (§ 8.2)

    The definitions section would apply to the entirety of part 8. Definitions that would apply only to OTPs would be revised to reflect this in the specific definition. Two definitions would be eliminated: “Registered opioid treatment program” would be deleted because the term is not used anywhere in the text of the regulations; and the definition for “opiate addiction” would be renamed “opioid use disorder.”

    This proposed rule also includes a definition of “patient.” At present, the definition of “patient” in § 8.2 is limited to those individuals receiving treatment at an OTP, which excludes those individuals receiving office-based opioid treatment with buprenorphine, i.e., those subject to 21 U.S.C. 823(g)(2). As a result, there has been confusion among providers, insurers, pharmacists, and diversion investigators. This stems in part from the difference between formal admission and discharge practices that are customarily used in OTPs and other substance use disorder treatment programs and the more open-ended relationship between patient and practitioner in general medical and psychiatric practice. This confusion has also complicated the data collection necessary to assess access to treatment on community, state, and national levels. It has also hindered cross-coverage due to a concern that covering a patient for a short period of time keeps a practitioner accountable for that patient for an extended period of time.

    The proposed rule would revise the definition of patient to make it inclusive of all persons receiving MAT with an opioid medication, consistent with the expanded scope of proposed revisions to 42 CFR part 8. By proposing that patient “means any individual who receives MAT from a practitioner or program subject to this part,” the definition would apply to the entire period during which the eligible medication is expected to be used by the patient while under that practitioner's care. For example, if a practitioner provides cross-coverage for another practitioner, and in the course of that coverage the covering practitioner provides a prescription for buprenorphine, the patient counts towards the cross-covering practitioner's patient limit until the prescription has expired. However, if a cross-covering practitioner is merely available for consult but does not provide a prescription for buprenorphine while the prescribing practitioner is away, the patients being covered do not count towards the cross-covering practitioner's patient limit at all. Therefore, this definition would be expected to help ensure consistency and clarity in how waivered practitioners count patients towards the limit. We seek comments on this definition and other examples of coverage arrangements where clarity would be helpful.

    The proposed rule would include the following definition of patient limit: “the maximum number of individual patients a practitioner may treat at any time using covered medications.”

    Taken together, these two definitions would provide clear and fair guidance for regulatory enforcement and would be expected to reduce undercounting of patients by practitioners and, furthermore, would exclude those patients with whom a practitioner interacts as a professional courtesy or in a transitory fashion on behalf of another waivered physician from being counted against the covering practitioner's patient limit for an extended period of time. In this way it is expected that waivered practitioners will be able to provide reciprocal cross-coverage of patients for brief periods, such as weekends or vacations, without implications, long-term or possibly at all, for their respective individual limits.

    Other new definitions would include “behavioral health services,” “nationally recognized evidence-based guidelines” and “emergency situation.” These definitions would be in-line with definitions offered elsewhere and applied in the field. They would be minimally modified from other existing definitions to clarify the application of these terms to the unique circumstances of the practitioner providing MAT under 21 U.S.C. 823(g)(2).

    In addition, this proposed rule would define “nationally recognized evidence-based guidelines” to mean a document produced by a national or international medical professional association, public health entity, or governmental body with the aim of ensuring the appropriate use of evidence to guide individual diagnostic and therapeutic clinical decisions. Some examples include the ASAM National Practice Guidelines for the Use of Medications in the Treatment of Addiction Involving Opioid Use; SAMHSA's Treatment Improvement Protocol 40: Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction; the World Health Organization Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence; and the Federation of State Medical Boards' Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. SAMHSA would expect that guidelines falling into this definition may change over time but would not plan to keep a list for practitioners to consult.

    D. Opioid Treatment Programs (§§ 8.3 Through 8.34)

    Proposed retitled subparts B, C, and D would contain §§ 8.3 through 8.34. Proposed changes to these sections would be limited to changing the mailing address for program certification and accreditation body approval and updating terms, such as “opiate” and “opiate addiction” to “opioid” and “opioid use disorder,” respectively.

    E. Which Practitioners Are Eligible for a Patient Limit of 200? (§ 8.610)

    This is the first proposed section of the new subpart F. Proposed § 8.610 would describe which practitioners are eligible for a patient limit of 200. Under routine conditions, a practitioner would qualify for the higher limit in one of two ways: By possessing subspecialty board certification in addiction medicine or addiction psychiatry or by practicing in a qualified practice setting as defined in the rule. In either case, practitioners with the higher limit would have to possess a waiver to treat 100 patients for at least 1 year in order to gain experience treating at a higher limit. The purpose of offering the 200 patient limit to practitioners in these two categories is to recognize the benefit offered to patients through: (1) The advanced training and maintenance of knowledge and skill associated with the acquisition of subspecialty board certification; and (2) the higher level of direct service provision and care coordination envisioned in the qualified practice setting. This approach would restrict access to the 200 patient limit to a subset of the practitioners waivered to provide care to up to 100 patients. In addition to ensuring higher quality of care, the criteria for the higher limit would be intended to minimize the risk of diversion of controlled substances to illicit use and accidental exposure that could result from increased prescribing of buprenorphine. A practitioner with board certification in an addiction subspecialty would have to have the training and experience necessary to recognize and address behaviors associated with increased risk of diversion. In the qualified practice settings, SAMHSA believes that the care team and practice systems will function to help ensure this same level of care. We seek comments on this proposed approach, including comments on whether there are other ways for SAMHSA to ensure quality and safety while encouraging practitioners to take on additional patients.

    F. What Constitutes a Qualified Practice Setting? (§ 8.615)

    Proposed § 8.615 would describe the necessary elements of a qualified practice setting, which can include practices with as few as one waived provider as long as these criteria are met and can include both private practices and community-based clinics. Necessary elements of a qualified practice setting would include having: (1) The ability to offer patients professional coverage for medical emergencies during hours when the practitioner's practice is closed; this does not need to involve another waivered practitioner, only that coverage be available for patients experiencing an emergency even when the office is closed; (3) the ability to ensure access to patient case-management services; (4) health information technology (HIT) systems such as electronic health records, when practitioners are required to use it in the practice setting in which he or she practices; (5) participation in a prescription drug monitoring program (PDMP), where operational, and in accordance with State law. PDMP means a statewide electronic database that collects designated data on substances dispensed in the State. For practitioners providing care in their capacity as employees or contractors of a Federal government agency, participation in a PDMP would be required only when such participation is not restricted based on State law or regulation based on their state of licensure and is in accordance with Federal statutes and regulations; and (6) employment, or a contractual obligation to treat patients in a setting that has the ability to accept third-party payment for costs in providing health services, including written billing, credit and collection policies and procedures, or Federal health benefits.

    The elements were identified as common to many high-quality practice settings, which includes both private practices as well as federally qualified health centers and community mental health centers, and therefore worthy of replication. The elements would be expected to be common to OTPs, and OTPs currently in operation but not providing MAT under 21 U.S.C. 823(g)(2). Taken together, this would facilitate additional opportunities to expand access to MAT. Another consideration in the selection of these elements would be the need to limit the expansion of group practices formed for the sole purpose of pooling the individual practitioner limits to maximize revenue but which fail to offer a full continuum of services. HHS seeks comment on additional, alternate pathways by which a practitioner may become eligible to apply for a patient waiver of 200.

    G. What is the process to request a patient limit of 200? (§ 8.620)

    Proposed § 8.620 would describe the process to request a patient limit of 200. Similar to the waiver process for the 30 and 100 patient limits, the process would begin with filing a Request for Patient Limit Increase. A proposed draft of the Request for Patient Limit Increase is in the docket. Public comment is requested. The higher patient limit would carry with it greater responsibility for behavioral health services, care coordination, diversion control, and continuity of care in emergencies and for transfer of care in the event approval to treat up to 200 patients is not renewed or is denied. The new Request for Patient Limit Increase process would require providers to affirm that they would meet these requirements. The proposed definitions of “behavioral health services,” “diversion control plan,” “emergency situation,” “nationally recognized evidence-based guidelines” and “practitioner incapacity” would be provided in § 8.2 to assist practitioners in understanding what is expected of them in making these attestations. These responsibilities would be aligned with the standards of ethical medical and business practice and would not be expected to be burdensome to practitioners. Resources exist to help in the development in patient placement in the event transfer to other addiction treatment would be required, for example, if a provider chose to no longer practice at the 200 patient limit. Examples of these resources would include but are not limited to: Single State Authorities and State Opioid Treatment Authorities. Practitioners approved to treat up to 200 patients would also be required to reaffirm their ongoing eligibility to fulfill these requirements every 3 years as described in § 8.640.

    H. How will a request for patient limit increase be processed? (§ 8.625)

    Proposed § 8.625 would describe how SAMHSA will process a Request for Patient Limit increase. The process for requesting a patient limit up to 200 would be processed similarly to how the current 30 or 100 patient waiver is processed, with one difference. Whereas the lower patient limit waivers are not time limited, the waiver for the higher limit of 200 would have a term not to exceed 3 years. Thus, a practitioner would be required to submit a new Request for Patient Limit Increase every 3 years if he or she desired to continue treating up to 200 patients.

    I. What must practitioners do in order to maintain their approval to treat up to 200 patients under § 8.625? (§ 8.630)

    Proposed § 8.630 would describe the conditions for maintaining a waiver for each 3-year period for which waivers are valid, including maintenance of all eligibility requirements specified in § 8.610, and all attestations made in accordance with § 8.620(b). Compliance with the requirements specified in § 8.620 would have to be continuous. This includes compliance with reporting requirements specified in § 8.635.

    J. What are the reporting requirements for practitioners whose request for patient limit increase is approved under § 8.625? (§ 8.635)

    Proposed § 8.635 would describe the reporting requirements for practitioners whose Request for Patient Limit Increase is approved under § 8.625. Reporting would be required annually to ensure that eligibility requirements are being maintained and that waiver conditions are being fulfilled. We seek comments on whether the proposed reporting periods and deadline could be combined with other, existing reporting requirements in a way that would make reporting less burdensome for practitioners. Reporting requirements may include a request for information regarding:

    a. The average monthly caseload of patients receiving buprenorphine-based MAT, per year b. Percentage of active buprenorphine patients (patients in treatment as of reporting date) that received psychosocial or case management services (either by direct provision or by referral) in the past year due to: 1. Treatment initiation 2. Change in clinical status c. Percentage of patients who had a prescription drug monitoring program query in the past month d. Number of patients at the end of the reporting year who: 1. Have completed an appropriate course of treatment with buprenorphine in order for the patient to achieve and sustain recovery 2. Are not being seen by the provider due to referral by the provider to a more or less intensive level of care 3. No longer desire to continue use of buprenorphine 4. Are no longer receiving buprenorphine for reasons other than 1-3. We seek comment on this list. K. What is the process for renewing a practitioner's request for patient limit increase approval? (§ 8.640)

    Proposed § 8.640 would describe the process for a practitioner renewing his or her approval for the higher patient limit. In order for a practitioner to renew an approval, he or she would have to submit a renewal Request for Patient Limit Increase in accordance with the procedures outlined under § 8.620 at least 90 days before the expiration of the approval term.

    L. What are the responsibilities of practitioners who do not submit a renewal request for patient limit increase or whose request is denied? (§ 8.645)

    Proposed § 8.645 would describe the responsibilities of practitioners who do not submit a renewal Request for Patient Limit Increase or whose request is denied. Under § 8.620(b)(7) practitioners would notify all patients affected above the 100 patient limit, that the practitioner would no longer be able to provide MAT services using covered medications and would make every effort to transfer patients to other addiction treatment.

    M. Can SAMHSA suspend or revoke a practitioner's patient limit increase approval? (§ 8.650)

    Proposed § 8.650 would describe under what circumstances SAMHSA would suspend or revoke a practitioner's patient limit increase of 200. If SAMHSA had reason to believe that immediate action would be necessary to protect public health or safety, SAMHSA would suspend the practitioner's patient limit increase of 200. If SAMHSA determined that the practitioner had made misrepresentations in his or her Request for Patient Limit Increase, or if the practitioner no longer satisfied the requirements of this subpart, or he or she has been found to have violated the CSA pursuant to 21 U.S.C. 824(a), SAMHSA would revoke the practitioner's patient limit increase of 200.

    N. Can a practitioner request to temporarily treat up to 200 patients in emergency situations? (§ 8.655)

    Proposed § 8.655 would describe the process, including the information and documentation necessary, for a practitioner with an approved 100 patient limit, to request approval to temporarily treat up to 200 patients in an emergency situation. The intention of this provision would be to help assure continuity of care for patients whose care might otherwise be abruptly terminated due to the death or disability of their practitioner. This provision would also help communities respond rapidly to a sudden increase in demand for medication assisted treatment. Sudden increases in demand for treatment may be experienced when there is a local disease outbreak associated with drug use, or when a natural or human-caused disaster either displaces persons in treatment from their practitioner or program or destroys program infrastructure. The emergency provision generally would not be intended to correct poor resource deployment due to lack of planning. The emergency provision of the proposed rule would only be considered if other options for addressing the increased demand for medication-assisted treatment could not address the situation.

    The practitioner must provide information and documentation that: (1) Describes the emergency situation in sufficient detail so as to allow a determination to be made regarding whether the emergency qualifies as an emergency situation as defined in § 8.2, and that provides a justification for an immediate increase in that practitioner's patient limit; (2) Identifies a period of time in which the higher patient limit should apply, and provides a rationale for the period of time requested; and (3) Describes an explicit and feasible plan to meet the public and individual health needs of the impacted persons once the practitioner's approval to treat up to 200 patients expires. Prior to taking action on a practitioner's request under this section, SAMHSA shall consult, to the extent practicable, with the appropriate governmental authority in order to determine whether the emergency situation that a practitioner describes justifies an immediate increase in the higher patient limit. If, after consultation with the governmental authority, SAMHSA determines that a practitioner's request under this section should be granted, SAMHSA will notify the practitioner that his or her request has been approved. The period of such approval shall not exceed six months. A practitioner wishing to receive an extension of the approval period granted must submit a request to SAMHSA at least 30 days before the expiration of the six month period and certify that the emergency situation continues. Except as provided in this section and § 8.650, requirements in other sections under subpart F do not apply to practitioners receiving waivers in this section.

    V. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA), agencies are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. Currently, the information collection associated with the 30-patient and 100-patient limits is approved under OMB Control No. 0930-0234. In order to fairly evaluate whether changes to an information collection should be approved by the OMB, section 3506(c)(2)(A) of the PRA requires that we solicit comment on the following issues:

    1. Whether the information collection is necessary and useful to carry out the proper functions of the agency;

    2. The accuracy of the agency's estimate of the information collection burden;

    3. The quality, utility, and clarity of the information to be collected; and

    4. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.

    Under the PRA, the time, effort, and financial resources necessary to meet the information collection requirements referenced in this section are to be considered in rulemaking. We explicitly seek, and will consider, public comment on our assumptions as they relate to the PRA requirements summarized in this section. This proposed rule includes changes to information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements, as defined under the PRA (5 CFR part 1320). Some of the provisions would involve changes from the information collections set out in the previous regulations.

    Information collection requirements would be:

    A. Approval, 42 CFR 8.620(a) through (c): In order for a practitioner to receive approval for a patient limit of 200, a practitioner must meet all of the requirements specified in § 8.610 and submit a Request for Patient Limit Increase to SAMHSA that includes all of the following:

    • Completed 3-page Request for Patient Limit Increase Form, a draft of which is available for review in the public docket;

    • Statement certifying that the practitioner:

    ○ Will adhere to nationally recognized evidence-based guidelines for the treatment of patients with opioid use disorders;

    ○ Will provide patients with necessary behavioral health services as defined in § 8.2 or will provide such services through an established formal agreement with another entity to provide behavioral health services;

    ○ Will provide appropriate releases of information, in accordance with Federal and State laws and regulations, including the Health Information Portability and Accountability Act Privacy Rule and part 2 of this chapter, if applicable, to permit the coordination of care with behavioral health, medical, and other service practitioners;

    ○ Will use patient data to inform the improvement of outcomes;

    ○ Will adhere to a diversion control plan to manage the covered medications and reduce the possibility of diversion of covered medications from legitimate treatment use;

    ○ Has considered how to assure continuous access to care in the event of practitioner incapacity or an emergency situation that would impact a patient's access to care as defined in § 8.2; and

    ○ Will notify all patients above the 100 patient level, in the event that the request for the higher patient limit is not renewed or is denied, that the practitioner will no longer be able to provide MAT services using buprenorphine to them and make every effort to transfer patients to other addiction treatment;

    B. Diversion Control Plan, 42 CFR 8.12(c)(2): Creating and maintaining a diversion control plan is one of the requirements that practitioners must attest to before they are approved to treat at the higher limit. This plan is not required to be submitted to SAMHSA.

    C. Reporting, 42 CFR 8.635: Reporting will be required annually to ensure that eligibility requirements are being maintained and that waiver conditions are being fulfilled. Reporting requirements may include a request for information regarding: (1) The average monthly caseload of patients receiving buprenorphine-based MAT, per year; (2) the percentage of active buprenorphine patients (patients in treatment as of reporting date) who received psychosocial or case management services (either by direct provision or by referral) in the past year due to treatment initiation or change in clinical status; (3) Percentage of patients who had a prescription drug monitoring program query in the past month; (4) Number of patients at the end of the reporting year who: (a) Have completed an appropriate course of treatment with buprenorphine in order for the patient to achieve and sustain recovery, (b) Are not being seen by the provider due to referral by the provider to a more or less intensive level of care, (c) No longer desire to continue use of buprenorphine, (d) Are no longer receiving buprenorphine for reasons other than (a) through (c). To facilitate public comment, we have placed a draft version of the collection template in the public docket.

    D. Renewal, 42 CFR 8.640: Describes the process for a practitioner renewing his or her approval for the higher patient limit. In order for a practitioner to renew an approval, he or she must submit a renewal Request for Patient Limit Increase in accordance with the procedures outlined under § 8.620 at least 90 days before the expiration of the approval term.

    E. Patient Notice, 42 CFR 8.645: Describes the responsibilities of practitioners who do not submit a renewal Request for Patient Limit Increase. Practitioners who do not renew their Request for Patient Limit Increase must notify all patients above the 100 patient limit that the practitioner will no longer be able to provide MAT services using covered medications and make every effort to transfer patients to other addiction treatment. The Patient Notice is a model notice to guide practitioners in this situation when they notify their patients.

    F. Emergency Provisions, 42 CFR 8.655: Describes the process for practitioners with a current waiver to prescribe up to 100 patients, and who are not otherwise eligible to treat up to 200 patients, to request a temporary increase to treat up to 200 patients in order to address emergency situations as defined in § 8.2. To initiate this process, the practitioner shall provide information and documentation that: (1) Describes the emergency situation in sufficient detail so as to allow a determination to be made regarding whether the situation qualifies as an emergency situation as defined in § 8.2, and that provides a justification for an immediate increase in that practitioner's patient limit; (2) Identifies a period of time, not longer than 6 months, in which the higher patient limit should apply, and provides a rationale for the period of time requested; and (3) Describes an explicit and feasible plan to meet the public and individual health needs of the impacted persons once the practitioner's approval to treat up to 200 patients expires. If a practitioner wishes to receive an extension of the approval period granted under this section, he or she must submit a request to SAMHSA at least 30 days before the expiration of the 6-month period, and certify that the emergency situation as defined in § 8.2 necessitating an increased patient limit continues.

    Annual burden estimates for these requirements are summarized in the following table:

    42 CFR
  • Citation
  • Purpose of submission Number of
  • respondents
  • Responses/
  • respondent
  • Burden/
  • response
  • (hour)
  • Total
  • burden
  • (hour)
  • Hourly wage cost ($) Total wage cost ($)
    8.620(a) through (c) Request for Patient Limit Increase 517 1 .5 259 $93.74 $24,232 8.12(c)(2) Diversion Control Plan 517 1 .5 259 93.74 24,232 8.635 Annual Report 1,350 1 3 4,050 64.47 261,104 8.640 Renewal Request for a Patient Limit Increase 0 1 .5 0 93.74 0 8.645 Patient Notice 0 1 3 0 93.74 0 8.655(d) Request for a Temporary Patient Increase for an Emergency 10 1 3 30 64.47 1,934 Total 2,394 4,598 311,502

    Note that these estimates differ from those found in the RIA because the estimates here are wage cost estimates while the estimates in the RIA are resource cost estimates which incorporate costs associated with overhead and benefits.

    For more detailed estimates, please refer to the public docket, which includes a copy of the draft supporting statement associated with this information collection.

    VI. Regulatory Impact Analysis A. Introduction

    HHS has examined the impact of this proposed rule under Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act of 1980 (Pub. L. 96-354, September 19, 1980), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995), and Executive Order 13132 on Federalism (August 4, 1999).

    Executive Order 12866 directs 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 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866. HHS expects that this proposed rule will have an annual effect on the economy of $100 million or more in at least 1 year and therefore is a significant regulatory action as defined by Executive Order 12866.

    The Regulatory Flexibility Act (RFA) requires agencies that issue a regulation to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. The RFA generally defines a “small entity” as (1) a proprietary firm meeting the size standards of the Small Business Administration; (2) a nonprofit organization that is not dominant in its field; or (3) a small government jurisdiction with a population of less than 50,000 (States and individuals are not included in the definition of “small entity”). HHS considers a rule to have a significant economic impact on a substantial number of small entities if at least 5 percent of small entities experience an impact of more than 3 percent of revenue. HHS anticipates that the proposed rule will not have a significant economic impact on a substantial number of small entities. We provide supporting analysis in section F.

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) implicit price deflator for the gross domestic product. HHS expects this proposed rule to result in expenditures that would exceed this amount.

    Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on State and local governments or has federalism implications. HHS has determined that the proposed rule, if finalized, would not contain policies that would have substantial direct effects on the States, on the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government. The proposed changes in the rule represent the Federal Government regulating its own program. Accordingly, HHS concludes that the proposed rule does not contain policies that have federalism implications as defined in Executive Order 13132 and, consequently, a federalism summary impact statement is not required.

    B. Summary of the Proposed Rule

    Section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)) allows individual practitioners to dispense and prescribe Schedule III, IV, or V controlled substances that have been approved by the FDA specifically for use in maintenance and detoxification treatment without obtaining the separate registration required by 21 CFR 1301.13(e) and imposes a limit on the number of patients a practitioner may treat at any one time.

    Section 303(g)(2)(B)(iii) of the CSA allows qualified practitioners who file an initial NOI to treat a maximum of 30 patients at a time. After one year, the practitioner may file a second NOI indicating his/her intent to treat up to 100 patients at a time. To qualify, the practitioner must be a practitioner, possess a valid license to practice medicine, be a registrant of the DEA, have the capacity to refer patients for appropriate counseling and other appropriate ancillary services, and have completed required training. The training requirement may be satisfied in several ways: One may hold subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties or addiction medicine from the American Osteopathic Association; hold an addiction certification from the American Society of Addiction Medicine (ASAM); complete an 8-hour training provided by an approved organization; have participated as an investigator in one or more clinical trials leading to the approval of a medication that qualifies to be prescribed under 21 U.S.C. 823(g)(2); or complete other training or have such other experience as the state medical licensing board or Secretary of HHS considers to demonstrate the ability of the practitioner to treat and manage persons with opioid use disorder.

    Pursuant to 21 U.S.C. 823(g)(2)(B)(iii), the Secretary is authorized to promulgate regulations that change the total number of patients that a practitioner may treat at any one time.

    The laws pertaining to the utilization of buprenorphine were last revised approximately ten years ago at a time when the extent of the opioid public health crisis was less well-documented. The purpose of the proposed rule is to expand access to MAT with buprenorphine while encouraging practitioners administering buprenorphine to ensure their patients can receive the full array of services that comprise evidence-based MAT and to minimize the risk of drug diversion. The proposed rule would revise the highest patient limit from 100 patients per practitioner with an existing waiver (waivered practitioner) to 200 patients for practitioners who meet certain criteria in addition to those established in statute. Practitioners who have had a waiver to treat 100 patients for at least one year could obtain approval to treat up to 200 patients if they meet the requirements defined in this proposed rule and after submitting a Request for Patient Limit Increase to SAMHSA. Practitioners approved to treat up to 200 patients will also be required to accept greater responsibility for providing behavioral health services and care coordination, and ensuring quality assurance and improvement practices, diversion control, and continuity of care in emergencies. The higher limit will also carry with it the duty to regularly reaffirm the practitioner's ongoing eligibility and to participate in data reporting and monitoring as required by SAMHSA. In addition, practitioners in good standing with a current waiver to treat up to 100 patients (i.e., the practitioner has filed a NOI and satisfied all required criteria) may request approval to treat up to 200 patients in specific emergency situations for a limited time period specified in the rule. We anticipate that qualifying emergency situations will occur very infrequently. As a result, we do not anticipate that this provision will contribute significantly to the impact of this proposed rule. SAMHSA will review all emergency situation requests, to the extent practicable, in consultation with appropriate governmental authorities before such requests are granted. Finally, the proposed rule defines patient limit in such a way that firmly ties the individual patient to the prescribing practitioner of record rather than to the covering practitioner at a given moment. This will enable waivered practitioners to provide reciprocal cross-coverage of patients for brief periods, such as weekends or vacations, without being considered to be in excess of their respective individual limits. Although this is a positive aspect of the proposed rule and will help to ensure continuity of care in select situations, we expect that this will primarily affect the timing of treatment rather than the quantity of treatment. As a result, we do not anticipate that this change will contribute significantly to the impact of this proposed rule, and we do not estimate the associated costs and benefits.

    C. Need for the Proposed Rule

    The United States is facing an unprecedented increase in prescription opioid abuse, heroin use and opioid-related overdose deaths. In 2014, 18,893 overdose deaths involved prescription opioids and 10,574 involved heroin.57 Underlying many of these deaths is an untreated opioid use disorder.58 59 60 In 2014, more than 2.2 million people met diagnostic criteria for an opioid use disorder.61

    57 Center for Disease Control and Prevention, National Center for Health Statistics, National Vital Statistics System, Mortality File. (2015). Number and Age-Adjusted Rates of Drug-poisoning Deaths Involving Opioid Analgesics and Heroin: United States, 2000-2014. Atlanta, GA: Center for Disease Control and Prevention. Available at http://www.cdc.gov/nchs/data/health_policy/AADR_drug_poisoning_involving_OA_Heroin_US_2000-2014.pdf.

    58 Johnson EM, Lanier WA, Merrill RM, et al. Unintentional Prescription opioid-related overdose deaths: description of decedents by next of kin or best contact, Utah, 2008-2009. J Gen Intern Med. 2013;28(4):522-529.

    59 Hall AJ, Logan JE, Toblin RL, et al. Patterns of abuse among unintentional pharmaceutical overdose fatalities. JAMA. 2008;300(22):2613-2620.

    60 Bohnert AS, Valenstein M, Bair MJ, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. 2011;305(13):1315-1321.

    61 Jones CM. Unpublished analysis of the 2014 National Survey on Drug Use and Health Public Use File. 2015.

    Beyond the increase in overdose deaths, the health and economic consequences of opioid use disorders are substantial. In 2011, the most recent year data are available, an estimated 660,000 emergency department visits were due to the misuse or abuse of prescription opioids, heroin, or both.62 A recent analysis estimated the costs associated with emergency department and hospital inpatient care for opioid abuse-related events in the United States was more than $9 billion per year.63 The societal costs of prescription opioid abuse, dependence, and misuse in the United States in 2011 were estimated at $55.7 billion annually, not including societal costs related to heroin use.64

    62 Id..

    63 Chandwani HS, Strassels SA, Rascati KL, Lawson KA, Wilson JP. Estimates of charges associated with emergency department and hospital inpatient care for opioid abuse-related events. J Pain Palliat Care Pharmacother. 2013;27(3):206-13.

    64 Birnhaum HG, White AG, Schiller M, Waldman T, et al. Societal costs of prescription opioid abuse, dependence, and misuse in the United States. Pain Med. 2011;12(4):657-67.

    Beginning around 2006, the United States started to experience a significant increase in the rate of hepatitis C virus infections. The available epidemiology indicates this increase is largely due to the increased injection of prescription opioids and heroin.65 66 In addition, in 2015, a large outbreak of HIV in a small rural community in Indiana was linked to injection of prescription opioids, primarily injection of the prescription opioid oxymorphone. Over 80 percent of the 135 cases, as of April 2015, identified in the outbreak were co-infected with hepatitis C virus.67 The infectious disease consequences associated with opioid injection have been found to account for a substantial proportion of the economic burden and disability associated with opioid use disorders.68

    65 Suryaprasad AG, White JZ, Xu F, et al. Emerging epidemic of hepatitis C virus infections among young nonurban persons who inject drugs in the United States, 2006-2012. Clin Infect Dis 2014;59:1411-9.

    66 Zibbell JE, Iqbal K, Patel RC, Suryaprasad A, et al. Increases in hepatitis C virus infection related to injection drug use related to injection drug use among persons aged ≤30 years—Kentucky, Tennessee, Virginia, and West Virginia, 2006-2012. MMWR Morb Mortal Wkly Rep. 2015;64(17):453-8.

    67 Conrad, supra note 17.

    68 Degenhardt L, Whiteford HA, Ferrari AJ, Charlson FJ, et al. Global burden of disease attributable to illicit drug use and dependence: findings from the Global Burden of Disease Study 2010. Lancet 2013;382(9904):1564-74.

    There is robust literature documenting the effectiveness and cost-effectiveness of the use of buprenorphine in the treatment of opioid use disorder. Buprenorphine has been shown to increase treatment retention and to reduce opioid use, relapse risk, and risk behaviors that transmit HIV and hepatitis.69 70 71 72 73 74 Reductions in opioid-related mortality also have been shown for buprenorphine.75 76 77

    69 Clark RE, Baxter JD, Aweh G, O'Connell E, et al. Risk factors for relapse and higher costs among Medicaid members with opioid dependence or abuse: opioid agonists, comorbidities, and treatment history. J Subst Abuse Treat. 2015;57:75-80.

    70 Mattick RP, Breen C, Kimber J, Davoli M. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2014 Feb 6;2:CD002207. doi: 10.1002/14651858.CD002207.pub4.

    71 Kraus ML, Alford DP, Kotz MM, et al. Statement of the American Society of Addiction Medicine consensus panel on the use of buprenorphine in office-based treatment of opioid addiction. J Addict Med. 2011;5 (4):254-263.

    72 Bonhomme J, Shim RS, Gooden R, Tyus D, Rust G. Opioid addiction and abuse in primary care practice: a comparison of methadone and buprenorphine as treatment options. J Natl Med Assoc. 2012;104(7-8):342-350.

    73 Tsui JI, Evans JL, Lum PJ, Hahn JA, Page K. Association of opioid agonist therapy with lower incidence of hepatitis C virus infection in young adult injection drug users. JAMA Intern Med. 2014;174(12):1974-1981.

    74 Woody GE, Bruce D, Korthuis PT, Chhatre S, et al. HIV risk reduction with buprenorphine-naloxone or methadone: findings from a randomized trial. J Acuir Immune Defic Syndr. 2015;68(5):554-61.

    75 Clark RE, Samnaliev M, Baxter JD, Leung GY. The evidence doesn't justify steps by state Medicaid programs to restrict opioid addiction treatment with buprenorphine. Health Aff (Millwood). 2011;30(8):1425-1433.

    76 Schwartz RP, Gryczynski J, O'Grady KE, et al. Opioid agonist treatments and heroin overdose deaths in Baltimore, Maryland, 1995-2009. Am J Public Health. 2013;103(5):917-922.

    77 Carrieri MP, Amass L, Lucas GM, Vlahov D, Wodak A, Woody GE. Buprenorphine use: the international experience. Clin Infect Dis. 2006;43(suppl 4):S197-S215.

    Despite these well-documented benefits, buprenorphine treatment for opioid use disorder is significantly underutilized and often does not incorporate the full scope of recommended clinical practices that make up evidence-based MAT. Generally, there is significant unmet need for MAT treatment among individuals with opioid use disorders.78 There is also substantial geographic variation in the capacity to prescribe buprenorphine. Research suggests that 10 percent of the population live in areas where there is a shortage of practitioners eligible to prescribe buprenorphine or in counties that have no practitioners with a waiver to prescribe buprenorphine.79 These are primarily rural counties and areas located in the middle of the country.80 Only about 5 percent of practitioners with the 100 patient limit are located in rural counties.81

    78 Jones, supra note 53.

    79 Rosenblatt RA, Andrilla CH, Catlin M, Larson EH. Geographic and specialty distribution of US physicians trained to treat opioid use disorder. Ann Fam Med. 2015 Jan-Feb;13(1):23-6. doi: 10.1370/afm.1735.

    80 Dick AW, Pacula RL, Gordon A.J, Sorbero M, et al. Growth in buprenorphine waivers for physicians increased potential access to opioid agonist treatment, 2002-11. Health Affairs 2015;34(6):1028-1034.

    81 Stein BD, Pacula RL, Gordon AJ, Burns RM, et al. Where is buprenorphine dispensed to treat opioid use disorders? The role of private offices, opioid treatment programs, and substance abuse treatment facilities in urban and rural counties. Milbank Quarterly 2015;93(3):56561-583.

    Evidence suggests that utilization of buprenorphine is limited directly by the existence of treatment caps. Practitioners currently providing MAT with buprenorphine under 21 U.S.C. 823(g)(2) report that being limited to treating not more than 100 patients at a time is a barrier to expanding treatment.82 83 84 A recent survey by ASAM found that among the 1,309 respondents (approximately 35 percent of ASAM's membership), comprising a range of addiction stakeholders, including those working in OTPs and outpatient or office-based practice settings, 544, or 41.6 percent, were currently treating more than 80 patients, and 796, or 60.8 percent, reported there was demand for treatment in excess of the current 100 patient limit under the Drug Addiction Treatment Act of 2000 (Pub. L. 106-310).85 Increasing the number of patients that a single practitioner can treat with buprenorphine, then, could have a direct impact on buprenorphine capacity and utilization.

    82 Molfenter T, Sherbeck C, Zehner M, Starr S. Buprenorphine Prescribing Availability in a Sample of Ohio Specialty Treatment Organizations. J Addict Behav Ther Rehabil. 2015;4(2). pii: 1000140.

    83 Molfenter T, Sherbeck C, Zehner M, Quanbeck A, et al. Implementing buprenorphine in addiction treatment: payer and provider perspectives in Ohio. Subst Abuse Treat Prev Policy. 2015;10:13. doi: 10.1186/s13011-015-0009-2.

    84 Substance Abuse and Mental Health Services Administration, supra note 49.

    85 American Society of Addiction Medicine. 2015. Available at: http://www.asam.org/magazine/read/article/2015/12/08/addiction-specialists-weigh-in-on-the-data-2000-patient-limits.

    In addition to direct barriers to treating additional patients imposed by the patient limit, there are indirect barriers to expanding treatment capacity. In particular, increases in a practitioner's ability to expand his or her patient base will allow the practitioner to take advantage of economies of scale to increase the practice's efficiency. For example, a practitioner with a larger practice is more likely to be able to afford to hire specialized support staff, which allows the practitioner to reduce time spent on tasks best suited for another individual. This may help to enable the provision of the full complement of ancillary services that make up evidence-based MAT. Increasing a practitioner's maximum capacity for treatment has the potential to make treating patients with buprenorphine more economically feasible, which furthers the argument that these proposed changes will increase capacity to prescribe buprenorphine.

    The statutory change implemented in 2007 that increased the limit on the number of buprenorphine patients a practitioner could treat from 30 to 100, after having a 30 patient limit for 1 year, was associated with a significant increase in the use of buprenorphine.86 In 2007, when practitioners were first able to treat up to 100 patients, nearly 25 percent of eligible practitioners submitted a NOI to treat 100 patients (1,937 practitioners out of 7,887 practitioners).87 The findings from the ASAM survey discussed above and additional information indicate there is sufficient demand from both providers and patients to raise the patient limit. In addition, based on the experience in 2007, it is expected that some proportion of eligible practitioners will respond to the proposed rule by submitting a Request for Patient Limit Increase to treat up to 200 patients.

    86 Stein supra note 82.

    87 Jones, supra note 53.

    D. Analysis of Benefits and Costs a. Increased Ability for Waivered Practitioners To Treat Patients With Buprenorphine-Based MAT

    This proposed rule directly expands opportunities for physicians who currently treat or who may treat patients with buprenorphine, as they will now have the potential to treat up to 200 patients with buprenorphine. We believe that this may translate to a financial opportunity for these physicians, depending on the costs associated with treating these additional patients.

    Relatedly, this proposed rule may increase the value of the waiver to treat opioid use disorder under 21 U.S.C. 823(g)(2). The proposed rule would require practitioners to have a waiver to treat 100 patients for 1 year and to have a subspecialty board certification in addiction medicine, a subspecialty board certification in addiction psychiatry, or to practice in a qualified practice setting as defined in the rule in order to request approval to treat 200 patients. If getting to the 200-patient limit provides sufficient benefits to practitioners, this proposed rule may also increase incentives for other practitioners to apply for the lower patient limit waivers, insofar as they are milestones towards the 200-patient cap. In addition, this rule may also make it more valuable for practitioners to have subspecialty board certifications in addiction medicine and addiction psychiatry, or to practice in a qualified practice setting. The proposed rule, then, may increase the number of practitioners in these categories and thus the number of practitioners eligible for the 200 patient limit in the future.

    b. Increased Treatment for Patients

    Permitting practitioners to treat up to 200 patients will only be successful if it results in practitioners serving additional patients. As discussed previously, there are many reasons to expect this to happen as a result of finalization of this proposed rule. In addition, we expect that other factors could amplify the impact of the changes proposed in the rule. First, following the implementation of the Affordable Care Act, health insurance coverage has expanded dramatically in the United States. The uninsured rate among adults age 18-64 declined from 22.3 percent in 2010 to 12.7 percent during the first 6 months of 2015.88 Further, the Affordable Care Act expanded coverage includes populations at high-risk for opioid use disorders that previously did not have sufficient access to health insurance coverage.89 Second, parity protections from the Mental Health Parity and Addiction Equity Act and the Affordable Care Act will include coverage for mental health and substance use disorder treatment that is comparable to medical and surgical coverage in many types of insurance policies. Insurance coverage and cost of treatment are often cited as important reasons that individuals seeking treatment have not used buprenorphine.90 91 92 93 A NPRM to extend parity protections to Medicaid managed care was released in the spring of 2015. These changes in health insurance coverage should improve access to substance use disorder treatment, including buprenorphine.

    88 Centers for Disease Control and Prevention. Health insurance coverage: early release of estimates from the National Health Interview Survey, January-June 2015. Available at: http://www.cdc.gov/nchs/data/nhis/earlyrelease/insur201511.pdf.

    89 Jones, supra note 53.

    90 Volkow, supra note 38.

    91 Sohler NL, Weiss L, Egan JE, et al. Consumer attitudes about opioid addiction treatment: a focus group study in New York City. J Opioid Manag. 2013;9(2):111-119.

    92 . Greenfield BL, Owens MD, Ley D. Opioid use in Albuquerque, New Mexico: a needs assessment of recent changes and treatment availability. Addict Sci Clin Pract. 2014;9:10. doi: 10.1186/1940-0640-9-10.

    93 American Society of Addiction Medicine. State Medicaid coverage and authorization requirements for opioid dependence medications. 2013. Available at: http://www.asam.org/docs/advocacy/Implications-for-Opioid-Addiction-Treatment.

    c. Increased Time To Treat Patients

    Lack of practitioner time to treat patients with opioid use disorder, which includes a patient exam, medication consultation, counseling, and other appropriate treatment services, and lack of behavioral health staff to provide these ancillary services, are additional barriers to providing MAT with buprenorphine in the office-based setting.94 95 These barriers could be addressed by leveraging the time and skills of clinical support staff, such as nurses and clinical social workers. For example, in Massachusetts and Vermont, nurses provide screening, intake, education, and other ancillary services for patients treated with buprenorphine. This enables practitioners to treat additional patients and to provide the requisite psychosocial services.96 97 98 However, in order to afford a nurse or other clinician dedicated to providing evidence-based treatment for an opioid use disorder, practitioners need a minimum volume of patients. Allowing practitioners to treat up to 200 patients at a time would be a step towards supporting practitioners that seek to hire nurses and other clinical staff to reduce practitioners' time requirements and to provide the ancillary services of high-quality MAT with buprenorphine. This impact of leveraging non-physicians to facilitate expanded access to buprenorphine has been demonstrated in both Vermont and Massachusetts.99 100

    94 Hutchinson E, Catlin M, Andrilla CH, Baldwin LM, Rosenblatt RA. Barriers to primary care physicians prescribing buprenorphine. Ann Fam Med. 2014 Mar-Apr;12(2):128-33.

    95 DeFlavio JR, Rolin SA, Nordstrom BR, Kazal LA Jr. Analysis of barriers to adoption of buprenorphine maintenance therapy by family physicians. Rural RemoteHealth. 2015;15:3019. Epub 2015 Feb 4.

    96 Alford D, LaBelle C, Richardson J, O'Connell J, et al. Treating homeless opioid dependent patients with buprenorphine in an office-based setting. Society of General Internal Medicine. 2007; 22: 171-176.

    97 Labelle, C. Nurse Care Manager Model. http://buprenorphine.samhsa.gov/presentations/LaBelle.pdf.

    98 State of Vermont: Concept for Medicaid Health Home Program http://hcr.vermont.gov/sites/hcr/files/VT_SPA_Concept_Paper_final_CMS_10_02_12.pdf.

    99 LaBelle CT, Han SC, Bergeron A, Samet JH. Office-Based Opioid Treatment with Buprenorphine (OBOT-B): Statewide Implementation of the Massachusetts Collaborative Care Model in Community Health Centers. J Subst Abuse Treat. 2016;60:6-13.

    100 Vermont Department of Health. The effectiveness of Vermont's System of Opioid Addiction Treatment. 2015. Available at: http://legislature.vermont.gov/assets/Legislative-Reports/Opioid-system-effectiveness-1.14.15.pdf.

    Discussions with stakeholders about approaches to expanding access to MAT, including the use of buprenorphine-based MAT, suggest that expanding the patient limit in general will result in increased efficiencies in treating opioid use disorder patients. It will allow treating practitioners to provide the physician-appropriate services consistent with their waiver. It will provide more efficient supportive care, not related to prescribing or administering buprenorphine-containing products, by allowing the treating practitioner to supervise this care, which can be provided by physician assistants, nurse practitioners, nurse case managers, and other behavioral health specialists.

    d. Federal Costs Associated With Disseminating Information About the Rule

    Following publication of a final rule that builds upon this proposal and public comments, SAMHSA will work to educate providers about the requirements and opportunities for requesting and obtaining approval to treat up to 200 patients under 21 U.S.C. 823(g)(2). SAMHSA will prepare materials summarizing the changes as a result of the final rule, and provide these materials to practitioners potentially affected by the rulemaking upon publication of the final rule. SAMHSA has already established channels for disseminating information about rule changes to stakeholders, it is estimated that preparing and disseminating these materials will cost approximately $40,000, based upon experience soliciting public comment on past rules and publications such as the Federal Opioid Treatment Program Standards.

    e. Practitioners Costs To Evaluate the Policy Change

    We expect that, if this proposed rule is finalized, practitioners potentially affected by this proposed policy change will process the information and decide how to respond. In particular, they will likely evaluate the requirements and opportunities associated with the ability to treat up to 200 patients, and decide whether or not it is advantageous to pursue approval to treat up to 200 patients and make any necessary changes to their practice, such as obtaining subspecialty board certifications in either addiction medicine or addiction psychiatry, or the ability to treat patients in a qualified practice setting.

    We estimate that practitioners may spend an average of thirty minutes processing the information and deciding what action to take. According to the U.S. Bureau of Labor Statistics,101 the average hourly wage for a physician is $93.74. After adjusting upward by 100 percent to account for overhead and benefits, we estimate that the per-hour cost of a physician's time is $187.48. Thus, the cost per practitioner to process this information and decide upon a course of action is estimated to be $93.74. SAMHSA will disseminate information to an estimated 50,000 practitioners, which includes practitioners with a waiver to prescribe buprenorphine (i.e., approximately 30,000 practitioners as of December 2015) and those who are reached through SAMHSA's dissemination network (i.e., 20,000 practitioners). For purposes of analysis we assume that 75 percent of these practitioners will review this information, and, as a result, we estimate that dissemination will result in a total cost of $3.5 million.

    101 U.S. Bureau of Labor Statistics. National Occupational Employment and Wage Estimates. Retrieved from: http://www.bls.gov/oes/current/oes_nat.htm#29-0000.

    f. Practitioner Costs To Submit a Request for Patient Limit Increase

    Practitioners who want to treat up to 200 patients at a given time are required to submit a Request for Patient Limit Increase form to SAMHSA. The proposed form is three pages in length. We estimate that the form takes a practitioner an average of 1 hour to complete the first time it is completed, implying a cost of $187.48 per submission after adjusting upward by 100 percent to account for overhead and benefits. A draft Request for Patient Limit Increase form is available in the docket. We seek comment on our assumptions regarding the time required to complete the form.

    We do not have ideal information with which to estimate the number of practitioners who will submit a Request for Patient Limit Increase form in response to this proposed rule, and we therefore acknowledge uncertainty regarding the estimate of the total associated cost. However, based on the experience with the patient limit increase from 30 to 100 implemented in 2007 102 103 , the results of the 2015 ASAM survey described earlier, and discussions with stakeholders, we estimate that between 500 and 1,800 practitioners will request approval to treat 200 patients within the first year of the proposed rule. We estimate that between 100 and 300 additional practitioners will request approval to treat 200 patients in each of the subsequent 4 years. This would result in 600 to 2,100 practitioners in the second year, 700 to 2,400 practitioners in the third year, 800 to 2,700 in the fourth year, and 900 to 3,000 practitioners in the fifth year. We use the midpoint of each of these ranges to estimate costs and benefits in the first 5 years following publication of the final rule. This would result in a range of $93,740 to $337,464 in costs related to Request for Patient Limit Increase submissions in the first year. We seek comment on information which will allow us to refine our estimate of the number of practitioners who will submit a Request for Patient Limit Increase in response to this proposed rule.

    102 Arfken, supra note 54.

    103 Jones, supra note 53.

    Number of
  • requests for
  • patient limit
  • increase
  • Cost ($)
    Year 1 1,150 $215,600 Year 2-5 200 37,500 Total 1,950 365,600
    g. Practitioner Costs To Resubmit a Request for Patient Limit Increase

    After approval, a practitioner would need to resubmit a Request for Patient Limit Increase every 3 years to maintain his or her waiver to treat up to 200 patients. A practitioner would use the same 3-page Request for Patient Limit Increase used for an initial waiver request. We estimate that this will take 30 minutes because practitioners will be more familiar with the Request for Patient Limit Increase. Consistent with the physician wage estimate above, we estimate that resubmissions will require a practitioner an average of 30 minutes to complete, implying a cost of $93.74 per resubmission. To calculate costs associated with resubmission, we assume that all physicians who submit a Request for Patient Limit Increase will submit a renewal 3 years later. Our estimates are summarized in the table below.

    Number of
  • renewals
  • Cost ($)
    Year 1-3 0 0 Year 4 1,150 $108,000 Year 5 200 19,000 Total 1,350 127,000
    h. Private-Sector Costs Associated With Newly Applying for Any Waiver

    Practitioners may also be interested in the ability to eventually treat up to 200 patients, and may make changes toward achieving that goal. As discussed previously, these proposed changes may increase the number of practitioners who apply for a waiver to treat 30 or 100 patients. This would require practitioners to complete the required training, possess a valid license to practice medicine, be a registrant of DEA, and have the capacity to refer patients for appropriate counseling and other appropriate ancillary services. In addition, these proposed changes could increase the number of practitioners who seek subspecialty board certifications in either addiction medicine or addiction psychiatry or meet the requirements for practicing in a qualified practice setting as outlined in the proposed rule. This would likely include practice experience requirements, fees and time associated with preparing for and taking an exam, time and fees for continuing medical education requirements, and payment of certification fees.

    We do not have information to estimate the number of practitioners who will change behavior along these dimensions in response to this proposed rule. We seek comment on information which will allow us to estimate the number of practitioners who would apply to treat additional patients, the number who will seek additional subspecialty board certifications, and the number who will move toward meeting the requirements for treating in a qualified practice setting in response to the proposed changes.

    i. Federal Costs Associated With Processing New 200 Patient Limit Waivers

    In addition to the costs associated with practitioners seeking approval for the higher patient limit, costs will be incurred by SAMHSA and DEA in order to process the additional Requests For Patient Limit Increase generated by the proposed rule. For purposes of analysis, and based on contractor estimates, SAMHSA estimates that it will pay a contractor $100 to process each waiver. As discussed previously, we estimate that between 500 and 1,800 practitioners will request approval to treat 200 patients within the first year of the rule, and between 100 and 300 additional practitioners will request approval to treat 200 patients in each of the subsequent 4 years. In addition, we estimate that physicians will resubmit 500 to 1,800 renewals in year 4, and 100 to 300 renewals in year 5. As a result, we estimate costs to SAMHSA to process these waivers of $50,000-$180,000 in year 1, $10,000-$30,000 in year 2, $10,000-$30,000 in year 3, $60,000-$210,000 in year 4, and $20,000-$60,000 in year 5 following publication of the final rule. We estimate that DEA will allocate the equivalent of 1 FTE at the GS-11 level to process the additional requests coming to DEA for issuance of a new DEA number designating the provider as eligible to prescribe buprenorphine for the treatment of opioid use disorder as a result of this proposed rule. We estimate the associated cost is $144,238, which we arrive at by multiplying the salary of a GS-11 employee at step 5, which is $72,219 in 2015, by two to account for overhead and benefits.

    j. Costs of New Treatment

    Once requests to treat up to 200 patients generated by the proposed rule are processed, approved practitioners would be able to increase the number of patients they treat with buprenorphine. These patients, then, could utilize additional medical services that are consistent with the expectations for high-quality, evidence-based MAT proposed in the rule. We estimate the cost for buprenorphine and these additional medical services, including behavioral health and psychosocial services, as a result of the proposed rule to total $4,349 per patient per year, as described below.

    This estimate was derived using claims data from the 2009-2014 Truven Health MarketScan® database. According to the MarketScan® data, the annual cost of buprenorphine prescriptions and ancillary services received totaled $3,500 for individuals with private insurance and $3,410 for individuals with Medicaid. Specifically, the average annual cost of buprenorphine prescriptions was $2,100 for commercial insurance based on receipt of an average of seven buprenorphine prescriptions annually and $2,600 for Medicaid based on receipt of an average of 10 buprenorphine prescriptions annually.

    According to the MarketScan® data, approximately 69 percent of Medicaid patients and 45 percent of privately insured patients received an outpatient psychosocial service related to substance use disorder in addition to their buprenorphine prescription. The average number of visits among those who received any psychosocial service was eight for privately insured patients at an average cost of $3,000 per year and 10 for Medicaid patients at an average cost of $1,100 per year. We assumed that the quality of care would increase among patients treated by practitioners with the 200-patient limit due to the extra oversight and quality of care requirements in the proposed rule. Specifically, we assumed that 80 percent of patients would receive outpatient psychosocial services. This would raise the cost of providing MAT with buprenorphine to $4,590 for commercial insurance and $3,525 for Medicaid beneficiaries. Based on data from IMS Health, it is estimated that approximately 18 percent of individuals receiving MAT with buprenorphine are Medicaid enrollees. Thus, we arrived at the estimated average cost for individuals new to the treatment system as a result of the proposed rule to be $4,349 per patient per year.

    The total resource costs associated with additional treatment is the product of additional treatment costs per person and the number of people who will receive additional treatment as a result of the proposed rule. For purposes of analysis, we assume that each practitioner who requests approval to treat 200 patients will treat between 20 and 40 additional patients each year. This is based on our experience with the increase from the 30 patient limit to the 100 patient limit.104 105 We note that in that case, there were no new costs imposed on practitioners beyond those associated with additional treatment, whereas in this proposed rule there are new costs beyond those associated with additional treatment. However, applying this assumption would result in an estimated range of 10,000 to 72,000 additional patients treated in the first year; and an additional 2,000 to 12,000 patients in each subsequent year. To estimate costs associated with this increase in the number of patients, we assume that, on average, each physician will treat the equivalent of 30 full-time patients (i.e., some patients might receive fewer services and others might receive more, but for cost estimates we assume it averages out to the equivalent of 30 patients receiving the full spectrum of care).We use these ranges to estimate costs and benefits of the rule as proposed. Based on this information, we estimate the treatment costs associated with new patients receiving treatment with buprenorphine as a result of this proposed rule will be between $43.5 million and $313 million in the first year with a central estimate of $150 million, and an additional $8.7 million to $52.2 million in each subsequent year with a central estimate of $26.1 million. We seek comment on information which will allow us to refine our efforts to quantify the number of people who may receive additional treatment with buprenorphine as a result of this proposed rule.

    104 Arfken, supra note 54.

    105 Jones, supra note 53.

    Additional people receiving treatment Treatment costs
  • (Millions)
  • Year 1 34,500 $150 Year 2 40,500 176 Year 3 46,500 202 Year 4 52,500 228 Year 5 58,500 254

    Evidence suggests that the benefits associated with additional buprenorphine utilization are likely to exceed their cost. One study estimated the costs and Quality Adjusted Life Year (QALY) gains associated with long-term office-based treatment with buprenorphine-naloxone for clinically stable opioid-dependent patients compared to no treatment. The authors estimate total treatment costs over 2 years of $7,700 and an associated 0.22 QALY gain compared to no treatment in their base case.106 107 . Following a food safety rule recently published by FDA,108 we use a value of $1,260 per quality-adjusted life day. This implies a value of $460,215 ($1,260 *365.25) per QALY, which we use to monetize the health benefits here. As a result, we estimate average annual benefits ranges of $51,000 per person who achieves 6 months of clinical stability. In the absence of data on the percentage of patients newly receiving buprenorphine treatment who would achieve this status, we illustrate the calculation of rule-induced benefits using 100 percent as an input. We acknowledge that this approach would, all else equal, lead to overestimation of health benefits and request comment that would allow for refinement of the estimates. As a result, we estimate monetized health benefits of $1,747 million in the first year, with estimated monetized health benefits rising by $304 million in each subsequent year as more individuals receive treatment as a result of the rule. These monetized health benefits are summarized below. We acknowledge that this approach may underestimate or overestimate health benefits and request comment that would allow for refinement of the estimates. We also explore the sensitivity of these results to our assumptions regarding the health benefits related to treatment in our section on sensitivity analysis.

