Federal Register Vol. 81, No.238,

Federal Register Volume 81, Issue 238 (December 12, 2016)

Page Range89357-89830
FR Document

81_FR_238
Current View
Page and SubjectPDF
81 FR 89464 - Sunshine Act MeetingPDF
81 FR 89510 - Sunshine Act Meeting; Notice of Agency MeetingPDF
81 FR 89521 - Sunshine Act Meeting; Notice of Closed MeetingPDF
81 FR 89521 - Notice of Closed Meeting; Sunshine ActPDF
81 FR 89564 - Sunshine Act MeetingPDF
81 FR 89407 - Approval of California Air Plan; Owens Valley Serious Area Plan for the 1987 24-Hour PM10PDF
81 FR 89393 - Health and Human Services Grants RegulationPDF
81 FR 89429 - Confidentiality Pledge Revision NoticePDF
81 FR 89436 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Port of Kalama Expansion Project on the Lower Columbia RiverPDF
81 FR 89499 - Land Acquisitions; Pokagon Band of Potawatomi Indians, Michigan and IndianaPDF
81 FR 89459 - Proposed CERCLA Section 122(h) Cost Recovery Settlement for the Columbia Smelting and Refining Works Site, Brooklyn, Kings County, New YorkPDF
81 FR 89504 - Indian Gaming; Approval of an Amendment to a Tribal-State Class III Gaming Compact in the State of MichiganPDF
81 FR 89458 - Senior Executive Service Performance Review Board; MembershipPDF
81 FR 89461 - Notice of Termination; 10487 Sunrise Bank of Arizona, Phoenix, ArizonaPDF
81 FR 89461 - Notice of Termination, 10500 Slavie Federal Savings Bank, Bel Air, MarylandPDF
81 FR 89461 - Notice of Termination; 10010 First Priority Bank, Bradenton, FloridaPDF
81 FR 89460 - Notice to All Interested Parties of the Termination of the Receivership of 10327-Oglethorpe Bank, Brunswick, GeorgiaPDF
81 FR 89462 - Notice of Termination; 10316 Gulf State Community Bank, Carrabelle, FloridaPDF
81 FR 89460 - Notice of Termination; 10256 Home National Bank, Blackwell, OKPDF
81 FR 89461 - Notice to All Interested Parties of the Termination of the Receivership of 10247-First National Bank, Rosedale, MississippiPDF
81 FR 89460 - Notice of Termination; 10123 Southern Colorado National Bank, Pueblo, ColoradoPDF
81 FR 89460 - Notice of Termination; 10045 Colorado National Bank, Colorado Springs, ColoradoPDF
81 FR 89382 - Drawbridge Operation Regulation; Connecticut River, East Haddam, CTPDF
81 FR 89465 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 89467 - Agency Forms Undergoing Paperwork Reduction Act ReviewPDF
81 FR 89490 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; FEMA Preparedness Grants: Homeland Security Grant Program (HSGP)PDF
81 FR 89382 - Miscellaneous Changes to Trademark Trial and Appeal Board Rules of Practice; CorrectionPDF
81 FR 89509 - Notice of Federal Advisory Committee MeetingPDF
81 FR 89469 - Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids; Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
81 FR 89506 - Public Land Order No. 7858; Extension of Public Land Order No. 7233, Rogue River; OregonPDF
81 FR 89396 - Fisheries of the Northeastern United States; Atlantic Bluefish Fishery; Quota TransferPDF
81 FR 89566 - Reporting and Recordkeeping Requirements Under OMB ReviewPDF
81 FR 89514 - In the Matter of Susquehanna Nuclear, LLC; Susquehanna Steam Electric Station, Units 1 and 2; Order Approving Indirect Transfer of Facility Operating LicensesPDF
81 FR 89508 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public InterestPDF
81 FR 89425 - Submission for OMB Review; Comment RequestPDF
81 FR 89516 - Vogtle Electric Generating Plant, Units 3 and 4PDF
81 FR 89511 - Duke Energy Florida, Inc., LLC; Crystal River Unit 3 Nuclear Generating PlantPDF
81 FR 89486 - Effective Date for the Automated Commercial Environment (ACE) Becoming the Sole CBP-Authorized Electronic Data Interchange (EDI) System for Processing Electronic Drawback and Duty Deferral Entry and Entry Summary FilingsPDF
81 FR 89434 - Seamless Refined Copper Pipe and Tube From Mexico: Preliminary Results of Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2014-2015PDF
81 FR 89468 - Proposed Information Collection Activity; Comment RequestPDF
81 FR 89570 - Notice of Buy America Waiver for Replacement Parts on Diesel Multiple Unit Rail VehiclesPDF
81 FR 89428 - Opportunity for Designation in Decatur, IN; Request for Comments on the Official Agency Servicing These Areas.PDF
81 FR 89428 - Designation for the Amarillo, TX; Cairo, IL; State of Louisiana; State of North Carolina and Belmond, IA; Minnesota; New Jersey and New York AreasPDF
81 FR 89486 - Modification of the National Customs Automation Program Test Regarding Reconciliation and Transition of the Test From the Automated Commercial System to the Automated Commercial EnvironmentPDF
81 FR 89433 - Civil Nuclear Trade Advisory Committee: Meeting of the Civil Nuclear Trade Advisory CommitteePDF
81 FR 89482 - Modification and Clarification of the National Customs Automation Program Tests Regarding Post-Summary Corrections and Periodic Monthly StatementsPDF
81 FR 89436 - Renewable Energy and Energy Efficiency Advisory Committee; MeetingPDF
81 FR 89450 - Record of Decision for Issuing a Presidential Permit to Transmission Developers, Inc.-New England, for the New England Clean Power Link Transmission Line ProjectPDF
81 FR 89454 - Northern California Power Agency; Notice of FilingPDF
81 FR 89455 - Western Area Power Administration; Notice of FilingPDF
81 FR 89456 - Western Area Power Administration; Notice of FilingPDF
81 FR 89455 - Texas Eastern Transmission, LP; Notice of Schedule for Environmental Review of the Proposed Marshall County Mine Panel 17W ProjectPDF
81 FR 89510 - Submission for OMB Review; Comment RequestPDF
81 FR 89462 - Notice of Termination of the Receivership of 10500, Slavie Federal Savings Bank, Bel Air, MarylandPDF
81 FR 89461 - Notice of Termination of the Receivership of 10010, First Priority Bank, Bradenton, FloridaPDF
81 FR 89462 - Notice of Termination of the Receivership of 10487, Sunrise Bank of Arizona, Phoenix, ArizonaPDF
81 FR 89465 - Notice of Proposals To Engage in or To Acquire Companies Engaged in Permissible Nonbanking ActivitiesPDF
81 FR 89464 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
81 FR 89446 - Proposed Information Collection; Comment Request; West Coast Region Vessel Monitoring System and Pre-Trip Reporting RequirementsPDF
81 FR 89426 - Siuslaw Resource Advisory CommitteePDF
81 FR 89572 - Notice of Buy America Public Interest Waiver for Hurricane Sandy Emergency Relief Work Performed for the World Trade CenterPDF
81 FR 89571 - Notice of Buy America Waiver for Radio ConsolesPDF
81 FR 89573 - Notice of Buy America Waiver for Ultrastraight RailPDF
81 FR 89498 - Proposed Candidate Conservation Agreement With Assurances for Camp Blanding Joint Training Center, FloridaPDF
81 FR 89569 - Notice of Final Federal Agency Actions on Transportation Project in Washington StatePDF
81 FR 89470 - Determination That SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (Sodium Chloride), Injectable, 234 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or EffectivenessPDF
81 FR 89426 - Black Hills National Forest Advisory BoardPDF
81 FR 89497 - Glacial Ridge National Wildlife Refuge, Polk County, Minnesota; Final Comprehensive Conservation Plan, Environmental Assessment, and Finding of No Significant ImpactPDF
81 FR 89533 - Self-Regulatory Organizations; The Depository Trust Company; Order Granting Approval of a Proposed Rule Change, as Modified by Amendment No. 1, To Impose Deposit Chills and Global Locks and Provide Fair Procedures to IssuersPDF
81 FR 89576 - Agency Information Collection Activity Under OMB Review: (VA Health Professional Scholarship and Visual Impairment and Orientation and Mobility Professional Scholarship Programs)PDF
81 FR 89575 - Agency Information Collection Activity Under OMB Review (Inquiry Routing & Information System (IRIS)).PDF
81 FR 89574 - Agency Information Collection Activity Under OMB Review: (Customer Satisfaction Surveys)PDF
81 FR 89574 - Agency Information Collection Activity Under OMB Review: (VA Homeless Providers Grant and Per Diem Program)PDF
81 FR 89575 - Agency Information Collection: Activity Under OMB Review (Request for Disinterment)PDF
81 FR 89510 - Assumptions Used for Evaluating the Potential Radiological Consequences of a Fuel Handling Accident in the Fuel Handling and Storage Facility for Boiling and Pressurized Water ReactorsPDF
81 FR 89427 - North Mt. Baker Snoqualmie Resource Advisory CommitteePDF
81 FR 89525 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fee Schedule on the BOX Market LLC (“BOX”) Options FacilityPDF
81 FR 89532 - Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Titles of Equities Rule 7015 and Options Chapter XV, Section 3, and To Make Related ChangesPDF
81 FR 89449 - President's Council of Advisors on Science and TechnologyPDF
81 FR 89375 - Electronic Notice of LiquidationPDF
81 FR 89431 - Solicitation of Input From Stakeholders Regarding the Food Safety Outreach ProgramPDF
81 FR 89567 - National Small Business Development Center Advisory BoardPDF
81 FR 89496 - Delegation of Authority for the Office of Lead Hazard Control and Healthy HomesPDF
81 FR 89525 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Amending NYSE Arca Equities Rules 7.35 (Auctions), 7.10 (Clearly Erroneous Executions), 7.31 (Orders and Modifiers), and 7.11 (Limit Up-Limit Down Plan and Trading Pauses in Individual Securities Due to Extraordinary Market Volatility)PDF
81 FR 89564 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Provide That the Exchange Would Not Be Required To Report to the Securities Information Processor an Official Closing Price, as Defined Under Rule 123C(1)(e)(i)-Equities, as an “M” Sale ConditionPDF
81 FR 89523 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Provide That the Exchange Would Not Be Required To Report to The Securities Information Processor an Official Closing Price, as Defined Under Rule 123C(1)(e)(i), as an “M” Sale ConditionPDF
81 FR 89559 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Rule 67 To Modify the Web site Data Publication Requirements Relating to the Regulation NMS Plan To Implement a Tick Size Pilot ProgramPDF
81 FR 89529 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Rule 7.46 to Modify the Web Site Data Publication Requirements Relating To the Regulation NMS Plan To Implement a Tick Size Pilot ProgramPDF
81 FR 89527 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Rule 67-Equities To Modify the Web Site Data Publication Requirements Relating to the Regulation NMS Plan To Implement a Tick Size Pilot ProgramPDF
81 FR 89543 - Self-Regulatory Organizations; Chicago Stock Exchange, Inc.; Notice of Filing of Proposed Rule Change in Connection With the Proposed Transaction Involving CHX Holdings, Inc. and North America Casin Holdings, Inc.PDF
81 FR 89562 - Self-Regulatory Organizations: Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Modify the Web site Data Publication Requirements Relating to the Regulation NMS Plan To Implement a Tick Size Pilot ProgramPDF
81 FR 89432 - Notice of Public Meeting of the Ohio Advisory Committee for a Meeting To Discuss Approval and Publication of a Report Regarding Civil Rights and Hate Crime in the StatePDF
81 FR 89381 - Changes to HOME Investment Partnerships (HOME) Program Commitment Requirement; CorrectionPDF
81 FR 89491 - Relief From HUD Requirements Available to Public Housing Agencies To Assist With Recovery and Relief Efforts on Behalf of Families Affected by Severe Storms and Flooding in LouisianaPDF
81 FR 89567 - Petition for Exemption; Summary of Petition Received; Flight Options, LLCPDF
81 FR 89568 - Noise Exposure Map Notice; Receipt of Noise Compatibility Program and Request for Review, Orlando Melbourne International Airport (MLB), Melbourne, FLPDF
81 FR 89462 - Notice to All Interested Parties of Intent To Terminate the Receivership of 10327, Oglethorpe Bank, Brunswick, GeorgiaPDF
81 FR 89463 - Notice of Termination of the Receivership of 10316, Gulf State Community Bank, Carrabelle, FloridaPDF
81 FR 89462 - Notice of Termination of the Receivership of 10271, Bayside Savings Bank, Port Saint Joe, FloridaPDF
81 FR 89460 - Notice of Termination of the Receivership of 10474, First Federal Bank, Lexington, KentuckyPDF
81 FR 89567 - Request for Information on Strategies for Improving Work Outcomes for Individuals With Musculoskeletal DisabilitiesPDF
81 FR 89401 - Proposed Establishment of Class E Airspace; Louisville, GAPDF
81 FR 89399 - Proposed Establishment of Class E Airspace; Kill Devil Hills, NCPDF
81 FR 89507 - National Register of Historic Places; Notification of Pending Nominations and Related ActionsPDF
81 FR 89506 - National Register of Historic Places; Notification of Pending Nominations and Related ActionsPDF
81 FR 89455 - Notice of Commission Staff AttendancePDF
81 FR 89457 - Electronic Tariff Filings; Notice of Additional eTariff Type of Filing CodesPDF
81 FR 89456 - River Street Associates; Contoocook Hydro, LLC; Notice of Transfer of ExemptionPDF
81 FR 89457 - City of Holyoke Gas and Electric Department; Notice of Application Accepted for Filing and Soliciting Motions To Intervene and ProtestsPDF
81 FR 89453 - Eugene Water and Electric Board; Notice of Settlement Agreement and Soliciting CommentsPDF
81 FR 89454 - TransCanada Hydro Northeast Inc.; TC Hydro Inc.; Notice of Application for Transfer of Licenses and Soliciting Comments and Motions To IntervenePDF
81 FR 89432 - Approval of Subzone Status; Romark Global Pharma, LLC Manatí, Puerto RicoPDF
81 FR 89432 - Foreign-Trade Zone (FTZ) 281-Miami, Florida; Authorization of Production Activity; Carrier InterAmerica Corporation (Heating, Ventilating and Air Conditioning Systems); Miami, FloridaPDF
81 FR 89433 - Application(s) for Duty-Free Entry of Scientific InstrumentsPDF
81 FR 89447 - Order Excluding Farm Credit System Institutions From the Commodity Exchange Act's Definition of “Commodity Trading Advisor”PDF
81 FR 89424 - Petition for Reconsideration of Action in Rulemaking ProceedingPDF
81 FR 89471 - Ebola Virus Disease Vaccines-AmendmentPDF
81 FR 89476 - Ebola Virus Disease Therapeutics-AmendmentPDF
81 FR 89463 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMBPDF
81 FR 89482 - Government-Owned Inventions; Availability for LicensingPDF
81 FR 89481 - National Eye Institute; Notice of MeetingPDF
81 FR 89481 - Center for Scientific Review; Notice of Closed MeetingPDF
81 FR 89521 - Proposed Collection; Comment RequestPDF
81 FR 89357 - Personnel Management in AgenciesPDF
81 FR 89520 - Agency Forms Submitted for OMB Review, Request for CommentsPDF
81 FR 89391 - Air Plan Approval/Disapproval; MS; Infrastructure Requirements for the 2012 PM2.5PDF
81 FR 89504 - Notice of Intent To Prepare a Resource Management Plan and Associated Environmental Impact Statement for the Missoula Field Office, MontanaPDF
81 FR 89402 - Designation of Alpha-Phenylacetoacetonitrile (APAAN), a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I ChemicalPDF
81 FR 89383 - Tiered Pharmacy Copayments for MedicationsPDF
81 FR 89418 - Outer Continental Shelf Air Regulations; Consistency Update for CaliforniaPDF
81 FR 89397 - Airworthiness Directives; Gulfstream Aerospace Corporation AirplanesPDF
81 FR 89371 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 89373 - Airworthiness Directives; Fokker Services B.V. AirplanesPDF
81 FR 89806 - Energy Conservation Program: Test Procedure for Uninterruptible Power SuppliesPDF
81 FR 89746 - Renewable Fuel Standard Program: Standards for 2017 and Biomass-Based Diesel Volume for 2018PDF
81 FR 89580 - Resource Management PlanningPDF
81 FR 89367 - Airworthiness Directives; Bombardier, Inc. AirplanesPDF
81 FR 89674 - Formaldehyde Emission Standards for Composite Wood ProductsPDF

Issue

81 238 Monday, December 12, 2016 Contents Agriculture Agriculture Department See

Forest Service

See

Grain Inspection, Packers and Stockyards Administration

See

National Agricultural Statistics Service

See

National Institute of Food and Agriculture

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 2016-29694 89425-89426 2016-29714
Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 89465-89468 2016-29730 2016-29731 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Accomplishments of Domestic Violence Hotline, Online Connections and Text Study, 89468-89469 2016-29709 Civil Rights Civil Rights Commission NOTICES Meetings: Ohio Advisory Committee, 89432 2016-29644 Coast Guard Coast Guard RULES Drawbridge Operations: Connecticut River, East Haddam, CT, 89382 2016-29732 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

Patent and Trademark Office

Commodity Futures Commodity Futures Trading Commission NOTICES Orders: Excluding Farm Credit System Institutions from Commodity Exchange Act's Definition of Commodity Trading Advisor, 89447-89449 2016-29613 Drug Drug Enforcement Administration PROPOSED RULES Designation of Alpha-Phenylacetoacetonitrile, Precursor Chemical Used in Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as List I Chemical, 89402-89407 2016-29523 Energy Department Energy Department See

Federal Energy Regulatory Commission

RULES Energy Conservation Program: Test Procedure for Uninterruptible Power Supplies, 89806-89830 2016-28972 NOTICES Meetings: President's Council of Advisors on Science and Technology, 89449-89450 2016-29657 Records of Decisions: Issuing Presidential Permit to Transmission Developers, Inc.—New England, for New England Clean Power Link—Transmission Line Project, 89450-89453 2016-29700
Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Mississippi; Infrastructure Requirements for 2012 PM2.5 National Ambient Air Quality Standard, 89391-89393 2016-29593 Formaldehyde Emission Standards for Composite Wood Products, 89674-89743 2016-27987 Renewable Fuel Standard Program: Standards for 2017 and Biomass-Based Diesel Volume for 2018, 89746-89804 2016-28879 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; Air Plan Approval; Owens Valley Serious Area Plan for 1987 24-Hour PM10 Standard, 89407-89418 2016-29758 Outer Continental Shelf Air Regulations: California; Consistency Update, 89418-89424 2016-29258 NOTICES Administrative Cost Recovery Settlements: CERCLA; Columbia Smelting and Refining Works Site, Brooklyn, Kings County, NY, 89459 2016-29745 Senior Executive Service Performance Review Board; Membership, 89458-89459 2016-29743 Federal Aviation Federal Aviation Administration RULES Airworthiness Directives: Bombardier, Inc. Airplanes, 89367-89371 2016-28597 Fokker Services B.V. Airplanes, 89373-89375 2016-29243 The Boeing Company Airplanes, 89371-89373 2016-29246 PROPOSED RULES Airworthiness Directives: Gulfstream Aerospace Corporation Airplanes, 89397-89399 2016-29257 Class E Airspace; Establishments: Kill Devil Hills, NC, 89399-89401 2016-29630 Louisville, GA, 89401-89402 2016-29631 NOTICES Noise Compatibility Programs: Orlando Melbourne International Airport, Melbourne, FL, 89568-89569 2016-29639 Petitions for Exemption; Summaries: Flight Options, LLC, 89567-89568 2016-29640 Federal Communications Federal Communications Commission PROPOSED RULES Petitions for Rulemaking: Petition for Reconsideration of Action in Rulemaking Proceeding, 89424 2016-29611 Federal Deposit Federal Deposit Insurance Corporation NOTICES Terminations of Receivership: 10010, First Priority Bank, Bradenton, FL, 2016-29692 89461 2016-29739 10045 Colorado National Bank Colorado Springs, CO, 89460 2016-29733 10123 Southern Colorado National Bank, Pueblo, CO, 89460 2016-29734 10247 First National Bank, Rosedale, MS, 89461 2016-29735 10256 Home National Bank, Blackwell, OK, 89460 2016-29736 10271, Bayside Savings Bank, Port Saint Joe, FL, 89462 2016-29636 10316 Gulf State Community Bank, Carrabelle, FL, 89462 2016-29737 10316, Gulf State Community Bank, Carrabelle, FL, 89463 2016-29637 10327 Oglethorpe Bank, Brunswick, GA, 89460 2016-29738 10327, Oglethorpe Bank, Brunswick, GA, 89462 2016-29638 10474, First Federal Bank, Lexington, KY, 89460 2016-29635 10487, Sunrise Bank of Arizona, Phoenix, AZ, 2016-29691 89461-89462 2016-29741 10500, Slavie Federal Savings Bank, Bel Air, MD, 2016-29693 89461-89462 2016-29740 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: FEMA Preparedness Grants; Homeland Security Grant Program, 89490-89491 2016-29729 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: City of Holyoke Gas and Electric Department, 89457-89458 2016-29621 Electronic Tariff Filings: Additional eTariff type of Filing Codes, 89457 2016-29623 Environmental Assessments; Availability, etc.: Texas Eastern Transmission, LP; Marshall County Mine Panel 17W Project; Environmental Review, 89455-89456 2016-29696 Filings: Northern California Power Agency, 89454 2016-29699 Western Area Power Administration, 89455-89457 2016-29697 2016-29698 License Transfer Applications: TransCanada Hydro Northeast Inc.; TC Hydro Inc., 89454-89455 2016-29619 Settlement Agreements: Eugene Water and Electric Board, 89453-89454 2016-29620 Staff Attendances, 89455 2016-29624 Transfers of Exemptions: River Street Associates; Contoocook Hydro, LLC, 89456 2016-29622 Federal Highway Federal Highway Administration NOTICES Final Federal Agency Actions: Transportation Project in Washington State, 89569-89570 2016-29675 Federal Reserve Federal Reserve System NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 89463-89464 2016-29606 Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 2016-29617 2016-29618 89464 2016-29689 Meetings; Sunshine Act, 89464-89465 2016-29892 Proposals to Engage in or to Acquire Companies Engaged in Permissible Nonbanking Activities, 89465 2016-29690 Federal Transit Federal Transit Administration NOTICES Buy American Waivers, 89570-89574 2016-29684 2016-29685 2016-29686 2016-29707 Fish Fish and Wildlife Service NOTICES Environmental Assessments; Availability, etc.: Glacial Ridge National Wildlife Refuge, Polk County, MN, Final Comprehensive Conservation Plan, 89497-89498 2016-29672 Permit Applications: Proposed Candidate Conservation Agreement with Assurances for Camp Blanding Joint Training Center, FL, 89498-89499 2016-29677 Food and Drug Food and Drug Administration NOTICES Determinations that Products Were not Withdrawn from Sale for Reasons of Safety or Effectiveness: SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (Sodium Chloride), Injectable, 234 Milligrams/Milliliter, 89470-89471 2016-29674 Guidance: Conditions for Sale for Air-Conduction Hearing Aids, 89469-89470 2016-29724 Foreign Trade Foreign-Trade Zones Board NOTICES Approvals of Subzone Status: Romark Global Pharma, LLC, Manati, PR, 89432-89433 2016-29616 Production Activities: Carrier InterAmerica Corp., Foreign-Trade Zone 281, Miami, FL, 89432 2016-29615 Forest Forest Service NOTICES Meetings: Black Hills National Forest Advisory Board, 89426 2016-29673 North Mt. Baker Snoqualmie Resource Advisory Committee, 89427 2016-29660 Siuslaw Resource Advisory Committee, 89426-89427 2016-29687 Grain Inspection Grain Inspection, Packers and Stockyards Administration NOTICES Designations: Amarillo, TX; Cairo, IL; State of Louisiana; State of North Carolina and Belmond, IA; Minnesota; New Jersey and New York Areas, 89428-89429 2016-29705 Decatur, IN Area, 89428 2016-29706 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Children and Families Administration

See

Food and Drug Administration

See

National Institutes of Health

RULES Grants Regulations, 89393-89396 2016-29752 NOTICES Declarations under Public Readiness and Emergency Preparedness Act for Ebola Virus Disease: Therapeutics, 89476-89481 2016-29609 Vaccines, 89471-89476 2016-29610
Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

See

U.S. Customs and Border Protection

Housing Housing and Urban Development Department RULES HOME Investment Partnerships Program; Changes: Commitment Requirement; Correction, 89381-89382 2016-29643 NOTICES Delegations of Authority: Office of Lead Hazard Control and Healthy Homes, 89496-89497 2016-29653 Relief from HUD Requirements: Public Housing Agencies to Assist with Recovery and Relief Efforts on Behalf of Families Affected by Severe Storms and Flooding in Louisiana, 89491-89496 2016-29642 Indian Affairs Indian Affairs Bureau NOTICES Indian Gaming: Tribal-State Class III Gaming Compact in State of Michigan, 89504 2016-29744 Land Acquisitions: Pokagon Band of Potawatomi Indians, Michigan and Indiana, 89499-89504 2016-29746 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

Land Management Bureau

See

National Park Service

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Seamless Refined Copper Pipe and Tube from Mexico; Preliminary Results of Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2014-2015, 89434-89436 2016-29710 Applications for Duty-Free Entry of Scientific Instruments, 89433-89434 2016-29614 Meetings: Civil Nuclear Trade Advisory Committee, 89433 2016-29703 Renewable Energy and Energy Efficiency Advisory Committee, 89436 2016-29701 International Trade Com International Trade Commission NOTICES Complaints: Solicitation of Comments Relating to Public Interest, 89508-89509 2016-29715 Justice Department Justice Department See

Drug Enforcement Administration

NOTICES Meetings: Federal Advisory Committee, 89509 2016-29725
Land Land Management Bureau RULES Resource Management Planning, 89580-89671 2016-28724 NOTICES Environmental Impact Statements; Availability, etc.: Missoula Field Office, MT, Resource Management Plan, 89504-89505 2016-29553 Public Land Orders: Rogue River; OR, 89506 2016-29721 National Agricultural National Agricultural Statistics Service NOTICES Confidentiality Pledge, 89429-89431 2016-29750 National Credit National Credit Union Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 89510 2016-29695 Meetings; Sunshine Act, 89510 2016-29884 National Institute Food National Institute of Food and Agriculture NOTICES Food Safety Outreach Program, 89431-89432 2016-29655 National Institute National Institutes of Health NOTICES Government-Owned Inventions; Availability for Licensing, 89482 2016-29605 Meetings: Center for Scientific Review, 89481 2016-29603 National Eye Institute, 89481-89482 2016-29604 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Northeastern United States: Atlantic Bluefish Fishery; Quota Transfer, 89396 2016-29720 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: West Coast Region Vessel Monitoring System and Pre-Trip Reporting Requirements, 89446-89447 2016-29688 Takes of Marine Mammals: Incidental to Specified Activities; Port of Kalama Expansion Project on Lower Columbia River, 89436-89446 2016-29748 National Park National Park Service NOTICES Pending Nominations: National Register of Historic Places, 89506-89508 2016-29627 2016-29628 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Exemptions: Duke Energy Florida, Inc., LLC, Crystal River Unit 3, Nuclear Generating Plant, 89511-89514 2016-29712 Guidance: Assumptions used for Evaluating Potential Radiological Consequences of Fuel Handling Accident in Fuel Handling and Storage Facility for Boiling and Pressurized Water Reactors; Withdrawl, 89510-89511 2016-29661 License Applications; Amendments: Vogtle Electric Generating Plant, Units 3 and 4, 89516-89520 2016-29713 License Transfer Applications: Susquehanna Nuclear, LLC; Susquehanna Steam Electric Station, Units 1 and 2, 89514-89516 2016-29716 Patent Patent and Trademark Office RULES Miscellaneous Changes to Trademark Trial and Appeal Board Rules of Practice; Correction, 89382-89383 2016-29728 Personnel Personnel Management Office RULES Personnel Management in Agencies, 89357-89367 2016-29600 Railroad Retirement Railroad Retirement Board NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 89520-89523 2016-29596 2016-29602 Meetings; Sunshine Act, 89521 2016-29861 2016-29862 Securities Securities and Exchange Commission NOTICES Meetings; Sunshine Act, 89564 2016-29794 Self-Regulatory Organizations; Proposed Rule Changes: BOX Options Exchange, LLC, 89525-89527 2016-29659 Chicago Stock Exchange, Inc., 89543-89559 2016-29646 Depository Trust Co., 89533-89543 2016-29668 Investors Exchange, LLC, 89562-89564 2016-29645 NASDAQ BX, Inc., 89532-89533 2016-29658 New York Stock Exchange, LLC, 89523-89525, 89559-89562 2016-29649 2016-29650 NYSE Arca, Inc., 89525, 89529-89531 2016-29648 2016-29652 NYSE MKT, LLC, 89527-89529, 89564-89566 2016-29647 2016-29651 Small Business Small Business Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 89566-89567 2016-29717 Meetings: National Small Business Development Center Advisory Board; Date Change, 89567 2016-29654 Social Social Security Administration NOTICES Requests for Information: Strategies for Improving Work Outcomes for Individuals with Musculoskeletal Disabilities, 89567 2016-29633 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Transit Administration

Treasury Treasury Department RULES Electronic Notice of Liquidation, 89375-89381 2016-29656 Customs U.S. Customs and Border Protection RULES Electronic Notice of Liquidation, 89375-89381 2016-29656 NOTICES Automated Commercial Environments: Sole CBP-Authorized Electronic Data Interchange System for Processing Electronic Drawback and Duty Deferral Entry and Entry Summary Filings, 89486 2016-29711 National Customs Automation Program Tests: Post-Summary Corrections and Periodic Monthly Statements; Modifications and Clarifications, 89482-89485 2016-29702 Reconciliation and Transition of Test from Automated Commercial System to Automated Commercial Environment; Modifications, 89486-89490 2016-29704 Veteran Affairs Veterans Affairs Department RULES Tiered Pharmacy Copayments for Medications, 89383-89391 2016-29515 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Customer Satisfaction Surveys, 89574 2016-29665 Inquiry Routing and Information System, 89575-89576 2016-29666 Request for Disinterment, 89575 2016-29663 VA Health Professional Scholarship and Visual Impairment and Orientation and Mobility Professional Scholarship Programs, 89576-89577 2016-29667 VA Homeless Providers Grant and Per Diem Program, 89574-89575 2016-29664 Separate Parts In This Issue Part II Interior Department, Land Management Bureau, 89580-89671 2016-28724 Part III Environmental Protection Agency, 89674-89743 2016-27987 Part IV Environmental Protection Agency, 89746-89804 2016-28879 Part V Energy Department, 89806-89830 2016-28972 Reader Aids

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

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81 238 Monday, December 12, 2016 Rules and Regulations OFFICE OF PERSONNEL MANAGEMENT 5 CFR PART 250 RIN 3206-AL98 Personnel Management in Agencies AGENCY:

Office of Personnel Management.

ACTION:

Final rule.

SUMMARY:

This rule is intended to align human capital management practices to broader agency strategic planning activities, and better align human capital activities with an agency's mission and strategic goals. This will enable agency leadership to better leverage the workforce to achieve results. In addition, the final regulation will allow agencies to gather additional information from employee surveys.

DATES:

This rule is effective April 11, 2017.

FOR FURTHER INFORMATION CONTACT:

For information, please contact Jan Chisolm-King by email at [email protected] or by telephone at (202) 606-1958.

SUPPLEMENTARY INFORMATION:

The Office of Personnel Management (OPM) maintains statutory responsibility under 5 U.S.C. 1103(c) to guide, enable, and assess agency strategic human capital management processes. On February 8, 2016, OPM published the Personnel Management in Agencies proposed rule in the Federal Register (81 FR 6469) that would amend 5 CFR part 250 subpart B, Strategic Human Capital Management, and 5 CFR part 250 subpart C, Employee Surveys. The purpose of this rule is to better assist agencies with developing strong human capital practices for achieving agency goals and objectives, and to further empower the human capital community to collectively identify and address cross-cutting human capital challenges. OPM issues a final rule to revise 5 CFR, part 250 subparts B and C.

The rule establishes the Human Capital Framework (HCF), which replaces the Human Capital Assessment and Accountability Framework (HCAAF). This rule also reduces and clarifies the reporting procedures agencies are required to follow; creates a data-driven review process (HRStat); and describes workforce planning methods that agencies are required to follow.

Lastly, the rule strengthens and modernizes the Employee Survey process by identifying questions that exhibit appropriate psychometric properties which better align to the topics cited in the National Defense Authorization Act for Fiscal Year 2004 (Pub. L. 108-136, sec. 1128, codified at 5 U.S.C. 7101).

Alignment of Strategic Human Capital Management (5 CFR, Part 250, Subpart B) to GPRA-MA

The final rule sets forth a set of actions and practices that will better position human capital to demonstrate its contribution to agency mission through the alignment of Strategic Human Capital Management practices to the Government Performance and Results Act Modernization Act (GPRA-MA) of 2010 (Pub. L. 111-352). GPRA-MA requires performance assessments of Government programs for purposes of assessing agency performance and improvement.

Following promulgation of this rule, OPM will provide additional guidance for agencies about the planning and implementation requirements presented within this regulation.

Strategic Human Capital Management (5 CFR Part 250 Subpart B)

The federal workforce plays a vital role in executing the important missions of federal agencies in service to the American people. As such, the Strategic Human Capital Management processes used to cultivate and manage the workforce must be integrated into agency planning and management processes, remain current with research and best practices, allow for proactive responses to anticipated environmental changes, and seek to continuously maximize the efficiency and effectiveness of Human Resource (HR) service delivery.

This rule supports the implementation of OPM's statutory responsibility under 5 U.S.C. 1103(c) to guide, enable, and assess agency strategic human capital management processes. Part 250 of Title 5, subpart B, implements the requirements of 5 U.S.C. 1103(c), and section 1103(c)(1) requires OPM to design a set of systems, including appropriate metrics, for assessing the management of human capital by federal agencies and to define those systems in regulation. Section 1103(c)(2) requires OPM to include standards addressing a series of specified topics. These requirements are further explained within this rule. Subpart B also provides an avenue for Chief Human Capital Officers (CHCOs) to carry out their required functions under 5 U.S.C. 1402(a).

Current regulations implement 5 U.S.C. 1103(c) by adopting the HCAAF system required by 5 U.S.C. 1103(c)(1) and providing the systems definitions and standards required by 5 U.S.C. 1103(c)(2). The HCAAF is a framework that integrates five human capital systems—Strategic Alignment, Leadership and Knowledge Management, Results-Oriented Performance Culture, Talent Management, and Accountability. These systems define practices for the effective and efficient management of human capital and support the steps involved in the planning and goal setting, implementation, and evaluation of human capital policies, programs, and initiatives in the Federal Government. This rule changes the current regulation, by replacing the HCAAF with the HCF.

As described throughout this section, in addition to replacing the HCAAF with the HCF, subpart B of this rule will:

1. Require agencies to develop a Human Capital Operating Plan (HCOP).

2. Require agencies to participate in Human Capital Reviews (HCRs) with OPM.

3. Institutionalize the requirement for agencies to conduct HRStat reviews.

4. Remove the requirement for agencies to develop and submit a Strategic Human Capital Plan.

5. Remove the requirement for agencies to develop and submit annual Human Capital Management Reports (HCMR).

6. Require OPM to issue the quadrennial Federal Workforce Priorities Report.

7. Communicate the workforce planning methods agencies are required to follow.

8. Ensure the consistent application of human capital practices by clearly defining key human capital management terms.

Replace the Human Capital Assessment and Accountability Framework (HCAAF) With the Human Capital Framework (HCF)

As discussed above, current regulations implement the requirements of 5 U.S.C 1103(c) by adopting the five systems of HCAAF. The HCF will replace the HCAAF and integrate four human capital systems—Strategic Planning and Alignment, Performance Culture, Talent Management, and Evaluation. OPM expects that the new systems and system definitions will result in improved outcomes for human capital programs that enable the accomplishment of agency mission objectives.

The HCF uses “Performance Culture” and “Talent Management” as the descriptors for the two systems under which the government's major people and organization activities and programs occur. It also prescribes “Strategic Planning and Alignment” and “Evaluation” as the two supporting management systems required for the development, measurement, and management of agency human capital agendas.

Standards are defined for each of the four systems and agencies will be expected to apply them as the bases for their work. Agencies will be required to implement each standard within their strategies, but will have autonomy to determine which focus areas (within each system) should be implemented to lead to the best outcomes.

Require Agencies To Develop a Human Capital Operating Plan (HCOP)

The HCOP is a planning document (not a report) that provides details about how human capital strategies are being implemented in support of agency strategic. Additionally, the HCOP serves as a tool for agency leadership to set a clear path for achieving stated human capital strategies; identify and secure resources for supporting human capital policies, programs, and initiatives; and determine which timeframes and measures to use to assess progress, while demonstrating how the standards of each HCF system are being fulfilled within each strategy. The HCOP will correspond to the same timeframe covered by agency strategic plans and reviewed and updated annually.

Human Capital Reviews (HCRs) With OPM

These reviews are annual, in-person meetings for agency human capital leaders to discuss the implementation and achievement of human capital goals, including risks, barriers and successful practices. The reviews will serve as an opportunity for OPM to provide feedback to agencies, as well as identify and share practices and identify cross-cutting human capital challenges. This rule does not impose new requirements for agencies to submit written narratives. Previously, agencies were required to submit reports containing human capital information to OPM via a static written document. The revised rule affords agencies, in discussions with OPM, to collaboratively review agencies progress towards achieving their specific goals while providing a mechanism for OPM to identify cross-cutting and agency- specific human capital challenges that warrant further attention.

Institutionalize the Requirement for Agencies To Conduct HRStat Reviews

The quarterly review process is managed by agencies to identify and monitor human capital measures and targets that inform the progress agencies are making towards meeting their agency specific goals. The outcomes from the reviews should report the approach agencies take for corrective actions in areas for which they are not making substantial progress.

Remove the Requirement for Agencies To Develop and Submit a Strategic Human Capital Plan (SHCP)

GPRA-MA requires agencies to indicate how human capital resources will support agency strategic goals within their strategic plans. Because human capital strategies supporting each mission-oriented goal and objective are identified in agency strategic plans, additional SHCPs are unnecessary. The increased alignment of human capital strategies to agency goals is intended to enhance human capital and organizational performance outcomes, by making data driven decisions.

Remove the Requirement for Agencies To Develop and Submit Annual Human Capital Management Reports (HCMR)

OPM will monitor agency outcomes in human capital management through the Human Capital Evaluation Framework (HCEF), which consists of evaluating progress achieved through HRStat reviews, HCRs, and independent audits. As such, agencies are no longer required to develop and submit annual Human Capital Management Reports (HCMR). As mentioned above, the regulation does not impose new requirements for agencies to submit written narratives.

Require OPM To Issue the Quadrennial Federal Workforce Priorities Report

The report is developed through research and the analysis of environmental trends, agency experiences and needs. The report communicates key governmentwide human capital priorities and suggested strategies to strengthen the communication amongst and between agency leadership and human capital practitioners. Additionally, the report serves as an informative tool for the Chief Human Capital Officers Council (CHCOC) because it signals what human capital priorities are required for the establishment of enterprise-wide plans and the coordination of resources amongst the human capital community. We anticipate that the first report would be released in mid-2017.

The changes to the regulation focus on establishing requirements that maintain efficient and effective (integrated) human capital management practices now and into the future. This also provides Federal agencies with the flexibility to determine how to identify and implement human capital strategies that will achieve strong organizational outcomes for their specific mission and goals.

The public comment period for the proposed regulation ended on April 8, 2016. OPM received 35 comments on the proposed rule: 15 from Federal agencies, 18 from private individuals, and two (2) from organizations. OPM carefully considered the comments and as a result, made minor revisions to the final regulation. The final regulation will become effective 120 days after the publication date of this notice, in order to give agencies time to amend policies and communicate changes to their human resources staff. Below is a discussion of the comments that OPM received.

Response to Comments, Subpart B—Strategic Human Capital Section 250.201—Small Agencies

Four agencies were concerned as to whom the regulation applied.

To clarify, OPM revised § 250.201, Coverage and Purpose, to explicitly state that Subpart B applies to agencies covered by sec. 901(b) of the Chief Financial Officers (CFO) Act of 1990 (Pub. L. 101-576), as well as 5 U.S.C. 1401.

Section 250.203—Human Capital Framework (HCF)

An agency questioned the reason behind placing the HCF in regulation.

Language within 5 U.S.C. 1103 requires OPM to design a set of systems, including appropriate metrics, for assessing the management of human capital by Federal agencies, which was known as the Human Capital Assessment Accountability Framework (HCAAF) and is now becoming the Human Capital Framework. The law further states that the systems shall be defined in regulation and include standards, which OPM has done with the inclusion of the systems and standards with their supporting definitions within regulation.

An agency stated that they believed that two of the four systems of the HCF, Talent Management (TM) and Performance Culture (PC), appear to have significant areas of overlap.

The two systems, Talent Management and Performance Culture, have two distinct definitions. For example, the definition for Talent Management incorporates workforce planning, or the process to identify and close skills gaps. It also states, the system “implements and maintains programs to attract, acquire, develop, promote and retain quality and diverse talent”. Within the proposed focus areas for the Talent Management system, the ways to “promote and retain” quality and diverse talent includes, for example, recruitment and outreach, as well as succession planning.

On the contrary, the Performance Culture system is defined as a system that “engages, develops, and inspires a diverse, high-performing workforce by creating, implementing, and maintaining effective performance management strategies, practices, and activities that support mission objectives.” The focus areas include performance management and diversity and inclusion.

The two systems are distinct as Talent Management includes the identification and hiring of a workforce needed to accomplish an organizations mission while Performance Culture promotes practices that work to retain talent after being on board.

An agency commented that using employee lifecycle terminology within the HCF would be easier for practitioners and managers to understand (e.g., staffing, performance management, awards, training, etc.). OPM's Human Capital Line of Business (HRLOB) recently developed a comprehensive set of terminology for its new Business Reference Model that is aligned with the employee lifecycle and maps to all existing OPM regulations. The agency preferred the HRLOB terminology and believed that using a consistent set of terms for planning and automation would be more beneficial to the HR community, as a whole.

The employee lifecycle terminology is included within the nomenclature of the Human Capital Framework (HCF), specifically within the focus areas. We concur that practitioners and managers must have an understanding of the language used to explain the various tools and strategies to effectively manage the Federal workforce, which is why we have and will continue to work closely with the HRLOB team and other groups to ensure the use of consistent terms and definitions. Also, it is important to note that the system terms for the HCF serve as overarching explanations for the broader human capital systems while sub elements, such as staffing and awards are subsumed within each of the systems.

Section 250.204(a)(1)—Federal Workforce Priorities Report (FWPR)

OPM determined there may be some confusion between the various requirements posed by GPRA-MA, particularly as it relates to developing and implementing strategic goals and initiatives. Therefore, OPM has removed references of the word “strategic” from the title of the “Federal Workforce Strategic Priorities Report” and is now titling it the “Federal Workforce Priorities Report.” The intent and purpose of the report remains the same as only the title of the report has changed.

An agency questioned why OPM was mandating agencies to align their human capital management strategies with the Federal Workforce Strategic Priorities Report (FWSPR). It was expressed that OPM should encourage agencies to develop human capital strategies that align to agency strategic goals and mission requirements.

The FWPR was developed (in response to a need identified by a Government Accountability Office (GAO) forum comprised of CHCOs) to “strengthen coordination to address a fragmented human capital community,” through the coordination of agencies collectively developing “enterprise solutions to address common human capital challenges” (GAO-14-168, May 7, 2014). Therefore, agencies are required to address governmentwide human capital priorities and suggested strategies contained in the FWPR as is determined by the CHCOC.

Agencies will continue to develop human capital strategies that align to their agency-specific mission and strategic goals while concurrently addressing cross-cutting human capital challenges. Specific requirements for how agencies implement human capital strategies in support of the FWPR will be clarified through guidance. OPM expects to issue this guidance after the publication of the final rule.

An individual representing an agency expressed concerns regarding the timing of the FWSPR and its effect on Presidential transitions and agency strategic planning.

The FWPR will communicate key governmentwide human capital priorities in advance of the development of an Administration's agenda and agency strategic plans. The report will focus on cross-cutting human capital challenges within the Federal Government, based upon a thorough evaluation of the state of Federal Human Capital Management. This will assist in the development of an Administration's human capital agenda, while ensuring agencies are aware of the key challenges and are prepared to take action as they develop their strategic plans. This will allow for the recruitment, development, and retention of an agile and capable workforce that has the requisite knowledge, skills, and abilities to support agencies' missions and Administration goals.

The publication deadline for the FWPR, which used to be the year in which the term of the President commences, has been modified to include OPM's ability to extend the deadline. This modification is intended to build in flexibility regarding the publication date.

An agency inquired whether agencies would be able to waive the requirement on supporting the priorities contained in the FWSPR by noting that the issue is not relevant to their agency.

Specific requirements and expectations regarding which agencies should align their human capital strategies to support the FWPR, including any exceptions, will be clarified within guidance, which OPM expects to issue after publication of the final rule.

An agency asked whether guidance on governmentwide standards and metrics will be included in the FWSPR.

The FWPR is designed to communicate key governmentwide human capital priorities and suggested strategies, and it will not include reporting requirements for agencies.

Required metrics, as stated within § 250.205 (system metrics) will be specified through guidance, which OPM expects to issue after publication of the final rule. Additionally, information regarding governmentwide standards and metrics as is related to each system within the Human Capital Framework will be made available through the Human Capital Framework Online Resource Guide.

An agency expressed confusion about the “Federal human capital assessment,” referenced in § 250.204(d) and the “Governmentwide Strategic Human Capital Strategy,” referenced in § 250.204(g).

Both references were in made in error and were actually intended to refer to the FWPR. Therefore, they have been corrected to refer to the FWPR defined under § 250.202.

Section 250.204 (Redesignated as § 250.207)—HRStat

One agency recommended clarifying that HRStat is a quarterly review process.

OPM agreed with the recommendation and noted such in both sections 202 and 207.

Six agencies expressed concern that § 250.204 was confusing. Specifically, they stated the regulation does not clearly demonstrate agencies' roles and expectations as related to HRStat. Also, an agency stated that HRStat Maturity guidelines are complex and descriptive.

OPM has not published guidance regarding the specific requirements for HRStat, other than noting the frequency for which the data-driven reviews should occur (quarterly) and who should lead the reviews (CHCO). The regulation does not note detailed information about the Maturity Model as the information will be made available within guidance.

HRStat is a monitoring process for agencies to identify, measure, and analyze agency human capital data to inform agency leadership about how human capital is contributing to and supporting the accomplishment of agency goals. Agencies, through the leadership of their CHCO, are solely responsible for conducting quarterly HRStat reviews.

These data-driven reviews led by agency CHCOs, in collaboration with the agency Performance Improvement Officers (PIOs), are to discuss and monitor agencies progress with implementing key human capital goals that support the implementation of an agencies Annual Performance Plan (APP). The requirement to establish an APP was established through GPRA-MA.

In addition, the review sessions allow agency leadership to identify and focus on human capital metrics that will inform the achievement of an agency's human capital goals and mission. The quarterly sessions allow for prompt course correction, if necessary, to ensure progress. Other supporting actions to be taken by agencies during their HRStat reviews will be specified through guidance, which OPM expects to issue after publication of this final rule.

Additionally, OPM removed all references to HRStat from § 250.204 and placed it in its own section (§ 250.207) to provide greater clarity about the purpose of HRStat. Section 250.204 has been renumbered in light of the removed language.

Three agencies stated that OPM should provide information on what measures or metrics are included in HRStat.

HRStat is a monitoring process for agencies to identify, measure, and analyze agency Human Capital data to inform agency leadership about how human capital is contributing to and supporting the accomplishment of agency goals. Therefore, the measures associated with the reviews are agency-specific as they are based on agency set goals, and are not prescribed by OPM. So, agencies have the autonomy and flexibility to identify and evaluate measures that will help evaluate the efficacy of their human capital strategies.

Three agencies stated that agencies should not be mandated to use OPM-identified metrics. Instead, agencies should be allowed to use metrics that address agency-specific human capital challenges.

There are two different laws at issue here. First, GPRA-MA establishes the requirement of using data to inform human capital progress towards mission accomplishment. The other law, 5 U.S.C 1103(c), enables OPM to determine the state of human capital through the evaluation of human capital metrics.

GPRA-MA requires that goals are expressed “in an objective, quantifiable, and measurable form,” and “establish common Federal Government performance indicators with quarterly targets to be used in measuring or assessing— overall progress toward each Federal Government performance goal.” Human capital management is a key contributor to ensuring that performance goals are met. Therefore, OPM established HRStat to provide agency CHCOs with the ability to quantify and report “objective” data about human capital progress towards meeting organizational goals. Therefore, agencies have the flexibility to identify, monitor, and measure data needed to assess their progress towards meeting their agency-specific goals through their HRStat reviews. Again, as noted above, the measures associated with the reviews are agency-specific as they are based on agency set goals, and are not prescribed by OPM.

Unlike the measure associated with the reviews that are agency-specific, OPM is required to “design a set of systems, including appropriate metrics, for assessing the management of human capital by Federal agencies” as noted within 5 U.S.C 1103(c). Therefore, in response, OPM will identify a set of measures to enable OPM to assess the state of human capital within the Federal Government. The determinants used to assess the state of human capital within the Federal Government warrants the identification of cross-cutting measures that apply to all agencies. Therefore, agency-specific measures used during agency HRStat reviews cannot serve as a resource to inform the state of human capital governmentwide. Agency requirements for governmentwide metrics set forth by OPM under HCF and 5 U.S.C. 1103(c) will be issued through guidance.

Three agencies inquired as to whether OPM will provide guidance on governmentwide standards and metrics.

OPM will issue guidance to fulfill its requirements within 5 U.S.C. 1103(c) to “design a set of systems, including appropriate metrics, for assessing the management of human capital by Federal agencies.”

An agency suggested that agencies should not be required to use the HRStat Maturity guidelines because: (1) they are complex and descriptive, and 2) they were not widely communicated to agencies.

The Maturity Model was developed by a Community of Practice (CoP) workgroup and vetted by the CoP, CHCOC, and OPM. All comments and feedback were addressed and considered prior to finalization of the Model. Consequently, the HRStat CoP and OPM are drafting instructions, which should improve the ability to implement and maintain the process.

An agency noted that HRStat Reviews and HRStat Maturity Guidelines were not described within the regulation.

OPM added language in the regulation stating that HRStat reviews are to be led by the CHCO, in collaboration with the Performance Improvement Officer (PIO), which has remained a requirement throughout the pilot process. OPM will issue guidance regarding further details and requirements of the HRStat review process and the Maturity Model after publication of the final rule.

An agency suggested if OPM intends to rely upon the HRStat Maturity guidelines, OPM must adhere to the requirements of 1 CFR part 51 and specifically utilize the term “incorporated by reference” in 5 CFR 250.207, as specified in 1 CFR 51.9.

OPM will not include the recommendation to adhere to the requirements of 1 CFR part 51 and specifically utilize the term “incorporated by reference” in 5 CFR 250.207, as specified in 1 CFR 51.9. As a practical matter, in order to comply with § 51.9(b)(2), the final rule would have to “state[s] the title, date, edition, author, publisher, and identification number of the publication”. The HRStat Maturity guidelines are currently under development, so much of the required information is not yet available.

Although the final rule requires agencies to use the guidelines to affect measurable improvements in maturity levels, like the Maturity Model itself, the HRStat Maturity guidelines are meant to serve as an “aspirational roadmap”. As such, the HRStat Maturity guidelines will provide helpful information, based on data from the Maturity Model Assessment Tool, to assist the agencies in attaining increasing levels of maturity in their HRStat processes, while maintaining flexibility in the management of their HRStat reviews.

An agency noted that the focus of the HRStat Maturity Model was the recognition that federal agencies operate at different levels of human capital maturity concerning the use of analytics, technology, talent/staff, collaboration, and leadership. OPM emphasized that not all agencies could achieve the scope of impact of aligning human capital outcomes aligned with mission imperatives. The final rule creates a gigantic leap in presuming agencies possess an optimized, mission delivery maturity level for aligning human capital outcomes with agency strategic and performance goals. This presumption may place inordinate burdens on agencies at a time when many HRStat programs are still in the emerging state of HRStat maturity.

The vision of the HRStat Community of Practice workgroup that developed the Maturity Model was that it partially serve as an “aspirational roadmap.” In that sense, it is intended to encourage continuous improvement but not to require a specific amount of improvement within a specific timeframe. Therefore, OPM will not include the recommendation, since no dictated schedule for maturity increases will be established at this time. Although guidance for HRStat is under development, the section pertaining to the Maturity Model will discuss the model, how it's used for assessment, and information on ways to manage programs for maturity.

An agency expressed concern about language that mandated that the Deputy Secretary and senior management team participate in the quarterly HRStat reviews.

The language in § 250.204(c) includes the option of a `designee.' OPM believes it is essential that agency leadership is aware of the progress and impact of human capital operations, policies, and strategies on an agency's ability to meet its mission, hence the modification of language in § 250.204(c)(3) referring to the necessity of Deputy Secretaries remaining informed about the progress and outcomes of agency's HRStat reviews.

This is particularly important as agency senior leadership, as stated in GPRA-MA, must identify and inform their progress towards meeting agency-specific goals, of which human capital management is a significant contributor. Therefore, it is imperative that the CHCO ensure that their senior leaders are provided with all relevant data about human capital contributions towards meeting agency goals. Additionally, it is expected that the information derived from the reviews will be used to inform agency leadership on how to best support the human capital community. OPM removed and will place into guidance any language regarding C-Suite and management officials' participation in the quarterly HRStat reviews, with the exception of the CHCO and PIO roles, which remain in the regulation.

An agency suggested that the HRStat definition should include all four elements of the new HCF. HRStat should not be limited to strategic planning and alignment.