    106 Schackman BR, Leff JA, Polsky D, Moore BA, Fiellin DA. Cost-Effectiveness of Long-Term Outpatient Buprenorphine-Naloxone Treatment for Opioid Dependence in Primary Care. Journal of General Internal Medicine. 2012;27(6):669-676. doi:10.1007/s11606-011-1962-8.

    107 These results omit lost utility associated with the illegal consumption of heroin or other opioids. Such omission is consistent with Zerbe, R.O. Is Cost-Benefit Analysis Legal? Three Rules. Journal of Policy Analysis and Management 17(3): 419-456, 1998.

    108 This RIA can be found here: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM472330.pdf

    Additional people receiving treatment Monetized health benefits
  • (millions)
  • Year 1 34,500 $1,747 Year 2 40,500 2,050 Year 3 46,500 2,354 Year 4 52,500 2,658 Year 5 58,500 2,961
    k. Potential for Diversion

    While we expect many benefits associated with this proposed rule, it is possible that there would be unintended negative consequences. First, prior research looked at Utah statewide increases in buprenorphine use and the number of reported pediatric exposures, and found that as buprenorphine use increased between 2002 and 2011, the number of unintentional pediatric exposures in the State increased.109 Thus, it is possible that the increased utilization of buprenorphine as a result of this proposed rule without appropriate patient counseling and action to ensure the safe use, storage, and disposal of buprenorphine, may lead to an increase in unintentional pediatric exposures. In addition, there has been an increase in diversion of buprenorphine as use of the product has increased. According to the National Forensic Laboratory Information System (NFLIS)—a system used to track diversion-buprenorphine is the third most common narcotic analgesic reported in NFLIS, with 15,209 cases reported in 2014. This represents 12.4 percent of all narcotic analgesic cases in NFLIS in 2014.110

    109 Centers for Disease Control and Prevention. Buprenorphine prescribing practices and exposures reported to a poison center—Utah, 2002-2011. MMWR 2012;61:997-1001.

    110 Drug Enforcement Administration. National Forensic Laboratory Information System. 2014 Annual Report. Available at: https://www.nflis.deadiversion.usdoj.gov/Reports.aspx.

    It is important to note that studies have found that the motivation to divert buprenorphine is often associated with lack of access to treatment or using the medication to manage withdrawal—as opposed to diversion for the medication's psychoactive effect.111 112 Thus, the overall effect of this rulemaking on diversion is not clear given that the increased utilization of buprenorphine could affect the opportunity for diversion, but also could, in some cases, reduce diversion because of improved access to high-quality, evidence-based buprenorphine treatment.

    111 Lofwall MR, Havens JR. Inability to access buprenorphine treatment as a risk factor for using diverted buprenorphine. Drug Alcohol Depend. 2012;126(3):379-83.

    112 Genberg BL, Gillespie M, Schuster CR, Johanson CE, et al. Prevalence and correlates of street-obtained buprenorphine use among current and former injectors in Baltimore, Maryland. Addict Behav. 2013;38(12):2868-73.

    Moreover, to reduce the risk of diversion, one of the additional requirements placed on providers who seek the 200 patient limit is implementation of a diversion control plan. However, it is possible that State and local law enforcement could incur additional costs if diversion increases as a result of this proposed rule. We do not have sufficient information to estimate the extent to which these unintended consequences could occur.

    l. Practitioner Reporting Requirements

    Under this proposed rule, as outlined earlier, practitioners approved to treat up to 200 patients would have to submit information about their practice annually to SAMHSA for purposes of monitoring regulatory compliance. The goal of the reporting requirement is to ensure that practitioners are providing high-quality, evidence-based buprenorphine treatment. It is anticipated that the data for the reporting requirement can be pulled directly from an electronic or paper health record, and that practitioners would not have to update their record-keeping practices after receiving approval to treat 200 patients. We estimate that compiling and submitting the report would require approximately 1 hour of physician time and 2 hours of administrative time. According to the U.S. Bureau of Labor Statistics 89, the average medical and health services manager's hourly pay in 2014 was $49.84, which corresponds to a cost of $99.68 per hour after adjusting upward by 100 percent to account for overhead and benefits. Therefore, the cost of this reporting requirement per practitioner approved for the 200 patient limit is estimated to be the cost of 1 hour of a practitioner's time plus an hour of an administrator's time.

    As noted above, using the mid-point estimate, we estimate that 1,150 practitioners will request a 200-patient waiver in year 1 and 200 practitioners will request a 200-patient waiver in subsequent years. We assume that all of these requests will be approved. The costs associated with this reporting requirement are reported below. In addition, it is estimated that SAMHSA will incur a cost of $100 per practitioner approved for the 200 patient limit to process the practitioner data reporting requirement. These costs are reported below as well.

    DEA may also incur costs in association with this proposed rule if, for example, DEA increases the number of site visits they conduct because providers are treating more than 100 patients. We tentatively assume that DEA will incur no costs as a result of these reporting requirements, and we seek comment on this assumption.

    Number of
  • physician
  • reports
  • Physician costs SAMHSA costs
    Year 1 1,150 $445,000 $115,000 Year 2 1,350 522,000 135,000 Year 3 1,550 600,000 155,000 Year 4 1,750 677,000 175,000 Year 5 1,950 754,000 195,000
    m. Costs Associated With Waiver Requests in Emergencies

    Under the proposed rule, practitioners in good standing with a current waiver to treat up to 100 patients may request temporary approval to treat up to 200 patients in specific emergency situations. As discussed previously, we anticipate that qualifying emergency situations will occur very infrequently. We estimate that practitioners will request ten of these waivers in each year. We estimate that requesting this waiver would require approximately 1 hour of physician time and 2 hours of administrative time, and responding to the request would require resources approximately equivalent to responding the three Requests for Patient Limit Increase submissions, which is $300. As a result, we estimate that this requirement is associated with costs of approximately $7,000 in each year following publication of the final rule. We seek comment on the assumptions in this section.

    n. Summary of Impacts

    The proposed rule's impacts will take place over a long period of time. As discussed previously, we expect the existence of the waiver to treat 200 patients will increase the desirability of waivers to treat 30 and 100 patients. This implies that more practitioners will work toward fulfilling the requirements associated with receiving these waivers. Further, this may make practitioners early in their career more likely to choose addiction medicine or addiction psychiatry as their specialty. All of this implies that the proposed rule will have a growing impact on capacity to prescribe buprenorphine as time passes. Since the lack of capacity to treat patients using buprenorphine is a barrier to its utilization, this suggests that the proposed rule will lead to growing increases in the utilization of buprenorphine, and growing increases in the associated positive health and economic effects.

    The following table presents these costs and benefits over the first 5 years of the proposed rule.

    Accounting Table of Benefits and Costs of All Proposed Changes BENEFITS Present value over 5 years by discount rate
  • (millions of 2014 dollars)
  • 3 Percent 7 Percent Annualized value over 5 years by discount rate
  • (millions of 2014 dollars)
  • 3 Percent 7 Percent
    Quantified Benefits 11,019 10,148 2,336 2,313 COSTS 3 Percent 7 Percent 3 Percent 7 Percent Quantified Costs 955 880 203 201
    E. Sensitivity Analysis

    The total estimated benefits of the changes proposed here are sensitive to assumptions regarding the number of practitioners who will seek a waiver to treat 200 patients as a result of the proposed rule, the number of individuals who will receive MAT as a result of the proposed rule, the average per-person health benefits associated with this additional treatment, and the dollar value of these health improvements. We estimate that 500 to 1,800 practitioners will apply for a waiver to treat up to 200 patients in the first year, and 100 to 300 practitioners will apply for a waiver to treat up to 200 patients in subsequent years following publication of the final rule, with central estimates at the midpoint of each range. For alternative estimates in these ranges using a 3 percent discount rate, all else equal, we estimate annualized benefits ranging from $1,054 million to $3,618 million and annualized costs ranging from $92 million to $313 million.

    We estimate that practitioners who receive a waiver to treat 200 patients will treat between 20 and 40 additional patients each year, with a central estimate of an average of 30 additional patients. For alternative estimates of 20 to 40 additional patients per year, all else equal, we estimate annualized benefits using a 3 percent discount rate ranging from $1,557 million to $3,115 million over the 5 years following implementation.

    We estimate that individuals who receive MAT as a result of the proposed rule will experience average health improvements equivalent to 0.11 QALYs. For alternative estimates of these health improvements between 0.06 and 0.16 QALYs, all else equal, we estimate annualized benefits using a 3 percent discount rate ranging from $1,274 million to $3,398 million over the 5 years following implementation. To estimate the dollar value of health benefits, we use a value of approximately $460,000 per QALY. For alternative values per QALY between $300,000 and $600,000, all else equal, we estimate annualized benefits using a 3 percent discount rate ranging from $1,523 million to $3,046 million over the 5 years following implementation.

    Alternative assumptions along these four dimensions, when varied together, using a 3 percent discount rate, imply annualized benefit estimates ranging from $250 million to $9,148 million and annualized cost estimates ranging from $62 million to $417 million. We note that, in all scenarios discussed in this section, annualized benefits substantially exceed annualized costs. There are, however, uncertainties not reflected in this sensitivity analysis, which might lead to net benefits results that are smaller or larger than the range of estimates summarized in the following table.

    Low, High, and Primary Benefit and Cost Estimates BENEFITS Annualized Value over 5 Years 3% Discount Rate
  • (Millions of 2014 Dollars)
  • Low Primary High
    Quantified Benefits 250 2,336 9,148 Quantified Costs 62 203 417
    F. Analysis of Regulatory Alternatives

    We carefully considered the option of not pursuing regulatory action. However, existing evidence indicates that opioid use disorder and its related health consequences is a substantial and increasing public health problem in the United States, and it can be addressed by increasing access to effective treatment. As discussed previously, the lack of sufficient access to treatment is directly affected by the existing limit on the number of patients each practitioner with a waiver can currently treat using buprenorphine, and removing this barrier to access is very likely to increase the provision of this treatment. Finally, the provision of MAT with buprenorphine provides tremendous benefits to the individual who experiences health gains associated with treatment, as well as to society which bears smaller costs associated with the negative effects of opioid use disorders. These benefits are expected to greatly exceed the costs associated with increases in treatment. As a result, we expect the benefits of the proposed regulatory action to exceed its costs.

    We also considered allowing practitioners waivered to treat up to 100 patients to apply for the higher prescribing limit without having to meet the specialty board certification or qualified practice setting requirements as defined in the proposed rule. One important objective of this proposed rule is to expand access while mitigating the risks associated with expanded access. In addition, the effects of this rule are difficult to project, leading us to adopt a conservative approach to increasing access. Given the complexity of the condition, the increased potential for diversion associated with a higher prescribing limit, and the need to ensure high quality care, it was determined that addiction specialist physicians and those with the infrastructure and capacity to deliver the full complement of services recommended by clinical practice guidelines would be best suited to balance these concerns.

    Finally, we considered the alternative of having no reporting requirement for physicians with the 200-patient limit. Although this alternative would reduce the 1 hour of physician time and 2 hours of administrative time estimated for data reporting in our analysis, we did not pursue this alternative. The reporting requirements are intended to reinforce recommendations included in clinical practice guidelines on the delivery of high quality, effective, and safe patient care. Specifically, nationally-recognized clinical guidelines on office-based opioid treatment with buprenorphine suggest that optimal care include administration of the medication and the use of psychotherapeutic support services. They also recommend that physicians and practices prescribing buprenorphine for the treatment of opioid use disorder in the outpatient setting take steps to reduce the likelihood of buprenorphine diversion. Each of these tenets is reflected in the proposed reporting requirements.

    G. Regulatory Flexibility Analysis

    As discussed above, the RFA requires agencies that issue a regulation to analyze options for regulatory relief of small entities if a rule has a significant impact on a substantial number of small entities. The categories of entities affected most by this proposed rule will be offices of practitioners and hospitals. We expect that the vast majority of these entities will be considered small based on the Small Business Administration size standards or non-profit status, and assume here that all affected entities are small. According to SAMHSA data, as of March 2016 there were 32,123 practitioners with a waiver to prescribe buprenorphine for the treatment of opioid use disorder. This group of practitioners is most likely to be impacted by the proposed rule, but we lack information on the total number of associated entities. We acknowledge that some practitioners with a waiver may provide services at multiple entities, many entities may employ multiple practitioners with a waiver, and some entities currently unaffiliated with these practitioners will be impacted by this proposed rule. As a result, we estimate that approximately 32,123 small entities will be affected by this proposed rule.

    HHS considers a rule to have a significant economic impact on a substantial number of small entities if at least 5 percent of small entities experience an impact of more than 3 percent of revenue. As discussed above, the proposed rule imposes a small burden on entities. This burden is primarily associated with processing information disseminated by SAMHSA, opting to completing the waiver process to treat additional patients, and submitting information after receiving a waiver to treat 200 patients, which are estimated to take a maximum of 4 hours per practitioner in any given year. This represents less than 1 percent of hours worked for an individual working full-time. Further, this proposed rule does not require practitioners to undertake these burdens, as this rulemaking does not require practitioners to seek a waiver to treat 200 patients. As a result, we anticipate that this proposed rule will not have a significant impact on a substantial number of small entities. We seek comment on the assumptions used in this section, and on the proposed rule's burden on small entities.

    VII. Agency Questions for Comment

    If any of the comments fall under any of the following questions, please indicate the question and number with your response.

    (1) Evidence Supporting an Optimal Patient Prescribing Limit—This proposed rule is intended to improve patient access to buprenorphine for the treatment of opioid use disorder while also minimizing the risk of diversion and patient safety concerns. Based on the available information, including clinical guideline recommendations and expert stakeholder input, HHS is proposing a new 200-patient prescribing limit. HHS seeks comment that provides evidence that an alternate prescribing limit would be more appropriate than the one proposed in this rulemaking.

    (2) Potential New Formulations—The Secretary shall establish a process by which patients who are treated with medications covered under 21 U.S.C. 823(g)(2)(C), and that have features that enhance safety or reduce diversion, as determined by the Secretary, may be counted differently toward the prescribing limit established in this proposed rule. The criteria for determining which if any of these medications or reformulations of existing medications may be considered, and how these patients will be counted toward the patient limit, will be based on the following principles:

    a. Relative risk of diversion associated with medications that become covered under 21 U.S.C. 823(g)(2)(C) after the effective date of this proposed rule; and

    b. Time required to monitor patient safety, assure medication compliance and effectiveness, and deliver or coordinate behavioral health services. HHS seeks comment on the principles by which the Secretary would determine which new medications would qualify.

    (3) Practitioner Training for 200 Patient Limit—HHS is seeking specific comment related to the level of training necessary to request a patient limit increase to 200 patients outside of a qualified practice setting. Specifically, under the current rule for the patient limit of 30 and 100, the training requirement may be satisfied at the time of initial NOI through a number of pathways, but the most common ways are via a subspecialty board certification in addiction psychiatry or addiction medicine, an addiction certification from ASAM, or completion of an 8-hour training provided by an approved organization. In this NPRM, SAMHSA would require board certification in addiction psychiatry or addiction medicine, but would not require additional training to progress to the 200-patient limit. However, this means that only practitioners with subspecialty board certifications will be eligible to apply for a patient waiver of 200 and practitioners satisfying training requirements via the other pathways for the 30 and 100 patients will not be eligible. SAMHSA is seeking comment on whether the range of provider qualifications is too broad or too narrow to expand access to high quality medication-assisted treatment for opioid use disorder. If commenters assert that opportunity to qualify should be broadened, we also welcome recommendations regarding alternate pathways that would affirm competence without necessitating specialty board certification.

    (4) Alternate pathways to qualify for 200-patient prescribing limit—Under this proposal, only practitioners with current 100-patient waivers who are either board-certified in addiction medicine or addiction psychiatry or who practice in “qualified practice settings” or who request a temporary increase to treat up to 200 patients in order to address emergency situations may apply for the higher limit. HHS seeks comment on additional, alternate pathways by which a practitioner may become eligible to apply for a patient waiver of 200.

    (5) Process to request a patient limit of 200—HHS is seeking specific comment related to the requirements as defined in § 8.620(a) through (c). Specifically, how much cost will be associated with each requirement and what fraction of practitioners practicing in qualified practice settings will be able to fulfill such requirements.

    (6) Patient Volume Necessary—We are not aware of data that indicate what patient volume per practitioner is necessary in order to make the provision of buprenorphine to patients not cost prohibitive. We seek data on how many patients a physician would need to treat in order to make the training requirements, administrative requirements, and other requirements not cost prohibitive to the practitioner by type of clinical environment type (e.g., large group practice, small physician-owned practice, hospitals, Medicaid-accepting addiction treatment centers, etc.).

    (7) Frequency of Renewal Request for Patient Limit Increase to 200 Patients—Currently, to be able to prescribe/dispense buprenorphine for the maintenance or detoxification of opioid use disorder, qualified practitioners must file a NOI with SAMHSA. Under this proposal, qualified practitioners in good standing with a current waiver to dispense to up to 100 patients may file a Request for Patient Limit Increase to treat up to 200 patients for a term of 3 years. SAMHSA is seeking comment on whether requiring the renewal for qualified practitioners seeking to treat up to 200 patients every 3 years is sufficient or whether practitioners should renew the waiver every year or every 2 years, instead of every 3 years.

    (8) Synchronization of Renewal Request with DEA Practitioner Registration Renewal—We seek comment on whether SAMHSA should synchronize the 3-year Request for Patient Limit Increase renewal with the renewal of the DEA practitioner registration to reduce practitioner burden.

    (9) Estimation of the Time Required to Seek Approval to Treat up to 200 Patients —As stated in the Regulatory Impact Analysis, SAMHSA is seeking comment on the assumptions regarding the time required to complete the request for the higher patient limit.

    (10) Estimation of the Change in Practitioner Behavior—As stated in the Regulatory Impact Analysis, SAMHSA does not have information to estimate the number of practitioners who would change behavior in response to this proposed rule. SAMHSA is seeking comment on the estimation of the number of practitioners who are not currently eligible to submit a Request for Patient Limit Increase to treat up to 200 patients but as a result of the proposed rule would take steps, such as obtain subspecialty board certification, or change practice settings, in order to qualify to treat up to 200 patients.

    (11) Estimation of the Number of Practitioners who are Eligible to Submit a Request for Patient Limit Increase to Treat up to 200 Patients—As stated in the Regulatory Impact Analysis, SAMHSA seeks comment on an estimation of the number of practitioners who, based on the proposed rule, would be eligible to submit a Request for Patient Limit Increase to treat up to 200 patients, and, as a result of the proposed rule, would do so.

    (12) Estimation of the Number of People who will Receive MAT with Buprenorphine—As stated in the Regulatory Impact Analysis, SAMHSA seeks comment in order to refine the estimation of the number of people who will receive MAT with buprenorphine as a result of the proposed rule.

    (13) Reporting Periods—SAMHSA seeks comment on whether the reporting periods and deadline could be combined with other, existing reporting requirements in a way that would make reporting less burdensome for practitioners.

    (14) Balance of Access and Safety—SAMHSA seeks comment on whether the proposed rule appropriately strikes the balance between ensuring that the credentials needed to prescribe MAT are within reach for interested practitioners, programs are practical to implement, and reporting requirements are not perceived as a barrier to participation.

    List of Subjects in 42 CFR Part 8

    Health professions, Methadone, Reporting and recordkeeping requirements.

    For the reasons stated in the preamble, HHS proposes to amend 42 CFR part 8 as follows:

    PART 8—MEDICATION ASSISTED TREATMENT FOR OPIOID USE DISORDERS 1. The authority citation for part 8 continues to read as follows: Authority:

    21 U.S.C. 823; 42 U.S.C. 257a, 290bb-2a, 290aa(d), 290dd-2, 300x-23, 300x-27(a), 300y-11.

    2. Revise the heading of part 8 as set forth above. 3. Amend part 8 as follows: a. Remove the word “opiate” and add the word “opioid” in its place wherever it appears; and b. Remove the phrases “opioid addiction” and “Opioid addiction” and add their places the phrases “opioid use disorder” and “Opioid use disorder”, respectively, wherever they appear. 4. Redesignate subpart C, consisting of §§ 8.21 through 8.34, as subpart D and revise the heading as follows: Subpart D—Procedures for Review of Suspension or Proposed Revocation of OTP Certification, and of Adverse Action Regarding Withdrawal of Approval of an Accreditation Body 5. Redesignate subpart B, consisting of §§ 8.11 through 8.15, as subpart C and revise the heading as follows: Subpart C—Certification and Treatment Standards for Opioid Treatment Programs 6. Add subpart B, redesignate §§ 8.3, 8.4, 8.5, and 8.6 to the new subpart B, and revise the heading to read as follows: Subpart B—Accreditation of Opioid Treatment Programs 7. Revise the heading to subpart A to read as follows: Subpart A—General Provisions 8. Revise § 8.1 to read as follows:
    § 8.1 Scope.

    (a) Subparts A through C of this part establish the procedures by which the Secretary of Health and Human Services (the Secretary) will determine whether a practitioner is qualified under section 303(g) of the Controlled Substances Act (CSA) (21 U.S.C. 823(g)) to dispense opioid drugs in the treatment of opioid use disorders. The regulations also establish the Secretary's standards regarding the appropriate quantities of opioid drugs that may be provided for unsupervised use by individuals undergoing such treatment (21 U.S.C. 823(g)(1)). Under these regulations, a practitioner who intends to dispense opioid drugs in the treatment of opioid use disorder must first obtain from the Secretary or, by delegation, from the Administrator, Substance Abuse and Mental Health Services Administration (SAMHSA), a certification that the practitioner is qualified under the Secretary's standards and will comply with such standards. Eligibility for certification will depend upon the practitioner obtaining accreditation from an accreditation body that has been approved by SAMHSA. These regulations establish the procedures whereby an entity can apply to become an approved accreditation body. This part also establishes requirements and general standards for accreditation bodies to ensure that practitioners are consistently evaluated for compliance with the Secretary's standards for treatment of opioid use disorder with an opioid agonist treatment medication.

    (b) The regulations in subpart F of this part establish the procedures and requirements that practitioners who are authorized to treat up to 100 patients pursuant to a waiver obtained under section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)), must satisfy in order to treat up to 200 patients with medications covered under section 303(g)(2)(C) of the CSA.

    9. Amend § 8.2 as follows: a. Revise the definitions of “Accreditation body” and “Accreditation body application”; b. Add, in alphabetical order, the definitions of “Approval term”, “Behavioral health services”, and “Board certification”; c. Revise the definition of “Certification”; d. Add, in alphabetical order, the definitions of “Covered medications”, “Dispense”, “Diversion control plan”, and “Emergency situation”; e. Revise the definition of “Interim maintenance treatment”; f. Add, in alphabetical order, the definition of “Nationally recognized evidence-based guidelines”; g. Add, in alphabetical order, the definition of “Opioid dependence”; h. Remove the definition of “Opioid treatment”; i. Revise the definitions of “Opioid treatment program” and “Opioid use disorder”; j. Add, in alphabetical order, the definition of “Opioid use disorder treatment”; k. Revise the definition of “Patient”; l. Add, in alphabetical order, the definitions of “Patient limit” and “Practitioner incapacity”; m. Remove the definition of “Registered opioid treatment program”; and n. Add, in alphabetical order, the definition of “Waivered practitioner”.

    The revisions and additions read as follows:

    § 8.2 Definitions.

    Accreditation body means a body that has been approved by SAMHSA in this part to accredit opioid treatment programs using opioid agonist treatment medications.

    Accreditation body application means the application filed with SAMHSA for purposes of obtaining approval as an accreditation body.

    Approval term means the 3 year period in which a practitioner is approved to treat up to 200 patients that commences when a practitioner's Request for Patient Limit Increase is approved in accordance with § 8.625.

    Behavioral health services means any non-pharmacological intervention carried out in a therapeutic context at an individual, family, or group level. Interventions may include structured, professionally administered interventions (e.g., cognitive behavior therapy or insight oriented psychotherapy) delivered in person, remotely via telemedicine shown in clinical trials to facilitate MAT outcomes or non-professional interventions.

    Board certification in addiction medicine or psychiatry means the receipt of board certification in a particular addiction medicine or psychiatry specialty and/or subspecialty of medical practice (e.g., subspecialty board certification in addiction medicine or psychiatry) from the American Board of Medical Specialties, a subspecialty board certification in addiction medicine from the American Osteopathic Association (AOA) or American Board of Addiction Medicine (ABAM), or an addiction certification from the American Society of Addiction Medicine (ASAM).

    Certification means the process by which SAMHSA determines that an opioid treatment program is qualified to provide opioid treatment under the Federal opioid treatment standards described in § 8.12.

    Covered medications means the drugs or combinations of drugs that are covered under 21 U.S.C. 823(g)(2)(C).

    Dispense means to deliver a controlled substance to an ultimate user by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance.

    Diversion control plan means a set of documented procedures that reduce the possibility that controlled substances will be transferred or used illicitly.

    Emergency situation means that an existing State, Tribal, or local system for substance use disorder services is overwhelmed or unable to meet the existing need for medication-assisted treatment as a direct consequence of a clear precipitating event. This precipitating event must have an abrupt onset such as practitioner incapacity, natural or human-caused disaster; an outbreak associated with drug use; and result in significant death, injury, exposure to life-threatening circumstances, hardship, suffering, loss of property, or loss of community infrastructure

    Interim maintenance treatment means maintenance treatment provided in an opioid treatment program in conjunction with appropriate medical services while a patient is awaiting transfer to a program that provides comprehensive maintenance treatment.

    Nationally recognized evidence-based guidelines means a document produced by a national or international medical professional association, public health agency, such as the World Health Organization, or governmental body with the aim of assuring the appropriate use of evidence to guide individual diagnostic and therapeutic clinical decisions.

    Opioid dependence means repeated self-administration that usually results in opioid tolerance, withdrawal symptoms, and compulsive drug-taking. Dependence may occur with or without the physiological symptoms of tolerance and withdrawal.

    Opioid treatment program or “OTP” means a program or practitioner engaged in opioid treatment of individuals with an opioid agonist treatment medication registered under 21 U.S.C. 823(g)(1).

    Opioid use disorder means a cluster of cognitive, behavioral, and physiological symptoms in which the individual continues use of opioids despite significant opioid-induced problems.

    Opioid use disorder treatment means the dispensing of an opioid agonist treatment medication, along with a comprehensive range of medical and rehabilitative services, when clinically necessary, to an individual to alleviate the adverse medical, psychological, or physical effects incident to an opioid use disorder. This term includes a range of services including detoxification treatment, short-term detoxification treatment, long-term detoxification treatment, maintenance treatment, comprehensive maintenance treatment, and interim maintenance treatment.

    Patient means any individual who receives MAT from a practitioner or program subject to this part.

    Patient limit means the maximum number of individual patients a practitioner may treat at any one time using covered medications.

    Practitioner incapacity means the inability of a waivered practitioner as a result of an involuntary event to physically or mentally perform the tasks and duties required to provide medication-assisted treatment in accordance with nationally recognized evidence-based guidelines.

    Waivered practitioner means a physician who is appropriately licensed by the State to dispense covered medications and who possesses a waiver under 21 U.S.C. 823(g)(2).

    10. Amend § 8.3 by revising the introductory text of paragraph (b) to read as follows:
    § 8.3 Application for approval as an accreditation body.

    (b) Application for initial approval. Electronic copies of an accreditation body application form [SMA-167] shall be submitted to: http://buprenorphine.samhsa.gov/pls/bwns/waiver. Accreditation body applications shall include the following information and supporting documentation:

    Subpart E [Reserved] 11. Reserve subpart E. 12. Add subpart F, consisting of §§ 8.610 through 8.655, to read as follows: Subpart F—Authorization to Increase Patient Limit to 200 Patients Sec. 8.610 Which practitioners are eligible for a patient limit of 200? 8.615 What constitutes a qualified practice setting? 8.620 What is the process to request a patient limit of 200? 8.625 How will a Request for Patient Limit Increase be processed? 8.630 What must practitioners do in order to maintain their approval to treat up to 200 patients? 8.635 What are the reporting requirements for practitioners whose Request for Patient Limit Increase is approved? 8.640 What is the process for renewing a practitioner's Request for Patient Limit Increase approval? 8.645 What are the responsibilities of practitioners who do not submit a renewal Request for Patient Limit Increase, or whose request is denied? 8.650 Can SAMHSA's approval of a practitioner's Request for Patient Limit Increase be suspended or revoked? 8.655 Can a practitioner request to temporarily treat up to 200 patients in emergency situations? Subpart F—Authorization to Increase Patient Limit to 200 Patients
    § 8.610 Which practitioners are eligible for a patient limit of 200?

    A practitioner is eligible for a patient limit of 200 if:

    (a) The practitioner possesses a current waiver to treat up to 100 patients under section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)) and has maintained the waiver in accordance with applicable statutory requirements without interruption for at least one year since the practitioner's notification of intent (NOI) under section 303(g)(2)(B) to treat up to 100 patients was approved;

    (b) The practitioner:

    (1) Holds a subspecialty board certification in addiction psychiatry or addiction medicine; or

    (2) Provides MAT utilizing covered medications in a qualified practice setting as defined in § 8.615;

    (c) The practitioner has not had his or her enrollment and billing privileges in the Medicare program revoked under § 424.535 of this title; and

    (d) The practitioner has not been found to have violated the Controlled Substances Act pursuant to 21 U.S.C. 824(a).

    § 8.615 What constitutes a qualified practice setting?

    A qualified practice setting is a practice setting which:

    (a) Provides professional coverage for patient medical emergencies during hours when the practitioner's practice is closed;

    (b) Provides access to case-management services for patients including referral and follow-up services for programs that provide, or financially support, the provision of services such as medical, behavioral, social, housing, employment, educational, or other related services;

    (c) Uses health information technology (HIT) systems such as electronic health records, if otherwise required to use it in the practice setting. HIT means the electronic systems that healthcare professionals and patients use to store, share, and analyze health information;

    (d) Is registered for their State prescription drug monitoring program (PDMP) where operational and in accordance with federal and State law. PDMP means a statewide electronic database that collects designated data on substances dispensed in the State. For practitioners providing care in their capacity as employees or contractors of a Federal government agency, participation in a PDMP is required only when such participation is not restricted based on their state of licensure and is in accordance with Federal statutes and regulations;

    (e) Accepts third-party payment for costs in providing health services, including written billing, credit and collection policies and procedures, or Federal health benefits.

    § 8.620 What is the process to request a patient limit of 200?

    In order for a practitioner to receive approval for a patient limit of 200, a practitioner must meet all of the requirements specified in § 8.610 and submit a Request for Patient Limit Increase to SAMHSA that includes all of the following:

    (a) Completed Request for Patient Limit Increase form;

    (b) Statement certifying that the practitioner:

    (1) Will adhere to nationally recognized evidence-based guidelines for the treatment of patients with opioid use disorders;

    (2) Will provide patients with necessary behavioral health services as defined in § 8.2 or through an established formal agreement with another entity to provide behavioral health services;

    (3) Will provide appropriate releases of information, in accordance with Federal and State laws and regulations, including the Health Information Portability and Accountability Act Privacy Rule and part 2 of this chapter, if applicable, to permit the coordination of care with behavioral health, medical, and other service practitioners;

    (4) Will use patient data to inform the improvement of outcomes;

    (5) Will adhere to a diversion control plan to manage the covered medications and reduce the possibility of diversion of covered medications from legitimate treatment use;

    (6) Has considered how to assure continuous access to care in the event of practitioner incapacity or an emergency situation that would impact a patient's access to care as defined in § 8.2; and

    (7) Will notify all patients above the 100 patient level, in the event that the request for the higher patient limit is not renewed or is denied, that the practitioner will no longer be able to provide MAT services using buprenorphine to them and make every effort to transfer patients to other addiction treatment;

    (c) Any additional documentation to demonstrate compliance with § 8.610 as requested by SAMHSA.

    § 8.625 How will a Request for Patient Limit Increase be processed?

    (a) Not later than 45 days after the date on which SAMHSA receives a practitioner's Request for Patient Limit Increase as described in § 8.620, or renewal Request for Patient Limit Increase as described in § 8.640, SAMHSA shall approve or deny the request.

    (1) A practitioner's Request for Patient Limit Increase will be approved if the practitioner satisfies all applicable requirements under §§ 8.610 and 8.620. SAMHSA will thereafter notify the practitioner who requested the patient limit increase, and the Drug Enforcement Administration (DEA), that the practitioner has been approved to treat up to 200 patients using covered medications. A practitioner's approval to treat up to 200 patients under this section will extend for a term not to exceed 3 years.

    (2) SAMHSA may deny a practitioner's Request for Patient Limit Increase if SAMHSA determines that:

    (i) The Request for Patient Limit Increase is deficient in any respect; or

    (ii) The practitioner has knowingly submitted false statements or made misrepresentations of fact in the practitioner's Request for Patient Limit Increase.

    (b) If SAMHSA denies a practitioner's Request for Patient Limit Increase (or renewal), SAMHSA shall notify the practitioner of the reasons for the denial.

    (c) If SAMHSA denies a practitioner's Request for Patient Limit Increase (or renewal) based solely on deficiencies that can be resolved, and the deficiencies are resolved to the satisfaction of SAMHSA in a manner and time period approved by SAMHSA, the practitioner's Request for Patient Limit Increase will be approved. If the deficiencies have not been resolved to the satisfaction of SAMHSA within the designated time period, the Request for Patient Limit Increase will be denied.

    § 8.630 What must practitioners do in order to maintain their approval to treat up to 200 patients?

    (a) A practitioner whose Request for Patient Limit Increase is approved in accordance with § 8.625 shall maintain all eligibility requirements specified in § 8.610, and all attestations made in accordance with § 8.620(b), during the practitioner's 3-year approval term. Failure to do so may result in SAMHSA withdrawing its approval of a practitioner's Request for Patient Limit Increase.

    (b) All practitioners whose Request for Patient Limit Increase has been approved under § 8.625 must provide reports to SAMHSA as specified in § 8.635.

    § 8.635 What are the reporting requirements for practitioners whose Request for Patient Limit Increase is approved?

    (a) All practitioners whose Request for Patient Limit Increase is approved under § 8.625 must submit reports to SAMHSA, along with documentation and data, as requested by SAMHSA, to demonstrate compliance with § 8.620, applicable eligibility requirements specified in § 8.610, and all attestation requirements in § 8.620(b).

    (b) Reporting requirements may include a request for information regarding:

    (1) The average monthly caseload of patients receiving buprenorphine-based MAT, per year.

    (2) Percentage of active buprenorphine patients (patients in treatment as of reporting date) that received psychosocial or case management services (either by direct provision or by referral) in the past year due to:

    (i) Treatment initiation.

    (ii) Change in clinical status.

    (3) Percentage of patients who had a prescription drug monitoring program query in the past month; and

    (4) Number of patients at the end of the reporting year who:

    (i) Have completed an appropriate course of treatment with buprenorphine in order for the patient to achieve and sustain recovery.

    (ii) Are not being seen by the provider due to referral by the provider to a more or less intensive level of care.

    (iii) No longer desire to continue use of buprenorphine.

    (iv) Are no longer receiving buprenorphine for reasons other than paragraph (b)(4)(i) through (iii) of this section.

    (c) The report must be submitted within twelve months after the date that a practitioner's Request for Patient Limit Increase is approved under § 8.625, and annually thereafter.

    (d) SAMHSA may check reports from practitioners prescribing under the higher patient limit against other existing data sources, such as PDMPs. If discrepancies between reported information and other existing data are identified, SAMHSA may require additional documentation from practitioners whose reports are identified as including these discrepancies.

    (e) Failure to submit reports under this section, or deficient reports, may be deemed a failure to satisfy the requirements for a patient limit increase, and may result in the withdrawal of SAMHSA's approval of the practitioner's Request for Patient Limit Increase.

    § 8.640 What is the process for renewing a practitioner's Request for Patient Limit Increase approval?

    (a) Practitioners who intend to continue to treat up to 200 patients beyond their current 3 year approval term must submit a renewal Request for Patient Limit Increase in accordance with the procedures outlined under § 8.620 at least 90 days before the expiration of their approval term.

    (b) If SAMHSA does not reach a final decision on a renewal Request for Patient Limit Increase before the expiration of a practitioner's approval term, the practitioner's existing approval term will be deemed extended until SAMHSA reaches a final decision.

    § 8.645 What are the responsibilities of practitioners who do not submit a renewal Request for Patient Limit Increase or whose request is denied?

    Practitioners who are approved to treat up to 200 patients in accordance with § 8.625, but who do not renew their Request for Patient Limit Increase, or whose request is denied, shall notify, under § 8.620(b)(7) in a time period specified by SAMHSA, all patients affected above the 100 patient limit, that the practitioner will no longer be able to provide MAT services using covered medications and make every effort to transfer patients to other addiction treatment.

    § 8.650 Can SAMHSA's approval of a practitioner's Request for Patient Limit Increase be suspended or revoked?

    (a) Suspension. SAMHSA may suspend its approval of a practitioner's Request for Patient Limit Increase under § 8.625 if it has reason to believe that immediate action is necessary to protect public health or safety.

    (b) Revocation. SAMHSA may revoke its approval of a practitioner's Request for Patient Limit Increase under § 8.625 at any time during the 3 year approval term if SAMHSA determines that the practitioner made any misrepresentations in the practitioner's Request for Patient Limit Increase, or if SAMHSA determines that the practitioner no longer satisfies the requirements of this subpart, or has been found to have violated the CSA pursuant to 21 U.S.C. 824(a).

    § 8.655 Can a practitioner request to temporarily treat up to 200 patients in emergency situations?

    (a) Practitioners with a current waiver to prescribe up to 100 patients and who are not otherwise eligible to treat up to 200 patients under § 8.610 may request a temporary increase to treat up to 200 patients in order to address emergency situations as defined in § 8.2 if the practitioner provides information and documentation that:

    (1) Describes the emergency situation in sufficient detail so as to allow a determination to be made regarding whether the situation qualifies as an emergency situation as defined in § 8.2, and that provides a justification for an immediate increase in that practitioner's patient limit;

    (2) Identifies a period of time, not longer than 6 months, in which the higher patient limit should apply, and provides a rationale for the period of time requested; and

    (3) Describes an explicit and feasible plan to meet the public and individual health needs of the impacted persons once the practitioner's approval to treat up to 200 patients expires.

    (b) Prior to taking action on a practitioner's request under this section, SAMHSA shall consult, to the extent practicable, with the appropriate governmental authority in order to determine whether the emergency situation that a practitioner describes justifies an immediate increase in the higher patient limit.

    (c) If SAMHSA determines that a practitioner's request under this section should be granted, SAMHSA will notify the practitioner that his or her request has been approved. The period of such approval shall not exceed six months.

    (d) If a practitioner wishes to receive an extension of the approval period granted under this section, he or she must submit a request to SAMHSA at least 30 days before the expiration of the six month period, and certify that the emergency situation as defined in § 8.2 necessitating an increased patient limit continues. Prior to taking action on a practitioner's extension request under this section, SAMHSA shall consult, to the extent practicable, with the appropriate governmental authority in order to determine whether the emergency situation that a practitioner describes justifies an extension of an increase in the higher patient limit.

    (e) Except as provided in this section and § 8.650, requirements in other sections under subpart F of this part do not apply to practitioners receiving waivers in this section.

    Dated: March 23, 2016. Kana Enomoto, Principal Deputy Administrator, Substance Abuse and Mental Health Services Administration. Approved: March 24, 2016. Sylvia M. Burwell, Secretary, Department of Health and Human Services.
    [FR Doc. 2016-07128 Filed 3-29-16; 8:45 am] BILLING CODE 4162-20-P
    81 61 Wednesday, March 30, 2016 Notices DEPARTMENT OF AGRICULTURE Forest Service Pacific Northwest National Scenic Trail Advisory Council AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Pacific Northwest National Scenic Trail Advisory Council (Council) will meet in Port Townsend, Washington. The Council is authorized under Section 5(d) of the National Trails System Act of 1968 (Act) and operates in compliance with the Federal Advisory Committee Act (FACA). Additional information concerning the Council, including the meeting summary/minutes, can be found by visiting the Council's Web site at: http://www.fs.usda.gov/main/pnt/working-together/advisory-committees.

    DATES:

    The meeting will be held on the following dates and times:

    • Wednesday, May 4, 2016 from 8:00 a.m. to 5:00 p.m. PDT.

    • Thursday, May 5, 2016 from 8:00 a.m. to 5:00 p.m. PDT.

    • Friday, May 6, 2016 from 8:00 a.m. to 5:00 p.m. PDT (optional field trip).

    All meetings are subject to cancellation. For updated status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Northwest Maritime Center, 431 Water Street, Port Townsend, WA 98368. Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses, when provided, are placed in the record and available for public inspection and copying. The public may inspect comments received at the Pacific Northwest Regional Office of the United States Forest Service: 1220 SW 3rd Avenue, Portland, OR 97204. Please call ahead at 503-808-2468 to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Matt McGrath, Pacific Northwest National Scenic Trail Program Manager, by phone at 425-583-9304, or by email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to provide:

    1. Review significant resources and current trail uses along the PNNST;

    2. Provide recommendations on the Nature and Purposes of the PNNST, including trail uses; and

    3. Discuss potential interpretive themes and strategies for youth and community engagement on the PNNST.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should submit a request in writing by May 19, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the Council may file written statements with the Council's staff before or after the meeting. Written comments and time requests for oral comments must be sent to Matt McGrath, Pacific Northwest National Scenic Trail Program Manager, 2930 Wetmore Avenue, Suite 3A, Everett, Washington 98201, or by email to [email protected]

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: March 23, 2016. Dianne C. Guidry, Deputy Regional Forester.
    [FR Doc. 2016-07137 Filed 3-29-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Shasta County Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Shasta County Resource Advisory Committee (RAC) will meet in Redding, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act. Additional RAC information, including the meeting agenda and the meeting summary/minutes can be found at the following Web site: www.fs.usda.gov/main/stnf/workingtogether/advisorycommittees.

    DATES:

    The meeting will be held from 9:00 a.m. to 3:00 p.m. on May 3 and 4, 2016.

    All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at USDA Service Center, Shasta-Trinity National Forest Headquarters, 3644 Avtech Parkway, Redding, California.

    Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at USDA Service Center, Shasta-Trinity National Forest Headquarters, 3644 Avtech Parkway, Redding, California. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Lesley Yen, Designated Federal Officer, by phone at 530-275-1587 or via email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to:

    1. Review proposals for Secure Rural Schools Title II funding, and

    2. Vote on proposals to recommend to the Shasta-Trinity National Forest Supervisor for approval.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by May 2, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Lesley Yen, Designated Federal Officer, 14225 Holiday Road, Redding, California 96003; by email to [email protected], or via facsimile to 530-275-1512.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: March 16, 2016. David R. Myers, Shasta-Trinity National Forest Supervisor.
    [FR Doc. 2016-07136 Filed 3-29-16; 8:45 am] BILLING CODE 3411-15-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Kansas Advisory Committee To Review Testimony Regarding Civil Rights and Voting Requirements 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 Kansas Advisory Committee (Committee) will hold a meeting on Friday, April 29, 2016, at 12:00 p.m. CDT for the purpose of reviewing and discussing testimony regarding voting rights in the State.

    This meeting is available to the public through the following toll-free call-in number: 888-587-0615, conference ID: 4700573. Any interested member of the public may call this number and listen to 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. 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.

    Members of the public are invited to make statements at the end of the conference call. In addition, members of the public may submit written comments; the comments must be received in the regional office within 30 days after 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 Administrative Assistant, Corrine Sanders 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 the following link: https://database.faca.gov/committee/meetings.aspx?cid=249. Click on the “Meeting Details” and “Documents” link 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 of Public Testimony on Voting Rights in Kansas Open Comment Adjournment
    DATES:

    The meeting will be held on Friday, April 29, 2016, at 12:00 p.m. CDT.

    Public Call Information: Dial: 888-587-0615; Conference ID: 4700573.

    FOR FURTHER INFORMATION CONTACT:

    Melissa Wojnaroski, DFO, at 312-353-8311 or [email protected]

    Dated: March 25, 2016. David Mussatt, Chief, Regional Programs Unit.
    [FR Doc. 2016-07125 Filed 3-29-16; 8:45 am] BILLING CODE 6335-01-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Oklahoma Advisory Committee To Discuss a Draft Report Regarding the Civil Rights Impact of School Disciplinary Policies That May Contribute to High Rates of Juvenile Incarceration in Oklahoma 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 Oklahoma Advisory Committee (Committee) will hold a meeting on Monday, May 02, 2016, from 12:00-1:00 p.m. CDT for the purpose of discussing a draft report regarding the civil rights impact of the “school to prison pipeline” in Oklahoma.

    Members of the public may listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-389-5988, conference ID: 4893967. Any interested member of the public may call this number and listen to 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.

    Members of the public are also invited to make statements at the end of the conference call. In addition, members of the public may 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 Administrative Assistant, Corrine Sanders 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=269. Clicking 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 Roll Call Discussion of draft Committee Report: “Civil Rights and the School to Prison Pipeline in Oklahoma” • Committee Comments/amendments • Public Comment • Vote for approval Future Projects Open Comment Adjournment DATES:

    The meeting will be held on Monday, May 02, 2016, from 12:00-1:00 p.m. CDT.

    Public Call Information: Dial: 888-389-5988; Conference ID: 4893967.

    FOR FURTHER INFORMATION CONTACT:

    Melissa Wojnaroski, DFO, at 312-353-8311 or [email protected]

    Dated: March 25, 2016. David Mussatt, Chief, Regional Programs Unit.
    [FR Doc. 2016-07126 Filed 3-29-16; 8:45 am] BILLING CODE 6335-01-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-504] Certain Petroleum Wax Candles From the People's Republic of China: Final Results of Expedited Fourth Sunset Review of the Antidumping Duty Order AGENCY:

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

    SUMMARY:

    On December 1, 2015, the Department of Commerce (the “Department”) published the notice of initiation of the first five-year (“sunset”) review of the antidumping duty order on certain petroleum wax candles (“candles”) from the People's Republic of China (“PRC”) pursuant to section 751(c) of the Tariff Act of 1930, as amended (the “Act”).1 As a result of this sunset review, the Department finds that revocation of the antidumping duty order on candles from the PRC would be likely to lead to continuation or recurrence of dumping. The magnitude of the dumping margins likely to prevail is indicated in the “Final Results of Review” section of this notice.

    1See Initiation of Five-Year (“Sunset”) Review, 80 FR 75064 (December 1, 2015).

    DATES:

    Effective Date: March 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Katie Marksberry, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-7906.

    SUPPLEMENTARY INFORMATION:

    Background

    As noted above, on December 1, 2015, the Department published the initiation of the fourth sunset review of candles from the PRC.2 On December 7, 2015, National Candle Association (“NCA”) (“Petitioner”) timely notified the Department of its intent to participate within the deadline specified in 19 CFR 351.218(d)(1)(i), claiming domestic interested party status under section 771(9)(C) of the Act.3 On December 31, 2015, the Department received an adequate substantive response from Petitioner within the deadline specified in 19 CFR 351.218(d)(3)(i).4 We received no responses from respondent interested parties. As a result, the Department conducted an expedited (120-day) sunset review of the order, pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2).

    2Id.

    3See Petitioners' December 7, 2015, submission.

    4See Petitioners' December 31, 2015, submission.

    Scope of the Order

    The products covered by the order are certain scented or unscented petroleum wax candles made from petroleum wax and having fiber or paper-cored wicks. They are sold in the following shapes: Tapers, spirals and straight-sided dinner candles; rounds, columns, pillars, votives; and various wax-filled containers. The products were originally classifiable under the Tariff Schedules of the United States item 755.25, Candles and Tapers. The products are currently classifiable under the Harmonized Tariff Schedule (“HTS”) item number 3406.00.00. The HTS item number is provided for convenience and customs purposes. The written description remains dispositive.

    Analysis of Comments Received

    All issues raised in this sunset review are addressed in the Issues and Decision Memorandum. The issues discussed in the Issues and Decision Memorandum include the likelihood of continuation or recurrence of dumping and the magnitude of the margins likely to prevail if the order were to be revoked. Parties may find a complete discussion of all issues raised in the review and the corresponding recommendations in this public memorandum which 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 7046 of the main Department of Commerce building. In addition, a complete version of the Decision Memorandum can be accessed directly on the Internet at http://enforcement.trade.gov/frn/index.html. The signed and electronic versions of the Issues and Decision Memorandum are identical in content.

    Final Results of Review

    Pursuant to section 752(c) of the Act, the Department determines that revocation of the order would be likely to lead to continuation or recurrence of dumping at weighted-average margins up to 95.86 percent.

    Administrative Protective Order

    This notice also serves as the only reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return of 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 violation which is subject to sanction.

    We are publishing these final results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act.

    Dated: March 17, 2016. Paul Piquado, Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-07186 Filed 3-29-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE442 Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Subsea Cable-Laying Operations in the Bering, Chukchi, and Beaufort Seas AGENCY:

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

    ACTION:

    Notice; proposed incidental harassment authorization; request for comments.

    SUMMARY:

    NMFS has received an application from Quintillion Subsea Operations, LLC (Quintillion) for an Incidental Harassment Authorization (IHA) to take marine mammals, by harassment, incidental to a subsea cable-laying operation in the state and federal waters of the Bering, Chukchi, and Beaufort seas, Alaska, during the open-water season of 2016. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an IHA to Quintillion to incidentally take, by Level B Harassments, marine mammals during the specified activity.

    DATES:

    Comments and information must be received no later than April 29, 2016.

    ADDRESSES:

    Comments on the application should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910. The mailbox address for providing email comments is [email protected] Comments sent via email, including all attachments, must not exceed a 25-megabyte file size. NMFS is not responsible for comments sent to addresses other than those provided here.

    Instructions: All comments received are a part of the public record and will generally be posted to http://www.nmfs.noaa.gov/pr/permits/incidental.htm without change. All Personal Identifying Information (for example, name, address, etc.) voluntarily submitted by the commenter may be publicly accessible. Do not submit Confidential Business Information or otherwise sensitive or protected information.

    An electronic copy of the application may be obtained by writing to the address specified above, telephoning the contact listed below (see FOR FURTHER INFORMATION CONTACT), or visiting the Internet at: http://www.nmfs.noaa.gov/pr/permits/incidental.htm. The following associated documents are also available at the same Internet address: Plan of Cooperation. Documents cited in this notice may also be viewed, by appointment, during regular business hours, at the aforementioned address.

    NMFS is also preparing a draft Environmental Assessment (EA) in accordance with the National Environmental Policy Act (NEPA) and will consider comments submitted in response to this notice as part of that process. The draft EA will be posted at the foregoing internet site.

    FOR FURTHER INFORMATION CONTACT:

    Shane Guan, Office of Protected Resources, NMFS, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    Background

    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

    An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring, and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].

    Summary of Request

    On October 29, 2015, NMFS received an IHA application and marine mammal mitigation and monitoring plan (4MP) from Quintillion for the taking of marine mammals incidental to conducting subsea cable laying activities in the U.S. Bering, Chukchi, and Beaufort seas. After receiving NMFS comments on the initial application, Quintillion made revisions and updated its IHA application and 4MP on February 3, 2016. NMFS determined that the application and the 4MP were adequate and complete on February 5, 2016.

    Quintillion proposes to install a subsea fiber optic network cable along the northern and western coasts of Alaska in the U.S. Bering, Chukchi, and Beaufort seas during the 2016 Arctic open-water season. The proposed activity would occur between June 1 and October 31, 2016. Noise generated from cable vessel's dynamic positioning thruster could impact marine mammals in the vicinity of the activities. Take, by Level B harassments, of individuals of 8 species of marine mammals is proposed to be authorized from the specified activity.

    Description of the Specified Activity Overview

    On October 29, 2015, NMFS received an application from Quintillion requesting an authorization for the harassment of small numbers of marine mammals incidental to subsea cable-laying operations in the Bering, Chukchi, and Beaufort seas off Alaska. After addressing comments from NMFS, Quintillion modified its application and submitted revised applications and 4MP on February 3, 2016. Quintillion's proposed activities discussed here are based on its February 3, 2016, IHA application and 4MP.

    Dates and Duration

    The proposed subsea cable-laying operation is planned for the 2016 open-water season (June 1 to October 31). All associated activities, including mobilization, pre-lay grapnel run (PLGR), cable-laying, post lay inspection and burial (PLIB), and demobilization of survey and support crews, would occur inclusive of the above seasonal dates. It is expected that the operations may last all season (approximately 150 days).

    Specified Geographic Region

    The planned fiber optic cable-laying project will occur in the offshore waters of the Bering, Chukchi, and Beaufort seas between Nome and Oliktok Point (the latter located 260 km [162 mi] southeast of Barrow). The specific area is provided in Figure 1 of Quintillion's IHA application.

    Detailed Description of Activities I. Cable Network

    The proposed subsea cable network is shown in Figure 1 of the IHA application. The cable network includes the main trunk line and six branch lines. The main trunk line is 1,317 km (818 mi) in length, and will run from the tail of the Nome branch line to the tail of the Oliktok Point branch line (Table 1). The branch lines range between 27 km (17 mi) and 233 km (145 mi) long. The branch lines connect to the main trunk line at the branching unit (BU), which is a piece of hardware that allows the interconnection of the branch cable from the main trunk line to the shore end facility. The cable is also “repeatered” in that approximately every 60 km (37 mi) a repeater is attached to the cable that amplifies the signal. Collectively, the cable, BUs, and repeaters make up the “submerged plant.” Depending on bottom substrate, water depth, and distance from shore, the cable would either lay on the ocean floor or will be buried using a plough or a remote operating vehicle (ROV) equipped for burial jetting.

    II. Vessels

    The cable-laying operations will be conducted from two ships, the Ile de Brehat and the Ile de Sein, and a large cable-laying barge. Both ships are 140 m (460 ft) in length, 23 m (77 ft) in breadth, with berths for a crew of 70. The ships are propelled by two 4,000 kW fixed-pitch propellers. Dynamic positioning is maintained by two 1,500 kW bow thrusters, two 1,500 kW aft thrusters, and one 1,500 kW fore thruster.

    Support vessels include a tug and barge that will remain in the vicinity of the main lay vessel. During cable laying activities occurring in nearshore waters too shallow of the Ile de Brehat, the tug and barge (using a dive team) will lay the final shore ends of the cable.

    The branch line segment between Oliktok Point and BU Oliktok crosses a hard seafloor that poses a more unique challenge to burying the cable in the ice scour zone. For this segment the CB Networker, a 60-m (197-ft) powered cable-lay barge, will be used because it includes a vertical injector powerful enough to cut a cable trench through the hard sediments found off Oliktok Point. The CB Networker is also large enough to operate offshore and will lay the full 75 km cable length between Oliktok Point and BU Oliktok.

    Table 1—Cable Network Route Lengths for Each Segment Segment (km) Main Branch lines Oliktok Barrow Wainwright Point Hope Kotzebue Nome Total Route Length 1,317 74 27 31 27 233 195 1,904 III. Pre-Lay Grapnel Run

    Before cable is laid, a pre-lay grapnel run (PLGR) will be carried out along the proposed cable route where burial is required. The objective of the PLGR operation is the identification and clearance of any seabed debris, for example wires, hawsers, wrecks, or fishing gear, which may have been deposited along the route. Any debris recovered during these operations would be discharged ashore on completion of the operations and disposed of in accordance with local regulations. If any debris cannot be recovered, then a local reroute would be planned to avoid the debris. The PLGR operation would be to industry standards employing towed grapnels; the type of grapnel being determined by the nature of the seabed. The PLGR operation would be conducted by a local tug boat ahead of the cable-laying.

    IV. Cable-Laying

    The objective of the surface laying operation is to install the cable as close as possible to the planned route with the correct amount of cable slack to enable the cable to conform to the contours of the seabed without loops or suspensions. A slack plan would be developed that uses direct bathymetric data and a catenary modeling system to control the ship and the cable pay out speeds to ensure the cable is accurately placed in its planned physical position.

    Where the BAS has determined that cable burial is possible, the cable would be buried using various methods. In water depths greater than about 12 m (about 40 ft), the cable would be buried using an SMD Heavy Duty HD3 Plough. The plough has a submerged weight of 25 tonnes (27.6 tons). The plough is pulled by the tow wire and the cable fed through a cable depressor that pushes it into the trench. Burial depth is controlled by adjusting the front skids. The normal tow speed is approximately 600 m/hr (approximately 0.37 mph).

    In water depths less than 12 m (40 ft), burial would be by jet burial using a towed sled, tracked ROV, or by diver jet burial, subject to seabed conditions in the area. The ROV would be used in areas accessible to the main lay vessel. The planned ROV, the ROVJET 400 series, is 5.8 m (19.0 ft) long and 3.4 m (11.2 ft) wide and weighs 9.1 tonnes (10 tons) in air, and has both a main and forward jet tool cable of trenching to 2 m (6.6 ft) depth.

    Nearer to shore, where seasonal ice scouring occurs, the cable with be floated on the surface and then pulled through an existing horizontal directional drilling (HDD) bore pipe to the beach man hole (BMH) where it would be anchor-clamped and spliced to the terrestrial cable. The floated cable portion is then lowered to the seabed by divers and buried (using a post-lay burial method as described above) from the HDD Bore pipe seaward.

    V. Post Lay Inspection and Burial

    While it is expected that the cable trench would fill back in by natural current processes, it is important to ensure that cable splices and BUs are fully buried, and that there are no unnecessary plough skips at locations where burial is critical. To ensure proper burial, a post lay inspection and burial (PLIB) would be conducted using the ROVJET 400 series mentioned above. It is expected that PLIB would be necessary for no more than about 10 km (6.2 mi) of the cumulative planned burial routes.

    Description of Marine Mammals in the Area of the Specified Activity

    The Bering, Chukchi, and Beaufort seas support a diverse assemblage of marine mammals. Table 2 lists the 12 marine mammal species under NMFS jurisdiction with confirmed or possible occurrence in the proposed project area.

    Table 2—Marine Mammal Species With Confirmed or Possible Occurrence in the Proposed Action Area Common name Scientific name Status Occurrence Seasonality Range Abundance Odontocetes: Beluga whale (Beaufort Sea stock) Delphinapterus leucas Common Mostly spring and fall with some in summer Mostly Beaufort Sea 39,258 Beluga whale (eastern Chukchi Sea stock) Common Mostly spring and fall with some in summer Mostly Chukchi Sea 3,710 Beluga whale (eastern Bering Sea stock) Common Year round Bering Sea 19,186 Killer whale (Alaska resident stock) Orcinus orca Occasional/Extralimital Mostly summer and early fall California to Alaska 2,347 Harbor porpoise (Bering Sea stock) Phocoena phocoena Occasional/Extralimital Mostly summer and early fall California to Alaska 48,215 Mysticetes: * Bowhead whale (W. Arctic stock) Balaena mysticetus Endangered; Depleted Common Mostly spring and fall with some in summer Russia to Canada 19,534 Gray whale (E. North Pacific stock) Eschrichtius robustus Somewhat common Mostly summer Mexico to the U.S. Arctic Ocean 20,990 * Fin whale (N. East Pacific) Balaenoptera physalus Endangered; Depleted Rare Mostly summer N.E. Pacific Ocean 1,650 * Humpback whale (Central North Pacific stock) Megaptera novaeangliae Endangered; Depleted Rare Mostly summer North Pacific Ocean 10,103 * Humpback whale (western North Pacific stock) Megaptera novaeangliae Endangered; Depleted Rare Mostly summer North Pacific Ocean 1,107 Pinnipeds: * Bearded seal (Alaska stock) Erigathus barbatus Threatened; Depleted Common Spring and summer Bering, Chukchi, and Beaufort Seas 155,000 * Ringed seal (Alaska stock) Phoca hispida Threatened; Depleted Common Year round Bering, Chukchi, and Beaufort Seas 249,000 Spotted seal (Alaska stock) Phoca largha Common Summer Japan to U.S. Arctic Ocean 460,268 Ribbon seal (Alaska stock) Histriophoca fasciata Occasional Summer Russia to U.S. Arctic Ocean 49,000 * Endangered, threatened, or species of concern under the Endangered Species Act (ESA); Depleted under the MMPA.

    Among these species, bowhead, humpback, and fin whales, and ringed and bearded are listed as endangered or threatened species under the Endangered Species Act (ESA). In addition, walrus and the polar bear could also occur in the Bering, Chukchi, and Beaufort seas; however, these species are managed by the U.S. Fish and Wildlife Service (USFWS) and are not considered in this Notice of Proposed IHA.

    Of all these species, bowhead and beluga whales and ringed, bearded, and spotted seals are the species most frequently sighted in the proposed activity area. The proposed action area in the Bering, Chukchi, and Beaufort seas also includes areas that have been identified as important for bowhead whale reproduction during summer and fall and for beluga whale feeding and reproduction in summer.

    Most bowheads fall migrate through the Alaskan Beaufort in water depths between 15 and 200 m (50 and 656 ft) deep (Miller et al. 2002), with annual variability depending on ice conditions. Hauser et al. (2008) conducted surveys for bowhead whales near the Colville River Delta (near Oliktok Point) during August and September 2008, and found most bowheads between 25 and 30 km (15.5 and 18.6 mi) north of the barrier islands (Jones Islands), with the nearest in 18 m (60 ft) of water about 25 km (16 mi) north of the Colville River Delta. No bowheads were observed inside the 18-m (60-ft) isobath. Most of the cable-lay activity planned for the Beaufort Sea will occur in water deeper than 15 m (50 ft) where migrating bowhead whales could most likely be encountered.

    Three stocks of beluga whale inhabit the waters where cable-lay is planned to occur: Beaufort Sea, Eastern Chukchi Sea, and Eastern Bering Sea (O'Corry-Crowe et al. 1997). All three stocks winter in the open leads and polynyas of the Bering Sea (Hazard 1988). In spring, the Beaufort Sea stock migrates through coastal leads more than 2,000 km (1,200 mi) to their summering grounds in the Mackenzie River delta where they molt, feed, and calve in the warmer estuarine waters (Braham et al. 1977). In late summer, these belugas move into offshore northern waters to feed (Davis and Evans 1982, Harwood et al. 1996, Richard et al. 2001). In the fall, they begin their migration back to their wintering grounds generally following an offshore route as they pass through the western Beaufort Sea (Richard et al. 2001).

    The Beaufort Sea stock beluga whales take a more coastal route during their fall migration, but compared to the vanguard of population and the survey effort expended, nearshore travel appears to be relatively rare. Most belugas recorded during aerial surveys conducted in the Alaskan Beaufort Sea in the last two decades were found more than 65 km (40 mi) from shore (Miller et al. 1999, Funk et al. 2008, Christie et al. 2010, Clarke and Ferguson 2010, Brandon et al. 2011). For the most part, beluga whales from this stock are expected to occur well north of the proposed cable route through the Beaufort Sea at the time of cable-lay activity.

    The Eastern Chukchi Sea beluga whale stock summers in Kotzebue Sound and Kasegaluk Lagoon where they breed and molt, and then in late summer and fall they also move in the Beaufort Sea (Suydam et al. 2005). Suydam et al. (2005) satellite-tagged 23 beluga whales in Kasegaluk Lagoon and found nearly all the whales move into the deeper waters of the Beaufort Sea post-tagging. However, virtually none of the whales were found in continental shelf waters (<200 m deep) of the Beaufort Sea, and all were in waters at least 65 km (40 mi) north of the northern Alaska coastline. The most recent stock estimate is 3,710 animals (Allen and Angliss 2015). The planned cable-lay activity is most likely to encounter this stock whale laying the Kotzebue and Wainwright branch lines, but the routes do avoid the Kasegaluk Lagoon breeding and molting area.

    There is little information on movements of the East Bering stock of beluga whales, although two whales were satellite tagged in 2012 near Nome wintered in Bristol Bay (Allen and Angliss 2015). These whales might be encountered while laying the Nome branch line.

    In addition, a few gray whales are expected to be encountered along the main trunk line route through the north Bering and Chukchi seas. However, they are expected to be commonly observed along the nearshore segments of the branch lines, especially the Wainwright branch where they are commonly found in large feeding groups.

    Three of the ice seal species—ringed, bearded, and spotted seals—are fairly common in the proposed subsea cable laying areas. However, there are no pinnipeds haulouts in the vicinity of the action area.

    Further information on the biology and local distribution of these species can be found in Quintillion's application (see ADDRESSES) and the NMFS Marine Mammal Stock Assessment Reports, which are available online at: http://www.nmfs.noaa.gov/pr/sars/species.htm.

    Potential Effects of the Specified Activity on Marine Mammals

    This section includes a summary and discussion of the ways that the types of stressors associated with the specified activity (e.g., operation of dynamic positioning thrusters) have been observed to or are thought to impact marine mammals. This section may include a discussion of known effects that do not rise to the level of an MMPA take (for example, with acoustics, we may include a discussion of studies that showed animals not reacting at all to sound or exhibiting barely measurable avoidance). The discussion may also include reactions that we consider to rise to the level of a take and those that we do not consider to rise to the level of a take. This section is intended as a background of potential effects and does not consider either the specific manner in which this activity will be carried out or the mitigation that will be implemented or how either of those will shape the anticipated impacts from this specific activity. The “Estimated Take by Incidental Harassment” section later in this document will include a quantitative analysis of the number of individuals that are expected to be taken by this activity. The “Negligible Impact Analysis” section will include the analysis of how this specific activity will impact marine mammals and will consider the content of this section, the “Estimated Take by Incidental Harassment” section, the “Proposed Mitigation” section, and the “Anticipated Effects on Marine Mammal Habitat” section to draw conclusions regarding the likely impacts of this activity on the reproductive success or survivorship of individuals and from that on the affected marine mammal populations or stocks.

    When considering the influence of various kinds of sound on the marine environment, it is necessary to understand that different kinds of marine life are sensitive to different frequencies of sound. Based on available behavioral data, audiograms have been derived using auditory evoked potentials, anatomical modeling, and other data. Southall et al. (2007) designate “functional hearing groups” for marine mammals and estimate the lower and upper frequencies of functional hearing of the groups. The functional groups and the associated frequencies are indicated below (though animals are less sensitive to sounds at the outer edge of their functional range and most sensitive to sounds of frequencies within a smaller range somewhere in the middle of their functional hearing range):

    • Low frequency cetaceans (13 species of mysticetes): Functional hearing is estimated to occur between approximately 7 Hz and 25 kHz;

    • Mid-frequency cetaceans (32 species of dolphins, six species of larger toothed whales, and 19 species of beaked and bottlenose whales): Functional hearing is estimated to occur between approximately 150 Hz and 160 kHz;

    • High frequency cetaceans (eight species of true porpoises, six species of river dolphins, Kogia, the franciscana, and four species of cephalorhynchids): Functional hearing is estimated to occur between approximately 200 Hz and 180 kHz;

    • Phocid pinnipeds (true seals): Functional hearing is estimated between 75 Hz to 100 kHz; and

    • Otariid pinnipeds (sea lions and fur seals): Functional hearing is estimated between 100 Hz to 48 kHz.

    Species found in the vicinity of Quintillion subsea cable-laying operation area include four low-frequency cetacean species (Bowhead whale, gray whale, humpback whale, and fin whale), two mid-frequency cetacean species (beluga whale and killer whale), one high-frequency cetacean species (harbor porpoise), and four pinniped species (ringed seal, spotted seal, bearded seal, and ribbon seal).

    The proposed Quintillion subsea cable-laying operation could adversely affect marine mammal species and stocks by exposing them to elevated noise levels in the vicinity of the activity area.

    Exposure to high intensity sound for a sufficient duration may result in auditory effects such as a noise-induced threshold shift—an increase in the auditory threshold after exposure to noise (Finneran et al., 2005). Factors that influence the amount of threshold shift include the amplitude, duration, frequency content, temporal pattern, and energy distribution of noise exposure. The magnitude of hearing threshold shift normally decreases over time following cessation of the noise exposure. The amount of threshold shift just after exposure is the initial threshold shift. If the threshold shift eventually returns to zero (i.e., the threshold returns to the pre-exposure value), it is a temporary threshold shift (Southall et al., 2007).

    Threshold Shift (noise-induced loss of hearing)—When animals exhibit reduced hearing sensitivity (i.e., sounds must be louder for an animal to detect them) following exposure to an intense sound or sound for long duration, it is referred to as a noise-induced threshold shift (TS). An animal can experience temporary threshold shift (TTS) or permanent threshold shift (PTS). TTS can last from minutes or hours to days (i.e., there is complete recovery), can occur in specific frequency ranges (i.e., an animal might only have a temporary loss of hearing sensitivity between the frequencies of 1 and 10 kHz), and can be of varying amounts (for example, an animal's hearing sensitivity might be reduced initially by only 6 dB or reduced by 30 dB). PTS is permanent, but some recovery is possible. PTS can also occur in a specific frequency range and amount as mentioned above for TTS.

    The following physiological mechanisms are thought to play a role in inducing auditory TS: Effects to sensory hair cells in the inner ear that reduce their sensitivity, modification of the chemical environment within the sensory cells, residual muscular activity in the middle ear, displacement of certain inner ear membranes, increased blood flow, and post-stimulatory reduction in both efferent and sensory neural output (Southall et al., 2007). The amplitude, duration, frequency, temporal pattern, and energy distribution of sound exposure all can affect the amount of associated TS and the frequency range in which it occurs. As amplitude and duration of sound exposure increase, so, generally, does the amount of TS, along with the recovery time. For intermittent sounds, less TS could occur than compared to a continuous exposure with the same energy (some recovery could occur between intermittent exposures depending on the duty cycle between sounds) (Kryter et al., 1966; Ward, 1997). For example, one short but loud (higher SPL) sound exposure may induce the same impairment as one longer but softer sound, which in turn may cause more impairment than a series of several intermittent softer sounds with the same total energy (Ward, 1997). Additionally, though TTS is temporary, prolonged exposure to sounds strong enough to elicit TTS, or shorter-term exposure to sound levels well above the TTS threshold, can cause PTS, at least in terrestrial mammals (Kryter, 1985). Although in the case of Quintillion's subsea cable laying operation, NMFS does not expect that animals would experience levels high enough or durations long enough to result in TS given that the noise levels from the operation are very low.

    For marine mammals, published data are limited to the captive bottlenose dolphin, beluga, harbor porpoise, and Yangtze finless porpoise (Finneran et al., 2000, 2002, 2003, 2005, 2007, 2010a, 2010b; Finneran and Schlundt, 2010; Lucke et al., 2009; Mooney et al., 2009a, 2009b; Popov et al., 2011a, 2011b; Kastelein et al., 2012a; Schlundt et al., 2000; Nachtigall et al., 2003, 2004). For pinnipeds in water, data are limited to measurements of TTS in harbor seals, an elephant seal, and California sea lions (Kastak et al., 1999, 2005; Kastelein et al., 2012b).

    Lucke et al. (2009) found a threshold shift (TS) of a harbor porpoise after exposing it to airgun noise with a received sound pressure level (SPL) at 200.2 dB (peak-to-peak) re: 1 μPa, which corresponds to a sound exposure level of 164.5 dB re: 1 μPa2 s after integrating exposure. NMFS currently uses the root-mean-square (rms) of received SPL at 180 dB and 190 dB re: 1 μPa as the threshold above which permanent threshold shift (PTS) could occur for cetaceans and pinnipeds, respectively. Because the airgun noise is a broadband impulse, one cannot directly determine the equivalent of rms SPL from the reported peak-to-peak SPLs. However, applying a conservative conversion factor of 16 dB for broadband signals from seismic surveys (McCauley, et al., 2000) to correct for the difference between peak-to-peak levels reported in Lucke et al. (2009) and rms SPLs, the rms SPL for TTS would be approximately 184 dB re: 1 μPa, and the received levels associated with PTS (Level A harassment) would be higher. This is still above NMFS' current 180 dB rms re: 1 μPa threshold for injury. However, NMFS recognizes that TTS of harbor porpoises is lower than other cetacean species empirically tested (Finneran & Schlundt, 2010; Finneran et al., 2002; Kastelein and Jennings, 2012).

    Marine mammal hearing plays a critical role in communication with conspecifics, and interpretation of environmental cues for purposes such as predator avoidance and prey capture. Depending on the degree (elevation of threshold in dB), duration (i.e., recovery time), and frequency range of TTS, and the context in which it is experienced, TTS can have effects on marine mammals ranging from discountable to serious (similar to those discussed in auditory masking, below). For example, a marine mammal may be able to readily compensate for a brief, relatively small amount of TTS in a non-critical frequency range that occurs during a time where ambient noise is lower and there are not as many competing sounds present. Alternatively, a larger amount and longer duration of TTS sustained during time when communication is critical for successful mother/calf interactions could have more serious impacts. Also, depending on the degree and frequency range, the effects of PTS on an animal could range in severity, although it is considered generally more serious because it is a permanent condition. Of note, reduced hearing sensitivity as a simple function of aging has been observed in marine mammals, as well as humans and other taxa (Southall et al., 2007), so one can infer that strategies exist for coping with this condition to some degree, though likely not without cost.

    In addition, chronic exposure to excessive, though not high-intensity, noise could cause masking at particular frequencies for marine mammals that utilize sound for vital biological functions (Clark et al. 2009). Acoustic masking is when other noises such as from human sources interfere with animal detection of acoustic signals such as communication calls, echolocation sounds, and environmental sounds important to marine mammals. Therefore, under certain circumstances, marine mammals whose acoustical sensors or environment are being severely masked could also be impaired from maximizing their performance fitness in survival and reproduction.

    Masking occurs at the frequency band which the animals utilize. Therefore, since noise generated from vessels dynamic positioning activity is mostly concentrated at low frequency ranges, it may have less effect on high frequency echolocation sounds by odontocetes (toothed whales). However, lower frequency man-made noises are more likely to affect detection of communication calls and other potentially important natural sounds such as surf and prey noise. It may also affect communication signals when they occur near the noise band and thus reduce the communication space of animals (e.g., Clark et al. 2009) and cause increased stress levels (e.g., Foote et al. 2004; Holt et al. 2009).

    Unlike TS, masking, which can occur over large temporal and spatial scales, can potentially affect the species at population, community, or even ecosystem levels, as well as individual levels. Masking affects both senders and receivers of the signals and could have long-term chronic effects on marine mammal species and populations. Recent science suggests that low frequency ambient sound levels have increased by as much as 20 dB (more than 3 times in terms of sound pressure level) in the world's ocean from pre-industrial periods, and most of these increases are from distant shipping (Hildebrand 2009). All anthropogenic noise sources, such as those from vessel traffic and cable-laying while operating dynamic positioning (DP) thrusters contribute to the elevated ambient noise levels, thus increasing potential for or severity of masking.

    Finally, exposure of marine mammals to certain sounds could lead to behavioral disturbance (Richardson et al. 1995), such as: Changing durations of surfacing and dives, number of blows per surfacing, or moving direction and/or speed; reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior (such as tail/fluke slapping or jaw clapping); avoidance of areas where noise sources are located; and/or flight responses (e.g., pinnipeds flushing into water from haulouts or rookeries).

    The onset of behavioral disturbance from anthropogenic noise depends on both external factors (characteristics of noise sources and their paths) and the receiving animals (hearing, motivation, experience, demography) and is also difficult to predict (Southall et al. 2007). Currently NMFS uses a received level of 160 dB re 1 μPa (rms) to predict the onset of behavioral harassment from impulse noises (such as impact pile driving), and 120 dB re 1 μPa (rms) for continuous noises (such as operating DP thrusters). No impulse noise is expected from the Quintillion subsea cable-laying operation. For the Quintillion subsea cable-laying operation, only the 120 dB re 1 μPa (rms) threshold is considered because only continuous noise sources would be generated.

    The biological significance of many of these behavioral disturbances is difficult to predict, especially if the detected disturbances appear minor. However, the consequences of behavioral modification could be biologically significant if the change affects growth, survival, and/or reproduction, which depends on the severity, duration, and context of the effects.

    Anticipated Effects on Marine Mammal Habitat

    Project activities that could potentially impact marine mammal habitats include acoustical impacts to prey resources associated with laying cable on sea bottom. Regarding the former, however, acoustical injury from thruster noise is unlikely. Previous noise studies (e.g., Greenlaw et al. 1988, Davis et al. 1998, Christian et al. 2004) with cod, crab, and schooling fish found little or no injury to adults, larvae, or eggs when exposed to impulsive noises exceeding 220 dB. Continuous noise levels from ship thrusters are generally below 180 dB, and do not create great enough pressures to cause tissue or organ injury.

    Nedwell et al. (2003) measured noise associated with cable trenching operations offshore of Wales, and found that levels (178 dB at source) did not exceed those where significant avoidance reactions of fish would occur. Cable burial operations involve the use of ploughs or jets to cut trenches in the sea floor sediment. Cable ploughs are generally used where the substrate is cohesive enough to be “cut” and laid alongside the trench long enough for the cable to be laid at depth. In less cohesive substrates, where the sediment would immediately settle back into the trench before the cable could be laid, jetting is used to scour a more lasting furrow. The objective of both is to excavate a temporary trench of sufficient depth to fully bury the cable. The plough blade is 0.2 m (0.7 ft) wide producing a trench of approximately the same width. Jetted trenches are somewhat wider depending on the sediment type. Potential impacts to marine mammal habitat and prey include (1) crushing of benthic and epibenthic invertebrates with the plough blade, plough skid, or ROV track, (2) dislodgement of benthic invertebrates onto the surface where they may die, and (3) and the settlement of suspended sediments away from the trench where they may clog gills or feeding structures of sessile invertebrates or smother sensitive species (BERR 2008). However, the footprint of cable trenching is generally restricted to 2 to 3 m (7-10 ft) width (BERR 2008), and the displaced wedge or berm is expected to naturally backfill into the trench. Jetting results in more suspension of sediments, which may take days to settle during which currents may transport it well away (up to several kilometers) from its source. Suspended sand particles generally settle within about 20 m (66 ft). BERR (2008) reviewed the effect of offshore wind farm construction, including laying of power and communication cables, on the environment. Based on a rating of 1 to 10, they concluded that sediment disturbance from plough operations rated the lowest at 1, with jetting rating from 2 to 4, depending on substrate. Dredging rated the highest (6) relative sediment disturbance.

    The maximum amount of trenching possible is about 1,900 km (1,180 mi), but the width of primary effect is only about 3 m (10 ft). Thus, the maximum impact footprint is less than 6 km2 (2.3 mi2), an insignificantly small area given the Chukchi Sea area alone is 595,000 km2 (230,000 mi2). Overall, cable-laying effects to marine mammal habitat and prey resources are considered not significant.

    Proposed Mitigation

    In order to issue an incidental take authorization (ITA) under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (where relevant).

    For the proposed Quintillion open-water subsea cable-laying operations in the Bering, Chukchi, and Beaufort seas, NMFS worked with Quintillion and its contractor to propose the following mitigation measures to minimize the potential impacts to marine mammals in the project vicinity as a result of the activities. The primary purpose of these mitigation measures is to detect marine mammals and avoid vessel interactions during the pre- and post-cable-laying activities. Due to the nature of the activities, the vessel will not be able to engage direction alternation during cable-laying operations. However, since the cable-laying vessel will be moving at a slow speed of 600 meter/hour (0.37 mile per hour or 0.32 knot) during cable-laying operation, it is highly unlikely that the cable vessel would have physical interaction with marine mammals. The following are mitigation measures proposed to be included in the IHA (if issued).

    (a) Establishing Zone of Influence (ZOI)

    Protected species observers (PSOs) would establish a ZOI where the received level is 120 dB during Qunitillion's subsea cable-laying operation and conduct marine mammal monitoring during the operation.

    (b) Vessel Movement Mitigation During Pre- and Post-Cable-Laying Activities

    When the cable-lay fleet is traveling in Alaskan waters to and from the project area (before and after completion of cable-laying), the fleet vessels would:

    • Not approach concentrations or groups of whales (an aggregation of 6 or more whales) within 1.6 km (1 mi) by all vessels under the direction of Quintillion.

    • Take reasonable precautions to avoid potential interaction with the bowhead whales observed within 1.6 km (1 mi) of a vessel.

    • Reduce speed to less than 5 knots when visibility drops to avoid the likelihood of collision with whales. The normal vessel travel speeds when laying cable is well less than 5 knots.

    Mitigation Conclusions

    NMFS has carefully evaluated Quintillion's proposed mitigation measures and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another:

    • The manner in which, and the degree to which, the successful implementation of the measures are expected to minimize adverse impacts to marine mammals;

    • The proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and

    • The practicability of the measure for applicant implementation.

    Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:

    1. Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).

    2. A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to received levels of activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

    3. A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to received levels of activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

    4. A reduction in the intensity of exposures (either total number or number at biologically important time or location) to received levels of activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing the severity of harassment takes only).

    5. Avoidance or minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.

    6. For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

    Based on our evaluation of the applicant's proposed measures, as well as other measures considered by NMFS, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammals species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance. Proposed measures to ensure availability of such species or stock for taking for certain subsistence uses are discussed later in this document (see “Impact on Availability of Affected Species or Stock for Taking for Subsistence Uses” section).

    Proposed Monitoring and Reporting

    In order to issue an ITA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth, “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for ITAs must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. Quintillion submitted a marine mammal monitoring plan as part of the IHA application. The plan may be modified or supplemented based on comments or new information received from the public during the public comment period or from the peer review panel (see the “Monitoring Plan Peer Review” section later in this document).

    Monitoring measures prescribed by NMFS should accomplish one or more of the following general goals:

    1. An increase in our understanding of the likely occurrence of marine mammal species in the vicinity of the action, i.e., presence, abundance, distribution, and/or density of species.

    2. An increase in our understanding of the nature, scope, or context of the likely exposure of marine mammal species to any of the potential stressor(s) associated with the action (e.g., sound or visual stimuli), through better understanding of one or more of the following: The action itself and its environment (e.g., sound source characterization, propagation, and ambient noise levels); the affected species (e.g., life history or dive pattern); the likely co-occurrence of marine mammal species with the action (in whole or part) associated with specific adverse effects; and/or the likely biological or behavioral context of exposure to the stressor for the marine mammal (e.g., age class of exposed animals or known pupping, calving or feeding areas).

    3. An increase in our understanding of how individual marine mammals respond (behaviorally or physiologically) to the specific stressors associated with the action (in specific contexts, where possible, e.g., at what distance or received level).

    4. An increase in our understanding of how anticipated individual responses, to individual stressors or anticipated combinations of stressors, may impact either: The long-term fitness and survival of an individual; or the population, species, or stock (e.g., through effects on annual rates of recruitment or survival).

    5. An increase in our understanding of how the activity affects marine mammal habitat, such as through effects on prey sources or acoustic habitat (e.g., through characterization of longer-term contributions of multiple sound sources to rising ambient noise levels and assessment of the potential chronic effects on marine mammals).

    6. An increase in understanding of the impacts of the activity on marine mammals in combination with the impacts of other anthropogenic activities or natural factors occurring in the region.

    7. An increase in our understanding of the effectiveness of mitigation and monitoring measures.

    8. An increase in the probability of detecting marine mammals (through improved technology or methodology), both specifically within the safety zone (thus allowing for more effective implementation of the mitigation) and in general, to better achieve the above goals.

    Proposed Monitoring Measures

    Monitoring will provide information on the numbers of marine mammals potentially affected by the subsea cable-laying operation and facilitate real-time mitigation to prevent injury of marine mammals by vessel traffic. These goals will be accomplished in the Bering, Chukchi, and Beaufort seas during 2016 by conducting vessel-based monitoring and passive acoustic monitoring to document marine mammal presence and distribution in the vicinity of the operation area.

    Visual monitoring by Protected Species Observers (PSOs) during subsea cable-laying operation, and periods when the operation is not occurring, will provide information on the numbers of marine mammals potentially affected by the activity. Vessel-based PSOs onboard the vessels will record the numbers and species of marine mammals observed in the area and any observable reaction of marine mammals to the cable-laying operation in the Bering, Chukchi, and Beaufort seas.

    Vessel-Based PSOs

    Vessel-based monitoring for marine mammals would be done by trained protected species observers (PSOs) throughout the period of subsea cable-laying operation. The observers would monitor the occurrence of marine mammals near the cable-laying vessel during all daylight periods during operation. PSO duties would include watching for and identifying marine mammals; recording their numbers, distances, and reactions to the survey operations; and documenting “take by harassment.”

    A sufficient number of PSOs would be required onboard each survey vessel to meet the following criteria:

    • 100% monitoring coverage during all periods of cable-laying operations in daylight;

    • Maximum of 4 consecutive hours on watch per PSO; and

    • Maximum of 12 hours of watch time per day per PSO.

    PSO teams will consist of Inupiat observers and experienced field biologists. Each vessel will have an experienced field crew leader to supervise the PSO team. The total number of PSOs may decrease later in the season as the duration of daylight decreases.

    (1) PSOs Qualification and Training

    Lead PSOs and most PSOs would be individuals with experience as observers during marine mammal monitoring projects in Alaska or other offshore areas in recent years. New or inexperienced PSOs would be paired with an experienced PSO or experienced field biologist so that the quality of marine mammal observations and data recording is kept consistent.

    Resumes for candidate PSOs would be provided to NMFS for review and acceptance of their qualifications. Inupiat observers would be experienced in the region and familiar with the marine mammals of the area. All observers would complete a NMFS-approved observer training course designed to familiarize individuals with monitoring and data collection procedures.

    (2) Specialized Field Equipment

    The PSOs shall be provided with Fujinon 7 × 50 or equivalent binoculars for visual based monitoring onboard all vessels.

    Laser range finders (Leica LRF 1200 laser rangefinder or equivalent) would be available to assist with distance estimation.

    Acoustic Monitoring (1) Sound Source Measurements

    Quintillion plans to conduct a sound source verification (SSV) on one of the cable-lay ships and the anchor-handling tugs when both are operating near Nome (early in the season).

    (2) Passive Acoustic Monitoring

    After consulting with NMFS Office of Protected Resources, the National Marine Mammal Laboratory (NMML), and the North Slope Borough Department of Wildlife, Quintillion proposes to contribute to the 2016 joint Arctic Whale Ecology Study (ARCWEST)/Chukchi Acoustics, Oceanography, and Zooplankton Study-extension (CHAOZ-X).

    The summer minimum extent of sea ice in the northern Bering Sea, Chukchi Sea, and western Beaufort Sea has diminished by more than 50% over the past two decades. This loss of ice has sparked concerns for long-term survival of ice-dependent species like polar bears, Pacific walrus, bearded seals, and ringed seals. In contrast, populations of some Arctic species such has bowhead and gray whales have increased in abundance, while subarctic species such as humpback, fin, and minke whales have expanded their ranges into the Arctic in response to warmer water and increased zooplankton production. The joint ARCWEST/CHAOZ-X program has been monitoring climate change and anthropogenic activity in the Arctic waters of Alaska since 2010 by tracking satellite tagged animals, sampling lower trophic levels and physical oceanography, and passively acoustically monitoring marine mammal and vessel activity. The current mooring locations for the passive acoustical monitoring (PAM) portion of the joint program align closely with the proposed Quintillion cable-lay route. Operating passive acoustic recorders at these locations in 2016 would provide information not only on the distribution and composition of the marine mammal community along the proposed cable-lay route at the time cable-lay activities would be occurring, but they could also record the contribution of the cable-lay activity on local acoustical environment where the route passes close to these stations.

    Monitoring Plan Peer Review

    The MMPA requires that monitoring plans be independently peer reviewed “where the proposed activity may affect the availability of a species or stock for taking for subsistence uses” (16 U.S.C. 1371(a)(5)(D)(ii)(III)). Regarding this requirement, NMFS' implementing regulations state, “Upon receipt of a complete monitoring plan, and at its discretion, [NMFS] will either submit the plan to members of a peer review panel for review or within 60 days of receipt of the proposed monitoring plan, schedule a workshop to review the plan” (50 CFR 216.108(d)).

    NMFS has established an independent peer review panel to review Quintillion's 4MP for the proposed subsea cable-laying operation in the Bering, Chukchi, and Beaufort seas. The panel is scheduled to meet via web conference in early March 2016, and will provide comments to NMFS in April 2016. After completion of the peer review, NMFS will consider all recommendations made by the panel, incorporate appropriate changes into the monitoring requirements of the IHA (if issued), and publish the panel's findings and recommendations in the final IHA notice of issuance or denial document.

    Reporting Measures (1) Final Report

    The results of Quintillion's subsea cable laying activities monitoring reports would be presented in the “90-day” final reports, as required by NMFS under the proposed IHA. The initial final reports are due to NMFS within 90 days after the expiration of the IHA (if issued). The reports will include:

    • Summaries of monitoring effort (e.g., total hours, total distances, and marine mammal distribution through the study period, accounting for sea state and other factors affecting visibility and detectability of marine mammals);

    • Summaries of initial analyses of the datasets that interpret the efficacy, measurements, and observations, rather than raw data, fully processed analyses, or a summary of operations and important observations;

    • Analyses of the effects of various factors influencing detectability of marine mammals (e.g., sea state, number of observers, and fog/glare);

    • Species composition, occurrence, and distribution of marine mammal sightings, including date, water depth, numbers, age/size/gender categories (if determinable), group sizes, and ice cover;

    • Estimates of uncertainty in all take estimates, with uncertainty expressed by the presentation of confidence limits, a minimum-maximum, posterior probability distribution, or another applicable method, with the exact approach to be selected based on the sampling method and data available;

    • A clear comparison of authorized takes and the level of actual estimated takes; and

    • A complete characterization of the acoustic footprint resulting from various activity states.

    The “90-day” reports will be subject to review and comment by NMFS. Any recommendations made by NMFS must be addressed in the final report prior to acceptance by NMFS.

    (2) Notification of Injured or Dead Marine Mammals

    In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by the IHA, such as a serious injury, or mortality (e.g., ship-strike, gear interaction, and/or entanglement), Quintillion would immediately cease the specified activities and immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, and the Alaska Regional Stranding Coordinators. The report would include the following information:

    • Time, date, and location (latitude/longitude) of the incident;

    • Name and type of vessel involved;

    • Vessel's speed during and leading up to the incident;

    • Description of the incident;

    • Status of all sound source use in the 24 hours preceding the incident;

    • Water depth;

    • Environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

    • Description of all marine mammal observations in the 24 hours preceding the incident;

    • Species identification or description of the animal(s) involved;

    • Fate of the animal(s); and

    • Photographs or video footage of the animal(s) (if equipment is available).

    Activities would not resume until NMFS is able to review the circumstances of the prohibited take. NMFS would work with Quintillion to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. Quintillion would not be able to resume its activities until notified by NMFS via letter, email, or telephone.

    In the event that Quintillion discovers a dead marine mammal, and the lead PSO determines that the cause of the death is unknown and the death is relatively recent (i.e., in less than a moderate state of decomposition as described in the next paragraph), Quintillion would immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, and the NMFS Alaska Stranding Hotline and/or by email to the Alaska Regional Stranding Coordinators. The report would include the same information identified in the paragraph above. Activities would be able to continue while NMFS reviews the circumstances of the incident. NMFS would work with Quintillion to determine whether modifications in the activities are appropriate.

    In the event that Quintillion discovers a dead marine mammal, and the lead PSO determines that the death is not associated with or related to the activities authorized in the IHA (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), Quintillion would report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, and the NMFS Alaska Stranding Hotline and/or by email to the Alaska Regional Stranding Coordinators, within 24 hours of the discovery. Quintillion would provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS and the Marine Mammal Stranding Network. Quintillion can continue its operations under such a case.

    Estimated Take by Incidental Harassment

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].

    Takes by Level B harassments of some species are anticipated as a result of Quintillion's proposed subsea cable-laying operation. NMFS expects marine mammal takes could result from noise propagation from dynamic position thrusters during cable-laying operation. NMFS does not expect marine mammals would be taken by collision with cable and support vessels, because the vessels will be moving at low speeds, and PSOs on the vessels will be monitoring for marine mammals and will be able to alert the vessels to avoid any marine mammals in the area.

    For non-impulse sounds, such as those produced by the dynamic positioning thrusters during Quintillion's subsea cable-laying operation, NMFS uses the 180 and 190 dB (rms) re 1 μPa isopleth to indicate the onset of Level A harassment for cetaceans and pinnipeds, respectively; and the 120 dB (rms) re 1 μPa isopleth for Level B harassment of all marine mammals. Quintillion provided calculations of the 120-dB isopleths expected to be produced by the dynamic positioning thrusters during the proposed cable-laying operation to estimate takes by harassment. NMFS used those calculations to make the necessary MMPA findings. Quintillion provided a full description of the methodology used to estimate takes by harassment in its IHA application, which is also provided in the following sections. There is no 180 or 190-dB zone from the proposed activities.

    Noise Sources

    The proposed cable-laying activity is expected to generate underwater noises from several sources, including thrusters, plows, jets, ROVs, echo sounders, and positioning beacons. The predominant noise source and the only underwater noise that is likely to result in take of marine mammals during cable laying operations is the cavitating noise produced by the thrusters during dynamic positioning of the vessel (Tetra Tech 2014). Cavitation is random collapsing of bubbles produced by the blades. The C/S Ile de Brehat maintains dynamic positioning during cable-laying operations by using two 1,500 kW bow thrusters, two 1,500 kW aft thrusters, and one 1,500 kW fore thruster. Sound source measurements have not been conducted specific to the C/S Ile de Brehat but other acoustical studies have shown thruster noise measurements ranging between 171 and 180 dB re 1 μPa (rms) at 1 m (Nedwell et al. 2003, MacGillivary 2006, Samsung 2009, Hartin et al. 2011, Deepwater Wind 2013, Tetra Tech 2014).

    Various acoustical investigations in the Atlantic Ocean have modeled distances to the 120 dB isopleth with results ranging between 1.4 and 3.575 km (Samsung 2009, Deepwater Wind 2013, Tetra Tech 2014) for water depths similar to where Quintillion would be operating in the Arctic Ocean. However, all these ranges were based on conservative modeling that included maximum parameters and worst-case assumptions.

    Hartin et al. (2011) physically measured dynamic positioning noise from the 104-m (341-ft) Fugro Synergy operating in the Chukchi Sea while it was using thrusters (2,500 kW) more powerful than those used on the C/S Ile de Brehat (1,500 kW). Measured dominant frequencies were 110 to 140 Hz, and the measured (90th percentile) radius to the 120-dB isopleth was 2.3 km (1.4 mi). Because this radius is a measured value from the same water body where Quintillion's cable-laying operation would occur, as opposed to a conservatively modeled value from the Atlantic Ocean, it is the value used in calculating marine mammal exposure estimates. Sound source levels from the Fugro Synergy during dynamic positioning did not exceed 180 dB, thus there are no Level A harassment or injury concerns.

    Acoustic Footprint

    The acoustical footprint (total ensonified area) was determined by assuming that dynamic position would occur along all trunk and branch lines within the proposed fiber optics cable network, regardless of the cable-lay vessel used. The sum total of submerged cable length is 1,902.7 km (1,182.3 mi). Assuming that the radius to the 120 dB isopleth is 2.3 km (1.4 mi) (Hartin et al. 2011), then the total ensonified area represents a swath that is 1,902.7 km (1,182.3 mi) in length and 4.6 km (2.8 mi) in width (2 x 2.3 km) or 8,752.4 km2 (3,379.3 mi2). The Nome branch (194.7 km [121.0 mi]) and 87.1 km (54.1 mi) of the trunk line between BU Nome and BU Kotzebue fall within the Bering Sea. The combined length is 281.8 km (175.1 mi) and the total ensonified area is 1,296.3 km2 (500.5 mi2). The Oliktok branch (73.9 km [45.9 mi]) and 254.1 km (157.9 mi) of the trunk line between Barrow and Oliktok are found in the Beaufort Sea. Here the combined length is 328 km (203.8 mi) and total ensonified area is 1,508.8 km2 (582.6 mi2). The remaining area 5,947.3 km2 (2,296.3 mi2) falls within the Chukchi Sea.

    Marine Mammal Densities

    Density estimates for bowhead, gray, and beluga whales were derived from aerial survey data collected in the Chukchi and Beaufort seas during the 2011 to 2013 Aerial Surveys of Arctic Marine Mammals (ASAMM) program (Clarke et al. 2012, 2013, 2014, 2015). The proposed cable routes cross ASAMM survey blocks 2, 11, and 12 in the Beaufort Sea, and blocks 13, 14, 18, 21, and 22 in the Chukchi Sea. Only data collected in these blocks were used to estimate densities for bowhead and gray whales. Beluga densities were derived from ASAMM data collected depth zones between 36 and 50 m (118 and 164 ft) within the Chukchi Sea between longitudes 157° and 169° W., and the depth zones between 21 and 200 m (68.9 and 656.2 ft) in the Beaufort Sea between longitudes 154° and 157° W. These depth zones reflect the depths where most of the cable-lay will occur. Harbor porpoise densities (Chukchi Sea only) are from Hartin et al. (2013), and ringed seal densities from Aerts et al. (2014; Chukchi Sea) and Moulton and Lawson (2002; Beaufort Sea). Spotted and bearded seal densities in the Chukchi Sea are also from Aerts et al. (2014), while spotted and bearded seal densities in the Beaufort Sea were developed by assuming both represented 5% of ringed seal densities. Too few sightings have been made in the Chukchi and Beaufort seas for all other marine mammal species to develop credible density estimates.

    The density estimates for the seven species are presented in Table 3 (Chukchi/Bering) and Table 4 (Beaufort) below. The specific parameters used in deriving these estimates are provided in the discussions that follow.

    Table 3—Marine Mammal Densities (#/km 2) in the Chukchi and Bering Seas Species Summer Fall Bowhead Whale 0.0025 0.0438 Gray Whale 0.0680 0.0230 Beluga Whale 0.0894 0.0632 Harbor Porpoise 0.0022 0.0022 Ringed Seal 0.0846 0.0507 Spotted Seal 0.0423 0.0253 Bearded Seal 0.0630 0.0440 Table 4—Marine Mammal Densities (#/km 2) in the Beaufort Sea Species Summer Fall Bowhead Whale 0.0444 0.0742 Gray Whale 0.0179 0.0524 Beluga Whale 0.0021 0.0142 Ringed Seal 0.3547 0.2510 Spotted Seal 0.0177 0.0125 Bearded Seal 0.0177 0.0125

    Bowhead Whale: The summer density estimate for bowhead whales was derived from June, July, and August aerial survey data collected in the Chukchi and Beaufort Sea during the 2011 to 2014 ASAMM program (Clarke et al. 2012, 2013, 2014, 2015). Fall data were collected during September and October. Data only from the survey blocks that will be crossed by the proposed cable route were used in the calculations, and included blocks 3, 11, and 12 in the Beaufort Sea and 13, 14, 18, 21, and 22 in the Chukchi Sea. ASAMM surveys did not extend more than about 25 km (15.5 mi) south of Point Hope, and there are no other systematic survey data for bowhead whales south of the point. During these three years, 87 bowhead whales were recorded in the three Beaufort Sea blocks during 12,161 km (7,556 mi) of summer survey effort (0.0072/km), and 201 whales during 16,829 km (10,457 mi) of fall effort (0.0019/km). In the five Chukchi Sea survey blocks, 11 bowheads were recorded during 27,183 km (16,891 mi) of summer effort (0.0004/km), and 160 during 22,678 km (14,091 mi) of fall survey (0.0071/km). Applying an effective strip half-width (ESW) of 1.15 (Ferguson and Clarke 2013), and a 0.07 correction factor for whales missed during the surveys, results in corrected densities of 0.0444 (Beaufort summer), 0.0742 (Beaufort fall), 0.0025 (Chukchi summer), and 0.0438 (Chukchi fall) whales per km2 (Tables 3 and 4).

    Gray whale: Gray whale density estimates were derived from the same ASAMM transect data used to determine bowhead whale densities. During the four years of aerial survey, 35 gray whales were recorded in the three Beaufort Sea blocks during 12,161 km (7,557 mi) of summer survey effort (0.0029/km), and 142 gray whales during 16,829 km (10,457 mi) of fall effort (0.0084/km). In the five Chukchi Sea survey blocks, 298 gray whales were recorded during 27,183 km (16,891 mi) of summer effort (0.0084/km), and 84 during 22,678 km (14,091 mi) of fall survey (0.0037/km). Applying an effective strip half-width (ESW) of 1.15 (Ferguson and Clarke 2013), and a correction factor of 0.07, results in corrected densities of 0.0179 (Beaufort summer), 0.0524 (Beaufort fall), 0.0680 (Chukchi summer), and 0.0230 (Chukchi fall) whales per km2 (Tables 3 and 4).

    Beluga Whale: Beluga whale density estimates were derived from the ASAMM transect data collected from 2011 to 2014 (Clarke et al. 2012, 2013, 2014, 2015). During the summer aerial surveys (June-August) there were 248 beluga whale observed along 3,894 km (2,420 mi) of transect in waters between 21 to 200 m (13-124 ft) deep and between longitudes 154° W. and 157° W. This equates to 0.0637 whales/km of trackline and a corrected density of 0.0894 whales per km2, assuming an ESW of 0.614 km and a 0.58 correction factor. Fall density estimates (September-October) for this region were based on 192 beluga whales seen along 4,267 km (2,651 mi). This equates to 0.0449 whales/km of trackline and a corrected density of 0.0632 whales per km2, assuming an ESW of 0.614 km and a 0.58 correction factor.

    During the summer aerial surveys (June-August) there were 30 beluga whale observed along 20,240 km (12,577 mi) of transect in waters less than 36 to 50 m (22-31 ft) deep and between longitudes 157° W. and 169° W. This equates to 0.0015 whales/km of trackline and a corrected density of 0.0021 whales per km2, assuming an ESW of 0.614 km and a 0.58 correction factor. Calculated fall beluga densities for the same region was based on 231 beluga whales seen during 22,887 km of transect (1,794 mi). This equates to 0.0101 whales/km and a corrected density of 0.142 whales per km2, again assuming an ESW of 0.614 km and a 0.58 correction factor.

    Harbor Porpoise: Although harbor porpoise are known to occur in low numbers in the Chukchi Sea (Aerts et al. 2014), no harbor porpoise were positively identified during COMIDA and ASAMM aerial surveys conducted in the Chukchi Sea from 2006 to 2013 (Clarke et al. 2011, 2012, 2013, 2014). A few small unidentified cetaceans that were observed may have been harbor porpoise. Hartin et al. (2013) conducted vessel-based surveys in the Chukchi Sea while monitoring oil and gas activities between 2006 and 2010 and recorded several harbor porpoise throughout the summer and early fall. Vessel-based surveys may be more conducive to sighting these small, cryptic porpoise than the aerial-based COMIDA/ASAMM surveys. Hartin et al.'s (2013) three-year average summer densities (0.0022/km2) and fall densities (0.0021/km2) were very similar, and are included in Table 3.

    Ringed and Spotted Seals: Aerts et al. (2014) conducted a marine mammal monitoring program in the northeastern Chukchi Sea in association with oil & gas exploration activities between 2008 and 2013. For seal sightings that were either ringed or spotted seals, the highest summer density was 0.127 seals/km2 (2008) and the highest fall density was 0.076 seals/km2 (2013). Where seals could be identified to species, they found the ratio of ringed to spotted seals to be 2:1. Applying this ratio to the combined densities results in species densities of 0.0846 seals/km2 (summer) and 0.0507 seals/km2 (fall) for ringed seals, and 0.0423 seals/km2 (summer) and 0.0253 seals/km2 (fall) for spotted seals. These are the densities used in the exposure calculations (Table 3) and to represent ringed and spotted seal densities for both the northern Bering and Chukchi seas.

    Moulton and Lawson (2002) conducted summer shipboard-based surveys for pinnipeds along the nearshore Alaskan Beaufort Sea coast, while the Kingsley (1986) conducted surveys here along the ice margin representing fall conditions. The ringed seal results from these surveys were used in the exposure estimates (Table 3). Neither survey provided a good estimate of spotted seal densities. Green and Negri (2005) and Green et al. (2006, 2007) recorded pinnipeds during barging activity between West Dock and Cape Simpson, and found high numbers of ringed seal in Harrison Bay, and peaks in spotted seal numbers off the Colville River Delta where a haulout site is located. Approximately 5% of all phocid sightings recorded by Green and Negri (2005) and Green et al. (2006, 2007) were spotted seals, which provide a suitable estimate of the proportion of ringed seals versus spotted seals in the Colville River Delta and Harrison Bay, both areas close to the proposed Oliktok branch line. Thus, the estimated densities of spotted seals in the cable-lay survey area were derived by multiplying the ringed seal densities from Moulton and Lawson (2002) and Kingsley (1986) by 5%.

    Spotted seals are a summer resident in the Beaufort Sea and are generally found in nearshore waters, especially in association with haulout sites at or near river mouths. Their summer density in the Beaufort Sea is a function of distance from these haul out sites. Near Oliktok Point (Hauser et al. 2008, Lomac-McNair et al. 2014) where the Oliktok cable branch will reach shore, they are more common than ringed seals, but they are very uncommon farther offshore where most of the Beaufort Sea cable-lay activity will occur. This distribution of density is taken into account in the take authorization request.

    Bearded Seal: The most representative estimates of summer and fall density of bearded seals in the northern Bering and Chukchi seas come from Aerts et al. (2014) monitoring program that ran from 2008 to 2013 in the northeastern Chukchi Sea. During this period the highest summer estimate was 0.063 seals/km2 (2013) and the highest fall estimate was 0.044 seals/km2 (2010). These are the values that were used in developing exposure estimates for this species for the northern Bering and Chukchi sea cable-lay areas (Table 3).

    There are no accurate density estimates for bearded seals in the Beaufort Sea based on survey data. However, Stirling et al. (1982) noted that the proportion of eastern Beaufort Sea bearded seals is 5% that of ringed seals. Further, Clarke et al. (2013, 2014) recorded 82 bearded seals in both the Chukchi and Beaufort seas during the 2012 and 2013 ASAMM surveys, which represented 5.1% of all their ringed seal and small unidentified pinniped sightings (1,586). Bengtson et al. (2005) noted a similar ratio (6%) during spring surveys of ice seals in the Chukchi Sea. Therefore, the density values in Table 3 (/km2) were determined by multiplying ringed seal density from Moulton and Lawson (2002) and Kingsley (1986) by 5% as was done with spotted seals.

    Level B Exposure Calculations

    The estimated potential harassment take of local marine mammals by QSO's fiber optics cable-lay project was determined by multiplying the seasonal animal densities in Tables 3 and 4 with the seasonal area that would be ensonified by thruster noise greater than 120 dB re 1 μPa (rms). The total area that would be ensonified in the Chukchi Sea is 5,947 km2 (2,296 mi2), and for the Bering Sea 1,296 km2 (500 mi2). Since there are no marine mammal density estimates for the northern Bering Sea, the ensonified area was combined with the Chukchi Sea for a total ZOI of 7,243 km2 (2,796 mi2). The ensonified area for the Beaufort Sea is 1,509 km2 (583 mi2).

    Because the cable laying plan is to begin in the south as soon as ice conditions allow and work northward, the intention is to complete the Bering and Chukchi seas portion of the network (1,575 km, [979 mi]) during the summer (June to August), and Beaufort Sea portion (328 km [204 mi]) during the fall (September and October). Thus, summer exposure estimates apply for the Bering and Chukchi areas and the fall exposure estimates for the Beaufort (Table 5).

    Table 5—The Estimated Number of Level B Harassment Exposures to Marine Mammals Species Exposures
  • Bering/Chukchi
  • Exposures
  • Beaufort
  • Exposures
  • total
  • Bowhead Whale 18 112 130 Gray Whale 493 79 572 Beluga Whale 648 21 669 Harbor Porpoise 16 0 16 Ringed Seal 613 379 992 Spotted Seal 306 19 325 Bearded Seal 451 19 470

    The estimated takes of marine mammals are based on the estimated exposures for marine mammals with known density information. For marine mammals whose estimated number of exposures were not calculated due to a lack of reasonably accurate density estimates, but for which occurrence records within the project area exist (i.e., humpback whale, fin whale, minke whale, killer whale, and ribbon seal), a small number of takes relatively based on group size and site fidelity have been requested in case they are encountered. A summary of estimated takes is provided in Table 6.