OPM agrees that HRStat is an approach that should be employed to make improvements in all HCF systems. Upcoming HRStat guidance will provide guiding principles on how to ensure the approach is used to make improvements within all of the systems. However, this fact is inherent in the definition as stated.

Section 250.204(d)—Human Capital Operation Plan (HCOP)

Six agencies expressed concern that § 250.204 was confusing. Specifically, they stated that it did not clearly demonstrate agencies' roles and expectations as related to the HCOP.

OPM removed all references to the HCOP from § 250.204 and placed it in its own section (§ 250.205) to enable OPM to clarify the intent of and purpose for the HCOP. Section 250.204 has been renumbered in light of the removed language. Guidance, which will be published after the final publication of the regulation, will communicate the roles and expectations of agencies as it relates to developing, implementing, and monitoring the implementation of the HCOP.

Two agencies expressed concern about the establishment of a work group, which would be led by the CHCO and comprised of the Chief Operating Officer (COO), Performance Improvement Officer (PIO), Chief Information Officer (CIO), Chief Financial Officer (CFO), Chief Acquisition Officer (CAO), and Equal Employment Opportunity (EEO) Director.

OPM revised § 250.204(d)(i) of the proposed rule to refer to the necessity to have the CHCO collaborate with the agency's senior management team as the integration of the various areas, such as Information Technology, Acquisition, and Finance serve an integral role with the implementation of human capital strategies. This is reinforced within the standards of the Strategic Planning and Alignment System within the HCF.

An agency suggested there needs to be specific timeframes for the HCOP, Evaluation System, Human Capital Strategic Review (HCSR), and Evaluation Report.

OPM expects to issue HCOP and HCR guidance after publication of the final rule, which will include timeframes.

Four agencies expressed concern about the requirement that agencies develop annual HCOPs, including a need to distinguish the difference between the HCOP and the “four-year annual HCOP.”

It should be noted that the proposed rule erroneously cited § 250.204(d)(ii). The correct citation should have been § 250.204(d)(2). OPM modified the language in the proposed rule to incorporate paragraph (d)(ii) into paragraph (d). In the final rule, this language is now contained within § 250.205. Additionally, the word “annual” was removed wherever it preceded “Human Capital Operation Plan” or “HCOP”.

The HCOP supports an agency's Annual Performance Plan (APP) as required through GPRA-MA, which in turn supports an agency's Strategic Plan. The HCOP should be developed with a perspective of how respective human capital policies, programs and implementation strategies will support a 4-year strategic plan with annual targets and goals that will be developed and assessed through the APP. The HCOP should be reviewed and updated, if needed, on an annual basis to ensure the continued alignment of human capital strategies that support agency goals. This is particularly important if agencies note, as a result of conducting their HRStat reviews, that course corrections are warranted. Therefore, changes for how human capital policies and programs support the accomplishment of a respective strategic goal may need to be modified. Thus, aspects of the HCOP will also need to be modified.

An agency questioned if the HCOP reporting requirements are redundant with agency Annual Performance Plan submissions.

All CFO Act agencies will be required to develop an HCOP, but are not required to submit it to OPM unless requested. The HCOP is intended to serve as a strategy development and implementation tool that agency leadership, in particular the CHCO, should use to determine how respective human capital policies, programs and implementation strategies directly support the goals and objectives outlined within the APP. This will include the identification of measures that will inform agency leadership about human capital contributions to and progress towards accomplishing the identified goals. The level of detail included in the HCOP regarding the implementation of human capital strategies is not suitable for inclusion within an agency's Annual Performance Plan, which covers a far greater scope.

250.204(e)—Human Capital Review (HCR)

To eliminate any confusion with the agency strategic review process, required by GPRA-MA (section 1116(f)), OPM is removing references of the word “strategic” from the title of the “Human Capital Strategic Reviews” and is now titling it the “Human Capital Reviews.” The intent and purpose of the reviews remains the same because only the title has changed.

Six agencies expressed concern that § 250.204(e) was confusing. Specifically, they stated that it did not clearly demonstrate agencies' roles and expectations as related to the HCSRs.

OPM removed all references to the HCRs from § 250.204 and placed it in a section dedicated to the HCR (§ 250.206), to enable quicker identification and understanding of the purpose of and intent for the HCRs. Section 250.204 has been renumbered in light of the removed language. OPM will publish guidance upon the publication of the final rule that specifies the roles and responsibilities of agencies as related to the HCRs.

Five agencies wanted a clear understanding of OPM's expectations regarding the HCRs.

As mentioned previously, OPM is required to “design a set of systems, including appropriate metrics, for assessing the management of human capital by Federal agencies” as noted within 5 U.S.C 1103(c). To enable OPM to capture critical information that will be used to formulate an assessment of human capital by Federal agencies, OPM is establishing the requirement for agencies to participate in annual HCRs. The reviews also serve as an opportunity for agencies to underscore their successful practices (that OPM would share with other agencies) while engaging in a discussion with OPM about suggested strategies that can address identified challenges.

The HCRs are annual, evidence-based reviews that evaluate and measure: (1) How agencies identify and implement (human capital) strategies that will lead to the success of a respective agency goal; (2) the efficacy of implementation strategies in support of achieving organizational goals (using the principles of the systems and standards of the HCF; and (3) assesses agencies ability to monitor their progress towards achieving their agency strategic goals through their HRStat reviews.

Agencies are required to meet with OPM on an annual basis to demonstrate how they are developing, implementing, and monitoring how their human capital strategies meet organizational goals. Agencies will discuss (and provide supporting information) to make evident how selected strategies supported organizational outcomes.

Additionally, information derived from agency HRStat reviews, accountability audits, HCRs, and submission of required metrics per 5 U.S.C. 1103(c), will inform the state of human capital within the Federal Government. The HCRs will provide OPM with information to enable OPM to determine human capital contributions towards and impact on agencies' ability to meet the goals identified within their strategic plans while identifying cross-cutting human capital challenges. The outcomes from the reviews will also inform the components of a policy agenda that should be established to support the development and implementation of governmentwide policies and strategies, and provide agencies with an opportunity to receive feedback from OPM to improve human capital implementation strategies and evaluation processes. Specific requirements and explanation of the process will be issued through guidance.

Two agencies asked whether the HCR will replace OPM's annual Accountability System Assessment Tool (ASAT) review.

The HCR will be in addition to the ASAT assessments. The HCRs are annual evidence-based reviews regarding the design and implementation of human capital strategies. The ASAT focuses on the effectiveness of the agency's overall Evaluation System.

Section 250.204(f)—Independent Audits

Two agencies suggested that OPM clarify its role in the Evaluation System. It appears that the new Evaluation System is the old Accountability System, which is “subject” to full OPM participation and evaluation. The agencies questioned whether this meant OPM will no longer conduct and “lead” periodic, full-scale human capital evaluations of the agencies.

OPM will continue its human capital evaluations. As part of OPM's statutory oversight responsibility, OPM may periodically conduct a full review of an agencies HR operations to ensure efficiency, effectiveness and regulatory compliance.

An agency expressed concern that Federal agencies are again required to submit a report to “its leadership and OPM” of the findings of the human capital evaluations (the subsection only references “audit findings”). OPM should clarify whether this report should include any HRStat or HCR findings, the two remaining mechanisms of the HCEF (as defined in § 250.202). Additionally, OPM should provide the timeframe for issuing the document to agency leadership and OPM.

It should be noted that the proposed rule erroneously cited § 250.204(f)(viii)(B). The proper citation should have been § 250.240(f)(8)(ii). The redesignated § 250.204(f)(8)(ii) is referring to human capital evaluations conducted by an agency's independent audit program or by OPM. HRStat is a quarterly data-driven review that informs agencies' human capital outcomes. The HCRs are annual, evidence-based reviews to assess the design and implementation of human capital strategies. Reports from independent audits should include information pertinent to both HRStat and HCRs. Depending on the scope of the independent or OPM audit, results of HRStat and HCRs may inform the focus of the evaluation and be referenced in the subsequent evaluation report. For example, if Time-to-Hire is one of the HRStat measures used by an agency, independent audits can assess whether timeliness is good or bad and why, which would then require agencies to make corrective actions. The timeframe for reporting back to OPM will always be included in the evaluation report provided to agency leadership.

Small agencies are not required to have independent audit programs. However, if they chose to develop one, the timeframe for reporting findings and corrective action should be explained in the agency evaluation system policy.

Section 250.206 (Redesignated as § 250.209)—Consequences—Improper Agency Actions

An agency believed OPM should include consequences for non-compliance with OPM position classification standards and inconsistency with OPM appeal determinations for like, identical, and similar positions within § 250.206.

According to 5 U.S.C. 5111, OPM has statutory authority to take corrective action and therefore, adding it to this section is unnecessary. In light of revisions to other sections, the proposed § 250.206 is redesignated as § 250.209.

Miscellaneous

An agency recommended that a section of the regulation should address HCOP and HRStat processes for mutual agency human capital collaboration for Cross-Agency Priority Goals, particularly in the area of collaborative ways to close mission critical occupation (MCO) skill gaps, share technologies and tools, participate in category management, and re-allocate tasks to be performed solely by certain agencies to promote efficiency and effectiveness. OPM should be an active partner in these collaborative efforts contained in such a regulatory section

OPM concurs that agency collaboration is an essential approach for implementing sound human capital strategies; however, with regards to Cross-Agency Priority (CAP) Goals, the regulation is not intended to address the implementation of CAP goals. We will encourage agencies to collaborate on implementing strong human capital strategies for other cross-cutting opportunities, such as those identified within the Federal Workforce Priorities Report.

An agency noted that agency strategic plans are four year planning documents that outline an agency's broadest mission goals and objectives. The agency believes OPM's desire to align both the HCOP and HRStat process with the strategic goals and objectives contained in an agency's strategic plan will create an overwhelming burden on federal agencies that will inhibit any meaningful, deep human capital planning in the HCOP and focused analysis through the HRStat process. Further, the agency believes that the task of aligning strategic goals and associated performance goals in the HCOP with human capital implementation strategies, and monitoring progress in relation to human capital policies and programs that cuts across such a vast expanse of agencies' mission imperatives will lead agencies to focus their attention on only the most broad human capital outcomes.

To maintain flexibility in the manner in which agencies may execute their responsibilities stated within the regulation, the details on how agencies are expected to fulfill them will be included in subsequent guidance rather than within the regulation itself. Specifying that alignment will pertain to APGs and CAP goals would be too restrictive for regulation. Therefore, the regulatory requirement to align human capital processes to the agency strategic plan will remain the same. The subsequent guidance, whose establishment will include input from the CHCO Community and relevant communities of practice (e.g. HRStat), will then specify the method that agencies will be expected to follow. This may or may not reflect the recommendation provided, depending on the outcome of the guidance development process.

In light of revisions to other sections, the proposed § 250.205 is redesignated as § 250.208. There was confusion within one agency regarding references to OMB Circular No. A-11 guidance on preparing the human capital portions of an agency's Annual Performance Plan (APP).

The current version of OMB Circular No. A-11 issued in 2015, does not contain specific guidance on preparing the human capital portions of an agency's APP. Therefore, specific references to OMB Circular No. A-11 was removed from the proposed rule.

Twelve agencies inquired as to whether or not OPM was going to issue guidance following the publication of the final rule. Of the twelve, one agency encouraged OPM to engage agencies in the timely drafting of such guidance.

OPM understands the need to assist agencies as they work to better integrate human capital within the agency strategic planning process. As such, OPM will host a series of meetings with agency human capital professionals, as it works to develop guidance per the regulation. Following publication of the final rule, OPM expects to issue guidance related to the HCOP, HCR, required metrics per § 250.208 (System Metrics) and HRStat Maturity Model.

An agency noted that the final rule contained an incorrect cite (31 U.S.C. 1116(d)(5)) as authority for 5 CFR 250, subpart B. The agency noted that the correct cite is 31 U.S.C. 1116(c)(5), which states that an agency's performance update shall “include a review of the performance goals and evaluation of the performance plan relative to the agency's strategic human capital management.”

OPM corrected the cite reference to read: 31 U.S.C. 1116(c)(5).

Employee Survey Process (5 CFR Part 250, Subpart C)

This rule will strengthen and modernize the Employee Survey process by identifying questions that are well written, understandable, and in better alignment to the topics cited in the National Defense Authorization Act for Fiscal Year 2004, Public Law 108-136, sec.1128, codified at 5 U.S.C. 7101.

Response to Comments, Subpart C—Employee Surveys

OPM received a total of 17 written comments directly addressing Subpart C—Employee Surveys. These comments were from 12 individuals, three agencies, and two organizations. These 17 comments are included in the total of 35 comments cited earlier. Below we summarize and respond to the comments received.

Two individuals indicated that Federal Employee Viewpoint Survey references to senior leader, manager and supervisory levels in questions are not clear to employees taking the survey, notwithstanding the terms' definitions in 5 CFR part 250.

OPM acknowledges that general terms and definitions for leadership levels (senior leader, manager, and supervisor) may vary greatly from agency to agency and it is imperative to give agencies and respondents a clearer understanding of each level for accurate answers/data. In light of the comments and ongoing discussions on the definitions of levels of leadership within organizations, OPM removed the definitions from the regulation to allow for additional discussion and revision for future versions of the survey towards the goal of achieving greater clarity for agencies and survey respondents.

OPM received multiple comments and suggestions on additions to, and deletions from, the proposed list of survey questions from seven individuals, two agencies and two organizations.

Section 1128 of the National Defense Authorization Act for Fiscal Year 2004 (Pub. L. 108-136, 5 U.S.C. 7101 note) requires each agency to conduct an annual survey of its employees to assess two topic areas (1) Leadership and Management Practices that contribute to agency performance, and (2) Employee Satisfaction with: (a) Leadership policies and practices; (b) work environment; (c) rewards and recognition; (d) opportunity for professional development and growth; and (e) opportunity to contribute to achieving organizational mission. Any questions suggested by commenters that did not fit these two main areas of the statute (and/or the five sub-areas) were considered to be out of the scope of this regulation and therefore not considered. OPM did not adopt comments suggesting adding new areas with associated new questions, because these areas are not covered in the statute that drives this regulation (cited above). OPM notes, however, that agencies maintain the flexibility to expand their own surveys and add agency-specific questions as appropriate to the agency's needs. In addition, although the questions referenced in this paragraph are outside the scope of the statute and do not need to be retained in regulation, OPM will maintain the suggestions for consideration for future additions to the non-mandatory portion of the Employee Survey.

An organization suggested seven (7) questions for addition to the regulation.

These questions were evaluated to the extent that they (a) fit within the existing areas covered in the statute and (b) were understandable and well-written. All of these questions had been included in past versions of the annual survey and are of continued interest for year-to-year agency trending. Of the seven questions suggested, five questions both clearly fit within the existing areas covered in the statute and were understandable and well-written. These five questions were added to the original 11 questions proposed for the current legislation, for a total of 16 questions going forward. Specifically, the additional questions included in the current regulation are:

1. I believe the results of this survey will be used to make my agency a better place to work.

2. Considering everything, how satisfied are you with your organization?

3. Considering everything, how satisfied are you with your job?

4. I can disclose a suspected violation of any law, rule or regulation without fear of reprisal.

5. I recommend my organization as a good place to work.

Two of the questions suggested for inclusion were: (a) “arbitrary action, personal favoritism and coercion for partisan political purposes are not tolerated” and (b) “prohibited personnel practices (for example, illegally discriminating for or against any employee/applicant, obstructing a person's right to compete for employment, knowingly violating veterans' preference requirements) are not tolerated.” They were not included in the current regulation because they lacked clarity and would not produce meaningful responses/data. These questions need to be more clearly written to be understandable to respondents and produce actionable results. These two questions also are outside the scope of the statute.

One agency suggested adding questions dealing with veteran issues; an individual and an agency suggested adding questions regarding training; another individual requested the survey include questions to ascertain the education and career of the respondent's parents and spouse; and two other individuals requested additional areas/questions be included that focused on employee motivation as well as burnout, turnover and productivity.

The questions and/or areas for additional questions suggested by these commenters were either outside the scope of the statute and/or already covered by questions included in the current revision of the regulation. No additional changes were made other than the five questions added above.

An individual suggested that the Federal Employee Viewpoint Survey (FEVS) should provide results by race and ethnicity. For instance, currently, results are consolidated into “minority” or “non-minority” categories.

Confidentiality concerns require the combining of some response categories into more general and less personally-identifiable categories to protect the privacy of the individual responders. In any event, this comment is outside the scope of the proposed rule.

Six individuals, two agencies and two organizations commented on what impact the reduction in survey questions in regulation will have on the existing metrics (indexes), trends and agency survey efforts.

About half the survey questions currently in use are not reflected in the regulation, however these questions have been asked by OPM since 2002. Many questions that have never been reflected in regulation have been used to produce the indexes provided to agencies each year, as well as the reports provided by OPM for year-to-year trending for agency use. Changes to the survey questions (regardless of whether the questions are represented in this regulation) are made only in consultation with OPM survey experts, agency representatives and stakeholders that use the survey results. OPM will continue to produce question trends and indexes as in prior years, but will be able to revise and improve questions as necessary for better measurement and remove questions which are no longer of interest to agencies. Index scores will continue to be produced but again, OPM will be able to revise, add or remove indexes to respond to agency needs. Information critical to agency success will not be lost, but instead the survey will move toward providing better and more accurate data to agencies as well as improved scientific rigor. Asking questions which are not well written or no longer relevant to agency success, as well as reporting indexes used in the past when newer indexes would better fit agency needs, confines the survey to be a formality rather than a dynamic and useful management tool.

For the purpose of the regulation, a smaller set of understandable and well-written questions directly related to the statute areas, are critical for governmentwide and agency measurement and trends, and this smaller set of 16 questions will be retained in regulation. This set of questions satisfies the statute requirements. Since these questions cannot be revised or removed without a change in regulation, retaining a large number of questions within a regulation limits the effectiveness of the survey to respond to agency needs, to update the survey to address new initiatives, and/or to revise or remove questions that are no longer useful. Therefore, the previous list of 45 statute-based questions has been reduced to a smaller, core set of 16 areas. The results required by statute will continue to be produced.

In addition, OPM will have the option to make revisions as needed to other parts of the survey and those relevant questions that used to appear in the regulation in order to improve measurement qualities and therefore, improve the overall scientific qualities of the annual survey and its value to the Federal Government, while satisfying the statue requirements.

One agency, one organization and two individuals provided comments related to survey methodology: For example, shortening the fielding period and reducing reporting timeframes, frequency of survey administration, and sampling methodologies.

These comments are outside the scope of the proposed rule; therefore, no response is needed.

An organization suggested requiring OPM to report FEVS data publically within 90 days of the date by which an agency completes survey administration.

Currently, while OPM provides services to all executive agencies for the annual survey, no such requirement is reflected in statute. Thus, no timeline can be established. Our goal is to provide agencies with the best information and reports possible, and imposing a timeline would hamper our ability to respond to dynamic situations and decision-needs.

Executive Order 13563 and Executive Order 12866, Regulatory Review

The Office of Management and Budget has reviewed this proposed rule in accordance with E.O. 13563 and 12866.

Paperwork Reduction Act

This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995 (Pub. L. 104-13).

Regulatory Flexibility Act

I certify that these regulations will not have a significant economic impact on a substantial number of small entities because they apply only to Federal agencies and employees.

List of Subjects in 5 CFR Part 250

Authority for Personnel actions in agencies, Employee surveys, Strategic Human Capital Management.

Office of Personnel Management. Beth F. Cobert, Acting Director.

Accordingly, OPM amends title 5, Code of Federal Regulations, as follows:

PART 250—PERSONNEL MANAGEMENT IN AGENCIES 1. The authority citation for part 250 continues to read as follows: Authority:

5 U.S.C. 1101 note, 1103(a)(5), 1103(c), 1104, 1302, 3301, 3302; E.O. 10577, 12 FR 1259, 3 CFR, 1954-1958 Comp., p. 218; E.O. 13197, 66 FR 7853, 3 CFR 748 (2002).

Subpart B—Strategic Human Capital Management 2. Subpart B is revised to read as follows: Subpart B—Strategic Human Capital Management Sec. 250.201 Coverage and purpose. 250.202 Definitions. 250.203 Strategic Human Capital management systems and standards. 250.204 Agency roles and responsibilities. 250.205 Human Capital Operating Plan (HCOP). 250.206 Human Capital Reviews (HCR). 250.207 HRStat. 250.208 System metrics. 250.209 Consequences of improper agency actions. Subpart B—Strategic Human Capital Management Authority:

5 U.S.C. 105; 5 U.S.C. 1103(a)(7), (c)(1), and (c)(2); 5 U.S.C. 1401; 5 U.S.C. 1402(a); 31 U.S.C. 901(b)(1); 31 U.S.C. 1115(a)(3); 31 U.S.C. 1115(f); 31 U.S.C. 1116(c)(5); Public Law 103-62; Public Law 107-296; Public Law 108-136, 1128; Public Law 111-352; 5 CFR 10.2; FR Doc No: 2011—19844; E.O. 13583; E.O. 13583, Sec 2(b)(ii).

§ 250.201 Coverage and purpose.

Pursuant to 5 U.S.C. 1103(c), this subpart defines a set of systems, including standards and metrics, for assessing the management of human capital by Federal agencies. These regulations apply to all Executive agencies as defined in 31 U.S.C. 901(b)(1) and support the performance planning and reporting that is required by sections 1115(a)(3) and (f) and 1116(d)(5) of title 31, United States Code.

§ 250.202 Definitions.

Chief Human Capital Officer (CHCO) is the agency's senior leader whose primary duty is to:

(1) Advise and assist the head of the agency and other agency officials in carrying out the agency's responsibilities for selecting, developing, training, and managing a high-quality, productive workforce in accordance with merit system principles; and

(2) Implement the rules and regulations of the President, the Office of Personnel Management (OPM), and the laws governing the civil service within the agency.

CHCO agency is an Executive agency, as defined by 5 U.S.C. 105, which is required by 5 U.S.C. 1401 and 31 U.S.C. 901(b)(1) to appoint a CHCO.

Director of OPM is, among other things, the President's advisor on actions that may be taken to promote an efficient civil service and a systematic application of the merit system principles, including recommending policies relating to the selection, promotion, transfer, performance, pay, conditions of service, tenure, and separation of employees. The Director of OPM provides governmentwide leadership and direction in the strategic management of the Federal workforce.

Evaluation system is an agency's overarching system for evaluating the results of all human capital planning and implementation of human capital strategies to inform the agency's continuous process improvement efforts. This system is also used for ensuring compliance with all applicable statutes, rules, regulations, and agency policies.

Federal Workforce Priorities Report (FWPR) is a strategic human capital report, published by OPM by the first Monday in February of any year in which the term of the President commences. OPM may extend the date of publication if needed. The report communicates key Governmentwide human capital priorities and suggested strategies. The report also informs agency strategic and human capital planning.

Focus areas are areas that agencies and human capital practitioners must focus on to achieve a system's standard.

HRStat is a strategic human capital performance evaluation process that identifies, measures, and analyzes human capital data to inform the impact of an agency's human capital management on organizational results with the intent to improve human capital outcomes. HRStat, which is a quarterly review process, is a component of an agency's strategic planning and alignment and evaluation systems that are part of the Human Capital Framework.

Human Capital Evaluation Framework underlies the three human capital evaluation mechanisms (i.e., HRStat, Audits, and Human Capital Reviews) to create a central evaluation framework that integrates the outcomes from each to provide OPM and agencies with an understanding of how human capital policies and programs are supporting missions.

Human Capital Framework (HCF) provides comprehensive guidance on the principles of strategic human capital management in the Federal Government. The framework, as described in § 250.203 below, provides direction on human capital planning, implementation, and evaluation in the Federal environment.

Human Capital Operating Plan (HCOP) is an agency's human capital implementation document, which describes how an agency will execute the human capital elements stated within Agency Strategic Plan and Annual Performance Plan (APP). Program specific workforce investments and strategies (e.g., hiring, closing skill gaps, etc.) should be incorporated into the APPs as appropriate. The HCOP should clearly execute each of the four systems of the HCF. The HCOP should align with the Government Performance and Results Act (GPRA) Modernization Act of 2010, annual performance plans and timelines.

Human Capital Review (HCR) is OPM's annual, evidence-based review of an agency's design and implementation of its HCOP, independent audit, and HRStat programs to support mission accomplishment and human capital outcomes.

Independent audit program is a component of an agency's evaluation system designed to review all human capital management systems and select human resources transactions to ensure efficiency, effectiveness, and legal and regulatory compliance.

Skill gap is a variance between the current and projected workforce size and skills needed to ensure an agency has a cadre of talent available to meet its mission and make progress towards achieving its goals and objectives now and into the future.

Standard is a consistent practice within human capital management in which agencies strive towards in each of the four HCF systems. The standards ensure that an agency's human capital management strategies, plans, and practices:

(1) Are integrated with strategic plans, annual performance plans and goals, and other relevant budget, finance, and acquisition plans;

(2) Contain measurable and observable performance targets;

(3) Are communicated in an open and transparent manner to facilitate cross-agency collaboration to achieve mission objectives; and

(4) Inform the development of human capital management priority goals for the Federal Government.

§ 250.203 Strategic human capital management systems and standards.

Strategic human capital management systems, standards, and focus areas are defined within the Human Capital Framework (HCF). The four systems described below provide definitions and standards for human capital planning, implementation, and evaluation. The HCF systems and standards are:

(a) Strategic planning and alignment. A system that ensures agency human capital programs are aligned with agency mission, goals, and objectives through analysis, planning, investment, and measurement. The standards for the strategic planning and alignment system require an agency to ensure their human capital management strategies, plans, and practices—

(1) Integrate strategic plans, annual performance plans and goals, and other relevant budget, finance, and acquisition plans;

(2) Contain measurable and observable performance targets; and

(3) Communicate in an open and transparent manner to facilitate cross-agency collaboration to achieve mission objectives.

(b) Talent management. A system that promotes a high-performing workforce, identifies and closes skill gaps, and implements and maintains programs to attract, acquire, develop, promote, and retain quality and diverse talent. The standards for the talent management system require an agency to—

(1) Plan for and manage current and future workforce needs;

(2) Design, develop, and implement proven strategies and techniques and practices to attract, hire, develop, and retain talent; and

(3) Make progress toward closing any knowledge, skill, and competency gaps throughout the agency.

(c) Performance culture. A system that engages, develops, and inspires a diverse, high-performing workforce by creating, implementing, and maintaining effective performance management strategies, practices, and activities that support mission objectives. The standards for the performance culture system require an agency to have—

(1) Strategies and processes to foster a culture of engagement and collaboration;

(2) A diverse, results-oriented, high-performing workforce; and

(3) A performance management system that differentiates levels of performance of staff, provides regular feedback, and links individual performance to organizational goals.

(d) Evaluation. A system that contributes to agency performance by monitoring and evaluating outcomes of its human capital management strategies, policies, programs, and activities by meeting the following standards—

(1) Ensuring compliance with merit system principles; and

(2) Identifying, implementing, and monitoring process improvements.

§ 250.204 Agency roles and responsibilities.

(a) An agency must use the systems and standards established in this part, and any metrics that OPM subsequently provides in guidance, to plan, implement, evaluate and improve human capital policies and programs. These policies and programs must—

(1) Align with Executive branch policies and priorities, as well as with individual agency missions, goals, and strategic objectives. Agencies must align their human capital management strategies to support the Federal Workforce Priorities Report, agency strategic plan, agency performance plan, and agency budget;

(2) Be based on comprehensive workforce planning and analysis;

(3) Monitor and address skill gaps within governmentwide and agency-specific mission-critical occupations by using comprehensive data analytic methods and gap closure strategies;

(4) Recruit, hire, develop, and retain an effective workforce, especially in the agency's mission-critical occupations;

(5) Ensure leadership continuity by implementing and evaluating recruitment, development, and succession plans for leadership positions;

(6) Implement a knowledge management process to ensure continuity in knowledge sharing among employees at all levels within the organization;

(7) Sustain an agency culture that engages employees by defining, valuing, eliciting, and rewarding high performance; and

(8) Hold the agency head, executives, managers, human capital officers, and human capital staff accountable for efficient and effective strategic human capital management, in accordance with merit system principles.

(b) Each agency must meet the statutory requirements of the Government Performance and Results Act (GPRA) Modernization Act of 2010, by including within the Annual Performance Plan (APP) human capital practices that are aligned to the agency strategic plan. The human capital portion of the APP must include performance goals and indicators.

(c) An agency's Deputy Secretary, equivalent, or designee is responsible for ensuring that the agency's strategic plan includes a description of the operational processes, skills and technology, and human capital information required to achieve the agency's goals and objectives. Specifically, the Deputy Secretary, equivalent, or designee will—

(1) Allocate resources;

(2) Ensure the agency incorporates applicable priorities identified within the Federal Workforce Strategic Priorities Report and is working to close governmentwide and agency-specific skill gaps; and

(3) Remain informed about the progress of their agency's quarterly HRStat reviews, which are led by the CHCO, in collaboration with the PIO.

(d) The Chief Human Capital Officer must design, implement and monitor agency human capital policies and programs that—

(1) Ensure human capital activities support merit system principles;

(2) Use the OPM designated method to identify governmentwide and agency-specific skill gaps;

(3) Demonstrate how the agency is using the principles within the HCF to address strategic human capital priorities and goals;

(4) Establish and maintain an Evaluation System to evaluate human capital outcomes that is—

(i) Formal and documented; and

(ii) Approved by OPM;

(5) Maintain an independent audit program, subject to full OPM participation and evaluation, to review periodically all human capital management systems and the agency's human resources transactions to ensure legal and regulatory compliance. An agency must—

(i) Take corrective action to eliminate deficiencies identified by OPM, or through the independent audit, and to improve its human capital management programs and its human resources processes and practices; and

(ii) Based on OPM or independent audit findings, issue a report to its leadership and OPM containing the analysis, results, and corrective actions taken; and

(6) Improve strategic human capital management by adjusting strategies and practices, as appropriate, after assessing the results of performance goals, indicators, and business analytics.

(7) The agency's human capital policies and programs must support the implementation and monitoring of the Federal Workforce Priorities Report, which is published by OPM every four years, and—

(i) Improve strategic human capital management by using performance goals, indicators, and business analytics to assess results of the human capital management strategies planned and implemented;

(ii) Ensure human capital activities support merit system principles;

(iii) Adjust human capital management strategies and practices in response to outcomes identified during HRStat quarterly data-driven reviews of human capital performance to improve organizational processes; and

(iv) Use the governmentwide and agency-specific human capital strategies to inform resource requests (e.g., staff full-time equivalents, training, analytical software, etc.) into the agency's annual budget process.

§ 250.205 Human Capital Operating Plan (HCOP).

Each agency must develop a Human Capital Operating Plan (HCOP) that aligns with an agency's Strategic Plan and Annual Performance Plan. The HCOP is to be reviewed and approved annually, and updated as needed. The HCOP must demonstrate how an agency's human capital implementation strategies follow the principles and standards of the HCF while including an explanation of how human capital policies, initiatives, objectives, and resources will be used to achieve agencies' human capital goals. The HCOP will be made available to OPM upon request. The HCOP must—

(a) Be established by the CHCO, in collaboration with the agency's senior management team;

(b) Be used to support the execution of an agency's strategic plan, as an agency's human capital can affect whether or not a strategy or strategic goal is achieved;

(c) Explicitly describe the agency-specific skill and competency gaps that must be closed through the use of agency selected human capital strategies;

(d) Include annual human capital performance goals and measures that will support the evaluation of the agency's human capital strategies, through HRStat quarterly reviews, and that are aligned to support mission accomplishment;

(e) Reflect the systems and standards defined in § 250.203 above, consistent with their agency strategic plan and annual performance plan, to address strategic human capital priorities and goals; and

(f) Address the governmentwide priorities identified in the Federal Workforce Strategic Priorities Report.

§ 250.206 Human Capital Reviews.

Each agency must participate with OPM in a Human Capital Review (HCR). The HCR will be conducted during the evaluation phase and OPM will issue guidance about the HCR requirements.

§ 250.207 HRStat.

The Chief Human Capital Officer must design, implement and monitor agency human capital policies and programs that—

(a) Use the HRStat quarterly reviews, in coordination with the agency Performance Improvement Officer (PIO), to assess the agency's progress toward meeting its strategic and performance goals;

(b) Implement the HRStat Maturity guidelines specified by OPM; and

(c) Use HRStat quarterly reviews to evaluate their agency's progress.

§ 250.208 System metrics.

OPM reserves the right to provide additional guidance regarding metrics.

§ 250.209 Consequences of improper agency actions.

If OPM finds that an agency has taken an action contrary to a law, rule, regulation, or standard that OPM administers, OPM may require the agency to take corrective action. OPM may suspend or revoke a delegation agreement established under 5 U.S.C. 1104(a)(2) at any time if it determines that the agency is not adhering to the provisions of the agreement. OPM may suspend or withdraw any authority granted under this chapter to an agency, including any authority granted by delegation agreement, when OPM finds that the agency has not complied with qualification standards OPM has issued, instructions OPM has published, or the regulations in this chapter of the regulation. OPM also may suspend or withdraw these authorities when it determines that doing so is in the interest of the civil service for any other reason.

3. Subpart C is revised to read as follows: Subpart C—Employee Surveys Sec. 250.301 Definitions. 250.302 Survey requirements. 250.303 Availability of results. Subpart C—Employee Surveys Authority:

5 U.S.C. 105; 5 U.S.C. 7101 note; Public Law 108-136

§ 250.301 Definitions.

Agency means an Executive agency, as defined in 5 U.S.C. 105.

§ 250.302 Survey requirements.

(a) Each executive agency must conduct an annual survey of its employees to assess topics outlined in the National Defense Authorization Act for Fiscal Year 2004, Public Law 108-136, sec. 1128, codified at 5 U.S.C. 7101.

(1) Each executive agency may include additional survey questions unique to the agency in addition to the employee survey questions prescribed by OPM under paragraph (a)(2) of this section.

(2) The 16 prescribed survey questions are listed in the following table:

(i) Leadership and Management practices that contribute to agency performance My work unit has the job-relevant skills necessary to accomplish organizational goals. Managers communicate the goals of the organization. I believe the results of this survey will be used to make my agency a better place to work. (ii) Employee Satisfaction with— (A) Leadership Policies and Practices: How satisfied are you with your involvement in decisions that affect your work? How satisfied are you with the information you receive from management on what is going on in your organization? Considering everything, how satisfied are you with your organization? (B) Work Environment: The people I work with cooperate to get the job done. My workload is reasonable. Considering everything, how satisfied are you with your job? I can disclose a suspected violation of any law, rule or regulation without fear of reprisal. (C) Rewards and Recognition: In my work unit, differences in performance are recognized in a meaningful way. How satisfied are you with the recognition you receive for doing a good job? (D) Opportunities for professional development and growth: I am given a real opportunity to improve my skills in my organization. My talents are used well in the workplace. (E) Opportunity to contribute to achieving organizational mission: I know how my work relates to the agency's goals. I recommend my organization as a good place to work.
§ 250.303 Availability of results.

(a) Each agency will make the results of its annual survey available to the public and post the results on its Web site unless the agency head determines that doing so would jeopardize or negatively impact national security. The posted survey results will include the following:

(1) The agency's evaluation of its survey results;

(2) How the survey was conducted;

(3) Description of the employee sample, unless all employees are surveyed;

(4) The survey questions and response choices with the prescribed questions identified;

(5) The number of employees surveyed and number of employees who completed the survey; and

(6) The number of respondents for each survey question and each response choice.

(b) Data must be collected by December 31 of each calendar year. Each agency must post the beginning and ending dates of its employee survey and either the survey results described in paragraph (a) of this section, or a statement noting the decision not to post, no later than 120 days after the agency completes survey administration. OPM may extend this date under unusual circumstances.

[FR Doc. 2016-29600 Filed 12-9-16; 8:45 am] BILLING CODE 6325-39-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-8178; Directorate Identifier 2015-NM-197-AD; Amendment 39-18721; AD 2016-24-04] RIN 2120-AA64 Airworthiness Directives; Bombardier, Inc. Airplanes AGENCY:

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

ACTION:

Final rule.

SUMMARY:

We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc. Model DHC-8-400 series airplanes. This AD was prompted by a determination by the manufacturer that shims might not have been installed between certain longerons and longeron joint fittings. This AD requires various repetitive and detailed visual inspections of the affected areas and corrective actions if necessary. This AD also provides terminating action for certain repetitive inspections. We are issuing this AD to address the unsafe condition on these products.

DATES:

This AD is effective January 17, 2017.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of January 17, 2017.

ADDRESSES:

For service information identified in this final rule, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-375-4000; fax 416-375-4539; email [email protected]; Internet http://www.bombardier.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-8178.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-8178; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

Aziz Ahmed, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7329; fax 516-794-5531.

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc. Model DHC-8-400 series airplanes. The NPRM published in the Federal Register on July 15, 2016 (81 FR 45995) (“the NPRM”). The NPRM was prompted by a determination by the manufacturer that shims might not have been installed between certain longerons and longeron joint fittings. The NPRM proposed to require repetitive inspections of the external surface of the fuselage skin panel for loose or working fasteners, and corrective action if necessary; a detailed visual inspection of the longeron joint fittings for the existence of shims and, if necessary, repetitive inspections of the longeron and the longeron joint fittings for any cracking, and corrective action if necessary. We are issuing this AD to detect and correct missing shims between the longerons and longeron joint fittings, which could result in a gapping condition and lead to stress corrosion cracking of the longeron joint fittings, and could adversely affect the structural integrity of the wing-to-fuselage attachment joints.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2015-22, dated August 3, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model DHC-8-400 series airplanes. The MCAI states:

The aeroplane manufacturer has determined that shims may not have been installed between the longerons and longeron joint fittings at fuselage station X373-380, stringers 7 on the left and right hand side, on certain aeroplanes. The missing shims could result in a gapping condition and could lead to stress corrosion cracking of the longeron joint fittings.

Failure of the longeron joint fitting could compromise the structural integrity of the wing-to-fuselage attachment joint.

This [Canadian] AD mandates inspections in the area of the longeron joint fittings.

Corrective actions include replacing any loose or working fasteners (fasteners that show signs of wear, fatigue, or corrosion), repairing any structural damage, and replacing any cracked longeron or longeron with an amplitude of 50% or more of the calibration signal. You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-8178. Comments

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

Request To Incorporate Revised Service Information

Horizon Air requested that we incorporate Bombardier Service Bulletin 84-53-65, Revision A, dated February 22, 2016.

We agree with the commenter's request to incorporate the revised service information because Bombardier Service Bulletin 84-53-65, Revision A, dated February 22, 2016, is the latest revision. We have changed all service bulletin references in this final rule to Bombardier Service Bulletin 84-53-65, Revision A, dated February 22, 2016.

Request To Provide Credit for Previous Actions

Horizon Air requested that we add a paragraph addressing credit for previous actions.

We agree. Since we have incorporated revised service information in this final rule, we agree to provide credit for required tasks performed before the effective date of this AD using Bombardier Service Bulletin 84-53-65, dated February 27, 2015. We have added a new paragraph (n) to this AD to provide credit for previous actions and redesignated subsequent paragraphs accordingly.

Additional Changes to NPRM

We have reformatted paragraph (l) in this AD to clarify the requirements.

Conclusion

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

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

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

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

Related Service Information Under1 CFR Part 51

We reviewed Bombardier Service Bulletin 84-53-65, Revision A, dated February 22, 2016. The service information describes procedures for inspections of the external surface of the fuselage skin panel for loose or working fasteners; a detailed visual inspection of the longeron joint fittings for the existence of shims; high frequency eddy current inspections of the longeron and the longeron joint fittings for any cracking; and replacement of longeron fittings, shims, and fasteners. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

We estimate that this AD affects 76 airplanes of U.S. registry.

We also estimate that it will take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $12,920, or $170 per product.

In addition, we estimate that any necessary follow-on actions will take about 3 work-hours for the inspection for missing shims, 9 work-hours for the replacement of longeron fittings and shims, and 1 work-hour for a reporting requirement; and would require parts costing $3,222; for a cost of up to $4,327 per product. We have no way of determining the number of aircraft that might need these actions. We have received no definitive data that will enable us to provide cost estimates for repair of loose or working fasteners or structural damage specified in this AD.

Paperwork Reduction Act

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.

Authority for This Rulemaking

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

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

Regulatory Findings

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

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

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

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

3. Will not affect intrastate aviation in Alaska; and

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

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

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

§ 39.13 [Amended]
2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2016-24-04 Bombardier, Inc: Amendment 39-18721; Docket No. FAA-2016-8178; Directorate Identifier 2015-NM-197-AD. (a) Effective Date

This AD is effective January 17, 2017.

(b) Affected ADs

None.

(c) Applicability

This AD applies to Bombardier, Inc. Model DHC-8-400, -401, and -402 airplanes, certificated in any category, serial numbers 4156 through 4453 inclusive, 4456, and 4457.

(d) Subject

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

(e) Reason

This AD was prompted by a determination by the manufacturer that shims might not have been installed between certain longerons and longeron joint fittings. We are issuing this AD to detect and correct missing shims between the longerons and longeron joint fittings, which could result in a gapping condition and lead to stress corrosion cracking of the longeron joint fittings, and could adversely affect the structural integrity of the wing-to-fuselage attachment joints.

(f) Compliance

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

(g) Inspection of the External Surface of the Fuselage Skin Panels

At the time specified in paragraph (g)(1) or (g)(2) of this AD, as applicable, do a detailed visual inspection of the external surface of the fuselage skin panel for loose or working fasteners (fasteners that show signs of wear, fatigue, or corrosion) and structural damage, in accordance with paragraph 3.B. of the Accomplishment Instructions of Bombardier Service Bulletin 84-53-65, Revision A, dated February 22, 2016.

(1) For airplanes that have accumulated less than 10,000 total flight hours, or less than 5 years in service since new, as of the effective date of this AD: Prior to accumulating 12,000 total flight hours or 6 years in service since new, whichever occurs first.

(2) For airplanes that have accumulated 10,000 total flight hours or more, or 5 years or more in service since new, as of the effective date of this AD: Within 2,000 flight hours or 12 months after the effective date of this AD, whichever occurs first.

(h) Corrective Actions

If any loose or working fastener or any structural damage is found during any inspection required by this AD: Before further flight, repair using a method approved by the Manager, New York Aircraft Certification Office (ACO), FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval Organization (DAO); and thereafter do the inspections required by paragraph (i) of this AD. Accomplishment of a repair in accordance with a method approved by the Manager, New York ACO, FAA; or TCCA; or Bombardier, Inc.'s TCCA DAO terminates the repetitive inspections required by paragraph (i) of this AD for the repaired area only.

(i) Repetitive Detailed Visual Inspections

Repeat the detailed visual inspection required by the introductory text to paragraph (g) of this AD at intervals not to exceed 12 months or 2,000 flight cycles, whichever occurs first after accomplishment of the most recent inspection, until the actions required by the introductory text to paragraph (j) of this AD are done.

(j) Inspection for Missing Shims

At the time specified in paragraph (j)(1) or (j)(2) of this AD, as applicable, do a detailed visual inspection of the longeron joint fittings for the existence of shims, in accordance with paragraph 3.C. of the Accomplishment Instructions of Bombardier Service Bulletin 84-53-65, Revision A, dated February 22, 2016.

(1) For airplanes that have accumulated less than 10,000 total flight hours, or less than 5 years in service since new, as of the effective date of this AD: Prior to accumulating 18,000 total flight hours or 9 years in service since new, whichever occurs first.

(2) For airplanes that have accumulated 10,000 total flight hours or more, or 5 years or more in service since new, as of the effective date of this AD: Within 8,000 flight hours or 4 years after the effective date of this AD, whichever occurs first; but not to exceed 30,000 total flight hours or 144 months in service since new, whichever occurs first.

(k) Airplanes With Installed Shims: No Further Action Required

If the inspection required by the introductory text to paragraph (j) of this AD reveals that shims are installed in the longeron joint fittings, no further action is required by this AD.

(l) Airplanes With Missing Shims: High Frequency Eddy Current (HFEC) Inspections and Corrective Actions

If the inspection required by the introductory text to paragraph (j) of this AD reveals that any shim is missing from the longeron joint fittings: Before further flight, do a high frequency eddy current (HFEC) inspection of the longeron and the longeron joint fittings for any cracking, in accordance with paragraph 3.D. of the Accomplishment Instructions of Bombardier Service Bulletin 84-53-65, Revision A, dated February 22, 2016.

(1) If any crack is found, or if any indication with an amplitude of 50% or more of the calibration signal is found, do the actions specified in paragraphs (l)(1)(i) and (l)(1)(ii) of this AD.

(i) Before further flight: Replace the longeron joint fittings, in accordance with paragraph 3.E. of the Accomplishment Instructions of Bombardier Service Bulletin 84-53-65, Revision A, dated February 22, 2016.

(ii) At the applicable time specified in paragraph (l)(1)(ii)(A) or (l)(1)(ii)(B) of this AD: Report the inspection results to Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-375-4000; fax 416-375-4539; email [email protected]; Internet http://www.bombardier.com.

(A) If the inspection was done on or after the effective date of this AD: Report within 30 days after that inspection.

(B) If the inspection was done before the effective date of this AD: Report within 30 days after the effective date of this AD.

(2) If no crack or indication with an amplitude of 50% or more of the calibration signal is found: Repeat the HFEC inspection required by the introductory text to paragraph (l) of this AD at intervals not to exceed 12,000 flight hours or 6 years, whichever occurs first after accomplishment of the most recent HFEC inspection, in accordance with paragraph 3.D. of the Accomplishment Instructions of Bombardier Service Bulletin 84-53-65, Revision A, dated February 22, 2016.

(m) Terminating Action for Repetitive HFEC Inspections

Replacement of the longeron joint fittings, in accordance with paragraph 3.E. of the Accomplishment Instructions of Bombardier Service Bulletin 84-53-65, Revision A, dated February 22, 2016, constitutes terminating action for the repetitive HFEC inspections required by paragraph (l)(2) of this AD.

(n) Credit for Previous Actions

This paragraph provides credit for actions required by paragraphs (g), (i), (j), (k), (l), and (m) of this AD, if those actions were performed before the effective date of this AD using Bombardier Service Bulletin 84-53-65, dated February 27, 2015.

(o) Other FAA AD Provisions

The following provisions also apply to this AD:

(1) Alternative Methods of Compliance (AMOCs): The Manager, New York ACO, ANE-170, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the ACO, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; fax 516-794-5531. Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office. The AMOC approval letter must specifically reference this AD.

(2) Contacting the Manufacturer: For any requirement in this AD to obtain corrective actions from a manufacturer, the action must be accomplished using a method approved by the Manager, New York ACO, ANE-170, FAA; or TCCA; or Bombardier, Inc.'s TCCA DAO. If approved by the DAO, the approval must include the DAO-authorized signature.

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

(p) Related Information

(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2015-22, dated August 3, 2015, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-8178.

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

(q) Material Incorporated by Reference

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

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

(i) Bombardier Service Bulletin 84-53-65, Revision A, dated February 22, 2016.

(ii) Reserved.

(3) For service information identified in this AD, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-375-4000; fax 416-375-4539; email [email protected]; Internet http://www.bombardier.com.

(4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

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

Issued in Renton, Washington, on November 17, 2016. Phil Forde, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2016-28597 Filed 12-9-16; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-5598; Directorate Identifier 2016-NM-001-AD; Amendment 39-18735; AD 2016-25-09] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final rule.

SUMMARY:

We are superseding Airworthiness Directive (AD) 2012-22-02 for certain The Boeing Company Model 747-400, -400D, and -400F series airplanes. AD 2012-22-02 required measuring the web at station (STA) 320 and, depending on findings, various inspections for cracks and missing fasteners, web and fastener replacement, and related investigative and corrective actions if necessary. This new AD requires, for certain airplanes, replacement of the web, including related investigative and corrective actions if necessary. This AD was prompted by a determination that there were no inspection or repair procedures included in AD 2012-22-02 for airplanes with a certain crown frame web thickness. We are issuing this AD to address the unsafe condition on these products.

DATES:

This AD is effective January 17, 2017.

The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of January 17, 2017.

ADDRESSES:

For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet: https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5598.

Examining the AD Docket

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-5598; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The address for the Docket Office (phone: 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2012-22-02, Amendment 39-17238 (77 FR 69739, November 21, 2012) (“AD 2012-22-02”). AD 2012-22-02 applied to certain The Boeing Company Model 747-400, -400D, and -400F series airplanes. The NPRM published in the Federal Register on April 28, 2016 (81 FR 25357) (“the NPRM”). The NPRM was prompted by a determination that there were no inspection or repair procedures included in AD 2012-22-02 for airplanes with a STA 320 crown frame web thickness less than 0.078 inch, or greater than or equal to 0.084 inch and less than or equal to 0.135 inch. The NPRM proposed to continue to require certain actions required by AD 2012-22-02. The NPRM also proposed to require, for certain airplanes, replacement of the web, including related investigative and corrective actions if necessary. We are issuing this AD to prevent complete fracture of the crown frame assembly, and consequent damage to the skin. Such damage could result in in-flight decompression of the airplane.

Comments

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

Support for the NPRM

United Airlines stated that it concurs with the NPRM.

Request To Remove Redundant Requirements

Boeing requested we change paragraph (i) of the proposed AD to remove redundant language. Boeing requested we remove the second half of the paragraph and subparagraphs (i)(1) and (i)(2) of the proposed AD because they include redundant requirements. Boeing also noted that the redundant requirements include an exception that does not apply to table 3 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015.

We agree to revise paragraph (i) of this AD for the reasons provided by Boeing. We have revised paragraph (i) of this AD accordingly.

Conclusion

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

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

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

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

Related Service Information Under 1 CFR Part 51

We reviewed Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015. The service information describes procedures for various inspections for cracks and missing fasteners, web and fastener replacement, and related investigative and corrective actions, if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

We estimate that this AD affects 29 airplanes.

We estimate the following costs to comply with this AD:

Estimated Costs Action Labor cost Parts cost Cost per product Cost on U.S.
  • operators
  • Measurement, inspection, and web replacement [retained actions from AD 2012-22-02] 219 work-hours × $85 per hour = $18,615 per inspection and replacement Up to $21,887 Up to $40,502 per inspection and replacement Up to $1,174,558 per inspection and replacement. Post-replacement inspection [retained actions from AD 2012-22-02] 135 work-hours × $85 per hour = $11,475 per inspection cycle $0 $11,475 per inspection cycle $332,775 per inspection cycle.
    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by removing Airworthiness Directive (AD) 2012-22-02, Amendment 39-17238 (77 FR 69739, November 21, 2012), and adding the following new AD: 2016-25-09 The Boeing Company: Amendment 39-18735; Docket No. FAA-2016-5598; Directorate Identifier 2016-NM-001-AD. (a) Effective Date

    This AD is effective January 17, 2017.

    (b) Affected ADs

    This AD replaces AD 2012-22-02, Amendment 39-17238 (77 FR 69739, November 21, 2012) (“AD 2012-22-02”).

    (c) Applicability

    This AD applies to The Boeing Company Model 747-400, -400D, and -400F series airplanes, certificated in any category, as specified in Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015.

    (d) Subject

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

    (e) Unsafe Condition

    This AD was prompted by a determination that there were no inspection or repair procedures included in AD 2012-22-02 for airplanes with a station (STA) 320 crown frame web thickness less than 0.078 inch, or greater than or equal to 0.084 inch and less than or equal to 0.135 inch. We are issuing this AD to prevent complete fracture of the crown frame assembly, and consequent damage to the skin. Such damage could result in in-flight decompression of the airplane.

    (f) Compliance

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

    (g) Crown Frame Web Measurement for Certain Airplanes

    For Group 1, Configuration 3 airplanes, identified in Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015: At the compliance time specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015, measure the thickness of the crown frame web at STA 320, and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015, except as required by paragraph (l)(2) of this AD. Do all related investigative and corrective actions at the applicable times specified in tables 2 and 3 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015.

    (h) Inspections (Web With No Repair Doubler) and Related Investigative and Corrective Actions (Including Web Replacement)

    For Group 1, Configuration 1 airplanes, identified in Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015: For airplanes with a web thickness less than 0.136 inch and no repair doubler installed on the web, at the time specified in table 2 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015, do a detailed inspection for cracks and a general visual inspection for missing fasteners of the crown frame web at STA 320, and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015, except as specified in paragraph (l)(2) of this AD. Do the applicable related investigative and corrective actions at the applicable times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015.

    (i) Inspection (Web With Repair Doubler) and Related Investigative and Corrective Actions (Including Web Replacement)

    For Group 1, Configuration 1 airplanes, identified in Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015: For airplanes with a web thickness less than 0.136 inch and a repair doubler installed on the web, at the time specified in table 3 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015, do a detailed inspection for any crack in the upper chord and lower chord of the STA 320 crown frame, and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015, except as specified in paragraph (l)(2) of this AD. Do the applicable related investigative and corrective actions at the applicable times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015.

    (j) Web Replacement for Certain Airplanes

    For Group 1, Configuration 2 airplanes, identified in Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015: At the applicable time specified in table 5 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015, except as provided by paragraph (l)(1) of this AD, replace the web, including doing related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015, except as required by paragraph (l)(2) of this AD. Do all applicable related investigative and corrective actions before further flight.

    (k) Post-Replacement Repetitive Inspections of Replaced Web

    Following any web replacement required by this AD, at the time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015: Do a detailed inspection for cracks of the web, upper chord, lower chord, and lower chord splice, and do all applicable corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015, except as required by paragraph (l)(2) of this AD. Do all applicable corrective actions before further flight. If no crack is found, repeat the inspection thereafter at the intervals specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015. Accomplishment of the inspections required by AD 2009-19-05, Amendment 39-16022 (74 FR 48138, September 22, 2009), terminates the requirements of this paragraph.

    (l) Exceptions to the Service Information, With Updated Service Information

    (1) Where Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015, specifies a compliance time “after the Revision 2 date of the service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.

    (2) Where Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015, specifies to contact Boeing for appropriate action, accomplish applicable actions before further flight using a method approved in accordance with the procedures specified in paragraph (n) of this AD.

    (m) Credit for Previous Actions

    (1) This paragraph provides credit for the actions required by paragraphs (h), (i), and (k) of this AD, if those actions were performed before December 26, 2012 (the effective date of AD 2012-22-02), using Boeing Service Bulletin 747-53A2784, dated August 27, 2009.

    (2) This paragraph provides credit for the actions required by paragraphs (h), (i), and (k) of this AD, if those actions were performed before the effective date of this AD using Boeing Service Bulletin 747-53A2784, Revision 1, dated September 14, 2011. This service information was incorporated by reference in AD 2012-22-02.

    (n) Alternative Methods of Compliance (AMOCs)

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

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

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

    (o) Related Information

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

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

    (p) Material Incorporated by Reference

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

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

    (i) Boeing Alert Service Bulletin 747-53A2784, Revision 2, dated August 20, 2015.

    (ii) Reserved.

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

    (4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

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

    Issued in Renton, Washington, on November 25, 2016. John P. Piccola, Jr., Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-29246 Filed 12-9-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2015-7530; Directorate Identifier 2014-NM-257-AD; Amendment 39-18730; AD 2016-25-04] RIN 2120-AA64 Airworthiness Directives; Fokker Services B.V. Airplanes AGENCY:

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

    ACTION:

    Final rule.

    SUMMARY:

    We are adopting a new airworthiness directive (AD) for all Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. This AD was prompted by a report of cracking in a certain section of the secondary structure of the wing. This AD requires a one-time inspection of the trailing edge rib, and corrective action if necessary. We are issuing this AD to address the unsafe condition on these products.

    DATES:

    This AD is effective January 17, 2017.

    The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of January 17, 2017.

    ADDRESSES:

    For service information identified in this final rule, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email [email protected]fokker.com; Internet http://www.myfokkerfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-7530.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-7530; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone 800-647-5527) is Docket Management Facility, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    FOR FURTHER INFORMATION CONTACT:

    Tom Rodriguez, Aerospace Engineer, ANM 116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1139.

    SUPPLEMENTARY INFORMATION:

    Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. The NPRM published in the Federal Register on December 24, 2015 (80 FR 80299) (“the NPRM”).

    The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0271, dated December 12, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. The MCAI states:

    Service experience with the Fokker 100 type design has shown that cracking can occur in the secondary structure of the wing at station 8700, rib Part Number (P/N) D15445-013/-014 (or lower dash number) in the trailing edge section. The hydraulic actuator assembly, hydraulic lines, the cable pulleys, the anti-upfloat quadrant and the associated mechanical linkages including flutter dampers are all positioned in the affected area, between wing stations 8200 and 9270.

    This condition, if not detected and corrected, could lead to failure of the affected rib, possibly resulting in reduced control of the aeroplane.

    To address this potential unsafe condition, Fokker Services published Service Bulletin (SB) SBF100-57-048, which provides inspection instructions to detect any cracks in the affected area.

    For the reasons described above, this [EASA] AD requires a one-time [detailed] inspection of the trailing edge rib at wing station 8700 and, depending on findings, accomplishment of applicable corrective action(s).

    This [EASA] AD is considered to be an interim action and further AD action may follow, possibly to introduce new ALS [Airworthiness Limitations Section] tasks, if justified by the inspection results.

    Corrective actions include repair of cracking in the secondary structure of the wing at station 8700, rib part number (P/N) D15445-013/-014 (or lower dash number), in the trailing edge section.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-7530.

    Comments

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

    Conclusion

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

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

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

    Related Service Information Under 1 CFR Part 51

    We reviewed Fokker Service Bulletin SBF100-57-048, dated October 27, 2014. This service information describes procedures for inspecting the trailing edge section at the rib of wing station 8700 for cracking. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    Costs of Compliance

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

    We also estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $0 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $680, or $85 per product.

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

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

    3. Will not affect intrastate aviation in Alaska; and

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

    List of Subjects in 14 CFR Part 39

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

    Adoption of the Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): 2016-25-04 Fokker Services B.V.: Amendment 39-18730; Docket No. FAA-2015-7530; Directorate Identifier 2014-NM-257-AD. (a) Effective Date

    This AD is effective January 17, 2017.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes, certificated in any category.

    (d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

    (e) Reason

    This AD was prompted by report of cracking in the secondary structure of the wing at station 8700. We are issuing this AD to detect and correct cracking that could lead to failure of the affected rib and consequent reduced control of the airplane.

    (f) Compliance

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

    (g) Inspection

    Within 12 months after the effective date of this AD: Do a detailed inspection for cracking of the trailing edge rib at wing station 8700, in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100-57-048, dated October 27, 2014. If any crack is found, before further flight, repair using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Fokker Services B.V.'s EASA Design Organization Approval (DOA).

    (h) Other FAA AD Provisions

    The following provisions also apply to this AD:

    (1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the International Branch, send it to ATTN: Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149. Information may be emailed to: [email protected] Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

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

    (i) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI) European AD 2014-0271, dated December 12, 2014, for related information. This MCAI may be found in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-7530.

    (j) Material Incorporated by Reference

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

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

    (i) Fokker Service Bulletin SBF100-57-048, dated October 27, 2014.

    (ii) Reserved.

    (3) For service information identified in this AD, contact Fokker Services B.V., Technical Services Dept., P.O. Box 1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350; fax +31 (0)88-6280-111; email [email protected]; Internet http://www.myfokkerfleet.com.

    (4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

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

    Issued in Renton, Washington, on November 25, 2016. John P. Piccola, Jr., Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-29243 Filed 12-9-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection DEPARTMENT OF THE TREASURY 19 CFR Parts 159 and 173 [USCBP-2016-0065; CBP Dec. No. 16-25] RIN 1515-AE16 Electronic Notice of Liquidation AGENCY:

    U.S. Customs and Border Protection, HDS; Department of the Treasury.

    ACTION:

    Final rule.

    SUMMARY:

    This document adopts as a final rule, with changes, proposed amendments to the U.S. Customs and Border Protection (CBP) regulations reflecting that official notice of liquidation, suspension of liquidation, and extension of liquidation will be posted electronically on the CBP Web site. The regulatory revisions reflect that official notice of liquidation will no longer be posted at the customhouses or stations and that official notices of suspension of liquidation and extension of liquidation will no longer be mailed. Additionally, this rule makes certain technical corrections to the CBP regulations to reflect statutory amendments.

    DATES:

    This final rule is effective on January 14, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Virginia McPherson, ACE Business Office, Office of Trade, [email protected] Randy Mitchell, Trade Policy and Programs, Office of Trade, [email protected]

    SUPPLEMENTARY INFORMATION: Background

    Section 500 of the Tariff Act of 1930, as amended (19 U.S.C. 1500), provides U.S. Customs and Border Protection (CBP) with the authority, under rules and regulations prescribed by the Secretary of the Treasury, to, among other things, give or transmit notice of liquidation pursuant to an electronic data interchange system. See 19 U.S.C. 1500(e). Similarly, CBP is authorized to give notice of extension of liquidation in such form and manner (which may include electronic transmittal) as prescribed by regulation and notice of suspension of liquidation in such manner as considered appropriate. See 19 U.S.C. 1504(b) and (c). Additionally, the National Customs Automation Program (NCAP) was established by Subtitle B of Title VI—Customs Modernization, in the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057, December 8, 1993), to provide for, among other things, the electronic status of liquidation. See 19 U.S.C. 1411.

    Currently, notices of liquidation for formal entry, including notices of liquidation by operation of law, are physically posted in the customhouse or station at the port of entry on CBP Form 4333, and this physical posting is deemed the legal evidence of liquidation. When extension or suspension of liquidation occurs, official notices are mailed on an appropriately modified CBP Form 4333-A.

    On October 14, 2016, CBP published a notice in the Federal Register (81 FR 71019) proposing to amend title 19 of the Code of Federal Regulations (“19 CFR”) to reflect that official notice of liquidation, suspension of liquidation, and extension of liquidation would be posted electronically on the CBP Web site rather than being physically posted at the customhouses or stations or mailed. CBP also proposed eliminating the mailed paper courtesy notices of liquidation but stated its intention to continue sending electronic courtesy notices of liquidation, extension, and suspension via a CBP-authorized electronic data interchange system to the electronic filer when entries liquidate or are extended or suspended. The proposed amendments were intended to modernize, centralize, and facilitate the method by which importers are provided official notice of liquidation, extension, and suspension. Additionally, CBP proposed certain technical corrections to sections 159.11(a), 159.12(f), and 173.4a of 19 CFR to update the regulatory language to reflect statutory changes to sections 504 and 520 of the Tariff Act of 1930, as amended (19 U.S.C. 1504 and 1520). The notice of proposed rulemaking requested public comments. The public comment period closed on November 14, 2016.

    CBP received four comments regarding the proposed amendments to part 159 of 19 CFR regarding posting official notice of liquidation, suspension of liquidation, and extension of liquidation on the CBP Web site. No comments were received on the technical corrections to the regulations contained in sections 159.11(a), 159.12(f), and 173.4a of 19 CFR reflecting the statutory changes to 19 U.S.C. 1504 and 1520.

    Discussion of Comments

    Four comments were received in response to the notice of proposed rulemaking. CBP has addressed the comments below:

    Comment: Three commenters expressed support for the proposed changes to post liquidation information on CBP's Web site, www.cbp.gov.

    CBP Response: CBP appreciates the support and the input from the commenters.

    Comment: One commenter suggested that the regulations state that the link will be visible on the CBP home page so that it remains conspicuous regardless of future CBP Web site changes and the public will not have to search for the link.

    CBP Response: CBP agrees that the link needs to be conspicuous although not necessarily on the homepage. The link will be labelled “Official Notices of Liquidation” and, pursuant to 19 CFR 159.9(b), it will be placed in a conspicuous place on CBP's Web site in such a manner that it can readily be located and consulted by all interested persons. CBP assures that the link will remain conspicuous regardless of any potential future CBP Web site changes.

    Comment: One commenter stated that the regulations should include a definition of what constitutes the posting and its data elements.

    CBP Response: CBP disagrees that adding a definition of what constitutes the posting and its data elements is necessary because CBP believes such a definition would not add value or clarity. As proposed, the regulations at 19 CFR 159.9 provide that the posting will occur on CBP's Web site, address the date of posting, state that the electronic posting will be deemed the legal evidence of liquidation, and address liquidations by operation of law.

    Comment: One commenter stated that the regulations appear not to deal with reliquidations and proposed adding reliquidation to 19 CFR 159.9(b).

    CBP Response: CBP disagrees with the commenter. CBP intends that the posting of reliquidations will also be done electronically. Section 173.3(b) regarding reliquidation (which is in the current regulations and was not proposed to be amended) provides that notice of reliquidation will be given in accordance with the requirements for giving notice of the original liquidation. Accordingly, CBP believes there is no need to add reliquidation to 19 CFR 159.9(b).

    Comment: One commenter stated that the regulation should spell out in detail how the date of posting will appear.

    CBP Response: CBP disagrees that the regulation needs to spell out in detail how the date of posting will appear as the posting will be in a format that is easy to understand. The date of posting will appear in standard MM/DD/YYYY format. For example, December 31, 2016, will appear as 12/31/2016.

    Comment: One commenter asked if importers or brokers will be able to print the notice and asked if the printed notices would include the posting date.

    CBP Response: A printed copy may be obtained using a web browser's print functionality which should include the information that is displayed on the screen, such as the posting date.

    Comment: One commenter stated that the liquidation information posted on the CBP Web site should be searchable using data elements.

    CBP Response: CBP agrees and has designed the liquidation information posted on the CBP Web site to be searchable using data elements.

    Comment: One commenter stated that the large majority of liquidations take place on a Friday and asked if that practice will continue.

    CBP Response: CBP has designed the functionality so that entries that are set for auto-liquidation, that is, liquidations that occur on the standard 314-day cycle without CBP intervention will continue to be made on Fridays. However, for manual liquidations where CBP action is required, liquidations will generally post to the Web site within 90 minutes after CBP processes the liquidation.

    Comment: Two commenters suggested that the 15-month timeline for maintaining liquidation information on the CBP Web site should be stated in the regulations.

    CBP Response: CBP agrees that adding this language to the regulations will be beneficial. Accordingly, CBP has added language to §§ 159.9(c)(1), 159.12(b), and 159.12(c) stating that notices of liquidation, extension, and suspension, respectively, will be maintained on the CBP Web site for a minimum of 15 months.

    Comment: One commenter requested that CBP place in the regulations the process for requesting access to notices that are no longer available on the Web site beyond the 15-month timeline.

    CBP Response: CBP disagrees that this process needs to be included in the regulations. Guidance will be provided in the Automated Commercial Environment (ACE) Business Rules Process Document, which can be updated in a quicker manner than the regulations should a more efficient process for obtaining historical information be developed. When the information is no longer available on the CBP Web site, a request may be made to CBP for historical information by contacting the filer's assigned client representative or by contacting the appropriate port or Center of Excellence and Expertise directly. Additionally, ACE account holders may run queries to obtain the historical information without having to contact CBP.

    Comment: One commenter stated that CBP has the ability to post notices regarding liquidations by operation of law immediately when they occur in the electronic environment rather than “within a reasonable period” after each liquidation by operation of law. Another commenter asked that CBP post notice of liquidation by operation of law within 14 days of the liquidation.

    CBP Response: CBP disagrees that it has the ability to post this information immediately upon occurrence because in many situations, CBP is unaware of the liquidation by operation of law for some time after it has occurred. However, the commenters validly pointed out that the electronic environment enables CBP to post notice without delay. Accordingly, based on these comments, CBP has amended the regulation at 19 CFR 159.9(c)(2)(i) to state that CBP will post this information when it has determined that an entry has liquidated by operation of law, and has removed the phrase regarding posting within a reasonable time period.

    Comment: One commenter asked if the term “filer” was the filer code or the name of the importer of record and noted that both the filer code and the importer of record should be included with the information posted on the CBP Web site.

    CBP Response: The term “filer” is not referencing the filer code or importer of record number but is instead referring to the party transmitting entry/entry summary data to CBP. The filer code is a searchable data element and will be displayed in the search results. However, as stated in the notice of proposed rulemaking, when the results of a search are viewed, the CBP Web site will not display the importer of record numbers.

    Comment: One commenter asked if people in one location may search the notices for another location and used the example of being in Miami and searching notices from Long Beach.

    CBP Response: Because information will be posted on the CBP Web site, all notices of liquidation throughout the country will be available to view and search regardless of the physical location of the searcher.

    Comment: One commenter asked that the liquidation information remain on the CBP Web site indefinitely until historical information is available to sureties through the ACE portal, so that the surety can generate search results easily for its own list of entries. This commenter also requested that “Surety Code” be added to the list of data elements.

    CBP Response: As stated elsewhere in the document, the liquidation information will be maintained on the CBP Web site for a minimum of 15 months. Regarding sureties, CBP has provided for surety code to be a searchable data element.

    Comment: One commenter asked that the surety on an entry be included in 19 CFR 159.9(d) as a party to receive courtesy notices of liquidation.

    CBP Response: A surety on an entry is able to receive courtesy notice if it is set up in ACE to receive courtesy notices of liquidation. However, based on this comment, CBP has amended the regulation at 19 CFR 159.9(d) to state that courtesy notices of the extension will be sent to the entry filer or its agent and the surety on an entry.

    Comment: One commenter asked that the filer and the surety be included as a recipient of courtesy notices of extension of liquidation in 19 CFR 159.12(d)(2) in order to maintain consistency with 19 CFR 159.12(b) and (c) regarding whom the regulations identify as parties receiving courtesy notices.

    CBP Response: CBP agrees that the regulations should each be consistent in this regard. Accordingly, based on this comment, CBP has amended the regulation at 19 CFR 159.12(b), (c), and (d)(2), to state that courtesy notices of the extension will be sent to the entry filer or its agent and the surety on an entry through a CBP-authorized electronic data interchange.

    Conclusion

    Accordingly, after review of the comments and further consideration, CBP has decided to adopt as final, with the changes discussed above, the proposed rule published in the Federal Register (81 FR 71019) on October 14, 2016. Specifically, the final rule contains the following changes based on the comments:

    —Clarification in § 159.9(c)(1), which pertains to the date of liquidation, that notices of liquidation will be maintained on www.cbp.gov for a minimum of 15 months. —Clarification in § 159.9(c)(2)(i), which pertains to entries liquidated by operation of law, that notice of such will be posted when CBP determines that an entry has liquidated by operation of law. —Clarification in § 159.9(c)(2)(ii) by making editorial changes for ease of reading. —Clarification in § 159.9(d), which pertains to courtesy notice of liquidation, that CBP will endeavor to provide courtesy notice to the entry filer or its agent and the surety on an entry. —Clarification in § 159.12(b), which pertains to notices of extension, that notices of extension will be maintained on www.cbp.gov for a minimum of 15 months and that courtesy notice will be sent to the entry filer or its agent and the surety on an entry. —Clarification in § 159.12(c), which pertains to notices of suspension, that notices of suspension will be maintained on www.cbp.gov for a minimum of 15 months and that courtesy notice will be sent to the entry filer or its agent and the surety on an entry. —Clarification in § 159.12(d)(2), which pertains to additional extensions at the importer's request, that courtesy notice will be sent to the entry filer or its agent and the surety on an entry. Executive Orders 13563 and 12866

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

    Regulatory Flexibility Act

    This section examines the impact of this rule on small entities per the requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996. The Regulatory Flexibility Act (5 U.S.C. 601 et seq.), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, requires agencies to assess the impact of regulations on small entities. A small entity may be a small business (defined as any independently owned and operated business not dominant in its field that qualifies as a small business per the Small Business Act); a small not-for-profit organization; or a small governmental jurisdiction (locality with fewer than 50,000 people).

    Background

    Most goods imported into the United States are subject to duty assessments, which CBP conducts during a process known as liquidation. During this liquidation process, CBP performs a final computation of duties (not including vessel repair duties) on the entry covering the imported merchandise and then closes out the entry. In accordance with current regulations, CBP officially notifies importers,1 as well as the public, of a formal entry's liquidation by posting a weekly bulletin notice of liquidation in a readily-located and consulted place in the customhouse or station at each port of entry.2 These notices are generally available for importers and the public to peruse for a few weeks before they are placed in CBP storage. CBP provides the same official notice of liquidation for informal entries where a duty cannot be determined at the time of entry and for reliquidated dutiable entries.3 For other informal, mail, and baggage entries, CBP furnishes official notice of liquidation to an importer (and its surety when required) by a suitable printed statement appearing on the receipt issued for duties collected, by release of the merchandise under a free entry, or by acceptance of the free entry after release under a special permit for immediate delivery.4 Once CBP provides official notice of liquidation or reliquidation, importers generally have 180 days to file a protest challenging certain aspects of their entry's liquidation.5 In addition to these official notices, CBP endeavors to provide importers (and their sureties) informal, courtesy notices of liquidation and reliquidation for entries scheduled to be liquidated or deemed liquidated by operation of law. For the majority of importers filing entries, who actually file electronically, CBP generally sends these filers (and their sureties) courtesy notices of liquidation and reliquidation via a CBP-authorized electronic data interchange system before the official notice (and protest period's start date). For the small portion of importers who file entries by paper, CBP typically mails paper courtesy notices of liquidation and reliquidation using CBP Form 4333-A to these filers on or around the date of the official notice's posting. These courtesy notices are not direct, formal, and decisive notices of liquidation or reliquidation; however, based on anecdotal evidence, most importers rely on these courtesy notices to determine liquidations and reliquidations to avoid the time and resource costs incurred to view official bulletin notices at U.S. customhouses or stations.

    1 For the purposes of this analysis, “importers” can also refer to agents, such as brokers, who act on behalf of importers.

    2See 19 CFR 159.9(b).

    3See 19 CFR 159.10.

    4See 19 CFR 159.10.

    5 For entries filed before December 18, 2004, the time limit is within 90 days after liquidation, but for entries filed on or after that date, it is now 180 days (see CFR part 174; see 19 U.S.C. 1514(c)(3) as amended by section 2103(2)(B), Pub. L. 108-429).

    Some liquidations may be extended or suspended. If liquidation is extended or suspended, CBP officially notifies the importer and its surety by mail using CBP Form 4333-A, as appropriately modified.6 CBP also provides importers who file entries electronically and their sureties with electronic courtesy notices of extension and suspension, which are generally sent in advance of mailed notifications. Although these courtesy notices are not direct, formal, and decisive notices of extension or suspension, CBP believes that most importers (and all sureties) rely on them to determine extensions and suspensions because importers receive them before the official notice and they contain the same information. Importers who file entries by paper do not receive electronic or paper courtesy notices of extension and suspension.

    6See 19 CFR 159.12.

    In an effort to modernize the liquidation, reliquidation, extension, and suspension notification processes, CBP, through this rulemaking, will discontinue physically posting official bulletin notices of liquidation and reliquidation at U.S. port of entry customhouses and stations. Instead, CBP will post these official notices in a readily-located, conspicuous place on the CBP Web site: www.cbp.gov. Additionally through this rule, CBP will begin posting electronically on www.cbp.gov official notices of extension and suspension that are currently mailed. CBP will tie all electronic notices directly to an already-developed, automated process by which entries are liquidated, reliquidated, extended, or suspended, ensuring that these actions and CBP's official notifications of these actions occur almost simultaneously. This rule will not change the method in which CBP provides electronic courtesy notices of liquidation, reliquidation, extension, or suspension, but it will discontinue the practice of mailing any paper notices. For other informal, mail, and baggage entries, CBP will continue to furnish official notices of liquidation and reliquidation to importers (and their sureties when required) by a suitable printed statement appearing on the receipt issued for duties collected, by release of the merchandise under a free entry, or by acceptance of the free entry after release under a special permit for immediate delivery. As described next, these regulatory changes will introduce benefits and costs to importers, including small entities.

    For most importers (and their sureties), this rule will simply change the way in which they can access official notices of liquidation, reliquidation, extension, and suspension. Instead of posting weekly official bulletin notices of liquidation and reliquidation at each U.S. customhouse and station and mailing official notices of extension and suspension, CBP will publish these notices on the CBP Web site once this rule is in effect. CBP will also discontinue mailing all paper courtesy notices of liquidation and reliquidation with this rule. Because the vast majority of importers (and all their sureties) already rely on the electronic courtesy notices of liquidation, reliquidation, extension, and suspension that CBP provides, this rule's transition to electronic official notice publications will presumably only affect a small portion of importers. Specifically, this transition to electronic notice publications will only affect those importers who currently rely on official bulletin notices physically posted at U.S. customhouses and stations and those importers who receive and rely on paper courtesy notifications of liquidation and reliquidation and paper official notices of extension and suspension due to their paper entry filings.

    Number of Small Entities Affected by Rule

    Using historical data, CBP estimates that importers took an average of 2,500 trips to U.S. customhouses or stations each year for the single purpose of viewing official bulletin notices because the official bulletin notice's posting date was significant to a protest that importer planned to file.7 CBP also estimates that CBP mailed an average of 23,500 paper courtesy notices of liquidation and reliquidation and 3,100 paper notices of extension and suspension each year to importers who filed paper entries.8 Considering this historical data, CBP estimates that this rule could affect up to approximately 29,100 importers per year. To the extent that the same importer took more than one trip to the U.S. customhouse or station to view an official bulletin notice or received and relied on more than one paper notice, the number of importers affected by this rule will be lower. Nonetheless, because the majority of importers are small businesses, CBP believes this rule will affect a substantial number of small entities.

    7 Based on the 2,500 Applications for Further Review (AFRs) filed with protests in 2015. Importers or their attorneys who file AFRs depend on the exact dates of liquidation or reliquidation to file a timely protest, and thus likely travel to a U.S. customhouse or station to physically view official bulletin notices with the official dates of liquidation and reliquidation. Using the 2015 AFR filings as a proxy for trips taken to view official bulletin notices, CBP estimates that importers or their attorneys took 2,500 trips to U.S. customhouses or stations each year for the single purpose of viewing official bulletin notices. Sources: 19 CFR 174.12(e) and email correspondence with CBP's Office of Trade on July 15, 2016.

    8 Based on data received through email correspondence with CBP's Office of Trade on May 26, 2016; June 22-24, 2016; August 29, 2016; and September 21, 2016.

    Impacts of Rule on Small Entities

    This rule's transition to fully electronic notices will require the estimated 29,100 importers who currently rely on official bulletin notices physically posted at U.S. customhouses and stations and those who rely on paper notices of liquidation, reliquidation, extension, and suspension to visit the CBP Web site to determine entry liquidations, reliquidations, extensions, and suspensions.9 To view this rule's official bulletin notices on the CBP Web site, CBP assumes that these importers will spend an added 4 minutes (0.0667 hours) 10 navigating the CBP Web site to find a liquidation, reliquidation, extension, or suspension notice, at a time cost of $2.01 based on the assumed hourly wage rate for importers.11 Most affected importers will presumably visit the CBP Web site once per year to view an entry's official notice of liquidation, reliquidation, extension, or suspension, for a total cost of $2.01 per year.12 However, some affected importers, such as those who receive extension and suspension notices that are in effect for an unknown amount of time, could visit the CBP Web site more than once per year for an entry, incurring the access cost of $2.01 each time they visit the CBP Web site. Even if an importer accesses the CBP Web site twice a month for an entry, or 24 times per year, it will incur only a $48.24 cost to do so. The average value per entry was $69,300 in FY 2015.13 The range of annual importer costs for this rule ($2.01 to $48.24) amounts to between 0.003 percent and 0.07 percent of this average entry value. Likewise, if an importer processes multiple entries per year, its total costs from this rule will be higher but the value of its entries will also be higher, meaning that the average cost to the importer will be between 0.003 percent and 0.07 percent of the entry value regardless of the number of entries the importer files per year. CBP does not consider this to be a significant economic impact.

    9 Importers could set up an Automated Commercial Environment (ACE) account to receive electronic courtesy notices of liquidation, reliquidation, extension, and suspension, but the time cost to do so is likely longer than the time it takes to view official notices on the CBP Web site. As such, CBP assumes that importers who receive and rely on paper notices of liquidation, reliquidation, extension, and suspension now will visit the CBP Web site for official notice rather than set up an ACE account to receive electronic courtesy notices once this rule is effective.

    10 The 4-minute added time burden represents the incremental change in the time burden over the current paper notification process. Source: Email correspondence with CBP's Office of Trade on April 26, 2016.

    11 The time cost estimate is equal to the assumed hourly wage for importers ($30.09) multiplied by the hourly time burden for a trade member to navigate the CBP Web site to find a liquidation, reliquidation, extension, or suspension notice (0.0667 hours), and then rounded. CBP bases the $30.09 hourly wage rate for importers on the Bureau of Labor Statistics' (BLS) 2015 median hourly wage rate for Cargo and Freight Agents ($20.13), which CBP assumes best represents the wage for importers, by the ratio of BLS' average 2015 total compensation to wages and salaries for Office and Administrative Support occupations (1.4799), the assumed occupational group for importers, to account for non-salary employee benefits. CBP then adjusted this figure, which was in 2015 U.S. dollars, to 2016 U.S. dollars by applying a 1.0 percent annual growth rate to the figure, as recommended by the U.S. Department of Transportation's value of travel time guidance. Source of median wage rate: U.S. Bureau of Labor Statistics. Occupational Employment Statistics, “May 2015 National Occupational Employment and Wage Estimates, United States—Median Hourly Wage by Occupation Code: 43-5011.” Updated March 30, 2016. Available at http://www.bls.gov/oes/2015/may/oes435011.htm. Accessed June 1, 2016.

    The total compensation to wages and salaries ratio is equal to the calculated average of the 2015 quarterly estimates (shown under Mar., June, Sep., Dec.) of the total compensation cost per hour worked for Office and Administrative Support occupations ($24.9475) divided by the calculated average of the 2015 quarterly estimates (shown under Mar., June, Sep., Dec.) of wages and salaries cost per hour worked for the same occupation category ($16.8575). Source of total compensation to wages and salaries ratio data: U.S. Bureau of Labor Statistics. Employer Costs for Employee Compensation. Employer Costs for Employee Compensation Historical Listing March 2004-March 2016, “Table 3. Civilian workers, by occupational group: employer costs per hours worked for employee compensation and costs as a percentage of total compensation, 2004-2016 by Respondent Type: Office and administrative support occupations.” June 9, 2016. Available at http://www.bls.gov/ncs/ect/sp/ececqrtn.pdf. Accessed June 14, 2016.

    Source of suggested growth rate: U.S. Department of Transportation, Office of Transportation Policy. The Value of Travel Time Savings: Departmental Guidance for Conducting Economic Evaluations Revision 2 (2015 Update), “Table 4 (Revision 2—corrected): Recommended Hourly Values of Travel Time Savings.” April 29, 2015. http://www.transportation.gov/sites/dot.gov/files/docs/Revised%20Departmental%20Guidance%20on%20Valuation%20of%20Travel%20Time%20in%20Economic%20Analysis.pdf. Accessed June 1, 2016.

    12 Importers will likely access the CBP Web site once a year to determine whether CBP has officially liquidated, reliquidated, extended, or suspended their entry. If CBP liquidates or reliquidates an entry, which will be the case for the importers who currently take 2,500 trips to U.S. customhouses or stations to view official bulletin notices and who receive 23,500 paper courtesy notices of liquidation and reliquidation annually, the importer will likely not have to access the CBP Web site again after the initial Web site visit to determine the entry's liquidation status. However, in a small number of cases, an importer may have to access the Web site more than once per year, over the course of more than one year to determine its entry's reliquidation status. If CBP extends or suspends an entry, which will be the case for the importers who receive 3,100 paper notices of extension and suspension annually, the importer may have to access the CBP Web site more than once per year, over the course of more than one year to determine the status of its entry's extension or suspension. However, considering the typical timeframes of extensions and suspensions, importers are most likely to access the CBP Web site only once per year for information on their entry's extension or suspension. Moreover, importers will likely receive information from CBP indicating whether CBP has reliquidated their entry or their extension or suspension has ended.

    13 Based on fiscal year 2015 U.S. entry and import value data. Source of entry data: U.S. Customs and Border Protection. Summary of Performance and Financial Information Fiscal Year 2015. May 2016. Available at https://www.cbp.gov/sites/default/files/assets/documents/2016-May/summary-performance-financial-info-2015.pdf. Accessed September 22, 2016. Source of import value data: U.S. Census Bureau. FT920: U.S. Merchandise Trade Selected Highlights—October 2014 through September 2015 Releases, “Exhibit 3: U.S. Imports—U.S. Customs District of Entry—Total General Customs Value by Month.” December 5, 2014-November 4, 2015. Available at https://www.census.gov/foreign-trade/Press-Release/ft920_index.html. Accessed September 22, 2016.

    Along with the minor Web site access cost imposed by this rule, this rule will provide benefits to importers who currently rely on official bulletin notices physically posted at U.S. customhouses and stations. This rule's electronic publication of official bulletin notices of liquidation and reliquidation will allow these importers to avoid visiting U.S. customhouses and stations for formal entry liquidation and reliquidation information, which typically occur 2,500 times a year. For each trip to a U.S. customhouse or station avoided, importers will save an estimated 45 minutes (0.75 hours), which will result in a time cost saving of $22.57 using the average hourly wage for importers of $30.09.14 Importers will also save $16.20 in travel costs per trip based on the estimated distance they sustain from traveling to and from a U.S. customhouse or station—30 miles—and the IRS's $0.54 standard mileage rate for business purposes.15 To the extent that some trips are taken for multiple purposes, not just for viewing an official bulletin notice of liquidation or reliquidation, fewer costs will be avoided and the benefits of this rule per trip will be lower.

    14 The time cost estimate is equal to the assumed hourly wage for importers ($30.09) multiplied by the estimated hourly time burden for a trade member to travel to and from a U.S. customhouse or station (0.75 hours), and then rounded.

    15 Source of miles traveled: Based on estimates from CBP's Office of Trade on May 2, 2016. Source of mileage rate: Internal Revenue Service. 2016 Standard Mileage Rates for Business, Medical and Moving Announced. IR-2015-137, December 17, 2015. Available at https://www.irs.gov/uac/Newsroom/2016-Standard-Mileage-Rates-for-Business-Medical-and-Moving-Announced. Accessed April 19, 2016.

    The electronic bulletin notices introduced with this rule will also provide benefits of eased access, relatively quicker notification, and extended viewing to importers. In particular, this electronic transition will allow importers to easily view and query a complete, consolidated list of U.S. entry liquidations, reliquidations, extensions, and suspensions, thus facilitating the process by which these individuals obtain such entry information. For importers who typically rely on paper courtesy notices for liquidation and reliquidation information, which they receive by mail after the official notice's posting, this electronic posting will provide the added benefit of more timely notice and additional protest time. Importers who receive and rely on paper courtesy notices will also benefit from this rule's consolidated electronic notice posting. This change will allow importers and their agents to view liquidation, reliquidation, extension, and suspension notices simultaneously instead of individually as they currently do through paper notices. Furthermore, importers will have at least 14 more months to view official liquidation, reliquidation, extension, and suspension notices before having to request access to the notices through CBP.

    Conclusion

    Although CBP believes that this rule will affect a substantial number of small entities, specifically importers, CBP believes that the (negative) economic impact of this rule on small entities will not be significant. Accordingly, CBP certifies that this regulation will not have a significant economic impact on a substantial number of small entities. CBP received no public comments on the Electronic Notice of Liquidation Notice of Proposed Rulemaking challenging this certification.

    Paperwork Reduction Act

    As there is no collection of information proposed in this document, the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) are inapplicable.

    Signing Authority

    This document is being issued in accordance with § 0.1(a)(1) of the CBP Regulations (19 CFR 0.1(a)(1)) pertaining to the authority of the Secretary of the Treasury (or his/her delegate) to approve regulations related to certain customs revenue functions.

    List of Subjects 19 CFR Part 159

    Antidumping, Countervailing duties, Customs duties and inspection, Foreign currencies.

    19 CFR Part 173

    Administrative practice and procedure, Customs duties and inspection.

    Amendments to the CBP Regulations

    For the reasons given above, parts 159 and 173 of title 19 of the Code of Federal Regulations (19 CFR parts 159 and 173) are amended as set forth below:

    PART 159—LIQUIDATION OF DUTIES 1. The general authority citation for part 159 continues to read as follows: Authority:

    19 U.S.C. 66, 1500, 1504, 1624.

    2. Section 159.9 is revised to read as follows:
    § 159.9 Notice of liquidation and date of liquidation for formal entries.

    (a) Notice of liquidation. Notice of liquidation of formal entries will be provided on CBP's public Web site, www.cbp.gov.

    (b) Posting of notice. The notice of liquidation will be posted for the information of importers in a conspicuous place on www.cbp.gov in such a manner that it can readily be located and consulted by all interested persons.

    (c) Date of liquidation—(1) Generally. The notice of liquidation will be dated with the date it is posted electronically on www.cbp.gov for the information of importers. This electronic posting will be deemed the legal evidence of liquidation. The notice of liquidation will be maintained on www.cbp.gov for a minimum of 15 months from the date of posting.

    (2) Exception: Entries liquidated by operation of law. (i) Entries liquidated by operation of law at the expiration of the time limitations prescribed in section 504, Tariff Act of 1930, as amended (19 U.S.C. 1504), and set out in §§ 159.11 and 159.12, will be deemed liquidated as of the date of expiration of the appropriate statutory period and will be posted on www.cbp.gov when CBP determines that each entry has liquidated by operation of law and will be dated with the date of liquidation by operation of law.

    (ii) For liquidation notices that were posted or lodged in the customhouse, pursuant to section 514, Tariff Act of 1930, as amended (19 U.S.C. 1514) and part 174 of this chapter, a protest of a decision relating to an entry made before December 18, 2004, must be filed within 90 days from the date of liquidation of an entry by operation of law or within 90 days from the date the bulletin notice thereof was posted or lodged in the customhouse, or, in the case of a protest of a decision relating to an entry made on or after December 18, 2004, within 180 days from the date of liquidation of an entry by operation of law.

    (iii) For liquidation notices posted on www.cbp.gov, pursuant to section 514, Tariff Act of 1930, as amended (19 U.S.C. 1514) and part 174 of this chapter, a protest of a decision relating to an entry made before December 18, 2004, must be filed within 90 days from the date of liquidation of an entry by operation of law or within 90 days from the date notice thereof is posted on www.cbp.gov, or, in the case of a protest of a decision relating to an entry made on or after December 18, 2004, within 180 days from the date of liquidation of an entry by operation of law.

    (d) Courtesy notice of liquidation. CBP will endeavor to provide the entry filer or its agent and the surety on an entry with a courtesy notice of liquidation for all electronically filed entries liquidated by CBP or deemed liquidated by operation of law. The courtesy notice of liquidation that CBP will endeavor to provide will be electronically transmitted pursuant to a CBP authorized electronic data interchange system if the entry was filed electronically in accordance with part 143 of this chapter. This notice will serve as an informal, courtesy notice and not as a direct, formal, and decisive notice of liquidation.

    § 159.10 [Amended]
    3. Section 159.10 is amended as follows: a. By removing the words “posting or lodging of” from the last sentence in paragraph (b); b. By removing the words “on CBP Form 4333 posted or lodged” from the last sentence of paragraph (c)(1); and c. By removing the words “on a bulletin notice of liquidation, CBP Form 4333,” from the last sentence of paragraph (c)(3). 4. In § 159.11, paragraph (a) is revised to read as follows:
    § 159.11 Entries liquidated by operation of law.

    (a) Time limit generally. Except as provided in § 159.12, an entry not liquidated within one year from the date of entry of the merchandise, or the date of final withdrawal of all merchandise covered by a warehouse entry, will be deemed liquidated by operation of law at the rate of duty, value, quantity, and amount of duties asserted by the importer of record. Notice of liquidation will be given electronically as provided in §§ 159.9 and 159.10(c)(3) of this part. CBP will endeavor to provide a courtesy notice of liquidation in accordance with § 159.9(d).

    5. In § 159.12, revise paragraphs (b), (c), (d)(2), and (f) and remove paragraph (g).

    The revisions read as follows:

    § 159.12 Extension of time for liquidation.

    (b) Notice of extension. If the port director extends the time for liquidation, as provided in paragraph (a)(1) of this section, the official notice of extension and reasons therefor will be posted on www.cbp.gov. The notice of extension will be maintained on www.cbp.gov for a minimum of 15 months from the date of posting. The port director will also endeavor to transmit a courtesy notice of extension to the entry filer or its agent and the surety on an entry through a CBP-authorized electronic data interchange system.

    (c) Notice of suspension. If the liquidation of an entry is suspended as required by statute or court order, as provided in paragraph (a)(2) of this section, the official notice of suspension will be posted on www.cbp.gov. The notice of suspension will be maintained on www.cbp.gov for a minimum of 15 months from the date of posting. The port director will also endeavor to transmit a courtesy notice of suspension to the entry filer or its agent and the surety on an entry through a CBP-authorized electronic data interchange system.

    (d) * * *

    (2) At importer's request. If the statutory period has been extended for one year at the importer's request, and the importer thereafter determines that additional time is necessary, it may request another extension in writing before the original extension expires, giving reasons for its request. If the port director finds that good cause (as defined in paragraph (a)(1)(ii) of this section) exists, the official notice of extension extending the time for liquidation for an additional period not to exceed one year will be posted on www.cbp.gov, and CBP will provide courtesy notice of the extension to the entry filer or its agent and the surety on an entry through a CBP-authorized electronic data interchange system.

    (f) Time limitation. An entry not liquidated within four years from either the date of entry, or the date of final withdrawal of all the merchandise covered by a warehouse entry, will be deemed liquidated by operation of law at the rate of duty, value, quantity, and amount of duty asserted by the importer of record, unless liquidation continues to be suspended by statute or court order. CBP will endeavor to provide a courtesy notice of liquidation, in accordance with § 159.9(d), in addition to the notice specified in § 159.9(c)(2)(i).

    PART 173—ADMINISTRATIVE REVIEW IN GENERAL 6. The general authority citation for part 173 continues to read as follows: Authority:

    19 U.S.C. 66, 1501, 1520, 1624.

    7. Revise § 173.4a to read as follows:
    § 173.4a Refund of excess duties, fees, charges, or exaction paid prior to liquidation.

    Pursuant to section 520(a)(4), Tariff Act of 1930, as amended (19 U.S.C. 1520(a)(4)), whenever an importer of record declares or it is ascertained that excess duties, fees, charges, or exactions have been deposited or paid, the port director may, prior to liquidation of an entry or reconciliation, take appropriate action to refund the deposit or payment of excess duties, fees, charges, or exactions.

    R. Gil Kerlikowske, Commissioner, U.S. Customs and Border Protection. Approved: December 6, 2016. Timothy E. Skud, Deputy Assistant Secretary of the Treasury.
    [FR Doc. 2016-29656 Filed 12-9-16; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Parts 91 and 92 [Docket No. FR-5792-C-02] RIN 2501-AD69 Changes to HOME Investment Partnerships (HOME) Program Commitment Requirement; Correction AGENCY:

    Office of General Counsel, HUD.

    ACTION:

    Interim final rule; correction.

    SUMMARY:

    On December 2, 2016, HUD published an interim final rule that changes the commitment requirement of the HOME Investment Partnerships (HOME) Program. After publication, HUD discovered that the effective dates and comment due dates were inadvertently reversed. This document corrects the preamble to reflect a 30-day effective date and a 60-day comment period.

    DATES:

    Effective Date: The corrected effective date for HUD's interim rule published on December 2, 2016 (81 FR 86947), is January 3, 2017.

    FOR FURTHER INFORMATION CONTACT:

    With respect to this supplementary document, contact Ariel Pereira, Associate General Counsel for Legislation and Regulations, Department of Housing and Urban Development, 451 7th Street SW., Room 10238, Washington, DC 20410; telephone number 202-708-1793 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number via TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).

    SUPPLEMENTARY INFORMATION:

    In the interim final rule FR Doc. 2016-28591, published on December 2, 2016, the following correction is made:

    On page 86947, in the first column, correct the DATES section to read as follows:

    Dates: Effective Date: January 3, 2017.

    Comment Due Date: January 31, 2017.

    Dated: December 6, 2016. Aaron Santa Anna, Assistant General Counsel for Regulations.
    [FR Doc. 2016-29643 Filed 12-9-16; 8:45 am] BILLING CODE 4210-67-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-1037] Drawbridge Operation Regulation; Connecticut River, East Haddam, CT AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Route 82 Bridge across the Connecticut River, mile 16.8, at East Haddam, Connecticut. This deviation is necessary to allow the bridge owner to perform emergency repairs at the bridge. This deviation allows the bridge to be opened with a 15 minute advance notice during the hours of 7 a.m. through 5 p.m. on December 20, 2016 and December 27, 2016.

    DATES:

    This deviation is effective from 7 a.m. on December 20, 2016 to 5 p.m. on December 27, 2016.

    ADDRESSES:

    The docket for this deviation, [USCG-2016-1037] is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email Judy Leung-Yee, Project Officer, First Coast Guard District, telephone (212) 514-4330, email [email protected]

    SUPPLEMENTARY INFORMATION:

    The Route 82 Bridge, mile 16.8, across the Connecticut River, has a vertical clearance in the closed position of 22 feet at mean high water and 25 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.205(c).

    The waterway is transited by seasonal recreational traffic and some commercial barge traffic of various sizes.

    The bridge owner, Connecticut Department of Transportation, requested a temporary deviation from the normal operating schedule to perform emergency repairs at the bridge.

    Under this temporary deviation, the Route 82 Bridge shall open on signal on December 20, 2016 between 7 a.m. and 5 p.m. and on December 27, 2016 between 7 a.m. and 5 p.m. if at least 15 minutes advance notice is given by calling the number posted at the bridge.

    Vessels able to pass under the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.

    The Coast Guard will inform the users of the waterways through our Local Notice and Broadcast to Mariners of the change in operating schedule for the bridge so that vessel operations can arrange their transits to minimize any impact caused by the temporary deviation.

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

    Dated: December 7, 2016. C.J. Bisignano, Supervisory Bridge Management Specialist, First Coast Guard District.
    [FR Doc. 2016-29732 Filed 12-9-16; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF COMMERCE Patent and Trademark Office 37 CFR Part 2 [Docket No. PTO-T-2016-0053] RIN 0651-AD13 Miscellaneous Changes to Trademark Trial and Appeal Board Rules of Practice; Correction AGENCY:

    United States Patent and Trademark Office, Commerce.

    ACTION:

    Final rule; correction.

    SUMMARY:

    The United States Patent and Trademark Office published in the Federal Register on October 7, 2016 a final rule, which will become effective on January 14, 2017, revising the Rules of Practice before the Trademark Trial and Appeal Board. This document corrects errors in certain cross-references, clarifies the manner of testimony taken in a foreign country and the process in depositions upon written questions, and reincorporates the time frames for cross appeals and cross actions in that rule.

    DATES:

    This rule is effective January 14, 2017, and applies to all proceedings pending on or after the effective date.

    FOR FURTHER INFORMATION CONTACT:

    Cheryl Butler, Trademark Trial and Appeal Board, by email at [email protected], or by telephone at (571) 272-4259.

    SUPPLEMENTARY INFORMATION:

    The USPTO issues this final rule to correct inadvertent errors in certain cross-references in §§ 2.124(f) and 2.126(c), to clarify the manner of testimony taken in a foreign country in § 2.123(a)(2), to clearly incorporate cross-examination in the process of depositions upon written questions in § 2.124(d)(1), and to reincorporate explicit timing requirements for cross-appeals and cross-actions in § 2.145(d)(1) and (3) of its October 7, 2016 final rule revising the Trademark Trial and Appeal Board Rules of Practice. (81 FR 69950) (published under RIN 0651-AC35).

    The first sentence of § 2.123(a)(2) is clarified to separate motions to take depositions upon written questions by oral examination from testimony by affidavit or declaration. To implement this clarification, the phrase “A testimonial deposition” is replaced with “Testimony” and the clause “by affidavit or declaration, subject to the right of any adverse party to elect to take and bear the expense of cross-examination by written questions of that witness” is moved to clearly delineate it.

    The first sentence of § 2.124(d)(1) should cross reference paragraphs (b)(1) and (2) rather than only (b). A paragraph was added to § 2.124(b) which operated to renumber that section, and the cross reference was not updated. In addition, in the first, third and sixth sentences, further clarification was needed to clearly incorporate the timing for cross-examination upon written questions of testimony by affidavit or declaration.

    The second sentence of § 2.124(f) should cross reference § 2.125(c) rather than § 2.125(b). A paragraph was added to § 2.125, which operated to renumber that section, and the cross reference was not updated.

    The first sentence of § 2.126(c) should cross reference § 2.125(f) rather than § 2.125(e). A paragraph was added to § 2.125, which operated to renumber that section, and the cross reference was not updated.

    The October 7, 2016 final rule amended the timing requirements for appeals and civil actions, but inadvertently omitted the timing requirement for cross-actions from § 2.145(d)(3). Therefore, this correction revises the last sentence in § 2.145(d)(3) to reincorporate the timing requirement for cross-actions. Also, this correction revises § 2.145(d)(1) concerning cross-appeals to have consistency between § 2.145(d)(3) and (d)(1).

    This correcting rule may be issued without prior notice and opportunity for comment as the corrections are nonsubstantive and being implemented to avoid inconsistencies and confusion with the rule issued on October 7, 2016. The USPTO corrects the errors as discussed below.

    In FR Doc. 2016-23092, published on October 7, 2016 (81 FR 69950), make the following corrections:

    § 2.123 [Corrected]
    1. On page 69981, column 2, in paragraph (a)(2) of § 2.123, the first sentence is corrected to read “Testimony taken in a foreign country shall be taken: by deposition upon written questions as provided by § 2.124, unless the Board, upon motion for good cause, orders that the deposition be taken by oral examination, or the parties so stipulate; or by affidavit or declaration, subject to the right of any adverse party to elect to take and bear the expense of cross-examination by written questions of that witness.”
    § 2.124 [Corrected]
    2. On page 69982, column 3, in paragraph (d)(1) of § 2.124: i. The cross reference to “paragraph (b)” is corrected to read “paragraphs (b)(1) and (2)”; ii. The term “direct testimony” is corrected to read “direct examination” in both instances; iii. In the third sentence the phrase “or service of a testimony affidavit or declaration,” is added before the phrase “any adverse party may serve cross questions upon the party who proposes to take the deposition”; and iv. In the sixth sentence the phrase “or who earlier offered testimony of the witness by affidavit or declaration” is added after the phrase “any party who served cross questions may serve recross questions upon the party who proposes to take the deposition”. 3. On page 69983, column 1, in paragraph (f) of § 2.124, the cross reference to “§ 2.125(b)” is corrected to read “§ 2.125(c)”.
    § 2.126 [Corrected]
    4. On page 69983, column 3, in paragraph (c) of § 2.126, the cross reference to “§ 2.125(e)” is corrected to read “§ 2.125(f)”.
    § 2.145 [Corrected]
    5. On page 69987, column 2, in paragraph (d)(1) of § 2.145, the last sentence is removed and added in its place is “In inter partes cases, the time for filing a notice of cross-appeal expires 14 days after service of the notice of appeal or 63 days from the date of the decision of the Trademark Trial and Appeal Board or the Director, whichever is later.” 6. On page 69987, column 2, in paragraph (d)(3) of § 2.145, this final sentence is added “In inter partes cases, the time for filing a cross-action expires 14 days after service of the summons and complaint or 63 days from the date of the decision of the Trademark Trial and Appeal Board or the Director, whichever is later.” Dated: December 6, 2016. Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office.
    [FR Doc. 2016-29728 Filed 12-9-16; 8:45 am] BILLING CODE 3510-16-P
    DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 17 RIN 2900-AP35 Tiered Pharmacy Copayments for Medications AGENCY:

    Department of Veterans Affairs.

    ACTION:

    Final rule.

    SUMMARY:

    The Department of Veterans Affairs (VA) adopts as a final rule, with changes, a proposal to amend its regulations concerning copayments charged to certain veterans for medication required on an outpatient basis to treat nonservice-connected conditions. Prior to this final rule, VA charged non-exempt veterans either $8 or $9 for each 30-day or less supply of medication, and that amount may have changed in future years. This rulemaking replaces those rates and establishes three classes of medications for copayment purposes, identified as Tier 1, Tier 2, and Tier 3. These tiers are defined further in the rulemaking and are distinguished in part based on whether the medications are available from multiple sources or a single source, with some exceptions. Copayment amounts are fixed and would vary depending upon the class of medication. The following medication copayment amounts are applicable on the effective date of this final rule: $5 for a 30-day or less supply of a Tier 1 medication, $8 for a 30-day or less supply of a Tier 2 medication, and $11 for a 30-day or less supply of a Tier 3 medication. For non-exempt veterans these copayment amounts will result in lower out-of-pocket costs, thereby encouraging greater adherence to taking prescribed medications and reducing the risk of fragmented care that results when veterans use non-VA pharmacies to fill their prescriptions. The proposed rule was published on January 5, 2016 and the public comment period closed on March 7, 2016. We received nine comments and respond to these comments here.

    DATES:

    Effective Date: This rule is effective on February 27, 2017.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    Under 38 U.S.C. 1722A(a), VA must require veterans to pay at least a $2 copayment for each 30-day supply of medication furnished on an outpatient basis for the treatment of a non-service-connected disability or condition, unless the veteran is exempt from having to pay a copayment because the veteran has a service-connected disability rated 50 percent or more, is a former prisoner of war, or has an annual income at or below the maximum annual rate of VA pension that would be payable if the veteran were eligible for pension. VA has the authority under 38 U.S.C. 1722A(b) to increase that copayment amount and establish a maximum annual copayment amount (a “cap”) through regulation. We have implemented this statute in 38 CFR 17.110. Both the copayment amount for certain priority groups, as well as an annual cap on those copayments, are addressed in 38 CFR 17.110(b).

    On January 5, 2016, we proposed a new medication copayment formula, in order to address longstanding concerns that the regulatory formula VA had been using was not competitive with non-VA retail copayment structures, lacked parity, may result in decreased medication adherence, and increased the likelihood of fragmented care due to price-shopping. 81 FR 196. The public comment period closed March 7, 2016, and we received nine comments, all of which were generally supportive. Several commenters expressed strong support for lowering the annual medication copayment amount. However, several commenters urged VA to make changes to different aspects of the proposed rule. The majority of the comments focused on the definition of multi-source medication. We address those comments, and make changes to the rulemaking as noted below.

    The new regulatory formula established by this rule focuses on the type of medication being prescribed and would remove the automatic escalator provision, meaning that changes in copayments would only occur through subsequent rulemakings. Veterans exempt by law from copayments under 38 U.S.C. 1722A(a)(3) continue to be exempt. This VA rulemaking includes a definition of “medication” and “multi-source medication.” We also establish three classes of medications for copayment purposes: Tier 1 medications, Tier 2 medications, and Tier 3 medications. Tiers 1 and 2 includes multi-source medications, a term that is defined in § 17.110(b)(1)(iv). Tier 3 includes medications that retain patent protection and exclusivity and are not multi-source medications. Copayment amounts vary depending upon the Tier in which the medication is classified. A 30-day or less supply of Tier 1 medications has a copayment of $5. For Tier 2 medications, the copayment is $8, and for Tier 3 medications, the copayment is $11. The rule also changes the annual cap for medication copayments, lowering the cap to $700 for all veterans who are required to pay medication copayments.

    On September 16, 2015, VA published a final rule maintaining, through December 31, 2016, medication copayment amounts at the 2014 rate for certain priority groups ($8 for veterans in priority groups 2-6 and $9 for veterans in priority groups 7 and 8). See 80 FR 55544. VA anticipated at that time that necessary information technology (IT) structure changes would be in place by December 31, 2016, allowing the current rulemaking to have an effective date of January 1, 2017. However, those changes will not be ready for a full roll-out until February 27, 2017. The effective date of this final rule is February 27, 2017. VA published a separate rulemaking that will extend the current copayment freeze until the effective date of the present rulemaking. The end result is that the higher annual copayment cap of $960 will be in effect through February 26, 2017, and the lower annual cap of $700 will apply the following day. We believe it is unlikely that a veteran will pay more than $700 in medication copayments during the short period of time before the lower annual cap goes into effect. However, in the event that any veteran exceeds the $700 cap in this final rule, before the rule takes effect, VA will refund the amount in excess of the $700 cap to the veteran.