    Table 6—Level B Take Request as Percentage of Stock Species Stock
  • abundance
  • Level B take requested Request Level B take by stock
  • (percent)
  • Bowhead whale 19,534 130 0.8 Beluga whale (Beaufort Sea stock) 39,258 669 1.7 Beluga whale (E. Chukchi Sea stock) 3,710 669 18.0 Beluga whale (E. Bering Sea stock) 19.186 669 3.5 Gray whale 20,990 572 2.7 Humpback whale (W.N. Pacific stock) 1,107 15 1.36 Humpback whale (Cent. N. Pacific stock) 10,103 15 0.14 Fin whale 1,652 15 0.91 Minke whale 1,233 5 0.40 Killer whale 2,347 5 0.21 Harbor porpoise 48,215 16 0.03 Ringed seal 249,000 992 0.49 Spotted seal 460,268 325 0.07 Bearded seal 155,000 470 0.08 Ribbon seal 61,100 5 0.01

    The estimated Level B takes as a percentage of the marine mammal stock are less than 1.72% in all cases (Table 6). The highest percent of population estimated to be taken is 18% for Level B harassments of the East Chukchi Sea stock of beluga whale. However, that percentage assumes that all beluga whales taken are from that population. Most likely, some beluga whales would be taken from each of the three stocks, meaning fewer than 669 beluga whales would be taken from either individual stock. The Level B takes of beluga whales as a percentage of populations would likely be below 1.7, 18, and 3.5% for the Beaufort Sea, East Chukchi Sea, and East Bering Sea stocks, respectively.

    Analysis and Preliminary Determinations Negligible Impact

    Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of Level B harassment takes, alone, is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through behavioral harassment, NMFS must consider other factors, such as the likely nature of any responses (their intensity, duration, etc.), the context of any responses (critical reproductive time or location, migration, etc.), as well as the number and nature of estimated Level A harassment takes, the number of estimated mortalities, effects on habitat, and the status of the species.

    To avoid repetition, this introductory discussion of our analyses applies to all the species listed in Table 6, given that the anticipated effects of Quintillion's subsea cable-laying operation on marine mammals (taking into account the proposed mitigation) are expected to be relatively similar in nature. Where there are meaningful differences between species or stocks, or groups of species, in anticipated individual responses to activities, impact of expected take on the population due to differences in population status, or impacts on habitat, they are described separately in the analysis below.

    No injuries or mortalities are anticipated to occur as a result of Quintillion's subsea cable-laying operation, and none are authorized. Additionally, animals in the area are not expected to incur hearing impairment (i.e., TTS or PTS) or non-auditory physiological effects. The takes that are anticipated and authorized are expected to be limited to short-term Level B behavioral harassment in the form of brief startling reaction and/or temporary vacating the area.

    Any effects on marine mammals are generally expected to be restricted to avoidance of a limited area around Quintillion's proposed activities and short-term changes in behavior, falling within the MMPA definition of “Level B harassment.” Mitigation measures, such as controlled vessel speed and dedicated marine mammal observers, will ensure that takes are within the level being analyzed. In all cases, the effects are expected to be short-term, with no lasting biological consequence.

    Of the 11 marine mammal species likely to occur in the proposed cable-laying area, bowhead, humpback, and fin whales, and ringed and bearded seals are listed as endangered or threatened under the ESA. These species are also designated as “depleted” under the MMPA. None of the other species that may occur in the project area are listed as threatened or endangered under the ESA or designated as depleted under the MMPA.

    The project area of the Quintillion's proposed activities is within areas that have been identified as biologically important areas (BIAs) for feeding for the gray and bowhead whales and for reproduction for gray whale during the summer and fall months (Clarke et al. 2015). In addition, the coastal Beaufort Sea also serves as a migratory corridor during bowhead whale spring migration, as well as for their feeding and breeding activities. Additionally, the coastal area of Chukchi and Beaufort seas also serve as BIAs for beluga whales for their feeding and migration. However, the Quintillion's proposed cable laying operation would briefly transit through the area in a slow speed (600 meters per hour). As discussed earlier, the Level B behavioral harassment on marine mammals from the proposed activity is expected to be brief startling reaction and temporary vacating of the area. There is no long-term biologically significant impact to marine mammals expected from the proposed subsea cable-laying activity.

    Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS preliminarily finds that the total marine mammal take from Quintillion's proposed subsea cable-laying operation in the Bering, Chukchi, and Beaufort seas is not expected to adversely affect the affected species or stocks through impacts on annual rates of recruitment or survival, and therefore will have a negligible impact on the affected marine mammal species or stocks.

    Small Numbers

    The requested takes represent less than 18% of all populations or stocks potentially impacted (see Table 6 in this document). These take estimates represent the percentage of each species or stock that could be taken by Level B behavioral harassment. The numbers of marine mammals estimated to be taken are small proportions of the total populations of the affected species or stocks.

    Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, NMFS finds that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.

    Impact on Availability of Affected Species for Taking for Subsistence Uses

    The proposed cable-lay activities will occur within the marine subsistence areas used by the villages of Nome, Wales, Kotzebue, Little Diomede, Kivalina, Point Hope, Wainwright, Barrow, and Nuiqsut. Subsistence use various considerably by season and location. Seven of the villages hunt bowhead whales (Suydam and George 2004). The small villages of Wales, Little Diomedes, and Kivalina take a bowhead whale about once every five years. Point Hope and Nuiqsut each harvest three to four whales annually, and Wainwright five to six. Harvest from Barrow is by far the highest with about 25 whales taken each year generally split between spring and fall hunts. Point Hope and Wainwright harvest occurs largely during the spring hunt, and Nuiqsut's during the fall. Nuiqsut whalers base from Cross Island, located 70 km (44 mi) east of Oliktok.

    Beluga are also annually harvested by the above villages. Beluga harvest is most important to Point Hope. For example, the village harvested 84 beluga whales during the spring of 2012, and averaged 31 whales a year from 1987 to 2006 (Frost and Suydam 2010). Beluga are also important to Wainwright villages. They harvested 34 beluga whales in 2012, and averaged 11 annually from 1987 to 2006 (Frost and Suydam 2010). All the other villages—Nome, Kotzebue, Wales, Kivalina, Little Diomede, and Barrow—averaged less than 10 whales a year (Frost and Suydam 2010).

    All villages utilize seals to one degree or another as well. Ringed seal harvest mostly occurs in the winter and spring when they are hauled out on ice near leads or at breathing holes. Bearded seals are taken from boats during the early summer as they migrate northward in the Chukchi Sea and eastward in the Beaufort Sea. Bearded seals are a staple for villages like Kotzebue and Kivalina that have limited access to bowhead and beluga whales (Georgette and Loon 1993). Thetis Island, located just off the Colville River Delta, is an important base from which villagers from Nuiqsut hunt bearded seals each summer after ice breakup. Spotted seals are an important summer resource for Wainwright and Nuiqsut, but other villages will avoid them because the meat is less appealing than other available marine mammals.

    The proposed cable-lay activity will occur in the summer after the spring bowhead and beluga whale hunts have ended, and will avoid the ice period when ringed seals are harvested. The Oliktok branch will pass within 4 km (2 mi) of Thetis Island, but the laying of cable along that branch would occur in late summer or early fall, long after the bearded seal hunt is over. Based on the proposed cable-lay time table relative to the seasonal timing of the various subsistence harvests, cable-lay activities into Kotzebue (bearded seal), Wainwright (beluga whale), and around Point Barrow (bowhead whale) could overlap with important harvest periods. Quintillion will work closely with the AEWC, the Alaska Beluga Whale Committee, the Ice Seal Committee, and the North Slope Borough to minimize any effects cable-lay activities might have on subsistence harvest.

    Plan of Cooperation or Measures To Minimize Impacts to Subsistence Hunts

    Regulations at 50 CFR 216.104(a)(12) require IHA applicants for activities that take place in Arctic waters to provide a Plan of Cooperation (POC) or information that identifies what measures have been taken and/or will be taken to minimize adverse effects on the availability of marine mammals for subsistence purposes.

    Quintillion has prepared a draft POC, which was developed by identifying and evaluating any potential effects the proposed cable-laying operation might have on seasonal abundance that is relied upon for subsistence use.

    Specifically, Quintillion has contracted with Alcatel-Lucent Submarine Networks to furnish and install the cable system. Alcatel-Lucent's vessel, Ile de Brehat, participates in the Automatic Identification System (AIS) vessel tracking system allowing the vessel to be tracked and located in real time. The accuracy and real time availability of AIS information via the web for the Bering, Chukchi, and Beaufort Seas will not be fully known until the vessels are in the project area. If access to the information is limited, Quintillion will provide alternate vessel information to the public on a regular basis. Quintillion can aid and support the AIS data with additional information provided to the local search and rescue, or other source nominated during the community outreach program.

    In addition, Quintillion will communicate closely with the communities of Pt. Hope, Pt. Lay, and Wainwright should activities progress far enough north in late June to mid-July when the villages are still engaged with their annual beluga whale hunt. Quintillion will also communicate closely with the communities of Wainwright, Barrow, and Nuiqsut to minimize impacts on the communities' fall bowhead whale subsistence hunts, which typically occur during late September and into October.

    Prior to starting offshore activities, Quintillion will consult with Kotzebue, Point Hope, Wainwright, Barrow, and Nuiqsut as well as the North Slope Borough, the Northwest Arctic Borough, and other stakeholders such as the EWC, the Alaska Eskimo Whaling Commission (AEWC), the Alaska Beluga Whale Committee (ABWC), and the Alaska Nanuuq Commission (ANC). Quintillion will also engage in consultations with additional groups on request.

    The draft POC is attached to Quintillion's IHA application.

    Endangered Species Act (ESA)

    Within the project area, the bowhead, humpback, and fin whales are listed as endangered and the ringed and bearded seals are listed as threatened under the ESA. NMFS' Permits and Conservation Division has initiated consultation with staff in NMFS' Alaska Region Protected Resources Division under section 7 of the ESA on the issuance of an IHA to Quintillion under section 101(a)(5)(D) of the MMPA for this activity. Consultation will be concluded prior to a determination on the issuance of an IHA.

    National Environmental Policy Act (NEPA)

    NMFS is preparing an Environmental Assessment (EA), pursuant to NEPA, to determine whether the issuance of an IHA to Quintillion for its subsea cable-laying operation in the Bering, Chukchi, and Beaufort seas during the 2016 Arctic open-water season may have a significant impact on the human environment. NMFS has released a draft of the EA for public comment along with this proposed IHA.

    Proposed Authorization

    As a result of these preliminary determinations, NMFS proposes to issue an IHA to Quintillion for subsea cable-laying operation in the Bering, Chukchi, and Beaufort Sea during the 2016 Arctic open-water season, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. The proposed IHA language is provided next.

    This section contains a draft of the IHA itself. The wording contained in this section is proposed for inclusion in the IHA (if issued).

    (1) This Authorization is valid from June 1, 2016, through October 31, 2016.

    (2) This Authorization is valid only for activities associated with subsea cable-laying related activities in the Bering, Chukchi, and Beaufort seas. The specific areas where Quintillion's operations will be conducted are within the Bering, Chukchi, and Beaufort seas, Alaska, as shown in Figure 1 of Quintillion's IHA application.

    (3)(a) The species authorized for incidental harassment takings by Level B harassment are: Beluga whales (Delphinapterus leucas); bowhead whales (Balaena mysticetus); gray whales (Eschrichtius robustus), humpback whale (Megaptera novaeangliae), fin whale (Balaenoptera physalus), killer whale, (Orcinus orca), harbor porpoise (Phocoena phocoena), ringed seal (Phoca hispida), bearded seals (Erignathus barbatus); and spotted seals (Phoca largha) (Table 6).

    (3)(b) The authorization for taking by harassment is limited to the following acoustic sources and from the following activities:

    (i) Operating dynamic positioning thrusters during subsea cable-laying activities; and

    (ii) Vessel activities related to subsea cable-laying activities.

    (3)(c) The taking of any marine mammal in a manner prohibited under this Authorization must be reported within 24 hours of the taking to the Alaska Regional Administrator (907-586-7221) or his designee in Anchorage (907-271-3023), National Marine Fisheries Service (NMFS) and the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, at (301) 427-8401, or her designee (301-427-8418).

    (4) The holder of this Authorization must notify the Chief of the Permits and Conservation Division, Office of Protected Resources, at least 48 hours prior to the start of subsea cable-laying activities (unless constrained by the date of issuance of this Authorization in which case notification shall be made as soon as possible).

    (5) Prohibitions

    (a) The taking, by incidental harassment only, is limited to the species listed under condition 3(a) above and by the numbers listed in Table 6. The taking by serious injury or death of these species or the taking by harassment, injury or death of any other species of marine mammal is prohibited and may result in the modification, suspension, or revocation of this Authorization.

    (b) The taking of any marine mammal is prohibited whenever the required source vessel protected species observers (PSOs), required by condition 7(a)(i), are not onboard in conformance with condition 7(a)(i) of this Authorization.

    (6) Mitigation

    (a) Establishing Disturbance Zones:

    (i) Establish zones of influence (ZOIs) surrounding the cable-laying vessel where the received level would be 120 dB (rms) re 1 µPa. The size of the modeled distance to the 120 dB (rms) re 1 µPa is 2.3 km.

    (ii) Immediately upon completion of data analysis of the field verification measurements required under condition 7(e)(i) below, the new 120 dB (rms) re 1 µPa ZOI shall be established based on the sound source verification.

    (b) Vessel Movement Mitigation:

    (i) When the cable-lay fleet is traveling in Alaskan waters to and from the project area (before and after completion of cable-laying), the fleet vessels would:

    (A) Not approach within 1.6 km (1 m) distance from concentrations or groups of whales (aggregation of six or more whales) by all vessels under the direction of Quintillion.

    (B) Take reasonable precautions to avoid potential interaction with the bowhead whales observed within 1.6 km (1 mi) of a vessel.

    (C) Reduce speed to less than 5 knots when weather conditions require, such as when visibility drops, to avoid the likelihood of collision with whales. The normal vessel travel speeds when laying cable is well less than 5 knots; however vessels laying cable cannot change course and cable-laying operations will not cease until the end of cable is reached.

    (c) Mitigation Measures for Subsistence Activities:

    (i) For the purposes of reducing or eliminating conflicts between subsistence whaling activities and Quintillion's subsea cable-laying program, Quintillion will provide a daily report of all Quintillion activities and locations to the subsistence communities (see reporting below).

    (ii) Quintillion will provide the Alaska Eskimo Whaling Association (Barrow), Kawerak, Inc, (Nome), and Maniilaq Association (Kotzebue) memberships with the Marine Exchange of Alaska so that subsistence communities can track all vessel operations via the vessels' autonomous information system.

    (iii) Quintillion will prepare a daily report of project activities, sea conditions, and subsistence interactions, and send to all interested community leaders.

    (iv) The daily reports will include a contact address and phone number where interested community leaders can convey any subsistence concerns.

    (v) Quintillion shall monitor the positions of all of its vessels and will schedule timing and location of cable-laying segments to avoid any areas where subsistence activity is normally planned.

    (vi) Barge and ship transiting to and from the project area:

    (A) Vessels transiting in the Beaufort Sea east of Bullen Point to the Canadian border shall remain at least 5 miles offshore during transit along the coast, provided ice and sea conditions allow. During transit in the Chukchi Sea, vessels shall remain as far offshore as weather and ice conditions allow, and at all times at least 5 miles offshore.

    (B) From August 31 to October 31, transiting vessels in the Chukchi Sea or Beaufort Sea shall remain at least 20 miles offshore of the coast of Alaska from Icy Cape in the Chukchi Sea to Pitt Point on the east side of Smith Bay in the Beaufort Sea, unless ice conditions or an emergency that threatens the safety of the vessel or crew prevents compliance with this requirement. This condition shall not apply to vessels actively engaged in transit to or from a coastal community to conduct crew changes or logistical support operations.

    (C) Vessels shall be operated at speeds necessary to ensure no physical contact with whales occurs, and to make any other potential conflicts with bowheads or whalers unlikely. Vessel speeds shall be less than 10 knots when within 1.6 kilometers (1 mile) of feeding whales or whale aggregations (6 or more whales in a group).

    (D) If any vessel inadvertently approaches within 1.6 kilometers (1 mile) of observed bowhead whales, except when providing emergency assistance to whalers or in other emergency situations, the vessel operator will take reasonable precautions to avoid potential interaction with the bowhead whales by taking one or more of the following actions, as appropriate:

    • Reducing vessel speed to less than 5 knots within 900 feet of the whale(s);

    • Steering around the whale(s) if possible;

    • Operating the vessel(s) in such a way as to avoid separating members of a group of whales from other members of the group;

    • Operating the vessel(s) to avoid causing a whale to make multiple changes in direction; and

    • Checking the waters immediately adjacent to the vessel(s) to ensure that no whales will be injured when the propellers are engaged.

    (vii) Quintillion shall complete operations in time to ensure that vessels associated with the project complete transit through the Bering Strait to a point south of 59 degrees North latitude no later than November 15, 2016. Any vessel that encounters weather or ice that will prevent compliance with this date shall coordinate its transit through the Bering Strait to a point south of 59 degrees North latitude with the appropriate Com-Centers. Quintillion vessels shall, weather and ice permitting, transit east of St. Lawrence Island and no closer than 10 miles from the shore of St. Lawrence Island.

    (7) Monitoring:

    (a) Vessel-based Visual Monitoring:

    (i) Vessel-based visual monitoring for marine mammals shall be conducted by NMFS-approved protected species observers (PSOs) throughout the period of survey activities.

    (ii) PSOs shall be stationed aboard the cable-laying vessels and the Oliktok cable-laying barge through the duration of the subsea cable-laying operation. PSOs will not be aboard the smaller barge in waters of depths less than 12 m.

    (iii) A sufficient number of PSOs shall be onboard the survey vessel to meet the following criteria:

    (A) 100% Monitoring coverage during all periods of cable-laying operations in daylight;

    (B) Maximum of 4 consecutive hours on watch per PSO, with a minimum 1-hour break between shifts; and

    (C) Maximum of 12 hours of watch time in any 24-hour period per PSO.

    (iv) The vessel-based marine mammal monitoring shall provide the basis for real-time mitigation measures as described in (6)(b) above.

    (b) Protected Species Observers and Training

    (i) PSO teams shall consist of Inupiat observers capable of carrying out requirements of the IHA and NMFS-approved field biologists.

    (ii) Experienced field crew leaders shall supervise the PSO teams in the field. New PSOs shall be paired with experienced observers to avoid situations where lack of experience impairs the quality of observations.

    (iii) Crew leaders and most other biologists serving as observers in 2016 shall be individuals with experience as observers during recent marine mammal monitoring projects in Alaska, the Canadian Beaufort, or other offshore areas in recent years.

    (iv) Resumes for PSO candidates shall be provided to NMFS for review and acceptance of their qualifications. Inupiat observers shall be experienced (as hunters or have previous PSO experience) in the region and familiar with the marine mammals of the area.

    (v) All observers shall complete an observer training course designed to familiarize individuals with monitoring and data collection procedures. The training course shall be completed before the anticipated start of the 2016 open-water season. The training session(s) shall be conducted by qualified marine mammalogists with extensive crew-leader experience during previous vessel-based monitoring programs.

    (vi) Training for both Alaska native PSOs and biologist PSOs shall be conducted at the same time in the same room. There shall not be separate training courses for the different PSOs.

    (vii) Crew members should not be used as primary PSOs because they have other duties and generally do not have the same level of expertise, experience, or training as PSOs, but they could be stationed on the fantail of the vessel to observe the near field, especially the area around the airgun array, and implement a power-down or shutdown if a marine mammal enters the safety zone (or exclusion zone).

    (viii) If crew members are to be used in addition to PSOs, they shall go through some basic training consistent with the functions they will be asked to perform. The best approach would be for crew members and PSOs to go through the same training together.

    (ix) PSOs shall be trained using visual aids (e.g., videos, photos), to help them identify the species that they are likely to encounter in the conditions under which the animals will likely be seen.

    (x) Quintillion shall train its PSOs to follow a scanning schedule that consistently distributes scanning effort appropriate for each type of activity being monitored. All PSOs should follow the same schedule to ensure consistency in their scanning efforts.

    (xi) PSOs shall be trained in documenting the behaviors of marine mammals. PSOs should record the primary behavioral state (i.e., traveling, socializing, feeding, resting, approaching or moving away from vessels) and relative location of the observed marine mammals.

    (c) Marine Mammal Observation Protocol

    (i) PSOs shall watch for marine mammals from the best available vantage point on the survey vessels, typically the bridge.

    (ii) PSOs shall scan systematically with the unaided eye and 7 × 50 reticle binoculars, and night-vision equipment when needed.

    (iii) Personnel on the bridge shall assist the marine mammal observer(s) in watching for marine mammals; however, bridge crew observations will not be used in lieu of PSO observation efforts.

    (iv) Monitoring shall consist of recording of the following information:

    (A) The species, group size, age/size/sex categories (if determinable), the general behavioral activity, heading (if consistent), bearing and distance from vessel, sighting cue, behavioral pace, and apparent reaction of all marine mammals seen near the vessel (e.g., none, avoidance, approach, paralleling, etc.);

    (B) The time, location, heading, speed, and activity of the vessel, along with sea state, visibility, cloud cover and sun glare at (I) any time a marine mammal is sighted, (II) at the start and end of each watch, and (III) during a watch (whenever there is a change in one or more variable);

    (C) The identification of all vessels that are visible within 5 km of the vessel from which observation is conducted whenever a marine mammal is sighted and the time observed;

    (D) Any identifiable marine mammal behavioral response (sighting data should be collected in a manner that will not detract from the PSO's ability to detect marine mammals);

    (E) Any adjustments made to operating procedures; and

    (F) Visibility during observation periods so that total estimates of take can be corrected accordingly.

    (vii) Distances to nearby marine mammals will be estimated with binoculars (7 × 50 binoculars) containing a reticle to measure the vertical angle of the line of sight to the animal relative to the horizon. Observers may use a laser rangefinder to test and improve their abilities for visually estimating distances to objects in the water.

    (viii) PSOs shall understand the importance of classifying marine mammals as “unknown” or “unidentified” if they cannot identify the animals to species with confidence. In those cases, they shall note any information that might aid in the identification of the marine mammal sighted. For example, for an unidentified mysticete whale, the observers should record whether the animal had a dorsal fin.

    (ix) Additional details about unidentified marine mammal sightings, such as “blow only,” mysticete with (or without) a dorsal fin, “seal splash,” etc., shall be recorded.

    (x) Quintillion shall use the best available technology to improve detection capability during periods of fog and other types of inclement weather. Such technology might include night-vision goggles or binoculars as well as other instruments that incorporate infrared technology.

    (d) Field Data-Recording and Verification

    (i) PSOs shall utilize a standardized format to record all marine mammal observations.

    (ii) Information collected during marine mammal observations shall include the following:

    (A) Vessel speed, position, and activity

    (B) Date, time, and location of each marine mammal sighting

    (C) Marine mammal information under (c)(iv)(A)

    (D) Observer's name and contact information

    (E) Weather, visibility, and ice conditions at the time of observation

    (F) Estimated distance of marine mammals at closest approach

    (G) Activity at the time of observation, including possible attractants present

    (H) Animal behavior

    (I) Description of the encounter

    (J) Duration of encounter

    (K) Mitigation action taken

    (iii) Data shall be recorded directly into handheld computers or as a back-up, transferred from hard-copy data sheets into an electronic database.

    (iv) A system for quality control and verification of data shall be facilitated by the pre-season training, supervision by the lead PSOs, and in-season data checks, and shall be built into the software.

    (v) Computerized data validity checks shall also be conducted, and the data shall be managed in such a way that it is easily summarized during and after the field program and transferred into statistical, graphical, or other programs for further processing.

    (e) Passive Acoustic Monitoring

    (i) Sound Source Measurements:

    (a) Using a hydrophone system, the holder of this Authorization is required to conduct sound source verification test for the dynamic positioning thrusters of the cable-laying vessel early in the season.

    (b) The test results shall be reported to NMFS within 5 days of completing the test.

    (ii) Marine Mammal Passive Acoustic Monitoring

    (a) Quintillion would support the 2016 joint Arctic Whale Ecology Study (ARCWEST)/Chukchi Acoustics, Oceanography, and Zooplankton Study-extension (CHAOZ-X).

    (9) Reporting:

    (a) Sound Source Verification Report: A report on the preliminary results of the sound source verification measurements, including the measured source level, shall be submitted within 14 days after collection of those measurements at the start of the field season. This report will specify the distances of the ZOI that were adopted for the survey.

    (b) Technical Report (90-day Report): A draft report will be submitted to the Director, Office of Protected Resources, NMFS, within 90 days after the end of Quintillion's subsea cable-laying operation in the Bering, Chukchi, and Beaufort seas. The report will describe in detail:

    (i) Summaries of monitoring effort (e.g., total hours, total distances, and marine mammal distribution through the project period, accounting for sea state and other factors affecting visibility and detectability of marine mammals);

    (ii) Summaries that represent an initial level of interpretation of the efficacy, measurements, and observations, rather than raw data, fully processed analyses, or a summary of operations and important observations;

    (iii) Analyses of the effects of various factors influencing detectability of marine mammals (e.g., sea state, number of observers, and fog/glare);

    (iv) Species composition, occurrence, and distribution of marine mammal sightings, including date, water depth, numbers, age/size/gender categories (if determinable), group sizes, and ice cover;

    (v) Estimates of uncertainty in all take estimates, with uncertainty expressed by the presentation of confidence limits, a minimum-maximum, posterior probability distribution, or another applicable method, with the exact approach to be selected based on the sampling method and data available; and

    (vi) A clear comparison of authorized takes and the level of actual estimated takes.

    (d) The draft report shall be subject to review and comment by NMFS. Any recommendations made by NMFS must be addressed in the final report prior to acceptance by NMFS. The draft report will be considered the final report for this activity under this Authorization if NMFS has not provided comments and recommendations within 90 days of receipt of the draft report.

    (10)(a) In the unanticipated event that survey operations clearly cause the take of a marine mammal in a manner prohibited by this Authorization, such as a serious injury or mortality (e.g., ship-strike, gear interaction, and/or entanglement), Quintillion shall immediately cease cable-laying operations and immediately report the incident to the Chief, Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401. The report must include the following information:

    (i) Time, date, and location (latitude/longitude) of the incident;

    (ii) The name and type of vessel involved;

    (iii) The vessel's speed during and leading up to the incident;

    (iv) Description of the incident;

    (v) Status of all sound source use in the 24 hours preceding the incident;

    (vi) Water depth;

    (vii) Environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

    (viii) Description of marine mammal observations in the 24 hours preceding the incident;

    (ix) Species identification or description of the animal(s) involved;

    (x) The fate of the animal(s); and

    (xi) Photographs or video footage of the animal (if equipment is available).

    (b) Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS shall work with Quintillion to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. Quintillion may not resume their activities until notified by NMFS via letter, email, or telephone.

    (c) In the event that Quintillion discovers an injured or dead marine mammal, and the lead PSO determines that the cause of the injury or death is unknown and the death is relatively recent (i.e., in less than a moderate state of decomposition as described in the next paragraph), Quintillion will immediately report the incident to the Chief, Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401 and the NMFS Alaska Stranding Hotline (1-877-925-7773). The report must include the same information identified in Condition 10(a) above. Activities may continue while NMFS reviews the circumstances of the incident. NMFS will work with Quintillion to determine whether modifications in the activities are appropriate.

    (d) In the event that Quintillion discovers an injured or dead marine mammal, and the lead PSO determines that the injury or death is not associated with or related to the activities authorized in Condition 3 of this Authorization (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), Quintillion shall report the incident to the Chief, Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401 and the NMFS Alaska Stranding Hotline (1-877-925-7773) within 24 hours of the discovery. Quintillion shall provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS and the Marine Mammal Stranding Network. Quintillion can continue its operations under such a case.

    (11) The Plan of Cooperation outlining the steps that will be taken to cooperate and communicate with the native communities to ensure the availability of marine mammals for subsistence uses, must be implemented.

    (12) This Authorization may be modified, suspended, or withdrawn if the holder fails to abide by the conditions prescribed herein or if the authorized taking is having more than a negligible impact on the species or stock of affected marine mammals, or if there is an unmitigable adverse impact on the availability of such species or stocks for subsistence uses.

    (13) A copy of this Authorization and the Incidental Take Statement must be in the possession of each vessel operator taking marine mammals under the authority of this Incidental Harassment Authorization.

    (14) Quintillion is required to comply with the Terms and Conditions of the Incidental Take Statement corresponding to NMFS' Biological Opinion.

    Request for Public Comments

    NMFS requests comment on our analysis, the draft authorization, and any other aspect of the Notice of Proposed IHA for Quintillion's proposed subsea cable-laying operation in the Bering, Chukchi, and Beaufort seas. Please include with your comments any supporting data or literature citations to help inform our final decision on Quintillion's request for an MMPA authorization.

    Dated: March 24, 2016. Donna S. Wieting, Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-07109 Filed 3-29-16; 8:45 am] BILLING CODE 3510-22-P
    COMMODITY FUTURES TRADING COMMISSION Market Risk Advisory Committee AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Commodity Futures Trading Commission (CFTC) announces that on April 26, 2016, from 10:00 a.m. to 1:30 p.m., the Market Risk Advisory Committee (MRAC) will hold a public meeting at the CFTC's Washington, DC, headquarters. The MRAC will describe and discuss how well the derivatives markets are currently functioning, including the impact and implications of the evolving structure of these markets on the movement of risk across market participants. Specific topics to be covered are listed in this Notice.

    DATES:

    The meeting will be held on April 26, 2016, from 10:00 a.m. to 1:30 p.m. Members of the public who wish to submit written statements in connection with the meeting should submit them by May 10, 2016.

    ADDRESSES:

    The meeting will take place in the Conference Center at the CFTC's headquarters, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581. Written statements should be submitted by mail to: Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581, attention: Secretary of the Commission; or by electronic mail to: [email protected] Please use the title “Market Risk Advisory Committee” in any written statement you submit. Any statements submitted in connection with the committee meeting will be made available to the public, including by publication on the CFTC Web site, www.cftc.gov.

    FOR FURTHER INFORMATION CONTACT:

    Petal Walker, MRAC Designated Federal Officer, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581; (202) 418-5794.

    SUPPLEMENTARY INFORMATION:

    The MRAC will describe and discuss how well the derivatives markets are currently functioning, including the impact and implications of the evolving structure of these markets on the movement of risk across market participants. Specifically, the MRAC will describe and discuss:

    (a) How effectively end-users and other market participants, in different asset classes (e.g., energy, rates), are able to find counterparties for transactions, receive accurate pricing and volume information, and otherwise access the markets; and

    (b) The extent and nature of the current use of portfolio compression and related services, and the benefits and challenges posed by portfolio compression activity in the derivatives markets.

    The meeting will be open to the public with seating on a first-come, first-served basis. Members of the public may also listen to the meeting by telephone by calling a domestic toll-free telephone or international toll or toll-free number to connect to a live, listen-only audio feed. Call-in participants should be prepared to provide their first name, last name, and affiliation.

    Domestic Toll Free: 1-866-844-9416.

    International Toll and Toll Free: Will be posted on the CFTC's Web site, www.cftc.gov, on the page for the meeting, under Related Documents.

    Pass Code/Pin Code: CFTC.

    After the meeting, a transcript of the meeting will be published through a link on the CFTC's Web site, www.cftc.gov. All written submissions provided to the CFTC in any form will also be published on the CFTC's Web site. Persons requiring special accommodations to attend the meeting because of a disability should notify the contact person listed in this Notice.

    Authority:

    5 U.S.C. app. 2 § 10(a)(2)).

    Dated: March 25, 2016. Christopher J. Kirkpatrick, Secretary of the Commission.
    [FR Doc. 2016-07131 Filed 3-29-16; 8:45 am] BILLING CODE 6351-01-P
    CONSUMER PRODUCT SAFETY COMMISSION [CPSC Docket No. 16-C0002] Gree Electric Appliances, Inc. of Zhuhai, Hong Kong Gree Electric Appliances Sales Co., Ltd., and Gree USA Sales, Ltd., Provisional Acceptance of a Settlement Agreement and Order AGENCY:

    Consumer Product Safety Commission.

    ACTION:

    Notice.

    SUMMARY:

    It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally-accepted Settlement Agreement with Gree Electric Appliances, Inc. of Zhuhai, Hong Kong Gree Electric Appliances Sales Co., Ltd., and Gree USA Sales, Ltd. containing a civil penalty in the amount of fifteen million four hundred fifty thousand dollars (US$15,450,000) within thirty (30) days of service of the Commission's final Order accepting the Settlement Agreement.1

    1 The Commission voted (4-1) to provisionally accept the Settlement Agreement and Order regarding Gree Electric Appliances, Inc. of Zhuhai, Hong Kong Gree Electric Appliances Sales Co., Ltd., and Gree USA Sales, Ltd. Chairman Kaye, Commissioner Adler, Commissioner Robinson and Commissioner Mohorovic voted to provisionally accept the Settlement Agreement and Order. Commissioner Buerkle voted to reject the Settlement Agreement and Order. Commissioner Mohorovic and Commissioner Robinson filed statements regarding this matter. The statements are available at the Office of the Secretary or the CPSC Web site, www.cpsc.gov.

    DATES:

    Any interested person may ask the Commission not to accept this agreement or otherwise comment on its contents by filing a written request with the Office of the Secretary by April 14, 2016.

    ADDRESSES:

    Persons wishing to comment on this Settlement Agreement should send written comments to the Comment 16-C0002, Office of the Secretary, Consumer Product Safety Commission, 4330 East West Highway, Room 820, Bethesda, Maryland 20814-4408.

    FOR FURTHER INFORMATION CONTACT:

    Daniel R. Vice, Trial Attorney, Division of Compliance, Office of the General Counsel, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, Maryland 20814-4408; telephone (301) 504-6996.

    SUPPLEMENTARY INFORMATION:

    The text of the Agreement and Order appears below.

    Dated: March 25, 2016. Todd A. Stevenson, Secretary. UNITED STATES OF AMERICA CONSUMER PRODUCT SAFETY COMMISSION In the Matter of: GREE ELECTRIC APPLIANCES, INC., OF ZHUHAI, HONG KONG GREE ELECTRIC APPLIANCES SALES CO., LTD., AND GREE USA SALES, LTD. CPSC Docket No.: 16-C0002 SETTLEMENT AGREEMENT

    1. In accordance with the Consumer Product Safety Act, 15 U.S.C. 2051-2089 (“CPSA”) and 16 CFR 1118.20, Gree Electric Appliances, Inc., of Zhuhai, Hong Kong Gree Electric Appliances Sales Co., Ltd., and Gree USA Sales, Ltd. (collectively “Gree”), and the United States Consumer Product Safety Commission (“Commission”), through its staff, hereby enter into this Settlement Agreement (“Agreement”). The Agreement, and the incorporated attached Order, resolve staff's charges that Gree is subject to civil penalties in this matter, under section 20 of the CPSA, 15 U.S.C. 2069, as set forth below.

    THE PARTIES

    2. The Commission is an independent federal regulatory agency, established pursuant to, and responsible for the enforcement of, the CPSA, 15 U.S.C. 2051-2089. By executing the Agreement, staff is acting on behalf of the Commission, pursuant to 16 CFR 1118.20(b). The Commission issues the Order under the provisions of the CPSA.

    3. Gree Electric Appliances, Inc., of Zhuhai, is incorporated in China, and its principal place of business is in China. Hong Kong Gree Electric Appliances Sales Co., Ltd., is incorporated in Hong Kong, and its principal place of business is in Hong Kong. Gree USA Sales, Ltd., is incorporated in California, and its principal place of business is in City of Industry, CA.

    STAFF CHARGES

    4. Between January 2005 and August 2013, Gree manufactured, imported, and sold approximately 2.5 million dehumidifiers manufactured before December 2012 (“Dehumidifiers”) in the United States.

    5. The Dehumidifiers are a “consumer product” that was “distributed in commerce,” as those terms are defined or used in sections 3(a)(5) and (8) of the CPSA, 15 U.S.C. 2052(a)(5) and (8). Gree was a “manufacturer” and “distributor” of the Dehumidifiers, as such terms are defined in sections 3(a)(7) and (11) of the CPSA, 15 U.S.C. 2052(a)(7) and (11).

    Violation of CPSA Section 19(a)(4)

    6. The Dehumidifiers are defective and create an unreasonable risk of serious injury or death because they can overheat, smoke and catch fire, posing smoke and burn hazards to consumers.

    7. In July 2012, Gree began receiving reports of smoking, sparking and fires involving the Dehumidifiers. Gree received reports of property damage due to these fires.

    8. In response to reports of smoking, sparking and fires, Gree implemented design changes to remedy the defect and unreasonable risk of injury or death associated with the Dehumidifiers.

    9. Despite having information reasonably supporting the conclusion of a defect or the creation of an unreasonable risk of serious injury or death associated with the Dehumidifiers, Gree did not notify the Commission immediately of such defect or risk, as required by sections 15(b)(3) and (4) of the CPSA, 15 U.S.C. 2064(b)(3) and (4).

    10. Because the information in Gree's possession constituted actual and presumed knowledge, Gree knowingly violated section 19(a)(4) of the CPSA, 15 U.S.C. 2068(a)(4), as the term “knowingly” is defined in section 20(d) of the CPSA, 15 U.S.C. 2069(d).

    Violation of CPSA Section 19(a)(12)

    11. Although Gree knew that the Dehumidifiers were not compliant with UL flammability standards, Gree sold, offered for sale, distributed in commerce, and imported the Dehumidifiers bearing the UL mark.

    12. The UL mark is a registered safety certification mark owned by UL, which is an accredited conformity assessment body.

    13. Because Gree knew, or should have known, that the sale, offer for sale, distribution, and importation of Dehumidifiers that were not compliant with UL standards was not authorized by UL, Gree knowingly violated section 19(a)(12) of the CPSA, 15 U.S.C. 2068(a)(12), as the term “knowingly” is defined in section 20(d) of the CPSA, 15 U.S.C. 2069(d).

    Violation of CPSA Section 19(a)(13)

    14. Gree made material misrepresentations to Commission staff that the Dehumidifiers met UL flammability standards, knowing such representations to be false.

    15. Gree also made material misrepresentations to Commission staff concerning the date when Gree became aware that the Dehumidifiers were not compliant with UL standards, knowing such representations to be false.

    16. By knowingly making material misrepresentations to Commission staff during the course of an investigation, Gree knowingly violated section 19(a)(13) of the CPSA, 15 U.S.C. 2068(a)(13), as the term “knowingly” is defined in section 20(d) of the CPSA, 15 U.S.C. 2069(d).

    Civil Penalties Pursuant to CPSA Section 20

    17. Pursuant to section 20 of the CPSA, 15 U.S.C. 2069, Gree is subject to civil penalties for its knowing violations of sections 19(a)(4), (12), and (13) of the CPSA, 15 U.S.C. 2068(a)(4), (12) and (13).

    RESPONSE OF GREE

    18. The signing of this Agreement does not constitute an admission by Gree that either reportable information or a substantial product hazard exists.

    19. Gree enters into this Agreement to settle this matter without the delay and expense of litigation. Gree enters into this Agreement and agrees to pay the amount referenced below in compromise of the staff's charges.

    20. Gree voluntarily notified the Commission in connection with the dehumidifiers in March 2013. Gree carried out a voluntary recall in cooperation with the Commission and acted to reduce the potential risk of injury.

    AGREEMENT OF THE PARTIES

    21. Gree submits to the jurisdiction of the Commission in the matter involving the Dehumidifiers.

    22. The parties enter into the Agreement for settlement purposes only. The Agreement does not constitute an admission by Gree or a determination by the Commission that Gree violated the CPSA's reporting requirements.

    23. In settlement of staff's charges, and to avoid the cost, distraction, delay, uncertainty, and inconvenience of protracted litigation, Gree shall pay a civil penalty in the amount of fifteen million four hundred fifty thousand dollars (US$15,450,000) within thirty (30) calendar days after receiving service of the Commission's final Order accepting the Agreement. All payments to be made under the Agreement shall constitute debts owing to the United States and shall be made by electronic wire transfer to the United States via: http://www.pay.gov for allocation to and credit against the payment obligations of Gree under this Agreement. Failure to make such payment by the date specified in the Commission's final Order shall constitute Default.

    24. All unpaid amounts, if any, due and owing under the Agreement shall constitute a debt due and immediately owing by Gree to the United States, and interest shall accrue and be paid by Gree at the federal legal rate of interest set forth at 28 U.S.C. 1961(a) and (b) from the date of Default until all amounts due have been paid in full (hereinafter “Default Payment Amount” and “Default Interest Balance”). Gree shall consent to a Consent Judgment in the amount of the Default Payment Amount and Default Interest Balance, and the United States, at its sole option, may collect the entire Default Payment Amount and Default Interest Balance or exercise any other rights granted by law or in equity, including but not limited to referring such matters for private collection, and Gree agrees not to contest, and hereby waives and discharges any defenses to, any collection action undertaken by the United States or its agents or contractors pursuant to this paragraph. Gree shall pay the United States all reasonable costs of collection and enforcement under this paragraph, respectively, including reasonable attorney's fees and expenses.

    25. After staff receives this Agreement executed on behalf of Gree, staff shall promptly submit the Agreement to the Commission for provisional acceptance. Promptly following provisional acceptance of the Agreement by the Commission, the Agreement shall be placed on the public record and published in the Federal Register, in accordance with the procedures set forth in 16 CFR 1118.20(e). If the Commission does not receive any written request not to accept the Agreement within fifteen (15) calendar days, the Agreement shall be deemed finally accepted on the 16th calendar day after the date the Agreement is published in the Federal Register, in accordance with 16 CFR 1118.20(f).

    26. This Agreement is conditioned upon, and subject to, the Commission's final acceptance, as set forth above, and it is subject to the provisions of 16 CFR 1118.20(h). Upon the later of: (i) Commission's final acceptance of this Agreement and service of the accepted Agreement upon Gree, and (ii) the date of issuance of the final Order, this Agreement shall be in full force and effect and shall be binding upon the parties.

    27. Effective upon the later of: (i) the Commission's final acceptance of the Agreement and service of the accepted Agreement upon Gree, and (ii) and the date of issuance of the final Order, for good and valuable consideration, Gree hereby expressly and irrevocably waives and agrees not to assert any past, present, or future rights to the following, in connection with the matter described in this Agreement: (i) an administrative or judicial hearing; (ii) judicial review or other challenge or contest of the Commission's actions; (iii) a determination by the Commission of whether Gree failed to comply with the CPSA and the underlying regulations; (iv) a statement of findings of fact and conclusions of law; and (v) any claims under the Equal Access to Justice Act.

    28. Gree shall implement and maintain a compliance program designed to ensure compliance with the CPSA and regulations enforced by the Commission with respect to any consumer product manufactured, imported, distributed, or sold by Gree, and which, at a minimum, shall contain the following elements:

    a. written standards and policies;

    b. written procedures that provide for the appropriate forwarding to compliance personnel of all information that may relate to, or impact, CPSA compliance, including all reports and complaints involving consumer products, whether an injury is referenced or not;

    c. a mechanism for confidential employee reporting of compliance-related questions or concerns to either a compliance officer or to another senior manager with authority to act as necessary;

    d. effective communication of company compliance-related policies and procedures regarding the CPSA to all applicable employees through training programs or otherwise;

    e. Gree senior management responsibility for CPSA compliance and accountability for violations of the statutes and regulations enforced by the Commission;

    f. Gree governing body oversight of CPSA compliance; and

    g. retention of all CPSA compliance-related records for at least five (5) years, and availability of such records to staff upon reasonable request.

    29. Gree shall implement, maintain, and enforce a system of internal controls and procedures designed to ensure that, with respect to all consumer products manufactured, imported, distributed, or sold by Gree:

    a. information required to be disclosed by Gree to the Commission is recorded, processed, and reported in accordance with applicable law;

    b. all reporting made to the Commission is timely, truthful, complete, accurate, and in accordance with applicable law; and

    c. prompt disclosure is made to Gree's management of any significant deficiencies or material weaknesses in the design or operation of such internal controls that are reasonably likely to affect adversely, in any material respect, Gree's ability to record, process, and report to the Commission in accordance with applicable law.

    30. Upon reasonable request of staff, Gree shall provide written documentation of its improvements, processes and controls, including, but not limited to, the effective dates of such improvements, processes and controls as set forth in paragraphs 28 through 29 above. Upon reasonable request, Gree shall cooperate fully and truthfully with staff and shall make available, in a manner agreed to by the parties, all non-privileged information and materials, and personnel deemed necessary by staff to evaluate Gree's compliance with the terms of the Agreement.

    31. The parties acknowledge and agree that the Commission may publicize the terms of the Agreement and the Order.

    32. Gree represents that the Agreement: (i) is entered into freely and voluntarily, without any degree of duress or compulsion whatsoever; (ii) has been duly authorized; and (iii) constitutes the valid and binding obligation of Gree, enforceable against Gree in accordance with its terms. Gree will not directly or indirectly receive any reimbursement, indemnification, insurance-related payment, or other payment in connection with the civil penalty to be paid by Gree pursuant to the Agreement and Order. The individuals signing the Agreement on behalf of Gree represent and warrant that they are duly authorized by Gree to execute the Agreement.

    33. The signatories represent that they are authorized to execute this Agreement.

    34. The Agreement is governed by the laws of the United States.

    35. The Agreement and the Order shall apply to, and be binding upon, Gree and each of its successors, transferees, and assigns, and a violation of the Agreement or Order may subject Gree, and each of its successors, transferees, and assigns, to appropriate legal action.

    36. Nothing herein shall preclude the Commission from initiating any other proceedings to enforce the Order.

    37. The Agreement and the Order constitute the complete agreement between the parties on the subject matter contained therein.

    38. The Agreement may be used in interpreting the Order. Understandings, agreements, representations, or interpretations apart from those contained in the Agreement and the Order may not be used to vary or contradict their terms. For purposes of construction, the Agreement shall be deemed to have been drafted by both of the parties and shall not, therefore, be construed against any party for that reason in any subsequent dispute.

    39. The Agreement may not be waived, amended, modified, or otherwise altered, except as in accordance with the provisions of 16 CFR 1118.20(h). The Agreement may be executed in counterparts.

    40. If any provision of the Agreement or the Order is held to be illegal, invalid, or unenforceable under present or future laws effective during the terms of the Agreement and the Order, such provision shall be fully severable. The balance of the Agreement and the Order shall remain in full force and effect, unless the Commission and Gree agree in writing that severing the provision materially affects the purpose of the Agreement and the Order.

    GREE ELECTRIC APPLIANCES, INC., OF ZHUHAI, HONG KONG GREE ELECTRIC APPLIANCES SALES CO., LTD., AND GREE USA SALES, LTD. Dated: March 12, 2016 By: Li Mingjing Counsel, Securities and Legal Affairs Department, Gree Electric Appliances, Inc., of Zhuhai, Hong Kong Gree Electric Appliances Sales Co., Ltd., and Gree USA Sales, Ltd. Dated: March 14, 2016 By: Ellen Nudelman Adler Morrison and Foerster LLP 12531 High Bluff Drive San Diego, CA 92130-2040 Counsel to Gree Electric Appliances, Inc., of Zhuhai, Hong Kong Gree Electric Appliances Sales Co., Ltd., and Gree USA Sales, Ltd. U.S. CONSUMER PRODUCT SAFETY COMMISSION Stephanie Tsacoumis General Counsel Mary T. Boyle Deputy General Counsel Mary B. Murphy Assistant General Counsel Dated: March 14, 2016 By: Daniel R. Vice Trial Attorney, Division of Compliance, Office of the General Counsel UNITED STATES OF AMERICA CONSUMER PRODUCT SAFETY COMMISSION In the Matter of: GREE ELECTRIC APPLIANCES, INC., OF ZHUHAI, HONG KONG GREE ELECTRIC APPLIANCES SALES CO., LTD., AND GREE USA SALES, LTD. CPSC Docket No.: 16-C0002 ORDER

    Upon consideration of the Settlement Agreement entered into between Gree Electric Appliances, Inc. of Zhuhai, Hong Kong Gree Electric Appliances Sales Co., Ltd., and Gree USA Sales, Ltd. (collectively “Gree”), and the U.S. Consumer Product Safety Commission (“Commission”), and Gree having submitted to the jurisdiction of the Commission with respect to the subject matter, and it appearing that the Settlement Agreement and the Order are in the public interest, it is:

    ORDERED that the Settlement Agreement be, and is, hereby, accepted; and it is

    FURTHER ORDERED that Gree shall comply with the terms of the Settlement Agreement and shall pay a civil penalty in the amount of fifteen million four hundred fifty thousand dollars (US$15,450,000) within thirty (30) days after service of the Commission's final Order accepting the Settlement Agreement. The payment shall be made by electronic wire transfer to the Commission via: http://www.pay.gov. Upon the failure of Gree to make the foregoing payment when due, interest on the unpaid amount shall accrue and be paid by Gree at the federal legal rate of interest set forth at 28 U.S.C. 1961(a) and (b). If Gree fails to make such payment or to comply in full with any other provision of the Settlement Agreement, such conduct will be considered a violation of the Settlement Agreement and Order.

    Provisionally accepted and provisional Order issued on the 25th day of March, 2016.

    BY ORDER OF THE COMMISSION:

    Todd A. Stevenson, Secretary U.S. Consumer Product Safety Commission
    [FR Doc. 2016-07124 Filed 3-29-16; 8:45 am] BILLING CODE 6355-01-P
    CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Proposed Information Collection; Comment Request AGENCY:

    Corporation for National and Community Service.

    ACTION:

    Notice.

    SUMMARY:

    The Corporation for National and Community Service (CNCS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. Sec. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirement on respondents can be properly assessed.

    Currently, CNCS is soliciting comments concerning its proposed AmeriCorps NCCC's (National Civilian Community Corps) Member Experience Survey. This survey was developed to support NCCC performance measurement for use in program development, funding, and evaluation. The survey instrument will be completed by NCCC Members following the completion of their service term. In particular, this survey will be administered to NCCC Members who are exiting early or have already exited early from the AmeriCorps NCCC program. Completion of this information collection is not required for the completion of a service term with NCCC.

    Copies of the information collection request can be obtained by contacting the office listed in the Addresses section of this Notice.

    DATES:

    Written comments must be submitted to the individual and office listed in the ADDRESSES section by May 31, 2016.

    ADDRESSES:

    You may submit comments, identified by the title of the information collection activity, by any of the following methods:

    (1) By mail sent to: Corporation for National and Community Service, National Civilian Community Corps; Attention Barbara Lane, Director Projects and Partnerships, Room 3240, 250 E. Street SW., Washington, DC 20525.

    (2) By hand delivery or by courier to the CNCS mailroom at Room 4200 at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday, except federal holidays.

    (3) Electronically through www.regulations.gov.

    Individuals who use a telecommunications device for the deaf (TTY-TDD) may call 1-800-833-3722 between 8:00 a.m. and 8:00 p.m. Eastern Time, Monday through Friday.

    FOR FURTHER INFORMATION CONTACT:

    Barbara Lane, 202-606-6867, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    CNCS is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are expected to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (e.g., permitting electronic submissions of responses).

    Background

    This information collection serves as part of an overall AmeriCorps NCCC logic model to help measure the degree to which the program is addressing the statuary areas of national and community needs in a way that strengthens communities and builds leaders. The survey will be administered electronically to all members departing early from the program.

    Current Action

    This is a new information collection request. The NCCC Member Experience Survey consists of between 29 and 30 questions, depending on which responses the respondents specify. All Members departing early from AmeriCorps NCC will receive their survey as a single instrument. Each NCCC Member will receive an individual survey. The exact same survey, not part of this information collection request, is administered to all graduating Members while they are in service and closed for completion prior to the completion of the program.

    Type of Review: New.

    Agency: Corporation for National and Community Service.

    Title: NCCC Member Experience Survey.

    OMB Number: None.

    Agency Number: None.

    Affected Public: The NCCC Member Experience Survey will be administered to the former NCCC Member for their most recent NCCC service term. These Members will have served with AmeriCorps NCCC for any length of time, without graduating. There are approximately 400 Members that depart the program early each year. The early exiting and former Members are uniquely able to provide the information sought in the NCCC Member Experience Survey.

    Total Respondents: Based on the number of Members who have departed the program early over the last five annual years, NCCC expects to administer 450 surveys each fiscal year to Members who departed the program early. These may not be unique responders as a few Members may have served with NCCC in a prior service term.

    Frequency: Biweekly. Each early departed Member will complete only one survey for their most recent service term.

    Average Time per Response: Averages 25 minutes.

    Estimated Total Burden Hours: 167 hours.

    Total Burden Cost (capital/startup): None.

    Total Burden Cost (operating/maintenance): None.

    Comments submitted in response to this Notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.

    Dated: March 23, 2016. Gina Cross, Acting Director, National Civilian Community Corps.
    [FR Doc. 2016-07160 Filed 3-29-16; 8:45 am] BILLING CODE 6050-28-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DoD-2016-OS-0031] Proposed Collection; Comment Request AGENCY:

    Defense Finance and Accounting Service (DFAS), DoD.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the DFAS announces a proposed public information collection and seeks public comment on the provisions thereof. 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 information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

    DATES:

    Consideration will be given to all comments received by May 31, 2016.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

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

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate of Oversight and Compliance, Regulatory and Audit Matters Office, 9010 Defense Pentagon, Washington, DC 20301-9010.

    Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at http://www.regulations.gov for submitting comments. Please submit comments on any given form identified by docket number, form number, and title.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Defense Finance and Accounting Services, 1240 East 9th Street, Enterprise Solutions and Standards Code JJFJB, Cleveland, Ohio 44199, ATTN: Stuart Kran, or email: [email protected], or call (216) 204-4377.

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Application for Pay in Arrears; DD Form 827; OMB Control Number 0730-XXXX.

    Needs and Uses: The information collected is provided by service members, former service members, or legal representatives of incapacitated members in claiming arrears of pay believed to be due the service member. The authority for this form is 5 U.S.C. Section 301 which states in part that the head of a military department may prescribe regulations for the government of his/her department and the custody, use and preservation of its records, papers and property. However, it does not authorize withholding information from the public or limiting the availability of records to the public.

    Affected Public: Individuals or households.

    Annual Burden Hours: 832.

    Number of Respondents: 3328.

    Responses per Respondent: 1.

    Annual Responses: 3328.

    Average Burden per Response: 15 Minutes.

    Frequency: On occasion.

    When the Disbursing Officer/Finance Officer is not authorized to make payment due to lapsed appropriations, more than the current and previous five years, the claim is forwarded to the appropriate DFAS site for settlements. Claims are to be submitted on a DD 827. All necessary documentation must be attached to the claim. If the member is on active duty or separated for less than one year, the claim will be sent to the site servicing that branch of service. Army and Air Force claims will be sent to DFAS-IN, Navy and Marine Corps claims will be sent to DFAS-CL. For members separated over one year, the claim will be sent to DFAS-IN, Debts and Claims Management Office.

    Dated: March 25, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-07162 Filed 3-29-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Navy Notice of Public Meetings for the Draft Environmental Impact Statement for the Disposal and Reuse of Surplus Property at Naval Station Newport, Rhode Island AGENCY:

    Department of the Navy, Department of Defense.

    ACTION:

    Notice.

    SUMMARY:

    Pursuant to the National Environmental Policy Act (NEPA) of 1969 (Public Law [Pub. L.] 91-190, 42 United States Code [U.S.C.] 4321-4347), as implemented by the Council on Environmental Quality (CEQ) regulations implementing NEPA (40 Code of Federal Regulations [CFR] Parts 1500-1508), the Department of the Navy (DoN) has prepared and filed the Draft Environmental Impact Statement (EIS) to evaluate the potential human and natural environmental consequences of the disposal of surplus property at Naval Station (NAVSTA) Newport, Rhode Island, by the Navy and its subsequent redevelopment by the respective municipalities in which the surplus property is geographically located. Public Law 101-510, the Defense Base Closure and Realignment Act of 1990, as amended in 2005 (BRAC Law), has directed the Navy to realign NAVSTA Newport. As a result of this action, the Navy has declared approximately 158 acres of land area at NAVSTA Newport to be surplus to the needs of the federal government.

    With the filing of the Draft EIS, the DoN is initiating a 45-day public comment period and has scheduled two public open house meetings to provide information and receive written comments on the Draft EIS. Federal, state, and local elected officials and agencies and the public are encouraged to provide written comments.

    DATES AND ADDRESSES:

    The Navy will hold two open house public meetings at the locations listed below and will allow individuals to review and comment on the information presented in the Draft EIS. DoN representatives will be available during the open house to clarify information presented in the Draft EIS, as necessary. There will not be a formal presentation.

    Thursday, April 14, 2016; 4:00 p.m. to 8:00 p.m.; Joseph H. Gaudet Middle School Cafeteria; 1113 Aquidneck Ave. (Turner Rd entrance); Middletown, Rhode Island 02842. Friday, April 15, 2016; 10:00 a.m. to 2:00 p.m.; Newport Police Department Assembly Room; 120 Broadway; Newport, Rhode Island 02840. FOR FURTHER INFORMATION CONTACT:

    Director, BRAC Program Management Office (PMO) East, Attn: Newport EIS, 4911 South Broad Street, Building 679, Philadelphia, PA 19112-1303, telephone 215-897-4900, fax: 215-897-4902; email: [email protected] For more information on the NAVSTA Newport BRAC Draft EIS, visit the Navy BRAC PMO Web site (http://www.bracpmo.navy.mil) or the project Web site http://www.newporteis.com/.

    SUPPLEMENTARY INFORMATION:

    The Draft EIS was prepared in accordance with the requirements of the BRAC Law; NEPA; the CEQ regulations implementing NEPA (40 CFR 1500-1508); Navy procedures for implementing NEPA (32 CFR 775), Office of the Chief of Naval Operations (OPNAV) Manual M-5090.1; and other applicable Department of Defense (DoD) and Navy policies and guidance. A Notice of Intent (NOI) to prepare this Draft EIS was published in the Federal Register on October 31, 2012 (Federal Register, Vol. 77, No. 211/Wednesday, October 31, 2012/Notices). The Navy is the lead agency for the proposed action.

    The purpose of the proposed action is to comply with the BRAC Law and provide for the disposal and reuse of surplus property at NAVSTA Newport in a manner consistent with the Aquidneck Island Reuse Planning Authority's (AIRPA) Redevelopment Plan for Surplus Properties at NAVSTA Newport (Redevelopment Plan). The proposed action is needed to provide the local community an opportunity for economic development and job creation.

    The Draft EIS has considered two redevelopment alternatives. Alternative 1, the preferred alternative, is the disposal of the surplus property and reuse in accordance with the Redevelopment Plan, which has been prepared and approved by the AIRPA. Alternative 1 includes mixed land use types and densities for each of four non-contiguous surplus properties as well as open space and natural areas. Alternative 2 provides for the disposal of the surplus property at NAVSTA Newport and redevelopment at a higher density and with a different mix of uses than Alternative 1. A No Action alternative was also considered, as required by NEPA and to provide a point of comparison for assessing impacts of the redevelopment alternatives.

    The four surplus properties to be redeveloped are located in three separate municipalities on Aquidneck Island: Former Navy Lodge (approximately 3 acres located in the Town of Middletown), Former Naval Hospital (approximately 15.2 acres, consisting of 8.3 acres of land and 6.9 acres of offshore riparian rights, located in the City of Newport), Tank Farms 1 and 2 (approximately 136 acres located in the Town of Portsmouth), and Midway Pier/Greene Lane (approximately 10.7 acres located in the Town of Middletown).

    Federal, state, and local agencies, as well as interested members of the public, are invited and encouraged to review and comment on the Draft EIS. The Draft EIS is available for viewing at the following locations: Newport Public Library (300 Spring Street, Newport, RI 02840), Town of Portsmouth Town Hall (2200 East Main Road, Portsmouth, RI 02871), City of Newport, City Hall (43 Broadway, Newport, RI 02840), and Town of Middletown Planning Department (350 East Main Road, Middletown, RI 02842).

    An electronic version of the Draft EIS can be viewed or downloaded at the following Web sites—http://www.bracpmo.navy.mil and http://www.newporteis.com/. A limited number of hard copies are available by contacting BRAC PMO East at the address in this notice.

    Comments can be made in the following ways: (1) Written statements can be submitted to a DoN representative at the public meeting; (2) written comments can be mailed to Director, BRAC PMO East, Attn: Newport EIS, 4911 South Broad Street, Building 679, Philadelphia, PA 19112-1303; (3) written comments can be emailed to [email protected]; or (4) comments can be faxed to 215-897-4902, Attn: Mr. James Anderson. Comments may be submitted without attending the public meeting. All comments postmarked or emailed no later than midnight, May 2, 2016, will become part of the public record and will be responded to in the Final EIS.

    Requests for special assistance, sign language interpretation for the hearing impaired, language interpreters, or other auxiliary aids for the scheduled public meetings must be sent by mail or email to Mr. Matthew Butwin, Ecology and Environment, Inc., 368 Pleasant View Drive, Lancaster, NY 14086, telephone: 716-684-8060, email: [email protected] no later than April 1, 2016.

    Dated: March 24, 2016. C. Pan, Lieutenant, Judge Advocate General's Corps, U.S. Navy, Alternate Federal Register Liaison Officer.
    [FR Doc. 2016-07141 Filed 3-29-16; 8:45 am] BILLING CODE 3810-FF-P
    ELECTION ASSISTANCE COMMISSION Sunshine Act Notice AGENCY:

    U.S. Election Assistance Commission.

    TIME AND DATE:

    Thursday, April 14, 2016, 9 a.m.-5 p.m. and Friday, April 15, 2016, 8:10 a.m.-12 p.m. (Executive Board Session: Thursday, April 14, 2016, 7:30 p.m.).

    PLACE:

    The Sheraton Carlsbad Hotel, 5480 Grand Pacific Drive, Carlsbad, CA 92008, Phone: (760) 827-2400.

    STATUS:

    This meeting will be open to the public.

    MATTERS TO BE CONSIDERED:

    The U.S. Election Assistance Commission (EAC) Standards Board will meet to address its responsibilities under the Help America Vote Act of 2002 (HAVA), to present its views on issues in the administration of Federal elections, formulate recommendations to the EAC, and receive updates on EAC activities.

    The Standards Board will receive an overview of EAC Agency Operations, and will receive updates on EAC Grants and Audits, EAC Testing and Certification, and EAC's New Web site Rollout. The Board will receive an update on the Status of State Testing and Certification Consortium. The Board will receive an update on the work of EAC's Technical Guidelines Development Committee (TGDC). The Board will discuss and vote on recommendations from the TGDC. The Board will receive briefings from the National Association of Secretaries of State (NASS), the Federal Voting Assistance Program (FVAP), and the United States Postal Service (USPS).

    The Standards Board will conduct committee breakout sessions and hear committee reports. The Board will discuss and vote on proposed Bylaws amendments, and will fill vacancies on the Executive Board of the Standards Board. The Executive Board will elect new officers, appoint Standards Board committee members and chairs, and consider other administrative matters.

    CONTACT PERSON FOR MORE INFORMATION:

    Bryan Whitener, Telephone: (301) 563-3961.

    Bryan Whitener, Director of Communications and Clearinghouse, U.S. Election Assistance Commission.
    [FR Doc. 2016-07287 Filed 3-28-16; 4:15 pm] BILLING CODE 6820-KF-P
    DEPARTMENT OF ENERGY Notice of Public Meeting To Inform the Design of a Consent-Based Siting Process for Nuclear Waste Storage and Disposal Facilities AGENCY:

    Fuel Cycle Technologies, Office of Nuclear Energy, Department of Energy.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    The U.S. Department of Energy (DOE) is implementing a consent-based siting process to establish an integrated waste management system to transport, store, and dispose of spent nuclear fuel and high-level radioactive waste. In a consent-based siting approach, DOE will work with communities, tribal governments and states across the country that express interest in hosting any of the facilities identified as part of an integrated waste management system. As part of this process, the Department is hosting a series of public meetings to engage communities and individuals and discuss the development of a consent-based approach to managing our nation's nuclear waste. A public meeting will be held in Tempe, AZ on June 23, 2016.

    DATES:

    The meeting will take place on Thursday, June 23, 2016 from 5:00 p.m. to 9:30 p.m. MST. Informal poster sessions will be held from 4:00 p.m. until 5:00 p.m. MST and again after 9:30 p.m. MST. Department officials will be available to discuss consent-based siting during the poster sessions.

    ADDRESSES:

    The meeting will be held at Marriott Phoenix Tempe at the Buttes, 2000 W Westcourt Way, Tempe, AZ 85282. To register for this meeting and to review the agenda for the meeting, please go to energy.gov/consentbasedsiting.

    FOR FURTHER INFORMATION CONTACT:

    Requests for further information should be sent to [email protected] or to Michael Reim at 202-586-2981. Updated information on this and other planned public meetings on consent based siting will be posted at energy.gov/consentbasedsiting.

    If you are unable to attend a public meeting or would like to further discuss ideas for consent-based siting, please request an opportunity for us to speak with you. The Department will do its best to accommodate such requests and help arrange additional opportunities to engage. To learn more about nuclear energy, nuclear waste, and ongoing technical work please go to energy.gov/consentbasedsiting.

    Privacy Act: Data collected via the mechanisms listed above will not be protected from the public view in any way.

    Issued in Washington, DC, on March 24, 2016. Andrew Griffith, Associate Deputy Assistant Secretary, Office of Nuclear Energy, Department of Energy.
    [FR Doc. 2016-07155 Filed 3-29-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Notice of Public Meeting To Inform the Design of a Consent-Based Siting Process for Nuclear Waste Storage and Disposal Facilities AGENCY:

    Fuel Cycle Technologies, Office of Nuclear Energy, Department of Energy.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    The U.S. Department of Energy (DOE) is implementing a consent-based siting process to establish an integrated waste management system to transport, store, and dispose of spent nuclear fuel and high-level radioactive waste. In a consent-based siting approach, DOE will work with communities, tribal governments and states across the country that express interest in hosting any of the facilities identified as part of an integrated waste management system. As part of this process, the Department is hosting a series of public meetings to engage communities and individuals and discuss the development of a consent-based approach to managing our nation's nuclear waste. A public meeting will be held in Denver, CO on May 24, 2016.

    DATES:

    The meeting will take place on Tuesday, May 24, 2016 from 5:00 p.m. to 9:30 p.m. MDT. Informal poster sessions will be held from 4:00 p.m. until 5:00 p.m. MDT and again after 9:30 p.m. MDT. Department officials will be available to discuss consent-based siting during the poster sessions.

    ADDRESSES:

    The meeting will be held at Embassy Suites Denver—Stapleton, 4444 N Havana Street, Denver, CO 80239. To register for this meeting and to review the agenda for the meeting, please go to energy.gov/consentbasedsiting.

    FOR FURTHER INFORMATION CONTACT:

    Requests for further information should be sent to [email protected] or to Michael Reim at 202-586-2981. Updated information on this and other planned public meetings on consent based siting will be posted at energy.gov/consentbasedsiting.

    If you are unable to attend a public meeting or would like to further discuss ideas for consent-based siting, please request an opportunity for us to speak with you. The Department will do its best to accommodate such requests and help arrange additional opportunities to engage. To learn more about nuclear energy, nuclear waste, and ongoing technical work please go to energy.gov/consentbasedsiting.

    Privacy Act: Data collected via the mechanisms listed above will not be protected from the public view in any way.

    Issued in Washington, DC, on March 24, 2016. Andrew Griffith, Associate Deputy Assistant Secretary, Office of Nuclear Energy, Department of Energy.
    [FR Doc. 2016-07153 Filed 3-29-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Notice of Public Meeting To Inform the Design of a Consent-Based Siting Process for Nuclear Waste Storage and Disposal Facilities AGENCY:

    Fuel Cycle Technologies, Office of Nuclear Energy, Department of Energy.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    The U.S. Department of Energy (DOE) is implementing a consent-based siting process to establish an integrated waste management system to transport, store, and dispose of spent nuclear fuel and high-level radioactive waste. In a consent-based siting approach, DOE will work with communities, tribal governments and states across the country that express interest in hosting any of the facilities identified as part of an integrated waste management system. As part of this process, the Department is hosting a series of public meetings to engage communities and individuals and discuss the development of a consent-based approach to managing our nation's nuclear waste. A public meeting will be held in Boston, MA on June 2, 2016.

    DATES:

    The meeting will take place on Thursday, June 2, 2016 from 5:00 p.m. to 9:30 p.m. EDT. Informal poster sessions will be held from 4:00 p.m. until 5:00 p.m. EDT and again after 9:30 p.m. EDT. Department officials will be available to discuss consent-based siting during the poster sessions.

    ADDRESSES:

    The meeting will be held at Hyatt Regency Boston, One Avenue De Lafayette, Boston, MA 02111. To register for this meeting and to review the agenda for the meeting, please go to energy.gov/consentbasedsiting.

    FOR FURTHER INFORMATION CONTACT:

    Requests for further information should be sent to [email protected] or to Michael Reim at 202-586-2981. Updated information on this and other planned public meetings on consent based siting will be posted at energy.gov/consentbasedsiting.

    If you are unable to attend a public meeting or would like to further discuss ideas for consent-based siting, please request an opportunity for us to speak with you. The Department will do its best to accommodate such requests and help arrange additional opportunities to engage. To learn more about nuclear energy, nuclear waste, and ongoing technical work please go to energy.gov/consentbasedsiting.

    Privacy Act: Data collected via the mechanisms listed above will not be protected from the public view in any way.

    Issued in Washington, DC, on March 24, 2016. Andrew Griffith, Associate Deputy Assistant Secretary, Office of Nuclear Energy, Department of Energy.
    [FR Doc. 2016-07154 Filed 3-29-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Quadrennial Energy Review: Notice of Public Meeting AGENCY:

    Office of Energy Policy and Systems Analysis, Secretariat, Quadrennial Energy Review Task Force, Department of Energy.

    ACTION:

    Notice of public meetings and updated meeting locations.

    SUMMARY:

    At the direction of the President, the U.S. Department of Energy (DOE or Department), as the Secretariat for the Quadrennial Energy Review Task Force (QER Task Force), will convene public meetings for the second installment of the Quadrennial Energy Review, an integrated study of the U.S. electricity system from generation through end use. A mixture of panel discussions and a public comment period will frame multi-stakeholder discourse around deliberative analytical questions relating to the intersection of electricity and its role in promoting economic competitiveness, energy security, and environmental responsibility. This document announces that the Atlanta meeting which was originally scheduled for March 31 will now be held on May 24.

    DATES:

    The public meetings will be held on April 15, 2016 in Boston, Massachusetts at 9:30 a.m.; April 25, 2016 in Salt Lake City, Utah at 8:30 a.m.; May 6, 2016 in Des Moines, Iowa; May 9, 2016 in Austin, Texas; May 10, 2016 in Los Angeles, California; and May 24, 2016 in Atlanta, Georgia. Written comments are welcome, especially following the public meetings, and should be submitted within 60 days of the meetings, but no later than July 1, 2016.

    ADDRESSES:

    The April 15, 2016, QER meeting in Boston will take place at the Marriott Long Wharf, Salons DEFL, 296 State Street, Boston, Massachusetts. The April 25 QER meeting in Salt Lake City will take place at Western Electricity Coordinating Council, 155 North 400 West, Suite 200, Salt Lake City, Utah. Additional QER meeting locations and addresses will be announced when they are available, in Federal Register notices and at energy.gov/qer.

    Between February 4, 2016 and July 1, 2016, you may submit written comments online at http://energy.gov/qer or by U.S. mail to the Office of Energy Policy and Systems Analysis, EPSA-60, QER Meeting Comments, U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585-0121.

    FOR FURTHER INFORMATION CONTACT:

    John Richards, EPSA-60, U.S. Department of Energy, Office of Energy Policy and Systems Analysis, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: 202-586-0507 Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    On January 9, 2014, President Obama issued a Presidential Memorandum—Establishing a Quadrennial Energy Review. To accomplish this review, the Presidential Memorandum establishes a Quadrennial Energy Review Task Force to be co-chaired by the Director of the Office of Science and Technology Policy, and the Director of the Domestic Policy Council. Under the Presidential Memorandum, the Secretary of Energy shall provide support to the Task Force, including support for coordination activities related to the preparation of the Quadrennial Energy Review (QER) Report, policy analysis and modeling, and stakeholder engagement.

    The Quadrennial Energy Review process itself involves robust engagement of federal agencies and outside stakeholders, and further enables the federal government to translate policy goals into a set of analytically based, integrated actions for proposed investments over a four year planning horizon. Unlike traditional federal Quadrennial Review processes, the QER is conducted in a multi-year installment series to allow for more focused analysis on particular sub-sectors of the energy system. The initial focus for the Quadrennial Energy Review was our Nation's transmission, storage and distribution infrastructures that link energy supplies to intermediate and end users, because these capital-intensive infrastructures tend to set supply and end use patterns, investments and practices in place for decades. On April 21, 2015, the Quadrennial Energy Review Task Force released its first Quadrennial Energy Review installment report entitled, “Energy Transmission, Storage, and Distribution Infrastructure”. Among the issues highlighted by the analysis in the first installment of the QER were the growing dependencies of all critical infrastructures and economic sectors on electricity, as well as, the increasing interdependence of the various energy subsectors. In response to these findings, and to provide an appropriate consideration of an energy sector undergoing significant technological and regulatory change, the second installment of the QER will conduct a comprehensive review of the nation's electricity system, from generation to end use, including a more comprehensive look at electricity transmission, storage, and distribution infrastructure covered in installment one. The electricity system encompasses not just physical structures, but also a range of actors and institutions. Under this broad framing, the second installment intends to consider the roles and activities of all relevant actors, industries, and institutions integral to continuing to supply reliable and affordable electricity at a time of dramatic change in technology development. Issues to be considered in QER analyses include fuel choices, distributed and centralized generation, physical and cyber vulnerabilities, federal, state, and local policy direction, expectations of residential and commercial consumers, and a review of existing and evolving business models for a range of entities throughout the system.

    Significant changes will be required to meet the transformational opportunities and challenges posed by our evolving electricity system. The Administration is seeking public input on key questions relating to possible federal actions that would address the challenges and take full advantage of the opportunities of this changing system to meet the Nation's objectives of reliable, affordable and clean electricity. Over the course of 2016, the Secretariat for the Quadrennial Energy Review Task Force will hold a series of public meetings to discuss and receive comments on the issues outlined above, and well as, others, as they relate to the second installment of the Quadrennial Energy Review.

    The Department of Energy has a broad role in energy policy development and the largest role in implementing the Federal Government's energy research and development portfolio. Many other executive departments and agencies also play key roles in developing and implementing policies governing energy resources and consumption, as well as, associated environmental impacts. In addition, non-Federal actors are crucial contributors to energy policies. Because most energy and related infrastructure is owned by private entities, investment by and engagement of, input from the private sector is necessary to develop and implement effective policies. State and local policies, the views of non-governmental, environmental, faith-based, labor, and other social organizations, and contributions from the academic and non-profit sectors are also critical to the development and implementation of effective Federal energy policies.

    The interagency Quadrennial Energy Review Task Force, which includes members from all relevant executive departments and agencies, will develop an integrated review of energy policy that integrates all of these perspectives. It will build on the foundation provided in the Administration's Blueprint for a Secure Energy Future of March 30, 2011, and Climate Action Plan released on June 25, 2013. The Task Force will offer recommendations on what additional actions it believes would be appropriate. These may include recommendations on additional executive or legislative actions to address the energy challenges and opportunities facing the Nation.

    Quadrennial Energy Review Public Meetings

    This document announces that the Atlanta meeting which was originally scheduled (81 FR 12885, March 11, 2016) for March 31 will now be held on May 24. The DOE will hold public meetings on electricity from generation through end use, in the following cities:

    Boston, Massachusetts, April 15, 2016 Salt Lake City, Utah, April 25, 2016 Des Moines, Iowa, May 6, 2016 Austin, Texas, May 9, 2016 Los Angeles, California, May 10, 2016 Atlanta, Georgia, May 24 2016

    Each meeting will feature facilitated panel discussions, followed by an open microphone session. People who would like to speak during the open microphone session at the public meeting should come prepared to speak for no more than five minutes and will be accommodated on a first-come, first-served basis, according to the order in which they register to speak on a sign-in sheet available at the meeting location, on the morning of the meeting. In advance of the meetings, DOE anticipates making publicly available a briefing memorandum providing useful background information regarding the topics under discussion at the meeting. DOE will post this memorandum on its Web site: http://energy.gov/qer.

    Submitting comments online. DOE will accept public comments on the QER from February 4, 2016, to July 1, 2016, at energy.gov/qer. Submitting comments online to the DOE Web site will require you to provide your name and contact information. Your contact information will be viewable to DOE staff only. Your contact information will not be publicly viewable except for your first and last names, organization name (if any), and submitter representative name (if any). Your contact information will be publicly viewable if you include it in the comment itself or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Otherwise, persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.

    Do not submit information for which disclosure is restricted by statute, such as trade secrets and commercial or financial information (hereinafter referred to as Confidential Business Information (CBI)). Comments submitted through the DOE Web site cannot be claimed as CBI. Comments received through the Web site will waive any CBI claims for the information submitted. For information on submitting CBI, see the Confidential Business Information section, below.

    If you do not want your personal contact information to be publicly viewable, do not include it in your comment or any accompanying documents. Instead, provide your contact information in a cover letter. Include your first and last names, email address, telephone number, and optional mailing address. The cover letter will not be publicly viewable as long as it does not include any comments.

    Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery/courier, please provide all items on a CD, if feasible, in which case it is not necessary to submit printed copies. No telefacsimiles (faxes) will be accepted.

    Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English, and are free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.

    Confidential Business Information. Pursuant to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email, postal mail, or hand delivery/courier two well-marked copies: One copy of the document marked “confidential” including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. Submit these documents via email or on a CD, if feasible. DOE will make its own determination about the confidential status of the information and treat it according to its determination. Confidential information should be submitted to the Confidential QER email address: [email protected]

    Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person which would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest. It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).

    Issued in Washington, DC, on March 25, 2016. April Salas, QER Secretariat Director, Quadrennial Energy Review Task Force, U.S. Department of Energy.
    [FR Doc. 2016-07170 Filed 3-29-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY [OE Docket No. EA-378-A] Application To Export Electric Energy; Cargill Power Markets, LLC AGENCY:

    Office of Electricity Delivery and Energy Reliability, DOE.

    ACTION:

    Notice of application.

    SUMMARY:

    Cargill Power Markets, LLC (Applicant or CPM) has applied to renew its authority to transmit electric energy from the United States to Mexico pursuant to section 202(e) of the Federal Power Act.

    DATES:

    Comments, protests, or motions to intervene must be submitted on or before April 29, 2016.

    ADDRESSES:

    Comments, protests, motions to intervene, or requests for more information should be addressed to: Office of Electricity Delivery and Energy Reliability, Mail Code: OE-20, U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585-0350. Because of delays in handling conventional mail, it is recommended that documents be transmitted by overnight mail, by electronic mail to [email protected], or by facsimile to 202-586-8008.

    SUPPLEMENTARY INFORMATION:

    Exports of electricity from the United States to a foreign country are regulated by the Department of Energy (DOE) pursuant to sections 301(b) and 402(f) of the Department of Energy Organization Act (42 U.S.C. 7151(b), 7172(f)) and require authorization under section 202(e) of the Federal Power Act (16 U.S.C. 824a(e)).

    On June 1, 2011, DOE issued Order No. EA-378 to CPM, which authorized the Applicant to transmit electric energy from the United States to Mexico as a power marketer for a five-year term using existing international transmission facilities. That authority expires on June 1, 2016. On March 16, 2016, the Applicant filed an application with DOE for renewal of the export authority contained in Order No. EA-378 for an additional five-year term.

    In its application, CPM states that it does not own or operate any electric generation or transmission facilities, and it does not have a franchised service area. The electric energy that CPM proposes to export to Mexico would be surplus energy purchased from third parties such as electric utilities and Federal power marketing agencies pursuant to voluntary agreements. The existing international transmission facilities to be utilized by CPM have previously been authorized by Presidential permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.

    Procedural Matters: Any person desiring to be heard in this proceeding should file a comment or protest to the application at the address provided above. Protests should be filed in accordance with Rule 211 of the Federal Energy Regulatory Commission's (FERC) Rules of Practice and Procedures (18 CFR 385.211). Any person desiring to become a party to these proceedings should file a motion to intervene at the above address in accordance with FERC Rule 214 (18 CFR 385.214). Five copies of such comments, protests, or motions to intervene should be sent to the address provided above on or before the date listed above.

    Comments and other filings concerning CPM's application to export electric energy to Mexico should be clearly marked with OE Docket No. EA-378-A. An additional copy is to be provided directly to Stephen Dvorske, Cargill Power Markets, LLC, 9350 Excelsior Blvd. MS 150, Hopkins, MN 55343.

    A final decision will be made on this application after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after a determination is made by DOE that the proposed action will not have an adverse impact on the sufficiency of supply or reliability of the U.S. electric power supply system.

    Copies of this application will be made available, upon request, for public inspection and copying at the address provided above, by accessing the program Web site at http://energy.gov/node/11845, or by emailing Angela Troy at [email protected]

    Issued in Washington, DC, on March 24, 2016. Christopher Lawrence, Electricity Policy Analyst, Office of Electricity Delivery and Energy Reliability.
    [FR Doc. 2016-07156 Filed 3-29-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY [OE Docket No. EA-209-D] Application To Export Electric Energy; Cargill Power Markets, LLC AGENCY:

    Office of Electricity Delivery and Energy Reliability, DOE.

    ACTION:

    Notice of application.

    SUMMARY:

    Cargill Power Markets, LLC (Applicant or CPM) has applied to renew its authority to transmit electric energy from the United States to Canada pursuant to section 202(e) of the Federal Power Act.

    DATES:

    Comments, protests, or motions to intervene must be submitted on or before April 29, 2016.

    ADDRESSES:

    Comments, protests, motions to intervene, or requests for more information should be addressed to: Office of Electricity Delivery and Energy Reliability, Mail Code: OE-20, U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585-0350. Because of delays in handling conventional mail, it is recommended that documents be transmitted by overnight mail, by electronic mail to [email protected], or by facsimile to 202-586-8008.

    SUPPLEMENTARY INFORMATION:

    Exports of electricity from the United States to a foreign country are regulated by the Department of Energy (DOE) pursuant to sections 301(b) and 402(f) of the Department of Energy Organization Act (42 U.S.C. 7151(b), 7172(f)) and require authorization under section 202(e) of the Federal Power Act (16 U.S.C. 824a(e)).

    On June 1, 2011, DOE issued Order No. EA-209-C to CPM, which authorized the Applicant to transmit electric energy from the United States to Canada as a power marketer for a five-year term using existing international transmission facilities. That authority expires on June 1, 2016. On March 16, 2016, CPM filed an application with DOE for renewal of the export authority contained in Order No. EA-216 for an additional five-year term.

    In its application, CPM states that it does not own or operate any electric generation or transmission facilities, and it does not have a franchised service area. The electric energy that CPM proposes to export to Canada would be surplus energy purchased from third parties such as electric utilities and Federal power marketing agencies pursuant to voluntary agreements. The existing international transmission facilities to be utilized by CPM have previously been authorized by Presidential permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.

    Procedural Matters: Any person desiring to be heard in this proceeding should file a comment or protest to the application at the address provided above. Protests should be filed in accordance with Rule 211 of the Federal Energy Regulatory Commission's (FERC) Rules of Practice and Procedures (18 CFR 385.211). Any person desiring to become a party to these proceedings should file a motion to intervene at the above address in accordance with FERC Rule 214 (18 CFR 385.214). Five copies of such comments, protests, or motions to intervene should be sent to the address provided above on or before the date listed above.

    Comments and other filings concerning CPM's application to export electric energy to Canada should be clearly marked with OE Docket No. EA-209-D. An additional copy is to be provided directly to Stephen Dvorske, Cargill Power Markets, LLC, 9350 Excelsior Blvd., MS 150, Hopkins, MN 55343.

    A final decision will be made on this application after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after a determination is made by DOE that the proposed action will not have an adverse impact on the sufficiency of supply or reliability of the U.S. electric power supply system.

    Copies of this application will be made available, upon request, for public inspection and copying at the address provided above, by accessing the program Web site at http://energy.gov/node/11845, or by emailing Angela Troy at [email protected].

    Issued in Washington, DC, on March 24, 2016. Christopher Lawrence, Electricity Policy Analyst, Office of Electricity Delivery and Energy Reliability.
    [FR Doc. 2016-07157 Filed 3-29-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY [OE Docket No. EA-289-C] Application To Export Electric Energy; Intercom Energy, Inc. AGENCY:

    Office of Electricity Delivery and Energy Reliability, DOE.

    ACTION:

    Notice of application.

    SUMMARY:

    Intercom Energy, Inc. (Applicant or Intercom) has applied to renew its authority to transmit electric energy from the United States to Mexico pursuant to section 202(e) of the Federal Power Act.

    DATES:

    Comments, protests, or motions to intervene must be submitted on or before April 29, 2016.

    ADDRESSES:

    Comments, protests, motions to intervene, or requests for more information should be addressed to: Office of Electricity Delivery and Energy Reliability, Mail Code: OE-20, U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585-0350. Because of delays in handling conventional mail, it is recommended that documents be transmitted by overnight mail, by electronic mail to [email protected], or by facsimile to 202-586-8008.

    SUPPLEMENTARY INFORMATION:

    Exports of electricity from the United States to a foreign country are regulated by the Department of Energy (DOE) pursuant to sections 301(b) and 402(f) of the Department of Energy Organization Act (42 U.S.C. 7151(b), 7172(f)) and require authorization under section 202(e) of the Federal Power Act (16 U.S.C. 824a(e)).

    On May 17, 2011, DOE issued Order No. EA-289-B to Intercom, which authorized the Applicant to transmit electric energy from the United States to Mexico as a power marketer for a five-year term using existing international transmission facilities. That authority expires on May 17, 2016. On March 22, 2016, Intercom filed an application with DOE for renewal of the export authority contained in Order No. EA-289 for an additional five-year term.

    In its application, Intercom states that it does not own or operate any electric generation or transmission facilities, and it does not have a franchised service area. The electric energy that Intercom proposes to export to Mexico would be surplus energy purchased from third parties such as electric utilities and Federal power marketing agencies pursuant to voluntary agreements. The existing international transmission facilities to be utilized by the Applicant have previously been authorized by Presidential permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.

    Procedural Matters: Any person desiring to be heard in this proceeding should file a comment or protest to the application at the address provided above. Protests should be filed in accordance with Rule 211 of the Federal Energy Regulatory Commission's (FERC) Rules of Practice and Procedures (18 CFR 385.211). Any person desiring to become a party to these proceedings should file a motion to intervene at the above address in accordance with FERC Rule 214 (18 CFR 385.214). Five copies of such comments, protests, or motions to intervene should be sent to the address provided above on or before the date listed above.

    Comments and other filings concerning Intercom's application to export electric energy to Mexico should be clearly marked with OE Docket No. EA-289-C. An additional copy is to be provided directly to Ernesto Pallares, Intercom Energy, Inc., 1224 Tenth Avenue, Suite 202, Coronado, CA 92118 and to William DeGrandis, Paul Hastings, LLP, 875 15th Street NW., Washington, DC 20005.

    A final decision will be made on this application after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after a determination is made by DOE that the proposed action will not have an adverse impact on the sufficiency of supply or reliability of the U.S. electric power supply system.

    Copies of this application will be made available, upon request, for public inspection and copying at the address provided above, by accessing the program Web site at http://energy.gov/node/11845, or by emailing Angela Troy at [email protected].

    Issued in Washington, DC, on March 24, 2016. Christopher Lawrence, Electricity Policy Analyst, Office of Electricity Delivery and Energy Reliability.
    [FR Doc. 2016-07159 Filed 3-29-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Notice of Public Meeting To Inform the Design of a Consent-Based Siting Process for Nuclear Waste Storage and Disposal Facilities AGENCY:

    Fuel Cycle Technologies, Office of Nuclear Energy, Department of Energy.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    The U.S. Department of Energy (DOE) is implementing a consent-based siting process to establish an integrated waste management system to transport, store, and dispose of spent nuclear fuel and high-level radioactive waste. In a consent-based siting approach, DOE will work with communities, tribal governments and states across the country that express interest in hosting any of the facilities identified as part of an integrated waste management system. As part of this process, the Department is hosting a series of public meetings to engage communities and individuals and discuss the development of a consent-based approach to managing our nation's nuclear waste. A public meeting will be held in Sacramento, CA on April 26, 2016.

    DATES:

    The meeting will take place on Tuesday April 26, 2016 from 5:00 p.m. to 9:30 p.m. PDT. Informal poster sessions will be held from 4:00 p.m. until 5:00 p.m. PDT and again after 9:30 p.m. PDT. Department officials will be available to discuss consent-based siting during the poster sessions.

    ADDRESSES:

    The meeting will be held at Holiday Inn Capitol Plaza—Sacramento, 300 J Street, Sacramento, CA 95814. To register for this meeting and to review the agenda for the meeting, please go to energy.gov/consentbasedsiting.

    FOR FURTHER INFORMATION CONTACT:

    Requests for further information should be sent to [email protected] or to Michael Reim at 202-586-2981. Updated information on this and other planned public meetings on consent based siting will be posted at energy.gov/consentbasedsiting.

    If you are unable to attend a public meeting or would like to further discuss ideas for consent-based siting, please request an opportunity for us to speak with you. The Department will do its best to accommodate such requests and help arrange additional opportunities to engage. To learn more about nuclear energy, nuclear waste, and ongoing technical work please go to energy.gov/consentbasedsiting.

    Privacy Act: Data collected via the mechanisms listed above will not be protected from the public view in any way.

    Issued in Washington, DC, on March 24, 2016. Andrew Griffith, Associate Deputy Assistant Secretary, Office of Nuclear Energy, Department of Energy.
    [FR Doc. 2016-07152 Filed 3-29-16; 8:45 am] BILLING CODE 6450-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2016-0125; FRL-9943-74] Agency Information Collection Activities; Proposed New Collection (EPA ICR No. 2532.01); Comment Request AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act (PRA), this document announces that EPA is planning to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). The ICR, entitled: “Use of Mercury and Mercury Compounds in Products and Processes” and identified by EPA ICR No. 2532.01 and OMB Control No. 2070-NEW, represents a new request. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection that is summarized in this document. The ICR and accompanying material are available in the docket for public review and comment.

    DATES:

    Comments must be received on or before May 31, 2016.

    ADDRESSES:

    Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2016-0125, by one of the following methods:

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

    Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

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

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

    FOR FURTHER INFORMATION CONTACT:

    For technical information contact: Sue Slotnick, National Program Chemicals Division (7404T), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 566-1973; email address: [email protected]

    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), EPA specifically solicits comments and information to enable it to:

    1. 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.

    2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

    3. Enhance the quality, utility, and clarity of the information to be collected. In particular, EPA seeks comment on these aspects of the questionnaire:

    • Are there additional products or product categories that should be included in the questionnaire?

    • Are there additional products or product categories that should be eliminated from the questionnaire?

    • Should the questionnaire ask respondents to identify which products are intended solely as replacement parts?

    4. 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. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

    II. What information collection activity or ICR does this action apply to?

    Title: Use of Mercury and Mercury Compounds in Products and Processes.

    ICR number: EPA ICR No. 2532.01.

    OMB control number: OMB Control No. 2070-NEW.

    ICR status: This ICR is for a new information collection activity. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the Code of Federal Regulations (CFR), after appearing in the Federal Register when approved, are listed in 40 CFR part 9, and are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.

    Abstract: The U.S. EPA is making efforts to reduce the non-essential use of mercury and mercury compounds in products and certain manufacturing processes to prevent future releases of mercury to the environment. After negotiating and joining a global agreement called the Minamata Convention on Mercury, EPA continues to pursue measures to reduce the use of mercury in various media. EPA has determined that significant data gaps exist that prevent the Agency from taking systematic, strategic, and effective actions to reduce the use of mercury and mercury compounds in order to prevent potential releases to the environment.

    To close such data gaps, EPA will collect information from persons who process, import, and/or export mercury or mercury-added products. In addition, EPA will request information from persons who process mercury or mercury compounds for use in certain industrial processes. EPA is particularly interested in the amount of mercury or mercury compounds used in mercury-added products as a whole and among various categories of products, including mercury or mercury compounds that are added during domestic manufacture, as well as contained in imported and exported products.

    Initially this will be a one-time information collection, but EPA may request subsequent renewals of OMB approval of the information collection as necessary. Information will be collected from companies that manufacture, import, or export a product or products containing mercury or mercury compounds, or companies that use mercury or mercury compounds in a manufacturing process or processes. EPA will request that companies voluntarily submit responses to a questionnaire during a period of 60 days after OMB approves the proposed collection. Thereafter, EPA will issue formal measures under section 11 of the Toxic Substances Control Act (TSCA) to obtain the information if appropriate. EPA anticipates that the information collection activity will involve 250 private entities, although the number of entities may be as high as 646. The years of interest are 2010, 2013, and 2016.

    EPA will use the collected information to determine whether and if so what type of actions, including voluntary and/or mandatory measures, are needed to reduce non-essential use of mercury or mercury compounds. The Agency will also use such information to prioritize where and how EPA applies measures in order to help prevent potential risks of mercury exposure to human health and the environment. In addition, this information will be used to facilitate compliance with obligations of the United States under the Minamata Convention to continue to reduce the use of mercury in products and processes and to report on actions taken to do so.

    Responses to the collection of information are voluntary. However, should EPA initiate TSCA section 11 actions to compel submission of information, those responses would be mandatory. Respondents may claim all or part of a notice confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2.

    Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 9.9 hours per response. Burden is defined in 5 CFR 1320.3(b).

    The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized here:

    Respondents/Affected Entities: Entities potentially affected by this ICR are persons who process mercury or mercury compounds for use in the production of mercury-added products, import mercury for use in the production of mercury-added products, import mercury-added products, export mercury-added products, and/or process mercury or mercury compounds for use in certain industrial processes.

    Estimated total number of potential respondents: 646.

    Frequency of response: One time.

    Estimated total average number of responses for each respondent: 1.0.

    Estimated total annual burden hours: 6,399 hours.

    Estimated total annual costs: $444,430. This includes an estimated burden cost of $444,430 and an estimated cost of $0 for capital investment or maintenance and operational costs.

    III. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the technical person listed under FOR FURTHER INFORMATION CONTACT.

    Authority:

    44 U.S.C. 3501 et seq.

    Dated: March 23, 2016. James Jones, Assistant Administrator, Office of Chemical Safety and Pollution Prevention.
    [FR Doc. 2016-07174 Filed 3-29-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2003-0162; FRL-9943-22-OEI] Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Regional Haze Regulations (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency has submitted an information collection request (ICR), “Regional Haze Regulations (Renewal)” (EPA ICR No. 1813.09, OMB Control No. 2060-0421) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through March 31, 2016. Public comments were previously requested via the Federal Register (80 FR 58473) on September 29, 2015 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments may be submitted on or before April 29, 2016.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2003-0162, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to [email protected] Address comments to OMB Desk Officer for EPA.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Chris Werner, Air Quality Policy Division, Office of Air Quality Planning and Standards, C539-04, Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number: (919) 541-5133; fax number: (919) 541-5315; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Abstract: This ICR is for activities related to the implementation of the EPA's regional haze rule, for the time period between March 31, 2016, and March 31, 2019, and renews the previous ICR. The regional haze rule codified at 40 CFR parts 308 and 309, as authorized by sections 169A and 169B of the Clean Air Act, requires states to develop implementation plans to protect visibility in 156 federally-protected Class I areas. Tribes may choose to develop implementation plans. For this time period, states will primarily be developing and submitting periodic comprehensive implementation plan revisions (or initial implementation plans) and progress reports to comply with the regulations.

    Form Numbers: None.

    Respondents/affected entities: Entities potentially affected by this action are state, local and tribal air quality agencies, regional planning organizations and facilities potentially regulated under the regional haze rule.

    Respondent's obligation to respond: Mandatory [see 40 CFR 51.308(b), (f) and (g) and 40 CFR 51.309(d)(10)].

    Estimated number of respondents: 52 (total); 52 state agencies.

    Frequency of response: Approximately every 5 years.

    Total estimated burden: 10,307 hours (per year). Burden is defined at 5 CFR 1320.03(b).

    Total estimated cost: $510,489 (per year). There are no annualized capital or operation and maintenance costs.

    Changes in the Estimates: There is an increase of 4,259 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase is due to this ICR renewal period covering different task elements than the previous renewal (EPA ICR No. 1813.08). These differences reflect the requirements of the current regional haze rule with respect to the scheduled events and activities in the implementation process. The last collection request anticipated the program consisting mainly of submission of 5-year progress reports. The change in burden reflects changes in labor rates and changes in the activities conducted due to the normal progression of the program, especially the fact that states will be working on and submitting periodic comprehensive State Implementation Plan (SIP) revisions (or initial SIPs).

    Courtney Kerwin, Acting Director, Collection Strategies Division.
    [FR Doc. 2016-07087 Filed 3-29-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9944-40-OW] Notice of a Public Meeting and Webinar: Managing Cyanotoxins in Drinking Water AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of a public meeting.

    SUMMARY:

    The U.S. Environmental Protection Agency (EPA) announces an opportunity for public input on the EPA's tools and information related to drinking water cyanotoxin management. The EPA is holding a public meeting for interested parties to provide input either in person or online via a webinar on lessons learned after the release of the June 2015 Recommendations for Public Water Systems to Manage Cyanotoxins in Drinking Water. The agency plans to use this information to inform development of additional tools to support states and/or utilities. The EPA seeks to engage with stakeholders on information the agency can provide to support states and public water systems in addressing cyanotoxin public health concerns in drinking water.

    DATES:

    The public meeting will be held on April 29, 2016, from 9:15 a.m. to 12:30 p.m., Central Standard Time. Registration and check-in begins at 8:45 a.m. Persons wishing to attend the meeting in person or online via webinar must register by April 28, 2016, as described in the SUPPLEMENTARY INFORMATION section.

    ADDRESSES:

    The public meeting will be held at 77 West Jackson Blvd., Chicago, Illinois, Lake Michigan conference room on the 12th floor. All attendees must show government-issued photo identification (e.g., a driver's license) when signing in. Please arrive at least 15 minutes early to allow time to clear security. This meeting will also be simultaneously broadcast as a webinar, available on the Internet.

    FOR FURTHER INFORMATION CONTACT:

    Members of the public who wish to receive further information about the public meeting or have questions about this notice should contact Hannah Holsinger at (202) 564-0403 or [email protected]

    SUPPLEMENTARY INFORMATION: I. General Information

    a. How may I participate in this meeting/webinar? Persons wishing to attend the meeting in person or online via the webinar must register in advance no later than 5:00 p.m., Eastern Daylight Savings Time, on April 28, 2016. To register, go online to: https://www.eventbrite.com/e/us-epa-public-meeting-managing-cyanotoxins-in-drinking-water-tickets-22748127261?utm_term=eventurl_text. Teleconferencing will be available for individuals participating via the webinar. The number of seats and webinar connections available for the meeting is limited and will be available on a first-come, first-served basis. Early registration is encouraged to ensure proper accommodations. The EPA will do its best to include all those interested in either meeting in person or via the webinar.

    b. How can I get a copy of the meeting/webinar materials? Prior to the public meeting, a link to the meeting materials will be sent by email to the registered attendees; copies will also be available for attendees at the meeting. For persons unable to attend the meeting, please contact Katie Foreman at [email protected] to request meeting materials.

    c. Special Accommodations: Individuals with disabilities who wish to attend the meeting in person can request special accommodations by contacting Hannah Holsinger at [email protected] no later than April 22, 2016.

    II. Background

    Cyanobacteria are naturally occurring organisms similar to algae. These organisms can occur in fresh water and may rapidly multiply causing “blooms” under favorable conditions. Conditions that enhance bloom formation and persistence include light intensity and duration, nutrient availability (such as nitrogen and phosphorus), water temperature, pH and water column stability. Some blooms produce cyanotoxins such as microcystin, cylindrospermopsin and anatoxin-a, which can be a health concern. For additional background information on cyanotoxins in drinking water, please go to: http://www2.epa.gov/sites/production/files/2014-08/documents/cyanobacteria_factsheet.pdf.

    The EPA released health advisories in June 2015 for two cyanotoxins: Microcystin and cylindrospermopsin. In June 2015, the EPA also released recommendations for public water systems on managing risks from cyanotoxins in drinking water. For additional background information on the health advisories and recommendations, please go to: http://www.epa.gov/nutrient-policy-data/guidelines-and-recommendations. The EPA's goal for this meeting is to obtain information on state, utility and public experiences in managing risks from cyanotoxins in drinking water. The EPA is seeking to get input on lessons learned after the release of the June 2015 recommendations document, Recommendations for Public Water Systems to Manage Cyanotoxins in Drinking Water. The EPA plans to use this information to develop additional tools or make modifications to the current recommendations document.

    Dated: March 24, 2016. Rebecca Clark, Acting Director, Office of Ground Water and Drinking Water.
    [FR Doc. 2016-07173 Filed 3-29-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9944-39-OA] Applicability Determination Index (ADI) Data System Recent Posting: Agency Applicability Determinations, Alternative Monitoring Decisions, and Regulatory Interpretations Pertaining to Standards of Performance for New Stationary Sources, National Emission Standards for Hazardous Air Pollutants, and the Stratospheric Ozone Protection Program AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of availability.

    SUMMARY:

    This notice announces applicability determinations, alternative monitoring decisions, and regulatory interpretations that the Environmental Protection Agency (EPA) has made under the New Source Performance Standards (NSPS); the National Emission Standards for Hazardous Air Pollutants (NESHAP); and/or the Stratospheric Ozone Protection Program.

    FOR FURTHER INFORMATION CONTACT:

    An electronic copy of each complete document posted on the Applicability Determination Index (ADI) data system is available on the Internet through the Resources and Guidance Documents for Compliance Assistance page of the Clean Air Act Compliance Monitoring Web site under “Air” at: https://www2.epa.gov/compliance/resources-and-guidance-documents-compliance-assistance. The letters and memoranda on the ADI may be located by date, office of issuance, subpart, citation, control number, or by string word searches. For questions about the ADI or this notice, contact Maria Malave at EPA by phone at: (202) 564-7027, or by email at: [email protected] For technical questions about individual applicability determinations, monitoring decisions or regulatory interpretations, refer to the contact person identified in the individual documents, or in the absence of a contact person, refer to the author of the document.

    SUPPLEMENTARY INFORMATION:

    Background

    The General Provisions of the NSPS in 40 Code of Federal Regulations (CFR) part 60 and the General Provisions of the NESHAP in 40 CFR part 61 provide that a source owner or operator may request a determination of whether certain intended actions constitute the commencement of construction, reconstruction, or modification. EPA's written responses to these inquiries are commonly referred to as applicability determinations. See 40 CFR 60.5 and 61.06. Although the NESHAP part 63 regulations [which include Maximum Achievable Control Technology (MACT) standards and/or Generally Available Control Technology (GACT) standards] and Section 111(d) of the Clean Air Act (CAA) contain no specific regulatory provision providing that sources may request applicability determinations, EPA also responds to written inquiries regarding applicability for the part 63 and Section 111(d) programs. The NSPS and NESHAP also allow sources to seek permission to use monitoring or recordkeeping that is different from the promulgated requirements. See 40 CFR 60.13(i), 61.14(g), 63.8(b)(1), 63.8(f), and 63.10(f). EPA's written responses to these inquiries are commonly referred to as alternative monitoring decisions. Furthermore, EPA responds to written inquiries about the broad range of NSPS and NESHAP regulatory requirements as they pertain to a whole source category. These inquiries may pertain, for example, to the type of sources to which the regulation applies, or to the testing, monitoring, recordkeeping, or reporting requirements contained in the regulation. EPA's written responses to these inquiries are commonly referred to as regulatory interpretations.

    EPA currently compiles EPA-issued NSPS and NESHAP applicability determinations, alternative monitoring decisions, and regulatory interpretations, and posts them to the ADI on a regular basis. In addition, the ADI contains EPA-issued responses to requests pursuant to the stratospheric ozone regulations, contained in 40 CFR part 82. The ADI is a data system on the Internet with over three thousand EPA letters and memoranda pertaining to the applicability, monitoring, recordkeeping, and reporting requirements of the NSPS, NESHAP, and stratospheric ozone regulations. Users can search for letters and memoranda by date, office of issuance, subpart, citation, control number, or by string word searches.

    Today's notice comprises a summary of 66 such documents added to the ADI on March 22, 2016. This notice lists the subject and header of each letter and memorandum, as well as a brief abstract of the letter or memorandum. Complete copies of these documents may be obtained from the ADI on the Internet through the Resources and Guidance Documents for Compliance Assistance page of the Clean Air Act Compliance Monitoring Web site under “Air” at: https://www2.epa.gov/compliance/resources-and-guidance-documents-compliance-assistance.

    Summary of Headers and Abstracts

    The following table identifies the control number for each document posted on the ADI data system on March 22, 2016; the applicable category; the section(s) and/or subpart(s) of 40 CFR part 60, 61, or 63 (as applicable) addressed in the document; and the title of the document, which provides a brief description of the subject matter.

    We have also included an abstract of each document identified with its control number after the table. These abstracts are provided solely to alert the public to possible items of interest and are not intended as substitutes for the full text of the documents. This notice does not change the status of any document with respect to whether it is “of nationwide scope or effect” for purposes of CAA section 307(b)(1) For example, this notice does not convert an applicability determination for a particular source into a nationwide rule. Neither does it purport to make a previously non-binding document binding.