    Definition of the Term “Medication”

    In paragraph (a) of proposed section 17.110, we proposed that for the purposes of this section, the term “medication” would mean prescription and over-the-counter medications as determined by FDA. One commenter noted that the term “medication” is not a regulatory term of art used by FDA and FDA does not determine whether an item is medication. The commenter stated that the rule should instead refer to the regulatory approval authorities for drugs and biologics, section 505 of the Food Drug and Cosmetic Act (FDCA) for drugs, and section 351 of the Public Health Service Act (PHSA) for biologics. The commenter stated that citing these authorities would clarify that the term “medication” does not include medical supplies, nutritional items, and devices.

    Section 505 of the FDCA is codified at 21 U.S.C. 355 (New drugs) and 355-1 (Risk evaluation and mitigation strategies). Citing the former would inappropriately limit the definition of “medication” to new drugs, and citing the latter would address only those instances where FDA determines that a risk evaluation and mitigation strategy is necessary to ensure that the benefits of a new drug outweigh the risks of the drug. While section 351 of the PHSA is applicable to the approval of all biologics, VA believes that it would be potentially confusing to the public if the rulemaking cited to statutory authority related to biologics but not for drugs. However, VA agrees with the commenter's concern that medical supplies and devices are not specifically excluded from the definition of “medication.” We have amended the definition accordingly to exclude medical supplies and devices. We also specifically excluded oral nutritional supplements from the definition of “medication” because they are exempt from copayments. Oral nutritional supplements are commercially prepared nutritionally enhanced products used to supplement the intake of individuals who cannot meet nutrient needs by diet alone.

    Definition of “Multi-Source Medication”: General Comments

    One commenter stated that the definition of multi-source medication in § 17.110(b)(2)(A) is inappropriately broad, misaligned with the conventional use and understanding of the term, risks public confusion, and poses a potential risk to patient safety. The commenter stated that the term is typically used to describe only those drugs that FDA has determined to be therapeutically equivalent (i.e., pharmaceutically equivalent and bioequivalent), and that FDA's definition is also consistent with Centers for Medicare and Medicaid Services' regulatory use of the term “multiple source” for purposes of the Medicare and Medicaid programs.

    Another commenter stated that the definition of “multi-source medication” “includes multiple categories of drugs defined separately under the Medicaid Drug Rebate Program in 42 U.S.C. 1396r-8(k)(7)(A) as `multiple source drug,' `innovator multiple source drug,' `non-innovator multiple source drug,' and `single source drug.'” The commenter asserts that VA's proposed definition of multi-source medication conflicts with these statutory definitions. Another commenter stated that the proposed definition of multi-source medication contributes to nonuniformity in federal regulations, noting that TRICARE regulations at 32 CFR 199.21(j) classify generic medications as multi-source products, and specifically define that term.

    In response to these commenters, we note that our definition of multi-source medication is intentionally broad to differentiate medication that would fall under Tiers 1 and 2 from those in Tier 3 in the regulation. We determined that the use of a single term to describe medications that do not retain patent protection and exclusivity is appropriate because veterans receiving care from VA, not drug manufacturers, are primarily affected by this rulemaking. VA considered several options on how to address the types of medications we include in the definition of multi-source medications in § 17.110(b)(1)(iv)(A). Our primary considerations were to ensure, first, that the types of medications were adequately defined and, second, that the rulemaking clearly states to which copayment tier each of these types of medications is assigned. It became evident during the drafting process that treating the types of medications currently described in § 17.110(b)(1)(iv)(A) as separately-defined terms was problematic, because adding multiple definitions could lead to confusion. VA believes that using a single term to refer to types of medication with a shared major characteristic is less confusing than referring to multiple separate definitions. The characteristic shared by each type of medication in current § 17.110(b)(1)(iv)(A) is that it is available from multiple sources. VA believes that using the term “multi-source medication” has a lower risk of confusing the public than does the use of separate terms like those suggested by the commenter. The various Medicaid definitions referred to by the commenters are necessary for administration of medication payments or reimbursement by Medicaid to states, retail or hospital pharmacies, other health care providers, and drug manufacturers. That degree of differentiation in definitions is unnecessary for tiered copayment purposes, and would lead to confusion in our veteran population. Likewise, adopting definitions of similar terms used by Medicaid would not be helpful to veterans, as the Medicaid definitions of terms were drafted to serve another purpose and were targeted to their specific audience. As one commenter stated, TRICARE regulations do classify generic drugs as multi-source products. However, as noted above, several classes of medications can properly be described as being multi-source. As the definition of multi-source medication in this rulemaking relates solely to determining whether a particular medication should be in one of three tiers for purposes of VA medication copayments, we do not anticipate that nonuniformity of VA and other agencies' terms will be a problem. We make no changes based on these comments.

    Two commenters stated that VA should clarify that the definition of “multi-source medication” applies only to VA's copayment structure in order to avoid confusion given the use of similar terminology in other federal regulations. We specify in § 17.110(b)(1)(iv) that the definition of “multi-source medication” is for purposes of that section only. We make no changes based on these comments.

    Definition of “Multi-Source Medication”: Biosimilarity and Interchangeability

    In paragraph (b)(1)(iv)(A)(1)(ii) we proposed that the term “multi-source medication” would include a medication that has been and remains approved by FDA under section 351(k) of PHSA (42 U.S.C. 262), and has been granted an I or B rating in the current version of the FDA's Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (the Purple Book). We received multiple, highly technical comments on this issue, which are summarized below. After the summary, we respond to the comments.

    Several commenters stated that VA should clarify that it defers to FDA regarding both therapeutic equivalence for drugs and interchangeability for biological products. The commenters asserted that by defining multi-source medication to mean, in part, a medication that has been granted an I or B rating by FDA, VA would treat both biological products that FDA has determined to be interchangeable (I rated) and those deemed biosimilar (B rated) exactly the same. The commenters stated that the proposed rule erroneously conflates entirely the two very distinct approval standards for these two very distinct categories of biological products.

    Several commenters stated that the proposed rulemaking failed to recognize the significant differences between generic drugs and biosimilar products. The commenters noted that biosimilar products are not necessarily interchangeable. Whereas drugs typically have small molecule structures that can be completely defined and entirely reproduced, biologics are large-protein molecules that are generally more complex, and reproductions are unlikely to be shown to be structurally identical to the innovator product. In recognition of this difference, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) established separate approval standards for biosimilar and interchangeable biological products, distinct from standards for generic drugs. Generic drugs must be the same as a previously approved Reference Product, and are approved for the same indications. In contrast, to receive FDA approval, biosimilar products must be demonstrated to be “highly similar,” but not identical, to the innovator product. Approved B rated biosimilar products have not been determined by FDA to be safe for substitution with the Reference Product. Biologics must meet additional criteria established by the FDA to be interchangeable, or I rated. One commenter urged VA to exclude biosimilar products that FDA has not determined to be interchangeable from the definition of multi-source medication. In the alternative, the commenter stated that VA should clarify that a biological product licensed by FDA as a biosimilar is not interchangeable absent an FDA determination of such.

    Commenters noted that the BPCIA sets forth criteria for a biologic being rated as a biosimilar product, and two additional requirements for interchangeability. Only those biosimilar products that have met these two additional criteria are deemed by FDA to be interchangeable. Two commenters stated that FDA sets a higher standard for interchangeability of biological products and other related biosimilar products than it does for biosimilarity or therapeutic equivalence for smaller molecule drugs. The commenters stated that, in the absence of the robust data that FDA requires to make a determination regarding biosimilarity or interchangeability, VA could potentially place patients at significant risk.

    One commenter stated that the proposed rulemaking encourages the use of the lowest cost biosimilar regardless of interchangeability and whether the biosimilar has been tested for the indication for which it is prescribed.

    One commenter noted that there are some smaller molecule drugs that have not been determined by FDA to be therapeutically equivalent. The commenter stated that VA should consider the unique safety questions surrounding substitution of biological products, including those that have been determined to be biosimilar, especially with regard to immunogenicity.

    One commenter stated that VA should clarify that B rated biological products have not been approved as interchangeable with the reference Product. FDA approval as an interchangeable biological product (I rated) requires the successful demonstration of an entirely separate and more rigorous set of standards. The commenter states that VA should clarify that the inclusion of B rated biologics in the definition of multi-source medication does not imply that B rated biologics have been determined by FDA to be interchangeable.

    We appreciate the complete analyses provided by the commenters on the topic of biosimilarity and interchangeability, and we have made changes to the regulation responsive to their concerns. Our reasoning follows.

    The Purple Book lists biological products, including any biosimilar and interchangeable biological products licensed by FDA under the PHSA. The lists include the date a biological product was licensed under 351(a) of the PHSA and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHSA. The Purple Book enables a user to see whether a biological product licensed under section 351(k) of the PHSA has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHSA are listed under the reference product to which biosimilarity or interchangeability was demonstrated.

    The BPCIA was enacted as part of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148) on March 23, 2010. The BPCIA amends the PHSA and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product (see sections 7001 through 7003 of the Affordable Care Act). Section 351(k) of the PHSA, added by the BPCIA, sets forth the requirements for an application for a proposed biosimilar product and an application or a supplement for a proposed interchangeable product. There are three relevant definitions in this statute.

    Section 351(i) defines biosimilarity to mean that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.

    To meet the standard for interchangeability, an applicant must provide sufficient information to demonstrate that the biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient. Additionally, if the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch (see section 351(k)(4) of the PHSA). Interchangeable products may be substituted for the reference product by a pharmacist without the intervention of the prescribing health care provider (see section 351(i)(3) of the PHSA).

    Reference product means the single biological product licensed under section 351(a) of the PHSA against which a biological product is evaluated in a 351(k) application (section 351(i)(4) of the PHSA).

    The definition of multi-source medication in this rulemaking was crafted for only one purpose—to differentiate several classes of medication (including drugs and biologics) that can be termed either Tier 1 or 2 for medication copayment purposes. This definition does not equate an I rated product with one that is B rated by FDA. Nor does it conflict with or supersede a determination by FDA that a particular drug is the therapeutic equivalent of another, or that two biologics are biosimilar. The Purple Book lists biological products, including any biosimilar and interchangeable biological products licensed by FDA, and the definition of multi-source medication at paragraph (b)(1)(iv)(A)(1)(ii) recognizes that fact and categorizes those already-licensed products for VA's purposes. We have added clarifying language to indicate that VA defers to FDA regarding both therapeutic equivalence for drugs and interchangeability for biological products.

    We do not agree with the commenter concerned that the rulemaking encourages the use of the lowest cost biosimilar regardless of interchangeability and whether it has been tested for the indication for which it is prescribed. A VA health care provider makes decisions on prescribing specific medications based on the clinical need of the individual patient being treated for a given illness or condition. Prescribing decisions are generally limited to those medications included in the VA National Formulary, which is discussed in greater detail below. If a particular medication is not available, sound clinical practice is for the health care provider to select an alternate medication that is interchangeable or otherwise approved by the FDA for treatment of the illness or medical condition. Cost is only one of several factors considered when VA determines which medications are on the National Formulary. In general, individual prescribing choices are influenced by medication copayment charges only when the issue is raised by the veteran, and only in those instances where a clinically justifiable alternative is available. We make no changes based on this comment.

    Definition of “Multi-Source Medication”: Substitutability

    In paragraph (b)(1)(iv)(A)(3) we proposed that the term “multi-source medication” would include a medication that has been and remains approved by the FDA pursuant to FDCA section 505(b)(1) or PHSA section 351(a); and has the same active ingredient or active ingredients, works in the same way and in a comparable amount of time, and is determined by VA to be substitutable for another medication that has been and remains approved by the FDA pursuant to FDCA section 505(b)(1) or PHSA section 351(a).

    One commenter expressed concerns that the proposed rule gives VA total discretion to determine whether two approved drugs or biological products are “substitutable.” The commenter stated that VA should defer to FDA's determination of therapeutic equivalence and interchangeability when making decisions regarding substitutability of products.

    The commenter also expressed concern that VA's determination that products are substitutable may be misconstrued by the public as indicating that the products have been determined by FDA to be interchangeable or therapeutically equivalent when they are not.

    One commenter stated that the portion of the proposed rulemaking addressing substitutability is written in a manner to suggest that there may be more treatment options, and thus there are competitive forces at play, when certain drugs and biologics have the “same active ingredient or ingredients, work . . . in the same way, and in a comparable amount of time.” The commenter argued that it is outside VA's authority to determine when products are “substitutable” with one another. The commenter stated that it is FDA's scientific determinations about therapeutic equivalence (for small molecule drugs) and interchangeability (for biologic products) that impact substitutability determinations.

    VA agrees that FDA determinations regarding therapeutic equivalence and interchangeability are important considerations. However, substitutability is not the same as therapeutic equivalence or interchangeability. Whether one medication can be substituted for another is a clinical decision made by a health care provider, based on sound clinical judgment, and the decision should be evidence-based. A health care provider may decide to substitute one medication for another to treat a given medical condition for several reasons including, but not limited to, a comparison of relative side effects, contraindications, and potential adverse reactions; patient tolerance of one medication over another; a request by the patient; or an effort to decrease costs for the patient while achieving the same or similar benefits. Therapeutic equivalence and interchangeability may play a part in the decision-making process, dependent upon the range of treatment options available to the health care provider. When therapeutic equivalence and interchangeability are considerations, FDA determinations on these issues are highly relevant. We make no changes based on this comment.

    Definition of “Multi-Source Medication”: Authorized Generics

    In paragraph (b)(1)(iv)(A)(4) we state that the term “multi-source medication” would also include a medication that is a listed drug, as defined in 21 CFR 314.3, that has been approved under FDCA section 505(c) and is marketed, sold, or distributed directly or indirectly to retail class of trade with either labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trademark that differs from that of the listed drug. The definition in paragraph (b)(1)(iv)(A)(4) is substantively identical to the definition of “authorized generic drug” found in FDA regulations at 21 CFR 314.3.

    One commenter stated that this definition unfairly precludes drugs approved as brand drugs and marketed as generics (authorized generics) from being included as a multiple-source medication at the Tier 1 or 2 copayment amount if there is no generic source rated in the Orange Book or if a drug approved as a brand drug is not lower in cost than other generic sources.

    For clarification, the FDA publication “Approved Drug Products with Therapeutic Equivalence Evaluations” is commonly known as the Orange Book. The Orange Book identifies drug products approved on the basis of safety and effectiveness by the FDA under the FDCA. The publication does not include drugs on the market approved only on the basis of safety covered by the ongoing Drug Efficacy Study Implementation review or pre-1938 drugs. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. In addition, the Orange Book contains therapeutic equivalence evaluations for approved generic drugs. Finally, the Orange Book lists patents that are purported to protect each drug.

    The commenter stated that it is unfair to charge veterans more for an authorized generic drug simply because there is no marketed generic drug approved under section 505(j), or when VA's cost for a drug approved as a brand drug is only slightly higher than another generic source.

    Nothing in this rulemaking precludes an authorized generic drug from inclusion in either Tier 1 or 2. Authorized generics are prescription drugs produced by brand pharmaceutical companies and marketed under a private label, at generic prices. Authorized generics compete with generic products in that they are identical to their brand counterpart in both active and inactive ingredients, while generic drugs are required to contain only the same active ingredient as the brand name. Pharmaceutical manufacturers typically launch an authorized generic when patent protection and exclusivity have expired, and the authorized generic competes in the marketplace against any generic equivalents approved by FDA.

    The three classes of medications defined for copayment purposes, Tier 1, Tier 2, and Tier 3, are found in paragraph (b)(1)(iv)(B)-(D). Multi-source medications generally fall under either Tier 1 or 2; placement in either tier being governed by whether the medication meets all the criteria found at paragraph (b)(2) for Tier 1 placement. The only medications that would fall under Tier 3 are those approved by the FDA under a New Drug Application (NDA) or a biological product approved by the FDA pursuant to a biologics license agreement (BLA) that retains its patent protection and exclusivity. The definition of multi-source medication specifically includes authorized generic drugs at paragraph (b)(1)(iv)(A)(4). There is nothing in the criteria for inclusion in Tier 1 or 2 that would disqualify an authorized generic because no other generic equivalent had yet been approved by FDA.

    The comment does highlight two elements of the Tier 3 definition that may cause confusion: Patent protection and exclusivity. Tier 3 medication includes medications approved by FDA under a NDA that retains exclusivity. An authorized generic medication is manufactured by the original patent holder under a NDA, but is not marketed under the brand name. While an authorized generic medication may not retain exclusivity for patent purposes, the term “exclusivity” does come into play. Authorized generic medications are typically brought to the market during the 180-day exclusivity period during which a first filer of an Abbreviated New Drug Application (ANDA) under the Drug Price Competition and Patent Term Restoration Act (Pub. L. 98-417) can bring to market a generic version of the brand name drug. During this 180 day period no other manufacturer may market a generic version of the medication, other than the original patent holder who can market the authorized generic. To clarify the scope of Tier 3, we will amend the definition of Tier 3 to explicitly state that Tier 3 does not include authorized generic medications defined in paragraph (b)(1)(iv)(A)(4).

    The commenter further stated that if the concern is that multiple source drug prices be competitive, the requirement should be that a drug approved as a brand drug be equivalent in cost to a generic version not lower in cost, particularly given generic drug pricing volatility. As noted above, the comment is based on an incorrect analysis of the definition of multi-source medication and what is included in each tier for copayment purposes. Authorized generic medications (which are generic versions of a medication that is marketed by the brand drug manufacturer) are not included in Tier 3. By definition, authorized generic medications are considered multi-source medication at paragraph (b)(1)(iv)(A)(4). A drug approved by the FDA as a brand drug is considered under this rule in one of two ways, dependent on whether the drug is marketed as both a brand drug and authorized generic medication, or solely as a brand drug. In the latter case, the brand drug would be considered a Tier 3 medication, while in the former case the authorized generic medication would be either a Tier 1 or 2, and the brand drug would be Tier 3. This differentiation between an authorized generic medication and a brand drug is consistent with how many non-VA health insurers categorize these products. The commenter correctly states that generic drug pricing can be volatile. However, VA has been successful at stabilizing generic drug acquisition prices through a variety of government contract vehicles and therefore has minimized generic price volatility. Generic price volatility is not the primary determining factor in whether an authorized generic medication is Tier 1 or 2. We do not agree with the commenter that VA should require brand drug to be equivalent to either the authorized generic version of that drug, or other generic versions of that drug. Finally, the description of authorized generic medication in paragraph (b)(1)(iv)(A)(4) does not include a requirement that the medication be lower in cost; that requirement is in (b)(1)(iv)(A)(2)(iii) and is not applicable to authorized generic medication. We make no change based on this comment.

    Tier Structure

    One commenter stated that, while the proposed rule is intended to align medication copayments charged by VA with commercial practice, the three-tiered system deviates further from established commercial practice than the current two-tiered system. The commenter stated that the proposed three-tiered model will lead to confusion, and veterans may be less likely to fill needed prescriptions.

    The primary purpose of this rulemaking is not to strictly align VA's medication copayment structure with commercial practice. Rather, it is to make medication copayments more affordable to the greatest number of affected veterans, while recognizing differences in costs of those medications to VA and the effect of that differential for veterans who may exercise a non-VA retail option. The previously utilized two-tiered system was inflexible and nonresponsive to changing conditions, and resulted in some veterans bearing a heavy financial burden to obtain necessary medication. We make no changes based on this comment.

    One commenter was concerned that a single source drug or biologic for which there is no generic version is precluded from Tier 2, even where there is a therapeutic alternative that is also a single source drug or biologic. The commenter noted that single source drugs on the VA National Formulary may be clinically effective and cost effective compared to alternative treatments. The VA National Formulary is a listing of products (drugs and supplies) that must be available for prescription at all VA facilities. Only those products that actually have been approved by FDA under a NDA, ANDA, or biologics license, may be added to the National Formulary.

    The commenter stated that many high use medications, such as oncology drugs and biologics, are for conditions for which no drug is available under another tier and which may not be on the VA formulary. The commenter asserted that the proposed tier structure will increase costs of these medications for veterans.

    One commenter did not support the tiered copayment model, specifically Tier 3. The commenter argued that requiring higher copayments for Tier 3 medication penalizes veterans who benefit from newer medication, those who have no other option than using medication that retain patent protection and exclusivity to treat their medical condition. The commenter further stated that raising copayment amounts may force veterans to pick and choose which of several medications they will fill.

    A medication is considered a therapeutic alternative if that medication differs chemically from the medication prescribed, but has the same therapeutic effect as the prescribed medication. An example is the various classes of calcium channel blockers that are prescribed to treat hypertension. One calcium channel blocking medication could be considered a therapeutic alternative to another, dependent upon case-specific factors. Placement of a medication into any of the three copayment tiers is not dependent on whether a therapeutic alternative exists. Rather, the issue is whether a particular medication is a multi-source or single source medication, and whether (in the case of a multi-source medication) the medication qualifies for Tier 1. The primary criteria for determining whether a medication is single source or multi-source is if it is a medication approved by the FDA under a New Drug Application (NDA) or a biological product approved by the FDA pursuant to a biologics license agreement (BLA) that retains its patent protection and exclusivity and is not a multi-source medication identified in paragraph (b)(1)(iv)(A)(3) or (4). Using “therapeutic alternative” as the touchstone to determine whether a medication is single source would not be consistent with the common usage of that term, and would be difficult to administer since medications may sometimes be prescribed to treat several different medical conditions. For one indication, medication X may be the therapeutic alternative to medication Y, and for another indication would be the therapeutic alternative to medication B.

    Medication copayment amounts paid in non-VA pharmacies vary dependent upon whether the prescription is for a generic or brand name medication. The tiered copayment structure in this rulemaking follows the same pattern. What is commonly referred to as a brand name medication is equivalent to a medication that would fall under Tier 3. VA estimates that approximately 15 percent of billable prescriptions dispensed in a year will be in Tier 3, and that the total copayments for veterans prescribed Tier 3 medications will remain the same for many veterans and will decrease for a sizable portion. A reduction in the copayment cap provides a unique benefit to veterans who exclusively use Tier 3 medications. The total annual copayment costs for these veterans will not exceed $700, whereas under the prior regulations the costs would be $960, or more for those veterans in priority groups 7 or 8 that are not currently subject to a cap. So, while some veterans may still decide not to fill all of their prescriptions, we estimate that fewer will do so for financial reasons as a result of these changes.

    We note that a veteran may request a waiver of medication copayment charges, as provided for in 38 CFR 17.105(c). That section states that the veterans must submit a form requesting a waiver, and that a hearing may be requested. We make no changes based on these comments.

    Copayment Amounts

    Two commenters stated that this rule will still result in veterans being subject to copayments higher than they would have to pay in a non-VA pharmacy. One commenter argued that VA should offer the same copayment rates available in non-VA pharmacies.

    In the impact analysis published concurrently with the proposed rule, VA considered the potential costs or savings to veterans as a result of this rulemaking. Based on a comparison of the current and proposed copayment amounts, we anticipate that most veterans would realize between a 10 and 50 percent reduction in their overall pharmacy copayment liability each year based on historic utilization patterns. By our estimates, 94 percent of copayment eligible veterans would experience no cost increase, and 80 percent would realize a savings of between $1 and $5 per 30-day equivalent of medications. While a small percentage of veterans may experience a small increase in medication copayments, a large majority will encounter no cost increase, or will realize savings, as a result of this rulemaking.

    Medication copayment amounts vary widely between different non-VA pharmacies and under commercial health insurer policies, due to many factors. There is no standard non-VA medication copayment rate structure that can be used as a model for creating a copayment structure in VA. Uniformly adopting the lowest level of copayments found outside of VA would result in a copayment system that is not sustainable in the long term, and could possibly violate statutory requirements in 38 U.S.C. 1722A(a), which requires VA to charge a minimum copayment, with certain limited exceptions. VA believes that this rulemaking will result in copayment amounts that will benefit the greatest number of veterans. We make no changes based on these comments.

    One commenter stated that manufacturers may be providing VA with competitive prices to increase market share of a single source drug within a therapeutic class, and the lower cost to VA should be passed along to veterans through a lower tier copayment amount. Given the number of pharmaceutical manufacturers and suppliers VA contracts with, and the varying terms and lengths of these contracts, determining copayments amounts on an individual contract basis would be difficult from an administrative standpoint and could lead to uncertainty as to the amount an individual veteran would pay for a medication copayment. In addition, this could result in different copayments for the same medication where more than one manufacturer or supplier provides that medication. Under this rulemaking, VA does include acquisition cost as an element considered in determining whether a medication will be included in Tier 1. See paragraph (b)(2). We make no changes based on this comment.

    Exemption From Copayments

    One commenter stated that if a large number of veterans are diagnosed with any one medical condition such as hypertension, medication to treat that condition should be considered service-connected and exempt from copayments. Another commenter stated that any veteran who has served in the military over 20 years, or served in a war or conflict, should be exempt from medication copayments. The commenter also stated that a pool of emergency funds should be set aside for use by veterans who are unable to afford medication copayments.

    Exemptions from the medication copayment are controlled by statute. Under 38 U.S.C. 1722A(a)(3), the following veterans are exempt from the medication copayment: A veteran with a service-connected disability rated 50 percent or more; a veteran who is a former prisoner of war; and, a veteran whose annual income (as determined under 38 U.S.C. 1503) does not exceed the maximum annual rate of pension which would be payable to such veteran if such veteran were eligible for a VA pension. VA does not have the statutory authority to exempt other veterans from the medication copayment. While VA does not have the statutory authority to exempt other veterans from medication copayment charges, as noted above a veteran may request a waiver of such charges under 38 CFR 17.105(c). Service connection is not determined by whether a certain number of veterans have been diagnosed with a particular disease or condition. “Service-connected” means that the disability was incurred or aggravated in the line of duty while in active military, naval, or air service. 38 CFR 3.1(k). A finding that a disability is service connected means that the facts, shown by evidence, establish that a particular injury or disease resulting in disability was incurred coincident with service in the Armed Forces, or if preexisting such service, was aggravated therein. 38 CFR 3.303(a). Likewise, VA does not have the statutory authority to set aside appropriated funds for the use of individual veterans. We make no changes based on these comments.

    Miscellaneous

    One commenter stated that, unlike the Department of Defense, VA provides no opportunity for veterans, manufacturers, or the public to address the comparative clinical benefits, and cost benefits or effectiveness of a drug or biologic under consideration for addition to the National Formulary. The commenter stated that VA should make the formulary decision-making process more transparent. The process VA utilizes to consider changes to the National Formulary is beyond the scope of the rulemaking, and we make no changes based on this comment.

    One commenter asked for a clarification on how this rulemaking will impact contracting decisions for the National Contract covering short acting and human insulins, along with future contracting processes. Although changes in the prices of certain medications may affect certain future contracting actions, VA will continue to follow all federal contracting requirements and will make purchases accordingly.

    Finally, we make a technical edit to paragraph (b)(1). This paragraph establishes the medication copayment amounts for each tier of medication. As drafted, each clause in paragraph (b)(1)(i) through (iii) reads “[f]or a 30-day supply or less of . . . medication, the copayment amount is . . .” This language could be misinterpreted to mean that no medication copayment is charged for medication amounts greater than 30 days. This would be inconsistent with the statutory mandate at 38 U.S.C. 1722A(a), that VA must require certain veterans to pay at least a $2 copayment for each 30-day supply of medication furnished on an outpatient basis for the treatment of a non-service-connected disability or condition. In prior rulemakings we used the phrase “for each 30-day or less supply of medication” when establishing copayment amounts. Paragraph (b)(1) is edited to reflect that same language.

    Based on the rationale set forth in the proposed rule and in this document, VA is adopting the provisions of the proposed rule as a final rule with changes as noted above.

    Effect of Rulemaking

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

    Paperwork Reduction Act

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

    Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). This final rule will generally be small business neutral. The rule will not affect pharmaceutical manufacturers, as it does not change the amount VA pays for medications to supply its pharmaceutical benefits program, only the amount VA collects from veterans as copayments. To the extent there are effects on pharmaceutical companies, we believe it will most likely have a positive affect if VA is purchasing more medications and supplies from them. Similarly, VA does not believe that this rule will have a significant economic impact on small pharmacies. It is possible that some veterans will choose to fill their prescriptions within VA rather than from a community pharmacist, but we anticipate such a shift will not result in a significant economic impact on a substantial number of such entities. Therefore, under 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

    Executive Order 12866 and 13563

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

    The economic, interagency, budgetary, legal, and policy implications of this final rule have been examined, and it has been determined to be a significant regulatory action under Executive Order 12866 because it is likely to result in a rule that may have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's Web site at http://www.va.gov/orpm/, by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year to Date.”

    Congressional Review Act

    This final rule is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801, et seq.), which specifies that before a rule can take effect, the Federal agency promulgating the rule shall submit to each House of the Congress and to the Comptroller General a report containing a copy of the rule along with other specified information. The required report and this rule have been submitted to Congress and the Comptroller General for review.

    Unfunded Mandates

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

    Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans Dental Care; 64.012, Veterans Prescription Service; 64.013, Veterans Prosthetic Appliances; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; 64.022, Veterans Home Based Primary Care; and 64.024, VA Homeless Providers Grant and Per Diem Program.

    Signing Authority

    The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on October 3, 2016, for publication.

    List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Government contracts, Grant programs—health, Grant programs—veterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and Dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Reporting and recordkeeping requirements, Travel and transportation expenses, Veterans.

    Dated: December 2, 2016. Michael Shores, Acting Director, Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs.

    For the reasons set out in the preamble, VA amends 38 CFR part 17 as follows:

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

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

    2. Amend § 17.110 by: a. Revising paragraph (a). b. Revising paragraphs (b)(1)(i) through (iii). c. Adding paragraph (b)(1)(iv). d. Revising paragraphs (b)(2) and (3), and adding a heading to paragraph (b)(4). e. Adding paragraph (b)(5).

    The revisions and additions read as follows:

    § 17.110 Copayments for medications.

    (a) General. This section sets forth requirements regarding copayments for medications provided to veterans by VA. For purposes of this section, the term “medication” means prescription and over-the-counter medications, as determined by the Food and Drug Administration (FDA), but does not mean medical supplies, oral nutritional supplements, or medical devices. Oral nutritional supplements are commercially prepared nutritionally enhanced products used to supplement the intake of individuals who cannot meet nutrient needs by diet alone.

    (b) * * *

    (1) * * *

    (i) For each 30-day or less supply of Tier 1 medications, the copayment amount is $5.

    (ii) For each 30-day or less supply of Tier 2 medications, the copayment amount is $8.

    (iii) For each 30-day or less supply of Tier 3 medications, the copayment amount is $11.

    (iv) For purposes of this section:

    (A) Multi-source medication is any one of the following:

    (1) A medication that has been and remains approved by the FDA—

    (i) Under sections 505(b)(2) or 505(j) of the Food, Drug, and Cosmetic Act (FDCA, 21 U.S.C. 355), and that has been granted an A-rating in the current version of the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book); or

    (ii) Under section 351(k) of the Public Health Service Act (PHSA, 42 U.S.C. 262), and that has been granted an I or B rating in the current version of the FDA's Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (the Purple Book). FDA determines both therapeutic equivalence for drugs and interchangeability for biological products.

    (2) A medication that—

    (i) Has been and remains approved by the FDA pursuant to FDCA section 505(b)(1) or PHSA section 351(a);

    (ii) Which is referenced by at least one FDA-approved product that meets the criteria of paragraph (b)(1)(iv)(A)(1) of this section; and

    (iii) Which is covered by a contracting strategy in place with pricing such that it is lower in cost than other generic sources.

    (3) A medication that—

    (i) Has been and remains approved by the FDA pursuant to FDCA section 505(b)(1) or PHSA section 351(a); and

    (ii) Has the same active ingredient or active ingredients, works in the same way and in a comparable amount of time, and is determined by VA to be substitutable for another medication that has been and remains approved by the FDA pursuant to FDCA section 505(b)(1) or PHSA section 351(a). This may include but is not limited to insulin and levothyroxine.

    (4) A listed drug, as defined in 21 CFR 314.3, that has been approved under FDCA section 505(c) and is marketed, sold, or distributed directly or indirectly to retail class of trade with either labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trademark that differs from that of the listed drug.

    (B) Tier 1 medication means a multi-source medication that has been identified using the process described in paragraph (b)(2) of this section.

    (C) Tier 2 medication means a multi-source medication that is not identified using the process described in paragraph (b)(2) of this section.

    (D) Tier 3 medication means a medication approved by the FDA under a New Drug Application (NDA) or a biological product approved by the FDA pursuant to a biologics license agreement (BLA) that retains its patent protection and exclusivity and is not a multi-source medication identified in paragraph (b)(1)(iv)(A)(3) or (4) of this section.

    (2) Determining Tier 1 medications. Not less than once per year, VA will identify a subset of multi-source medications as Tier 1 medications using the criteria below. Only medications that meet all of the criteria in paragraphs (b)(2)(i), (ii), and (iii) will be eligible to be considered Tier 1 medications, and only those medications that meet all of the criteria in paragraph (b)(2)(i) of this section will be assessed using the criteria in paragraphs (b)(2)(ii) and (iii).

    (i) A medication must meet all of the following criteria:

    (A) The VA acquisition cost for the medication is less than or equal to $10 for a 30-day supply of medication;

    (B) The medication is not a topical cream, a product used to treat musculoskeletal conditions, an antihistamine, or a steroid-containing medication;

    (C) The medication is available on the VA National Formulary;

    (D) The medication is not an antibiotic that is primarily used for short periods of time to treat infections; and

    (E) The medication primarily is used to either treat or manage a chronic condition, or to reduce the risk of adverse health outcomes secondary to the chronic condition, for example, medications used to treat high blood pressure to reduce the risks of heart attack, stroke, and kidney failure. For purposes of this section, conditions that typically are known to persist for 3 months or more will be considered chronic.

    (ii) The medication must be among the top 75 most commonly prescribed multi-source medications that meet the criteria in paragraph (b)(2)(i) of this section, based on the number of prescriptions issued for a 30-day or less supply on an outpatient basis during a fixed period of time.

    (iii) VA must determine that the medication identified provides maximum clinical value consistent with budgetary resources.

    (3) Information on Tier 1 medications. Not less than once per year, VA will publish a list of Tier 1 medications in the Federal Register and on VA's Web site at www.va.gov/health.

    (4) Veterans Choice Program. * * *

    (5) Copayment cap. The total amount of copayments for medications in a calendar year for an enrolled veteran will not exceed $700.

    [FR Doc. 2016-29515 Filed 12-9-16; 8:45 am] BILLING CODE 8320-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R04-OAR-2014-0424; FRL-9956-35-Region 4] Air Plan Approval/Disapproval; MS; Infrastructure Requirements for the 2012 PM2.5 National Ambient Air Quality Standard AGENCY:

    Environmental Protection Agency.

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is taking final action to approve, in part, and disapprove in part, the State Implementation Plan (SIP) submission, submitted by the State of Mississippi, through the Mississippi Department of Environmental Quality (MDEQ), on December 11, 2015, to demonstrate that the State meets the infrastructure requirements of the Clean Air Act (CAA or Act) for the 2012 annual fine particulate matter (PM2.5) national ambient air quality standard (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an “infrastructure SIP submission.” MDEQ certified that the Mississippi SIP contains provisions that ensure the 2012 Annual PM2.5 NAAQS is implemented, enforced, and maintained in Mississippi. With the exception of the PSD permitting requirements and the interstate transport provisions, for which EPA is not acting upon, and the state board majority requirements respecting significant portion of income, for which EPA is finalizing disapproval, EPA is finalizing that portions of Mississippi's infrastructure submission, submitted to EPA on December 11, 2015, as satisfying certain required infrastructure elements for the 2012 Annual PM2.5 NAAQS.

    DATES:

    This rule will be effective January 11, 2017.

    ADDRESSES:

    EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2014-0424. All documents in the docket are listed on the www.regulations.gov Web site. Although listed in the index, some information is not publicly available, i.e., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you contact the person listed in the FOR FURTHER INFORMATION CONTACT section to schedule your inspection. The Regional Office's official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Tiereny Bell, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Ms. Bell can be reached via electronic mail at [email protected] or via telephone at (404) 562-9088.

    SUPPLEMENTARY INFORMATION:

    I. Background and Overview

    On December 14, 2012, EPA promulgated a revised primary annual PM2.5 NAAQS. The standard was strengthened from 15.0 micrograms per cubic meter (μg/m 3) to 12.0 μg/m 3. See 78 FR 3086 (January 15, 2013). Pursuant to section 110(a)(1) of the CAA, states are required to submit SIPs meeting the applicable requirements of section 110(a)(2) within three years after promulgation of a new or revised NAAQS or within such shorter period as EPA may prescribe. Section 110(a)(2) requires states to address basic SIP elements such as requirements for monitoring, basic program requirements and legal authority that are designed to assure attainment and maintenance of the NAAQS. States were required to submit such SIPs for the 2012 Annual PM2.5 NAAQS to EPA no later than December 14, 2015.

    In a proposed rulemaking published on June 8, 2016 (81 FR 36848), EPA proposed to approve in part and disapprove in part Mississippi's December 11, 2015, SIP submission for the 2012 Annual PM2.5 NAAQS. In the June 8, 2016 proposed rulemaking, EPA proposed to disapprove the state board majority requirements respecting significant portion of income of 110(a)(2)(E)(ii). Also in the June 8, 2016 proposal, EPA did not propose any action regarding the preconstruction PSD permitting requirements for major sources of sections 110(a)(2)(C), prong 3 of (D)(i), and (J), and the interstate transport requirements of section 110(a)(2)(D)(i)(I) and (II) (prongs 1, 2, and 4). On March 18, 2015 (80 FR 14019), EPA approved Mississippi's December 11, 2015, infrastructure SIP submission regarding the PSD permitting requirements for major sources of sections 110(a)(2)(C), prong 3 of D(i), and (J) for the 2012 Annual PM2.5 NAAQS. Therefore, EPA is not taking any action today pertaining to sections 110(a)(2)(C), prong 3 of D(i), and (J). Additionally, on May 25, 2016, EPA finalized a rule related to prong 4 of 110(a)(2)(D)(i)(II) of Mississippi's December 11, 2015, SIP submission for the 2012 Annual PM2.5 NAAQS and will therefore not be acting upon this element today. See 81 FR 33139. With respect to the interstate transport requirements of section 110(a)(2)(D)(i)(I) (prongs 1 and 2), EPA will consider these requirements in relation to Mississippi's 2012 Annual PM2.5 NAAQS infrastructure submission in a separate rulemaking. The details of Mississippi's submission and the rationale for EPA's actions for this final rule are explained in the June 8, 2016, proposed rulemaking. Comments on the proposed rulemaking were due on or before July 8, 2016. EPA received no adverse comments on the proposed action.

    II. Final Action

    With regard to the state board majority requirements respecting significant portion of income, EPA is finalizing a disapproval of Mississippi's December 11, 2015, infrastructure submission. Under section 179(a) of the CAA, final disapproval of a submittal that addresses a requirement of a CAA Part D Plan or is required in response to a finding of substantial inadequacy as described in CAA section 110(k)(5) (SIP call) starts a sanctions clock. The portion of section 110(a)(2)(E)(ii) provisions (the provisions being proposed for disapproval in this notice) were not submitted to meet requirements for Part D or a SIP call, and therefore, no sanctions will be triggered. However, this final action will trigger the requirement under section 110(c) that EPA promulgate a Federal Implementation Plan (FIP) no later than two years from the date of the disapproval unless the State corrects the deficiency, and EPA approves the plan or plan revision before EPA promulgates such FIP. With the exceptions noted above, EPA is taking final action to approve Mississippi's infrastructure SIP submission for the 2012 Annual PM2.5 NAAQS because the submission is consistent with section 110 of the CAA.

    III. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

    In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

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

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 10, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: November 28, 2016. Heather McTeer Toney, Acting Regional Administrator, Region 4.

    40 CFR part 52 is amended as follows:

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

    42 U.S.C. 7401 et seq.

    Subpart Z—Mississippi 2. Section 52.1270(e) is amended by adding a new entry “110(a)(1) and (2) Infrastructure Requirements for the 2012 Annual PM 2.5 NAAQS” at the end of the table to read as follows:
    § 52. 1270 Identification of plan.

    (e) * * *

    EPA Approved Mississippi Non-Regulatory Provisions Name of non-regulatory SIP provision Applicable geographic or nonattainment area State submittal date/effective date EPA approval date Explanation *         *         *         *         *         *         * 110(a)(1) and (2) Infrastructure Requirements for the 2012 Annual PM 2.5 NAAQS Mississippi 12/11/2015 12/12/2016, [Insert citation of publication in Federal Register] With the exception of sections: 110(a)(2)(C) and (J) concerning PSD permitting requirements; 110(a)(2)(D)(i)(I) and (II) (prongs 1 through 4) concerning interstate transport requirements and the state board majority requirements respecting significant portion of income of section 110(a)(2)(E)(ii).
    [FR Doc. 2016-29593 Filed 12-9-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 75 RIN 0991-AC06 Health and Human Services Grants Regulation AGENCY:

    Division of Grants, Office of Grants Policy, Oversight, and Evaluation, Office of the Assistant Secretary for Financial Resources, Department of Health and Human Services.

    ACTION:

    Final rule.

    SUMMARY:

    This final rule makes changes to the Department of Health and Human Services' (HHS) adoption of the Office of Management and Budget's (OMB) (“Uniform Administrative Requirements”) published on December 19, 2014 and the technical amendments published by HHS on January 20, 2016. HHS codified the OMB language, with noted modifications as explained in the preamble to the December promulgation. The HHS-specific modifications to the Uniform Administrative Requirements adopted prior regulatory language that was not in conflict with OMB's language, and provided additional guidance to the regulated community. Unlike all of the other modifications to the Uniform Administrative Requirements, these additional changes, although based on existing law or HHS policy, were not previously codified in regulation. HHS sought comment on these proposed changes in a notice of proposed rulemaking published on July 13, 2016. This final rule implements these regulatory changes. It also corrects one typographical error that was recently discovered in the most recent promulgation of the Uniform Administrative Requirements.

    DATES:

    This rule is effective on January 11, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Quadira Dantro, MSHS, CRA at (202) 260-6825.

    SUPPLEMENTARY INFORMATION:

    Background

    This final rule makes changes to the HHS's adoption of the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards published on December 19, 2014 (79 FR 75871) and the technical amendments published by HHS on January 20, 2016 (81 FR 3004). HHS codified the OMB language, with noted modifications, in 45 CFR part 75. Unlike all of the other modifications to the Uniform Administrative Requirements, these additional changes, although based on existing law or HHS policy, were not previously codified in regulation. This final rule implements these regulatory changes.

    HHS received 24 relevant comments on the notice of proposed rulemaking, half of which were strongly supportive of the proposed rule. HHS addresses all of the comments below.

    A. Nondiscrimination Provisions

    Comment: HHS received twelve comments on these provisions, all of which were strongly supportive of the codification of the nondiscrimination provisions in HHS awards and the recognition of same-sex marriages. Several of these supportive comments also provided additional areas for consideration specifically regarding the definition of discrimination on the basis of sex. Collectively, the comments indicated that HHS should define discrimination on the basis of sex explicitly to include discrimination on the basis of sex stereotyping, gender identity, sexual orientation, pregnancy, intersex traits, and the presence of atypical sex characteristics.

    Response: HHS appreciates the comments received, and thanks commenters for their positive reactions and helpful suggestions. For the time being, HHS does not believe it is necessary to add additional categories to the list of non-merit based factors. We note that the determination whether a factor is merit-based for purposes of applying the prohibition will depend on the nature of the particular grant at issue. HHS has therefore decided not to amend the nondiscrimination language proposed in 45 CFR 75.300.

    Comment: One comment urged HHS and its partner federal agencies to broadly construe age discrimination protections to support young people as well as older Americans. The comment noted that while many age discrimination laws are enacted with older adults in mind, it is important to recognize the stigmatization of young people and adolescents, particularly in the healthcare arena.

    Response: HHS agrees that young people and adolescents should have access to health care and services free from discrimination. No alterations of the regulatory text are necessary to implement these protections. We note that, while employment laws enforced by the Equal Employment Opportunity Commission apply to applicants and employees forty or older, youth have additional rights under other federal, state, or local laws. The Age Discrimination Act of 1975 (Age Act), for instance, prohibits discrimination against young people and older Americans on the basis of age in federally funded programs and activities. In some cases, the Age Act permits age distinctions that reasonably take into account age as a factor necessary to the normal operation or the achievement of any statutory objective. State and local discrimination laws may offer broader protection.

    Comment: One commenter indicated that HHS should specify that the nondiscrimination provisions included in § 75.300(c) flow down to subawards.

    Response: HHS notes that the provisions of 45 CFR part 75 already address the flow down of requirements. 45 CFR 75.101(b)(1) stating that the terms and conditions of Federal awards flow down to subawards to subrecipients unless a particular section of this part or the terms and conditions of the Federal award specifically indicate otherwise.

    Comment: Several commenters noted that the provisions of § 75.300(c) do not apply to funding under the Temporary Assistance for Needy Families Program (TANF) (title IV-A of the Social Security Act, 42, U.S.C. 601-619). These commenters suggested that HHS should provide additional guidance to TANF grantees on nondiscrimination.

    Response: HHS appreciates the importance of continued education on the full scope of nondiscrimination obligations. The Administration for Children and Families shares this commitment.

    B. Indirect Cost Rates

    Comment: HHS received three comments regarding the proposed eight percent cap on indirect cost rates for foreign organizations. Notably, HHS did not receive any comments that objected to the imposition of the same eight percent cost cap on indirect cost rates for training grants. The comments received suggested that the proposed provision was in conflict with § 75.414(f), and that HHS should instead adopt a ten percent cap on indirect cost rates for these organizations.

    Response: A non-Federal entity that has never received an indirect cost rate that is a foreign organization or foreign public entity, or that would conduct a training grant, would be limited to the eight percent modified total direct cost rate as articulated in § 75.414(c)(3). Commenters indicated that this limitation conflicts with § 75.414(f), which would permit an entity that had never received an indirect cost rate to charge a de minimis rate of ten percent.

    HHS agrees that this is inconsistent, and has added clarifying language to paragraph (f) to ensure that there is no conflict.

    C. Indian Self Determination and Education Assistance Act

    Comment: HHS received numerous comments, both through the regulations.gov portal and separately through the HHS Office of Intergovernmental and External Affairs, on the proposed language clarifying that applicability of certain provisions of the Uniform Administrative Requirements to contracts and compacts awarded pursuant to the Indian Self Determination and Education Assistance Act (ISDEAA). The comments received requested additional tribal consultation on these issues.

    Response: The Department is in the process of conducting this tribal consultation, and will proceed as appropriate after that consultation has concluded. The regulatory language from the notice of proposed rulemaking is not included in this final rule.

    D. Other Issues

    HHS received no comments on the portions of the notice of proposed rulemaking suggesting changes to the proposed language regarding same-sex spouses, marriages, and households, payment provisions as applied to states, public access to records, or shared responsibility payments. Consequently, HHS is finalizing the regulatory language without modification. In addition, HHS is amending one provision to correct a typographical error that was inadvertently included in the most recent promulgation of the Uniform Administrative Requirements, so that the HHS promulgation matches the OMB guidance as intended.

    Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Ch. 3506; 5 CFR 1320 Appendix A.1), HHS reviewed this final rule and determined that there are no new collections of information contained therein.

    Regulatory Flexibility Act

    The Regulatory Flexibility Act requires that an agency provide a final regulatory flexibility analysis or to certify that the rule will not have a significant economic impact on a substantial number of small entities. This final rule aligns 45 CFR part 75 with various regulatory and statutory provisions, implements Supreme Court decisions, and codifies long-standing policies thus clarifying and enhancing the provisions in HHS's interim final guidance issued December 19, 2014, and amended on January 20, 2016. In order to ensure that the public receives the most value, it is essential that HHS grant programs function as effectively and efficiently as possible, and that there is a high level of accountability to prevent waste, fraud, and abuse. The additions provide enhanced direction for the public and will not have a significant economic impact beyond HHS's current regulations.

    Executive Order 12866 Determination

    Pursuant to Executive Order 12866, HHS has designated this final rule to be economically non-significant. This rule is not being treated as a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget.

    Unfunded Mandates Reform Act of 1995 Determination

    Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded Mandates Act) (2 U.S.C. 1532) requires that covered agencies prepare a budgetary impact statement before promulgating a 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 million or more in any one year. If a budgetary impact statement is required, section 205 of the Unfunded Mandates Act also requires covered agencies to identify and consider a reasonable number of regulatory alternatives before promulgating a rule. HHS has determined that this final rule will not result in expenditures by State, local, and tribal governments, or by the private sector, of $100 million or more in any one year. Accordingly, HHS has not prepared a budgetary impact statement or specifically addressed the regulatory alternatives considered.

    Executive Order 13132 Determination

    HHS has determined that this final rule does not have any Federalism implications, as required by Executive Order 13132.

    List of Subjects in 45 CFR Part 75

    Accounting, Administrative practice and procedure, Cost principles, Grant programs, Grant programs—health, Grants administration, Hospitals, Indians, Nonprofit organizations reporting and recordkeeping requirements, State and local governments.

    Dated: November 25, 2016. Sylvia M. Burwell, Secretary, Department of Health and Human Services.

    For the reasons set forth in the preamble, part 75 of title 45 of the Code of Federal Regulations is amended as follows:

    PART 75—UNIFORM ADMINISTRATIVE REQUIREMENTS, COST PRINCIPLES, AND AUDIT REQUIREMENTS FOR HHS AWARDS 1. The authority citation for 45 CFR part 75 continues to read as follows: Authority:

    5 U.S.C. 301.

    2. Amend § 75.101 by adding paragraph (f) to read as follows:
    § 75.101 Applicability.

    (f) Section 75.300(c) does not apply to the Temporary Assistance for Needy Families Program (title IV-A of the Social Security Act, 42 U.S.C. 601-619).

    § 75.110 [Amended]
    3. Amend § 75.110(a) by removing “75.355” and adding, in its place, “75.335”. 4. Amend § 75.300 by adding paragraphs (c) and (d) to read as follows:
    § 75.300 Statutory and national policy requirements.

    (c) It is a public policy requirement of HHS that no person otherwise eligible will be excluded from participation in, denied the benefits of, or subjected to discrimination in the administration of HHS programs and services based on non-merit factors such as age, disability, sex, race, color, national origin, religion, gender identity, or sexual orientation. Recipients must comply with this public policy requirement in the administration of programs supported by HHS awards.

    (d) In accordance with the Supreme Court decisions in United States v. Windsor and in Obergefell v. Hodges, all recipients must treat as valid the marriages of same-sex couples. This does not apply to registered domestic partnerships, civil unions or similar formal relationships recognized under state law as something other than a marriage.

    5. Revise § 75.305(a) to read as follows:
    § 75.305 Payment.

    (a)(1) For states, payments are governed by Treasury-State CMIA agreements and default procedures codified at 31 CFR part 205 and TFM 4A-2000 Overall Disbursing Rules for All Federal Agencies.

    (2) To the extent that Treasury-State CMIA agreements and default procedures do not address expenditure of program income, rebates, refunds, contract settlements, audit recoveries and interest earned on such funds, such funds must be expended before requesting additional cash payments.

    6. Revise § 75.365 to read as follows:
    § 75.365 Restrictions on public access to records.

    Consistent with § 75.322, HHS awarding agencies may require recipients to permit public access to manuscripts, publications, and data produced under an award. However, no HHS awarding agency may place restrictions on the non-Federal entity that limit public access to the records of the non-Federal entity pertinent to a Federal award identified in §§ 75.361 through 75.364, except for protected personally identifiable information (PII) or when the HHS awarding agency can demonstrate that such records will be kept confidential and would have been exempted from disclosure pursuant to the Freedom of Information Act (5 U.S.C. 552) or controlled unclassified information pursuant to Executive Order 13556 if the records had belonged to the HHS awarding agency. The Freedom of Information Act (5 U.S.C. 552) (FOIA) does not apply to those records that remain under a non-Federal entity's control except as required under § 75.322. Unless required by Federal, state, local, or tribal statute, non-Federal entities are not required to permit public access to their records identified in §§ 75.361 through 75.364. The non-Federal entity's records provided to a Federal agency generally will be subject to FOIA and applicable exemptions.

    7. In § 75.414, add paragraphs (c)(1)(i) through (iii) and revise the first sentence of paragraph (f) to read as follows:
    § 75.414 Indirect (F&A) costs.

    (c) * * *

    (1) * * *

    (i) Indirect costs on training grants are limited to a fixed rate of eight percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000;

    (ii) Indirect costs on grants awarded to foreign organizations and foreign public entities and performed fully outside of the territorial limits of the U.S. may be paid to support the costs of compliance with federal requirements at a fixed rate of eight percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000; and,

    (iii) Negotiated indirect costs may be paid to the American University, Beirut, and the World Health Organization.

    (f) In addition to the procedures outlined in the appendices in paragraph (e) of this section, any non-Federal entity that has never received a negotiated indirect cost rate, except for those non-Federal entities described in paragraphs (c)(1)(i) and (ii) and section (D)(1)(b) of appendix VII to this part, may elect to charge a de minimis rate of 10% of modified total direct costs (MTDC) which may be used indefinitely.* * *

    8. Add § 75.477 to read as follows:
    § 75.477 Shared responsibility payments.

    (a) Payments for failure to maintain minimum essential health coverage. Any payments or assessments imposed on an individual or individuals pursuant to 26 U.S.C. 5000A(b) as a result of any failure to maintain minimum essential coverage as required by 26 U.S.C. 5000A(a) are not allowable expenses under Federal awards from an HHS awarding agency.