    ADI Determinations Uploaded on March 22, 2016 Control No. Categories Subparts Title 1500021 NSPS J Change to Alternative Sulfur Monitoring Plan for Flare System. 1500022 NSPS J Alternative to Hydrogen Sulfide Monitoring for Flare System. 1500023 NSPS EEEE Applicability Determination for a Rural Institutional Waste Incinerator. 1500024 NSPS DD Regulatory Interpretation for Grain Elevators with Expanded Capacity. 1500025 NSPS AAAA Applicability Determination for a Small Municipal Waste Combustor. 1500026 NSPS Y NSPS Source Test Plan Approval. 1500027 NSPS A, DD Performance Test Waivers for New Design and Identical Units at Grain Elevators. 1500028 NSPS A, JJJJ Test Waiver for Identical Biogas-fueled Generators. 1500029 NSPS A, JJJJ 30-Day Advance Test Notice Waiver for Generators. 1500030 NSPS CCCC, EEEE Applicability Determination for Incinerator Burning MSW or RDF. 1500031 NSPS Dc Applicability Determination for Boiler De-rating. 1500033 NSPS KKKK Request for Performance Test Waiver at Combustion Turbine. 1500034 NSPS Ec Alternative Monitoring of Waste Combusted. 1500035 NSPS CCCC Applicability Determination for Incinerator Burning MSW or RDF. 1500036 NSPS GG Monitoring at Turbines During Non-Operational Periods. 1500038 NSPS A, JJJJ 30-Day Advance Test Notice Waiver for Generators. 1500039 NSPS Cb, Eb Carbon Feed Rate Monitoring Waiver Request. 1500049 NSPS KKKK Performance Test Waiver for Identical Turbines. 1500051 NSPS J, Ja Alternative Monitoring Plan for Tank Degassing and Vapor Control Projects at Petroleum Refineries. 1500054 NSPS NNN Alternative Monitoring for an Absorber on a Distillation Unit. 1500056 NSPS OOO Applicability Determination for Nonmetallic Mineral Processing Loading Station Enclosed in a Building. 1500057 NSPS Ce, Ec Alternative Monitoring for Wet Scrubber at a Waste Incinerator. 1500058 NSPS J Alternative Monitoring for Wet Gas Scrubber In Lieu of COMS at an FCCU. 1500059 NSPS IIII Emergency Generator Applicability with Respect to Readiness Testing and Commissioning. 1500060 MACT, NESHAP, NSPS IIII, ZZZZ Regulatory Interpretation of NSPS and NESHAP Emergency Internal Combustion Engine Provisions. 1500062 NSPS Ja Alternative Monitoring of Hydrogen Sulfide and TRS in Sour Gas Routed to Flares. 1500063 NSPS J Alternative Monitoring Plan for Wet Gas Scrubber at a Refinery. 1500064 NSPS OOOO Alternate Reporting Schedule for Gas Plant. 1500065 NSPS JJJJ Applicability Determination and Testing Waiver Request for Spark Ignition Engines. 1500066 NSPS JJJJ Alternative Testing for Spark Ignition Engines. 1500067 NSPS IIII Alternative Test Method Request for Compression Ignition Engines Switching to Biodiesel. 1500068 NSPS J, Ja Alternative Monitoring of Hydrogen Sulfide from Portable Thermal Oxidizers at Multiple Refineries. 1500069 NSPS JJJJ Alternative Test Method to Cutter Analyzers for Emissions from an Internal Combustion Engine. 1500071 NSPS JJJJ Alternative Test Method for Non-methane Organic Emissions from Stationary Spark Ignition Combustion Engines. 1500072 NSPS J Alternative Monitoring Plan for Hydrogen Sulfide Content of Refinery Fuel Gas. 1500073 MACT, NSPS ZZZZ, JJJJ Alternative Test Method for Non-methane Organic Emissions from Stationary Spark Ignition Combustion Engines. 1500074 NSPS Ec Deadline for Initial Compliance Testing of a Waste Incinerator. 1600004 NSPS DD Clarification of the Definition of Permanent Storage Facilities. A150001 Asbestos M Standard Practice for Comprehensive Building Asbestos Surveys. C150001 CFC C Regulatory Interpretation of Evaporator Coil Leak Repair Requirement. M150010 MACT, NESHAP, NSPS A, PPPPPP, KK Request for Opacity Test Waiver. M150011 MACT, NSPS ZZZZ, IIII Applicability of Emergency and Certified Engines to NSPS and NESHAP. M150012 MACT ZZZZ Applicability Determination for Nonroad versus Stationary Engine. M150013 MACT, NESHAP HHHHHH Applicability Determination for Vehicle Undercoating. M150015 MACT, NESHAP A, PPPPPP Alternative Visible Emission Monitoring at a Lead Acid Battery Plant. M150016 MACT, NESHAP MMMMMM, YY Applicability of Tire Reclamation Facility to Carbon Black Production NESHAP. M150017 MACT, NESHAP HHHHHH Regulatory Interpretation of Applicability of Truck Bed Lining Operations to Area Source NESHAP for Paint Stripping and Miscellaneous Surface Coating. M150023 MACT LLL Alternative Monitoring for Particulate Matter on a Common Stack at a Portland Cement Plant. M150024 MACT S Alternative Averaging Time for Inlet Flow Monitoring as a Surrogate for Methanol Destruction at a Pulp and Paper Facility. M150025 MACT ZZZZ Alternative Load Level for Pressure Drop Measurement at Internal Combustion Engines. M150026 MACT, NSPS ZZZZ, IIII Applicability Determination for Internal Combustion Engine to NSPS and NESHAP. M150027 MACT ZZZZ Applicability Determination for Remote Reciprocating Internal Combustion Engine. M150028 MACT DDDD, DDDDD Applicability Determination for Rotary Gasifiers as Process Heaters to the Boiler MACT. M150029 MACT ZZZZ Performance Test Waiver for Reciprocating Internal Combustion Engines. M150030 MACT DDDDD Applicability Determination for a Hybrid Suspension Grate Biomass Boiler under the Boiler MACT. M150031 MACT JJJJJJ Applicability Determination for Electric Generating Units under the Boiler Area Source NESHAP. M150034 MACT ZZZZ Applicability Determination for Backup Power Generator under RICE NESHAP. M150036 MACT, NESHAP A 60-day Advance Test Notice Waiver. Z150002 NESHAP N Applicability Determination for Manufacture of Colored Art Glass. Z150004 MACT, NESHAP, NSPS ZZZZ, Db, IIII, JJJJ Applicability Determination for Offshore Gas Port Emission Units. Z150005 MACT, NESHAP ZZZZ Applicability Determination for Emergency Stationary Internal Combustion Engines at an Institutional Facility. Z150006 MACT, NESHAP ZZZZ Regulatory Interpretation on Minimizing Engine Idle Time for Internal Combustion Engines. Z150009 MACT, NESHAP ZZZZ Regulatory Interpretation of Emergency Generator Provisions under NESHAP Subpart ZZZZ. Z150010 MACT, NESHAP ZZZZ Regulatory Interpretation on Rule Applicability to Stationary Engines. Z150011 MACT, NESHAP ZZZZ Applicability Determination for Emergency Engines to RICE NESHAP. Abstracts Abstract for [1500021]

    Q: Will EPA approve a change to the previously approved March 22, 2011 alternative monitoring plan (AMP) for Shell Oil Products Puget Sound Refinery (PSR) in Anacortes, Washington?

    A: Yes. EPA conditionally approves Shell's revision to the PSR 2011 AMP. For the monitoring of H2S, PSR is requesting to monitor as required by NSPS subpart J, rather than the alternative monitoring method that was specified in the 2011 AMP. PSR requests that certain portions of the approved AMP stay in place to maintain approval of an alternative means for demonstrating compliance for three interconnected flares. The conditions that must be satisfied to allow PSR to rely on the AMP instead of utilizing an H2S continuous monitoring system according to subpart J are stated in the EPA approval letter.

    Abstract for [1500022]

    Q: Will EPA approve an alternative monitoring plan (AMP) for the Shell Oil Anacortes, Washington facility to install, maintain, and operate a total sulfur continuous monitoring system (CMS) as an alternative to a hydrogen sulfide (H2S) CMS, and to use sulfur data collected at the east flare to represent the sulfur content at the north and south flares?

    A: Yes. EPA conditionally approves Shell's AMP for utilizing a H2S CMS. The conditions to allow Shell to rely on the AMP instead of utilizing an H2S CMS are stated in the EPA is approval letter.

    Abstract for [1500023]

    Q: Will EPA grant approval of exempted status under 40 CFR 60.2887(h) of the NSPS subpart EEEE as a rural institutional waste incinerator for an incineration unit that Glacier Bay National Park and Preserve (the Park) in Alaska intends to purchase and install?

    A: Yes. EPA determines that the proposed incinerator meets the exclusion for rural institutional waste incinerators because the unit is located more than 50 miles from the boundary of the nearest Metropolitan Statistical Area, alternative disposal options are not available or are economically infeasible, and the Park has submitted this request prior to initial startup of the incinerator.

    Abstract for [1500024]

    Q: Are all on-site units at Kalama Export located in Kalama, Washington that were constructed after August 3, 1978, subject to NSPS subpart DD for Grain Elevators when applicability is triggered due to expanded capacity?

    A: No. In its response to the Southwest Clean Air Agency in Vancouver, Washington, EPA explains that the rule applies to each individual affected facility at a grain elevator. Therefore, only the units that are constructed, modified, or reconstructed when and after the NSPS is triggered because of expanded capacity become subject to the rule.

    Abstract for [1500025]

    Q1: Does NSPS subpart AAAA for Small Municipal Waste Combustion (MWC) Units apply to gas combustion turbine that combust a small amount of non-condensable hydrocarbon gases, which is located at the Green Power facility in Pasco, Washington?

    A1: Yes. In a response to the Washington State Department of Ecology and the counsel to the source, EPA indicates that the NSPS subpart AAAA applies to the gas combustion turbine it is considered to be within the MWC unit boundaries and based on the capacity of the MWC. Based on the MWC definition at 40 CFR 60.1465, the catalytic pressure-less de-polymerization process (CDP) begins the MWC since it is used to convert municipal solid waste into synthetic liquid petroleum fuel, which includes a small amount of non-condensable hydrocarbon gases. Since the non-condensable hydrocarbon gas generated by the CDP is combusted in the turbine, the compressor section and combustor section of the turbine at the facility are within the MWC boundaries. In addition, it is determine that the combustion capacity of the MWC, which would not include the capacity attributable to the flare since it is a control device, is within the applicable range of subpart AAAA. Furthermore, the Green Power operation does not combust landfill gases and the landfill gas exemption, therefore, is not applicable.

    Q2: Does NSPS subpart AAAA apply to the Green Power CDP if it operates in anaerobic environment, exposed only to inert gases, due to explosion hazard?

    A2: No. EPA determines that the Green Power CDP would not be subject to Subpart AAAA due to the absence of combustion if the plant is constructed such that there is no combustion of the synthetic fuel product.

    Q3: Does NSPS subpart AAAA apply to the Green Power proposed Algae Production Alternative whereby the non-condensable hydrocarbon gases produced in the reactor are routed to a biological treatment unit as a nutrient in the production of algae which would subsequently be harvested and reintroduced as a feedstock for the CDP process?

    A3: No. EPA determines that in this scenario Subpart AAAA would not apply due to the absence of combustion.

    Abstract for [1500026]

    Q: Will EPA approve a source test plan submitted by Eielson Air Force Base in Alaska for a particulate matter source test on six bin vent filters for a new mechanical coal tipper subject to NSPS subpart Y?

    A: Yes. EPA approves the Eielson source test plan under subpart Y. Eielson has incorporated the guidance received by EPA regarding the proper location for a testing port installation to address issues with inadequate duct diameter sizing for that bin into the source test plan.

    Abstract for [1500027]

    Q1: Will EPA, in consideration of difficulty in applying existing methods to new technology, waive the Method 5 and a portion of the Method 9 readings for three ship loader bustle filters at EGT Development, LLC's (EGT's) Export Elevator facility at Port of Longview, Washington?

    A1: Yes. EPA grants EGT the waiver for the Method 5 reading required under the initial performance and for a portion of the required Method 9 readings for the three bustle filters for several reasons. There are technical difficulties that arise in performing the test methods with the new loading spout dust control system design. Specifically, technical issues arise with conducting the Method 5 test where the loading spout dust control system has been moved to the bottom of the ship loader spout, and with conducting a Method 9 opacity reading while the loading spout is within the hold of the ship loading grain. These technical issues combined with the anticipated significant margin of compliance, the testing of other units with identical filter media at the same facility, and the opacity readings that can be performed justifies the waiver approval.

    Q2: Will EPA approve a waiver of initial performance testing for certain Donaldson bin vent CPV design PowerCore Filters (CPV filters) that EGT plans to install at this facility when they are in a group of identical units?

    A2: Yes. EPA waives the initial Method 5 performance test for certain CPV filters as outlined in the EPA approval letter. NSPS emission test results with Duraplex filter media show maximum emissions are an order of magnitude lower than the manufacturer's guarantee (0.002 grains/dscf), and two orders of magnitude lower than the 0.01 grains/dscf NSPS limit. Furthermore, the local air permitting authority will be requiring additional testing on a reasonable schedule and there will be a rotation of testing within a group, so that a different unit within the group is tested each time for any future performance tests. This applies to a total of 14 NSPS test units, which represents a group of identical units where that group is unique, has a unique air volume and aspirates a conveyor or facility with a unique conveying capacity.

    Abstract for [1500028]

    Q: Will EPA waive the requirement for Cargill Environmental Finance (Cargill) to performance test at two biogas-fueled generators under NSPS subpart JJJJ based on the test results of an identical (third) biogas-fueled generator at the Dry Creek Dairy in Hanson, Idaho?

    A: Yes. EPA waives the Cargill performance test for the three generators that are located at the same facility, produced by the same manufacture, have the same model number, rated capacity, operating specifications, and are maintained in a similar manner. There is a substantial margin of compliance documented by the prior performance test results that were submitted.

    Abstract for [1500029]

    Q: Will EPA waive the requirement of 40 CFR 60.8(d) to provide notification 30 days in advance of a performance test for recently installed biogas-fueled generators at Big Sky West in Gooding, Idaho due to winter weather conditions and the pending holidays?

    A: Yes. EPA waives the requirement to provide notification 30 days in advance of a performance test pursuant to the provisions at 40 CFR 60.19(f)(3) to implement it early in December due to weather conditions and the pending Holidays. EPA requests that you provide the exact testing date, a copy of the full testing protocol, and the results of the test once completed to the regulatory agencies.

    Abstract for [1500030]

    Q: Does EPA determine that Shell Offshore's incineration unit located on the Discoverer Drill vessel, operated in the Chukchi Sea is exempted from the requirements of 40 CFR part 60 subpart CCCC for Commercial and Industrial Solid Waste Incineration Units pursuant to the exemption provided in 40 CFR 60.2020(c)(2)?

    A: Yes. Based on the information provided, EPA determines that Shell's incinerator qualifies for the exemption in 40 CFR 60.2020(c)(2) for units under a certain capacity that burn greater than 30 percent municipal solid waste or refuse-derived fuel, provided that Shell keeps the records required to demonstrate that it continues to qualify for the exemption on an ongoing basis.

    Abstract for [1500031]

    Q: Does EPA determine that physical changes made to two boilers subject to NSPS subpart Dc owned and operated by Yakama Forest Products (YFP) at the Large Log Complex have de-rated the boilers' heat input capacity?

    A: Yes. Based on the test data submitted following the physical changes of replacing the burners on each boiler, EPA determines that boilers No. 3 and 4 have been permanently de-rated to a heat input capacity below 30 MM BTU/hr. YFP must ensure that oil pressure at the burners meets the conditions of this determination to remain consistent with the conditions during the source test that was the basis for this determination.

    Abstract for [1500033]

    Q: Will EPA approve Northwest Pipeline's request for an extension of the deadline to conduct a performance test required by 40 CFR 60.4340(a) in NSPS subpart KKKK for a turbine located at the Chehalis Compressor Station?

    A: No. EPA determines that an applicable basis for waiving the testing requirement has not been identified. According to 40 CFR 60.4340(a), testing can be performed once every two years when emissions are less than 75 percent of the emission limit. Therefore, Northwest Pipeline must perform annual performance tests in accordance with § 60.4400.

    Abstract for [1500034]

    Q: Will EPA approve an alternative monitoring procedure (AMP)for monitoring the amount of waste combusted in the Northstar incinerator to demonstrate that the incinerator qualifies for the co-fired combustor exemption under 40 CFR part 60 subpart Ec for Hospital Medical Infectious Waste (HMIW) Incinerators located at BP Exploration Alaska's (BPXA's) Northstar Development Facility in the Beaufort Sea?

    A: No. EPA denies the AMP because use of the proposed method to weigh only the HMIW incinerated, instead of weighing both the HMIW and the non-HMIW, will not assure compliance with BPXA's claim that the incinerator meets the exemption for co-fired combustors under 40 CFR part 60 subpart Ec, as well as the exemption for “municipal waste combustion units” in 40 CFR 62.14525(c)(2).

    Abstract for [1500035]

    Q: Does EPA determine that Andarko's incineration unit located at various drilling locations within the Gubik and Chandler Prospects in Alaska is exempted from the requirements of 40 CFR part 60 subpart CCCC pursuant to the provisions at 40 CFR 60.2020(c)(2)?

    A: Yes. Based on the information provided, EPA determines that Andarko's incinerator qualifies for the exemption in 40 CFR 60.2020(c)(2) for units under a certain capacity that burn greater than 30 percent municipal solid waste or refuse-derived fuel. Andarko must keep the records required to demonstrate that it continues to qualify for the exemption on an ongoing basis.

    Abstract for [1500036]

    Q: Is fuel sampling required for two turbines owned by Black Hills Corporation that monitor under NSPS subpart GG custom fuel monitoring schedules for semi-annual periods in which the turbines have not operated for the entire semi-annual period? The turbines are located at the Glenns Ferry Cogeneration Partners and Rupert Cogeneration Partners facilities in Idaho.

    A: No. EPA determines that fuel sampling required by a custom fuel monitoring schedule is not required for semi-annual periods in which the turbine has not operated for the entire semi-annual period. Sampling must be done upon re-startup.

    Abstract for [1500038]

    Q: Will EPA waive the requirement in 40 CFR 60.8(d) for Cargill to provide a notification 30 days in advance of a performance test for the recently installed biogas-fueled generators at Dry Creek Dairy in Hansen, Idaho?

    A: Yes. EPA waives the requirement to provide notification 30 days in advance of a performance test pursuant to the provisions at 40 CFR 60.19(f)(3). The source identified a date on which testing would be conducted.

    Abstract for [1500039]

    Q: Will EPA grant a waiver to Covanta Marion, Incorporated (CMI) in Brooks, Oregon, for the municipal waste combustor (MWC) unit load level limitations, under 40 CFR 60.53b(b)(2), for the two weeks preceding, and during the annual dioxin/furan and mercury performance tests for the purpose of evaluating system performance?

    A: Yes. For the purpose of evaluating system performance, EPA waives the MWC load limit for the two week period preceding, and during the annual dioxin/furan and mercury performance test.

    Abstract for [1500049]

    Q: Will EPA provide a waiver pursuant to 40 CFR 60.8(b)(4) from the initial and subsequent performance testing requirement under NSPS subpart KKKK for three identical Solar Saturn T-1301 turbines operating under the same conditions on the same platform in the Cook Inlet at XTO Energy's Kenai, Alaska facility?

    A: Yes. EPA grants the request to expand the November 9, 2011 waiver to Solar Saturn T-1301 turbine, serial number SDR-105092 under the condition that a different turbine will be tested each year on a three year rotation. If any tests exceeds 50 percent of the NOx emission limits, all turbines will be required to conduct performance tests.

    Abstract for [1500051]

    Q: Can EPA approve an Alternative Monitoring Plan (AMP) for Envent Corporation to conduct monitoring of hydrogen sulfide (H2S) emissions, in lieu of installing a continuous emission monitoring system when performing tank degassing and other similar operations controlled by portable, temporary thermal oxidizers, at refineries in Region 6 States that are subject to NSPS subparts J or Ja?

    A: Yes. EPA conditionally approves the AMP based on the description of the process, the vent gas streams, the design of the vent gas controls, and the H2S monitoring data furnished. EPA specifies the proposed operating parameter limits and data which the refineries must furnish as part of the conditional approval. The approved AMP applies only to similar degassing operations conducted by ENVENT at refineries in EPA Region 6.

    Abstract for [1500054]

    Q: Is the alternative monitoring plan (AMP) submitted to the Tennessee Department of Environment and Conservation (TDEC) for the distillation unit in Source B-99A-2 at the Eastman Chemical Company (Eastman) facility in Kingsport, Tennessee acceptable?

    A: Yes. Based upon the information provided in the AMP by Eastman, EPA determines that the AMP is acceptable since the proposed monitoring parameters (water flow rate, propionic acid flow rate, and propionic acid inlet temperature) will provide adequate assurance of compliance. We agree that three of the parameters that the company would be required to monitor under NSPS subpart NNN (propionic acid specific gravity, water specific gravity, and water temperature) will not be useful indicators of absorber performance for the source in question. For ongoing compliance demonstration, EPA also provides guidance on how to define excess emissions in terms of the alternative monitoring parameters.

    Abstract for [1500056]

    Q1: Does a silo or frame structure enclosing a railcar loading station at three separate Hi-Crush Proppant nonmetallic mineral processing plants located in Augusta, Independence, and Blair, Wisconsin meet the definition of a “building” under NSPS subpart OOO?

    A1: Yes. Based on Hi-Crush's representation that the enclosed railcar loading stations are housed in structures with roofs, EPA concludes that these structures would meet the definition of “building” in NSPS subpart OOO.

    Q2: Would the openings of those buildings be considered a “vent”?

    A2: No. The building openings have no mechanically induced air flow for the purpose of exhausting from a building.

    Q3: Since these railcar loading stations are contained in a building, would the applicable particulate matter standard only be that fugitive emissions from the building openings must not exceed 7 percent opacity?

    A3: Yes. One emission limit option for an enclosed railcar loading station that is itself enclosed in a building is to restrict fugitive emissions from the building openings (except for vents as defined in 40 CFR 60.671) to 7 percent opacity, per section 60.672(e)(1).

    Abstract for [1500057]

    Q: Does EPA approve a waiver from the 40 part 60 subpart Ec requirement to monitor the minimum pressure drop across a wet scrubber that control emissions of acid gases (i.e., HCl) and is part of the emission control system for the Stericycle hospital/medical/infectious waste incineration (HMIWI) unit in Apopka, Florida? The Stericycle HMIWI unit is equipped with a dry scrubber followed by a fabric filter and a wet scrubber and with a selective noncatalytic reduction system. All other applicable parameter monitoring requirements are proposed to be met by the facility.

    A: Yes. EPA approves the waiver request since the removal of acid gases is not dependent on the monitoring of wet scrubber minimum pressure drop and all other applicable monitoring parameters for the control system will be met. Monitoring of the other wet scrubber monitoring parameters identified in Table 3 of subpart Ec (i.e., the minimum scrubber liquor flow rate and the minimum scrubber liquor pH) will indicate if the scrubber is working properly. Further, compliance with the PM emission limit is achieved without the use of the wet scrubber based on information.

    Abstract for [1500058]

    Q: May an Alternative Monitoring Plan (AMP) be conditionally approved for parametric monitoring in lieu of a continuous opacity monitoring system (COMS) for a Wet Gas Scrubber (WGS) on a Fluidized Catalytic Cracking Unit (FCCU) subject to NSPS subpart J, at the Phillips 66 Company Alliance Refinery in Belle Chasse, Louisiana?

    A: Yes. Based on the information provided, EPA approves the AMP for the proposed operating parameters conditioned on the source conducting a performance test that demonstrates compliance and that establishes the operating parameter limits (OPLs) for the WGS. EPA approves the two proposed operating parameters, including the 1) minimum Liquid-to-Gas (L/G) Ratio on a 3-hour rolling average basis; and, 2) minimum slurry liquid circulation pump discharge pressure on a 3-hour rolling average basis. The OPLs are to be recalculated based on the average of three runs, provided the average PM emissions for the three runs meet the PM emissions limit of the rule in pounds per kilopounds of coke processed.

    Abstract for [1500059]

    Q: Is Capitol One National Association required to petition the Administrator under 40 CFR 60.4211(e) for approval to exceed the 100 hour readiness testing limit for emergency generators testing for commissioning purposes under subpart IIII for internal compression engines during the initial onsite commissioning process of its Data Center in Chester, Virginia?

    A: No. A petition is not necessary or appropriate. When a new greenfield source is under construction, subpart IIII allows emergency generators to be used as needed to complete the construction process, so long as Capitol One abides by the 100 hours limitation when the Data Center is in commercial operation.

    Abstract for [1500060]

    Q: Portland General Electric Company (PGE) seeks verification that the emergency diesel-fired emergency generators at its Carver Readiness Center in Clackamas, Oregon, run for 50 of 100 hours total use to supply power, allowed under NSPS subpart IIII and NESHAP subpart ZZZZ, can be part of its Dispatchable Standby Generation (DSG) program.

    A: 40 CFR 60.4211 and 63.6640 authorize limited non-emergency use of diesel engines that are classified and regulated as emergency engines. EPA determines that the language in 40 CFR 63.6640 of subpart ZZZZ regarding emergency engines dispatched under a financial arrangement with another entity was not intended to prohibit utilities from dispatching engines that they own and operate under the 50-hour non-emergency operation option provided.

    Abstract for [1500062]

    Q: Does EPA approve revisions to the Alternative Monitoring Plan (AMP) for monitoring hydrogen sulfide (H2S) concentration and determining the total reduced sulfur (TRS) concentration in the sour gas routed to flares at the Lion Oil Company El Dorado (Lion Oil), Arkansas Refinery, which are subject to NSPS subpart Ja?

    A: Yes. EPA conditionally approves Lion Oil's revised AMP, which supersedes previous approvals to expand use of the approved AMP for determining TRS under NSPS subpart Ja, and that includes additional operating parameters, clarifications on sampling locations, and test protocol specifications.

    Abstract for [1500063]

    Q: Does EPA approve a revision to an Alternative Monitoring Plan (AMP) that has been conditionally approved for the wet gas scrubber (WGS) on a Fluidized Catalytic Cracking Unit (FCCU) at Marathon Petroleum's refinery in Texas City, Texas subject to NSPS Part 60 subpart J, be resubmitted for approval of a revision based on an additional operation mode at reduced charge rate?

    A: Yes. EPA conditionally approves the revision to the EPA-approved AMP based on the additional information provided by Marathon to add an additional mode of operation. The condition for approval requires Marathon to conduct performance testing to demonstrate compliance and to establish the operating parameter limits (OPLs) for the WGS at the additional FCCU reduced charge rate, as established in the EPA response letter.

    Abstract for [1500064]

    Q: Does EPA approve alternate semiannual reporting periods under section 60.5420(b) of NSPS subpart OOOO to run from April 1 through September 30, and from October 1 through March 31, at the Atlas Pipeline Driver Gas Plant in Midland, Texas?

    A: Yes. EPA approves the proposed alternate reporting schedule to align the periodic reporting time period requirements of NSPS subpart 0000 since it does not extend the reporting period that would be covered by the next semiannual report, as allowed under section 60.5420(b). The alternate reporting schedule does not extend the reporting period that would be covered by the next semiannual.

    Abstract for [1500065]

    Q1: Are the five City of Rock Island Public Works Department 880 HP spark ignition natural gas fired engines (plus one offline spare) at their wastewater treatment plant in Wisconsin considered emergency engines under NSPS subpart JJJJ?

    A1: No. Since the engines would be operated approximately 16 times per year for 270 hours, EPA determines that the engines do not meet the definition of emergency stationary internal combustion engines. Therefore, the engines are subject to subpart JJJJ.

    Q2: Can a waiver from performance testing be granted for the engines?

    A2: No. EPA cannot grant a waiver of performance testing for these engines, but due to the potential difficulties in testing, EPA encourages the City to request alternative testing if necessary.

    Abstract for [1500066]

    Q: May EPA approve an alternative to stack testing under NSPS subpart JJJJ for nine identical non-certified Riverview bio-gas fueled generators located on three farms (Riverview Dairy, West River Dairy, and District 45 Dairy) in Minnesota?

    A: No. EPA does not approve any of the five alternative options proposed by Riverview for its generators, which included: (1) exemption from ongoing testing for engines that meet the standard, (2) retroactive certification by the manufacturer, (3) self-certification through testing, (4) provide certification to manufacturers that have met the standards, and (5) test one engine and apply results to all nine. However, EPA does provide two alternatives, Modified Option 1A and 1B that could be used to demonstrate compliance. Modified Option 1A is annual testing for NO, NOX, CO and O2 using a portable analyzer. Modified Option 1B is to test each dairy's engine sets at least once every three years, rotating annually on a three-year cycle.

    Abstract for [1500067]

    Q: May an alternative test method be approved for Hawaiian Electric Company's four new compression ignition engines subject to NSPS subpart IIII at the Honolulu International Airport in Oahu that were certified on diesel but will be operated on biodiesel?

    A: Yes. EPA determines that operation of the engines on biodiesel would not void the certification if all of the following conditions are met: the biodiesel meets the requirements of 40 CFR 60.4207(b), the manufacturer's warranty includes the use of the biodiesel, and the biodiesel meets ASTM D6751. The engines must also be installed, configured, operated and maintained per the manufacturer's instructions.

    Abstract for [1500068]

    Q: Does EPA approve an Alternative Monitoring Plan (AMP) for Evergreen Industrial Services (EIS) to conduct monitoring of hydrogen sulfide (H2S) emissions in lieu of installing a continuous emission monitoring system (CEMS), to monitor emissions controlled by portable and temporary thermal oxidizers units (TOUs) during tank degassing and other similar operations at refineries in Region 6 that are subject to NSPS subparts J or Ja?

    A: Yes. Based on the description of the process, the vent gas streams, the design of the vent gas controls, and the H2S monitoring data furnished, EPA conditionally approves the AMP when EIA is conducting degassing operations at refineries in Region 6 since it is impractical to use a H2S CEMS in a portable TOUs. The EPA response letter list the operating conditions for degassing operations and data which the refineries must furnish to EIS as part of the conditional approval.

    Abstract for [1500069]

    Q: May Derenzo & Associates in Livonia, Michigan use a TECO Model 55C analyzer in lieu of Method 18 that will be used with Method 25A to determine nonmethane organic compounds emitted from an internal combustion engine subject to NSPS subpart JJJJ?

    A: Yes. EPA approves the request to use TECO Model 55C as an alternative to Method 18 for measuring methane since it should produce results similar to the “cutter” analyzers already allowed by the regulation.

    Abstract for [1500071]

    Q: Does EPA approve the use by TRC Companies located in Lowell, Massachusetts of a TECO Model 55C analyzer to measure non-methane organic compounds (NMOC) from engines subject to NSPS subpart JJJJ?

    A: Yes. EPA approve TRC Companies request for use of the TECO Model 55C analyzer in lieu of Method 18 to measure NMOC from subpart JJJJ engines, and the analyzer may be used by other engines subject to NSPS subpart JJJJ. EPA will announce this as broadly applicable to all stationary spark ignition combustion engines on our Web site at http://www.epa.gov/ttn/emc/trnethods.html#CatB).

    Abstract for [1500072]

    Q1: Does EPA conditionally approve a revision to a previously approved Alternative Monitoring Plan (AMP) to allow for an automatic sampling system, and an associated flow meter for collecting and recording hydrogen sulfide (H2S) content, to be included for the West Operations Ground Flare (Multi Jet Flare), which is part of a Flare Gas Recovery System (FGRS) subject to NSPS subpart Ja, at the Motiva Enterprises Norco Refinery in Norco, Louisiana?

    A1: Yes. EPA conditionally approves the AMP revision based on how the automatic sampling system functions regarding the configuration and operation of the FGRS. The H2S concentration of the combined refinery fuel gas stream routed to the FGRS and the Multi Jet Flare was less than 1 part per million. This satisfied EPA's condition for approval that the H2S content shall be inherently low. Additionally, the automatic sampling device samples the blended fuel gas stream before it is sent to the Multi Jet Flare, and there are no crossover points between the FGRS and other fuel gas streams. This satisfied EPA's condition for approval that no crossover points shall exist in the fuel gas vent stream going to the Multi Jet Flare. Based on review by EPA Headquarters, Motiva also was authorized to use an alternate test method for testing and analysis, which removed the previous requirement to measure and record refinery fuel gas H2S concentrations using the Length of Stain Tube method. EPA's “Conditions for Approval of the Alternative Monitoring Plan for Miscellaneous Refinery Fuel Gas Streams, dated December 7, 1999, are incorporated by reference, except for the monitoring provisions in Steps 1 through 7, as described in the EPA response letter.

    Q2: What recordkeeping and report requirements are included in the conditional approval?

    A2: Motiva shall maintain the H2S concentration data from the sampling system and the alternate test method in the laboratory information management system. The gas flow data from the flow meter will be maintained in the electronic process data storage system. Additional records shall be kept to note when the FGRS is operating in either of two different scenarios. Quarterly reporting must be submitted, except more frequently under certain circumstances, as outlined in the conditional EPA approval letter.

    Abstract for [1500073]

    Q: May Derenzo & Associates in Livonia, Michigan use the TECO Model 55I analyzer (which is a newer version of the previously approved Model 55C) in lieu of Method 18 and Method 25A to determine non-methane organic compounds (NMOC) emitted from RICE subject to NSPS subpart JJJJ or NESHAP subpart ZZZZ?

    A: Yes. EPA approves the alternative testing request for NSPS subpart JJJJ, provided that the facility follows all applicable requirements in Method 25A for sample heating, appropriate test procedures, calibration and standardization. Since NESHAP subpart ZZZZ does not require the measurement of NMOC that part of the request is not considered.

    Abstract for [1500074]

    Q: Can EPA confirm the proposed deadline for completing the initial performance test under 40 CFR part 60 subpart Ec for the University of Texas Medical Branch's medical infectious waste incinerator in Galveston, Texas?

    A: Yes. EPA confirms that the initial compliance performance test should be completed within 60 days of achieving maximum production rate, and not later than 180 days after initial startup as required under section 60.8 of the General Provisions.

    Abstract for [A150001]

    Q: Does the use of the Pre-Construction Survey, as described in ASTM E2356-14 “Standard Practice for Comprehensive Building Asbestos Surveys,” demonstrate compliance with the “thorough inspection” requirement at 40 CFR 61.145(a)?

    A: Yes. If an owner/operator follows the steps described in Sections 1 through 5 and Section 8 in ASTM E2356-14 “Standard Practice for Comprehensive Building Asbestos Surveys”, it would provide a thorough inspection of the facility. However, EPA would not accept the Limited Asbestos Screen (i.e., Practice E2308) described in Section 1.5 as a substitute for the Comprehensive Building Asbestos Survey, and would not consider the Limited Asbestos Screen as a thorough inspection.

    Abstract for [C150001]

    Q: Do regulations related to ozone depleting substances under 40 CFR part 82 prohibit the use of Leak Stop to repair leaks in residential air conditioning systems that contain chlorofluorocarbons?

    A: No. The use of aerosol chemical products such as Leak Stop are not prohibited as long as there is no “knowing venting” or “knowing release” of an ozone depleting substance taking place. We do not currently have any information about the propellant used by the Leak Stop product. However, if it is propelled by a Class I or II ozone depleting substance, then it is banned under the non-essential products exclusion found at 40 CFR 82.60.

    Abstract for [M150010]

    Q: Will EPA approve a waiver of the initial performance test according to the provisions of 40 CFR 60.8(b)(4) and 63.7(h) for a new chemset chamber subject to the NESHAP for Lead Acid Battery Manufacturing, 40 CFR part 63 subpart PPPPPP, and the NSPS for Lead Acid Battery Manufacturing, 40 CFR part 60 subpart KK, at the Johnson Controls Battery Group Inc.'s (JCBGI”s) facility in Canby, Oregon?

    A: No. EPA is denying the requested waiver because the new unit is not identical to the previously installed units and could have a different capacity. While emissions are expected to be low, the initial performance test is valuable to verify the installations of new equipment.

    Abstract for [M150011]

    Q: Will EPA approve a National Security Exemption (NSE)for the Department of Defense to waive the performance testing requirements for twelve stationary diesel fired engines constructed between 2003 and 2009, all of which are subject to the National Emissions Standard for Hazardous Air Pollutants for Stationary Reciprocating Internal Combustion Engines (RICE) at 40 CFR part 63, subpart ZZZZ, while five engines are also subject to the New Source Performance Standard for Compression Ignition RICE at 40 CFR part 60, subpart IIII, which are located at Fort Greely, Alaska?

    A: No. An NSE exemption is not necessary because 40 CFR part 63 subpart ZZZZ does not require performance testing for emergency engines; according, an exemption from performance testing is not necessary for these twelve engines if they meet the definition of “emergency stationary RICE” under subpart XXXX. In addition, subpart IIII does not require performance testing for manufactured-certified engines; accordingly, an exemption from performance testing under subpart IIII is not necessary for the five manufactured-certified engines located at Fort Greely.

    Abstract for [M150012]

    Q: Does EPA determine that the operation of an emergency generator owned and operated by the Union Pacific Railroad's rail yard facility in Lane County, Oregon is classified as a stationary source under NESHAP subpart ZZZZ?

    A: No. EPA determines that the engine used to provide power restoration for emergencies at railroad tunnels in Oregon is a portable diesel generator. Because the engine has not provided power, or operated for emergency use, or any other purpose other than testing at the location where it has been stored for more than 12 months, it does not meet the definition of stationary engine for that location under subpart ZZZZ.

    Abstract for [M150013]

    Q1: Does EPA determine that 40 CFR part 63 subpart HHHHHH, National Emission Standards for Hazardous Air Pollutants: Paint Stripping and Miscellaneous Surface Coating Operations at Area Sources, apply to the process of spray applying vehicle undercoating?

    A1: Yes. EPA determines the process of spray applying vehicle undercoating is subject to NESHAP subpart HHHHHH. The undercoating would be considered a coating under the NESHAP definitions and would not be a sealant. It is generally spray-applied using a hand-held device that creates an atomized mist of coating and deposits the coating on a sub straight, just as are other automotive coatings.

    Q2: Does EPA determine that the exemption for facilities that do not spray-apply target HAP-containing coatings is available to part of a facility?

    A2: No. EPA determines that a facility that is not exempt must satisfy the rule requirements for all of their spray-applied coating operations. If the facility spray-applies no target HAP, then it may request exemption from the rule.

    Abstract for [M150015]

    Q: Will EPA approve an alternative to the visible emissions monitoring requirement of 40 CFR 63.11423(b) of the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Lead Acid Battery Manufacturing Area Sources, subpart PPPPPP, for Johnson Controls Battery Group Incorporated's facility in Canby, Oregon to shut down equipment per permit conditions if any visible emissions are observed rather than continuing to operate and conduct a Method 9 test?

    A: Yes. EPA approves this minor change in monitoring methodology pursuant to 40 CFR 63.8(b)(i) because it will be more stringent than that which is required according to 40 CFR 63.11423(b) by the NESHAP standard.

    Abstract for [M150016]

    Q: Does 40 CFR part 63 subpart MMMMMM for Area Source Carbon Black Production apply to Reklaim Technologies' tire reclamation facility at the Port of Morrow near Boardman, Oregon?

    A: No. Based on the information provided by Reklaim, EPA determines that the process at Reklaim's facility is materially different from the “carbon black production” process that is subject to subpart MMMMMM. The process involves heating shredded tires in an oxygen starved environment to recover carbon black, oil and steel from the tires. As such the process does not fall within the definition of “carbon black production” and is not subject to subpart MMMMMM.

    Abstract for [M150017]

    Q: The Olympic Region Clean Air Agency (ORCAA) in Port Angeles, Washington asked if 40 CFR part 63 subpart HHHHHH for Paint Stripping and Miscellaneous Surface Coating Operations apply to the process of spray-applied truck bed lining.

    A: EPA determines that operations that spray-apply coatings to truck bed liners, including color coatings, are subject to subpart HHHHHH, based on the definitions of coatings and spray-applied coating operations in 40 CFR 63.11180. Although the definition of “truck bed liner coating” does exclude color coats, that definition is not referred in 40 CFR 63.11170, the applicability section for subpart HHHHHH. The lining operation is generally spray-applied using a hand-held device that creates an atomized mist of coating and deposits the coating on a substrate, just as are other automotive coatings.

    Abstract for [M150023]

    Q: Does EPA approve Holcim's particulate matter (PM) alternative continuous parameter monitoring system (CPMS) plan for the common stack venting exhaust emissions from different sources at their Portland cement plant in Florence, Colorado, subject to the National Emission Standards for Hazardous Air Pollutants From the Portland Cement Manufacturing Industry, subpart LLL?

    A: Yes. Pursuant to 40 CFR 63.8(f)(2) and 63.1350(o)(4), EPA conditionally approves the use of one PM CPMS on the common stack whereby a site-specific operating limit is established that corresponds to the results of performance testing demonstrating compliance with the kiln and clinker cooler emission limits. The conditions for approval are specified in the EPA response letter.

    Abstract for [M150024]

    Q: Does EPA approve an alternative monitoring plan that uses a longer averaging time for inlet flow monitoring as a surrogate parameter for monitoring methanol destruction in the Aeration Stabilization Basin (ASB) subject to the National Emission Standards for Hazardous Air Pollutants (NESHAP) from the Pulp and Paper Industry, subpart S, at the Clearwater Paper Corporation, Cypress Bend Mill located in McGehee, Arkansas?

    A: Yes. Based on the monitoring data provided by the company and performance test results, EPA approves the AMP request. EPA agrees that a daily flow is not representative of the actual hydraulic retention time in the ASB, whereas a nine-day rolling average inlet flow established per 40 CFR 63.453(n)(4) provides an actual representation of the treatment system retention time.

    Abstract for [M150025]

    Q: Does EPA approve an alternative monitoring request to conduct monthly pressure differential measurements across the catalyst at load conditions within plus or minus 10 percent of the baseline load established during the initial engine performance tests outlined in QEP Field Services Company's (QEP) Consent Decree, rather than the plus or minus 10 percent of 100 percent load as required in 40 CFR part 63 subpart ZZZZ for Stationary Reciprocating Internal Combustion Engines located at Chapita, Coyote Wash, Island and Wonsits Valley Compressor Stations?

    A: Yes. EPA conditionally approves the AMP request pursuant to § 63.8(t)(2) based on the performance testing negotiated as part of the QEP Consent Decree. EPA believes that it is technically appropriate to conduct the monthly pressure drop readings at plus or minus 10 percent of the load at an affected facility engine when the initial performance test that was conducted is showing compliance with the MACT ZZZZ. The conditions for approval are described in the EPA response letter.

    Abstract for [M150026]

    Q: Do NSPS subpart IIII and NESHAP subpart ZZZZ apply to the engine of a mobile power generator in Springdale, Arkansas that is designed to supply electrical power on a temporary basis, at various locations within the Kawneer Springdale Plant, and does not remain at any location greater than 12 months?

    A: No. EPA determines that NSPS subpart IIII and NESHAP subpart ZZZZ do not apply since this engine is considered a nonroad mobile source. The mobile generator is a wheeled unit and its engine meets the criteria for a nonroad engine that it be by itself or in or on a piece of equipment that is portable or transportable. Furthermore, it will not remain in a single location for longer than 12 consecutive months.

    Abstract for [M150027]

    Q1: Is the stationary gas compression reciprocating internal combustion engine (RICE) at the Dimension Energy Company Coquille Bay, Louisiana facility a remote affected source under 40 CFR part 63 subpart ZZZZ?

    A1: Yes. After reviewing the description of the RICE and its operations, EPA determines that it is an existing area source which meets the definition of a remote stationary RICE under 40 CFR 63.6675.

    Q2: What are the continuing compliance requirements for a remote stationary RICE?

    A2: The operator must: Perform prescribed preventative maintenance at certain intervals; maintain the RICE according to the manufacturer's instructions; minimize startup time or develop a maintenance plan using good air pollution prevention practices; and, maintain records to demonstrate that applicable requirements have been completed.

    Abstract for [M150028]

    Q: Does EPA agree that the Callidus Closed Loop Gasification System (CCLGS) at the Del-Tin Fiber plant in El Dorado, Arkansas is exempt from the Boiler MACT, subpart DDDDD under the exemption at 40 CFR 63.7491(h) because it is subject to and complying with the Plywood MACT, subpart DDDD?

    A: No. The EPA determines that both the Boiler MACT and the Plywood MACT apply to specific components of the CCLGS based on a review of the design and operation information available for the Del-Tin Fiber facility, so the exemption at 40 CFR 63.7491(h) does not apply. The rotary gasifiers and secondary combustion chamber (SCC) are considered affected sources, specifically defined as “process heaters” under the Boiler MACT when combustion gases are not used to directly heat process material. The portion of combustion gases that directly flow through the dryer units are considered affected sources under the Plywood MACT (§ 63.2232(b) and § 63.2292) and are thereby exempted from the Boiler MACT requirements (§ 63.7491(1)). However, any combustion gases from the rotary gasifiers and the SCC that bypass the dryer units and are used for indirect heat transfer to process material or to heat transfer material for use in a process unit are subject to the Boiler MACT (§ 63.7575).

    Abstract for [M150029]

    Q: Does EPA agree to accept data from a prior performance test in lieu of a new performance test to demonstrate initial compliance with 40 CFR part 63 subpart ZZZZ for six natural gas fueled spark plug ignition engines at the ExxonMobil Chemical facility in Baton Rouge, Louisiana?

    A: Yes. EPA accepts a previous performance testing for six engines conducted in lieu of implementing an initial test. The testing was done using the same methods specified in subpart ZZZZ, and was conducted within two years of the performance test deadline. Additionally, the equipment was not modified following the April 2012 testing.

    Abstract for [M150030]

    Q: Does EPA agree that the RockTenn Hodge Mill Boiler in Hodge, Louisiana is a biomass hybrid suspension grate boiler under 40 CFR part 63 subpart DDDDD?

    A: Yes. EPA agrees that the boiler is subject to NESHAP subpart DDDDD since the description provided meets the definition of a hybrid suspension grate boiler found in the rule. Since natural gas and tire derived fuel (TDF) are also used, the facility must keep records to demonstrate the annual average moisture content is at or above 40 percent. The facility must use natural gas for startup, shutdown, and flame stabilization, and use TDF when excessively firing wet biomass fuel.

    Abstract for [M150031]

    Q: Are three Electric Utility Generating Units (EUGUs) located at the Lafayette Utilities System (LUS) Doc Bonin Electric Generating Station in Lafayette, Louisiana considered to be affected sources with gas-fired boilers that are not subject to Boiler Area Source MACT, subpart JJJJJJ?

    A: EPA determines that the boilers are not affected sources subject to the Boiler Area Source MACT if all conditions at 40 CFR 63.11237 are met. Gas-fired boilers are excluded from subpart JJJJJJ per 40 CFR 63.11195(e). A permit limitation is necessary to verify applicability requirements are met for each EUGU for burning fuel oil only during natural gas curtailment, and to not exceed testing hours with fuel oil during any calendar year.

    Abstract for [M150032]

    Q1: Does EPA approve an Alternative Monitoring Plan (AMP) for three Reciprocating Internal Combustion Engines (RICE) subject to NESHAP subpart ZZZZ at the Occidental Permian Terrill Gas Treating Facility for testing at less than 100 percent maximum load?

    A1: Yes. EPA approves Occidental Permian proposed AMP for a lower engine load be set as a maximum load for compliance demonstration. Specifically, we approve performance testing at the alternate lower maximum engine load with monitoring required at plus or minus 10 percent. The three RICE cannot operate at 100 percent load due to site-specific operations at the facility, and therefore cannot be tested at 100 percent plus or minus 10 percent operational capacity, as specified at 40 CFR 63.6620(b)(2). If operations change such that the maximum load of the engines exceeds the alternative lower maximum load, the AMP approval will be terminated, and retesting will be required to demonstrate compliance with NESHAP subpart ZZZZ at the higher engine load.

    Abstract for [M150034]

    Q: Does EPA agree that the backup power generator at the Freddie MAC facility in Carrollton, Texas is classified as an existing commercial emergency stationary Reciprocating Internal Combustion Engine (RICE) that is not subject to 40 CFR part 63 subpart ZZZZ?

    A: Yes. EPA determines that the Freddie MAC facility is an area source with a commercial NAICS code, and the backup power generator meets the exemption provided at 40 CFR 63.6585(f)(2) applicable to emergency stationary RICE operated at an area source. This RICE, used solely for backup power generation, have not exceeded 50 hours for any activities during any one year period within the past two year period.

    Abstract for [M150036]

    Q: Will EPA provide a waiver to CertainTeed Corporation of the 60-day requirement under 40 CFR 63.9(c) to notify EPA in advance of the initial performance test at the GS Roofing facility in Portland, Oregon?

    A: Yes. EPA is granting a waiver of the 60-day requirement for a notification prior to the initial performance test pursuant to 40 CFR 63.9(i) of the 40 CFR 63.9(c) requirement to enable testing during facility's highest volume period with the maximum ambient temperature, which is will occur in less than 60 days. This would enable the estimation of what the emissions are during a worst case scenario to test the limits of our system.

    Abstract for [Z150002]

    Q: Does 40 CFR part 61 subpart N apply to the Bullseye Glass Company's manufacture of colored art glass in its Portland, Oregon facility?

    A: Yes. NESHAP subpart N applies to the company's manufacture of colored art glass. According to 40 CFR 61.160(a), 40 CFR part 61 subpart N does not apply to pot furnaces but rather to each glass melting furnace that uses commercial arsenic as a raw material. However, based on information provided by Bullseye Glass including descriptions, photos and diagrams, EPA determines that the vessels used by Bullseye do not meet the definition of pot furnaces because they are not sealed off from the furnace atmosphere so that there is potential for emissions to escape with the furnace exhaust.

    Abstract for [Z150004]

    Q: Are boilers/engines/marine equipment on a liquefied natural gas carrier (LNGC) at the proposed Aguirre Gasport located approximately 3 miles offshore of the Puerto Rico Electric Power Authority subject to NSPS and NESHAP standards when the LNGC will be converted into a Floating Storage and Regasification Unit (FSRU) to be permanently moored at the GasPort?

    A: Yes. Based on the information provided, EPA determines that the FSRU is a stationary source because it utilizes boilers as the main propulsion devices instead of reciprocating internal combustion engines (RICE) and it will be permanently moored, except when there is a need to take the unit to safer water due to and special circumstances. Therefore, the affected equipment on the FSRU, except for non-reciprocating internal combustion engine (RICE), is subject to NSPS and NESHAP standards. All non-reciprocating RICE equipment on the FSRU is not a stationary sources because it falls under the definition of nonroad engines as they will be used on self-propelled equipment. Therefore, the NSPS and NESHAP do not apply to the nonroad RICE. However, the nonroad RICE must comply with the applicable nonroad engine standards in 40 CFR parts 89, 94, 1039, 1042, 1043, 1045, 1048, 1054, 1065, and 1068, if applicable. Specific questions on the requirements and applicability of a particular NSPS and NESHAP rules can be discussed separately on a case-by-case basis as the need arises.

    Abstract for [Z150005]

    Q: Are the 39 emergency stationary reciprocating internal combustion engines (RICE) at Los Alamos National Laboratory (LANL) area source facility subject to RICE NESHAP requirements?

    A: No. EPA determines that the 39 emergency RICE at LANL are not subject to the RICE NESHAP because they are located at an area source that is classified as an “institutional” facility. The RICE rule excludes existing stationary emergency engines located at residential, commercial, or institutional facilities that are area sources of HAP. Note that the engines must meet the definition of “Emergency stationary RICE” in 40 CFR 63.6675.

    Abstract for [Z150006]

    Q: Northern Natural Gas based in Omaha, Nebraska asked that, under 40 CFR 63.6625(h), part 63 NESHAP subpart ZZZZ for spark ignition reciprocating internal combustion engines (RICE) regarding minimizing engine idle time, if an engine does not complete start up within the thirty minute time limit, are there any restrictions on initiating another startup of the engine and/or the time frame to complete the subsequent startup?

    A: No. An engine does not need to be shut off if it does not complete startup within thirty minutes. However, any further activity after thirty minutes is considered part of normal operation. Multiple startups should be counted as separate events with a thirty minute time limit per event. If startups occur consecutively with short durations in between, they could be considered as one startup since startups are part of a single occasion where the engine is working up to normal operations.

    Abstract for [Z150009]

    Q1: May emergency Reciprocating Internal Combustion Engines (RICE) that currently do not qualify for the exclusion in 40 CFR 63.6585(f)(2) because they are contractually obligated to be available for more than 15 hours for the purposes specified at 40 CFR 63.6640(f)(2)(ii) and (iii) and (f)(4)(ii), later qualify for exclusion once those contracts expire, provided that the other conditions of 40 CFR 63.6585(f)(2) are met?

    A1: If an emergency stationary RICE does not meet the conditions for the exclusion in 40 CFR 63.6585(f)(2) as of the compliance date, then it is subject to subpart ZZZZ at the date of compliance. However, if the engine's status subsequently changes to meet the conditions of 40 CFR 63.6585(f)(2) after the compliance date, the engine would no longer be subject to subpart ZZZZ.

    Q2: Can emergency RICE located at area sources continue to participate in peak shaving programs for up to 50 hours per year until May 3, 2014 without losing their emergency engine status?

    A2: An emergency stationary RICE located at an area source of HAP emissions can be used for peak shaving for up to 50 hours per year until May 3, 2014 if the engine is operated as part of a peak shaving (load management program) with the local distribution system operator and the power is provided only to the facility itself or to support the local distribution system. This is the case whether or not the engine will be retrofitted to comply with the subpart ZZZZ standards for non-emergency engines.

    Q3: Do 40 CFR 63.6640(f)(4)(i) and (ii) address separate and distinct non-emergency situations, and does the “local reliability” exception set forth in 40 CFR 63.6640(f)(4)(ii) have no sunset provision?

    A3: Yes. 40 CFR 63.6640(f)(4)(i) and (ii) are separate and distinct situations and there is no sunset provision for the operation specified in § 63.6640(f)(4)(ii). An emergency stationary RICE at an area source of HAP emissions can continue to operate for up to 50 hours per calendar year for the purpose specified in § 63.6640(f)(4)(ii) beyond May 3, 2014.

    Q4: How does EPA interpret 40 CFR 63.6640(f)(4)(ii)(A), which requires that to qualify for the 50 hour exemption, the emergency RICE must be dispatched by the local balancing or local transmission and distribution system operator?

    A4: If the local transmission and distribution system operator informs the facility that they will be cutting their power, which, in turn, causes the facility to engage its emergency stationary RICE, the engine would be considered dispatched by the local transmission and distribution system operator.

    Abstract for [Z150010]

    Q1: What date is used under NESHAP subpart ZZZZ to determine if engines located at Allison Transmission Indianapolis facility in Indiana, are “existing” or “new”?

    A1: The rule uses the date that the engine commenced construction to determine if the engine is existing or new. The General Provisions to 40 CFR part 63 define both “construction” and “commenced” and those definitions are applied to the subpart.

    Q2: Does NESHAP subpart ZZZZ apply to an engine that has been rebuilt, specifically where the engine core is reused, but components such as pistons, rings and bearings are reconditioned or replaced?

    A2: A rebuilt engine would need to be evaluated to determine if reconstruction had occurred. The General Provisions to part 63 defines “reconstruction.”

    Abstract for [Z150011]

    Q: Are the emergency engines located at the NASA Langley Research Facility in Hampton, VA subject to NESHAP subpart ZZZZ for Reciprocating Internal Combustion Engines?

    A: No. EPA determines that the emergency engines are located at a facility that is an area source and classified as an “institutional” facility. Therefore, under 40 CFR 63.6590(b)(3), emergency engines at the facility are exempt from requirements under NESHAP subpart ZZZZ.

    Abstract for [1600004]

    Q: Does EPA accept the industry coalition request to rescind a November 21, 2007, letter to the National Grain and Feed Association in which EPA stated that temporary storage facilities meet the definition of “permanent storage capacity” under 40 CFR part 60, subpart DD, NSPS for Grain Elevators (Subpart DD), and required it be included when determining applicability of Subpart DD for a particular facility?

    A: Yes. The EPA is proposing revisions to Subpart DD and has also decided to re-evaluate the rationale for the November 21, 2007 letter. While the definition of “permanent storage capacity” in Subpart DD is broad, we are now aware that temporary storage facilities (TSFs) generally handle the grain less time throughout the year than other types of permanent storage facilities and may require different treatment. Also, while not dispositive as to the applicability of the rule to these units, we note that TSFs did not exist during the development of Subpart DD, and their processes and handling techniques were not specifically considered during the rulemaking process. For these reasons, EPA rescinds the November 21, 2007 letter. As a result, TSFs do not meet the definition of “permanent storage capacity” under Subpart DD and should not be included when determining applicability under Subpart DD for a particular facility.

    Dated: February 25, 2016. Betsy Smidinger, Acting Director, Office of Compliance.
    [FR Doc. 2016-07185 Filed 3-29-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1213] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The Commission may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before May 31, 2016.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email [email protected] and to [email protected] Include in the comments the Title as shown in the Supplementary Information section below.

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-1213.

    Title: Application to Participate in a Reverse Incentive Auction, FCC Form 177.

    Form Number: FCC Form 177.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities, not-for-profit institutions, and state, local or tribal governments.

    Estimated Number of Respondents and Responses: 600 respondents and 600 responses.

    Estimated Time per Response: 90 minutes.

    Frequency of Response: One-time reporting requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for the currently approved information collection is contained in sections 154(i) and 309(j)(5) of the Communications Act, as amended, 47 U.S.C. 4(i), 309(j)(5), and sections 1.2204 and 73.3700(h)(4)(i), (h)(4)(ii), and (h)(6) of the Commission's rules, 47 CFR 1.2204, 73.3700(h)(4)(i), (h)(4)(ii), and (h)(6).

    Estimated Total Annual Burden: 900 hours.

    Total Annual Costs: None.

    Nature and Extent of Confidentiality: Certain information collected on FCC Form 177 will be treated as confidential for various periods of time during the course of the broadcast incentive auction (BIA) pursuant to 47 U.S.C. 1452(a)(3) and section 1.2206(b) of the Commission's rules, 47 CFR 1.2206(b). To the extent necessary, respondents may request confidential treatment of information collected on FCC Form 177 that is not already being treated as confidential pursuant to section 0.459 of the Commission's rules. See 47 CFR 0.459.

    Privacy Act Impact Assessment: No impact(s).

    Needs and Uses: A request for approval of this information collection will be submitted to the Office of Management and Budget (OMB) after this 60-day comment period in order to obtain the full three year clearance from OMB. On February 22, 2012, the President signed the Spectrum Act, which, among other things, authorized the Commission to conduct incentive auctions, and directed that the Commission use this innovative tool for an incentive auction of broadcast television spectrum to help meet the Nation's growing spectrum needs. See Middle Class Tax Relief and Job Creation Act of 2012, Public Law 112-96, sections 6402, 6403, 125 Stat. 156 (2012) (Spectrum Act). The Commission's broadcast incentive auction (BIA) will have three main components: (1) A reverse auction in which broadcast television licensees will submit bids to voluntarily relinquish their spectrum usage rights in exchange for defined shares of proceeds from the forward auction; (2) a repacking of the broadcast television bands; and (3) a forward auction of initial licenses for flexible use of the newly available spectrum. The information collection requirements reported under this new collection are the result of various Commission actions in which the Commission adopted general rules to govern the auction—including various application disclosures and certifications that must be made by broadcast television licensees to establish their eligibility to participate in the reverse auction—in order to implement the new and novel incentive auction approach for use in the BIA.

    Under this information collection, the Commission will collect information that will be used to determine whether an applicant is legally qualified to participate in a reverse incentive auction. To aid in collecting this information, the Commission has created FCC Form 177, which the public will use to participate in reverse incentive auctions, including the Commission's upcoming broadcast incentive reverse auction. The Commission's auction rules and related requirements are designed to ensure that the competitive bidding process is limited to serious qualified applicants, deter possible abuse of the bidding and licensing process, and enhance the use of competitive bidding to assign Commission licenses and permits in furtherance of the public interest. The information collected on FCC Form 177 will be used by the Commission to determine if an applicant is legally qualified to participate in the reverse auction. Commission staff will review the information collected on FCC Form 177 as part of the pre-auction process, prior to the start of the reverse auction. Staff will determine whether each applicant satisfies the Commission's requirements to participate in the reverse auction. Without the information collected on FCC Form 177, the Commission will not be able to determine if an applicant is legally qualified to participate in the reverse auction and has complied with the various applicable regulatory and statutory auction requirements for such participation.

    Federal Communications Commission. Marlene H. Dortch, Secretary. Office of the Secretary.
    [FR Doc. 2016-07116 Filed 3-29-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1214] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before May 31, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-1214.

    Title: Direct Access to Numbers Order, FCC 15-70, Conditions.

    Form Number: N/A

    Type of Review: Revision of currently approved collection.

    Respondents: Business or other for-profit.

    Number of Respondents and Responses: 13 respondents; 13 responses.

    Estimated Time per Response: 10-20 hours.

    Frequency of Response: One-time application, on-going and bi-annual reporting requirements.

    Obligation to Respond: Voluntary. Statutory authority for this information collection is contained in 47 U.S.C. 251(e)(1).

    Total Annual Burden: 520 hours.

    Total Annual Costs: No cost.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: If respondents submit information which respondents believe is confidential, respondents may request confidential treatment of such information pursuant to section 0.459 of the Commission's rules, 47 CFR 0.459.

    Needs and Uses: In a June 2015 Report and Order (FCC 15-70), the Commission established the Numbering Authorization Application process, which allows interconnected VoIP providers to apply for a blanket authorization from the FCC that, once granted, will allow them to demonstrate that they have the authority to provide service in specific areas, thus enabling them to request numbers directly from the Numbering Administrators. This collection covers the information and certifications that applicants must submit in order to comply with the Numbering Authorization Application process. The data, information, and documents acquired through this collection will allow interconnected VoIP providers to obtain numbers with minimal burden or delay while also preventing providers from obtaining numbers without first demonstrating that they can deploy and properly utilize such resources. This information will also help the Federal Communications Commission (FCC) protect against number exhaust while promoting competitive neutrality among traditional telecommunications carriers and interconnected VoIP providers by allowing both entities to obtain numbers directly from the Numbering Administrators. It will further help the FCC to maintain efficient utilization of numbering resources and ensure that telephone numbers are not being stranded.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2016-07115 Filed 3-29-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0600 and 3060-0995] Information Collections Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before May 31, 2016.

    ADDRESSES:

    Direct all PRA comments to Cathy Williams, FCC, via email [email protected] and to [email protected] Include in the comments the Title as shown in the SUPPLEMENTARY INFORMATION section below.

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Cathy Williams at (202) 418-2918.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0600.

    Title: Application to Participate in an FCC Auction, FCC Form 175.

    Form Number: FCC Form 175.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities, not-for-profit institutions, and state, local or tribal governments.

    Estimated Number of Respondents and Responses: 500 respondents and 500 responses.

    Estimated Time per Response: 90 minutes.

    Frequency of Response: On occasion reporting requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for the currently approved information collection is contained in sections 154(i) and 309(j)(5) of the Communications Act, as amended, 47 U.S.C. 4(i), 309(j)(5), and sections 1.2105, 1.2110, 1.2112 of the Commission's rules, 47 CFR 1.2105, 1.2110, 1.2112. Statutory authority for the revised information collection is contained in sections 154(i) and 309(j)(5) of the Communications Act of 1934, as amended, 47 U.S.C. 4(i), 309(j)(5), and sections 1.2105, 1.2110, 1.2112 of the Commission's rules, as amended, 47 CFR 1.2105, 1.2110, 1.2112.

    Estimated Total Annual Burden: 750 hours.

    Total Annual Costs: None.

    Nature and Extent of Confidentiality: Information collected on FCC Form 175 is made available for public inspection, and the Commission is not requesting that respondents submit confidential information on FCC Form 175. Respondents seeking to have information collected on FCC Form 175 withheld from public inspection may request confidential treatment of such information pursuant to section 0.459 of the Commission's rules, 47 CFR 0.459.

    Privacy Act Impact Assessment: No impact(s).

    Needs and Uses: A request for extension of this information collection (no change in requirements) will be submitted to the Office of Management and Budget (OMB) after this 60-day comment period in order to obtain the full three year clearance from OMB. On February 22, 2012, the President signed the Spectrum Act, which, among other things, authorized the Commission to conduct incentive auctions, and directed that the Commission use this innovative tool for an incentive auction of broadcast television spectrum to help meet the Nation's growing spectrum needs. See Middle Class Tax Relief and Job Creation Act of 2012, Pub. L. 112-96, sections 6402, 6403, 125 Stat. 156 (2012) (Spectrum Act). The Commission's broadcast incentive auction (BIA) will have three main components: (1) A reverse auction in which broadcast television licensees will submit bids to voluntarily relinquish their spectrum usage rights in exchange for defined shares of proceeds from the forward auction; (2) a repacking of the broadcast television bands; and (3) a forward auction of initial licenses for flexible use of the newly available spectrum.

    The Commission is revising the currently approved information collection on FCC Form 175 to implement new collection requirements that are the result of (1) various Commission actions in which the Commission adopted general rules and procedures to govern the BIA, including rules applicable to applicants seeking to participate in the forward auction component of the BIA and, (2) the Commission's adoption of new and modified competitive bidding rules and requirements in the Updating Part 1 Report and Order, which will apply to applicants seeking to participate in a Commission auction, including the forward auction component of the BIA.

    The Commission's auction rules and related requirements are designed to ensure that the competitive bidding process is limited to serious qualified applicants, deter possible abuse of the bidding and licensing process, and enhance the use of competitive bidding to assign Commission licenses in furtherance of the public interest. The information collected on FCC Form 175 is used by the Commission to determine if an applicant is legally, technically, and financially qualified to participate in a Commission auction. Additionally, if an applicant applies for status as a particular type of auction participant pursuant to Commission rules, the Commission uses information collected on FCC Form 175 to determine whether the applicant is eligible for the status requested. Commission staff reviews the information collected on FCC Form 175 for a particular auction as part of the pre-auction process, prior to the auction being held. Staff determines whether each applicant satisfies the Commission's requirements to participate in the auction and, if applicable, is eligible for the status as a particular type of auction participant it requested. Without the information collected on FCC Form 175, the Commission will not be able to determine if an applicant is legally, technically, and financially qualified to participate in a Commission auction, including the forward auction component of the BIA, and has complied with the various applicable regulatory and statutory auction requirements for such participation.

    The Commission plans to continue to use the FCC Form 175 for all upcoming, non-reverse spectrum auctions, including those required or authorized to be conducted pursuant to the Spectrum Act, collecting only the information necessary for each particular auction.

    OMB Control Number: 3060-0995.

    Title: Section 1.2105(c), Bidding Application and Certification Procedures; Sections 1.2105(c) and 1.2205, Prohibition of Certain Communications.

    Form Number: N/A.

    Type of Review: Extension of a currently approved collection.

    Respondents: Business or other for-profit entities, not-for-profit institutions, and state, local or tribal governments.

    Estimated Number of Respondents and Responses: 10 respondents and 10 responses.

    Estimated Time per Response: 1.5 hours to 2 hours.

    Frequency of Response: On occasion reporting requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this currently approved information collection is contained in sections 154(i) and 309(j) of the Communications Act, as amended, 47 U.S.C. 4(i), 309(j)(5), and section 1.2105(c) of the Commission's rules, 47 CFR 1.2105(c). Statutory authority for the revised information collection is contained in sections 154(i), 309(j), and 1452(a)(3) of the Communications Act, as amended, 47 U.S.C. 4(i), 309(j)(5), 1452(a)(3), and sections 1.2105(c) and 1.2205 of the Commission's rules, 47 CFR 1.2105(c), 1.2205.

    Estimated Total Annual Burden: 50 hours.

    Total Annual Costs: $9,000.

    Nature and Extent of Confidentiality: The Commission will take all reasonable steps to protect the confidentiality of all Commission-held data of a reverse auction applicant consistent with the confidentiality requirements of the Spectrum Act and the Commission's rules. See 47 U.S.C. 1452(a)(3); 47 CFR 1.2206. In addition, to the extent necessary, a full power or Class A television broadcast licensee may request confidential treatment of any report of a prohibited communication submitted to the Commission that is not already being treated as confidential pursuant to section 0.459 of the Commission's rules, 47 CFR 0.459. Forward auction applicants are entitled to request confidentiality in accordance with section 0.459 of the Commission's rules, 47 CFR 0.459.

    Privacy Act Impact Assessment: No impact(s).

    Needs and Uses: A request for extension of this information collection (no change in requirements) will be submitted to the Office of Management and Budget (OMB) after this 60-day comment period in order to obtain the full three year clearance from OMB. On February 22, 2012, the President signed the Spectrum Act, which, among other things, authorized the Commission to conduct incentive auctions, and directed that the Commission use this innovative tool for an incentive auction of broadcast television spectrum to help meet the Nation's growing spectrum needs. See Middle Class Tax Relief and Job Creation Act of 2012, Public Law 112-96, sections 6402, 6403, 125 Stat. 156 (2012) (Spectrum Act), codified at 47 U.S.C. 309(j)(8)(G), 1452. The Commission's broadcast incentive auction (BIA) will have three main components: (1) A reverse auction in which broadcast television licensees will submit bids to voluntarily relinquish their spectrum usage rights in exchange for defined shares of proceeds from the forward auction; (2) a repacking of the broadcast television bands; and (3) a forward auction of initial licenses for flexible use of the newly available spectrum.

    The Commission is revising the currently approved information collection to implement new collection requirements resulting from the Commission's adoption of new and modified rules prohibiting certain communications for full power and Class A television broadcast licensees and for applicants seeking to participate in the forward auction component of the BIA and requiring such covered parties to file a report with the Commission within a specified period of time if they make or receive a prohibited communication. Subject to certain exceptions, section 1.2205(b) of the Commission's rules provides that, beginning on the deadline for submitting applications to participate in the reverse auction and until the results of the incentive auction are announced by public notice, all full power and Class A broadcast television licensees are prohibited from communicating directly or indirectly any incentive auction applicant's bids or bidding strategies to any other full power or Class A broadcast television licensee or to any forward auction applicant. Section 1.2205(c) requires any party that makes or receives a prohibited communication to report such communication in writing to the Commission immediately, and in no case later than five business days after the communication occurs. Section 1.2205(d) provides the procedures for filing any reports required under section 1.2205(c). Subject to certain exceptions, forward auction applicants in the BIA are subject to a BIA-specific provision in section 1.2105(c) of the Commission's rules (in addition to the Commission's existing prohibited communications rule applicable to applicants in traditional Commission auctions), which provides that, beginning on the deadline for submitting applications to participate in the forward auction and until the results of the incentive auction have been announced by public notice, all forward auction applicants are prohibited from communicating directly or indirectly any incentive auction applicant's bids or bidding strategies to any full power or Class A broadcast television licensee. Section 1.2105(c) requires forward applicants that make or receive a prohibited communications that is prohibited under section 1.2105(c) to file a report of such a communication with the Commission.

    The Commission's rules prohibiting certain communications in Commission auctions are designed to reinforce existing antitrust laws, facilitate detection of collusive conduct, and deter anticompetitive behavior, without being so strict as to discourage pro-competitive arrangements between auction participants. They also help assure participants that the auction process will be fair and objective, and not subject to collusion. The information collected through the Commission's existing reporting requirement under section 1.2105(c) allows the Commission to enforce the prohibition on forward auction applicants by making clear the responsibility of parties who receive information that potentially violates the rules to promptly report to the Commission, thereby enhancing the competitiveness and fairness of its spectrum auctions. The revised information collection under the BIA-specific rule in section 1.2105(c) and in sections 1.2205(c) and 1.2205(d) will likewise help the Commission enforce the prohibition on covered parties in the BIA, further assuring incentive auction participants that the auction process will be fair and competitive. The prohibited communication reporting requirement required of covered parties will enable the Commission to ensure that no bidder gains an unfair advantage over other bidders in its auctions and thus enhances the competitiveness and fairness of Commission's auctions. The information collected will be reviewed and, if warranted, referred to the Commission's Enforcement Bureau for possible investigation and administrative action. The Commission may also refer allegations of anticompetitive auction conduct to the Department of Justice for investigation.

    Federal Communications Commission. Marlene H. Dortch, Secretary, Office of the Secretary.
    [FR Doc. 2016-07121 Filed 3-29-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0895] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before May 31, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0895.

    Title: Numbering Resource Optimization, CC Docket No. 99-200.

    Form Number: FCC Form 502.

    Type of Review: Revision of a currently approved collection.

    Respondents: Business or other for-profit entities and state, local or tribal government.

    Number of Respondents and Responses: 2,793 respondents; 10,165 responses.

    Estimated Time per Response: 1 hour-44.4 hours.

    Frequency of Response: On occasion and semi-annual reporting requirements and recordkeeping requirement.

    Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in 47 U.S.C. 151, 153, 154, 201-205 and 251 of the Communications Act of 1934.

    Total Annual Burden: 132,384 hours.

    Total Annual Cost: $3,465,570.20.

    Privacy Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: Disaggregated, carrier specific forecast and utilization data will be treated as confidential and will be exempt from public disclosure under 5 U.S.C. 552(b)(4).

    Needs and Uses: The data collected on FCC Form 502 helps the Commission manage the ten-digit North American Numbering Plan (NANP), which is currently being used by the United States and 19 other countries. Under the Communications Act of 1934, as amended, the Commission was given “exclusive jurisdictions over those portions of the North American Numbering Plan that pertains to the United States.” Pursuant to that authority, the Commission conducted a rulemaking in March 2000 that the Commission found that mandatory data collection is necessary to efficiently monitor and manage numbering use. The Commission is revising this information collection to implement its newly adopted rules that allow interconnected Voice over Internet Protocol (VoIP) providers to obtain numbering resources directly from the Numbering Administrators. The following information collection requirements will be contained in this collection:

    (1) Utilization/Forecast Report;

    (2) Application for initial numbering resource;

    (3) Application for growth numbering resources;

    (4) Recordkeeping requirement;

    (5) Notifications by state commissions;

    (6) Demonstration to state commission; and

    (7) Petitions for additional delegation of numbering authority.

    The data from this information collection is used by the FCC, state regulatory commissions, and the NANPA to monitor numbering resource utilization by all carriers using the resource and to project the dates of area code and NANP exhaust.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2016-07148 Filed 3-29-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-0953] Information Collection Being Reviewed by the Federal Communications Commission AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.

    The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

    DATES:

    Written PRA comments should be submitted on or before May 31, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-0953.

    Title: Sections 95.1111 and 95.1113, Frequency Coordination/Coordinator, Wireless Medical Telemetry Service (WMTS).

    Form No.: N/A.

    Type of Review: Revision of a currently approved collection.

    Respondents: Business or other for-profit and not-for-profit institutions.

    Number of Respondents and Responses: 3,000 respondents; 3.000 responses.

    Estimated Time per Response: 1-5 hours.

    Frequency of Response: On occasion reporting requirement, third party disclosure requirement and recordkeeping requirement.

    Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 154 and 303.

    Total Annual Burden: 15,000 hours.

    Total Annual Cost: $750,000.

    Privacy Act Impact Assessment: N/A.

    Nature and Extent of Confidentiality: No information is requested that would require assurance of confidentiality.

    Needs and Uses: The Commission will submit this information collection to OMB as a revision after this 60 day comment period to obtain the full three-year clearance from them.

    On August 11, 2015 the Federal Communications Commission released a Report and Order, Amendment of Part 15 of the Commission's Rules for Unlicensed Operations in the Television Bands, Repurposed 600 MHz Band, 600 MHz Guard Bands and Duplex Gap, and Channel 37, and Amendment of Part 74 of the Commission's Rules for Low Power Auxiliary Stations in the Repurposed 600 MHz Band and 600 MHz Duplex Gap, ET Docket No 14-165, GN Docket No. 12-268, FCC 15-99, which modifies Commission rules for unlicensed wireless devices and wireless microphones in the reconstituted TV bands and the new 600 MHz band.

    On June 12, 2000, the Commission released a Report and Order, ET Docket No. 99-255, FCC 00-211, which allocated spectrum and established rules for a “Wireless Medical Telemetry Service” (WMTS) that allows potentially life-critical equipment to operate in an interference-protected basis. Medical telemetry equipment is used in hospitals and health care facilities to transmit patient measurement data such as pulse and respiration rate to a nearby receiver, permitting greater patient mobility and increased comfort. The Commission designated a frequency coordinator, who maintains a database of all WMTS equipment. All parties using equipment in the WMTS are required to coordinate/register their operating frequency and other relevant technical operating parameters with the designated coordinator. The database provides a record of the frequencies used by each facility or device to assist parties in selecting frequencies to avoid interference. Without a database, there would be no record of WMTS usage because WMTS transmitters will not be individually licensed. The designated frequency coordinator has the responsibility to maintain an accurate engineering database of all WMTS transmitters, identified by location (coordinates, street address, and building), operating frequency, emission type and output power, frequency range(s) used, modulation scheme used, effective radiated power, number of transmitters in use at the health care facility at the time of registration, legal name of the authorized health care provider, and point of contact for authorized health care provider. The frequency coordinator will make the database available to WMTS users, equipment manufacturers and the public. The coordinator will also notify users of potential frequency conflicts. In addition, in order to receive interference protection, parties operating WMTS networks on channel 37 shall notify one of the white space database administrators of their operating location pursuant to §§ 15.713(j)(11) and 15.715(p) of that chapter.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2016-07117 Filed 3-29-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION FDIC Systemic Resolution Advisory Committee; Notice of Meeting AGENCY:

    Federal Deposit Insurance Corporation.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, Pub. L. 92-463 (Oct. 6, 1972), 5 U.S.C. App. 2, notice is hereby given of a meeting of the FDIC Systemic Resolution Advisory Committee (the “SR Advisory Committee”), which will be held in Washington, DC. The SR Advisory Committee will provide advice and recommendations on a broad range of issues regarding the resolution of systemically important financial companies pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act, Pub. L. 111-203 (July 21, 2010), 12 U.S.C. 5301 et seq. (the “Dodd-Frank Act”).

    DATES:

    Thursday, April 14, 2016, from 9:00 a.m. to 3:00 p.m.

    ADDRESSES:

    The meeting will be held in the FDIC Board Room on the sixth floor of the FDIC Building located at 550 17th Street NW., Washington, DC.

    FOR FURTHER INFORMATION CONTACT:

    Requests for further information concerning the meeting may be directed to Mr. Robert E. Feldman, Committee Management Officer of the FDIC, at (202) 898-7043.

    SUPPLEMENTARY INFORMATION:

    Agenda

    The agenda will include a discussion of a range of issues and developments related to the resolution of systemically important financial companies pursuant to the Dodd-Frank Act. The agenda may be subject to change. Any changes to the agenda will be announced at the beginning of the meeting.

    Type of Meeting

    The meeting will be open to the public, limited only by the space available, on a first-come, first-served basis. For security reasons, members of the public will be subject to security screening procedures and must present valid photo identification to enter the building. The FDIC will provide attendees with auxiliary aids (e.g., sign language interpretation) required for this meeting. Those attendees needing such assistance should call (703) 562-6067 (Voice or TTY) at least two days before the meeting to make necessary arrangements. Written statements may be filed with the SR Advisory Committee before or after the meeting. This SR Advisory Committee meeting will be Webcast live via the Internet and subsequently made available on-demand approximately two weeks after the event. Visit https://fdic.primetime.mediaplatform.com/#!/channel/1384300429544/ Advisory+Committee+on+Systemic+Resolution to view the event. If you need any technical assistance, please visit our Video Help page at: https://www.fdic.gov/video.html.

    Dated: March 25, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary, Federal Deposit Insurance Corporation.
    [FR Doc. 2016-07127 Filed 3-29-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL MARITIME COMMISSION [Docket No. 16-07] Notice of Filing of Complaint and Assignment

    Jill M. Alban, Grant M. Alban, Mary Arnold, Al Baker, Katrina Bonar, Emmett R. Brophy, Steven Bruzonsky, Monica Bushey, Craig Buske, Doda “Danny” Camaj, Stephanie B. Crosby, Melinda Deneau, Jennifer Dillon, Jeffrey L. Gannon, Pamela Goessling,Thomas Goessling, Sean Gurney, Sheryl Haley, Lesley Denise Hart, Bruce Hertz, Elizabeth Ashley Hill Nèe Edwards, Maria Kooken, Adair Lara, Christine Laster, Kori Lehrkamp, Michael Lehrkamp, John Leyva, Joan Macquarrie, Daniel Morris, Tony Nikprelaj, Gustavo Adolfo Perez, Judy A. Reiber, Roberta Rothstein, Jeffrey Rubinstein, Alexandra Scott, Jason Smith, Catherine Taylor, Richard Tomasko, and Demian Vargas,

    V.

    Nippon Yusen Kabushiki Kaisha, Nyk Line (North America) Inc., Mitsui O.S.K. Lines, Ltd., Mitsui O.S.K. Bulk Shipping (USA), Inc., World Logistics Service (USA) Inc., Höegh Autoliners AS, Höegh Autoliners, Inc., Nissan Motor Car Carriers Co. Ltd., Kawasaki Kisen Kaisha, Ltd., “K” Line America, Inc., Wallenius Wilhelmsen Logistics AS, Wallenius Wilhelmsen Logistics Americas LLC, EUKOR Car Carriers Inc., Compañía Sud Americana De Vaporess.A., and CSAV Agency North America, LLC

    Notice is given that a Complaint has been filed with the Federal Maritime Commission (Commission) by the above named Complainants, on behalf of themselves and all others similarly situated, hereinafter “Complainants,” against the above named providers of “Vehicle Carrier Services” and unnamed co-conspirators, hereinafter “Respondents.” The Complaint is brought as a proposed class action. Complainants “seek to represent all persons and entities in the United States who purchased or leased a new, assembled motor vehicle for personal use and not for resale, incorporating a Vehicle Carrier Service charge charged by any Respondent or any current or former subsidiary or affiliate thereof, or any co-conspirator, from and including January 1, 2000. . . .” Complainants allege that Respondents “transport large numbers of cars, trucks, and other automotive vehicles including agriculture and construction equipment . . . across large bodies of water using specialized cargo ships known as Roll On/Roll Off vessels. . . .”

    Complainants allege that Respondents violated provisions of the Shipping Act of 1984, including 46 U.S.C. 40302(a), 41102(b)(1), 41102(c), 41103(a)(1) and (2), 41104(10), 41105(1) and (6), and the Commission's regulations at 46 CFR 535.401 et seq., because they “participated in a combination and conspiracy to suppress and eliminate competition in the Vehicle Carrier Services market by agreeing to fix, raise, stabilize and/or maintain the prices of, and allocate the market and customers for Vehicle Carrier Services sold to automobile manufacturers and others in the United States, and elsewhere, for the import and export of new, assembled motor vehicles to and from the United States.”

    Complainants request the following relief:

    (1) That Respondents be required to answer the charges herein;

    (2) That after due investigation and hearing Respondents be found to have violated 46 U.S.C. 40302(a), 41102(b)(l), 41102(c), 41103(a)(l) and (2), 41104(10), 41105(1) and (6), and 46 CFR 535.401, et seq., and such other provisions as to which violations may be proved hereunder;

    (3) The FMC determine that this action may be maintained as a class action under Rule 23(a), (b)(2) and (b)(3) of the Federal Rules of Civil Procedure, and direct that reasonable notice of this action, as provided by Rule 23(c)(2) of the Federal Rules of Civil Procedure, be given to each and every member of the Class;

    (4) That Complainants be awarded reparations in a sum to be proven under 46 U.S.C. 41305, with interest (46 U.S.C. 41305(a)) and reasonable attorneys' fees (46 U.S.C. 41305 (b));

    (5) That Complainants be awarded double its proven actual injury under 46 U.S.C. 41305(c) because Respondents and their co-conspirators violated 46 U.S.C. 41102(b) and 41105(1);

    (6) That Respondents be found jointly and severally liable for the conduct alleged herein including that of their co-conspirators; and

    (7) That such other and further order or orders be made as the FMC determines to be proper.

    The full text of the complaint can be found in the Commission's Electronic Reading Room at www.fmc.gov/16-07.

    This proceeding has been assigned to the Office of Administrative Law Judges. The initial decision of the presiding officer in this proceeding shall be issued by March 24, 2017 and the final decision of the Commission shall be issued by October 10, 2017.

    Karen V. Gregory, Secretary.
    [FR Doc. 2016-07105 Filed 3-29-16; 8:45 am] BILLING CODE 6731-AA-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Agency for Healthcare Research and Quality, HHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “Survey of Hospital Quality Leaders.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

    DATES:

    Comments on this notice must be received by May 31, 2016.

    ADDRESSES:

    Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at [email protected]

    Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.

    FOR FURTHER INFORMATION CONTACT:

    Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]

    SUPPLEMENTARY INFORMATION: Proposed Project Survey of Hospital Quality Leaders

    The Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Hospital Survey (HCAHPS) was first implemented on a voluntary basis in 2006 to assess patients' experiences with care. Today, hospitals subject to the Inpatient Prospective Payment System (IPPS) annual payment update provisions are required to collect and submit HCAHPS data in order to receive their full annual payment update. In addition, HCAHPS performance was added to the calculation of the value-based incentive payment in the Hospital Value-Based Purchasing (Hospital VBP) program, beginning with discharges in October 2012. The FY 2015 Hospital VBP program links 30% of the Inpatient Prospective Payment System hospitals' payment from CMS to HCAHPS performance.

    Despite the high stakes associated with HCAHPS scores, little is known about the ways in which hospitals are using HCAHPS data and supplemental information about patient experience to understand and improve their patients' experiences.

    This research has the following goals:

    (1) To characterize the role of HCAHPS in hospitals' efforts to improve patient experiences

    (2) to identify the types of quality improvement activities that hospitals implement to improve their HCAHPS scores

    (3) to describe hospitals' perspectives on HCAHPS

    (4) to determine the types of information collected by hospitals beyond those required for Hospital VBP

    This study is being conducted by AHRQ through its contractor, the RAND Corporation, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).

    Method of Collection

    Survey of Hospital Quality Leaders: This survey will elicit information from approximately 500 hospital quality leaders in a variety of hospital settings, including high- and low-performing hospitals, facilities of varying sizes, and hospitals representing all nine geographic Census divisions. Hospital quality leaders will be asked to provide information about the use of HCAHPS in their hospital, with questions addressing all of the substantive areas identified in the goals section above.

    Characterizing hospitals' use of HCAHPS data will provide important insight into the activities hospitals conduct to improve patient experience scores. This information may be useful in supporting hospitals that lag behind their peers, learning from hospitals with outstanding records of patient experience, and providing recommendations that may be used to refine HCAHPS survey content.

    Estimated Annual Respondent Burden

    Table 1 shows the estimated annualized burden and cost for the respondents' time to participate in this data collection. These burden estimates are based on tests of data collection conducted on nine or fewer entities. As indicated below, the annual total burden hours are estimated to be 294 hours. The annual total cost associated with the annual total burden hours is estimated to be $14,708.

    Table 1 shows the estimated annualized burden for the respondents' time to participate in this data collection. The Survey of Hospital Quality Leaders will be administered to 500 individuals. Prior work suggests that 3-5 items can typically be completed per minute, depending on item complexity and respondent characteristics, (Hays & Reeve, 2010; Berry, 2009). We have calculated our burden estimate using a conservative estimate of 4.5 items per minute. The survey contains 159 items and is thus estimated to require an average administration time of 35 minutes. As indicated below, the annual total burden hours are estimated to be 294 hours.

    Table 1—Estimated Annualized Burden Hours and Cost Collection task Number of
  • respondents
  • Number of
  • responses per respondent
  • Hours
  • per response
  • Total burden hours Average
  • hourly wage
  • rate *
  • Total cost
  • burden
  • Survey of Hospital Quality Leaders 500 1 .59 294 $49.96 $14,708 Totals 294 $14,708 * Based upon mean hourly wages, “National Compensation Survey: All United States December 2009-January 2011,” U.S. Department of Labor, Bureau of Labor Statistics.
    Request for Comments

    In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

    Sharon B. Arnold, Acting Director.
    [FR Doc. 2016-07118 Filed 3-29-16; 8:45 am] BILLING CODE 4160-90-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members AGENCY:

    Agency for Healthcare Research and Quality (AHRQ), HHS.

    ACTION:

    Notice of request for nominations for public members.

    SUMMARY:

    42 U.S.C. 299c establishes a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to carry out its mission. AHRQ's mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used.

    The terms of seven current members will expire in November 2016. To fill these positions, we are seeking individuals who are distinguished in: (1) The conduct of research, demonstration projects, and evaluations with respect to health care; (2) the fields of health care quality research or health care improvement; (3) the practice of medicine; (4) other health professions; (5) representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) the representation of the interests of patients and consumers of health care. 42 U.S.C. 299c(c)(2).

    Individuals are particularly sought with experience and success in activities specified in the summary above.

    DATES:

    Nominations should be received on or before 60 days after date of publication.

    ADDRESSES:

    Nominations should be sent to Jaime Zimmerman AHRQ, 5600 Fishers Lane, 06E37A, Rockville, Maryland 20857. Nominations may also be emailed to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Jaime Zimmerman, AHRQ, at (301) 427-1456.

    SUPPLEMENTARY INFORMATION:

    42 U.S.C. 299c provides that the Secretary shall appoint 21 appropriately qualified individuals to the National Advisory Council for Healthcare Research and Quality. At least 17 members shall be representatives of the public and at least one member shall be a specialist in the rural aspects of one or more of the professions or fields listed in the above summary. In addition, the Secretary designates, as ex officio members, representatives from other Federal agencies, principally agencies that conduct or support health care research, as well as Federal officials the Secretary may consider appropriate. 42 U.S.C. 299c(c)(3). The Council meets approximately 3 times a year in the Washington, DC, metropolitan area, generally in Rockville, Maryland, to provide broad guidance to the Secretary and AHRQ's Director on the direction of and programs undertaken by AHRQ.

    Seven individuals will be selected by the Secretary to serve on the Council beginning with the meeting in the spring of 2017. Members generally serve 3-year terms. Appointments are staggered to permit an orderly rotation of membership.

    Interested persons may nominate one or more qualified persons for membership on the Council. Self-nominations are accepted. Nominations shall include: (1) A copy of the nominee's resume or curriculum vitae; and (2) a statement that the nominee is willing to serve as a member of the Council. Selected candidates will be asked to provide detailed information concerning their financial interests, consultant positions and research grants and contracts, to permit evaluation of possible sources of conflict of interest. Please note that once a candidate is nominated, AHRQ may consider that nomination for future positions on the Council. Federally registered lobbyists are not permitted to serve on this advisory board pursuant to the Presidential Memorandum entitled “Lobbyists on Agency Boards and Commissions” dated June 10, 2010, and the Office of Management and Budget's “Final Guidance on Appointment of Lobbyists to Federal Boards and Commissions,” 76 FR 61756 (October 5, 2011).

    The Department seeks a broad geographic representation. In addition, AHRQ conducts and supports research concerning priority populations, which include: Low-income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. See 42 U.S.C. 299(c). Nominations of persons with expertise in health care for these priority populations are encouraged.

    Sharon B. Arnold, Acting Director .
    [FR Doc. 2016-07119 Filed 3-29-16; 8:45 am] BILLING CODE 4160-90-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review

    In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces a meeting for the initial review of applications in response to Funding Opportunity Announcement (FOA) DP 16-003, Johnston County Osteoarthritis Project: Arthritis, Disability, and Other Chronic Diseases.

    Time and Date: 11:00 a.m.-2:00 p.m., EDT, April 12, 2016 (Closed).

    This notice did not publish within the 15-day regulatory requirement, although it was submitted to the Office of the Federal Register on March 4, 2016. This is a re-submission for publication.

    Place: Teleconference.

    Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c) (4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463.

    Matters for Discussion: The meeting will include the initial review, discussion, and evaluation of applications received in response to “Johnston County Osteoarthritis Project: Arthritis, Disability, and Other Chronic Diseases”, FOA DP16-003.

    Contact Person for More Information: Jaya Raman Ph.D., Scientific Review Officer, CDC, 4770 Buford Highway, Mailstop F80, Atlanta, Georgia 30341, Telephone: (770) 488-6511, [email protected].

    The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

    Catherine Ramadei, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
    [FR Doc. 2016-07134 Filed 3-29-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA-4263-DR; Docket ID FEMA-2016-0001] Louisiana; Amendment No. 1 to Notice of a Major Disaster Declaration AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice amends the notice of a major disaster declaration for the State of Louisiana (FEMA-4263-DR), dated March 13, 2016, and related determinations.

    DATES:

    Effective Date: March 15, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.

    SUPPLEMENTARY INFORMATION:

    The notice of a major disaster declaration for the State of Louisiana is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of March 13, 2016.

    The parishes of Beauregard, Bienville, Caddo, Caldwell, De Soto, La Salle, Livingston, Madison, Natchitoches, St. Tammany, Tangipahoa, Union, Vernon, Washington, West Carroll, and Winn for Individual Assistance and assistance for debris removal and emergency protective measures (Categories A and B), including direct federal assistance, under the Public Assistance program.

    The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.

    W. Craig Fugate, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2016-07095 Filed 3-29-16; 8:45 am] BILLING CODE 9111-23-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA-4263-DR; Docket ID FEMA-2016-0001] Louisiana; Amendment No. 2 to Notice of a Major Disaster Declaration AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice amends the notice of a major disaster declaration for the State of Louisiana (FEMA-4263-DR), dated March 13, 2016, and related determinations.

    DATES:

    Effective Date: March 17, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.

    SUPPLEMENTARY INFORMATION:

    The notice of a major disaster declaration for the State of Louisiana is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of March 13, 2016.

    The parishes of Allen, Ascension, and Calcasieu for Individual Assistance and assistance for debris removal and emergency protective measures (Categories A and B), including direct federal assistance, under the Public Assistance program.

    The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.

    W. Craig Fugate, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2016-07102 Filed 3-29-16; 8:45 am] BILLING CODE 9111-23-P
    DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Internal Agency Docket No. FEMA-4263-DR; Docket ID FEMA-2016-0001] Louisiana; Major Disaster and Related Determinations AGENCY:

    Federal Emergency Management Agency, DHS.

    ACTION:

    Notice.

    SUMMARY:

    This is a notice of the Presidential declaration of a major disaster for the State of Louisiana (FEMA-4263-DR), dated March 13, 2016, and related determinations.

    DATES:

    Effective Date: March 13, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.

    SUPPLEMENTARY INFORMATION:

    Notice is hereby given that, in a letter dated March 13, 2016, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”), as follows:

    I have determined that the damage in certain areas of the State of Louisiana resulting from severe storms and flooding beginning on March 8, 2016, and continuing, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”). Therefore, I declare that such a major disaster exists in the State of Louisiana.

    In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.

    You are authorized to provide Individual Assistance and assistance for debris removal and emergency protective measures (Categories A and B) under the Public Assistance program in the designated areas, Hazard Mitigation throughout the State, and any other forms of assistance under the Stafford Act that you deem appropriate subject to completion of Preliminary Damage Assessments (PDAs). Direct Federal assistance is authorized.

    Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, with the exception of projects that meet the eligibility criteria for a higher Federal cost-sharing percentage under the Public Assistance Alternative Procedures Pilot Program for Debris Removal implemented pursuant to section 428 of the Stafford Act.

    Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.

    The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration.

    The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Gerard M. Stolar, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.

    The following areas of the State of Louisiana have been designated as adversely affected by this major disaster:

    The parishes of Bossier, Claiborne, Grant, Morehouse, Ouachita, Richland, and Webster for Individual Assistance.

    The parishes of Bossier, Claiborne, Grant, Morehouse, Ouachita, Richland, and Webster for debris removal and emergency protective measures (Categories A and B), including direct federal assistance, under the Public Assistance program.

    All areas within the State of Louisiana are eligible for assistance under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.

    W. Craig Fugate, Administrator, Federal Emergency Management Agency.
    [FR Doc. 2016-07094 Filed 3-29-16; 8:45 am] BILLING CODE 9111-23-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-HQ-FAC-2016-N050; FF09F42300-FVWF97920900000-XXX] Sport Fishing and Boating Partnership Council AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of meeting.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), announce a public meeting of the Sport Fishing and Boating Partnership Council (Council). A Federal advisory committee, the Council was created in part to foster partnerships to enhance public awareness of the importance of aquatic resources and the social and economic benefits of recreational fishing and boating in the United States. This meeting is open to the public, and interested persons may make oral statements to the Council or may file written statements for consideration.

    DATES:

    The meeting will take place Tuesday, May 3, 2016, from 8:30 a.m. to 4:30 p.m. (Eastern Time) and Wednesday, May 4, 2016, from 8:30 a.m. to 3:30 p.m. For deadlines and directions on registering to attend the meeting, submitting written material, and/or giving an oral presentation, please see “Public Input” under SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    The meeting will be held at the National Oceanic and Atmospheric Administration's Florida Keys Eco-Discovery Center, 35 East Quay Road, Key West, Florida 33040.

    FOR FURTHER INFORMATION CONTACT:

    Brian Bohnsack, Sport Fishing and Boating Partnership Council Coordinator, 5275 Leesburg Pike, Mailstop FAC, Falls Church, VA 22041; telephone (703) 358-2435; fax (703) 358-2487; or email [email protected]

    SUPPLEMENTARY INFORMATION:

    In accordance with the requirements of the Federal Advisory Committee Act, 5 U.S.C. App., we announce that the Sport Fishing and Boating Partnership Council will hold a meeting.

    Background

    The Council was formed in January 1993 to advise the Secretary of the Interior, through the Director of the Service, on aquatic conservation endeavors that benefit recreational fishery resources and recreational boating and that encourage partnerships among industry, the public, and government. The 18-member Council, appointed by the Secretary of the Interior, includes the Service Director and the president of the Association of Fish and Wildlife Agencies, who both serve in ex officio capacities. Other Council members are directors from State agencies responsible for managing recreational fish and wildlife resources and individuals who represent the interests of saltwater and freshwater recreational fishing, recreational boating, the recreational fishing and boating industries, recreational fisheries resource conservation, Native American tribes, aquatic resource outreach and education, and tourism. Background information on the Council is available at http://www.fws.gov/sfbpc.

    Meeting Agenda

    During the meeting, the Council will consider issues affecting recreational fishing and boating programs on Federal lands. An abbreviated list of planned agenda items includes:

    • An update and discussion on the Council's assessment of the Recreational Boating and Fishing Foundation's implementation of the National Outreach and Communication Program (Catalog of Federal Domestic Assistance number 15.653);

    • An update and discussion regarding the Council's proposed pilot project to improve the efficiency of Federal agencies' permitting review processes associated with boating infrastructure projects (e.g., boat dock replacement and maintenance, boat ramp construction and maintenance);

    • An update of the fishing and boating programs administered by the Florida Fish and Wildlife Conservation Commission;

    • Status of the Council's nomination process and charter update; and

    • Other miscellaneous Council business.

    The final agenda will be posted on the Internet at http://www.fws.gov/sfbpc.

    Public Input If you wish to Then you must contact the Council Coordinator (see FOR FURTHER INFORMATION CONTACT) no later than Attend the meeting Wednesday, April 27, 2016. Submit written information or questions before the meeting for the Council to consider during the meeting Wednesday, April 27, 2016. Give an oral presentation during the meeting Wednesday, April 27, 2016. Attendance

    The Council meeting will be held at the National Oceanic and Atmospheric Administration's Florida Keys Eco-Discovery Center, 35 East Quay Road, Key West, Florida. Signs will be posted to direct attendees to the specific conference room.

    Submitting Written Information or Questions

    Interested members of the public may submit relevant information or questions for the Council to consider during the meeting. Written statements must be received by the date listed above in “Public Input.” Written statements must be supplied to the Council Coordinator either by sending one hard copy with original signature via the mail or one electronic copy via email (acceptable file formats are Adobe Acrobat PDF, MS Word, MS PowerPoint, or rich text file).

    Giving an Oral Presentation

    Individuals or groups requesting to make an oral presentation during the meeting will be limited to 2 minutes per speaker, with no more than a total of 30 minutes for all speakers. Interested parties should contact the Council Coordinator, in writing (preferably via email; see FOR FURTHER INFORMATION CONTACT), to be placed on the public speaker list for this meeting. To ensure an opportunity to speak during the public comment period of the meeting, members of the public must register with the Council Coordinator. Registered speakers who want to expand on their oral statements, or those who wanted to speak but could not be accommodated on the agenda, may submit written statements to the Council Coordinator up to 30 days after the meeting.

    Meeting Minutes

    Summary minutes of the meeting will be maintained by the Council Coordinator (see FOR FURTHER INFORMATION CONTACT) and will be available for public inspection within 90 days of the meeting. They will be posted on the Council's Web site at http://www.fws.gov/sfbpc.

    James W. Kurth, Acting Director.
    [FR Doc. 2016-07133 Filed 3-29-16; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-HQ-IA-2014-0019; FXIA167109ADV16-156-FF09A00000] Advisory Council on Wildlife Trafficking AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of meeting.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), announce a public meeting of the Advisory Council on Wildlife Trafficking (Council). The Council's purpose is to provide expertise and support to the Presidential Task Force on Wildlife Trafficking. You may attend the meeting in person, or you may participate via telephone. At this time, we are inviting submissions of questions and information for consideration during the meeting.

    DATES:

    Meeting: The meeting will be held on Friday, April 15, 2016, from 9 a.m. to 1 p.m. Eastern Time.

    Registering to Attend the Meeting: To attend the meeting in person, you must register by close of business on April 8, 2016. (You do not need to register to listen via phone.) Please submit your name, email address, and phone number to Mr. Cade London to complete the registration process (see FOR FURTHER INFORMATION CONTACT). Because there is limited seating available, registrations will be taken on a first-come, first-served basis. Members of the public requesting reasonable accommodations, such as hearing interpreters, must contact Mr. London, in writing (preferably by email), no later than April 5, 2015.

    Submitting Questions or Information: If you want to provide us with questions and information to be considered during the meeting, your material must be received or postmarked on or before April 8, 2015. Comments submitted electronically using the Federal eRulemaking Portal (see ADDRESSES section) must be received by 11:59 p.m. Eastern Time on April 8, 2015.

    Making an Oral Presentation at the Meeting: If you want to make an oral presentation at the meeting (in person or by phone), contact Mr. London no later than April 8, 2015 (see FOR FURTHER INFORMATION CONTACT). For more information, see Making an Oral Presentation under SUPPLEMENTARY INFORMATION.

    ADDRESSES:

    Meeting Location: The meeting will be held at the U.S. Department of the Interior, South Interior Building Auditorium, 1951 Constitution Avenue NW., Washington, DC 20240.

    Meeting Call-In Numbers: Members of the public unable to attend the meeting in person may call in at 888-606-5920 (toll free) or 630-395-0312 (toll) using the dial-in passcode 1214001. To ensure that enough call-in lines are available, we request that members of the public register as call-in participants athttps://www.mymeetings.com/emeet/rsvp/index.jsp?customHeader=mymeetings&Conference_ID=7459947&passcode=1214001. Members may register to give an oral presentation over the phone as well. For more information, see Making an Oral Presentation under SUPPLEMENTARY INFORMATION.

    Submitting Questions or Information: You may submit questions or information for consideration during the meeting by one of the following methods:

    1. Electronically: Go to the Federal eRulemaking Portal: http://www.regulations.gov. In the Search box, enter FWS-HQ-IA-2014-0019. Then click on the “Search” button. You may submit questions or information by clicking on “Comment Now!”

    2. By hard copy: Submit by U.S. mail or hand-delivery to: Public Comments Processing, Attn: FWS-HQ-IA-2014-0019; Division of Policy, Performance, and Management Programs; U.S. Fish and Wildlife Service; 5275 Leesburg Pike, MS: BPHC; Falls Church, VA 22041-3803.

    We will not accept email or faxes. We request that you send comments only by the methods described above. We will post all comments on http://www.regulations.gov. This generally means that we will post any personal information you provide us (see the Submitting Public Comments section for more information).

    Reviewing Comments Received by the Service: See Reviewing Public Comments in the SUPPLEMENTARY INFORMATION section.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Cade London, Policy Advisor, International Affairs, U.S. Fish and Wildlife Service, by email at [email protected] (preferable method of contact); by U.S. mail at U.S. Fish and Wildlife Service; 5275 Leesburg Pike, MS: IA; Falls Church, VA 22041-3803; by telephone at (703) 358-2584; or by fax at (703) 358-2276.

    SUPPLEMENTARY INFORMATION:

    In accordance with the requirements of the Federal Advisory Committee Act (5 U.S.C. App.), we announce that the Advisory Council on Wildlife Trafficking (Council) will hold a meeting to discuss the implementation of the National Strategy for Combating Wildlife Trafficking, and other Council business as appropriate. The Council's purpose is to provide expertise and support to the Presidential Task Force on Wildlife Trafficking.

    You may attend the meeting in person, or you may participate via telephone. At this time, we are inviting submissions of questions and information for consideration during the meeting.

    Background

    Executive Order 13648 established the Advisory Council on Wildlife Trafficking on August 30, 2013, to advise the Presidential Task Force on Wildlife Trafficking, through the Secretary of the Interior, on national strategies to combat wildlife trafficking, including, but not limited to:

    1. Effective support for anti-poaching activities;

    2. Coordinating regional law enforcement efforts;

    3. Developing and supporting effective legal enforcement mechanisms; and

    4. Developing strategies to reduce illicit trade and consumer demand for illegally traded wildlife, including protected species.

    The eight-member Council, appointed by the Secretary of the Interior, includes former senior leadership within the U.S. Government, as well as chief executive officers and board members from conservation organizations and the private sector. For more information on the Council and its members, visithttp://www.fws.gov/international/advisory-council-wildlife-trafficking/.

    Meeting Agenda

    The Council will consider:

    1. Task Force discussions,

    2. Administrative topics, and

    3. Public comment and response.

    The final agenda will be posted on the Internet at http://www.fws.gov/international/advisory-council-wildlife-trafficking/.

    Making an Oral Presentation

    Members of the public who want to make an oral presentation in person or by telephone at the meeting will be prompted during the public comment section of the meeting to provide their presentation and/or questions. If you want to make an oral presentation in person or by phone, contact Mr. Cade London (FOR FURTHER INFORMATION CONTACT) no later than the date given in the DATES section.

    Registered speakers who want to expand on their oral statements, or those who wanted to speak but could not be accommodated on the agenda, are invited to submit written statements to the Council after the meeting. Such written statements must be received by Mr. London, in writing (preferably via email), no later than April 22, 2016.

    Submitting Public Comments

    You may submit your questions and information by one of the methods listed in ADDRESSES. We request that you send comments by only one of the methods described in ADDRESSES.

    If you submit information via the Federal eRulemaking Portal (http://www.regulations.gov), your entire submission—including any personal identifying information—will be posted on the Web site.

    If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions at http://www.regulations.gov.

    Reviewing Public Comments

    Comments and materials we receive will be available for public inspection at http://www.regulations.gov. Alternatively, you may view them by appointment during normal business hours at 5275 Leesburg Pike, Falls Church, VA 22041-3803. Please contact Mr. London (see FOR FURTHER INFORMATION CONTACT).

    Obtaining Meeting Minutes

    Summary minutes of the meeting will be available on the Council Web site at http://www.fws.gov/international/advisory-council-wildlife-trafficking/. Alternatively, you may view them by appointment during normal business hours at 5275 Leesburg Pike, Falls Church, VA 22041-3803. Please contact Mr. London (see FOR FURTHER INFORMATION CONTACT).

    Gloria Bell, Deputy Assistant Director, International Affairs, U.S. Fish and Wildlife Service.
    [FR Doc. 2016-07113 Filed 3-29-16; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [16X.LLWO320000.L13200000.PP0000] Notice of Intent To Prepare a Programmatic Environmental Impact Statement To Review the Federal Coal Program and To Conduct Public Scoping Meetings AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), the Bureau of Land Management (BLM), Washington Office, intends to prepare a Programmatic Environmental Impact Statement (EIS) to review the Federal coal program.

    This Notice of Intent begins the process of defining the scope of the Programmatic EIS by providing background on the Federal coal program and identifying the issues that may be addressed in the Programmatic EIS. This Notice informs the public about: Concerns that have been raised about the Federal coal program; issues that are expected to be assessed in the Programmatic EIS; and potential modifications to the Federal coal program suggested by stakeholders during the listening sessions that could be considered in the Programmatic EIS. This Notice of Intent also announces plans to conduct public scoping meetings, invites public participation in the scoping process, and solicits public comments for consideration in establishing the scope and content of the Programmatic EIS.

    DATES:

    The BLM will invite interested agencies, States, American Indian tribes, local governments, industry, organizations and members of the public to submit comments or suggestions to assist in identifying significant issues and in determining the scope of this Programmatic EIS.

    The BLM will be holding public scoping meetings to obtain comments on the Programmatic EIS and plans to hold these meetings in the following locations: Casper, WY; Grand Junction, CO; Knoxville, TN; Pittsburgh, PA; Salt Lake City, UT; and Seattle, WA. The BLM will announce the specific dates and locations of the scoping meetings at least 15 days in advance through local media, newspapers, and the project Web site at: http://www.blm.gov/wo/st/en/prog/energy/coal_and_non-energy/details_on_coal_peis.html. In addition, the BLM will consider all written comments received or postmarked during the public comment period on scoping, which will close 30 days after the final public meeting.

    ADDRESSES:

    You may submit written comments by the following methods:

    Email: [email protected] This is the preferred method of commenting.

    Mail, personal, or messenger delivery: Coal Programmatic EIS Scoping, Bureau of Land Management, 20 M St. SE., Room 2134LM, Washington, DC 20003.

    FOR FURTHER INFORMATION CONTACT:

    Mitchell Leverette, Chief, Division of Solid Minerals, email: [email protected], telephone: 202-912-7113, or visit the Coal Programmatic EIS Web site at: http://www.blm.gov/wo/st/en/prog/energy/coal_and_non-energy/details_on_coal_peis.html.