    (b) Payments for failure to offer health coverage to employees. Any payments or assessments imposed on an employer pursuant to 26 U.S.C. 4980H as a result of the employer's failure to offer to its full-time employees (and their dependents) the opportunity to enroll in minimum essential coverage under an eligible employer-sponsored plan are not allowable expenses under Federal awards from an HHS awarding agency.

    [FR Doc. 2016-29752 Filed 12-9-16; 8:45 am] BILLING CODE 4150-24-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 648 [Docket No. 151130999-6225-01] RIN 0648-XF069 Fisheries of the Northeastern United States; Atlantic Bluefish Fishery; Quota Transfer AGENCY:

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

    ACTION:

    Temporary rule; approval of quota transfer.

    SUMMARY:

    NMFS announces its approval of a transfer of 2016 commercial bluefish quota from the State of Maryland to the State of New York. The approval of the transfer complies with the Atlantic Bluefish Fishery Management Plan quota transfer provision. This announcement also informs the public of the revised commercial quotas for Maryland and New York.

    DATES:

    Effective December 9, 2016 through December 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Reid Lichwell, Fishery Management Specialist, (978) 281-9112.

    SUPPLEMENTARY INFORMATION:

    Regulations governing the Atlantic bluefish fishery are found in 50 CFR 648.160 through 648.167. The regulations require annual specification of a commercial quota that is apportioned among the coastal states from Maine through Florida. The process to set the annual commercial quota and the percent allocated to each state are described in § 648.162.

    The final rule implementing Amendment 1 to the Bluefish Fishery Management Plan published in the Federal Register on July 26, 2000 (65 FR 45844), and provided a mechanism for transferring bluefish quota from one state to another. Two or more states, under mutual agreement and with the concurrence of the Administrator, Greater Atlantic Region, NMFS (Regional Administrator), can request approval of a transfer of bluefish commercial quota under § 648.162(e)(1)(i) through (iii). The Regional Administrator must first approve any such transfer based on the criteria in § 648.162(e).

    Maryland and New York have requested the transfer of 50,000 lb (22,680 kg) of bluefish commercial quota from Maryland to New York. Both states have certified that the transfer meets all pertinent state requirements. This quota transfer was requested by New York to ensure that its 2016 quota would not be exceeded. The Regional Administrator has approved this quota transfer based on his determination that the criteria set forth in § 648.162(e)(1)(i) through (iii) have been met. The revised bluefish quotas for calendar year 2016 are: Maryland, 96,631 lb (43,831 kg); and New York, 927,289 lb (420,611 kg). These quota adjustments revise the quotas specified in the final rule implementing the 2016-2018 Atlantic Bluefish Specifications published on August 4, 2016 (81 FR 51370), and reflect all subsequent commercial bluefish quota transfers completed to date. For information of previous transfers for fishing year 2016 visit: http://go.usa.gov/xZT8H.

    Classification

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

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: December 7, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-29720 Filed 12-9-16; 8:45 am] BILLING CODE 3510-22-P
    81 238 Monday, December 12, 2016 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-9437; Directorate Identifier 2016-NM-131-AD] RIN 2120-AA64 Airworthiness Directives; Gulfstream Aerospace Corporation Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for all Gulfstream Aerospace Corporation Model G-IV airplanes. This proposed AD was prompted by a report indicating that the G-IV gust lock system allows more throttle travel than was intended and could allow the throttle to be advanced to reach take-off thrust. This proposed AD would require modification of the gust lock system, and a revision of the maintenance or inspection program to incorporate functional tests. We are proposing this AD to address the unsafe condition on these products.

    DATES:

    We must receive comments on this proposed AD by January 26, 2017.

    ADDRESSES:

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

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

    Fax: 202-493-2251.

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

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

    For service information identified in this NPRM, contact Gulfstream Aerospace Corporation, Technical Publications Dept., P.O. Box 2206, Savannah, GA 31402-2206; telephone 800-810-4853; fax 912-965-3520; email [email protected]; Internet http://www.gulfstream.com/product_support/technical_pubs/pubs/index.htm. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9437; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Gideon Jose, Aerospace Engineer, Systems and Equipment Branch, ACE-119A, FAA, Atlanta Aircraft Certification Office (ACO), 1701 Columbia Avenue, College Park, GA 30337; phone: 404-474-5569; fax: 404-474-5606; email: [email protected].

    SUPPLEMENTARY INFORMATION:

    Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-9437; Directorate Identifier 2016-NM-131-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

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

    Discussion

    We have received a report indicating that the G-IV gust lock system allows more throttle travel than was intended and could allow the throttle to be advanced to reach take-off thrust. The intended function of the gust lock system is to restrict throttle lever movement to a maximum of 6 degrees of forward travel, which provides an unmistakable warning to the pilot that the gust lock system is still engaged, prohibiting the use of the primary flight control surfaces. This condition, if not corrected, could result in the aircraft reaching near take-off thrust and high velocities without primary flight controls (aileron, elevator, and rudder) that can cause a failure to rotate and high-speed runway overrun.

    Related Service Information Under 1 CFR Part 51

    We reviewed Gulfstream IV Customer Bulletin Number 236A, dated August 8, 2016; Gulfstream G300 Customer Bulletin Number 236A, dated August 8, 2016; and Gulfstream G400 Customer Bulletin Number 236A, dated August 8, 2016. The service information describes procedures for modifying the gust lock system by doing a retrofit of the gust lock throttle interlock. These documents are distinct since they apply to different airplane models.

    We reviewed Gulfstream IV Maintenance Manual Temporary Revision (TR) 27-3, dated April 29, 2016; Gulfstream IV MSG-3 Maintenance Manual TR 27-3, dated April 29, 2016; Gulfstream G300 Maintenance Manual TR 27-3, dated April 29, 2016; and Gulfstream G400 Maintenance Manual TR 27-3, dated April 29, 2016. The service information describes procedures for a functional test of the throttle lever gust lock protection. These documents are distinct since they apply to different airplane models.

    We reviewed Gulfstream IV Maintenance Manual TR 5-7, dated April 29, 2016; Gulfstream IV MSG-3 Maintenance Manual TR 5-6, dated April 29, 2016; Gulfstream G300 Maintenance Manual TR 5-3, dated April 29, 2016; and Gulfstream G400 Maintenance Manual TR 5-3, dated April 29, 2016. The service information describes an airworthiness limitation (certification maintenance requirement) task to do functional tests of the throttle lever gust lock protection. These documents are distinct since they apply to different airplane models.

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

    FAA's Determination

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

    Proposed AD Requirements

    This proposed AD would require modification of the gust lock system, and a revision of the maintenance or inspection program to incorporate functional tests of the throttle level gust lock protection.

    Costs of Compliance

    We estimate that this proposed AD affects 425 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

    Estimated Costs Action Labor cost Parts cost Cost per
  • product
  • Cost on U.S. operators
    Modification and Maintenance or Inspection Program Revision 109 work-hours × $85 per hour = $9,265 $9,080 $18,345 $7,796,625

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

    According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

    Authority for This Rulemaking

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

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

    Regulatory Findings

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

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

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

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

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

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

    List of Subjects in 14 CFR Part 39

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

    The Proposed Amendment

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

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

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

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD): Gulfstream Aerospace Corporation: Docket No. FAA-2016-9437; Directorate Identifier 2016-NM-131-AD. (a) Comments Due Date

    We must receive comments by January 26, 2017.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all Gulfstream Aerospace Corporation Model G-IV airplanes, certificated in any category.

    (d) Subject

    Air Transport Association (ATA) of America Code 27, Flight controls.

    (e) Unsafe Condition

    This AD was prompted by a report indicating that the G-IV gust lock system allows more throttle travel than was intended and could allow the throttle to be advanced to reach take-off thrust. The intended function of the gust lock system is to restrict throttle lever movement to a maximum of 6 degrees of forward travel, which provides an unmistakable warning to the pilot that the gust lock system is still engaged, prohibiting the use of the primary flight control surfaces. We are issuing this AD to prevent the throttle lever movement from advancing more than 6 degrees of forward travel, which could result in the aircraft reaching near take-off thrust and high velocities without primary flight controls (aileron, elevator, and rudder) that can cause a failure to rotate and high speed runway overrun.

    (f) Compliance

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

    (g) Modification

    Within 36 months after the effective date of this AD, modify the gust lock system by doing a retrofit of the gust lock throttle interlock, in accordance with the applicable service information specified in paragraph (g)(1), (g)(2), or (g)(3) of this AD.

    (1) Gulfstream IV Customer Bulletin Number 236A, dated August 8, 2016.

    (2) Gulfstream G300 Customer Bulletin Number 236A, dated August 8, 2016.

    (3) Gulfstream G400 Customer Bulletin Number 236A, dated August 8, 2016.

    (h) Maintenance or Inspection Program Revision To Include a Functional Test

    Within 90 days after the effective date of this AD, revise the maintenance or inspection program, as applicable, to incorporate a functional test of the throttle lever gust lock protection specified in the applicable temporary revision (TR) identified in paragraphs (h)(1) through (h)(4) of this AD. The initial compliance time for the functional test is within the applicable time specified in paragraphs (h)(1) through (h)(4) of this AD, or within 90 days after the effective date of this AD, whichever occurs later. The functional test must be done in accordance with the applicable service information specified in paragraphs (i)(1) through (i)(4) of this AD.

    (1) For Gulfstream IV Maintenance Manual TR 5-7, dated April 29, 2016: Within 12 months or 4,500 flight hours, whichever occurs first after accomplishing the modification required by paragraph (g) of this AD.

    (2) For Gulfstream IV MSG-3 Maintenance Manual TR 5-6, dated April 29, 2016: Before the next 1C maintenance check or within 4,500 flight hours, whichever occurs first after accomplishing the modification required by paragraph (g) of this AD.

    (3) For Gulfstream G300 Maintenance Manual TR 5-3, dated April 29, 2016: Before the next 1C maintenance check or within 4,500 flight hours, whichever occurs first after accomplishing the modification required by paragraph (g) of this AD.

    (4) For Gulfstream G400 Maintenance Manual TR 5-3, dated April 29, 2016: Before the next 1C maintenance check or within 4,500 flight hours, whichever occurs first after accomplishing the modification required by paragraph (g) of this AD.

    (i) Service Information for the Functional Test of the Throttle Lever Gust Lock Protection

    The functional test of the throttle lever gust lock protection specified in paragraph (h) of this AD must be done in accordance with the applicable service information specified in paragraphs (i)(1) through (i)(4) of this AD.

    (1) Gulfstream IV Maintenance Manual TR 27-3, dated April 29, 2016.

    (2) Gulfstream IV MSG-3 Maintenance Manual TR 27-3, dated April 29, 2016.

    (3) Gulfstream G300 Maintenance Manual TR 27-3, dated April 29, 2016.

    (4) Gulfstream G400 Maintenance Manual TR 27-3, dated April 29, 2016.

    (j) No Alternative Actions and Intervals

    After the maintenance or inspection program has been revised as required by paragraph (h) of this AD, no alternative actions (e.g., inspections) or intervals may be used unless the actions or intervals are approved as an alternative method of compliance (AMOC) in accordance with the procedures specified in paragraph (m) of this AD.

    (k) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using the applicable service information identified in paragraph (k)(1), (k)(2), or (k)(3) of this AD.

    (1) Gulfstream IV Customer Bulletin Number 236, dated June 1, 2016.

    (2) Gulfstream G300 Customer Bulletin Number 236, dated June 1, 2016.

    (3) Gulfstream G400 Customer Bulletin Number 236, dated June 1, 2016.

    (l) Exception for Reporting and Return of Parts

    Although the service information identified in paragraph (g) of this AD specifies to submit certain information to the manufacturer and to return parts to the manufacturer, this AD does not include those requirements.

    (m) Alternative Methods of Compliance (AMOCs)

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

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

    (3) Except as required by paragraph (l) of this AD: For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (m)(3)(i) and (m)(3)(ii) of this AD apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

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

    (n) Related Information

    (1) For more information about this AD, contact Gideon Jose, Aerospace Engineer, Systems and Equipment Branch, ACE-119A, FAA, Atlanta ACO, 1701 Columbia Avenue, College Park, GA 30337; phone: 404-474-5569; fax: 404-474-5606; email: [email protected]

    (2) For service information identified in this AD, contact Gulfstream Aerospace Corporation, Technical Publications Dept., P.O. Box 2206, Savannah, GA 31402-2206; telephone 800-810-4853; fax 912-965-3520; email [email protected]; Internet http://www.gulfstream.com/product_support/technical_pubs/pubs/index.htm. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on November 25, 2016. John P. Piccola, Jr., Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-29257 Filed 12-9-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2016-9266; Airspace Docket No. 16-ASO-5] Proposed Establishment of Class E Airspace; Kill Devil Hills, NC AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to establish Class E airspace at Kill Devil Hills, NC, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures (SIAPs) serving First Flight Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the heliport.

    DATES:

    Comments must be received on or before January 26, 2017.

    ADDRESSES:

    Send comments on this rule to: U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Bldg. Ground Floor, Rm. W12-140, Washington, DC 20590; Telephone: 1-800-647-5527, or 202-647-9826. You must identify the Docket No. FAA-2016-9266; Airspace Docket No. 16-ASO-5, at the beginning of your comments. You may also submit and review received comments through the Internet at http://www.regulations.gov. You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays.

    FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: 202-267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11A at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

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

    Comments Invited

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

    Communications should identify both docket numbers and be submitted in triplicate to the address listed above. You may also submit comments through the Internet at http://www.regulations.gov.

    Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-9266; Airspace Docket No. 16-ASO-5.” The postcard will be date/time stamped and returned to the commenter.

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

    Availability of NPRMs

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

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

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to establish Class E airspace at Kill Devil Hills, NC, providing the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for First Flight Airport. Controlled airspace extending upward from 700 feet above the surface within a 6.5-mile radius of the airport would be established for IFR operations.

    Class E airspace designations are published in Paragraph 6005 of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

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

    Environmental Review

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

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, effective September 15, 2016, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASO NC E5 Kill Devil Hills, NC [New] First Flight Airport, NC (Lat. 36°1′3″ N., long. 75°40′18″ W.) That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of First Flight Airport. Issued in College Park, Georgia, on December 1, 2016. Ryan W. Almasy, Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
    [FR Doc. 2016-29630 Filed 12-9-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2015-0581; Airspace Docket No. 15-ASO-4] Proposed Establishment of Class E Airspace; Louisville, GA AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    This action proposes to establish Class E Airspace at Louisville, GA, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures (SIAPs) serving Louisville Municipal Airport. Controlled airspace is necessary for the safety and management of Instrument Flight Rules (IFR) operations at the heliport.

    DATES:

    Comments must be received on or before January 26, 2017.

    ADDRESSES:

    Send comments on this rule to: U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Bldg. Ground Floor, Rm. W12-140, Washington, DC 20590; Telephone: 1-800-647-5527, or 202-647-9826. You must identify the Docket No. FAA-2015-0581; Airspace Docket No. 15-ASO-4, at the beginning of your comments. You may also submit and review received comments through the Internet at http://www.regulations.gov. You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays.

    FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: 202-267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11A at NARA, call 202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

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

    SUPPLEMENTARY INFORMATION:

    Authority for This Rulemaking

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

    Comments Invited

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

    Communications should identify both docket numbers and be submitted in triplicate to the address listed above. You may also submit comments through the Internet at http://www.regulations.gov.

    Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2015-0581; Airspace Docket No. 15-ASO-4.” The postcard will be date/time stamped and returned to the commenter.

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

    Availability of NPRMs

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

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

    Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11A lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to establish Class E airspace at Louisville, GA, providing the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for Louisville Municipal Airport. Controlled airspace extending upward from 700 feet above the surface within a 6.8-mile radius of the airport would be established for IFR operations.

    Class E airspace designations are published in Paragraph 6005 of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

    Regulatory Notices and Analyses

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

    Environmental Review

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

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    The Proposed Amendment

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

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

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

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, effective September 15, 2016, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASO GA E5 Louisville, GA [New] Louisville Municipal Airport, GA (Lat. 32°59′09″ N., long. 82°23′05″ W.)

    That airspace extending upward from 700 feet above the surface within a 6.8-mile radius of Louisville Municipal Airport.

    Issued in College Park, Georgia, on November 30, 2016. Ryan W. Almasy, Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
    [FR Doc. 2016-29631 Filed 12-9-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1310 [Docket No. DEA-379] RIN 1117-ZA04 Designation of Alpha-Phenylacetoacetonitrile (APAAN), a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical AGENCY:

    Drug Enforcement Administration, Department of Justice.

    ACTION:

    Notice of proposed rulemaking.

    SUMMARY:

    The Drug Enforcement Administration is proposing to designate the chemical alpha-phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers, as a list I chemical under the Controlled Substances Act. APAAN is used in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine and is important to the manufacture of these controlled substances. This action does not propose the establishment of a threshold for domestic and international transactions of APAAN. As such, all transactions involving APAAN, regardless of size, would be regulated. In addition, this action proposes that chemical mixtures containing APAAN would not be exempt from regulatory requirements at any concentration. Therefore, all transactions of chemical mixtures containing any quantity of APAAN would be regulated pursuant to the Controlled Substances Act.

    DATES:

    Electronic comments must be submitted, and written comments must be postmarked, on or before January 11, 2017. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.

    ADDRESSES:

    To ensure proper handling of comments, please reference “Docket No. DEA-379” on all correspondence, including any attachments.

    The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the Web page or to attach a file for lengthier comments. Please go to http://www.regulations.gov/ and follow the online instructions at that site for submitting comments. Upon completion of your submission, you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. Paper comments that duplicate the electronic submission are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152.

    FOR FURTHER INFORMATION CONTACT:

    Michael J. Lewis, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.

    SUPPLEMENTARY INFORMATION: Posting of Public Comments

    Please note that all comments received are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all of the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

    If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.

    Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

    An electronic copy of this proposed rule is available at http://www.regulations.gov for easy reference.

    Legal Authority

    The DEA implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21 U.S.C. 801-971. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.

    The CSA gives the Attorney General the authority to specify, by regulation, chemicals as list I or list II chemicals. 21 U.S.C. 802(34) and (35). A “list I chemical” is a chemical that is used in manufacturing a controlled substance in violation of title II of the CSA and is important to the manufacture of the controlled substance. 21 U.S.C. 802(34). A “list II chemical” is a chemical (other than a list I chemical) that is used in manufacturing a controlled substance in violation of title II of the CSA. 21 U.S.C. 802(35). The current list of all listed chemicals is published at 21 CFR 1310.02. Pursuant to 28 CFR 0.100(b), the Attorney General has delegated her authority to designate list I and list II chemicals to the Administrator of the Drug Enforcement Administration.

    In addition, the United States is a Party to the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988 Convention). When the United States receives notification that a chemical has been added to Table I or Table II of the 1988 Convention pursuant to article 12, the United States is required to take measures it deems appropriate to monitor the manufacture and distribution of that chemical within the United States and to prevent its diversion. In addition, the 1988 Convention requires the United States to take other specified measures related to that chemical, including measures related to its international trade.

    Background

    By a letter dated April 9, 2014, the Secretary-General of the United Nations informed the United States Government that the chemical alpha-phenylacetoacetonitrile (APAAN) was added to Table I of the 1988 Convention. This letter was prompted by a March 19, 2014, decision at the 57th Session of the United Nations Commission on Narcotic Drugs (CND) to add APAAN to Table I. As a Party to the 1988 Convention, the United States is obligated, pursuant to article 12, to take measures it deems appropriate to monitor the manufacture and distribution of APAAN within the United States and to prevent its diversion. Article 12 also obligates the United States to take other specified measures related to APAAN, including measures related to its international trade. By designating APAAN as a list I chemical, the United States will fulfill its obligations under the 1988 Convention.

    APAAN is a primary precursor for the manufacture of phenylacetone (also known as phenyl-2-propanone (P2P) or benzyl methyl ketone), methamphetamine, and amphetamine. Throughout the 1970s, methamphetamine was illicitly produced in the United States, primarily with the precursor chemical P2P. In response to the illicit use of P2P, the DEA controlled P2P as a schedule II controlled substance in 1980 pursuant to the “immediate precursor” provisions of the CSA, specifically 21 U.S.C. 811(e). Clandestine laboratory operators responded by developing a variety of synthetic methods for producing P2P.

    Congress and the DEA responded with the implementation of controls on P2P precursor chemicals such as phenylacetic acid (and its salts and esters), acetic anhydride, benzyl cyanide, benzaldehyde, and nitroethane, all of which are controlled as listed chemicals. 21 CFR 1310.02 (a)-(b). However, clandestine laboratory operators soon adjusted to these controls on P2P (and its precursors). As an alternative for methamphetamine production, clandestine laboratory operators used the precursors ephedrine and pseudoephedrine, and as an alternative for amphetamine production, they used the precursor phenylpropanolamine.

    This led Congress and the DEA to implement stringent controls on the manufacture, distribution, importation, and exportation of ephedrine (its salts, optical isomers, and salts of optical isomers), pseudoephedrine, and phenylpropanolamine (controlled as list I chemicals), and pharmaceutical products containing these chemicals. The international community soon took similar measures.

    With the growing problem of illicit drug production, the issue of precursor chemical control has gained global attention. International efforts to prevent the illicit production of amphetamine-type stimulants (including amphetamine and methamphetamine), and international control of precursors, have made significant progress. International controls on precursors were established under article 12 of the 1988 Convention.1 The 1988 Convention established two categories of controlled illicit drug precursor substances: Table I and Table II.2 Two international entities have played a crucial role in this effort: The United Nations Commission on Narcotic Drugs (CND) and the International Narcotics Control Board.

    1 Dec. 20, 1988, 1582 U.N.T.S. 95.

    2 Table I and Table II are annexed to the Convention.

    In response to domestic and international controls on amphetamine and methamphetamine precursors, clandestine laboratory operators have continued to explore alternate methods of making these illicit drugs, including developing techniques to manufacture their own precursors and diverting other precursors to produce these precursors. This has led clandestine laboratory operators to utilize the P2P precursor APAAN. Clandestine laboratory operators currently use APAAN to manufacture P2P, which they then convert to methamphetamine and amphetamine.

    APAAN

    APAAN also goes by the names: 1-cyano-1-phenylpropan-2-one; 2-phenylacetoacetonitrile; 2-acetyl-2-phenylacetonitrile; alpha-acetyl-benzene acetonitrile; phenyl aceto-acetonitrile; α-acetylphenylacetonitrile; 3-oxo-2-phenylbutanenitrile; CAS Number: 4468-48-8; and Identification Number: UN3439.

    The DEA has long been aware of APAAN's potential illicit use as a primary precursor for the production of P2P. The synthesis of P2P from benzyl cyanide involves the manufacture of APAAN prior to the final synthesis of P2P. Therefore, benzyl cyanide and APAAN share the same synthetic pathway in the production of P2P. In the late 1980's the DEA advocated for the Congressional control of the P2P precursor benzyl cyanide as a list I chemical.

    Due to the lack of industrial uses of APAAN, there has historically been a lack of available product for potential diversion. In recent years, however, large international seizures of APAAN have been made, primarily in Europe, which suggest there is a ready supply of APAAN from international chemical manufacturers.

    While the DEA has encountered one clandestine laboratory in the United States utilizing this synthetic pathway in recent years, the DEA's European counterparts have made a large number of APAAN seizures. For calendar years 2009 through 2014, the European Commission has documented at least 113 seizures and stop shipments, involving over 80 metric tons of APAAN. Many of these seizures were associated with seizures of P2P and amphetamine. Many of these APAAN seizures originated from chemical suppliers based in Asia.

    The DEA has determined that APAAN is now readily available from commercial chemical suppliers and has identified 34 potential suppliers in China, 6 potential suppliers in the United States, 2 in Russia, and 1 each in Bulgaria, Cameroon, the Czech Republic, France, and Germany.

    The DEA is concerned about the ease with which APAAN serves as a precursor chemical for illicit controlled substance production and with the international trafficking in this chemical. The international community echoes this concern. As noted above, the CND has added APAAN to Table I of the 1988 Convention. Therefore, the DEA is proposing the designation of APAAN as a list I chemical.

    Proposed Designation of APAAN and Its Salts, Optical Isomers, and Salts of Optical Isomers as a List I Chemical

    The CSA, specifically 21 U.S.C. 802(34), and its implementing regulations at 21 CFR 1310.02(c), provides the Attorney General with the authority to specify, by regulation, a chemical as a “list I chemical” if the chemical is used in the manufacture of a controlled substance in violation of the CSA and is important to the manufacture of these controlled substances. Clandestine laboratory operators are using APAAN as the precursor material for the illicit manufacture of P2P, methamphetamine, and amphetamine. These three substances are all controlled substances under the CSA. APAAN is a primary precursor for P2P, for subsequent conversion to methamphetamine or amphetamine. Therefore, APAAN is important to the manufacture of a controlled substance. This action proposes the designation of APAAN as a list I chemical because the DEA finds that APAAN is used in the illicit manufacture of these controlled substances and is important to the illicit manufacture of these controlled substances.

    If finalized, handlers of APAAN would become subject to the chemical regulatory provisions of the CSA, including 21 CFR parts 1309, 1310, 1313, and 1316. Since even a small amount of APAAN can make a significant amount of P2P, this action does not propose the establishment of a threshold for domestic and import transactions of APAAN in accordance with the provisions of 21 CFR 1310.04(g). Therefore, the DEA is proposing that all APAAN transactions, regardless of size, will be regulated transactions as defined in 21 CFR 1300.02(b). As such, if finalized, all APAAN transactions will be subject to recordkeeping, reporting, import and export controls, and other CSA chemical regulatory requirements. In addition, each regulated bulk manufacturer shall submit manufacturing, inventory, and use data on an annual basis.

    Chemical Mixtures of APAAN

    This rulemaking also proposes that chemical mixtures containing APAAN would not be exempt from regulatory requirements at any concentration unless an application for exemption of a chemical mixture is submitted by an APAAN manufacturer and the application is reviewed and accepted and the mixture exempted by the DEA under 21 CFR 1310.13 (Exemption by Application Process). Since even a small amount of APAAN yields a significant amount of P2P, the DEA believes that regulation of chemical mixtures containing any amount of APAAN is necessary to prevent the illicit extraction, isolation, and use of the APAAN. Therefore, all chemical mixtures containing any quantity of APAAN would be subject to CSA control, unless the APAAN manufacturer is granted an exemption by the application process in accordance with 21 CFR 1310.13. This rule proposes the modification of the “Table of Concentration Limits” in 21 CFR 1310.12(c) to reflect the fact that chemical mixtures containing any amount of APAAN are subject to CSA chemical control provisions.

    Exemption by Application Process

    The DEA has implemented an application process to exempt certain chemical mixtures from the requirements of the CSA and its implementing regulations. 21 CFR 1310.13. Manufacturers may submit an application for exemption for those mixtures that do not qualify for automatic exemption. Exemption status may be granted if the DEA determines that the mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance and that the listed chemical or chemicals cannot be readily recovered. 21 CFR 1310.13(a)(1)-(2).

    Requirements for Handling List I Chemicals

    If finalized as proposed, the designation of APAAN as a list I chemical will subject APAAN handlers (manufacturers, distributors, importers, and exporters), and proposed handlers, to all of the regulatory controls and administrative, civil, and criminal actions applicable to the manufacture, distribution, importing, and exporting of a list I chemical. Upon publication of a final rule, persons potentially handling APAAN, including regulated chemical mixtures containing APAAN, would be required to comply with the following list I chemical regulations:

    1. Registration. Any person who manufactures, distributes, imports, or exports APAAN, or proposes to engage in the manufacture, distribution, importation, or exportation of APAAN, must obtain a registration pursuant to 21 U.S.C. 822, 823, 957, 958. Regulations describing registration for list I chemical handlers are set forth in 21 CFR part 1309. Consistent with 21 CFR parts 1309 and 1310, separate registrations will be required for manufacturing, distribution, importing, and exporting of APAAN. Different locations operated by a single entity require separate registration if any location is involved with the manufacture, distribution, importation, or exportation of APAAN. Further, a separate registration is required for each principal place of business at one general physical location where list I chemicals are manufactured, distributed, imported, or exported by a person. 21 CFR 1309.23. Any person manufacturing, distributing, importing, or exporting an APAAN chemical mixture will be subject to the registration requirement under the CSA as well.

    The DEA notes that warehouses are exempt from the requirement of registration and may lawfully possess list I chemicals, if the possession of those chemicals is in the usual course of business or employment. 21 U.S.C. 822(c)(2), 21 U.S.C. 957(b)(1)(B). For purposes of this exemption, the warehouse must receive the list I chemical from a DEA registrant and shall only distribute the list I chemical back to the DEA registrant and registered location from which it was received. All other activities conducted by a warehouse do not fall under this exemption; a warehouse that distributes list I chemicals to persons other than the registrant and registered location from which they were obtained is conducting distribution activities and is required to register as such. 21 CFR 1309.23(b)(1).

    Upon publication of a final rule, any person manufacturing, distributing, importing, or exporting APAAN or a chemical mixture containing APAAN will become subject to the registration requirement under the CSA. The DEA recognizes, however, that it is not possible for persons who are subject to the registration requirement to immediately complete and submit an application for registration and for the DEA to immediately issue registrations for those activities. Therefore, to allow continued legitimate commerce in APAAN, the DEA is proposing to establish in 21 CFR 1310.09 a temporary exemption from the registration requirement for persons desiring to engage in activities with APAAN, provided that the DEA receives a properly completed application for registration on or before 30 days after publication of a final rule implementing regulations regarding APAAN. The temporary exemption for such persons will remain in effect until the DEA takes final action on their application for registration or application for exemption of a chemical mixture.

    The temporary exemption applies solely to the registration requirement; all other chemical control requirements, including recordkeeping and reporting, would become effective on the effective date of the final rule. Therefore, all transactions of APAAN and chemical mixtures containing APAAN will be regulated while an application for registration or exemption is pending. This is necessary because not regulating these transactions could result in increased diversion of chemicals desirable to drug traffickers.

    Additionally, the temporary exemption does not suspend applicable federal criminal laws relating to APAAN, nor does it supersede State or local laws or regulations. All handlers of APAAN must comply with applicable State and local requirements in addition to the CSA regulatory controls.

    2. Records and Reports. Every DEA registrant would be required to maintain records and reports with respect to APAAN pursuant to 21 U.S.C. 830 and in accordance with 21 CFR part 1310. Pursuant to 21 CFR 1310.04, a record must be made and maintained for two years after the date of a transaction involving a listed chemical, provided the transaction is a regulated transaction.

    Each regulated bulk manufacturer of a listed chemical will be required to submit manufacturing, inventory, and use data on an annual basis. 21 CFR 1310.05(d). Existing standard industry reports containing the required information will be acceptable, provided the information is separate or readily retrievable from the report.

    21 CFR 1310.05(a) requires that each regulated person shall report to the DEA any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of the CSA and its corresponding regulations. Regulated persons are also required to report any proposed regulated transaction with a person whose description or other identifying characteristics the Administration has previously furnished to the regulated person; any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person; any in-transit loss in which the regulated person is the supplier; and any domestic regulated transaction in a tableting or encapsulating machine.

    3. Importation and Exportation. All importation and exportation of APAAN would need to be in compliance with 21 U.S.C. 957, 958, and 971 and in accordance with 21 CFR part 1313.

    4. Security. All applicants and registrants would be required to provide effective controls against theft and diversion in accordance with 21 CFR 1309.71-1309.73.

    5. Administrative Inspection. Places, including factories, warehouses, or other establishments and conveyances, where registrants or other regulated persons may lawfully hold, manufacture, distribute, or otherwise dispose of a list I chemical or where records relating to those activities are maintained, are controlled premises as defined in 21 U.S.C. 880(a) and 21 CFR 1316.02(c). The CSA (21 U.S.C. 880) allows for administrative inspections of these controlled premises as provided in 21 CFR part 1316, subpart A.

    6. Liability. Any activity involving APAAN not authorized by, or in violation of, the CSA, would be unlawful, and may subject the person to administrative, civil, and/or criminal action.

    Regulatory Analyses Executive Orders 12866 and 13563

    This notice of proposed rulemaking, which proposes the designation of APAAN as a list I chemical, has been developed in accordance with the principles of Executive Orders 12866 and 13563. The DEA followed the principles of these Executive Orders, even though it has been determined that this action is not a significant regulatory action.

    To determine whether this action is a significant regulatory action, the DEA utilized a least cost option analysis. At the outset, the DEA determined that the primary costs of this rule would come from complying with the registration, recordkeeping, reporting, and export and import requirements set forth in the CSA. Therefore, under the least cost option, an entity would choose to discontinue the sale of APAAN if proceeds from the sale are less than the cost of complying with the rule.

    The DEA has not identified any industrial uses of APAAN by domestic entities and its potential usage appears to be limited to research. Based on independent research following a 2013 United Nations Questionnaire/Survey on APAAN, the DEA identified three entities that have each imported APAAN. Two of the three entities had average annual sales of APAAN totaling $13 during the analysis period. The third entity had average annual sales of APAAN totaling $1,440 during the same period. Other chemical distributors list APAAN in their chemical catalogs. However, these entities do not manufacture APAAN, instead opting to purchase APAAN from international sources to fill special orders. These entities do not stock APAAN in inventory and the vast majority had no previous sales of APAAN.

    The registration fee to import a list I chemical is $1,523 per year. Based on the least cost option, these three entities would choose to discontinue the sale of APAAN because complying with the rule is more costly. Thus, the annual economic impact of the rule is $1,467 (total annual sales of APAAN from the three affected entities). Therefore, this is evidence that this proposed rule would not have an annual effect on the economy of $100 million or more and is not a significant regulatory action.

    Executive Order 12988

    This proposed regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

    Executive Order 13132

    This proposed rulemaking does not have federalism implications warranting the application of Executive Order 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.

    Executive Order 13175

    This proposed rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

    Regulatory Flexibility Act

    The Acting Administrator, in accordance with the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, has reviewed this proposed rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. The purpose of this proposed rule is to designate APAAN as a list I chemical under the CSA. No less restrictive measures (i.e., non-control or control in list II) would enable the DEA to meet its statutory obligation under the CSA and its international obligations of the 1988 Convention. The DEA estimates that this rule affects three small entities. As discussed above, the DEA compared the dollar value of APAAN sales to the cost of registration. Further, the DEA assumed that if the cost of registration is more than the dollar value of APAAN sales, then each entity would discontinue the sale of APAAN.

    Two entities earned $13 in annual sales of APAAN while the third entity earned $1,440 in annual sales of APAAN. The cost of registration alone is $1,523 for each entity. Therefore, the DEA anticipates that each entity will discontinue the sale of APAAN because the cost of compliance is greater than the annual sales. As a result, the annual economic impact of the rule is $1,467.

    Using 1% of annual revenue as the criteria for significant economic impact, the DEA estimates that none of the three small entities will experience a significant economic impact if the proposed rule is finalized. The cost of the rule as a percentage of annual revenue for the three entities is, 0.00044%, 0.00036%, and 0.038%, respectively, which is less than 1% of the entities' annual income. Therefore, the proposed rule will not have a significant effect on a substantial number of small entities.

    Unfunded Mandates Reform Act of 1995

    On the basis of information contained in the “Regulatory Flexibility Act” section above, the DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501 et seq., that this action would not result in 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 for inflation) in any one year. Therefore, neither a Small Government Agency Plan nor any other action is required under provisions of the UMRA of 1995.

    Paperwork Reduction Act

    This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. The DEA does not anticipate that it will receive new registration applications for the purpose of engaging in transactions involving this chemical. The transactions in this chemical of which the DEA is aware are very small, and it does not appear to the DEA that it would be economically justifiable because DEA believes there is no legitimate market for manufacturing or engaging in commercial transactions in this chemical. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. 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.

    List of Subjects 21 CFR Part 1310

    Drug traffic control, Exports, Imports, Reporting and recordkeeping requirements.

    Accordingly, for the reasons set forth in the preamble, part 1310 of title 21 of the Code of Federal Regulations is proposed to be amended as follows:

    PART 1310—RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES 1. The authority citation for part 1310 continues to read as follows: Authority:

    21 U.S.C. 802, 827(h), 830, 871(b), 890.

    2. Amend § 1310.02 by redesignating paragraphs (a)(1) through (a)(30) as paragraphs (a)(2) through (a)(31), respectively, and adding a new paragraph (a)(1) in the table “List I chemicals” to read as follows:
    § 1310.02 Substances covered.

    (a) * * *

    (1) Alpha-phenylacetoacetonitrile and its salts, optical isomers, and salts of optical isomers (APAAN) 8512
    3. Amend § 1310.04 by redesignating paragraphs (g)(1)(i) through (g)(1)(x) as paragraphs (g)(1)(ii) through (g)(1)(xi), respectively, and adding a new paragraph (g)(1)(i) to read as follows:
    § 1310.04 Maintenance of records.

    (g) * * *

    (1) * * *

    (i) Alpha-phenylacetoacetonitrile and its salts, optical isomers, and salts of optical isomers (APAAN)

    4. Amend § 1310.09 by adding new paragraph (n) to read as follows:
    § 1310.09 Temporary exemption from registration.

    (n)(1) Each person required under Sections 302 and 1007 of the Act (21 U.S.C. 822, 957) to obtain a registration to manufacture, distribute, import, or export regulated alpha-phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers, including regulated chemical mixtures pursuant to Section 1310.12 of this part, is temporarily exempted from the registration requirement, provided that the DEA receives a properly completed application for registration or application for exemption for a chemical mixture containing alpha-phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers, pursuant to Section 1310.13 of this part on or before (30 days after publication of a Final Rule implementing regulations regarding APAAN). The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in the Act and parts 1309, 1310, 1313, and 1316 of this chapter remain in full force and effect.

    (2) Any person who manufactures, distributes, imports or exports a chemical mixture containing alpha-phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers whose application for exemption is subsequently denied by the DEA must obtain a registration with the DEA. A temporary exemption from the registration requirement will also be provided for those persons whose applications for exemption are denied, provided that the DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has been denied. The temporary exemption for such persons will remain in effect until the DEA takes final action on their registration application.

    5. Amend § 1310.12 paragraph (c) by adding in alphabetical order an entry “Alpha-phenylacetoacetonitrile, and its salts, optical isomers, and salts of optical isomers. (APAAN)” in the table “Table of Concentration Limits” to read as follows:
    § 1310.12 Exempt chemical mixtures.

    (c) * * *

    Table of Concentration Limits DEA chemical code No. Concentration Special conditions *         *         *         *         *         *         * Alpha-phenylacetoacetonitrile, and its salts, optical isomers, and salts of optical isomers. (APAAN) 8512 Not exempt at any concentration Chemical mixtures containing any amount of APAAN are not exempt. *         *         *         *         *         *         *
    Dated: December 2, 2016. Chuck Rosenberg, Acting Administrator.
    [FR Doc. 2016-29523 Filed 12-9-16; 8:45 am] BILLING CODE 4410-09-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2016-0660; FRL-9956-27-Region 9] Approval of California Air Plan; Owens Valley Serious Area Plan for the 1987 24-Hour PM10 Standard AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve a state implementation plan (SIP) revision submitted by the State of California and Great Basin Unified Air Pollution Control District (GBUAPCD or “District”) to meet Clean Air Act (CAA or “Act”) requirements applicable to the Owens Valley PM10 nonattainment area (NA). The Owens Valley PM10 NA is located in the southern portion of the Owens Valley in Inyo County, California. It is classified as a Serious nonattainment area for the national ambient air quality standards (NAAQS) for particulate matter of ten microns or less (PM10). The submitted SIP revision is the “Great Basin Unified Air Pollution Control District 2016 Owens Valley Planning Area PM10 State Implementation Plan” (“2016 PM10 Plan” or “Plan”). The GBUAPCD's obligation to submit the 2016 PM10 Plan was triggered by the EPA's 2007 finding that the Owens Valley PM10 NA had failed to meet its December 31, 2006, deadline to attain the PM10 NAAQS. The CAA requires a Serious PM10 nonattainment area that fails to meet its attainment deadline to submit a plan providing for attainment of the PM10 NAAQS and for an annual emission reduction in PM10 of not less than five percent until attainment of the PM10 NAAQS. The EPA is proposing to approve the 2016 PM10 Plan as meeting all relevant statutory and regulatory requirements.

    DATES:

    Any comments on this proposal must arrive by January 11, 2017.

    ADDRESSES:

    Submit comments, identified by docket number EPA-R09-OAR-2016-0660, at http://www.regualtions.gov, or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the Web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the EPA's full public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Ginger Vagenas, EPA Region IX, 415-972-3964, [email protected]

    SUPPLEMENTARY INFORMATION:

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

    Table of Contents I. Background: PM10 Air Quality Planning in the Owens Valley PM10 Nonattainment Area A. Planning History B. Description of the Owens Valley PM10 Nonattainment Area C. Public Notice, Public Hearing, and Completeness Requirements for SIP Submittals D. CAA Requirements for PM10 Serious Area Plans II. Evaluation of the Owens Valley PM10 Plan's Compliance With CAA Requirements A. Review of the Owens Valley PM10 Nonattainment Area Emissions Inventories B. Demonstration of Attainment C. Five Percent Requirement D. BACM/BACT and Adopted Control Strategy E. Reasonable Further Progress/Quantitative Milestones F. Contingency Measures G. Transportation Conformity III. Summary of the EPA's Proposed Action IV. Statutory and Executive Order Reviews I. Background: PM10 Air Quality Planning in the Owens Valley PM10 Nonattainment Area A. Planning History

    The NAAQS are standards for certain ambient air pollutants set by the EPA to protect public health and welfare. PM10 is among the ambient air pollutants for which the EPA has established health-based standards. By penetrating deep in the lungs, PM10 causes adverse health effects including lung damage, increased respiratory disease, and premature death. Children, the elderly, and people with asthma and heart conditions are the most vulnerable.

    On July 1, 1987, the EPA revised the health-based national ambient air quality standards, replacing the standards for total suspended particulates with new standards applying only to PM10.1 At that time, the EPA established two PM10 standards, annual and 24-hour. Effective December 18, 2006, the EPA revoked the annual PM10 standard but retained the 24-hour PM10 standard.2 The 24-hour PM10 standard of 150 micrograms per cubic meter (μg/m3) is attained when the expected number of days with a 24-hour average concentration above 150 μg/m3 per calendar year averaged over a three-year period, as determined in accordance with appendix K to 40 CFR part 50, is equal to or less than one.3

    1 52 FR 24672.

    2 71 FR 61144 (October 17, 2006).

    3 40 CFR 50.6 and 40 CFR part 50, appendix K.

    On the date of enactment of the 1990 CAA Amendments, the Owens Valley (along with many other areas meeting the qualifications of section 107(d)(4)(B) of the amended Act) was designated nonattainment by operation of law.4 The Owens Valley PM10 NA is located in Inyo County in east-central California. The EPA codified the boundaries of the Owens Valley PM10 NA at 40 CFR 81.305.

    4 56 FR 11101 (March 15, 1991).

    Once an area is designated nonattainment for PM10, section 188 of the CAA outlines the process for classifying the area as Moderate or Serious and establishes the area's attainment deadline. In accordance with section 188(a), at the time of designation, all PM10 nonattainment areas, including the Owens Valley PM10 NA, were initially classified as Moderate. A Moderate PM10 nonattainment area can subsequently be reclassified as Serious either before the applicable attainment date if the EPA determines the area cannot practicably attain the PM10 NAAQS by this attainment date, or after the passage of the applicable Moderate area PM10 attainment date if the EPA determines that the area has failed to attain the standard. In accordance with section 188(b)(1) of the CAA, on February 8, 1993, the EPA determined the Owens Valley PM10 NA could not practicably attain the PM10 NAAQS by December 31, 1994 and reclassified the area as Serious.5

    5 58 FR 3334 (January 8, 1993).

    As a Serious area, the Owens Valley PM10 NA acquired a new attainment deadline of no later than December 31, 2001. CAA section 188(c)(2). However, CAA section 188(e) authorizes the EPA to grant up to a 5-year extension of that attainment deadline if certain conditions are met by the state. In order to obtain the extension, the state must make a SIP submission showing that: (1) Attainment by the applicable attainment date would be impracticable; (2) the state complied with all requirements and commitments pertaining to the area in the implementation plan for the area; and (3) the plan for the area includes the most stringent measures (MSM) that are included in the implementation plan of any state or are achieved in practice in any state and can feasibly be implemented in the specific area.

    In its 1998 Owens Valley PM10 Plan (submitted to the EPA on September 10, 1998), California requested an attainment date extension under CAA section 188(e) for the Owens Valley PM10 NA from December 31, 2001 to December 31, 2006. On September 3, 1999, the EPA approved the Serious area 1998 PM10 Plan for the Owens Valley PM10 NA as meeting the requirements for such areas in CAA sections 189(b) and (c), including the requirements for implementation of best available control measures (BACM) in section 189(b)(1)(B) and MSM in section 188(e). In the same action, the EPA approved the submission with respect to the requirements of section 188(e) and granted California's request to extend the attainment date for the area to December 31, 2006. This final action and the proposal preceding it provide a more detailed discussion of the history of PM10 planning in the Owens Valley PM10 NA.6

    6See 64 FR 34173 (June 25, 1999) and 64 FR 48305 (September 3, 1999).

    On June 6, 2007, the EPA found that the Owens Valley PM10 NA failed to attain the 24-hour PM10 NAAQS by the applicable attainment date of December 31, 2006.7 Accordingly, the State was required to submit a new plan meeting the requirements of section 189(d) by December 31, 2007.

    7 72 FR 31183.

    The Governing Board of the GBUAPCD adopted the “2008 Owens Valley PM10 Planning Area Demonstration of Attainment State Implementation Plan” (“2008 Plan”) on February 1, 2008. The 2008 Plan, which included a request for an attainment date extension, was submitted by the State to the EPA on June 11, 2009. The 2008 Plan was subsequently updated and superseded by the submittal of the 2016 PM10 Plan, which reiterates the request for an attainment date extension and incorporates agreements reached between the GBUAPCD and the City of Los Angeles, and is the subject of this action.8

    8See Chapter 8 of the 2016 PM10 Plan and letter from Phillip L. Kiddoo, Air Pollution Control Officer, GBUAPCD to Elizabeth Adams, Acting Air Division Director, U.S. EPA, Region 9, dated October 26, 2016.

    B. Description of the Owens Valley PM10 Nonattainment Area

    Owens Lake is located in Inyo County in east central California in the southern portion of the Owens Valley. It is part of a chain of lakes formed over 140,000 thousand years ago.9 In 1913, the Los Angeles Department of Water and Power (LADWP) completed an aqueduct system and began diverting the waters of the Owens River to the City of Los Angeles. By 1930, these diversions from the Owens River had drained the Owens Lake almost completely dry.10

    9 2016 PM10 Plan, p. 7.

    10Id., p. 8.

    Strong winds blowing over the surface of the dry, alkaline bed of the Owens Lake have produced among the highest measured concentrations of PM10 ever recorded, including a monitored reading that exceeded 12,000 μg/m3—more than 80 times over the federal 24-hour standard.11 Past data from the EPA's approval of the 1998 PM10 Plan indicated that during days when violations were recorded, 94 percent of the PM10 concentrations came from the Owens Lake bed and another five percent came from re-entrained Owens Lake dust already deposited in the area.12 Since our approval of the 1998 PM10 Plan, PM10 emissions occurring directly from the Owens Lake bed and those attributable to re-entrained Owens Lake dust deposited in the two-kilometer area surrounding the Owens Lake bed, particularly the Keeler and Olancha Dunes, have declined. Despite this reduction, the predominant source of PM10 emissions contributing to nonattainment in the Owens Valley PM10 NA continues to be the dry Owens Lake bed and the two-kilometer perimeter surrounding it.13

    11Id., p. S-2.

    12 64 FR 34173 at 34174.

    13 2016 PM10 Plan, page S-4, Table S-2, and Chapter 8.

    Approximately 40,000 permanent residents live in the area affected by the Owens Lake PM10 emissions.14 Some of these residents are members of four Tribes: The Lone Pine Paiute/Shoshone Tribe, the Fort Independence Tribe, the Big Pine Tribe, and the Bishop Tribe. Residents and visitors to the area suffer the adverse health effects from high PM10 concentrations.15

    14Id. at S-2.

    15Id.

    As noted previously, the State of California and the GBUAPCD submitted a PM10 Plan in 1998 that the EPA approved in 1999.16 The EPA recognized in approving the 1998 PM10 Plan that the Owens Valley PM10 NA presented one of the most challenging air quality problems nationally, requiring a reduction of PM10 concentrations from almost 4000 μg/m3 to the 24-hour NAAQS of 150 μg/m3. The EPA also recognized that while the origin of the PM10 problem was well understood—the draining of Owens Lake by the City of Los Angeles in the early part of this century and continued LADWP withdrawals from the Owens River—the solution to the problem remained controversial.17 The EPA's evaluation of the 1998 PM10 Plan noted the unique complexities of the Owens Valley PM10 planning process, including the competing authorities and responsibilities of the GBUAPCD to protect Owens Valley residents from the harmful effects of air pollution and those of the City of Los Angeles to provide its residents with an adequate water supply.18

    16 64 FR 48305.

    17 64 FR 34173 at 34174.

    18Id.

    Historically, there have been significant disputes between the GBUAPCD and the City of Los Angeles concerning the appropriateness, location, and extent of control measures to reduce PM10 emissions from the Owens Lake bed and surrounding areas, which interfered with the adoption of a fully approvable plan. The legal history between the GBUAPCD and the City of Los Angeles is described in some detail in the EPA's proposed approval of the 1998 PM10 Plan and in the 2016 PM10 Plan.19 In summary, California legislation followed by litigation in state and federal courts resulted in a series of agreements requiring the City of Los Angeles to implement a variety of control measures to mitigate PM10 emissions from the dry Owens Lake bed. The most recent iteration of these agreements, reached after extensive negotiations, is the 2014 Stipulated Judgment between the City of Los Angeles and the GBUAPCD.20 It is our understanding that the 2014 Stipulated Judgment resolves all disputes between the District and the City of Los Angeles and it appears to clearly articulate the responsibilities of both parties, providing certainty and eliminating the risk of further litigation regarding the Owens Lake bed controls required for attainment and contingency measures. The 2014 Stipulated Judgment adds to and incorporates prior agreements between the parties and constitutes the foundation for the 2016 PM10 Plan that we are proposing to approve in this action.21

    19 2016 PM10 Plan, pp. 9-12.

    20Id., Appendix II-1.

    21Id., p.12 (“The judgment requires the City of Los Angeles to implement the dust control measures ordered in 2011 and 2012 and provides for additional dust control measures up to 53.4 square miles in total for all ordered dust control areas.”)

    The EPA is proposing to approve the 2016 PM10 Plan because it meets the CAA requirements for Serious area plans. As was true of the 1998 PM10 Plan, this 2016 PM10 Plan is an important blueprint for clean air in one of the most unique and challenging PM10 nonattainment areas in the United States.22 Successful implementation will require continued joint efforts by the GBUAPCD and the City of Los Angeles.23

    22 In 2016, the EPA bestowed its Clean Air Excellence Award for Regulatory and Policy Innovations on the GBUAPCD in recognition of the District's development of leading methods to identify pollution source areas, analyze particulate emissions, and determine suitable pollution control measures. The EPA noted the Owens Lake project constitutes the world's largest PM10 emission control project and has led to annual air pollution reductions of 75,000 tons. See the EPA's Web site: https://www.epa.gov/caaac/clean-air-excellence-awards.

    23 In 2016, the EPA bestowed its Clean Air Excellence Award for Regulatory and Policy Innovations on the GBUAPCD in recognition of the District's development of leading methods to identify pollution source areas, analyze particulate emissions, and determine suitable pollution control measures. The EPA noted the Owens Lake project constitutes the world's largest PM10 emission control project and has led to annual air pollution reductions of 75,000 tons. See the EPA's Web site: https://www.epa.gov/caaac/clean-air-excellence-awards.

    The establishment of controls on the lake bed has resulted in significant improvements to air quality in the Owens Valley. Between 1993 and 2014, the number of NAAQS exceedances decreased substantially at monitors located in the Owens Valley PM10 NA. For example, the peak three-year average number of exceedances at the Dirty Socks monitor declined from 41 to 9 in 2014, at the Keeler monitor from 20 to 8, and at the Shell Cut monitor from 19 to 5.24 As shown in Table 1, the 2016 PM10 Plan demonstrates that PM10 design concentrations are predicted to be below the NAAQS when all required controls are implemented by the City of Los Angeles and the GBUAPCD.25 Through the continued efforts of the GBUAPCD and the City of Los Angeles, the 2016 PM10 Plan demonstrates attainment of the 24-hour PM10 NAAQS within the attainment year of 2017.

    24 2016 PM10 Plan, Appendix III-2, Table 1.

    25Id., Table 7-5.

    Table 1—Decline in Owens Valley PM10 Concentrations [μg/m3] Monitoring site July 2009-June 2014
  • maximum PM10
  • Hybrid model 2017
  • design concentration
  • predictions
  • Dirty Socks 1,437 93 Flat Rock 871 94 Keeler 2,994 67 Lizard Tail 4,571 142 Mill Site 754 125 North Beach 1,536 67 Olancha 779 41 Shell Cut 2,149 105 Stanley 286 39 Source: 2016 PM10 Plan, Tables 7-1 and 7-5.
    C. Public Notice, Public Hearing, and Completeness Requirements for SIP Submittals

    CAA section 110(a)(1) and (2) and 110(l) require each state to provide reasonable public notice and opportunity for public hearing prior to the adoption and submission of a SIP or SIP revision to the EPA. To meet this requirement, every SIP submission should include evidence that adequate public notice was given and an opportunity for a public hearing was provided consistent with the EPA's implementing regulations in 40 CFR 51.102.

    Both the GBUAPCD and the California Air Resources Board (CARB) satisfied applicable statutory and regulatory requirements for reasonable public notice and hearing prior to adoption of the 2016 PM10 Plan. The District provided a public comment period and conducted a public hearing on April 13, 2016, before its Board adopted the 2016 PM10 Plan.26 CARB provided the required public notice and opportunity for public comment prior to its May 19, 2016 public hearing.27 The submission provides proof of publication of notices for the respective public hearings. We find, therefore, that the 2016 PM10 Plan meets the procedural requirements for public notice and hearing in CAA sections 110(a) and 110(l).

    26Id., Chapter 13—Declaration of Clerk of the Board and Resolutions Certifying the EIR and Approving the SIP.

    27 State of California Air Resources Board Resolution 16-3, May 19, 2016.

    CAA section 110(k)(1)(B) requires the EPA to determine whether a SIP submission is complete within 60 days of receipt. This section of the CAA also provides that any plan that the EPA has not affirmatively determined to be complete will become complete by operation of law six months after the date of submission. The EPA's completeness criteria are found in 40 CFR part 51, Appendix V. The EPA determined the SIP submission dated June 9, 2016, to be complete on November 21, 2016.28

    28See letter from Elizabeth Adams, Acting Air Division Director, U.S. EPA Region 9 to Richard Corey, Executive Officer, California Air Resource Board.

    D. CAA Requirements for PM10 Serious Area Plans

    As a Serious PM10 nonattainment area that failed to meet its applicable attainment date of December 31, 2006, the Owens Valley PM10 NA is subject to CAA sections 188 and 189. Section 188 establishes attainment dates for Serious PM10 nonattainment areas. However, when an area such as the Owens Valley PM10 NA fails to attain the PM10 NAAQS within the time prescribed in section 188, a new attainment date may be approved. The new attainment date is established by section 179(d)(3), which establishes that the attainment date applicable to the revision required under paragraph (1) of section 179(d) shall be the same as provided in the provisions of section 172 of the CAA. That section of the statute requires the area attain as expeditiously as practicable, but no later than five years from the date of designation.29 It also includes a provision that allows the EPA to extend the attainment date for up to an additional five years (i.e., a period of no greater than 10 years) to the extent the Administrator determines appropriate, considering the severity of nonattainment and the availability and feasibility of pollution control measures.30

    29 In accordance with CAA section 179(d)(3) and 172(a)(2)(A), the attainment deadline applicable to an area that misses the Serious area attainment date is as soon as practicable, but no later than five years from the publication date of the nonattainment finding notice. The EPA's finding that the Owens Valley PM10 NA failed to attain by the Serious area nonattainment date was published on June 6, 2007.

    30 42 U.S.C. 7502(a)(2)(A). See also Ass'n of Irritated Residents v. United States EPA, 423 F.3d 989, 993-94 (9th Cir. 2015).

    Section 189(d) provides that the state shall submit within 12 months after the applicable attainment date, plan revisions that provide for attainment of the PM10 air quality standard and, from the date of such submission until attainment, for an annual reduction of PM10 or PM10 precursor emissions within the area of not less than five percent of the amount of such emissions as reported in the most recent inventory prepared for the area.

    The general planning and control requirements for all nonattainment plans are found in CAA sections 110 and 172. More specific planning and control requirements relevant to the PM10 NAAQS are found in Part D, Subpart 4, in CAA sections 188 and 189, as noted above. The EPA has issued a General Preamble 31 and Addendum to the General Preamble 32 to provide guidance to states for meeting the CAA's requirements for the PM10 NAAQS. The General Preamble mainly addresses the requirements for moderate nonattainment areas and the Addendum addresses requirements for Serious nonattainment areas. The EPA has also issued other guidance documents related to PM10 plans that are discussed and cited below. The specific PM10 plan requirements addressed by this proposed action are summarized below.

    31 “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 57 FR 13498 (April 16, 1992) (General Preamble) and 57 FR 18070 (April 28, 1992).

    32 “State Implementation Plans for Serious PM10 Nonattainment Areas, and Attainment Date Waivers for PM10 Nonattainment Areas Generally; Addendum to the General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 59 FR 41998 (August 16, 1994) (Addendum).

    1. Emissions Inventories

    CAA section 172(c)(3) requires that an attainment plan include a comprehensive, accurate, and current inventory of actual emissions from all sources of the relevant pollutants.

    2. Attainment Demonstration and Five Percent Requirement

    For Serious PM10 nonattainment areas that do not attain the PM10 NAAQS by the applicable attainment date, CAA section 189(d) requires the state to submit plan revisions that provide for attainment of the NAAQS and provide for an annual five percent reduction in PM10 or PM10 precursor emissions for each year from the date of submission until attainment.33 Section 189(d) specifies that the state must submit these plan revisions within 12 months of the applicable attainment date that the area failed to meet.

    33 The EPA has previously determined that PM10 precursors are not significant contributors to PM10 levels in the Owens Valley PM10 NA. See 64 FR 34173 at 34716 (June 25, 1999). In that rulemaking notice, the EPA noted that the contribution from secondary aerosols is insignificant. Inventory information submitted by the GBUAPCD in association with the 2016 PM10 Plan also demonstrates that precursors do not contribute significantly to PM10 levels that exceed the standard. See section II.D.2.b of this notice.

    3. Best Available Control Measures for Sources of PM10

    CAA section 189(b)(1)(B) requires provisions to assure that BACM, including the best available control technology (BACT) for stationary sources, for the control of PM10 shall be implemented no later than four years after the date a nonattainment area is reclassified as Serious.

    When a Moderate area is reclassified to Serious, the requirements to implement reasonably available control measures (RACM), including such reductions in emissions from existing sources in the area as may be obtained through the adoption, at a minimum, of reasonably available control technology (RACT), in CAA sections 172(c)(1) and 189(a)(1)(C) remain applicable. Thus, a Serious area PM10 plan must also provide for the implementation of RACM and RACT to the extent that the RACM and RACT requirements have not been satisfied in the area's Moderate area plan.

    CAA section 189(e) requires that control requirements applicable to major stationary sources of PM10 shall also apply to major stationary sources of PM10 precursors, except where the Administrator determines that such sources do not contribute significantly to PM10 levels that exceed the standards in the area.

    4. Reasonable Further Progress and Quantitative Milestones

    CAA section 172(c)(2) requires that implementation plans demonstrate reasonable further progress (RFP) as defined in section 171(1). Section 171(1) defines RFP as such annual incremental reductions in emissions of the relevant air pollutant as are required by part D of title I or may reasonably be required by the Administrator for the purpose of ensuring attainment of the applicable national ambient air quality standard by the applicable date. The general RFP requirement of section 172(c)(2) applies to SIP submissions necessary to meet CAA section 189(d) for the PM10 NAAQS.

    In addition, CAA section 189(c)(1), which is specifically applicable to the PM10 NAAQS, requires that an implementation plan contain quantitative milestones that will be achieved every three years and that will demonstrate that RFP is being met.

    5. Contingency Measures

    CAA section 172(c)(9) requires that implementation plans provide for the implementation of specific measures to be undertaken if the area fails to make RFP or to attain the NAAQS by the attainment date applicable under part D of title I. Such measures are to take effect in any such case without further action by the State or the Administrator. The contingency measure requirement of CAA section 179(c)(9) applies to the SIP submissions necessary to meet CAA section 189(d) for the PM10 NAAQS.

    6. Transportation Conformity and Motor Vehicle Emissions Budgets

    Transportation conformity is required by CAA section 176(c). Our conformity rule (40 CFR part 93, subpart A) requires that transportation plans, programs, and projects conform to state air quality implementation plans and establishes the criteria and procedures for determining whether or not they do so. Conformity to a SIP means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the NAAQS or any interim milestone. Once a SIP that contains motor vehicle emissions budgets has been submitted to the EPA, and the EPA has found them adequate, these budgets are used for determining conformity (i.e., emissions from planned transportation activities must be less than or equal to the budgets).

    II. Evaluation of the Owens Valley PM10 Plan's Compliance With CAA Requirements A. Review of the Owens Valley PM10 Nonattainment Area Emissions Inventories

    The 2016 PM10 Plan includes PM10 emissions inventories for the Owens Valley PM10 NA for the years 1999 through 2019. For the most part, the emissions data presented in the Plan were derived from the CARB 2012 and 2015 emission inventories for Inyo County and apportioned to the Owens Valley PM10 NA using factors such as population, roadway miles, and land area.34 The GBUAPCD calculated fugitive windblown dust emissions using a combination of modeling and data collected at monitors located around the Owens Lake bed. The unpaved road dust emissions were calculated using the GBUAPCD's emission factors. These calculations are included in Tables 3 and 4 of Appendix IV-1 of the 2016 PM10 Plan.

    34 An overview of the 2016 PM10 Plan emissions inventory is provided here. For detailed results and a complete discussion of the methodologies used to produce the emissions inventories, see the following sections of the 2016 PM10 Plan: Summary, S.1; Chapter 4, “PM10 Emissions Inventory and Determination of Significant Sources;” and Appendix IV-1, “2016 SIP Inventory.”

    The District has also provided an inventory of emissions of PM10 precursors (i.e., sulfur oxides, nitrogen oxides, volatile organic compounds, and ammonia) for a 2015 exceedance day.35 In this inventory, ammonia emission estimates “were derived from Inyo County emissions that were queried from the USEPA's 2014 National Emissions Inventory.” Estimates for the other precursors “were derived from Inyo County emissions that were queried from the CARB CEPAM Standard Emissions Tool (2013 Almanac).” In all cases, emissions were apportioned to the Owens Valley PM10 NA using various factors.36 The EPA previously determined that PM10 precursors are not significant contributors to PM10 levels in the Owens Valley PM10 NA.37 At that time, the EPA noted that the contribution from secondary aerosols is insignificant. The EPA proposes to find again that precursors do not play a significant part in the PM10 problem in the Owens Valley PM10 NA. We discuss this in more detail in Section II.D., below.

    35 See attachment to letter from Phillip L. Kiddoo, Air Pollution Control Officer, GBUAPCD to Elizabeth Adams, Acting Air Division Director, U.S. EPA, Region 9, dated October 26, 2016.

    36Id. The metrics used to ratio emissions from Inyo County to the Owens Valley PM10 NA are specified in the attachment.

    37See 64 FR 34173 at 34716 (June 25, 1999).

    The emissions inventories provided in the Plan show that fugitive dust emissions resulting from wind erosion on the exposed Owens Lake bed, off-lake deposits of lake bed dust such as the Keeler Dunes, and open desert are by far the largest sources of PM10 in the Owens Valley PM10 NA. Other, much smaller sources of windblown dust include small mining facilities and the Lone Pine Landfill. The remaining sources of PM10 within the Owens Valley PM10 NA include wood stoves, fireplaces, unpaved and paved road dust, and vehicle tailpipe emissions. The District also notes that prescribed burning is a source of PM10 in the nonattainment area. There are no large industrial sources of PM10 in the Owens Valley PM10 NA.

    The GBUAPCD also grouped emissions into three location-based categories: “lake bed emissions,” “near-lake emissions,” and “remaining Owens Valley NA emissions.” Emissions originating from the lake bed are included in the lake bed category. The near-lake category consists of emissions generated within a two-kilometer zone surrounding the lake bed and includes fugitive windblown dust emissions from paved and unpaved roads and open desert, emissions from other sources within two kilometers of the lake bed such as the Lone Pine Dump, and the Keeler and Olancha dunes. Emissions generated outside the two-kilometer zone are grouped in the remaining Owens Lake NA emissions category. The “Owens Lake Subarea” encompasses the lake bed and the near-lake emissions. Emissions from unpaved roads and open desert areas generated within the two-kilometer zone surrounding the lake were used in the District's analysis of which sources contribute significantly to nonattainment, thereby allowing the District to factor in the impact of the distance between emission sources and affected monitors.

    Table 2 provides a summary of the annual emissions forecast for all PM10 emission source categories in the Owens Valley PM10 NA for 2006, 2007, and for 2016 through 2019 (tons per year).

    38 Values presented represent the emissions at the end of the calendar year, after all scheduled controls are in place.

    39 Includes PM10 emissions from Lone Pine Landfill, which equal on average approximately 60 tons per year.

    40 Emissions assumed constant over time.

    41 Miscellaneous sources include: Manufacturing and industrial, service and commercial, mineral processes, metal processes, residential fuel combustion, construction and demolition, paved and unpaved road dust (activity related), windblown dust from agricultural lands, managed burning and disposal, on-road mobile, and wildfires.

    Table 2—Summary of PM10 Annual Emissions in the OVPA Year end 38 Lake bed emissions Near-lake emissions Keeler Dunes Olancha Dunes 2-km buffer (excluding dunes) 39 Remaining Owens Valley NA emissions Windblown dust unpaved roads Windblown dust open desert 40 Misc. sources 41 Total 2006 789 5,324 6,395 4,217 416 19,617 854 37,613 2007 7,448 4,476 5,011 3,143 416 19,617 854 40,964 2016 1,222 172 1,506 1,358 416 19,617 747 25,038 2017 355 41 1,093 1,180 416 19,617 747 23,450 2018 355 41 798 1,053 416 19,617 747 23,027 2019 355 41 586 962 416 19,617 750 22,726 Source: 2016 PM10 Plan, Table 4-3.

    The EPA is proposing to find that the 2016 PM10 Plan's emissions inventories for 2006 through 2019 are comprehensive, accurate, and current inventories of actual emissions from all sources in the Owens Valley PM10 NA and that these emissions inventories meet the requirements of section 172(c)(3) of the CAA and EPA guidance.42 The GBUAPCD has provided a 2006 base year and future year emissions inventories to 2019, comprehensively addressing all source categories in the Owens Valley PM10 NA. Consequently, we are proposing to find that the emissions inventories provided by the GBUAPCD meet the requirements of section 172(c)(3) and provide an adequate basis for the attainment demonstration as well as for the BACM and RFP demonstrations.

    42 Emissions Inventory Guidance for Implementation of Ozone and Particulate Matter National Ambient Air Quality Standards (NAAQS) and Regional Haze Regulations. U.S. EPA, September 29, 2016 (draft).

    B. Demonstration of Attainment

    The 2016 PM10 Plan must provide a detailed demonstration (including air quality modeling) that the specified control strategy will reduce PM10 emissions so that the 24-hour NAAQS will be attained as soon as practicable but no later than June 6, 2017, assuming final approval of the attainment deadline extension discussed above. CAA section 189(b)(1)(A).

    1. Attainment Deadline

    In 2007, the EPA notified the GBUAPCD that it had failed to attain the PM10 NAAQS by the attainment date at the end of 2006.43 The GBUAPCD has requested that the EPA extend the attainment date for the Owens Valley PM10 NA for an additional 10 years.44 The EPA is proposing to approve the requested attainment date extension because, considering the severity of nonattainment and the availability and feasibility of pollution control measures, the EPA believes such an extension to June 6, 2017 is warranted based on various factors, including the following.

    43See 72 FR 31183 (June 6, 2007).

    44 As discussed above, CAA section 188 and 179 allow up to a 10-year extension of the attainment date after the EPA issues a finding that a Serious PM10 nonattainment area has failed to attain the NAAQS. CAA section 172(a) authorizes the EPA to extend the attainment deadline to the extent it deems appropriate for a period of no greater than 10 years from the publication of the nonattainment finding, considering the severity of nonattainment and the availability and feasibility of pollution control measure.

    First, the EPA acknowledges the severity of the PM10 problem. As discussed above, prior to the application of controls, the Owens Valley PM10 NA experienced dust storms of unprecedented magnitude that originated from the dry Owens Lake bed under certain meteorological conditions. The magnitude of these dust storms from the dry lake bed were unique within California and the United States.

    Second, the factors creating the dry Owens Lake bed, specifically the diversion of water in the early 20th century to the City of Los Angeles, resulted in complex legal and technical agreements for installation of control measures that were untested in kind and scope. Since approval of the 1998 PM10 Plan, the GBUAPCD and City of Los Angeles have worked consistently to refine and optimize the complex set of control measures leading to substantial reductions of PM10 from the dry Owens Lake bed and surrounding near-lake sources. The culmination of decades of work on this problem by the GBUAPCD and the City of Los Angeles is the Stipulated Judgment leading to the District's adoption and the EPA's approval of Rule 433 into the SIP in 2016.45 Rule 433 will ensure that the mitigation measures leading to the final reductions in PM10 will occur and lead to attainment of the NAAQS.

    45 Because some of the controls required in the 2016 PM10 Plan are required to be installed prior the end of 2017, this leaves open the possibility that some of the required controls will not be completed by June of 2017. We do not believe this will be an impediment to reaching attainment due to the seasonal nature of PM10 emissions in the Owens Lake NA, which are generally elevated in the winter and spring months.

    For these reasons, the EPA concurs that an extension of the attainment deadline to June 6, 2017 is warranted.

    2. PM10 Attainment Demonstration Approaches

    A key part of a PM10 attainment plan is the attainment demonstration. This is a demonstration by the state that the existing and planned emission control measures, in this case, the controls that have been incorporated into Rule 433 and the Keeler Dunes Project, are sufficient to result in attainment of the PM10 NAAQS by the required attainment date (i.e., 2017). Under CAA section 189(b)(1)(A), the attainment demonstration for a Serious nonattainment area must include air quality modeling. Please see the EPA's accompanying Technical Support Document (TSD), located in the docket for this action, for our detailed analysis of the air quality modeling supporting the District's demonstration of attainment. In summary, the EPA's preferred PM10 attainment demonstration approach is dispersion modeling, with receptor modeling or emissions inventory approaches as adjuncts. However, emissions from fugitive dust sources such as the dry Owens Lake bed are uncertain and variable in comparison with the typical industrial point sources to which dispersion modeling is usually applied. Also, in a fugitive dust-dominated area there are few if any chemical differences between the various emitting source regions within the area, so receptor modeling is of limited use. Therefore, emissions inventory-based modeling approaches have been used in fugitive dust and other PM10 nonattainment areas. These include the “rollback” of monitored concentrations in proportion to emissions, sometimes in conjunction with a dispersion model in order to account for the spatial and temporal variation of emissions and their various distances from the monitor(s). In all of the approaches, projected emissions reductions due to control measures are applied to the emission source contributions, and attainment is demonstrated if the resulting concentrations are below the NAAQS.46

    46 Monitored concentrations meet the 24-hour PM10 NAAQS when the “design value,” the expected number of daily exceedances of the NAAQS level of 150 μg/m3, is no more than one per year, 40 CFR 50.6. However, for a modeled attainment demonstration, when five years of meteorology are modeled, the 6th highest concentration is used as the “design concentration” to compare to the NAAQS level; at most five exceedances of that level are acceptable for attainment, one per modeled year. Guideline on Air Quality Models, 40 CFR 51 Appendix W, section 7.2.1.1, “Design Concentrations for SO2, PM10, CO, Pb, and NO2” The design concentration is sometimes referred to as the “design value,” but strictly speaking, the PM10 design value is the expected number of exceedances per year.

    3. Modeling in Submittal

    The District used a hybrid modeling approach combining the CALPUFF (“California Puff”) dispersion model 47 with a monitored component. CALPUFF is used to model the effect of emissions from sources on the Owens Lake bed and the Keeler Dunes. The monitored component is used to represent the effect of other sources off the lake bed (“out-of-network”), which are not otherwise included in the CALPUFF modeling; it is a time-varying background concentration that declines over time as lake bed emissions are controlled. The District's hybrid model and its inputs are discussed in more detail in our TSD.

    47 Model code and documentation are available at no cost for download from http://www.src.com/calpuff/calpuff1.htm.

    The District's model performance evaluation 48 of the hybrid model, which checked model predictions against monitored observations during the five-year period of July 2009 to June 2014, showed a high correlation between them and acceptable model performance.

    48 2016 PM10 Plan, Appendix VII-1: Air Quality Modeling Report, sec. 5.

    The attainment demonstration also examined the effect of the controls through implementation of Rule 433 and controls on the Keeler Dunes that would be in place by the end of 2017, the attainment year. Each of the five meteorology years was modeled, and for a given receptor the highest sixth-high concentration taken as the design concentration. The design concentration results for each monitor site for 2014 through 2019 are shown in Table 7-5 of the 2016 PM10 Plan. For 2017, the highest design concentration is 142 μg/m3 and all concentrations are less than 150 μg/m3, demonstrating attainment of the PM10 NAAQS.

    4. Evaluation of Modeled Attainment Demonstration

    The dry Owens Lake bed presents a unique situation for which unconventional modeling approaches may be appropriate. The EPA has consulted with the District and CARB on the modeling approach numerous times over the past decade, including during the year prior to the current Plan submittal. As discussed in detail in our TSD and in the summary below, the District's air quality modeling analysis is appropriate for this area.

    a. Model Emissions Input

    The District's Dust Identification (ID) Program, described in detail in the TSD, provides estimates of PM10 emissions based on real-time measurements at numerous locations. It provides a level of detail and accuracy that is unique, and is a considerable refinement over standard emission factors, and even over locale-specific emission factors that account for soil type and wind speed. It provides a strong foundation for the emission estimates needed for a modeled attainment demonstration.

    b. Model Choice

    The District's method for estimating PM10 emission factors (i.e., back-calculation from monitored concentrations, also discussed in detail in the TSD), depends on good characterization of source-receptor relationships (emitting source square and monitor receptor) to determine which particular emitting areas are contributing to a given monitored concentration. A Lagrangian puff model like CALPUFF, which allows PM10 emissions to follow a realistic curved trajectory between the source area and the monitor and allows different wind direction to vary by location at any given time, is appropriate for this demonstration. CALPUFF is preferable to a steady-state Gaussian model like AERMOD, which has “straight-line” trajectories along a single wind direction within any given hour for all sources.

    c. Modeling Domain and Background Concentration

    The District's monitoring and modeling network is focused on the lake bed and the immediately surrounding area. In order for the attainment demonstration to account for all the PM10 emission sources contributing to NAAQS violations, off-lake sources must be adequately represented in the background concentration that is added to the model prediction. The District's procedure for determining background concentration is discussed in detail in the TSD. The EPA finds the District's reasoning and supporting documentation for the assumptions convincing.

    d. Modeling Receptors

    By default, a grid of model receptors is used to cover much of a nonattainment area, to ensure that the NAAQS is attained everywhere in the area. In the 2016 PM10 Plan, receptors are placed only along the lake bed shoreline, and further, only at monitor locations. As stated in the 2016 PM10 Plan, the monitoring sites were chosen to be downwind of the largest PM10 source areas, i.e. the lake bed, and so are representative of the highest expected impacts.49 Because concentrations necessarily decline with distance from a non-buoyant source like fugitive dust, the EPA agrees that the highest PM10 concentrations would be expected at the shoreline.

    49Id., p. 62 sec.7.1.

    5. The EPA's Proposed Action

    In summary, the attainment demonstration is based on a unique modeling approach that incorporates real-world measurements and is well-suited to the special conditions at Owens Lake. The EPA is proposing to find that the attainment demonstration in the 2016 PM10 Plan is approvable.

    C. Five Percent Requirement

    Section 189(d) of the CAA requires a state with a Serious PM10 nonattainment area that fails to attain the PM10 NAAQS by the applicable attainment deadlines to submit within 12 months after the attainment applicable attainment date, a plan showing an annual five percent reduction in emissions of PM10 in the area from the date of the submission until attainment, based on the most recent inventory.

    Table 4-3 in the 2016 PM10 Plan provides a summary of the annual emissions forecast for sources of emissions in the nonattainment area for the years 1999 through 2019. The inventory values are derived using a combination of modeling data, monitoring results, CARB emissions inventories and control measure efficiencies.50

    50Id., at 34-35.

    The 2016 PM10 Plan includes a demonstration of annual five percent reductions in Chapter 8. As noted, fugitive windblown emissions, “which are tied to meteorology and are highly irregular year-to-year,” 51 account for most of the emissions in the Owens Valley PM10 NA.52 To accommodate this variability for a more stable and realistic assessment of reductions, the District used a three-year rolling average to calculate the annual reductions. Using average annual emissions from 2005-2007 (62,734 tpy) as the starting point for the required five percent per year reductions, the District is required to reduce emissions by 31,367 tons per year by the attainment year (2017) to 32,367 tons per year. The GBUAPCD projects three-year annual average emissions in 2017 to be 24,783 tons per year, which exceeds the required amount of required reductions by 7,584 tons per year. Figure 8-1 in the 2016 PM10 Plan illustrates emissions trends for various sources in the nonattainment area from 1999 through 2019 along with the three-year average total, and compares these values with a five percent reduction line.53

    51 For example, emissions totaled 109,635 tons in 2005, dropped to 37,613 tons in 2006, then rose to 73,999 tons in 2009 before beginning to consistently decline. Emissions in 2010 totaled 70,343 tons and by 2017 when attainment will be reached, emissions are projected to be 23,450 tons per year. 2016 PM10 Plan, Table 4-3.

    52Id., p. 81.

    53 The EPA believes the use of 2007 as the baseline for five percent reductions is reasonable and consistent with Congress' intent. Section 189(d) states that plans are due within 12 months of the missed attainment deadline and that the plans should provide for annual five percent reductions from the date of the submission until attainment. The attainment deadline for the Owens Valley PM10 NA was December 31, 2006. 64 FR 48305 (September 3, 1999). Accordingly, a submittal to fulfill section 189(d) was due by December 31, 2007. Arguably, some of the reductions in the RFP demonstration occurred outside the literal time frame specified by Congress (i.e., “the date of the submission” of the Plan) because the 2016 PM10 Plan was not submitted until June 9, 2016. The EPA believes that it is appropriate and consistent with Congress's intent for expeditious attainment of the NAAQS that we consider reductions that occurred prior to the submittal of the 2016 PM10 Plan.

    Although annual emissions increase in the first few years of the planning period, a steady decline begins in 2009.54 The average emissions reductions catch up with the five percent per year reduction target in 2013, and subsequently exceed the required reductions beyond the projected attainment year. The EPA recognizes the unprecedented challenges faced by the District in achieving this target. In light of the unique nature of the source of emissions in the Owens Valley PM10 NA, the groundbreaking technical efforts needed to characterize and control emissions from the lake bed, and the unavoidable delays in implementing controls on the lake bed caused by litigation, and in recognition of the achievement of reductions beyond those required under CAA section 189(d) after 2013, we are proposing to approve the five percent demonstration in the 2016 PM10 Plan.

    54 The District notes that a substantial portion of the total reductions achieved beginning in 2006 and forecast through 2017 occur from 2010 to 2014 with the implementation of the 2008 SIP Control Areas and Phase 8 Control Area, which are described in Sections 6.2.1.4 and 6.2.1.5 of the Plan. 2016 PM10 Plan, p. 85.

    D. BACM/BACT and Adopted Control Strategy 1. Background

    Section 189(b)(1)(B) of the CAA requires areas designated as Serious nonattainment for PM10 to implement BACM and BACT 55 on all significant sources of direct PM10 and PM10 precursors. The CAA does not define a BACM-level of control for specific sources. In our guidance for Serious PM10 nonattainment area plans, the EPA defined BACM to be, among other things, the maximum degree of emission reduction achievable from a source or source category which is determined on a case-by-case basis, considering energy, economic and environmental impacts.56 Consistent with the General Preamble Addendum, a BACM analysis should include the following elements for the Owens Valley PM10 NA:

    55 BACT, which applies to stationary sources, is a subset of BACM.

    56See 59 FR 41998, 42010 (August 16, 1994).

    • Preparation of an inventory of PM10 sources;

    • Identification of source categories having a greater than de minimis impact on ambient PM10 concentrations;

    • Comparative analysis of the controls implemented in the Owens Valley PM10 NA and BACM in other Serious nonattainment areas for significant source categories; and

    • Evaluation of reducing emissions from a particular source category and costs associated with controls.

    2. Analysis

    The GBUAPCD BACM analysis, which addresses the four elements described in the General Preamble Addendum,57 is summarized below. The GBUAPCD's Rule 433 contains the BACM control measures for the Owens Lake bed. The EPA approved Rule 433 into the SIP on November 10, 2016.58 In addition, the GBUAPCD is directly implementing controls at the Keeler Dunes as discussed further below.

    57 2016 PM10 Plan, page 38.

    58 Acting Regional Administrator Alexis Strauss signed the EPA's final action approving Rule 433 on November 10, 2016. It will be published in the Federal Register in the near future.

    a. Inventory

    The emissions inventories included in the 2016 PM10 Plan and in additional information submitted on October 26, 2016 are summarized and evaluated in section II.A, above. As noted previously, the EPA is proposing to find that the 2016 PM10 Plan's emissions inventories for 2006 through 2019 are comprehensive, accurate, and current inventories of actual emissions from all sources in the Owens Valley PM10 NA and that these emissions inventories meet the requirements of Section 172(c)(3) of the CAA and the EPA.

    b. Identification of Source Categories

    The General Preamble Addendum provides that BACM are required for all categories of sources in Serious areas unless the State adequately demonstrates a particular source category does not contribute significantly to nonattainment of the NAAQS. A source category is presumed to contribute significantly to a violation of the 24-hour PM10 NAAQS if its PM10 impact at the location of expected violation would exceed 5 μg/m3.59

    59 59 FR 41998, 42011.

    To determine which sources contribute significantly to PM10 violations and are therefore subject to BACM level controls, the GBUAPCD selected a day on which measured levels of particulate approached the level of the standard and the predominant source of emissions was characterized as “non-lake.” The District noted that its choice is conservative because it “produces a small de minimis emissions level and makes it feasible for non-lake sources to be considered significant.” 60 By dividing the threshold value for a significant contribution (i.e., 5 μg/m3) by ambient level of PM10 on the chosen day (150.1 μg/m3), Great Basin calculated a de minimis factor of 3.33 percent.

    60 2016 PM10 Plan, page S-3.

    The GBUAPCD provided an inventory of sources of precursor emissions that we used to determine if sources of precursors contribute significantly to ambient levels of PM10 exceeding the standard in the Owens Valley PM10 NA. Because of the gaseous nature of precursor emissions, these compounds would have the potential for long distance transport, so emissions from the entire nonattainment area are considered. Adding together emissions of PM10 from within the near-lake area on a near exceedance day and precursor emissions from throughout the nonattainment area results in a total of 535.37 tons per day of emissions. Multiplying this number by 3.33 percent yields a de minimis threshold of 17.8 tons per day.

    In determining whether sources of precursors contribute significantly to PM10 levels, we made two conservative assumptions. First, we assumed that all precursor emissions would result in the formation of PM10. Second, we compared the total emissions for all precursors (i.e., 4.7 tons per day), rather than emissions of each precursor from each source category, to the de minimis threshold of 17.8 tons per day. Given total precursor emissions are far below the de minimis threshold, we conclude precursors do not contribute significantly to PM10 levels in the Owens Valley.

    To determine which sources of direct PM10 are significant, the District multiplied the near-exceedance day PM10 emissions inventory (530.65 tons per day 61 ) by the de minimis factor, yielding a de minimis emissions threshold of 17.7 tons per day.62

    61 This number does not include precursor emissions, which is acceptable because precursors do not significantly contribute and excluding precursor emissions results in a slightly lower (more conservative) threshold for significance.

    62 2016 PM10 Plan, p. 4.

    Table 3 below summarizes the sources of PM10 emissions in the Owens Lake subarea, on the analyzed day.63

    63 The GBUAPCD notes that “monitoring and modeling analyses indicate that emissions from off-lake sources more than two kilometers away do not have an impact on achieving attainment” and cites a similar approach taken in the “Five Percent Plan for PM10 for the Maricopa County Nonattainment Area.” Id. Page 56.

    Table 3—PM10 Exceedance Day Inventory for Owens Lake Subarea [2 km buffer] Category 2015
  • (tons per day) 64
  • Fugitive Windblown Dust from Exposed Lake Beds 45.30 Fugitive Windblown Dust from Keeler Dunes 169.20 Fugitive Windblown Dust from Olancha Dunes 312.00 Other sources within the Owens Lake Subarea, including mineral processing, paved and unpaved road dust, and the Lone Pine Landfill 65 4.15 Total 530.65

    Using the 17.7 tons per day threshold, the GBUAPCD identified three significant PM10 source categories in the OVPA:

    64Id. Table S-2.

    65 BACT, which applies to stationary sources, is generally not applicable within the Owens Valley PM10 NA where all PM10 sources except for wind erosion from the dry Owens Lake bed and the dune systems are de minimis.

    • Fugitive windblown dust from exposed lake bed.

    • Fugitive windblown dust from Keeler Dunes.

    • Fugitive windblown dust from Olancha Dunes.

    Based on this analysis, the District focused its BACM demonstration on the controls required on the lake bed and on the Keeler Dunes.66 According to the GBUAPCD, the Olancha dunes are primarily natural. If PM10 violations are attributed to these dunes, the violations will be treated as natural events and a Natural Events Action Plan will be developed and implemented in accordance with the EPA's guidance and rules on Exceptional Events.67 Further, emissions from the Olancha Dunes are expected to be reduced by about 2090 tons per year as the result of lake bed controls, which will reduce sand migration from nearby areas and allow redeposited lake bed particulate to winnow away until emissions are those of a natural dune system.68

    66 The GBUAPCD has investigated the history and morphology of the Keeler Dunes and determined that the drying of the Owens Lake bed resulted in the expansion of the pre-existing, natural dune area. 2016 PM10 Plan, page 61.

    67Id. See Appendix V-1, “OVPA 2016 SIP BACM Assessment,” Appendix E, “2013 GBUAPCD Board Order No. 130916-01,” p. 7.

    68Id., pp. 34 and 56.

    c. Comparative Analysis

    To fulfill the requirement for a comparative analysis, the GBUAPCD searched for requirements for analogous lake bed and dune sources in other PM10 nonattainment areas including Imperial County, the San Joaquin Valley, Maricopa County (Phoenix area), the South Coast, and Clark County (Las Vegas area). However, the District was unable to identify any analogous active controls for these kinds of sources in other areas. The District concludes that “these measures are unique in the US and are, by definition, the most stringent requirements for these sources.” 69 A description of the lake bed and dune controls follows.

    69Id. See Appendix V-1, “OVPA 2016 SIP BACM Assessment,” p. 22.

    i. Lake Bed Controls

    Lake bed controls are set forth in the GBUAPCD's Rule 433, which is included in the 2016 PM10 Plan. The EPA has approved Rule 433 into the SIP in a separate action.70 Rule 433 requires the control measures described in Chapter 6 of the 2016 PM10 Plan and summarized in our TSD to be implemented by the City of Los Angeles on various portions of the dry Owens Lake bed.71 In brief, Rule 433 requires the City of Los Angeles to conduct shallow flooding through application of water, install managed vegetation or a gravel blanket, or in some cases use tillage with a brine back-up. These control measures typically result in a 99 to 100 percent control efficiency. Beginning in 2001, lake bed controls have been constructed in phases as modeling and empirical evidence have demonstrated the need for additional controls. Rule 433 requires ongoing implementation of previously established control requirements and includes an enforceable implementation schedule for the most recent phase of controls, with all controls in place in the attainment year of 2017.

    70 81 FR 62849 (September 13, 2016); final approval signed November 10, 2016.

    71 For more detail on the Owens Lake bed controls, see Chapter 6 of the 2016 PM10 Plan and our TSD. Some of these control measures are also described in our proposed approval of the 1998 Plan (64 FR 34173, June 25, 1999).

    ii. Dune Controls

    The District is in the process of implementing a dust control project on Keeler Dunes that involves the placement of approximately 82,000 straw bales and planting of approximately 246,000 native shrubs.72 The goal of the project is to create a stable, non-emissive, low-impact vegetated dune system that requires minimal resources to maintain. The placement of the straw bales was completed in 2015 and plantings are scheduled to be complete by the end of 2016. At full build-out, the GBUACPD projects the project will reduce PM10 emissions by approximately 95 percent and bring the community of Keeler into compliance with state and federal PM10 standards.73 Implementation of this project is made federally enforceable by approval of the 2016 PM10 Plan, which includes Resolution 2016-03 wherein the Governing Board of the GBUAPCD authorizes and commits the District to complete the Keeler Dunes Project as set forth in the Plan.

    72 As noted above, no additional active controls are anticipated for the Olancha Dunes.

    73 2016 PM10 Plan, pp. 19 and 50-53

    In the context of its environmental review of the Keeler Dunes Project, the District considered alternatives for reducing the windblown dust from the Keeler Dunes, such as covering with geotextile fabric and gravel or excavation and removal of the dunes, but found them to be infeasible.74

    74Id. See Appendix V-1, “OVPA 2016 SIP BACM Assessment,” pp. 16-17.

    d. Evaluation of Reducing Emissions From Windblown Dust and Associated Costs

    The GBUAPCD estimated cost and emission impacts of the exposed lake bed and Keeler Dune controls as shown in Table 4 below:

    Table 4—Impact Analysis: Control Effectiveness, Cost Information, and Cost Effectiveness 75 Source category
  • (and windblown
  • dust controls)
  • Average
  • annual
  • emissions
  • (tons)
  • Control
  • effectiveness
  • Costs Cost
  • effectiveness
  • (tons)
  • Dry Lake Bed (varied controls, including shallow flooding, gravel blanket, and managed vegetation. See Rule 433.) 2006: 73,174; 2010: 43,325; 2014: 1,936 Up to 99 percent depending on control and location $145.8M (annualized) for 2016 SIP $2,390 Off-Lake Dunes (straw bales and re-vegetation) 3,309 95 percent based on straw bales with future shrub establishment $700,000 (annualized) for straw bales and revegetation with watering 222
    3. EPA Evaluation and Proposed Action

    In the 2016 PM10 Plan, the GBUAPCD has provided documentation on Rule 433 and on the Keeler Dunes Project, quantifying the cost of construction, materials, operation, and maintenance, and examining other factors such as energy and environmental impacts. The EPA agrees that adequate time must be allowed to fully implement Rule 433 successfully because the control measures in the Rule are uniquely vast in scale, materials, and required construction activity. Rule 433 establishes an aggressive, phased, implementation schedule that we are proposing to find is as expeditious as practicable. We also find that the implementation schedule for the Keeler Dunes project is as expeditious as practicable.

    75Id. See Appendix V-1, “OVPA 2016 SIP BACM Assessment,” p. 21.

    The EPA concludes that the 2016 PM10 Plan demonstrates:

    (1) Wind erosion from the dry Owens Lake bed (and secondarily, from the Keeler Dunes, which have expanded as a result of redeposited particles transported from the dry lake bed 76 ), is the predominant source of PM10 emissions that cause or contribute to PM10 violations in the Owens Valley PM10 NA and that applying BACM to other source categories would not contribute significantly to achieving the NAAQS as expeditiously as practicable;

    76Id., page 61.

    (2) Rule 433's control measures to reduce windblown dust from the dry Owens Lake bed and area immediately surrounding the bed of Owens Lake are unique and satisfy the requirement for BACM.

    (3) The goal of the Keeler Dunes Project is to create a stable self-sustaining low-impact vegetated dune system to reduce wind erosion. Implementation of these controls represents BACM since there are no analogous dust control projects or alternative controls for this type of source; and

    (4) No analogous source has been identified to support the economic and technological feasibility of any alternative or additional measures for the control of significant sources of wind erosion emissions in the Owens Valley PM10 NA.

    E. Reasonable Further Progress/Quantitative Milestones

    CAA section 189(c) requires that PM10 nonattainment areas must include quantitative milestones that are to be achieved every three years and that show RFP toward attainment by the applicable attainment deadline. Quantitative milestones may be met in a variety of ways, including by establishing a percent implementation of various control strategies, by percent compliance with implemented control measures, or adherence to a compliance schedule.77 Prior to submittal of the 2016 PM10 Plan, lake bed controls were established that yielded significant emissions reductions, as reflected in the annual emissions inventory 78 and illustrated in Figure 8-1 of the Plan. Unsurprisingly, given the variable nature of the emissions sources and the periodic delays due to disputed control measures, the decline is not linear; however, as noted previously, reductions sufficient to provide for attainment will be achieved within the required timeframe. Under the circumstances, we find that the progress achieved prior to the 2016 adoption of the Plan is reasonable.

    77 59 FR 41998 at 42016.

    78 2016 PM10 Plan, Table 4-3.

    The GBUAPCD's Rule 433 and the Keeler Dunes Project establish requirements for additional controls that will be completed in 2017 and that provide for additional emissions reductions. Under Rule 433, the City of Los Angeles must continue to implement all control measures that are already in place,79 and must implement Phase 9/10, which requires the control of an additional 3.62 square miles of the Owens Lake bed by December 31, 2017. These control requirements include enforceable schedules for implementation of the specified control measures, and the Plan includes quantification of the emissions reductions that will be achieved by implementation of the control measures.

    79 These areas consist of the 2003 Dust Control Area (29.8 square miles), the 2006 Dust Control Area and Channel Area (13.2 square miles), and the Phase 8 area (2.0 square miles).

    In its discussion of the requirement for quantitative milestone reports, the District noted that the remaining milestone for the 2016 PM10 Plan is the completion of the Phase 9/10 dust controls, which are enforceable through Rule 433. In other words, the final quantitative milestone for the 2016 PM10 Plan is 100 percent implementation of the required controls. The GBUAPCD commits to submitting a report to the EPA by April 1, 2018, as required by Section 189(c)(2) of the Act, that demonstrates RFP thorough the achievement of the December 31, 2017 quantitative milestone.

    The EPA proposes to approve the enforceable schedule in Rule 433 and commitment for completion of the Keeler Dunes Project in 2016 as meeting the RFP requirements of CAA section 189(c).

    F. Contingency Measures

    The CAA requires that the 2016 PM10 Plan include contingency measures to be implemented if the area fails to meet progress requirements or fails to attain the NAAQS by the applicable deadline. These contingency measures should take effect without requiring further action by the state or the EPA and should be fully implemented as expeditiously as practicable.80 Contingency measures should also provide for emissions reductions equivalent to one year's average increment of RFP.81

    80 59 FR 41998 at 42015.

    81Id.

    Because it is not possible to predict which areas of the lake bed may become emissive and cause a failure to meet progress requirements or to attain the NAAQS, Rule 433 requires the District to evaluate at least once per calendar year whether additional areas of the lake bed require controls. If the GBUAPCD determines that the Owens Valley PM10 NA has not met progress requirements or will not timely attain, Rule 433 requires the implementation of BACM control measures on up to an additional 4.78 square miles of the Owens Lake bed as expeditiously as practicable. The implementation of the contingency measure in Rule 433 does not require additional rulemaking actions or public hearings. The EPA has concluded, therefore, that the contingency measure included in the 2016 PM10 Plan through adopted Rule 433 provides for the implementation of contingency measures as expeditiously as practicable.

    The GBUAPCD has demonstrated that the dry lake bed is the overwhelming contributor the exceedances of the PM10 NAAQS, both through PM10 originating directly from the lake bed, or from lake bed particles that have been deposited nearby, which then become a secondary source of particulate (e.g., the Keeler Dunes).82 Therefore, we have focused our analysis on the control of emissions emanating from the lake bed in assessing whether the contingency measure in the 2016 PM10 Plan provides a year's worth of average RFP increment.

    82 For additional discussion, see Chapter 7 of the 2016 PM10 Plan and the attainment demonstration analysis in the TSD for this action.

    Determining the amount of emissions reductions needed for contingency measures (i.e., a year's worth of reductions) presents a unique challenge in the Owens Valley PM10 NA due to the nature of the lake bed and the meteorological influence on emissions, which leads to a degree of variability in annual emissions that is somewhat independent of the application of controls. For this reason, we have used the annual average area of the lake bed on which controls are required for the period of 2007 (the year the EPA made a finding of failure to attain) through 2017 (the attainment year) as a surrogate for the annual amount (tons) of emissions reductions required. This results in an annual average area of 1.8 square miles.83 Rule 433 provides for the implementation of controls on an additional 4.78 square miles of lake bed, which is more than double the annual average. We therefore conclude the contingency measure provisions in Rule 433 satisfy the contingency measure requirements under CAA section 172(c)(9).

    83 A total of 18.2 square miles will be controlled in 10-year period of 2007 through 2017 (the 2006 Dust Control and Channel Area encompasses 13.2 square miles; the Phase 8 Area encompasses 2.0 square miles; the Phase 9/10 Area encompasses 3.62—the provisionally excluded Cultural Resource Areas encompass approximately 0.6 square miles).

    G. Transportation Conformity

    Transportation conformity is required by CAA section 176(c). Our conformity rule (40 CFR part 93, subpart A) requires that transportation plans, programs, and projects conform to state air quality implementation plans and establishes the criteria and procedures for determining whether or not they do so. Conformity to a SIP means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the NAAQS or the timely achievement of interim milestones. However, if the EPA determines that a SIP demonstrates that motor vehicle emissions are an insignificant contributor to the air quality problem, states are not required to establish motor vehicle emissions budgets or perform a regional emissions analysis for transportation conformity purposes.84

    84 40 CFR 93.109(f).

    In section 6.1.2 of the Plan, the GBUAPCD provides its argument for why motor vehicle emissions are insignificant contributors to the PM10 problem in the Owens Valley PM10 NA. First, the District noted that motor vehicle tailpipe emissions and re-entrained roadway dust contribute just 1.4 percent of the 2016 PM10 emissions. The District also observed that the State estimates the annual population growth (about 0.7 percent) and increase in vehicle miles traveled (about 1.2 percent annually) and argued that it is unlikely that “these emissions would grow to such an extent as to cause a NAAQS violation in the future.” Finally, the District pointed out the absence of measures in the SIP that control motor vehicle emissions. In light of these factors, the EPA concurs with the District's conclusion that motor vehicle emissions are insignificant contributors to the PM10 problem in the Owens Valley. Accordingly, the GBUAPCD is not required to establish motor vehicle budgets in this plan or to perform regional emissions analyses for transportation conformity.

    III. Summary of the EPA's Proposed Action

    The EPA is proposing to approve the Serious area 2016 PM10 Plan submitted by the State of California for the Owens Valley PM10 nonattainment area. Specifically, the EPA is proposing to approve the 2016 PM10 Plan with respect to the CAA requirements for public notice and involvement under section 110(a)(1); emissions inventories under section 172(c)(3); the control measures in Rule 433 under section 110(k)(3), as meeting the requirements of sections 110(a) and 189(b)(1)(B); RFP and quantitative milestones under section 189(c); the contingency measure in Rule 433 under section 172(c)(9); and demonstration of attainment under section 189(b)(1)(A). The EPA is also proposing to approve the State's request for an extension of the attainment date to June 6, 2017 pursuant to CAA sections 188 and 179.

    IV. Statutory and Executive Order Reviews

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

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

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

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

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

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

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

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

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

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

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

    List of Subjects in 40 CFR Part 52

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

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: December 1, 2016. Deborah Jordan, Acting Regional Administrator, Region IX.
    [FR Doc. 2016-29758 Filed 12-9-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 55 [OAR-2004-0091; FRL-9956-07-Region 9] Outer Continental Shelf Air Regulations; Consistency Update for California AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to update portions of the Outer Continental Shelf (“OCS”) Air Regulations. Requirements applying to OCS sources located within 25 miles of States' seaward boundaries must be updated periodically to remain consistent with the requirements of the corresponding onshore area (“COA”), as mandated by section 328(a)(1) of the Clean Air Act, as amended in 1990 (“the Act”). The portions of the OCS air regulations that are being updated pertain to the requirements for OCS sources for which the Santa Barbara County Air Pollution Control District (“Santa Barbara County APCD”) and Ventura County Air Pollution Control District (“Ventura County APCD”) are the designated COAs. The intended effect of approving the OCS requirements for the Santa Barbara County APCD and Ventura County APCD is to regulate emissions from OCS sources in accordance with the requirements onshore. The changes to the existing requirements discussed in this document are proposed to be incorporated by reference into the Code of Federal Regulations and listed in the appendix to the OCS air regulations.

    DATES:

    Any comments must arrive by January 11, 2017.

    ADDRESSES:

    Submit comments, identified by docket number OAR-2004-0091, by one of the following methods:

    I. Federal eRulemaking Portal: www.regulations.gov. Follow the on-line instructions. II. Email: [email protected] III. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105-3901.

    Instructions: All comments will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through www.regulations.gov or email. www.regulations.gov is an “anonymous access” system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send email directly to EPA, your email address will be automatically captured and included as part of the public comment. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

    Docket: The index to the docket for this action is available electronically at www.regulations.gov and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section.

    FOR FURTHER INFORMATION CONTACT:

    Christine Vineyard, Air Division (Air-4), U.S. EPA Region 9, 75 Hawthorne Street, San Francisco, CA 94105, (415) 947-4125, [email protected]

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Background Information A. Why is EPA taking this action? II. EPA's Evaluation A. What criteria were used to evaluate rules submitted to update 40 CFR part 55? B. What requirements were submitted to update 40 CFR part 55? III. Incorporation by Reference IV. Administrative Requirements I. Background Information A. Why is EPA taking this action?

    On September 4, 1992, EPA promulgated 40 CFR part 55,1 which established requirements to control air pollution from OCS sources in order to attain and maintain federal and state ambient air quality standards and to comply with the provisions of part C of title I of the Act. Part 55 applies to all OCS sources offshore of the States except those located in the Gulf of Mexico west of 87.5 degrees longitude. Section 328 of the Act requires that for such sources located within 25 miles of a State's seaward boundary, the requirements shall be the same as would be applicable if the sources were located in the COA. Because the OCS requirements are based on onshore requirements, and onshore requirements may change, section 328(a)(1) requires that EPA update the OCS requirements as necessary to maintain consistency with onshore requirements.

    1 The reader may refer to the Notice of Proposed Rulemaking, December 5, 1991 (56 FR 63774), and the preamble to the final rule promulgated September 4, 1992 (57 FR 40792) for further background and information on the OCS regulations.

    Pursuant to section 55.12 of the OCS rule, consistency reviews will occur (1) at least annually; (2) upon receipt of a Notice of Intent under section 55.4; or (3) when a state or local agency submits a rule to EPA to be considered for incorporation by reference in part 55. This proposed action is being taken in response to the submittal of requirements by the Ventura County APCD. Public comments received in writing within 30 days of publication of this document will be considered by EPA before publishing a final rule. Section 328(a) of the Act requires that EPA establish requirements to control air pollution from OCS sources located within 25 miles of States' seaward boundaries that are the same as onshore requirements. To comply with this statutory mandate, EPA must incorporate applicable onshore rules into part 55 as they exist onshore. This limits EPA's flexibility in deciding which requirements will be incorporated into part 55 and prevents EPA from making substantive changes to the requirements it incorporates. As a result, EPA may be incorporating rules into part 55 that do not conform to all of EPA's state implementation plan (SIP) guidance or certain requirements of the Act. Consistency updates may result in the inclusion of state or local rules or regulations into part 55, even though the same rules may ultimately be disapproved for inclusion as part of the SIP. Inclusion in the OCS rule does not imply that a rule meets the requirements of the Act for SIP approval, nor does it imply that the rule will be approved by EPA for inclusion in the SIP.

    II. EPA's Evaluation A. What criteria were used to evaluate rules submitted to update 40 CFR part 55?

    In updating 40 CFR part 55, EPA reviewed the rules submitted for inclusion in part 55 to ensure that they are rationally related to the attainment or maintenance of federal or state ambient air quality standards or part C of title I of the Act, that they are not designed expressly to prevent exploration and development of the OCS and that they are applicable to OCS sources. 40 CFR 55.1. EPA has also evaluated the rules to ensure they are not arbitrary or capricious. 40 CFR 55.12(e). EPA has excluded administrative and procedural rules 2 that regulate toxics, which are not related to the attainment and maintenance of federal and state ambient air quality standards.

    2 Each COA which has been delegated the authority to implement and enforce part 55 will use its administrative and procedural rules as onshore. However, in those instances where EPA has not delegated authority to implement and enforce part 55, EPA will use its own administrative and procedural requirements to implement the substantive requirements. 40 CFR 55.14(c)(4).

    B. What requirements were submitted to update 40 CFR part 55?

    1. After review of the requirements submitted by the Santa Barbara County APCD against the criteria set forth above and in 40 CFR part 55, EPA is proposing to make the following Santa Barbara County APCD requirements applicable to OCS sources. Earlier versions of the District rules with a revised date are currently implemented on the OCS. The District rules with an adopted date are newly implemented on the OCS. The District rule with a repealed date is no longer implemented on the OCS.

    Rule No. Name Revised date 102 Definition 08/25/16 105 Applicability 08/25/16 202 Exemption to Rule 201 08/25/16 204 Applications 08/25/16 323.1 Architectural Coatings 08/25/16 801 New Source Review—Definitions and General Requirements 08/25/16 802 New Source Review 08/25/16 804 Offsets 08/25/16 805 Air Quality Impact Analysis, Modeling, Monitoring, and Air Quality Increment Consumption 08/25/16 806 Emission Reduction Credits 08/25/16 1301 Part 70 Operating Permits—General Information 08/25/16 Adopted date 323.1 Architectural Coatings 06/19/14 809 Federal Minor Source New Source Review 08/25/16 Repealed date 803 Prevention of Significant Deterioration 08/25/16

    2. After review of the requirements submitted by the Ventura County APCD against the criteria set forth above and in 40 CFR part 55, EPA is proposing to make the following Ventura County APCD requirements applicable to OCS sources. Earlier versions of the District rules with a revised date are currently implemented on the OCS. The District rules with an adopted date are newly implemented on the OCS. The District rule with a repealed date is no longer implemented on the OCS.