    SUPPLEMENTARY INFORMATION:

    On January 15, 2016, the Secretary of the Interior issued Order No. 3338 directing the BLM to conduct a broad, programmatic review of the Federal coal program it administers through preparation of a Programmatic EIS under NEPA. 42 U.S.C. 4321 et seq. The Order was issued in response to a range of concerns raised about the Federal coal program, including, in particular, concerns about whether American taxpayers are receiving a fair return from the development of these publicly owned resources; concerns about market conditions, which have resulted in dramatic drops in coal demand and production in recent years, with consequences for coal-dependent communities; and concerns about whether the leasing and production of large quantities of coal under the Federal coal program is consistent with the Nation's goals to reduce greenhouse gas emissions to mitigate climate change. In light of these issues, the Programmatic EIS will identify and evaluate potential reforms to the Federal coal program. This review will enable the Department to consider how to modernize the program to allow for the continued development of Federal coal resources, as appropriate, while addressing the substantive issues raised by the public, other stakeholders, and the Department's own review of the comments it has received during recent listening sessions held last year in Washington, DC; Billings, Montana; Gillette, Wyoming; Denver, Colorado; and Farmington, New Mexico.

    Background and Need for Agency Action A. Overview of Federal Coal Program

    Under the Mineral Leasing Act of 1920, as amended, 30 U.S.C. 181 et seq., and the Mineral Leasing Act for Acquired Lands of 1947, as amended, 30 U.S.C. 351 et seq., the BLM is responsible for the leasing of Federal coal and regulation of the development of that coal on approximately 570 million acres of the 700 million acres of mineral estate that is owned by the Federal government. This includes Federal mineral rights on Federal lands and Federal mineral rights located under surface lands with non-Federal ownership. Under the authority of the Mineral Leasing Act, the BLM administers leasing and monitors coal production. Other Departmental bureaus, in particular the Office of Surface Mining Reclamation and Enforcement (OSMRE) and the Office of Natural Resources Revenue (ONRR), also take actions related to coal mining on Federal lands. The OSMRE, and those States that have regulatory primacy under the Surface Mining Control and Reclamation Act of 1977 (SMCRA), permit coal mining and reclamation activities, and monitor reclamation and reclamation bonding actions. The ONRR collects and audits all payments required under the lease, including bonus bids, royalties, and rental payments, and distributes those funds between the Federal Treasury and the States where coal resources are located.

    1. Federal Coal Leasing and Production

    On average, over the last few years, about 41 percent of the Nation's annual coal production came from Federal land. Federal coal produced from the Powder River Basin in Montana and Wyoming accounts for over 85 percent of all Federal coal production. Federal coal was used to generate an estimated 14 percent of the Nation's electricity in 2015. Coal is also used for other critical processes, including making steel (metallurgical coal).

    As of FY2015, the BLM administered 306 coal leases, covering 482,691 acres in 11 States, with an estimated 7.75 billion tons of recoverable Federal coal. Over the last decade (2006-2015), the BLM sold 32 coal leases and managed leases that produced approximately 4.3 billion tons of coal and resulted in $9.55 billion in revenue collections by the United States.

    The U.S. Energy Information Administration (EIA) estimates total U.S. coal production in 2015 was about 895 million short tons (MMst), 10 percent lower than in 2014 and the lowest level since 1986.1 EIA projects that coal production will fall by another 12 percent in 2016, then rise by 2 percent in 2017.2 The approximately 7.75 billion tons of recoverable reserves of Federal coal currently under lease is estimated to be sufficient to continue production at current levels for 20 years, averaged across all leases, and these reserves would be sufficient to cover production, on average, for even longer if coal production declines, as is projected.

    1 U.S. EIA, Short Term Energy Outlook: Coal (Mar. 8, 2016) (http://www.eia.gov/forecasts/steo/report/coal.cfm); U.S. EIA, Today in Energy: Coal Production and Prices Decline in 2015 (Jan. 8, 2016) (http://www.eia.gov/todayinenergy/detail.cfm?id=24472). Note that the EIA data referenced in this Notice is more recent than the EIA data referenced in the Secretarial Order.

    2 U.S. EIA, Short Term Energy Outlook: Coal (Mar. 8, 2016) (http://www.eia.gov/forecasts/steo/report/coal.cfm).

    EIA estimates that U.S. coal exports decreased 23 MMst (24 percent) from 2014 levels to 74 MMst in 2015, and EIA expects the current global coal market trends to continue.3 EIA forecasts that coal exports will decline by an additional 10 MMst (13 percent) in 2016 and by 1 MMst (2 percent) in 2017.4

    3 U.S. EIA, Short Term Energy Outlook: Coal (Mar. 8, 2016) (http://www.eia.gov/forecasts/steo/report/coal.cfm).

    4 U.S. EIA, Short Term Energy Outlook: Coal (Mar. 8, 2016) (http://www.eia.gov/forecasts/steo/report/coal.cfm).

    In terms of employment and revenues to the States, coal mining employed almost 90,000 people in 2012. More recently, there were an estimated 74,000 direct jobs in coal mining as of May 2014, including roughly 6,500 in Wyoming.5 Revenues from Federal coal provided Wyoming approximately $556 million in FY2014. Other States received the following approximate amounts: Utah—$44 million; Montana—$43 million; Colorado—$36 million; and New Mexico—$16 million.

    5 Bureau of Labor Statistics, May 2014 National Industry-Specific Occupational Employment and Wage Estimates; NAICS 212100—Coal Mining (http://www.bls.gov/oes/current/naics4_212100.htm); Wyoming Department of Workforce Services, Wyoming Labor Market Information (http://doe.state.wy.us/lmi/CES/nawy14.htm).

    2. Federal Coal Program

    The current BLM coal leasing program includes land use planning, processing applications (e.g., for exploration licenses and lease sales), estimating the value of proposed leases, holding lease sales, and post-leasing actions (e.g., production verification, lease and production inspection and enforcement, royalty reductions, and bond review).

    The Federal Government receives revenue from coal leasing in three ways: (1) A bonus that is paid at the time BLM issues a lease; (2) Rental fees; and (3) Production royalties. The royalty rates are set by regulation at a fixed 8 percent for underground mines and not less than 12.5 percent for surface mines. All receipts from a lease are shared with the State in which the lease is located (51 percent to the Federal Government and 49 percent to the State).

    The BLM's planning process for Resource Management Plans, supported by environmental analysis under NEPA, identifies areas that are potentially available to be considered for coal leasing. The planning process considers, among other things, the impacts of a “reasonably foreseeable development scenario,” but it does not directly authorize any coal leasing or determine which coal will actually be leased.

    The Federal Coal Leasing Amendments Act of 1976 (FCLAA), which amended Section 2 of the Mineral Leasing Act of 1920, requires that, with limited exceptions, Federal lands available for coal leasing be sold by competitive bid, with the BLM receiving “fair market value” for the lease. While multiple bids are not required, all successful bids must equal or exceed the estimated pre-sale fair market value for the lease, as calculated by the BLM. Competitive leasing is not required for: (1) Preference right lease applications for owners of pre-FCLAA prospecting permits; and (2) Modifications of existing leases, where Congress has authorized the Secretary to allow up to 960 acres (increased from 160 acres by the Energy Policy Act of 2005) of contiguous lands for noncompetitive leasing by modifying an existing lease.

    The BLM issued coal leasing regulations in 1979 that provided for two separate competitive coal leasing processes: (1) Regional leasing, where the BLM selects tracts within a region for competitive sale; and (2) Leasing by application, where an industry applicant nominates a particular tract of coal for competitive sale.

    Regional coal leasing requires the BLM to select potential coal leasing tracts based on land use planning, expected coal demand, and potential environmental and economic impacts.6 This process includes use of a Federal/State advisory board known as a Regional Coal Team,7 to provide input on leasing decisions. The regional leasing system has not been used since 1990, and currently all BLM coal leasing is done by application.8 Leasing by application begins with the submission of an application to lease a tract of coal identified by the applicant.9 The BLM reviews the application for completeness, to ensure that it conforms to existing land use plans, and to ensure that it contains sufficient geologic data to determine the fair market value of the coal. The agency then prepares an analysis under NEPA (either an Environmental Assessment or an EIS) and seeks public comment on the proposed lease sale. Through this process, the BLM evaluates alternative tract configurations to maximize competitiveness and value, and to avoid bypassing Federal coal. The BLM also consults with other appropriate Federal, State, and tribal government agencies, and the BLM determines whether the surface owner consents to leasing in situations where the surface is not administered by the BLM. Preparations for the actual lease sale begin with the BLM formulating, after obtaining public comment, a pre-sale estimate of the fair market value of the coal. This estimate is kept confidential and is used to evaluate the bids for the lease “bonus” received during the sale. Sealed bids are accepted prior to the date of the sale and are publicly announced during the sale. The winning bid is the highest bid that meets or exceeds the coal tract's presale estimated fair market value, assuming that the bidder meets all eligibility requirements and has paid the appropriate fees and payments.

    6 43 CFR part 3420.

    7 The BLM regulations require a Regional Coal Team to be established for each coal production region, comprised of representatives from the BLM and the Governors of each State in the region. The Regional Coal Teams are to guide the coal planning process for each coal production region, serve as the forum for BLM and State consultation, and make recommendations on coal leasing levels. 43 CFR 3400.4.

    8 While the Powder River Basin (PRB) coal production region was decertified in 1992, the PRB regional coal team is still in place and meets periodically to review regional activity and make recommendations on coal leasing in the region.

    9See 43 CFR subpart 3425.

    There are two separate bonding requirements for Federal coal leases. The BLM requires a bond adequate to ensure compliance with the terms and conditions of the lease, which must cover a portion of potential liabilities associated with the bonus bid, rental fees, and royalties. In addition, under SMCRA, the OSMRE or the State with regulatory primacy requires sufficient bonding to cover anticipated reclamation costs.

    A Federal coal lease has an initial term of 20 years, but it may be terminated after 10 years if the coal resources are not diligently developed. 30 U.S.C. 207. Existing leases that have met their diligence requirements may be renewed for additional 10 year terms following the initial 20 year term.

    3. Previous Comprehensive Reviews

    The Department has previously conducted two separate, comprehensive reviews of the Federal coal program. In the late 1960s, there were serious concerns about speculation in the coal leasing program. A BLM study discovered a sharp increase in the total Federal acreage under lease and a consistent decline in coal production. In response, the Department undertook the development of a planning system to determine the size, timing, and location of future coal leases, and the preparation of a Programmatic EIS for the entire Federal coal leasing program. Beginning in February 1973, the short-term actions included a complete moratorium on the issuance of new coal prospecting permits, and a moratorium with limited exceptions on the issuance of new Federal coal leases. New leases were issued only to maintain existing mines or to supply reserves for production in the near future, where “near future” meant that development and production were to commence within 3 and 5 years, respectively. The moratorium was scaled back over time, but was not completely lifted until 1981, after the Programmatic EIS had been completed, a new leasing system had been adopted through regulation, and litigation was resolved.

    In 1982, concerns about the Federal coal program arose again, this time related to allegations that the Government did not receive fair market value from a large lease sale in the Powder River Basin under the new procedures adopted as part of the programmatic review in the 1970s. Among other reports on the issue, in May 1983, the Government Accountability Office (GAO) issued a report concluding that the Department had received roughly $100 million less than it should have for the leases sold. In response, in July 1983, Congress directed the Secretary to appoint members to a commission, known as the Linowes Commission, to investigate fair market value policies for Federal coal leasing. Congress also, in the 1984 Appropriations Act, directed the Office of Technology Assessment (OTA) to study whether the Department's coal leasing program was compatible with the nationally mandated environmental protection goals.

    As part of the 1984 Appropriations Bill, Congress imposed a moratorium on the sale or lease of coal on public lands, subject to certain exceptions, starting in 1983 and ending 90 days after publication of the Linowes Commission's report. The Linowes Commission published the Report of the Commission on Fair Market Value Policy for Federal Coal Leasing in February 1984. The OTA report, Environmental Protection in the Federal Coal Leasing Program, was released in May 1984. The principal thrust of these reports was that the Department should: (1) Temper its pace of coal leasing; (2) Improve and better document its procedures for receiving fair market value; and (3) Take care to balance competing resource uses in making lease decisions.

    Interior Secretary William P. Clark extended the suspension of coal leasing (with exceptions for emergency leasing and processing preference right lease applications, among other things), while the Department completed its comprehensive review of the program. This review included proposed modifications to be made by the Department in response to the Linowes Commission and OTA reports. Secretary Clark announced on August 30, 1984, that the Department would prepare an EIS supplement to the 1979 Programmatic EIS for the Federal coal management program. The Department issued the Record of Decision for the Programmatic EIS supplement in January 1986, in the form of a Secretarial Issue Document. That document recommended continuation of the leasing program with modifications. In conjunction with those modifications, Interior Secretary Donald Hodel lifted the coal leasing moratorium in 1987.

    B. Need for Comprehensive Review of Federal Coal Program

    On March 17, 2015, Secretary Jewell called for “an honest and open conversation about modernizing the Federal coal program.” As described above, the last time the Federal coal program underwent comprehensive review was in the mid-1980s, and market conditions, infrastructure development, scientific understanding, and national priorities have changed considerably since that time. The Secretary's call also responded to continued concerns from numerous stakeholders about the Federal coal program, including concerns raised by the GAO,10 the Department's Office of Inspector General (OIG),11 members of Congress, interested stakeholders, and the public. The concerns raised by the GAO and OIG centered on whether taxpayers are receiving fair market value from the sale of coal. Others raised concerns that the current Federal leasing structure lacks transparency and competition and is therefore not ensuring that the American taxpayer receives a fair return from Federal coal resources, while also raising questions regarding current market conditions for the coal industry generally and related implications for Federal resources. Stakeholders also questioned whether the leasing program results in over-supply of a commodity that has significant environmental and health impacts, including impacts on global climate change.

    10 GAO, Coal Leasing: BLM Could Enhance Appraisal Process, More Explicitly Consider Coal Exports, and Provide More Public Information, GAO 14-140 (Dec. 2013).

    11 OIG, Coal Management Program, U.S. Department of the Interior, Report No.: CR-EV-BLM-0001-2012 (June 2013).

    In response to the Secretary's call for a conversation to address these concerns, the BLM held 5 listening sessions regarding the Federal coal program in the summer of 2015. Sessions were held in Washington, DC; Billings, Montana; Gillette, Wyoming; Denver, Colorado; and Farmington, New Mexico. The Department heard from 289 individuals during the sessions and received more than 92,000 written comments before the comment period closed on September 17, 2015. The oral and written comments reflected several recurring themes:

    • Concern about global climate change and the impact of coal production and use.

    • Concern about the loss of jobs and local revenues if coal production is reduced.

    • Support for increased transparency and public participation in leasing and royalty decisions and concern that the structure of the leasing program does not provide for adequate competition or a fair return to the taxpayer for the use of Federal resources.

    • Support for increasing coal royalty rates because: (1) The royalty rate should account for the environmental costs of coal production; (2) The royalty rate should match the rate for offshore Federal leases; and (3) Taxpayers are not receiving a fair return.

    • Support for maintaining or lowering coal royalty rates because: (1) The coal industry already pays more than its fair share and existing Federal rates are too high given current market conditions; (2) Raising rates will lower production and revenues; and (3) Raising rates will cost jobs and harm communities.

    • Support for streamlining the current leasing process, so that the Federal coal program is administered in a way that better promotes economic stability and jobs, especially in coal communities which are already suffering from depressed economic conditions.

    Of these concerns, three aspects of the current Federal coal program received the most attention. First, numerous stakeholders are concerned that American taxpayers are not receiving a fair return on public coal resources. Second, many stakeholders are concerned that the Federal coal program conflicts with the Administration's climate policy and our national climate goals, making it more difficult for us to achieve those goals. Third, there are numerous and varying concerns about the structure of the Federal coal program in light of current market conditions, including how implementation of the Federal leasing program affects current and future coal markets, coal-dependent communities and companies, and the reclamation of mined lands. These three main concerns are addressed in more detail below.

    1. Concerns About Fair Return

    In 2013, both GAO and OIG issued reports expressing concerns about the Federal coal program, particularly with respect to the leasing process and fair market value. In response, in 2014, the BLM developed new protocols and issued policy guidance, a manual, and a handbook to implement these changes. Nevertheless, stakeholders have expressed concerns that the BLM's response, while helpful, was insufficient to rectify fundamental weaknesses in the program with respect to fair return.12

    12See, e.g., Taxpayers for Common Sense, Federal Coal Leasing: Fair Market Value and a Fair Return for the American Taxpayer (Sept. 2013). (http://www.taxpayer.net/images/uploads/downloads/TCS_Federal_Coal_Leasing_Report_-_Final_-_Updated_10.4.13.pdf); Center for American Progress, Modernizing the Federal Coal Program (Dec. 2014) (https://cdn.americanprogress.org/wp-content/uploads/2014/12/FederalCoal.pdf); Headwaters Economics, An Assessment of U.S. Federal Coal Royalties (Jan. 2015) (http://headwaterseconomics.org/wphw/wp-content/uploads/Report-Coal-Royalty-Valuation.pdf); Center for American Progress, Cutting Subsidies and Closing Loopholes in the U.S. Department of the Interior's Coal Program (Jan. 6, 2015) (https://cdn.americanprogress.org/wp-content/uploads/2015/01/CoalSubs-brief2.pdf); Institute for Policy Integrity, Harmonizing Preservation and Production (June 2015) (http://policyintegrity.org/publications/detail/harmonizing-preservation-and-production/); Institute for Policy Integrity, Illuminating the Hidden Costs of Coal (Dec. 2015) (http://policyintegrity.org/publications/detail/hidden-costs-of-coal).

    These concerns arise, at least in part, because there is currently very little competition for Federal coal leases. About 90 percent of lease sales receive bids from only one bidder, typically the operator of a mine adjacent to the new lease, given the investment required to open a new mine. While the BLM conducts a peer-reviewed analysis to estimate a pre-sale fair market value of the coal and will not sell a lease unless the bid meets or exceeds that value, commenters have questioned whether an accurate fair market value can be identified in the absence of a truly competitive marketplace.

    Commenters also raised concerns about the royalty rates set in Federal leases, which are set by regulation at a fixed 8 percent for underground mines and not less than 12.5 percent for surface mines. Many stakeholders believe that these rates do not adequately compensate the public for the removal of the coal and the externalities associated with its use. Still others have suggested that the large volumes and relatively low costs of Federal coal, which currently represents approximately 41 percent of total domestic production, have the effect of artificially lowering market prices for coal, further reducing the amount of royalties received.

    Stakeholders also criticize the Federal coal program for obtaining even lower returns through certain types of leasing actions, such as lease modifications, and through royalty rate reductions, which may result in royalty rates as low as 2 percent. In addition, stakeholders have noted that the $100 acre minimum bid requirement established in the regulations is outdated, and although the minimum bid does not apply frequently, given fair market value requirements, there are situations in which it sets the floor for the bid price.

    Some stakeholders further suggest that a fair return to the taxpayer should also include compensation for externalities such as the environmental damage (or lost environmental benefits) from the removal and combustion of the coal.

    2. Concerns About Market Conditions

    Stakeholders raised a variety of concerns about the implications of current and future coal market conditions. As reported by EIA, between 2008 and 2013, U.S. coal production fell by 16 percent in total, as declining natural gas prices and other factors made coal less competitive as a fuel for generating electricity.13 In 2015, U.S. coal production was roughly 891 MMst, 11 percent lower than 2014, and the lowest level since 1986.14 World-wide demand for coal appears to be softening as well, with EIA estimating a 23 percent decline in total U.S. coal exports in 2015 from the previous year.15 As a result of these market trends, a number of mines in the U.S. have idled production, companies have asked the BLM to hold off on processing certain lease tracts for sale, several major coal companies have entered Chapter 11 bankruptcy, many coal miners have been laid off, and coal-dependent communities have suffered.16 The EIA and other projections of future coal production anticipate continuing declines.

    13 U.S. EIA, Annual Energy Outlook 2015, 22 (Apr. 14, 2015).

    14 U.S. EIA, Short Term Energy Outlook: Coal (Feb. 9, 2016) (http://www.eia.gov/forecasts/steo/report/coal.cfm) ; U.S. EIA, Coal Production and Prices Decline in 2015 (January 8, 2016) (http://www.eia.gov/todayinenergy/detail.cfm?id=24472).

    15 U.S. EIA, Short Term Energy Outlook: Coal (Feb. 9, 2016) (http://www.eia.gov/forecasts/steo/report/coal.cfm); see also U.S. EIA, Coal Production and Prices Decline in 2015 (Jan. 8, 2016) (http://www.eia.gov/todayinenergy/detail.cfm?id=24472).

    16See, e.g., Wall Street Journal, Pressure on Coal Industry Intensifies, B1 (Jan. 12, 2016).

    Stakeholders have urged the BLM to modify the Federal coal program to take these significant market changes into account, although the recommended changes vary. Some suggest that the program should attempt to improve the economic viability of the coal industry by reducing royalties and streamlining the leasing and permitting processes. Others raise concerns that the program has contributed to low coal prices by incentivizing over-production through non-competitive sales that oversupply the market.

    Some have focused on how current market conditions threaten reclamation of lands disturbed by coal mining and may leave State and Federal governments with billions of dollars of unfunded reclamation liabilities. Specifically, many coal companies “self-bond” to meet reclamation bonding requirements, and some stakeholders have asserted that these companies may no longer have the funds to support reclamation activities, and/or they may attempt to shed reclamation obligations in bankruptcy.17 OSMRE currently estimates that there is over $3.6 billion in outstanding self-bonded reclamation liability in the United States.

    17See, e.g., In re Alpha Natural Resources, Inc., et al., Case No. 15-33896 (KRH) United States Bankruptcy Court, Eastern District of Virginia, Richmond Division (Alpha Resources bankruptcy filing) (Aug. 3, 2015) (http://www.kccllc.net/alpharestructuring); In re Arch Coal, Inc., et al, Case No. 16-40120-705, United States Bankruptcy Court, Eastern District of Missouri, Eastern Division (Arch Coal bankruptcy filing (Jan. 11, 2016) (http://www.archcoal.com/restructuring/).

    Stakeholders also expressed a number of views regarding export of Federal coal. Some see export markets as a possible way to maintain or expand Federal coal production, while others view the production of coal for export as a less valuable activity than coal production for domestic use. A number of stakeholders expressed concern that exports, or the potential for exports, were not adequately considered as part of the leasing process.

    3. Concerns About Climate Change

    The third broad category of concerns about the Federal coal program relates to its impacts on climate change. The United States has pledged under the United Nations Framework Convention on Climate Change to reduce its greenhouse gas (GHG) emissions by 26-28 percent below 2005 levels by 2025. The Obama Administration has made, and is continuing to make, unprecedented efforts to reduce U.S. GHG emissions in line with this target through measures such as vehicle efficiency standards, the Clean Power Plan, energy efficiency standards, requirements to reduce methane reductions from oil and gas production, and many other measures. Numerous scientific studies indicate that reducing GHG emissions from coal use worldwide is critical to addressing climate change.18

    18See, e.g., McGlade and Ekins, The geographical distribution of fossil fuels unused when limiting global warming to 2 °C, Nature, 517, 187-190 (Jan. 8, 2015) (finding that globally over 80% of current coal reserves should remain unused from 2010 to 2050 to meet the target of 2 degrees C).

    As noted above, the Federal coal program is a significant component of overall U.S. coal production. In recent years, Federal coal has comprised about 41 percent of the coal produced in the U.S.19 When combusted, this Federal coal contributes roughly 10 percent of total U.S. GHG emissions.20

    19 U.S. EIA, Sales of Fossil Fuels Produced from Federal and Indian Lands, FY 2003 through FY 2014 (July 17, 2015) (https://www.eia.gov/analysis/requests/federallands/) (quantity of Federal coal production in 2014 and percent of total U.S. coal production).

    20Id.; U.S. EPA, Inventory of U.S. Greenhouse Gas Emissions and Sinks, 3-2 (April 2015) (http://www3.epa.gov/climatechange/Downloads/ghgemissions/US-GHG-Inventory-2015-Chapter-3-Energy.pdf) (quantity of U.S. emissions from coal in 2013).

    Many stakeholders highlighted the tension between producing very large quantities of Federal coal while pursuing policies to reduce U.S. GHG emissions substantially, including from coal combustion. They also stated that the current leasing system does not provide a way to systematically consider the climate impacts and costs to the public of Federal coal development, either as a whole, or in the context of particular projects. In addition, they raise concerns that exporting Federal coal, and the associated GHG emissions, undermines our nation's efforts to encourage all countries to contribute to climate change mitigation efforts.

    C. Secretarial Order

    On January 15, 2016, the Secretary of the Interior issued Order No. 3338 directing the BLM to conduct a broad, programmatic review of the Federal coal program it administers through the preparation of a Programmatic EIS under NEPA. The Order stated:

    Given the broad range of issues raised over the course of the past year (and beyond) and the lack of any recent analysis of the Federal coal program as a whole, a more comprehensive, programmatic review is in order, building on the BLM's public listening sessions . . . .

    [T]he purpose of the P[rogrammatic] EIS is to identify, evaluate, and potentially recommend reforms to the Federal coal program. This review will enable the Department to consider how to modernize the program to allow for the continued development of Federal coal resources while addressing the substantive issues raised by the public, other stakeholders, and the Department's own review of the comments it has received.

    The Order does not apply to the coal program on Indian lands, as that program is distinct from the BLM's program and is subject to the unique trust relationship between the United States and federally recognized Indian tribes and government-to-government consultation requirements. The Order also does not apply to any action of OSMRE or ONRR.

    D. Scoping Discussion

    The Programmatic EIS will identify and review potential modifications to the Federal coal program to address the concerns discussed above and others that may be identified during the scoping process, and potentially, identify a preferred set of actions. Such modifications could include changes to guidance, regulations, and/or land use plans. The process of developing the Programmatic EIS will be used to identify and develop potential changes to the program and evaluate their projected effects on the quality of the human environment. In addition, the Programmatic EIS will consider, as an alternative, a continuation of the current Federal coal program without any modifications, as required by NEPA. The scoping process will refine the specific issues to be addressed in the Programmatic EIS and the potential modifications to be evaluated. Cooperating agencies may include any Federal, State, or local agency or tribal government with jurisdiction or special expertise in matters within the scope of the Programmatic EIS.

    1. Issues To Be Addressed

    The full set of issues to be assessed in the Programmatic EIS will be determined through the public scoping process, but it is expected to include the following topics. The Order identified most of these, but the following list has been expanded to include additional topics and details raised through the listening sessions.

    a. How, When, and Where to Lease. The regional leasing program authorized in the 1979 regulations has not worked as envisioned and, instead, the BLM has conducted leasing only in response to industry applications. Given concerns about the lack of competition in the lease-by-application system, as well as consideration of environmental goals, the Programmatic EIS will examine whether the current regulatory framework should be changed to provide a better mechanism or mechanisms to decide which coal resources should be made available and how the leasing process should work.

    As part of this evaluation, the Programmatic EIS will examine the issue of when to lease. Some leasing programs for other Federal resources operate with an established schedule for leasing or consideration of leasing (e.g., BLM holds onshore oil and gas lease sales on a quarterly basis if parcels are available; offshore oil and gas leasing occurs using a schedule established in a five-year plan). The Programmatic EIS will examine whether scheduled sales should be used for Federal coal. In addition, the Programmatic EIS will look at the factors that should be considered in decisions about the timing of leasing. For example, it will evaluate whether market conditions should affect the timing of lease sales, such that sales would occur when coal values are higher rather than during periods of market downturns, when revenues from lease sales would be lower.

    The Programmatic EIS will also examine where to lease and where not to lease, consistent with taking a landscape level view of this question. The Federal Land Policy and Management Act requires the BLM to develop land use plans, also known as Resource Management Plans to guide the BLM's management of public lands. The BLM uses this planning process to identify and address, at a broad scale, potential conflicts over and impacts of possible resource uses. The Programmatic EIS will consider whether the BLM's unsuitability screening criteria adequately address the questions of where and/or where not to lease for coal production, as well as other potential factors that could be applied during the planning process to provide guidance on the most appropriate locations for coal leasing. This question is particularly timely in light of the BLM's recent proposal to update the current planning regulations (“Planning 2.0”).21 The proposed regulatory changes highlight, in particular, opportunities for early public involvement in the planning process and landscape level planning efforts that may cross traditional administrative boundaries, both of which are relevant for planning related to the coal program.

    21 Dept. of Interior, Bureau of Land Management, Resource Management Planning, Proposed Rule, 81FR 9674 (Feb. 25, 2016).

    b. Fair Return. The Programmatic EIS will address whether the bonus bids, rents, and royalties received under the Federal coal program are successfully securing a fair return to the American public for Federal coal, and, if not, what adjustments could be made to provide such compensation. As part of this analysis, the Programmatic EIS will examine how each of these components of fair return should be calculated, including whether (and if so, what) externalities should be considered as part of the fair return calculation.

    c. Climate Impacts. With respect to the climate impacts of the Federal coal program, the Programmatic EIS will examine how best to measure and assess the climate impacts of continued Federal coal production, transportation, and combustion. This will include evaluation of potential substitution effects from any changes in Federal coal production, and consideration of how best to ensure no unnecessary and undue degradation of public lands from climate change impacts. It will also consider whether and how to mitigate, account for, or otherwise address those impacts through the structure and management of the coal program, including, as appropriate, land use planning, adjustments to the scale and pace of leasing, adjustments to royalties or other means of internalizing externalities, mitigation through greenhouse gas reductions elsewhere, information disclosure, and other approaches. The Programmatic EIS will examine the climate impacts of the coal program in the context of the Nation's climate objectives, as well as the Nation's energy and security needs.

    d. Other Impacts. The Federal coal program has other potential impacts on public health and the environment, beyond climate impacts, that will also be assessed in the Programmatic EIS. These include the effects of coal production on: The quantity and quality of water resources, including aquifer drawdown and impacts on streams and alluvial valley floors; air quality and the associated effects on health and visibility; wildlife, including endangered species; and other land uses such as grazing and recreation. These impacts are commonly addressed through mitigation requirements. Recent mitigation directives focus on developing a comprehensive, clear, and consistent approach for avoidance and minimization of, and compensatory mitigation for, the impacts of agency activities and the projects agencies approve.22 The Programmatic EIS will evaluate the BLM's general approach to mitigation for these impacts from coal production, and specifically, whether impacts from mining and combusting Federal coal are adequately mitigated across the Federal coal program, including the timing and certainty of mitigation, and whether standard mitigation at the programmatic level should be required, in addition to on a project-by-project basis.

    22 Secretary of the Interior, Secretarial Order 3330 (Oct. 31, 2013) (establishing a Department-wide mitigation strategy) (https://www.doi.gov/sites/doi.gov/files/migrated/news/upload/Secretarial-Order-Mitigation.pdf); President Obama, Presidential Memorandum: Mitigating Impacts on Natural Resources from Development and Encouraging Related Private Investment (Nov. 3, 2015) (https://www.whitehouse.gov/the-press-office/2015/11/03/mitigating-impacts-natural-resources-development-and-encouraging-related). Consistent with these directives, the BLM is currently working on a mitigation policy that will bring consistency to the consideration and application of avoidance, minimization, and compensatory actions or development activities and projects impacting public lands and resources.

    e. Socio-Economic Considerations. Beyond the issue of fair market value, the Programmatic EIS will assess whether the current Federal coal leasing program adequately accounts for externalities related to Federal coal production, including environmental and social impacts. It will more broadly examine how the administration, availability, and pricing of Federal coal affect State, regional, and national economies (including job impacts), and energy markets in general, including the pricing and viability of other coal resources (both domestic and foreign) and other energy sources. The impact of possible program alternatives on the projected fuel mix and cost of electricity in the United States will also be examined.

    f. Exports. The Programmatic EIS will address whether and, if so, how leasing decisions should consider actual and/or projected exports of domestic coal from any given tract and potential mechanisms that could be used to appropriately evaluate export potential.

    g. Energy Needs. Finally, the Programmatic EIS will examine how Federal coal supports fulfilling the energy needs of the United States. The evaluation will include an assessment of how the administration, availability, and pricing of Federal coal impacts electricity generation in the United States, particularly in light of other regulatory influences, and what other sources of energy supply (including efficiency) are projected to be available.

    2. Potential Modifications to the Federal Coal Program To Be Considered

    The BLM is considering various approaches for reforming the Federal coal program to address some or all of the identified issues above, including providing a fair return to taxpayers and providing appropriate consideration of the impacts the program has on the environment. These approaches may be considered separately or in any combination.

    To date, stakeholders have made suggestions that range from maintaining the status quo to undertaking sweeping changes. During the listening sessions, commenters suggested a variety of modifications that could be made to the Federal coal program to better address concerns about fair return to taxpayers, market conditions, and effects on climate change, among others. Some of these suggestions were sufficiently specific to constitute potential approaches that could be evaluated in the Programmatic EIS. These proposals are summarized below.

    The BLM requests comment on whether the Programmatic EIS should further evaluate some or all of these specific approaches, or some variation on them. The BLM also welcomes suggestions for other potential approaches that should be evaluated in the Programmatic EIS, including approaches that may be contrary to those articulated below, such as reforming the leasing process to promote coal development through steps that might accelerate leasing and reduce delays and costs. As previously noted, the Programmatic EIS will also consider a “no action alternative”—the continuation of the program without any modifications—as required by NEPA. We encourage commenters to be as specific as possible in identifying the types of changes to the program that the Programmatic EIS should evaluate, including changes to regulations, guidance, and management practices.

    To address concerns about fair returns to taxpayers, the BLM is considering evaluating the following approaches:

    • Raise the royalty rate or adjust the royalty terms of new leases, such as:

    ○ Raise the royalty rate to 18.75 percent, consistent with the royalty rate for Federal offshore oil and gas;

    ○ Raise the royalty rate to a level that would provide parity on an energy content (Btu) basis with the royalties currently collected for Federal onshore natural gas, a common substitute fuel;

    ○ Raise the royalty rate to the point that would maximize revenues to the taxpayer, taking into consideration any decrease in demand that may result from the higher royalty rate; or

    ○ Identify and require an “adder” to be paid to reflect the cost of the harm to the public from negative externalities from coal development;

    • Limit the use of royalty rate reductions;

    • Change the methodology for determining fair market value when establishing the minimum bid or valuing lease modifications, such as:

    ○ Use the market price of non-Federal coal in the region or nation-wide;

    ○ Include the option value of leasing the coal resource at a given point in time;

    ○ Include the social cost of mining (i.e., the cost to taxpayers of mining imposed by fixed cost non-internalized externalities, such as loss of recreational or other values, which do not vary by quantity produced);

    ○ Explicitly include export value in establishing fair market value;

    ○ Replace the lease by application approach with an open process of setting (after public comment and expert advice) minimal acceptable bid levels for tracts; or

    ○ Update the minimum bid established by regulation to account for inflation, and/or establish state-specific minimum bids;

    • Raise rental rates to adjust for inflation and/or incorporate lost value of other uses of the land and anticipated externalities of exploratory activities;

    • Do not lease to companies that have more than 10 years of recoverable reserves coal at the time of lease application; and

    • Evaluate whether there is an over-supply of Federal coal that is undercutting market prices for coal in the United States and thereby leading to lower royalty revenue.

    The BLM received the following industry proposals concerned with promoting coal production that are also under consideration:

    • Lower royalty rates, including as a means of increasing overall government take;

    • Broaden the applicability of royalty rate reductions;

    • Reform the leasing process to accelerate leasing and reduce delays and costs;

    • Base bonus bids on the amount of recoverable coal, not coal reserves;

    • Convert revenue streams to pay-as-you go, instead of an upfront payment of bonus bids over five years; and

    • Reestablish the Royalty Policy Committee to guide changes to royalties.

    To address concerns about climate impacts and/or other public health and environmental harms, the BLM is considering evaluating the following approaches:

    • Change the methodology for determining which, or how much, Federal coal and/or acreage is made available for leasing, such as:

    ○ Establish a “budget,” or other quantity-based schedule, for the amount of Federal coal and/or acreage to be leased over a given period, with the budget set on a declining schedule consistent with the United States' climate goals and commitments and market demand;

    ○ Re-establish an updated version of the regional planning and leasing process, using land use planning and environmental evaluation to decide whether an area should be leased; or

    ○ Develop a landscape-level approach to identify geographic areas for potential leasing to identify and address potential conflicts

    • Raise royalty rates or require an “adder” to be paid to reflect the cost of the harm to the public from negative externalities from coal development (could include production-related externalities, transportation-related externalities, externalities from use of coal, and/or costs of infrastructure demand, such as water and power), such as:

    ○ Incorporating the social cost of carbon;

    ○ Incorporating the social cost of methane; or

    ○ Reflecting other externalities;

    • Require climate and/or other public health and environmental harms to be mitigated; and

    • Prohibit or otherwise limit leasing to entities that are not meeting their environmental responsibilities, such as:

    ○ Entities listed in the Office of Surface Mining Reclamation and Enforcement Applicator Violator System; or

    ○ Entities that have not met their reclamation or bonding (including bond release) requirements.

    E. Scoping Process

    The Federal coal program Programmatic EIS process will provide opportunities for formal public participation through commenting during public scoping and on the draft Programmatic EIS, when that is published. The BLM aims to complete the Coal Programmatic EIS over roughly 3 years. The process will include public and agency scoping, including public scoping meetings, collection of public comments during the scoping period, issuance of a summary of substantive comments received during the scoping period, as well as issuance of a scoping report at the end of the scoping process; coordination and consultation with Federal, State, tribal and local governments; publication of a draft Programmatic EIS; public review of and comments on the draft Programmatic EIS; and publication of a final Programmatic EIS, which will include the BLM's responses to substantive comments received on the draft Programmatic EIS. The Programmatic EIS process is intended to involve all interested agencies (Federal, State, county, and local), Native American tribes, public interest groups, businesses, and members of the public.

    At this time, interested parties are invited to participate in the scoping process to assist the BLM in identifying and refining the issues and policy proposals to be analyzed in depth and in eliminating from detailed study those policy proposals and issues that are not feasible or pertinent. Participation in the scoping process may take the form of attendance at public scoping meetings, speaking at public scoping meetings, and/or submitting written comments.

    In addition to taking comment on the specific approaches discussed above, as well as welcoming suggestions for other potential approaches that should be evaluated in the Programmatic EIS, BLM is soliciting input on the following:

    1. Potential new leasing models, or potential reforms to the previous or existing leasing models of regional leasing and lease by application; 2. Other approaches to increase competition in the leasing process; 3. Data or analyses that justify a specific change to the royalty rate; 4. Potential approaches to improve the pre-sale estimate of fair market value; 5. Whether, and how, to account in the leasing process for the extent to which reclamation responsibilities have been met; 6. Potential approaches to design a `budget' for the amount of Federal coal and/or acreage to be leased over a given period; and 7. How to account for export potential in the leasing process.

    Public scoping meetings will be held as indicated above under the DATES section. These scoping meetings will be informal. The presiding officer will establish only those procedures needed to ensure that everyone who wishes to speak has a chance to do so, to the extent practicable, and that the agency representatives understand all issues and comments. Persons wishing to speak on behalf of an organization should identify that organization in their request to speak. Should any speaker wish to provide for the record further information that cannot be presented within the designated time, such information may be submitted in writing or electronically by the date listed in the DATES section to the addresses listed in the ADDRESSES section.

    In submitting written comments, individuals should be aware that the entire comment—including personal identifying information (including address, phone number, and email address)—may be made publicly available at any time. While the commenter can request in the comment that the commenter's personal identifying information be withheld from public review, this cannot be guaranteed. All comments from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be available for public inspection in their entirety. If you would like to receive a copy of the draft Programmatic EIS and other project materials, you are encouraged to make this request through the project Web site (http://www.blm.gov/wo/st/en/prog/energy/coal_and_non-energy/details_on_coal_peis.html), or you may contact Mitchell Leverette as provided in the ADDRESSES section of this notice.

    Pursuant to 36 CFR 800.2(d)(3), the BLM will use the NEPA public participation requirements to satisfy the public involvement requirements under Section 106 of the National Historic Preservation Act (NHPA), 16 U.S.C. 470(f). The BLM will consult with Indian tribes on a government-to-government basis in accordance with Executive Order 13175 and other policies. Tribal concerns, including impacts on Indian trust assets and potential impacts to cultural resources, will be given due consideration. Federal, State, and local agencies, along with tribes and other stakeholders that may be interested in or affected by the Federal coal program, are invited to participate in the scoping process and, if eligible, may request or be requested by the BLM to participate in the development of the environmental analysis as a cooperating agency.

    After gathering public comments on issues and policy proposals that should be addressed in the Programmatic EIS, the BLM will identify the issues and policy proposals to be addressed in the Programmatic EIS and the issues and proposals determined to be beyond the scope of the Programmatic EIS. Following closure of the scoping period, the BLM will prepare a scoping summary report and will make the report available to the public. The report will be posted on the project Web site (http://www.blm.gov/wo/st/en/prog/energy/coal_and_non-energy/details_on_coal_peis.html), or may be requested from Mitchell Leverette, as provided in the ADDRESSES section of this notice.

    Authority:

    The BLM will prepare the Programmatic EIS in accordance with, but not limited to, the National Environmental Policy Act, 42 U.S.C. 4321 et seq.; the Council on Environmental Quality regulations (CEQ), 40 CFR parts 1500-1508; the U.S. Department of the Interior regulations implementing NEPA, 43 CFR part 46; and the Federal Land Policy and Management Act of 1976 (FLPMA), 43 U.S.C. 1701 et seq.

    This notice is published in accordance with section 40 CFR 1501.7 of the CEQ regulations and 43 CFR 46.235 of the DOI regulations implementing the NEPA.

    Neil Kornze, Director, Bureau of Land Management, Department of the Interior.
    [FR Doc. 2016-07138 Filed 3-29-16; 8:45 am] BILLING CODE 4310-84-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLWO2200000.L10200000.PK0000.00000000; Control No. 1004-0019] Renewal of Approved Information Collection AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    60-Day notice and request for comments.

    SUMMARY:

    In compliance with the Paperwork Reduction Act, the Bureau of Land Management (BLM) invites public comments on, and plans to request approval to continue, the collection of information from individuals, households, farms, and businesses interested in cooperating with the BLM in constructing or maintaining range improvement projects that enhance or improve livestock grazing management, improve watershed conditions, enhance wildlife habitat, or serve similar purposes. The BLM also invites public comments on this collection of information. The Office of Management and Budget (OMB) has assigned control number 1004-0019 to this information collection.

    DATES:

    Please submit comments on the proposed information collection by May 31, 2016.

    ADDRESSES:

    Comments may be submitted by mail, fax, or electronic mail.

    Mail: U.S. Department of the Interior, Bureau of Land Management, 1849 C Street NW., Room 2134LM, Attention: Jean Sonneman, Washington, DC 20240.

    Fax: to Jean Sonneman at 202-245-0050.

    Electronic mail: [email protected]

    Please indicate “Attn: 1004-0019” regardless of the form of your comments.

    FOR FURTHER INFORMATION CONTACT:

    Kimberly Hackett, at 202-912-7216. Persons who use a telecommunication device for the deaf may call the Federal Information Relay Service at 1-800-877-8339, to leave a message for Ms. Hackett.

    SUPPLEMENTARY INFORMATION:

    OMB regulations at 5 CFR part 1320, which implement provisions of the Paperwork Reduction Act, 44 U.S.C. 3501-3521, require that interested members of the public and affected agencies be given an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8 (d) and 1320.12(a)). This notice identifies an information collection that the BLM plans to submit to OMB for approval. The Paperwork Reduction Act provides that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. Until OMB approves a collection of information, you are not obligated to respond.

    The BLM will request a 3-year term of approval for this information collection activity. Comments are invited on: (1) The need for the collection of information for the performance of the functions of the agency; (2) the accuracy of the agency's burden estimates; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the information collection burden on respondents, such as use of automated means of collection of the information. A summary of the public comments will accompany our submission of the information collection requests to OMB.

    Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    The following information pertains to this request:

    Title: Grazing Management: Range Improvements Agreements and Permits (43 CFR Subpart 4120).

    OMB Control Number: 1004-0019.

    Summary: This request pertains to range improvements on public lands managed by the BLM. Range improvements enhance or improve livestock grazing management, improve watershed conditions, enhance wildlife habitat, or serve similar purposes. At times, the BLM may require holders of grazing permits or gazing leases to install range improvements to meet the terms and conditions of their permits or leases. Operators may also come to the BLM with proposals for range improvements. Often the BLM, operators, and other interested parties work together and jointly contribute to construction of range improvements in order to facilitate improved grazing management or enhance other multiple uses. Cooperators may include lenders which provide the funds that operators contribute for improvements.

    Frequency of Collection: On occasion.

    Forms:

    • Form 4120-6 (Cooperative Range Improvement Agreement); and

    • Form 4120-7 (Range Improvement Permit).

    Description of Respondents: Holders of BLM grazing permits or grazing leases; affected individuals and households; and affected tribal, state, and county agencies.

    Estimated Annual Responses: 1,110.

    Estimated Annual Burden Hours: 1,640.

    Estimated Annual Non-Hour Costs: None.

    The estimated burdens are itemized in the following table:

    Type of response Number of
  • responses
  • Hours per
  • response
  • Total hours
  • (Column B × Column C)
  • A B C D Cooperative Range Improvement Agreement, 43 CFR 4120.3-2, Form 4120-6 and related non-form information 500 2 1,000 Range Improvement Permit, 43 CFR 4120.3-3, Form 4120-7 and related non-form information 30 2 60 Affected Public/Individuals and Households, 43 CFR 4120.5-1 50 1 50 Affected Public/Tribal, State, and County Agencies, 43 CFR 4120.5-2 530 1 530 Total 1,110 1,640
    Jean Sonneman, Bureau of Land Management, Information Collection Clearance Officer.
    [FR Doc. 2016-07091 Filed 3-29-16; 8:45 am] BILLING CODE 4310-84-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLWO320000 L13300000.PP0000 12X] Renewal of Approved Information Collection; OMB Control No. 1004-0121 AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    30-Day notice and request for comments.

    SUMMARY:

    The Bureau of Land Management (BLM) has submitted an information collection request to the Office of Management and Budget (OMB) to continue the collection of information regarding authorizations pertaining to solid minerals other than coal and oil shale. The Office of Management and Budget (OMB) previously approved this information collection activity, and assigned it control number 1004-0121.

    DATES:

    The OMB is required to respond to this information collection request within 60 days but may respond after 30 days. For maximum consideration, written comments should be received on or before April 29, 2016.

    ADDRESSES:

    Please submit comments directly to the Desk Officer for the Department of the Interior (OMB #1004-0121), Office of Management and Budget, Office of Information and Regulatory Affairs, fax 202-395-5806, or by electronic mail at [email protected] Please provide a copy of your comments to the BLM. You may do so via mail, fax, or electronic mail.

    Mail: U.S. Department of the Interior, Bureau of Land Management, 1849 C Street NW., Room 2134LM, Attention: Jean Sonneman, Washington, DC 20240.

    Fax: to Jean Sonneman at 202-245-0050.

    Electronic mail: [email protected]

    Please indicate “Attn: 1004-0121” regardless of the form of your comments.

    FOR FURTHER INFORMATION CONTACT:

    Vince Vogt, at 202-912-7125. Persons who use a telecommunication device for the deaf may call the Federal Information Relay Service at 1-800-877-8339, to leave a message for Mr. Vogt. You may also review the information collection request online at http://www.reginfo.gov/public/do/PRAMain.

    SUPPLEMENTARY INFORMATION:

    The Paperwork Reduction Act (44 U.S.C. 3501-3521) and OMB regulations at 5 CFR part 1320 provide that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. Until OMB approves a collection of information, you are not obligated to respond. In order to obtain and renew an OMB control number, Federal agencies are required to seek public comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d) and 1320.12(a)).

    As required at 5 CFR 1320.8(d), the BLM published a 60-day notice in the Federal Register on September 16, 2015 (80 FR 55640), and the comment period ended November 16, 2015. The BLM received no comments.

    The BLM now requests comments on the following subjects:

    1. Whether the collection of information is necessary for the proper functioning of the BLM, including whether the information will have practical utility;

    2. The accuracy of the BLM's estimate of the burden of collecting the information, including the validity of the methodology and assumptions used;

    3. The quality, utility and clarity of the information to be collected; and

    4. How to minimize the information collection burden on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other forms of information technology.

    Please send comments as directed under ADDRESSES and DATES. Please refer to OMB control number 1004-0121 in your correspondence. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    The following information pertains to this request:

    Title: Leasing of Solid Minerals Other Than Coal and Oil Shale (43 CFR parts 3500, 3580, and 3590).

    OMB Control Number: 1004-0121.

    Abstract: This control number enables the BLM to fulfill its responsibilities regarding prospecting permits, exploration licenses, leases, the exchange of leases, use permits, and the regulation of mining activities for solid minerals other than coal or oil shale. The information activities currently approved under control number 1004-0121 include requirements that an applicant, a permittee or a lessee submit information that enables the BLM to:

    • Determine if applicants, permittees, and lessees meet qualification criteria;

    • Assure compliance with various other legal requirements relating to the leasing of solid minerals other than coal or oil shale;

    • Gather data needed to determine the environmental impacts of developing solid leasable minerals other than coal or oil shale;

    • Maintain accurate leasing records; and

    • Oversee and manage the leasing of solid minerals other than coal or oil shale.

    Forms:

    Form 3504-1, Personal Bond and Power of Attorney;

    Form 3504-3, Bond under Lease;

    Form 3504-4, Statewide or Nationwide Personal Mineral Bond;

    Form 3510-1, Prospecting Application and Permit;

    Form 3510-2, Phosphate or Sodium Use Permit; and

    Form 3520-7, Lease.

    Frequency of Collection: On occasion.

    Description of Respondents: Applicants for, and holders of, the following authorizations in connection with solid minerals other than coal or oil shale:

    • Prospecting permits;

    • Exploration licenses;

    • Leases; and

    • Use permits.

    Obligation to Respond: To obtain or retain a benefit.

    Estimated Annual Responses: 473.

    Estimated Annual Burden Hours: 16,346.

    The following table itemizes the estimated burden hours:

    Type of response Number of
  • responses
  • Hours per
  • response
  • Total hours
  • (Column B ×
  • Column C)
  • A. B. C. D. Request for Effective Date, 43 CFR 3501.20 10 1 10 Qualification Requirements/Individuals or Households, Guardians or Trustees, Heirs, and Devisees, 43 CFR 3502.27, 3502.29, 3502.33, 3502.34, and 3502.40 3 2 6 Qualification Requirements/Associations and Partnerships, 43 CFR 3502.28, 3502.33, and 3502.34 3 2 6 Qualification Requirements/Corporations, 43 CFR 3502.30, 3502.33, and 3502.34 44 2 88 Surface Owner Consultation/State or Local Government, 43 CFR 3503.21(b) 1 2 2 Surface Owner Consultation/Educational, Charitable, or Religious Organization, 43 CFR 3503.21(b) 2 2 4 Applicant's Land Description, 43 CFR 3503.30 through 3503.32 50 2 100 Bonding, 43 CFR 3504.50 through 3504.71, Forms 3504-1, 3504-3, and 3504-4 40 4 160 Application for a Prospecting Permit, 43 CFR 3505.12 and 3505.13, Form 3510-1 50 10 500 Amendment or Withdrawal of an Application for Prospecting Permit, 43 CFR 3505.30 and 3505.31 10 5 50 Exploration Plan, 43 CFR 3505.40, 3505.45, and 3592.1(a) 25 400 10,000 Application to Extend a Prospecting Permit, 43 CFR 3505.60 through 3505.66 5 40 200 Application for an Exploration License, 43 CFR 3506.11 through 3506.25 4 10 40 Application for a Preference Right Lease, 43 CFR 3507.11 through 3507.19, Form 3520-7 2 300 600 Application for a Competitive Lease, 43 CFR 3508.12 through 3508.22 5 20 100 Application for a Fractional or Future Interest Lease, 43 CFR 3509.10 through 3509.51 1 80 80 Application for a Fringe Acreage Lease or Lease Modification, (43 CFR 3510.12) 10 20 200 Objection to Proposed Readjustment of Lease Terms and Conditions, 43 CFR 3511.25 and 3511.26 20 2 40 Request for Renewal of a Lease, 43 CFR 3511.27 20 2 40 Assignment, Sublease, or Transfer, 43 CFR 3512.11 through 3512.17 30 6 180 Application for Waiver, Suspension, or Reduction of Rental or Minimum Royalties, or for a Reduction in the Royalty Rate, 43 CFR 3513.11 through 3513.26 2 100 200 Lease Relinquishment, 43 CFR 3514.11 through 3514.21 10 40 400 Mineral Lease Exchange, 43 CFR 3515.23 through 3515.27 1 40 40 Application for a Use Permit, 43 CFR 3516.15 through 3516.30, Form 3510-2 1 10 10 Application for Approval of a Hardrock Mineral Development Contract or Processing or Milling Arrangement, 43 CFR 3517.15 1 20 20 Application for a Gold, Silver, or Quicksilver Lease in a Confirmed Private Land Grant, 43 CFR 3581.3 and 3581.4, Form 3520-7 1 20 20 Application for a Hardrock Mineral Lease in the Shasta and Trinity Units of the Whiskeytown-Shasta-Trinity National Recreation Area, 43 CFR 3583.3 1 20 20 Application for a Mineral Lease in the White Mountain National Recreation Area, 43 CFR 3585.3-2 1 20 20 Mining Plan, 43 CFR 3592.1 through 3592.3 5 300 1,500 Modification of an Exploration or Mining Plan, 43 CFR 3592.1(d) 10 150 1,500 Data on Bore Holes and Samples, 43 CFR 3593.1 25 2 50 Production Records, 43 CFR 3597.1 and 3597.2 80 2 160 Totals 473 16,346
    Dated: March 23, 2016. Jean Sonneman, Bureau of Land Management Information Collection Clearance Officer.
    [FR Doc. 2016-07164 Filed 3-29-16; 8:45 am] BILLING CODE 4310-84-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLWO3200000-L19900000.PP0000] Renewal of Approved Information Collection; Control No. 1004-0114