    Rule No. Name Revised date 23 Exemptions from Permit 11/12/13 42 Permit Fees 04/12/16 54 Sulfur Compounds 01/14/14 74.11.1 Large Water Heaters and Small Boilers 09/11/12 74.20 Adhesives and Sealants 09/11/12 74/24 Marine Coating Operations 09/11/12 Adopted date 74.31 Metal Working Fluids and Direct-Contact Lubricants 11/12/13 Repealed date 67 Vacuum Producing Devices 06/12/12 III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the Santa Barbara County APCD and Ventura County APCD rules described in Tables 1 and 2, respectively, of this preamble. The EPA has made, and will continue to make, these materials available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

    IV. Administration Requirements

    Under the Clean Air Act, the Administrator is required to establish requirements to control air pollution from OCS sources located within 25 miles of States' seaward boundaries that are the same as onshore air control requirements. To comply with this statutory mandate, EPA must incorporate applicable onshore rules into part 55 as they exist onshore. 42 U.S.C. 7627(a)(1); 40 CFR 55.12. Thus, in promulgating OCS consistency updates, EPA's role is to maintain consistency between OCS regulations and the regulations of onshore areas, provided that they meet the criteria of the Clean Air Act. Accordingly, this action simply updates the existing OCS requirements to make them consistent with requirements onshore, without the exercise of any policy discretion by EPA. For that reason, this action:

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

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

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

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

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

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

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

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

    In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, nor does it impose substantial direct compliance costs on tribal governments, nor preempt tribal law.

    Under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., 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. OMB has approved the information collection requirements contained in 40 CFR part 55 and, by extension, this update to the rules, and has assigned OMB control number 2060-0249. Notice of OMB's approval of EPA Information Collection Request (“ICR”) No. 1601.07 was published in the Federal Register on February 17, 2009 (74 FR 7432). The approval expires January 31, 2012. As EPA previously indicated (70 FR 65897-65898 (November 1, 2005)), the annual public reporting and recordkeeping burden for collection of information under 40 CFR part 55 is estimated to average 549 hours per response, using the definition of burden provided in 44 U.S.C. 3502(2).

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

    Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 25, 2013. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

    List of Subjects in 40 CFR Part 55

    Environmental protection, Administrative practice and procedure, Air pollution control, Hydrocarbons, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Nitrogen oxides, Outer Continental Shelf, Ozone, Particulate matter, Permits, Reporting and recordkeeping requirements, Sulfur oxides.

    Dated: November 14, 2016. Alexis Strauss, Acting Regional Administrator, Region IX.

    For the reasons set out in the preamble, title 40 of the Code of Federal Regulations, part 55, is proposed to be amended as follows:

    PART 55—OUTER CONTINENTAL SHELF AIR REGULATIONS 1. The authority citation for part 55 continues to read as follows: Authority:

    Section 328 of the Clean Air Act (42 U.S.C. 7401 et seq.) as amended by Public Law 101-549.

    2. Section 55.14 is amended by revising paragraphs (e)(3)(ii)(F) and (H) to read as follows:
    § 55.14. Requirements that apply to OCS sources located within 25 miles of States' seaward boundaries, by State.

    (e) * * *

    (3) * * *

    (ii) * * *

    (F) Santa Barbara County Air Pollution Control District Requirements Applicable to OCS Sources.

    (H) Ventura County Air Pollution Control District Requirements Applicable to OCS Sources.

    3. Appendix A to part 55 is amended by revising paragraphs (b)(6) and (8) under the heading “California” to read as follows: Appendix A to Part 55—Listing of State and Local Requirements Incorporated by Reference Into Part 55, by State

    California

    (b) * * *

    (6) The following requirements are contained in Santa Barbara County Air Pollution Control District Requirements Applicable to OCS Sources:

    Rule 102 Definitions (Revised 08/25/16). Rule 103 Severability (Adopted 10/23/78). Rule 105 Applicability (Revised 08/25/16). Rule 107 Emergencies (Adopted 04/19/01). Rule 201 Permits Required (Revised 06/19/08). Rule 202 Exemptions to Rule 201 (Revised 08/25/16). Rule 203 Transfer (Revised 04/17/97). Rule 204 Applications (Revised 08/25/16). Rule 205 Standards for Granting Permits (Revised 04/17/97). Rule 206 Conditional Approval of Authority to Construct or Permit to Operate (Revised 10/15/91). Rule 207 Denial of Application (Adopted 10/23/78). Rule 210 Fees (Revised 03/17/05). Rule 212 Emission Statements (Adopted 10/20/92). Rule 301 Circumvention (Adopted 10/23/78). Rule 302 Visible Emissions (Revised 6/1981). Rule 303 Nuisance (Adopted 10/23/78). Rule 304 Particulate Matter-Northern Zone (Adopted 10/23/78). Rule 305 Particulate Matter Concentration-Southern Zone (Adopted 10/23/78). Rule 306 Dust and Fumes-Northern Zone (Adopted 10/23/78). Rule 307 Particulate Matter Emission Weight Rate—Southern Zone (Adopted 10/23/78). Rule 308 Incinerator Burning (Adopted 10/23/78). Rule 309 Specific Contaminants (Adopted 10/23/78). Rule 310 Odorous Organic Sulfides (Adopted 10/23/78). Rule 311 Sulfur Content of Fuels (Adopted 10/23/78). Rule 312 Open Fires (Adopted 10/02/90). Rule 316 Storage and Transfer of Gasoline (Revised 01/15/09). Rule 317 Organic Solvents (Adopted 10/23/78). Rule 318 Vacuum Producing Devices or Systems-Southern Zone (Adopted 10/23/78). Rule 321 Solvent Cleaning Operations (Revised 06/21/12). Rule 322 Metal Surface Coating Thinner and Reducer (Adopted 10/23/78). Rule 323 Architectural Coatings (Revised 11/15/01). Rule 323.1 Architectural Coatings (Adopted 06/19/14, Effective 01/01/15). Rule 324 Disposal and Evaporation of Solvents (Adopted 10/23/78). Rule 325 Crude Oil Production and Separation (Revised 07/19/01). Rule 326 Storage of Reactive Organic Compound Liquids (Revised 01/18/01). Rule 327 Organic Liquid Cargo Tank Vessel Loading (Revised 12/16/85). Rule 328 Continuous Emission Monitoring (Adopted 10/23/78). Rule 330 Surface Coating of Metal Parts and Products (Revised 06/21/12). Rule 331 Fugitive Emissions Inspection and Maintenance (Revised 12/10/91). Rule 332 Petroleum Refinery Vacuum Producing Systems, Wastewater Separators and Process Turnarounds (Adopted 06/11/79). Rule 333 Control of Emissions from Reciprocating Internal Combustion Engines (Adopted 06/19/08). Rule 342 Control of Oxides of Nitrogen (NOx) from Boilers, Steam Generators and Process Heaters) (Revised 04/17/97). Rule 343 Petroleum Storage Tank Degassing (Adopted 12/14/93). Rule 344 Petroleum Sumps, Pits, and Well Cellars (Adopted 11/10/94). Rule 346 Loading of Organic Liquid Cargo Vessels (Revised 01/18/01). Rule 349 Polyester Resin Operations (Revised 06/21/12). Rule 352 Natural Gas-Fired Fan-Type Central Furnaces and Residential Water Heaters (Revised 10/20/11). Rule 353 Adhesives and Sealants (Revised 06/21/12). Rule 359 Flares and Thermal Oxidizers (Adopted 06/28/94). Rule 360 Emissions of Oxides of Nitrogen from Large Water Heaters and Small Boilers (Adopted 10/17/02). Rule 361 Small Boilers, Steam Generators, and Process Heaters (Adopted 01/17/08). Rule 370 Potential to Emit—Limitations for Part 70 Sources (Revised 01/20/11). Rule 505 Breakdown Conditions Sections A.,B.1, and D. only (Adopted 10/23/78). Rule 603 Emergency Episode Plans (Adopted 06/15/81). Rule 702 General Conformity (Adopted 10/20/94). Rule 801 New Source Review—Definitions and General Requirements (Revised 08/25/16). Rule 802 New Source Review (Revised 08/25/16). Rule 804 Emission Offsets (Revised 08/25/16). Rule 805 Air Quality Impact Analysis, Modeling, Monitoring, and Air Quality Increment Consumption (Revised 08/25/16). Rule 806 Emission Reduction Credits (Revised 08/25/16). Rule 808 New Source Review for Major Sources of Hazardous Air Pollutants (Adopted 05/20/99). Rule 809 Federal Minor Source New Source Review (Revised 08/25/16). Rule 810 Federal Prevention of Significant Deterioration (PSD) (Revised 06/20/13). Rule 1301 Part 70 Operating Permits—General Information (Revised 08/25/16). Rule 1302 Part 70 Operating Permits—Permit Application (Adopted 11/09/93). Rule 1303 Part 70 Operating Permits—Permits (Revised 01/18/01). Rule 1304 Part 70 Operating Permits—Issuance, Renewal, Modification and Reopening (Revised 01/18/01). Rule 1305 Part 70 Operating Permits—Enforcement (Adopted 11/09/93).

    (8) The following requirements are contained in Ventura County Air Pollution Control District Requirements Applicable to OCS Sources:

     . Rule 2 Definitions (Revised 04/12/11). Rule 5 Effective Date (Revised 04/13/04). Rule 6 Severability (Revised 11/21/78). Rule 7 Boundaries (Adopted 06/14/77). Rule 10 Permits Required (Revised 04/13/04). Rule 11 Definition for Regulation II (Amended 03/14/06). Rule 12 Applications for Permits (Adopted 06/13/95). Rule 13 Action on Applications for an Authority To Construct (Adopted 06/13/95). Rule 14 Action on Applications for a Permit To Operate (Adopted 06/13/95). Rule 15.1 Sampling and Testing Facilities (Adopted 10/12/93). Rule 16 BACT Certification (Adopted 06/13/95). Rule 19 Posting of Permits (Revised 05/23/72). Rule 20 Transfer of Permit (Revised 05/23/72). Rule 23 Exemptions From Permits (Revised 11/12/13). Rule 24 Source Recordkeeping, Reporting, and Emission Statements (Revised 09/15/92). Rule 26 New Source Review—General (Amended 03/14/06). Rule 26.1 New Source Review—Definitions (Revised 11/14/06). Rule 26.2 New Source Review—Requirements (Revised 03/14/06). Rule 26.3 New Source Review—Exemptions (Revised 3/14/06). Rule 26.6 New Source Review—Calculations (Revised 3/14/06). Rule 26.8 New Source Review—Permit To Operate (Adopted 10/22/91). Rule 26.11 New Source Review—ERC Evaluation at Time of Use (Adopted 05/14/02). Rule 26.12 Federal Major Modifications (Adopted 06/27/06). Rule 26.13 New Source Review-Prevention of Significant Deterioration (PSD) (Revised 11/10/15). Rule 28 Revocation of Permits (Revised 07/18/72). Rule 29 Conditions on Permits (Revised 03/14/06). Rule 30 Permit Renewal (Revised 04/13/04). Rule 32 Breakdown Conditions: Emergency Variances, A., B.1., and D. only. (Revised 02/20/79). Rule 33 Part 70 Permits—General (Revised 04/12/11). Rule 33.1 Part 70 Permits—Definitions (Revised 04/12/11). Rule 33.2 Part 70 Permits—Application Contents (Revised 04/10/01). Rule 33.3 Part 70 Permits—Permit Content (Revised 09/12/06). Rule 33.4 Part 70 Permits—Operational Flexibility (Revised 04/10/01). Rule 33.5 Part 70 Permits—Timeframes for Applications, Review and Issuance (Adopted 10/12/93). Rule 33.6 Part 70 Permits—Permit Term and Permit Reissuance (Adopted 10/12/93. Rule 33.7 Part 70 Permits—Notification (Revised 04/10/01). Rule 33.8 Part 70 Permits—Reopening of Permits (Adopted 10/12/93). Rule 33.9 Part 70 Permits—Compliance Provisions (Revised 04/10/01). Rule 33.10 Part 70 Permits—General Part 70 Permits (Adopted 10/12/93). Rule 34 Acid Deposition Control (Adopted 03/14/95). Rule 35 Elective Emission Limits (Revised 04/12/11). Rule 36 New Source Review—Hazardous Air Pollutants (Adopted 10/06/98). Rule 42 Permit Fees (Revised 04/12/16). Rule 44 Exemption Evaluation Fee (Revised 04/08/08). Rule 45 Plan Fees (Adopted 06/19/90). Rule 45.2 Asbestos Removal Fees (Revised 08/04/92). Rule 47 Source Test, Emission Monitor, and Call-Back Fees (Adopted 06/22/99). Rule 50 Opacity (Revised 04/13/04). Rule 52 Particulate Matter—Concentration (Grain Loading) (Revised 04/13/04). Rule 53 Particulate Matter-Process Weight (Revised 04/13/04). Rule 54 Sulfur Compounds (Revised 01/14/14). Rule 56 Open Burning (Revised 11/11/03). Rule 57 Incinerators (Revised 01/11/05). Rule 57.1 Particulate Matter Emissions From Fuel Burning Equipment (Adopted 01/11/05). Rule 62.7 Asbestos-Demolition and Renovation (Adopted 06/16/92, Effective 09/01/92). Rule 63 Separation and Combination of Emissions (Revised 11/21/78). Rule 64 Sulfur Content of Fuels (Revised 04/13/99). Rule 68 Carbon Monoxide (Revised 04/13/04). Rule 71 Crude Oil and Reactive Organic Compound Liquids (Revised 12/13/94). Rule 71.1 Crude Oil Production and Separation (Revised 06/16/92). Rule 71.2 Storage of Reactive Organic Compound Liquids (Revised 09/26/89). Rule 71.3 Transfer of Reactive Organic Compound Liquids (Revised 06/16/92). Rule 71.4 Petroleum Sumps, Pits, Ponds, and Well Cellars (Revised 06/08/93). Rule 71.5 Glycol Dehydrators (Adopted 12/13/94). Rule 72 New Source Performance Standards (NSPS) (Revised 09/9/08). Rule 73 National Emission Standards for Hazardous Air Pollutants (NESHAPS (Revised 09/9/08). Rule 74 Specific Source Standards (Adopted 07/06/76). Rule 74.1 Abrasive Blasting (Revised 11/12/91). Rule 74.2 Architectural Coatings (Revised 01/12/10). Rule 74.6 Surface Cleaning and Degreasing (Revised 11/11/03—effective 07/01/04). Rule 74.6.1 Batch Loaded Vapor Degreasers (Adopted 11/11/03—effective 07/01/04). Rule 74.7 Fugitive Emissions of Reactive Organic Compounds at Petroleum Refineries and Chemical Plants (Revised 10/10/95). Rule 74.8 Refinery Vacuum Producing Systems, Waste-Water Separators and Process Turnarounds (Revised 07/05/83). Rule 74.9 Stationary Internal Combustion Engines (Revised 11/08/05). Rule 74.10 Components at Crude Oil Production Facilities and Natural Gas Production and Processing Facilities (Revised 03/10/98). Rule 74.11 Natural Gas-Fired Residential Water Heaters-Control of NOX (Revised 05/11/10). Rule 74.11.1 Large Water Heaters and Small Boilers (Revised 09/11/12). Rule 74.12 Surface Coating of Metal Parts and Products (Revised 04/08/08). Rule 74.15 Boilers, Steam Generators and Process Heaters (5MMBTUs and greater) (Revised 11/08/94). Rule 74.15.1 Boilers, Steam Generators and Process Heaters (1 to 5 MMBTUs) (Revised 06/23/15). Rule 74.16 Oil Field Drilling Operations (Adopted 01/08/91). Rule 74.20 Adhesives and Sealants (Revised 09/11/12). Rule 74.23 Stationary Gas Turbines (Revised 1/08/02). Rule 74.24 Marine Coating Operations (Revised 09/11/12). Rule 74.24.1 Pleasure Craft Coating and Commercial Boatyard Operations (Revised 01/08/02). Rule 74.26 Crude Oil Storage Tank Degassing Operations (Adopted 11/08/94). Rule 74.27 Gasoline and ROC Liquid Storage Tank Degassing Operations (Adopted 11/08/94). Rule 74.28 Asphalt Roofing Operations (Adopted 05/10/94). Rule 74.30 Wood Products Coatings (Revised 06/27/06). Rule 74.31 Metal Working Fluids and Direct-Contact Lubricants (Adopted 11/12/13). Rule 75 Circumvention (Revised 11/27/78). Rule 101 Sampling and Testing Facilities (Revised 05/23/72). Rule 102 Source Tests (Revised 04/13/04). Rule 103 Continuous Monitoring Systems (Revised 02/09/99). Rule 154 Stage 1 Episode Actions (Adopted 09/17/91). Rule 155 Stage 2 Episode Actions (Adopted 09/17/91). Rule 156 Stage 3 Episode Actions (Adopted 09/17/91). Rule 158 Source Abatement Plans (Adopted 09/17/91). Rule 159 Traffic Abatement Procedures (Adopted 09/17/91). Rule 220 General Conformity (Adopted 05/09/95). Rule 230 Notice To Comply (Revised 9/9/08)
    [FR Doc. 2016-29258 Filed 12-9-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [MB Docket No. 13-236; Report No. 3057] Petition for Reconsideration of Action in Rulemaking Proceeding AGENCY:

    Federal Communications Commission.

    ACTION:

    Petition for reconsideration.

    SUMMARY:

    A Petition for Reconsideration (Petition) has been filed in the Commission's rulemaking proceeding by John R. Feore, on behalf of ION MEDIA NETWORKS, INC., and Colby M. May, on behalf of TRINITY CHRISTIAN CENTER OF SANTA ANA, INC.

    DATES:

    Oppositions to the Petition must be filed on or before December 27, 2016. Replies to an opposition must be filed on or before January 6, 2017.

    ADDRESSES:

    Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.

    FOR FURTHER INFORMATION CONTACT:

    Brendan Holland, Media Bureau, phone: (202) 418-2757, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's document, Report No. 3057, released December 1, 2016. The full text of the Petition is available for viewing and copying at the FCC Reference Information Center, 445 12th Street SW., Room CY-A257, Washington, DC 20554. It also may be accessed online via the Commission's Electronic Comment Filing System at https://www.fcc.gov/ecfs/filing/1123447502233/document/1123447502233fbd7. The Commission will not send a copy of this document pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A), because this document does not have an impact on any rules of particular applicability.

    Subject: National Television Multiple Ownership Rule, FCC 16-116, Report and Order, published at 81 FR 73035, October 24, 2016, in MB Docket No. 13-236. This document is being published pursuant to 47 CFR 1.429(e). See also 47 CFR 1.4(b)(1) and 1.429(f), (g).

    Number of Petitions Filed: 1.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2016-29611 Filed 12-9-16; 8:45 am] BILLING CODE 6712-01-P
    81 238 Monday, December 12, 2016 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request December 7, 2016.

    The Department of Agriculture will submit the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13 on or after the date of publication of this notice. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, Washington, DC; New Executive Office Building, 725 17th Street NW., Washington, DC 20503. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602.

    Comments regarding these information collections are best assured of having their full effect if received by January 11, 2017. Copies of the submission(s) may be obtained by calling (202) 720-8681.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Agricultural Marketing Service

    Title: National Organic Program.

    OMB Control Number: 0581-0191.

    Summary of Collection: The Organic Foods Production Act (OFPA) of 1990, Title XXI of the Food, Agriculture, Conservation and Trade Act of 1990 (Farm Bill), U.S.C. Title 7 Section 6503(a) mandates that the Secretary of Agriculture develop a national organic program. The purposes of the regulation mandated by OFPA are: (1) To establish national standards governing the marketing of certain agricultural products as organically produced products; (2) to assure consumers that organically produced products meet a consistent standard; and (3) to facilitate interstate commerce in fresh and processed food that is organically produced. The National Organic Program (NOP) regulation fulfills the requirements of the OFPA. It includes comprehensive production and handling standards, labeling provisions, requirements for the certification of producers and handlers, accreditation of certifying agents by USDA and an administrative subpart for fees, State Programs, National List, appeals, compliance and pesticide residue testing. Agricultural Marketing Service will approve programs for State governments wishing to establish State Organic Programs.

    Need and Use of the Information: The information collected is used by USDA, State program governing State officials, and certifying agents. The information is used to evaluate compliance with OFPA and NOP for administering the program, for management decisions and planning, for establishing the cost of the program and to support any administrative and regulatory actions in response to non-compliance with OFPA. Certifying agents will have to submit an application to USDA to become accredited to certify organic production and handling operations. Auditors will review the application, perform site evaluation and submit reports to USDA, who will make a decision to grant or deny accreditation. Producers, handlers and certifying agents whose operations are not approved have the right to mediation and appeal the decision. Reporting and recordkeeping are essential to the integrity of the organic certification system.

    In this renewal submission, AMS has removed the record-keeping burden attributed to the implementation of two organic certification cost-share programs: The National Organic Certification Cost-Share Program and the Agricultural Management Assistance Organic Certification Cost-Share Program. Responsibility for the Organic Cost-Share Programs is being transferred to the Farm Services Agency (FSA).

    Description of Respondents: Farms; Individuals or households; Business or other for-profit; State, Local or Tribal Government.

    Number of Respondents: 33,254.

    Frequency of Responses: Reporting: Annually; Recordkeeping.

    Total Burden Hours: 7,239,709.

    Charlene Parker, Departmental Information Collection Clearance Officer.
    [FR Doc. 2016-29694 Filed 12-9-16; 8:45 am] BILLING CODE 3410-02-P
    DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request December 7, 2016.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by January 11, 2017 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Animal Plant and Health Inspection Service

    Title: Irradiation Phytosanitary Treatment for Fresh Fruits and Vegetables.

    OMB Control Number: 0579-0155.

    Summary of Collection: Under the Plant Protection Act (7 U.S.C. 7701-7772), the Animal and Plant Health Inspection Service (APHIS) is authorized, among other things, to regulate the importation of plants, plant products, and other articles to prevent the introduction of plant pests into the United States. The regulations in 7 CFR 319 include specific requirements for the importation of fruits and vegetables. The regulations in 7 CFR 305 provide for the use of irradiation as a phytosanitary treatment for certain fruits and vegetables imported in the United States. The irradiation treatment provides protection against all inspect pest including fruit flies, the mango seed weevil, and others.

    Need and Use of the Information: APHIS will collect information using a compliance agreement, 30-day notification, labeling packaging, dosimetry recordings, requests for dosimetry device approval, recordkeeping, requests for facility approval, work plan, trust fund agreement, phytosanitary certificate, and denial and withdrawal certification. Without the collection of this information, APHIS would have no practical way of determining that any given commodity had actually been irradiated. Irradiation leaves no residue and usually causes no discernible change to the commodity's color or texture.

    Description of Respondents: Business or other for profit; Federal Government.

    Number of Respondents: 63.

    Frequency of Responses: Recordkeeping; Reporting: On occasion.

    Total Burden Hours: 347.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2016-29714 Filed 12-9-16; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Forest Service Black Hills National Forest Advisory Board AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Black Hills National Forest Advisory Board (Board) will meet in Rapid City, South Dakota. Additional information concerning the Board, including the meeting summary/minutes, can be found by visiting the Board's Web site at: http://www.fs.usda.gov/main/blackhills/workingtogether/advisorycommittees.

    DATES:

    The meeting will be held on Wednesday, January 4, 2017, at 1:00 p.m.

    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 Mystic Ranger District, 8221 Mount Rushmore Road, Rapid City, South Dakota.

    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 Black Hills National Forest Supervisor's Office. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Scott Jacobson, Board Coordinator, by phone at 605-440-1409 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 Board is established consistent with the Federal Advisory Committee Act of 1972 (5 U.S.C. App. II), the Forest and Rangeland Renewable Resources Planning Act of 1974 (16 U.S.C. 1600 et. seq.), the National Forest Management Act of 1976 (16 U.S.C. 1612), and the Federal Public Lands Recreation Enhancement Act (Pub. L. 108-447).

    The purpose of the meeting is to provide:

    (1) Orientation Topic—Special Uses;

    (2) 2016 Aerial Photo Results/Update;

    (3) Black Hills Resilient Landscapes (BHRL) Project update;

    (4) Pile Burning on the Forest;

    (5) Over Snow Use; and

    (6) Non-Motorized Trails Working Group update.

    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 December 26, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the Board may file written statements with the Board's staff before or after the meeting. Written comments and time requests for oral comments must be sent to Scott Jacobson, Black Hills National Forest Supervisor's Office, 1019 North Fifth Street, Custer, South Dakota 57730; by email to [email protected], or via facsimile to 605-673-9208.

    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: December 6, 2016. Mark Van Every, Forest Supervisor.
    [FR Doc. 2016-29673 Filed 12-9-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Siuslaw Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Siuslaw Resource Advisory Committee (RAC) will meet in Corvallis, Oregon. 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. RAC information can be found at the following Web site: http://www.fs.usda.gov/main/siuslaw/workingtogether/advisorycommittees.

    DATES:

    The meeting will be held on January 23, 2017, from 9:00 a.m. to 5:00 p.m.

    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 the Corvallis Forestry Sciences Lab and Siuslaw National Forest Supervisor's Office, 3200 Southwest Jefferson Way, Corvallis, Oregon.

    Written comments may be submitted as described under Supplementary Information. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at the Siuslaw National Forest Supervisor's Office. Please call ahead at 541-750-7075 to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Lisa Romano, RAC Coordinator by phone at 541-750-7075, or via email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is:

    1. To conduct RAC business,

    2. Elect a RAC chairperson,

    3. Share information,

    4. Provide a public forum, and

    5. Review Siuslaw National Forest's recreation fee proposal.

    The meeting is open to the public. Individuals wishing to make an oral statement should request to do so in writing by January 3, 2017, 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 Lisa Romano, RAC Coordinator, 3200 Southwest Jefferson Way, Corvallis, Oregon 97331; 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, please contact the person listed in the section titled For Further Information Contact. All reasonable accommodation requests are managed on a case by case basis.

    Dated: December 5, 2016. Jeremiah Ingersoll, Forest Supervisor, Siuslaw National Forest.
    [FR Doc. 2016-29687 Filed 12-9-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service North Mt. Baker Snoqualmie Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The North Mt. Baker-Snoqualmie Resource Advisory Committee (RAC) will meet in Sedro-Woolley, WA. 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: http://cloudapps-usda-gov.force.com/FSSRS/RAC_Page?id=001t0000002JcwIAAS.

    DATES:

    The meeting will be held January 19, 2017 from 8:00 a.m.-5:00 p.m.

    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 810 State Route 20, Sedro-Woolley, WA 98284.

    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 810 State Route 20, Sedro-Woolley, WA 98284. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Erin Uloth, District Ranger by phone at 360-854-2601 or via email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is:

    1. For the committee to review project proposals put forward by proponents for Secure Rural Schools Title II funding.

    2. The committee will also put forward its recommendation to the Deciding Official for what projects to fund at what levels.

    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 January 6, 2017 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 Erin Uloth, Mt. Baker District Ranger, 810 State Route 20, Sedro-Woolley, WA 98284; or by email to [email protected], or via facsimile to 360-856-1934.

    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: November 3, 2016. Erin Uloth, Mt. Baker District Ranger.
    [FR Doc. 2016-29660 Filed 12-9-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration Opportunity for Designation in Decatur, IN; Request for Comments on the Official Agency Servicing These Areas. AGENCY:

    Grain Inspection, Packers and Stockyards Administration (GIPSA), USDA.

    ACTION:

    Notice.

    SUMMARY:

    The designation of the official agency listed below will end on December 31, 2016. We are asking persons or governmental agencies interested in providing official services in the areas presently served by this agency to submit an application for designation. In addition, we are asking for comments on the quality of services provided by the following designated agency: Northeast Indiana Grain Inspection, Inc. (Northeast Indiana).

    DATES:

    Applications and comments must be received by January 11, 2017.

    ADDRESSES:

    Submit applications and comments concerning this Notice using any of the following methods:

    Applying for Designation on the Internet: Use FGISonline (https://fgis.gipsa.usda.gov/default_home_FGIS.aspx) and then click on the Delegations/Designations and Export Registrations (DDR) link. You will need to obtain an FGISonline customer number and USDA eAuthentication username and password prior to applying.

    Submit Comments Using the Internet: Go to Regulations.gov (http://www.regulations.gov). Instructions for submitting and reading comments are detailed on the site.

    Mail, Courier or Hand Delivery: Sharon Lathrop, Compliance Officer, USDA, GIPSA, FGIS, QACD, 10383 North Ambassador Drive, Kansas City, MO 64153.

    Fax: Sharon Lathrop, 816-872-1258.

    Email: [email protected]

    Read Applications and Comments: All applications and comments will be available for public inspection at the office above during regular business hours (7 CFR 1.27(c)).

    FOR FURTHER INFORMATION CONTACT:

    Sharon Lathrop, 816-891-0415 or [email protected]

    SUPPLEMENTARY INFORMATION:

    Section 79(f) of the United States Grain Standards Act (USGSA) authorizes the Secretary to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services (7 U.S.C. 79(f)). Under section 79(g) of the USGSA, designations of official agencies are effective for no longer than five years, unless terminated by the Secretary, and may be renewed according to the criteria and procedures prescribed in section 79(f) of the USGSA.

    Areas Open for Designation Northeast Indiana

    Pursuant to Section 79(f)(2) of the United States Grain Standards Act, the following geographic area, in the State of Indiana, is assigned to this official agency.

    In Indiana

    Bounded on the North by the northern Lagrange and Steuben County lines; Bounded on the East by the eastern Steuben, De Kalb, Allen, and Adams County lines; Bounded on the South by the southern Adams and Wells County lines; and Bounded on the West by the western Wells County line; the southern Huntington and Wabash County lines; the western Wabash County line north to State Route 114; State Route 114 northwest to State Route 19; State Route 19 north to Kosciusko County; the western and northern Kosciusko County lines; the western Noble and Lagrange County lines.

    The following grain elevator is part of this geographic area's assignment. In Michigan Grain Inspection Services, Inc.'s area: Trupointe Elevator, Payne, Paulding County, Ohio.

    Opportunity for Designation

    Interested persons or governmental agencies may apply for designation to provide official services in the geographic areas specified above under the provisions of section 79(f) of the USGSA and 7 CFR 800.196. Designation in the specified geographic area in the State of Indiana is for the period beginning January 1, 2017, to December 31, 2021. To apply for designation or to request more information, contact Sharon Lathrop at the address listed above.

    Request for Comments

    We are publishing this Notice to provide interested persons the opportunity to comment on the quality of services provided by the Northeast Indiana official agency. In the designation process, we are particularly interested in receiving comments citing reasons and pertinent data supporting or objecting to the designation of the applicant. Submit all comments to Sharon Lathrop at the above address or at http://www.regulations.gov.

    We consider applications, comments, and other available information when determining which applicants will be designated.

    Authority:

    7 U.S.C. 71-87k.

    Larry Mitchell, Administrator, Grain Inspection, Packers and Stockyards Administration.
    [FR Doc. 2016-29706 Filed 12-9-16; 8:45 am] BILLING CODE 3410-KD-P
    DEPARTMENT OF AGRICULTURE Grain Inspection, Packers and Stockyards Administration Designation for the Amarillo, TX; Cairo, IL; State of Louisiana; State of North Carolina and Belmond, IA; Minnesota; New Jersey and New York Areas AGENCY:

    Grain Inspection, Packers and Stockyards Administration (GIPSA), USDA.

    ACTION:

    Notice.

    SUMMARY:

    GIPSA is announcing the designations of Amarillo Grain Exchange, Inc. (Amarillo); Cairo Grain Inspection Agency, Inc. (Cairo); Louisiana Department of Agriculture and Forestry (Louisiana); North Carolina Department of Agriculture (North Carolina) and D.R. Schaal Agency, Inc. (Schaal) to provide official services under the United States Grain Standards Act (USGSA), as amended.

    DATES:

    Effective Date: October 1, 2016.

    ADDRESSES:

    Sharon Lathrop, Compliance Officer, USDA, GIPSA, FGIS, QACD, 10383 North Ambassador Drive, Kansas City, MO 64153.

    FOR FURTHER INFORMATION CONTACT:

    Sharon Lathrop, 816-891-0415, [email protected] or [email protected]

    Read Applications: All applications and comments are available for public inspection at the office above during regular business hours (7 CFR 1.27(c)).

    SUPPLEMENTARY INFORMATION:

    In the August 24, 2016, and August 30, 2016, Federal Register (81 FR 57882 through 57885 and 59598), GIPSA requested applications for designation to provide official services in the geographic areas presently serviced by Amarillo, Cairo, Louisiana, North Carolina, and Schaal. Applications were due by September 23, 2016, for the areas presently serviced by Amarillo, Cairo, Louisiana, and North Carolina, and September 29, 2016, for the area presently serviced by Schaal.

    The current official agencies: Amarillo, Cairo, Louisiana, North Carolina, and Schaal were the only applicants for designation to provide official services in these areas. As a result, GIPSA did not ask for additional comments.

    GIPSA evaluated the designation criteria in section 79(f) of the USGSA (7 U.S.C. 79(f)) and determined that Amarillo, Cairo, Louisiana, North Carolina, and Schaal are qualified to provide official services in the geographic areas specified in the Federal Register on August 24 and 30, 2016. This designation to provide official services in the specified areas of Amarillo, Cairo, Louisiana, North Carolina, and Schaal is effective October 1, 2016, to September 30, 2021.

    Interested persons may obtain official services by contacting these agencies at the following telephone numbers:

    Official agency Headquarters location and telephone Designation start Designation end Amarillo Amarillo, TX; 806-372-8511 10/1/2016 9/30/2021 Cairo Cairo, IL; 618-734-0689 10/1/2016 9/30/2021 Louisiana Baton Rouge, LA; 225-922-1341 10/1/2016 9/30/2021 North Carolina Raleigh, NC; 919-202-5774 10/1/2016 9/30/2021 Schaal Belmond, IA; 641-444-3122 10/1/2016 9/30/2021

    Section 79(f) of the USGSA authorizes the Secretary to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services (7 U.S.C. 79(f)).

    Larry Mitchell, Administrator, Grain Inspection, Packers and Stockyards Administration.
    [FR Doc. 2016-29705 Filed 12-9-16; 8:45 am] BILLING CODE 3410-KD-P
    DEPARTMENT OF AGRICULTURE National Agricultural Statistics Service Confidentiality Pledge Revision Notice AGENCY:

    National Agricultural Statistics Service, USDA.

    ACTION:

    Notice of Revision of Confidentiality Pledge under the Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA) and Title 7, Chapter 55, Section 2276 (Confidentiality of Information).

    SUMMARY:

    Under 44 U.S.C. 3506(e), and 44 U.S.C. 3501, the National Agricultural Statistics Service (NASS) is announcing a revision to the confidentiality pledge it provides to its respondents under CIPSEA and Title 7, Chapter 55, Section 2276. The revision is required by the passage and implementation of provisions of the Federal Cybersecurity Enhancement Act of 2015 (H.R. 2029, Division N, Title II, Subtitle B, Sec. 223), which permit and require the Secretary of Homeland Security to provide Federal civilian agencies' information technology systems with cybersecurity protection for their Internet traffic. More details on this announcement are presented in the SUPPLEMENTARY INFORMATION section below.

    DATES:

    This revision becomes effective upon publication of this notice in the Federal Register. In a parallel Federal Register notice, NASS is seeking public comment on this confidentiality pledge revision.

    ADDRESSES:

    Questions about this notice may be submitted by any of the following methods:

    Email: [email protected] Include the title “Confidentiality Pledge Revision Notice” in the subject line of the message.

    Efax: (855) 838-6382.

    Mail or Hand Delivery/Courier: David Hancock, NASS Clearance Officer, U.S. Department of Agriculture, Room 5336 South Building, 1400 Independence Avenue SW., Washington, DC 20250-2024.

    FOR FURTHER INFORMATION CONTACT:

    R. Renee Picanso, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, (202) 720-4333, or email [email protected] Because of delays in the receipt of regular mail related to security screening, respondents are encouraged to use phone or electronic communications.

    SUPPLEMENTARY INFORMATION:

    Under CIPSEA; Title 7, Chapter 55, Section 2276; and similar statistical confidentiality protection statutes, many federal statistical agencies, including NASS, make statutory pledges that the information respondents provide will be seen only by statistical agency personnel or their sworn agents, and will be used only for statistical purposes. CIPSEA and Title 7, Chapter 55, Section 2276 protect such statistical information from administrative, law enforcement, taxation, regulatory, or any other non-statistical use and immunize the information submitted to statistical agencies from legal process. Moreover, many of these statutes carry criminal penalties of a Class E felony (fines up to $250,000, or up to five years in prison, or both) for conviction of a knowing and willful unauthorized disclosure of covered information.

    As part of the Consolidated Appropriations Act for Fiscal Year 2016 signed on December 17, 2015, the Congress included the Federal Cybersecurity Enhancement Act of 2015 (H.R. 2029, Division N, Title II, Subtitle B, Sec. 223). This Act, among other provisions, permits and requires the Secretary of Homeland Security to provide federal civilian agencies' information technology systems with cybersecurity protection for their Internet traffic. The technology currently used to provide this protection against cyber malware is known as “Einstein 3A”. It electronically searches Internet traffic in and out of federal civilian agencies in real time for malware signatures.

    When such a signature is found, the Internet packets that contain the malware signature are shunted aside for further inspection by Department of Homeland Security (DHS) personnel. Because it is possible that such packets entering or leaving a statistical agency's information technology system may contain confidential statistical data, statistical agencies can no longer promise their respondents that their responses will be seen only by statistical agency personnel or their sworn agents. However, they can promise, in accordance with provisions of the Federal Cybersecurity Enhancement Act of 2015, that such monitoring can be used only to protect information and information systems from cybersecurity risks, thereby, in effect, providing stronger protection to the integrity of the respondents' submissions.

    Consequently, with the passage of the Federal Cybersecurity Enhancement Act of 2015, the federal statistical community has an opportunity to welcome the further protection of its confidential data offered by DHS' Einstein 3A cybersecurity protection program. The DHS cybersecurity program's objective is to protect federal civilian information systems from malicious malware attacks. The federal statistical system's objective is to ensure that the DHS Secretary performs those essential duties in a manner that honors the Government's statutory promises to the public to protect their confidential data. Given that the Department of Homeland Security is not a federal statistical agency, both DHS and the federal statistical agencies have been engaged in finding a way to balance both objectives and achieve these mutually reinforcing objectives.

    Accordingly, DHS and federal statistical agencies (including NASS), in cooperation with their parent departments, have developed a Memorandum of Agreement for the installation of Einstein 3A cybersecurity protection technology to monitor their Internet traffic and have incorporated an associated Addendum on Highly Sensitive Agency Information that provides additional protection and enhanced security handling of confidential statistical data. However, CIPSEA; Title 7, Chapter 55, Section 2276; and similar statistical confidentiality pledges promise that respondents' data will be seen only by statistical agency personnel or their sworn agents. Since it is possible that DHS personnel could see some portion of those confidential data in the course of examining the suspicious Internet packets identified by the Einstein 3A technology, statistical agencies need to revise their confidentiality pledges to reflect this process change.

    Therefore, NASS is providing this notice to alert the public to this confidentiality pledge revision in an efficient and coordinated fashion. Below is the revised confidentiality pledge as it will appear on NASS survey questionnaires, as well as the revision to NASS's confidentiality Web page. A list of the NASS OMB numbers and information collection titles that will be affected by this revision is also included below.

    The revised confidentiality pledge to appear on NASS questionnaires is below:

    The information you provide will be used for statistical purposes only. Your responses will be kept confidential and any person who willfully discloses ANY identifiable information about you or your operation is subject to a jail term, a fine, or both.

    This survey is conducted in accordance with the Confidential Information Protection provisions of Title V, Subtitle A, Public Law 107-347 and other applicable Federal laws. For more information on how we protect your information please visit: https://www.nass.usda.gov/About_NASS/Confidentiality_Pledge/index.php.

    For voluntary surveys the statement, “Response to this survey is voluntary.” Will follow this pledge. For mandatory surveys the statement, “Response to this survey is mandatory.” will follow.

    The NASS confidentiality pledge Web page (https://www.nass.usda.gov/About_NASS/Confidentiality_Pledge/index.php) will be revised to include a fifth item explaining that DHS will monitor the transmission of data for cybersecurity threats. Item 5 is below:

    5. Data are protected from cybersecurity threats

    Per the Cybersecurity Enhancement Act of 2015, your data are further protected by the Department of Homeland Security (DHS) through cybersecurity monitoring of the systems that transmit your data. DHS will be monitoring these systems to look for viruses, malware and other threats. In the event of a cybersecurity incident, and pursuant to any required legal process, information from these sources may be used to help identify and mitigate the incident.

    Affected information collections:

    OMB No. Expiration date Information collection title 0535-0001 04/30/2019 Cold Storage. 0535-0002 10/31/2018 Field Crops Production. 0535-0003 07/31/2019 Agricultural Prices. 0535-0004 01/31/2019 Egg, Chicken, and Turkey Surveys. 0535-0005 11/30/2017 Livestock Slaughter. 0535-0007 01/31/2019 Stocks Reports. 0535-0020 07/31/2018 Milk and Milk Products. 0535-0037 08/31/2019 Vegetable Surveys. 0535-0039 10/31/2019 Fruit, Nuts, and Specialty Crops. 0535-0088 07/31/2018 Field Crops Objective Yield. 0535-0093 11/30/2018 Floriculture Survey. 0535-0109 03/31/2018 Agricultural Labor. 0535-0140 01/31/2019 List Sampling Frame Survey. 0535-0150 06/30/2017 Aquaculture. 0535-0153 12/31/2018 Honey Survey. 0535-0212 11/30/2018 Mink Survey. 0535-0213 06/30/2017 Agricultural Surveys Program. 0535-0218 07/31/2018 Agricultural Resource Management and Chemical Use Surveys (ARMS). 0535-0220 03/31/2017 Cotton Ginnings. 0535-0226 10/31/2019 Census of Agriculture. 0535-0243 08/31/2018 Census of Agriculture Content Test. 0535-0244 11/30/2019 Nursery Production Survey and Nursery and Floriculture Chemical Use Survey. 0535-0245 09/30/2017 CEAP—NRI Conservation Tillage and Nutrient Management Survey. 0535-0248 04/30/2019 Generic Clearance of Survey Improvement Projects. 0535-0249 12/31/2017 Organic Production Survey. 0535-0251 05/30/2019 Residue and Biomass Field Survey. 0535-0254 07/31/2017 Current Agricultural Industrial Reports (CAIR). 0535-0255 04/30/2018 Colony Loss. 0535-0256 06/30/2018 Feral Swine Survey. 0535-0257 610/31/2018 Organic Certifier Census. 0535-0258 611/30/2018 Cost of Pollination Survey. 0535-0259 603/31/2019 Local Foods Survey. Signed at Washington, DC, November 30, 2016. Hubert Hamer, Administrator.
    [FR Doc. 2016-29750 Filed 12-9-16; 8:45 am] BILLING CODE 3410-20-P
    DEPARTMENT OF AGRICULTURE National Institute of Food and Agriculture Solicitation of Input From Stakeholders Regarding the Food Safety Outreach Program AGENCY:

    National Institute of Food and Agriculture, USDA.

    ACTION:

    Notice of Stakeholder Listening Session and request for stakeholder input.

    SUMMARY:

    As part of the National Institute of Food and Agriculture's (NIFA) strategy to successfully expand the Food Safety Outreach Program, NIFA will host a virtual listening session. The focus of the listening session is to gather stakeholder input to develop the priorities for the Request for Applications (RFA) in Fiscal Year (FY) 2018. NIFA is particularly interested in reaching the intended audience, achieving the most impact, and identifying suggested priorities in the third year of the Food Safety Outreach Program.

    DATES:

    The listening session will be held on Tuesday, January 31, 2017 from 1:00 p.m. to 3:00 p.m., Eastern Standard Time (EST). All written comments must be received by 5 p.m. EST on January 31, 2017 to be considered in the initial drafting of the FY 2018 Food Safety Outreach Program request for applications.

    ADDRESSES:

    The listening session will be hosted using Adobe Connect. On January 31, 2017, please access the following Web site, http://nifa-connect.nifa.usda.gov/r271ozhv661/. In addition, audio conference call capabilities are accessible at 1-888-844-9904, participant code 4715738#.

    Please submit comments, identified as NIFA-2017-0002, by any of the following methods:

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

    Email: [email protected] Include NIFA-2017-0002 in the subject line of the message.

    Fax: 202-401-4888.

    Mail: Paper, disk or CD-ROM submissions should be submitted to FSOP; Institute of Food Safety and Nutrition (IFSN), National Institute of Food and Agriculture, U.S. Department of Agriculture, STOP 2225, 1400 Independence Avenue SW., Washington, DC 20250-2225.

    Hand Delivery/Courier: FSOP, IFSN, National Institute of Food and Agriculture, U.S. Department of Agriculture, Room 2458, Waterfront Centre, 800 9th Street SW., Washington, DC 20024.

    Instructions: All submissions received must include the agency name and reference to NIFA-2017-0002. All comments received will be posted to http://www.regulations.gov, including any personal information provided.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Dawanna James-Holly, (202) 401-1950 (phone), (202) 401-4888 (fax), or [email protected]

    SUPPLEMENTARY INFORMATION: Additional Webinars and Comment Procedures

    Persons wishing to present during the web-based listening session on Tuesday, January 31, 2017, are requested to pre-register by contacting Dr. Dawanna James-Holly. Participants may reserve one 5-minute comment period. More time may be available, depending on the number of people wishing to make a presentation. Reservations will be confirmed on a first-come, first-served basis. All other participants may provide comments during the listening session if time permits, or by previous listed means.

    Background and Purpose

    On January 4, 2011, the Food Safety Modernization Act (FSMA) was signed into legislation. The Act amended the Food and Drug Cosmetic Act, 21 U.S.C. 391 et seq. Section 209 of FSMA added section 1011, Subsection (d) entitled “National Food Safety Training, Education, Extension, Outreach and Technical Assistance Program”. In 2015 NIFA and FDA formed a collaboration to establish the National Food Safety Training, Education, Extension, Outreach and Technical Assistance Competitive Grant Program. In 2016, the Food Safety Outreach Program at NIFA expanded the National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Competitive Grant Program. Both programs award competitive grants to eligible recipients for projects that develop and implement FSMA-related food safety training, education, extension, outreach, and technical assistance to owners and operators of small and medium-sized farms, beginning farmers, socially disadvantaged farmers, small processors or small fresh fruit and vegetable merchant wholesalers.

    In FY 2016, the Food Safety Outreach Program at NIFA built upon the national infrastructure, with a focus on delivery of customized training to very specific target audiences. Grant applications were solicited directly from those in local communities—to include those from community-based organizations, non-governmental organizations, food hubs, farm cooperatives, extension, and other local groups. Proposals were solicited for three project types: (1) Pilot Projects; (2) Community Outreach Projects; and (3) Multistate Education and Training Projects. Pilot Projects support the development of potentially high-risk and high-impact food safety education and outreach programs in local communities, addressing the needs of small, specialized audiences from among the various target groups. Pilot projects focus on building the capacity of local groups to identify very specific needs within their communities, and implementing appropriately-customized food safety education and outreach programs to meet those specific needs.

    Community Outreach Projects support the growth and expansion of already existing food safety education and outreach programs currently offered in local communities. In addition, these projects enable existing programs to reach a broader target audience. These projects enable existing education and training curricula to be modified to ensure that they are consistent with new FSMA rules and to ensure that they meet the needs of expanded audiences.

    Multistate Education and Training Projects support the development of multi-county, state-wide or multi-state programs. These projects support collaborations among states not necessarily located within the same regions, but having common food safety concerns, or addressing common commodities.

    Since its inception in FY 2015, the program has awarded over $7 million to Community Based Organizations, Cooperative Extension at 1890 and 1862 land-grant institutions, and local food hubs and established 27 new Food Safety Education and Outreach Projects. Many of these projects will work at the local level to provide training and technical assistance to small, mid-sized and hard to reach producers and processors to address the new requirements associated with FSMA.

    Implementation Plans

    All comments and the official transcript of the listening session, once available, may be reviewed on the NIFA Web page, https://nifa.usda.gov/food-safety-outreach-program, for six months. NIFA plans to consider stakeholder input received from this listening session as well as other written comments in developing the Fiscal Year 2018 solicitations for this program.

    Dated: December 2, 2016. Sonny Ramaswamy, Director, National Institute of Food and Agriculture.
    [FR Doc. 2016-29655 Filed 12-9-16; 8:45 am] BILLING CODE 3410-22-P
    COMMISSION ON CIVIL RIGHTS Notice of Public Meeting of the Ohio Advisory Committee for a Meeting To Discuss Approval and Publication of a Report Regarding Civil Rights and Hate Crime 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 Ohio Advisory Committee (Committee) will hold a meeting on Tuesday, December 20, 2016, at 10:30 a.m. EST for the purpose of discussing a draft report regarding civil rights and human trafficking in the state.

    DATES:

    The meeting will be held on Tuesday, December 20, 2016, at 10:30 a.m. EST

    ADDRESSES:

    Public call information: Dial: 888-726-2413, Conference ID: 7752037

    FOR FURTHER INFORMATION CONTACT:

    Melissa Wojnaroski, DFO, at [email protected] or 312-353-8311.

    SUPPLEMENTARY INFORMATION:

    Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-726-2413, conference ID: 7752037. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. 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 also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Carolyn Allen at [email protected] Persons who desire additional information may contact the Midwestern Regional Office at (312) 353-8311.

    Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Ohio Advisory Committee link (http://www.facadatabase.gov/committee/meetings.aspx?cid=268). Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Midwestern Regional Office at the above email or street address.

    Agenda:

    Welcome and Introductions Discussion of Draft Report: Human Trafficking in Ohio Public Comment Future Plans and Actions: Civil Rights in Ohio Adjournment

    Exceptional Circumstance: Pursuant to the Federal Advisory Committee Management Regulations (41 CFR 102-3.150), the notice for this meeting cancelation is given less than 15 calendar days prior to the meeting due to exceptional circumstance of the Committee's recent reappointment.

    Dated: December 6, 2016. David Mussatt, Supervisory Chief, Regional Programs Unit.
    [FR Doc. 2016-29644 Filed 12-9-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-55-2016] Foreign-Trade Zone (FTZ) 281—Miami, Florida; Authorization of Production Activity; Carrier InterAmerica Corporation (Heating, Ventilating and Air Conditioning Systems); Miami, Florida

    On August 5, 2016, Miami-Dade County, grantee of FTZ 281, submitted a notification of proposed production activity to the FTZ Board on behalf of Carrier InterAmerica Corporation, within Site 3, in Miami, Florida.

    The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the Federal Register inviting public comment (81 FR 58472, August 25, 2016). The FTZ Board has determined that no further review of the activity is warranted at this time. The production activity described in the notification is authorized, subject to the FTZ Act and the Board's regulations, including Section 400.14.

    Dated: December 5, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-29615 Filed 12-9-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [S-139-2016] Approval of Subzone Status; Romark Global Pharma, LLC Manatí, Puerto Rico

    On September 29, 2016, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Puerto Rico Industrial Development Company, grantee of FTZ 7, requesting subzone status subject to the existing activation limit of FTZ 7 on behalf of Romark Global Pharma, LLC, in Manatí, Puerto Rico.

    The application was processed in accordance with the FTZ Act and Regulations, including notice in the Federal Register inviting public comment (81 FR 69039, October 5, 2016). The FTZ staff examiner reviewed the application and determined that it meets the criteria for approval.

    Pursuant to the authority delegated to the FTZ Board's Executive Secretary (15 CFR 400.36(f)), the application to establish Subzone 7P is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, and further subject to FTZ 7's 2,000-acre activation limit.

    Dated: December 6, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-29616 Filed 12-9-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration Civil Nuclear Trade Advisory Committee: Meeting of the Civil Nuclear Trade Advisory Committee AGENCY:

    International Trade Administration, U.S. Department of Commerce.

    ACTION:

    Notice of Federal Advisory Committee Meeting.

    SUMMARY:

    This notice sets forth the schedule and proposed agenda for a meeting of the Civil Nuclear Trade Advisory Committee (CINTAC).

    DATES:

    The meeting is scheduled for Wednesday, December 21, 2016, from 10:30 a.m. to 11:30 a.m. Eastern Standard Time (EST). The deadline for members of the public to register, including requests to make comments during the meeting and for auxiliary aids, or to submit written comments for dissemination prior to the meeting, is 5:00 p.m. EST on December 16, 2016.

    ADDRESSES:

    The meeting will be held via conference call. The call-in number and passcode will be provided by email to registrants. Requests to register (including to speak or for auxiliary aids) and any written comments should be submitted to: Mr. Jonathan Chesebro, Office of Energy & Environmental Industries, International Trade Administration, Room 20010, 1401 Constitution Ave. NW., Washington, DC 20230. (Fax: 202-482-5665; email: [email protected]). Members of the public are encouraged to submit registration requests and written comments via email to ensure timely receipt.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Jonathan Chesebro, Office of Energy & Environmental Industries, International Trade Administration, Room 20010, 1401 Constitution Ave. NW., Washington, DC 20230. (Phone: 202-482-1297; Fax: 202-482-5665; email: [email protected]).

    SUPPLEMENTARY INFORMATION:

    Background: The CINTAC was established under the discretionary authority of the Secretary of Commerce and in accordance with the Federal Advisory Committee Act (5 U.S.C. App.), in response to an identified need for consensus advice from U.S. industry to the U.S. Government regarding the development and administration of programs to expand United States exports of civil nuclear goods and services in accordance with applicable U.S. laws and regulations, including advice on how U.S. civil nuclear goods and services export policies, programs, and activities will affect the U.S. civil nuclear industry's competitiveness and ability to participate in the international market.

    Topics to be considered: The agenda for the Wednesday, December 21, 2016 CINTAC meeting is as follows: Administrative meeting of the newly re-chartered Committee.

    Public attendance is limited and available on a first-come, first-served basis. Members of the public wishing to attend the meeting must notify Mr. Jonathan Chesebro at the contact information above by 5:00 p.m. EST on Friday, December 16, 2016 in order to pre-register. Please specify any requests for reasonable accommodation at least five business days in advance of the meeting. Last minute requests will be accepted, but may not be possible to fill.

    A limited amount of time will be available for pertinent brief oral comments from members of the public attending the meeting. To accommodate as many speakers as possible, the time for public comments will be limited to two (2) minutes per person, with a total public comment period of 30 minutes. Individuals wishing to reserve speaking time during the meeting must contact Mr. Chesebro and submit a brief statement of the general nature of the comments and the name and address of the proposed participant 5:00 p.m. EST on Friday, December 16, 2016. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, ITA may conduct a lottery to determine the speakers.

    Any member of the public may submit pertinent written comments concerning the CINTAC's affairs at any time before and after the meeting. Comments may be submitted to the Civil Nuclear Trade Advisory Committee, Office of Energy & Environmental Industries, Room 20010, 1401 Constitution Ave. NW., Washington, DC 20230. For consideration during the meeting, and to ensure transmission to the Committee prior to the meeting, comments must be received no later than 5:00 p.m. EST on Friday, December 16, 2016. Comments received after that date will be distributed to the members but may not be considered at the meeting.

    Copies of CINTAC meeting minutes will be available within 90 days of the meeting.

    Dated: December 5, 2016. Man Cho, Deputy Director, Office of Energy and Environmental Industries.
    [FR Doc. 2016-29703 Filed 12-9-16; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE International Trade Administration Application(s) for Duty-Free Entry of Scientific Instruments

    Pursuant to Section 6(c) of the Educational, Scientific and Cultural Materials Importation Act of 1966 (Pub. L. 89-651, as amended by Pub. L. 106-36; 80 Stat. 897; 15 CFR part 301), we invite comments on the question of whether instruments of equivalent scientific value, for the purposes for which the instruments shown below are intended to be used, are being manufactured in the United States.

    Comments must comply with 15 CFR 301.5(a)(3) and (4) of the regulations and be postmarked on or before January 3, 2017. Address written comments to Statutory Import Programs Staff, Room 3720, U.S. Department of Commerce, Washington, DC 20230. Applications may be examined between 8:30 a.m. and 5:00 p.m. at the U.S. Department of Commerce in Room 3720.

    Docket Number: 16-017. Applicant: California Institute of Technology, 1200 E. California Blvd., Pasadena, CA 91125. Instrument: Photonic Professional GT 3D laser Lithography System. Manufacturer: Nanoscribe GmbH, Germany. Intended Use: The instrument will be used to develop structural meta-materials that are mechanically robust and multi-functional. The instrument allows the fabrication of 3-dimensional architectures out of polymer, with dimensions on the order of nanometers. There is no other instrument capable of resolving features down to that size because to attain such resolution it is necessary to have the two-photon laser capability. Justification for Duty-Free Entry: There are no instruments of the same general category manufactured in the United States. Application accepted by Commissioner of Customs: October 28, 2016.

    Docket Number: 16-018. Applicant: UChicago Argonne, 9700 S. Cass Avenue, Lemont, IL 60439. Instrument: Electron Microscope. Manufacturer: FEI Company, Czech Republic. Intended Use: The instrument will be used for research including studies of the morphology, grain structure and defect structure in modern structural materials. Justification for Duty-Free Entry: There are no instruments of the same general category manufactured in the United States. Application accepted by Commissioner of Customs: October 31, 2016.

    Docket Number: 16-019. Applicant: University of Nebraska—Lincoln, 1700 Y St., Lincoln, NE 68588. Instrument: Electron Microscope. Manufacturer: Elmitec, Germany. Intended Use: The instrument will be used to research the synthesis and properties of novel nanomaterials, using the interaction of an electron beam with the surface of materials to image the surface with very high (nanometer scale) resolution, independent of temperature (in the range from ~−100 C to well over 1000 C) and in the presence of different gases and vapors. Justification for Duty-Free Entry: There are no instruments of the same general category manufactured in the United States. Application accepted by Commissioner of Customs: November 4, 2016.

    Docket Number: 16-020. Applicant: Lafayette College, 730 High Street, Easton, PA 18042. Instrument: High Power Q-Switched Diode-Pumped Solid State Laser. Manufacturer: EdgeWave GMBH, Germany. Intended Use: The instrument will be used to study time-dependent finite chemical rate and mixing effects in turbulent combustion and the investigation of coherent structures in turbulent boundary layers. The instrument is approximately 10 times more powerful than any other high-repetition diode-pumped solid state available from a U.S. manufacturer. Techniques to be performed include Planar Laser Induced Fluorescence imaging, exploiting the high-repetition rate and tenability features of the instrument. Justification for Duty-Free Entry: There are no instruments of the same general category manufactured in the United States. Application accepted by Commissioner of Customs: November 4, 2016.

    Docket Number: 16-022. Applicant: Regents of the University of Colorado, 1800 Grant St., Denver, CO 80203. Instrument: Electron Microscope. Manufacturer: FEI Company, Brno Czech Republic. Intended Use: The instrument will be used to research the structural basis for macromolecular function in both healthy and diseased cells. Justification for Duty-Free Entry: There are no instruments of the same general category manufactured in the United States. Application accepted by Commissioner of Customs: November 4, 2016.

    Dated: December 5, 2016. Gregory W. Campbell, Director of Subsidies Enforcement, Enforcement and Compliance.
    [FR Doc. 2016-29614 Filed 12-9-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-201-838] Seamless Refined Copper Pipe and Tube From Mexico: Preliminary Results of Antidumping Duty Administrative Review and Preliminary Determination of No Shipments; 2014-2015 AGENCY:

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

    SUMMARY:

    The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on seamless refined copper pipe and tube from Mexico. The review covers three producers/exporters of the subject merchandise, GD Affiliates S. de R.L. de C.V. (Golden Dragon), Nacional de Cobre, S.A. de C.V. (Nacobre), and IUSA, S.A. de C.V. (IUSA). The period of review (POR) is November 1, 2014, through October 31, 2015. We have preliminarily found that sales of subject merchandise have been made at prices below normal value. Interested parties are invited to comment on these preliminary results.

    DATES:

    Effective December 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Dennis McClure or George Ayache, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-5973 or (202) 482-2623, respectively.

    SUPPLEMENTARY INFORMATION:

    Scope of the Order

    The merchandise subject to the Order1 is seamless refined copper pipe and tube. The product is currently classified under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7411.10.1030 and 7411.10.1090, and also may enter under HTSUS subheadings 7407.10.1500, 7419.99.5050, 8415.90.8065, and 8415.90.8085. The HTSUS subheadings are provided for convenience and customs purposes only; the written product description of the scope of the Order is dispositive.2

    1See Seamless Refined Copper Pipe and Tube from Mexico and the People's Republic of China: Antidumping Duty Orders and Amended Final Determination of Sales at Less Than Fair Value from Mexico, 75 FR 71070 (November 22, 2010) (the Order).

    2See Memorandum from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Paul Piquado, Assistant Secretary for Enforcement and Compliance, entitled “Seamless Refined Copper Pipe and Tube from Mexico: Decision Memorandum for Preliminary Results of Antidumping Duty Administrative Review; 2014-2015,” dated concurrently with and hereby adopted by this notice (Preliminary Decision Memorandum), for a complete description of the Scope of the Order.

    Methodology

    The Department is conducting this review in accordance with section 751(a)(2) of the Tariff Act of 1930, as amended (the Act). Constructed export price is calculated in accordance with section 772 of the Act. Normal value is calculated in accordance with section 773 of the Act.

    For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and it is available to all parties in the Central Records Unit, room B0824 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/index.html. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content. A list of the topics discussed in the Preliminary Decision Memorandum is attached as the Appendix to this notice.

    Preliminary Determination of No Shipments

    Among the companies under review, IUSA properly filed a statement reporting that it made no shipments of subject merchandise to the United States during the POR.3 Because U.S. Customs and Border Protection (CBP) did not provide any information contradicting IUSA's claim to have made no shipments, the Department preliminarily determines that IUSA did not have any reviewable transactions during the POR. Consistent with our practice, we are not preliminarily rescinding the review with respect to IUSA but, rather, we will complete the review with respect to this company and issue appropriate instructions to CBP based on the final results of this review.4

    3 For a full explanation of the Department's analysis, see the Preliminary Decision Memorandum.

    4See e.g., Certain Frozen Warmwater Shrimp from Thailand; Preliminary Results of Antidumping Duty Administrative Review, Partial Rescission of Review, Preliminary Determination of No Shipments; 2012-2013, 79 FR 15951, 15952 (March 24, 2014), unchanged in Certain Frozen Warmwater Shrimp from Thailand: Final Results of Antidumping Duty Administrative Review, Final Determination of No Shipments, and Partial Rescission of Review; 2012-2013, 79 FR at 51306 (August 28, 2014).

    Preliminary Results of Review

    The Department preliminarily determines that the following weighted-average dumping margins exist:

    Producer/exporter Weighted-average
  • dumping
  • margin
  • (percent)
  • GD Affiliates S. de R.L. de C.V 5 1.93 Nacional de Cobre, S.A. de C.V 6.50
    Disclosure and Public Comment

    The Department intends to disclose the calculations performed in connection with these preliminary results to interested parties within five days after the date of publication of this notice.6 Interested parties may submit case briefs to the Department no later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may be filed no later than five days after the time limit for filing case briefs.7 Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.8 Case and rebuttal briefs should be filed using ACCESS.9

    5 The Department previously treated GD Affiliates S. de R.L. de C.V. as part of a single entity including: GD Copper Cooperatief U.A./Hong Kong GD Trading Co. Ltd./Golden Dragon Holding (Hong Kong) International, Ltd./GD Copper U.S.A. Inc./GD Affiliates Servicios S. de R.L. de C.V./GD Affiliates S. de R.L. de C.V., which is collectively referred to as Golden Dragon. See, e.g., Seamless Refined Copper Pipe and Tube from Mexico: Final Results of Antidumping Duty New Shipper Review, 77 FR 59178 (September 26, 2012), and accompanying Issues and Decision Memorandum.

    6See 19 CFR 351.224(b).

    7See 19 CFR 351.309(d).

    8See 19 CFR 351.309(c)(2) and (d)(2).

    9See 19 CFR 351.303.

    Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. An electronically-filed document must be received successfully in its entirety by ACCESS by 5 p.m. Eastern Standard Time within 30 days after the date of publication of this notice.10 Hearing requests should contain: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to issues raised in the briefs. If a request for a hearing is made, parties will be notified of the time and date for the hearing to be held at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.11

    10See 19 CFR 351.310(c).

    11Id.

    The Department intends to issue the final results of this administrative review, including the results of its analysis of the issues raised in any written briefs, no later than 120 days after the date of publication of this notice, pursuant to section 751(a)(3)(A) of the Act and 19 CFR 351.213(h), unless this deadline is extended.

    Assessment Rates

    Upon issuance of the final results, the Department shall determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.12 Golden Dragon and Nacobre reported the names of the importers of record and the entered value for all of their sales to the United States during the POR. If Golden Dragon's and Nacobre's weighted-average dumping margins are not zero or de minimis (i.e., less than 0.50 percent) in the final results of this review, we will calculate importer-specific assessment rates on the basis of the ratio of the total amount of dumping calculated for the importer's examined sales and the total entered value of those sales in accordance with 19 CFR 351.212(b)(1), and we will instruct CBP to assess antidumping duties on all appropriate entries covered by this review. Where either the respondent's weighted-average dumping margin is zero or de minimis, or an importer-specific assessment rate is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

    12See 19 CFR 351.212(b).

    In accordance with the Department's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Golden Dragon and Nacobre for which they did not know their merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediary involved in the transaction.13 Further, if we continue to find in the final results that IUSA had no shipments of subject merchandise during the POR, we will instruct CBP to liquidate any suspended entries that entered under its antidumping duty case number at the all-others rate.

    13 For a full discussion of this clarification, see Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003).

    We intend to issue instructions to CBP 41 days after the publication date of the final results of this review.

    Cash Deposit Requirements

    The following deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of seamless refined copper pipe and tube from Mexico entered, or withdrawn from warehouse, for consumption on or after the date of publication as provided by section 751(a)(2) of the Act: (1) The cash deposit rates for Golden Dragon and Nacobre will be equal to the weighted-average dumping margins established in the final results of this administrative review; (2) for merchandise exported by manufacturers or exporters not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently-completed segment; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation but the manufacturer is, the cash deposit rate will be the rate established for the most recently-completed segment for the manufacturer of the merchandise; (4) the cash deposit rate for all other manufacturers or exporters will continue to be 26.03 percent, the all-others rate established in the Order. These cash deposit requirements, when imposed, shall remain in effect until further notice.

    Notification to Importers

    This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(h) and 351.221(b)(4).

    Dated: December 5, 2016. Paul Piquado, Assistant Secretary, for Enforcement and Compliance. Appendix List of Topics Discussed in the Preliminary Decision Memorandum 1. Summary 2. Background 3. Scope of the Order 4. Preliminary Determination of No Shipments 5. Discussion of the Methodology i. Normal Value Comparisons ii. Determination of Comparison Method iii. Product Comparisons iv. Date of Sale v. Constructed Export Price vi. Normal Value vii. Currency Conversion 6. Recommendation
    [FR Doc. 2016-29710 Filed 12-9-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration Renewable Energy and Energy Efficiency Advisory Committee; Meeting AGENCY:

    International Trade Administration, U.S. Department of Commerce.

    ACTION:

    Notice of an open meeting.

    SUMMARY:

    The Renewable Energy and Energy Efficiency Advisory Committee (REEEAC) will hold a conference call on Thursday, December 22, 2016 at 11:00 a.m. The conference call is open to the public with registration instructions provided below.

    DATES:

    December 22, 2016, from approximately 11:00 a.m. to 12:00 p.m. Eastern Standard Time (EST). Members of the public wishing to participate must register in advance with Victoria Gunderson at the contact information below by 5:00 p.m. EST on Tuesday, December 20, 2016, including any requests to make comments during the meeting or for accommodations or auxiliary aids.

    FOR FURTHER INFORMATION CONTACT:

    Victoria Gunderson, Designated Federal Officer, Office of Energy and Environmental Industries (OEEI), International Trade Administration, U.S. Department of Commerce at (202) 482-7890; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background: The Secretary of Commerce established the REEEAC pursuant to discretionary authority and in accordance with the Federal Advisory Committee Act, as amended (5 U.S.C. App.), on July 14, 2010. The REEEAC was re-chartered on June 18, 2012, June 12, 2014, and June 9, 2016. The REEEAC provides the Secretary of Commerce with consensus advice from the private sector on the development and administration of programs and policies to enhance the export competitiveness of the U.S. renewable energy and energy efficiency industries.

    During the December 22 conference call of the REEEAC, committee members will recommend/approve the Sub-Committee structure, select their recommendations for Sub-Committee leadership, and potentially approve recommendations and/or a letter for input to the Secretary of Commerce.

    The meeting will be open to the public and will be accessible to people with disabilities. All guests are required to register in advance by the deadline identified under the DATES caption. Requests for auxiliary aids must be submitted by the registration deadline. Last minute requests will be accepted, but may not be possible to fill.

    A limited amount of time before the close of the meeting will be available for pertinent oral comments from members of the public attending the meeting. To accommodate as many speakers as possible, the time for public comments will be limited to two to five minutes per person (depending on the number of public participants). Individuals wishing to reserve speaking time during the meeting must contact Ms. Gunderson and submit a brief statement of the general nature of the comments, as well as the name and address of the proposed participant by 5:00 p.m. EST on Tuesday, December 20, 2016. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, the International Trade Administration may conduct a lottery to determine the speakers. Speakers are requested to submit a copy of their oral comments by email to Ms. Gunderson for distribution to the participants in advance of the meeting.

    Any member of the public may submit pertinent written comments concerning the REEEAC's affairs at any time before or after the meeting. Comments may be submitted to the Renewable Energy and Energy Efficiency Advisory Committee, c/o: Victoria Gunderson, Designated Federal Officer, Office of Energy and Environmental Industries, U.S. Department of Commerce; 1401 Constitution Avenue NW.; Mail Stop: 4053; Washington, DC 20230. To be considered during the meeting, written comments must be received no later than 5:00 p.m. EST on Tuesday, December 20, 2016, to ensure transmission to the Committee prior to the meeting. Comments received after that date will be distributed to the members but may not be considered at the meeting.

    Copies of REEEAC meeting minutes will be available within 30 days following the meeting.

    Dated: December 6, 2016. Edward A. O'Malley, Director, Office of Energy and Environmental Industries.
    [FR Doc. 2016-29701 Filed 12-9-16; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE395 Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Port of Kalama Expansion Project on the Lower Columbia River AGENCY:

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

    ACTION:

    Notice; issuance of an Incidental Harassment Authorization (IHA).

    SUMMARY:

    In accordance with the Marine Mammal Protection Act (MMPA), notification is hereby given that NMFS has issued an IHA to the Port of Kalama (POK) for an IHA to take small numbers of marine mammals, by Level B harassment, incidental to in-water construction activities associated with the Port of Kalama Expansion Project.

    DATES:

    Effective September 1, 2017, through August 31, 2018.

    ADDRESSES:

    An electronic copy of the final Authorization, POK's application and the environmental assessment (EA) may be obtained by writing to the address specified below, telephoning the contact listed below (see FOR FURTHER INFORMATION CONTACT), or visiting the internet at: http://www.NOAA Fisheries.noaa.gov/pr/permits/incidental.html. Documents cited in this notice may also be requested by writing to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910.

    FOR FURTHER INFORMATION CONTACT:

    Dale Youngkin, Office of Protected Resources, NOAA Fisheries, (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 NOAA Fisheries 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. NOAA Fisheries 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 September 28, 2015, NOAA Fisheries received an application from the Port of Kalama (POK) for the taking of marine mammals incidental to the construction of a new pier. On December 10, 2015, a final revised version of the application was submitted and NOAA Fisheries determined that the application was adequate and complete. NMFS published a notice making preliminary determinations and proposing an IHA on March 21, 2016 (81 FR 15064). The notice initiated a 30-day comment period. At the end of the 30-day comment period, POK notified NMFS that work would be postponed until the 2017 season. NMFS reviewed the initial application and EA and has determined that there are no substantial changes to the specified activities that would require reinitiating the process.

    The POK proposes to construct the Kalama Marine Manufacturing and Export Facility, including a new marine terminal and dredging of a berth extension, for the export of methanol. The proposed action also includes the installation of engineered log jams, restoration of riparian wetlands, and the removal of existing wood piles in a side channel as mitigation activities. The proposed activity is expected to occur during the 2017-2018 in-water work season for ESA listed fish species (September 1 through January 31). This IHA covers from September 1, 2017 to August 31, 2018, to allow for adjustments to the schedule in-water work based on logistics, weather, and contractor needs. It is possible that the work would require a second season, at which time the applicant will seek another IHA covering the second season. The following specific aspects of the proposed activities are likely to result in the take of marine mammals: Impact pile driving and vibratory pile driving. Take, by Level B Harassment only, of individuals of harbor seals (Phoca vitulina), Steller sea lions (Eumetopias jubatus), and California sea lions (Zalophus californianus) is anticipated to result from the specified activity.

    Description of the Specified Activity

    A detailed description of the project construction activities is provided in the Federal Register notice for the proposed IHA (81 FR 15064, March 21, 2016). Since that time, no changes have been made to the planned activities. Therefore, a detailed description is not provided here. Please refer to the referenced Federal Register notice for the description of the specific activity.

    Comments and Responses

    A notice of preliminary determinations and proposed IHA for POK's in-water construction activities was published in the Federal Register on March 21, 2016 (81 FR 15064). During the 30-day public comment period, NMFS received comments from the Marine Mammal Commission (Commission). The comments are posted online at: http://www.nmfs.noaa.gov/pr/permits/incidental/construction.html. Following are the substantive comments and NMFS's responses:

    Comment 1: The Commission concurs with NMFS's preliminary findings and recommends that NMFS issue the requested IHA, subject to inclusion of the proposed mitigation, monitoring, and reporting measures.

    Response: NMFS concurs with the Commission's recommendation and has issued the IHA to the Port of Kalama.

    Description of Marine Mammals in the Area of the Specified Activity

    Marine mammal species that have been observed within the region of activity consist of the harbor seal, California sea lion, and Steller sea lion. Pinnipeds follow prey species into freshwater up to, primarily, the Bonneville Dam (RM 146) in the Columbia River, but also to Willamette Falls in the Willamette River (RM 26). None of the species of marine mammal that occur in the project area are listed under the ESA or is considered depleted or strategic under the MMPA. See Table 1, below.

    Table 1—Marine Mammal Species Addressed in This IHA Request Species Common name Scientific name ESA listing
  • status
  • Stock
    Harbor Seal Phoca vitulina; ssp. richardsi Not Listed OR/WA Coast Stock. California Sea Lion Zalophus californianus Not Listed US Stock. Steller Sea Lion Eumatopius jubatus Not Listed Eastern DPS.

    The sea lion species use this portion of the river primarily for transiting to and from Bonneville Dam, which concentrates adult salmonids and sturgeon returning to natal streams, providing for increased foraging efficiency. The U.S. Army Corps of Engineers (USACE) has conducted surface observations to evaluate the seasonal presence, abundance, and predation activities of pinnipeds in the Bonneville Dam tailrace each year since 2002. This monitoring program was initiated in response to concerns over the potential impact of pinniped predation on adult salmonids passing Bonneville Dam in the spring. An active sea lion hazing, trapping, and permanent removal program was in place below the dam from 2008 through 2013.

    Pinnipeds remain in upstream locations for a couple of days or longer, feeding heavily on salmon, steelhead, and sturgeon, although the occurrence of harbor seals near Bonneville Dam is much lower than sea lions (Stansell et al., 2013). Sea lions congregate at Bonneville Dam during the peaks of salmon return, from March through May each year, and a few California sea lions have been observed feeding on salmonids in the area below Willamette Falls during the spring adult fish migration.

    There are no pinniped haul-out sites in the area of potential effects from the proposed project. The nearest haul-out sites, shared by harbor seals and California sea lions, are near the Cowlitz River/Carroll Slough confluence with the Columbia River, approximately 3.5 miles downriver from the proposed project (Jeffries et al., 2000). The nearest known haul-out for Steller sea lions is a rock formation (Phoca Rock) near RM 132 and the jetty (RM 0) near the mouth of the Columbia River. There are no pinniped rookeries located in or near the region of activity.

    A detailed description of the species likely to be affected by the project's in-water construction activities were provided in the Federal Register notice for the proposed IHA (81 FR 15064, March 21, 2016). Since that time, we are not aware of any changes in the status of these species/stocks. Therefore, detailed descriptions are not provided here. Please refer to the referenced Federal Register notice for these descriptions. Please also refer to NMFS's Web site (www.nmfs.noaa.gov/species/mammals) for generalized species accounts.

    Potential Effects of the Specified Activity on Marine Mammals and Their Habitat

    In-water construction activities associated with the POK project such as impact and vibratory pile driving components of the specified activity have the potential to result in impacts to marine mammals and their habitat in the project area. The Federal Register notice for the proposed IHA (81 FR 15064, March 21, 2016) included a detailed discussion of the behavioral and acoustic effects on marine mammals. Therefore, that information is not repeated here. Please refer to the referenced Federal Register notice for that information. No take by injury, serious injury, or death is anticipated as a result of the construction activities.

    Mitigation Measures

    In order to issue an Incidental Take Authorization (ITA) under section 101(a)(5)(D) of the MMPA, NMFS must prescribe, where applicable, 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).

    On August 4, 2016, NMFS released its Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Guidance). This new guidance established new thresholds for predicting auditory injury, which equates to Level A harassment under the MMPA. In the Federal Register Notice (81 FR 51694), NMFS explained the approach it would take during a transition period, wherein we balance the need to consider this new best available science with the fact that some applicants have already committed time and resources to the development of analyses based on our previous guidance and have constraints that preclude the recalculation of take estimates, as well as where the action is in the agency's decision-making pipeline. In that Notice, we included a non-exhaustive list of factors that would inform the most appropriate approach for considering the new Guidance, including: The scope of effects; how far in the process the applicant has progressed; when the authorization is needed; the cost and complexity of the analysis; and the degree to which the guidance is expected to affect our analysis.

    In this case, POK submitted an adequate and complete application in a timely manner and indicated that they would need to receive an IHA (if issued) by September 1, 2016. After the close of the public comment period for the Proposed IHA, POK informed NMFS that they would postpone construction activities until September, 2017. Therefore, although the action had substantially progressed through the decision-making pipeline, there was enough time to allow for re-evaluation under the new Guidance prior to when the IHA was needed. POK's original analysis considered the potential for Level A take (auditory injury (PTS)), but ultimately concluded that no Level A takes would occur due to mitigation monitoring and the implementation of shut down procedures if any marine mammals entered or approached the Level A harassment zone. POK utilized the alternative methodology provided by NMFS in the new Guidance to evaluate how it may affect the analysis. Based on the new Guidance, likely injury zones would increase in size for the two hearing groups that may be present in the project area. POK provided NMFS with an updated Monitoring Plan (available online at: http://www.nmfs.noaa.gov/pr/permits/incidental/construction.html), which increased the mitigation monitoring thresholds to avoid Level A harassment. More detail on the previously identified and updated mitigation monitoring zones is provided below.

    Mitigation Monitoring

    Initial monitoring zones were based on a practical spreading loss model and data found in Illingworth and Rodkin (2007). A minimum distance of 10 m was used for all shutdown zones, even if actual or initial calculated distances are less. A maximum distance of in-water line of sight is used for all disturbance zones for vibratory pile driving, even if actual or calculated values are greater. To provide the best estimate of transmission loss at a specific range, the data were estimated using a practical spreading loss model.

    Table 2—Distance to Initial Shutdown and Disturbance Monitoring Zones for In-water Sound in the Columbia River From Proposed Rule Pile type Hammer type Distance to monitoring zones (m) 1 190 dB 2 160 dB 2 120 dB 2 24in Concrete pile Impact 10 117 N/A. 18in Steel pipe pile Vibratory 10 N/A Line of Sight, (max 5.7km). 18in Steel pipe pile Impact 18 1,848 NA. 1 Monitoring zones based on a practical spreading loss model and data from Illingworth and Rodkin (2007). A minimum distance of 10 m is used for all shutdown zones, even if actual or initial calculated distances are less. 2 All values unweighted and relative to 1 µPa.

    Among other changes, the new Guidance established a dual metric for analysis: A peak (PK) sound pressure level (SPL) for impulsive sounds (e.g., impact pile driving) and a cumulative sound exposure level (SELcum) for both impulsive and non-impulsive (e.g., vibratory pile driving). Table 3 provides a summary of the thresholds established in the new Guidance for phocids and otariids (pinnipeds), which are anticipated to be located in the action area. As shown in Table 3, the thresholds established for phocids are lower than those established for otariids, so the updated analysis was based on the phocid pinniped thresholds.

    Table 3—New Acoustic Thresholds [From NMFS 2016] Hearing group Acoustic thresholds
  • (received levels)
  • Impulsive sounds Non-impulsive sounds
    Phocid pinnipeds (underwater) Lpk, flat: 218 dB; LEPW, 24hr: 185 dB LEPW, 24hr: 201 dB. Otariid pinnipeds (underwater) Lpk, flat: 232 dB; LEOW, 24hr: 203 dB LEOW, 24hr: 219 dB. Note: Peak sound pressure (Lpk) has a reference value of 1 µPa, and cumulative sound exposure level (LE) has a reference value of 1 µPa2s. In this table, thresholds are abbreviated to reflect American National Standards Institute standards (ANSI 2013). However, peak sound pressure is defined by ANSI as incorporating frequency weighting, which is not the intent for this Technical Guidance. Hence, the subscript “flat” is being included to indicate peak sound pressure should be flat weighted or unweighted within the generalized hearing range. The subscript associated with cumulative sound exposure level thresholds indicates the designated marine mammal auditory weighting function (PW and OW pinnipeds) and that the recommended accumulation period is 24 hours (NMFS 2016).

    The new guidance does not affect the thresholds for behavioral disturbance (Level B harassment), and would not affect the extent of Level B harassment requested by POK. Therefore, the analysis of Level B harassment in the original application and Proposed Rule remains valid and is not discussed further. In addition, the peak sound pressure thresholds (218 dB for phocids and 232 dB for otariids) would not be exceeded during any project activities. The greatest single strike peak sound pressure levels would be generated during impact installation of steel piles and these sound levels would not exceed 207 dB (CALTRANS 2012). As noted in POK's application and Proposed Rule, it is anticipated that all steel piles will be driven with a vibratory hammer, and that it will not be necessary to impact drive or impact proof any of the steel piles. However, impact driving of steel piles is analyzed as a precaution in the event that this is required. As peak sound pressure thresholds would not be exceeded for either phocids or otariids, there is no further discussion of peak sound pressure levels.

    Distances for which the Level A (PTS) threshold for cumulative sound pressure exposure could be exceeded are provided in Table 4, below.

    Table 4—New Level A Isopleths (Distances) Using NMFS New Technical Guidance Activity Level A
  • (PTS) threshold
  • Isopleth
  • (distance)
  • Impact-driving concrete piles 185 dB SELcum 40 m (131 ft). Impact-driving steel piles 185 dB SELcum 252 m (828 ft). Vibratory-driving steel piles 201 dB SELcum 16.5 m (54 ft).

    POK has updated the marine mammal monitoring plan to revise the Level A injury protection zone to fully cover the Level A isopleths for potential injury from cumulative sound pressure exposure, as established under the new Guidance. This modification to the monitoring plan would ensure that Level A takes of marine mammals would be avoided in a similar manner as presented in the Proposed Rule (i.e., shut down procedures would be implemented if any marine mammals approach or enter the Level A harassment zone). Therefore, our analysis remains the same as presented in the Proposed Rule.

    In order to accomplish appropriate monitoring for mitigation purposes, POK will have an observer stationed on each active impact pile driving location to closely monitor the shutdown zone as well as the surrounding area. In addition, POK will post two shore-based observers (one upstream of the project, and another downstream of the project area; see application), whose primary responsibility would be to record pinnipeds in the disturbance zone and to alert barge-based observers to the presence of pinnipeds in the disturbance zone, thus creating a redundant alert system for prevention of injurious interaction as well as increasing the probability of detecting pinnipeds in the disturbance zone. POK estimates that shore-based observers would be able to scan approximately 800 m (upstream and downstream) from the available observation posts; therefore, shore-based observers would be capable of monitoring the agreed-upon disturbance zone.

    As described, at least three observers will be on duty during pile vibratory driving activity for the first two days, and thereafter on every third day to allow for estimation of Level B takes. The first observer will be positioned on a work platform or barge where the entire 10 m shutdown zone is clearly visible, with the shore-based observers positioned to observe the disturbance zone from the bank of the river. Protocols will be implemented to ensure that coordinated communication of sightings occurs between observers in a timely manner.

    In summary:

    • POK will implement shutdown zones around all pile driving that encompasses the Level A harassment zones as defined in Table 4, above to avoid Level A take of marine mammals. These shutdown zones provides a buffer for the Level A harassment threshold but would also further avoid the risk of direct interaction between marine mammals and the equipment.

    • POK will have a redundant monitoring system, in which one observer would be stationed at the area of active pile driving, while two observers would be shore-based, as required to provide complete observational coverage of the reduced disturbance zone for each pile driving site. The former will be capable of providing comprehensive monitoring of the proposed shutdown zones. This observer's first priority will be shutdown zone monitoring in prevention of injurious interaction, with a secondary priority of counting takes by Level B harassment in the disturbance zone. The additional shore-based observers will be able to monitor the same distances, but their primary responsibility will be counting of takes in the disturbance zone and communication with barge-based observers to alert them to pinniped presence in the action area.

    • The shutdown and disturbance zones will be monitored throughout the time required to drive a pile. If a marine mammal is observed within the disturbance zone, a take will be recorded and behaviors documented. However, that pile segment will be completed without cessation, unless the animal approaches or enters the shutdown zone, at which point all pile driving activities will be halted.

    • Soft start procedures shall be implemented at the start of each day's impact pile driving and at any time following cessation of impact pile driving for a period of thirty minutes or longer. Soft start procedures require that the contractor provides an initial set of three strikes at reduced energy, followed by a thirty-second waiting period, then two subsequent reduced energy strike sets.

    • If steel piles require impact installation or proofing, a bubble curtain will be used for sound attenuation

    The following measures will apply to visual monitoring:

    • If the shutdown zone is obscured by fog or poor lighting conditions, pile driving will not be initiated until the entire shutdown zone is visible. Work that has been initiated appropriately in conditions of good visibility may continue during poor visibility.

    • The shutdown zone will be monitored for the presence of pinnipeds before, during, and after any pile driving activity. The shutdown zone will be monitored for 30 minutes prior to initiating the start of pile driving, during the activity, and for 30 minutes after activities have ceased. If pinnipeds are present within the shutdown zone prior to pile driving, the start of pile driving will be delayed until the animals leave the shutdown zone of their own volition, or until 15 minutes elapse without re-sighting the animal(s).

    • Monitoring will be conducted using binoculars. When possible, digital video or still cameras will also be used to document the behavior and response of pinnipeds to construction activities or other disturbances.

    • Each observer will have a radio or cell phone for contact with other monitors or work crews. Observers will implement shut-down or delay procedures when applicable by calling for the shut-down to the hammer operator.

    • A GPS unit or electric range finder will be used for determining the observation location and distance to pinnipeds, boats, and construction equipment.

    Monitoring will be conducted by qualified observers. In order to be considered qualified, observers must meet the following criteria:

    • Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target. Advanced education in biological science, wildlife management, mammalogy, or related fields (bachelor's degree or higher is required).

    • Experience and ability to conduct field observations and collect data according to assigned protocols (this may include academic experience).

    • Experience or training in the field identification of pinnipeds, including the identification of behaviors.

    • Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations.

    • Writing skills sufficient to prepare a report of observations including but not limited to the number and species of pinnipeds observed; dates and times when in-water construction activities were conducted; dates and times when in-water construction activities were suspended to avoid potential incidental injury from construction sound of pinnipeds observed within a defined shutdown zone; and pinniped behavior.

    • Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on pinnipeds observed in the area as necessary.

    Other Mitigation and Best Management Practices

    In addition, NOAA Fisheries and POK, together with other relevant regulatory agencies, have developed a number of mitigation measures designed to protect fish through prevention or minimization of turbidity and disturbance and introduction of contaminants, among other things. These measures have been prescribed under the authority of statutes other than the MMPA, and are not a part of this proposed rulemaking. However, because these measures minimize impacts to pinniped prey species (either directly or indirectly, by minimizing impacts to prey species' habitat), they are summarized briefly here. Additional detail about these measures may be found in POK's application. Timing restrictions will be used to avoid in-water work when ESA-listed fish are most likely to be present.

    POK will work to ensure minimum degradation of water quality in the project area, and requires compliance with Surface Water Quality Standards for Washington. In addition, the contractor will prepare a Spill Prevention, Control, and Countermeasures (SPCC) Plan prior to beginning construction. The SPCC Plan will identify the appropriate spill containment materials; as well as the method of implementation. All equipment to be used for construction activities will be cleaned and inspected prior to arriving at the project site, to ensure no potentially hazardous materials are exposed, no leaks are present, and the equipment is functioning properly. Equipment that will be used below OHW will be identified; daily inspection and cleanup procedures will insure that identified equipment is free of all external petroleum-based products. Should a leak be detected on heavy equipment used for the project, the equipment must be immediately removed from the area and not used again until adequately repaired.

    The contractor will also be required to prepare and implement a Temporary Erosion and Sediment Control (TESC) Plan and a Source Control Plan for project activities requiring clearing, vegetation removal, grading, ditching, filling, embankment compaction, or excavation. The BMPs in the plans would be used to control sediments from all vegetation removal or ground-disturbing activities.

    Conclusions for Effectiveness of Mitigation

    NOAA Fisheries has carefully evaluated the applicant's proposed mitigation measures and considered a range of other measures in the context of ensuring that NOAA Fisheries prescribes the means of affecting the least practicable adverse 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 measure is 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.

    While the Level A harassment zone for impact hammering of steel piers would be fairly large (252 m), we feel confident that all Level A zones would be able to be monitored to effectively implement shut down procedures to avoid Level A takes for the following reasons:

    • The applicant has past experience with monitoring much larger areas from previous projects in other areas on the same river;

    • The largest Level A harassment zone (252 m) is associated with impact hammering of steel piers; however, steel piers are anticipated to be driven with a vibratory hammer and impact hammering is only included as a precaution in the event that vibratory hammering is unable to be completed. Therefore, if impact hammering of steel piers were to be conducted, it would be for a very short duration and on a very few occasions. Additionally, if impact hammering of steel piers were to be conducted, bubble curtains would be utilized to attenuate sound and reduce the Level A harassment zone;

    • Level A harassment zones associated with impact hammering of concrete piers and vibratory hammering of steel piers (40 m and 16.5 m, respectively) would be easily monitored for shut down procedures/avoidance of Level A takes;

    • Even without the use of bubble curtains, the Level A harassment zone for impact hammering of steel piers would encompass approximately half of the width of the river in the action area, which allows for approximately half of the width of the river in the action area for marine mammals to avoid the Level A harassment zone, which we would expect them to do;

    • Other mitigation measures (e.g., monitoring prior to starting, or restarting, construction activities and the use of soft-start procedures for impact pile driving) would ensure that marine mammals are able to avoid injury; therefore, only temporary short-term Level B harassment of marine mammals is anticipated.

    Based on our evaluation, NOAA Fisheries has determined that the mitigation measures proposed from both NOAA Fisheries and POK provide the means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

    Reporting

    Discussion of reporting requirements were unintentionally omitted from the Federal Register notice for the proposed IHA. Therefore, the following sections on reporting requirements include language that was not part of the proposed IHA notification, but represents standard reporting requirements for NMFS IHAs.

    In order to issue an incidental take authorization (ITA) for an activity, section 101(a)(5)(A) of the MMPA states that NOAA Fisheries must, where applicable, 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 would 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.

    POK will submit a draft summary report of marine mammal observations and construction activities to the NMFS West Coast Regional Office and the Headquarters Office of Protected Resources 90 days after expiration of the current Authorization. A final report must be submitted to NMFS within 30 days after receiving comments from NMFS on the draft report. If no comments are received from NMFS within 30 days after submittal of the draft report, the draft report would be considered the final report. This report will summarize the information gathered pursuant to the monitoring requirements set forth in the IHA, including dates and times of operations and all marine mammal sightings (dates, times, locations, species, behavior observations [activity, and any changes in activity observed including causes if known], associated construction activities, and weather conditions.

    While the IHA does not authorize injury (i.e., Level A harassment), serious injury, or mortality, should anyone associated with the project observe an injured or dead marine mammal, the incident (regardless of cause) will be reported to NMFS as soon as practicable. The report should include species or description of the animal, condition of the animal, location, time first found, observed behaviors (if alive) and photo or video footage, if available.

    Reporting Prohibited Take

    In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited in this IHA, such as an injury (Level A harassment), serious injury, or mortality, POK shall immediately cease the specified activity and immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401 and/or by email to [email protected] The report must contain the following information: (i) Time, date, and location (latitude/longitude) of the incident; (ii) The type of activity involved; (iii) Description of the circumstances during and leading up to the incident; (iv) Description of marine mammal observations (including species identification/descriptions of animal(s) involved) and construction activities/status of all sound sources used in the 24 hours preceding the incident; (v) The fate of the animal(s), and photographic or video footage of the animal, if available.

    Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS shall work with POK to determine the action necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. POK may not resume its activities until notified by NMFS via letter, email, or telephone.

    Reporting an Injured or Dead Marine Mammal With an Unknown Cause of Injury/Death

    In the event that POK discovers an injured or dead marine mammal during its in-water construction activities in this IHA, and the cause of the injury or death is unknown and/or the death is relatively recent (i.e., in less than a moderate state of decomposition as described below), POK will immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401, and/or by email to [email protected], and the NMFS West Coast Regional Office and/or the West Coast Regional Stranding Coordinator at (206) 526-6550. The report must include the same information identified above. Activities may continue while NMFS reviews the circumstances of the incident. NMFS will work with POK to determine whether modification of the construction activities is appropriate.

    Reporting an Injured or Dead Marine Mammal Not Related to Construction Activities

    In the event that POK discovers an injured or dead marine mammal and it is determined that the injury or death is not associated with or related to the activities authorized in this IHA (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), POK shall report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401, and/or by email to [email protected], and the NMFS West Coast Regional Office and/or the West Coast Regional Stranding Coordinator at (206) 526-6550 within 24 hours of the discovery. POK shall provide photographs or video footage, if available, or other documentation of the stranded animal sighting to NMFS. Activities may continue while NMFS reviews the circumstances of the incident.

    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]. Take by Level B harassment only is anticipated as a result of POK's proposed project. Take of marine mammals is anticipated to be associated with the installation of piles via impact and vibratory methods (including installation and removal of temporary piles). The following activities are not anticipated to result in takes of marine mammals: Dredging; Removal of 157 wood piles from a former trestle in the freshwater intertidal backwater area; and ELJ construction. No take by injury, serious injury, or death is anticipated, nor is any such take authorized.

    Table 5—Current Acoustic Exposure Criteria Non-explosive sound criterion Criterion definition Threshold Level A Harassment (Injury) Permanent Threshold Shift (PTS) see Table 3 above. Level B Harassment Behavioral Disruption (for impulse noises) 160 dB re 1 microPa-m (rms). Level B Harassment Behavioral Disruption (for continuous, noise) 120 dB re 1 microPa-m (rms).

    The area of potential Level B harassment varies with the activity being conducted. For impact pile driving that will be used for the concrete piles, the area of potential harassment extends 117m from the pile driving activity. For vibratory pile driving associated with the installation of steel pipe piles, the zone of potential harassment extends in a line of sight from the pile driving activities to the nearest shoreline, covering an area of approximately 1800 acres of riverine habitat (Figure 1). Because there are no haul outs, feeding areas, or other important habitat areas for marine mammals in the action area, it is anticipated that take exposures will result primarily from animals transiting from downstream areas to upstream feeding areas.

    Assumptions regarding numbers of pinnipeds and number of round trips per individual per year in the Region of Activity are based on information from ongoing pinniped research and management activities conducted in response to concern over California sea lion predation on fish populations concentrated below Bonneville Dam. An intensive monitoring program has been conducted in the Bonneville Dam tailrace since 2002, using surface observations to evaluate seasonal presence, abundance, and predation activities of pinnipeds. Minimum estimates of the number of pinnipeds present in the tailrace from 2002 through 2014 are presented in Table 4.

    Table 3—Minimum Estimated Total Numbers of Pinnipeds Present at Bonneville Dam on an Annual Basis From 2002 Through 2013 [Stansell et al., 2013] Species 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Harbor seals 1 2 2 1 3 2 2 2 2 1 0 0 California sea lions 30 104 99 81 72 71 82 54 89 54 39 56 Steller sea lions 0 3 3 4 11 9 39 26 75 89 73 80 Harbor Seals

    There is no documented breeding or pupping activity in the action area (Jeffries 1985), and only adult males and females are anticipated to be present in the action area. There is no current data estimating abundance of harbor seals either locally or for the Oregon-Washington coastal stock (Carretta et al., 2014). In this case, we must rely on estimates provided in the application that are believed to provide a conservative estimate of the number of harbor seals potentially affected by the proposed action. The conservative estimate of harbor seals likely to be present in the action area when construction activities are occurring is up to 10 animals per day based on local anecdotal reports (lacking local observational data), with the animals primarily transiting between the mouth of the Columbia River and the Cowlitz or Kalama Rivers. Because harbor seals occur in the action area throughout the year, and in-water construction activities are expected to take up to 153 days, it is possible that harbor seals could be exposed above the Level B harassment threshold up to 1,530 times, although some of these exposures would likely be exposures of the same individual across multiple days so the number of individual harbor seals taken is likely lower. We believe that this estimate is doubly conservative, because the majority of pile driving work will be impact pile driving of concrete piles. Impact pile driving of concrete piles has a much smaller area of potential harassment (a radius of 117m from pile driving) than vibratory pile driving, and this area covers only approximately 1/6th of the channel width of the Columbia River, indicating a large portion of the river will be passable by pinnipeds without experiencing take in the form of harassment during most pile driving activities.

    California Sea Lions

    California sea lions are the most frequently observed pinnipeds upstream of the project site. California sea lions do not breed or bear their young near the Columbia River watershed, with the nearest breeding grounds off the coast of southern California (Caretta et al., 2014). There are no documented haulouts within the action area, so the only California sea lions expected to be present in the action area are adult males and females traveling to and from dams upstream of the project location.

    Historically (prior to 2008), California sea lions were the most frequently observed pinniped species at Bonneville Dam (Stansell et al., 2013). However, between 2008 and 2014, the number of California sea lions observed at the dam declined. Then, in 2015, an estimated 190 individually branded California sea lions were recorded, which was in contrast to the 56 unique individuals identified in 2013. Typically the run time for California sea lions has begun later in the year than the run for Steller sea lions. The first California sea lion observed at the dam in 2015 was observed on February 9. For this reason, the bulk of the California sea lion run would be expected to occur outside of the pile driving window. However, a number of factors could cause the run to appear earlier or later. In addition, any estimate of anticipated run size must take into account the increased California sea lion presence at the dam in 2015. For this reason, to make a conservative assessment, the anticipated take estimate is based on the average daily abundance of up to 12 pinnipeds per day reported at the dam in 2015. Using this number, it is estimated that up to 372 California sea lions could be exposed to Level B harassment in the 2016-2017 work window. However, this is a very conservative estimate and the actual number could be less. Additionally, the majority of pile driving work will be impact pile driving of concrete piles. Impact pile driving of concrete piles has a much smaller area of potential harassment (a radius of 117m from pile driving) than vibratory pile driving, and this area covers only approximately 1/6th of the channel width of the Columbia River, indicating a large portion of the river will be passable by pinnipeds without experiencing take in the form of harassment during most pile driving activities. Thus we would expect that less than 1/3 of the transits would occur during the project's in-water work window based on avoiding peak transit periods, and that some proportion of those transits would occur in unaffected areas of the Columbia River during impact pile driving activities.

    Steller Sea Lions

    Steller sea lions do not breed or bear their young near the Columbia River watershed, with the nearest breeding grounds on the marine coast of Oregon (Stansell et al., 2013). There are no documented haulouts within the action area, so the only Steller sea lions expected to be present in the action area are adult males and females traveling to and from dams upstream of the project location.

    Prior to 2002, Steller sea lions were sighted infrequently at Bonneville Dam, with fewer than 10 individuals recorded in most years. However, since 2008, the number of Steller sea lions documented at the dam has increased steadily. In 2010, 75 individual Steller sea lions were identified, at an average rate of less than 12.6 individuals per day (between January 1 and May 31). In 2015 an average of 12 pinnipeds were observed at the dam per day in January (van der Leeuw, 2015). While no specific data exists regarding the number of trips up and down the river each individual sea lion makes, it is assumed that on average each individual makes one round trip during the spring migration. All pile driving will occur between September 1, 2016 and January 31, 2017, which will avoid the April and May peak of the run. Steller sea lion presence at the dam in January and February represents approximately one third of the total run in a given year (Stansell et al., 2013). Using these numbers, it has been estimated that up to 12 individual Steller sea lions per day could be exposed to Level B harassment. This represents up to 372 individual takes of Steller sea lions in the 2016-2017 work window. However, this is a conservative estimate, and the actual number of takes could be less. Additionally, the majority of pile driving work will be impact pile driving of concrete piles. Impact pile driving of concrete piles has a much smaller area of potential harassment (a radius of 117m from pile driving) than vibratory pile driving, and this area covers only approximately 1/6th of the channel width of the Columbia River, indicating a large portion of the river will be passable by pinnipeds without experiencing take in the form of harassment during most pile driving activities. Thus we would expect that less than 1/3 of the transits would occur during the project's in-water work window based on avoiding peak transit periods, and that some proportion of those transits would occur in unaffected areas of the Columbia River during impact pile driving activities.

    Analysis and 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 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”, NOAA Fisheries 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, and the status of the species. To avoid repetition, the discussion of our analyses applies to all three species of pinnipeds (harbor seals, California sea lions, and Steller sea lions), given that the anticipated effects of this project on these species are expected to be relatively similar in nature. There is no information about the nature or severity of the impacts, or the size, status, or structure of any species or stock that would lead to a different analysis for any species, else species-specific factors would be identified and analyzed.

    Incidental take, in the form of Level B harassment only, is likely to occur primarily as a result of pinniped exposure to elevated levels of sound caused by impact and vibratory installation and removal of pipe and sheet pile and steel casings. No take by injury, serious injury, or death is anticipated and is not authorized. By incorporating the proposed mitigation measures, including pinniped monitoring and shut-down procedures described previously, harassment to individual pinnipeds from the proposed activities is expected to be limited to temporary behavioral impacts. POK assumes that all individuals travelling past the project area would be exposed each time they pass the area and that all exposures would cause disturbance. NOAA Fisheries agrees that this represents a worst-case scenario and is therefore sufficiently precautionary. There are no pinniped haul-outs or rookeries located within or near the Region of Activity.

    The shutdown zone monitoring proposed as mitigation, and the small size of the zones in which injury may occur, makes any potential injury of pinnipeds extremely unlikely, and therefore discountable. Because pinniped exposures would be limited to the period they are transiting the disturbance zone, with potential repeat exposures (on return to the mouth of the Columbia River) separated by days to weeks, the probability of experiencing TTS is also considered unlikely.

    In addition, it is unlikely that pinnipeds exposed to elevated sound levels would temporarily avoid traveling through the affected area, as they are highly motivated to travel through the action area in pursuit of foraging opportunities upriver. Sea lions have shown increasing habituation in recent years to various hazing techniques used to deter the animals from foraging in the Bonneville tailrace area, including acoustic deterrent devices, boat chasing, and above-water pyrotechnics (Stansell et al., 2013). Many of the individuals that travel to the tailrace area return in subsequent years (Stansell et al., 2013). Therefore, it is likely that pinnipeds would continue to pass through the action area even when sound levels are above disturbance thresholds.

    Although pinnipeds are unlikely to be deterred from passing through the area, even temporarily, they may respond to the underwater sound by passing through the area more quickly, or they may experience stress as they pass through the area. Sea lions already move quickly through the lower river on their way to foraging grounds below Bonneville Dam (transit speeds of 4.6 km/hr in the upstream direction and 8.8 km/hr in the downstream direction (Brown et al., 2010). Any increase in transit speed is therefore likely to be slight. Another possible effect is that the underwater sound would evoke a stress response in the exposed individuals, regardless of transit speed. However, the period of time during which an individual would be exposed to sound levels that might cause stress is short given their likely speed of travel through the affected areas. In addition, there would be few repeat exposures for individual animals. Thus, it is unlikely that the potential increased stress would have a significant effect on individuals or any effect on the population as a whole.

    Therefore, NOAA Fisheries finds it unlikely that the amount of anticipated disturbance would significantly change pinnipeds' use of the lower Columbia River or significantly change the amount of time they would otherwise spend in the foraging areas below Bonneville Dam. Pinniped usage of the Bonneville Dam foraging area, which results in transit of the action area, is a relatively recent learned behavior resulting from human modification (i.e. fish accumulation at the base of the dam). Even in the unanticipated event that either change was significant and animals were displaced from foraging areas in the lower Columbia River, there are alternative foraging areas available to the affected individuals. NOAA Fisheries does not anticipate any effects on haul-out behavior because there are no proximate haul-outs within the areas affected by elevated sound levels. All other effects of the proposed action are at most expected to have a discountable or insignificant effect on pinnipeds, including an insignificant reduction in the quantity and quality of prey otherwise available.

    Any adverse effects to prey species would occur on a temporary basis during project construction. Given the large numbers of fish in the Columbia River, the short-term nature of effects to fish populations, and extensive BMPs and minimization measures to protect fish during construction, as well as conservation and habitat mitigation measures that would continue into the future, the project is not expected to have significant effects on the distribution or abundance of potential prey species in the long term. Therefore, these temporary impacts are expected to have a negligible impact on habitat for pinniped prey species.

    A detailed description of potential impacts to individual pinnipeds was provided previously in the Federal Register notice for the proposed IHA (81 FR 15064, March 21, 2016). The following sections put into context what those effects mean to the respective populations or stocks of each of the pinniped species potentially affected.

    Harbor Seal

    The Oregon/Washington coastal stock of harbor seals consisted of about 24,732 animals in 1999 (Carretta et al., 2014). As described previously, both the Washington and Oregon portions of this stock have reached carrying capacity and are no longer increasing, and the stock is believed to be within its optimum sustained population level (Jeffries et al., 2003; Brown et al., 2005). The estimated take of up to 1,530 individuals (though likely somewhat fewer, as the estimate really indicates instances of take and some individuals are likely taken more than once across the 153-day period) by Level B harassment is small relative to a stable population of approximately 24.732 (6.2 percent), and is not expected to impact annual rates of recruitment or survival of the stock.

    California Sea Lion

    The U.S. stock of California sea lions had a minimum estimated population of 153,337 in the 2013 Stock Assessment Report (Carretta et al., 2014). The estimated take of 372 individuals by Level B harassment is small relative to a population of approximately 153,337 (0.2 percent), and is not expected to impact annual rates of recruitment or survival of the stock.

    Steller Sea Lion

    The total population of the eastern DPS of Steller sea lions had a minimum estimated population of 59,968 animals with an overall annual rate of increase of 4 percent throughout most of the range (Oregon to southeastern Alaska) since the 1970s (Allen and Angliss, 2015). In 2006, the NOAA Fisheries Steller sea lion recovery team proposed removal of the eastern stock from listing under the ESA based on its annual rate of increase, and the population was delisted in 2013 (though still considered depleted under the MMPA). The total estimated take of 372 individuals per year is small compared to a population of approximately 59,968 (0.6 percent) and is not expected to impact annual rates of recruitment or survival of the stock.

    Summary

    The anticipated behavioral harassment is not expected to impact recruitment or survival of the any affected pinniped species. The Level B harassment experienced is expected to be of short duration, with 1-2 exposures per individual separated by days to weeks, with each exposure resulting in minimal behavioral effects (increased transit speed or avoidance). For all species, because the type of incidental harassment is not expected to actually remove individuals from the population or decrease significantly their ability to feed or breed, this amount of incidental harassment is anticipated to have a negligible impact on the stock.

    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 mitigation and monitoring measures, NOAA Fisheries finds that POK's proposed activities would have a negligible impact on the affected species or stocks.

    Small Numbers

    Using the estimated take described previously, the species with the greatest proportion of affected population is harbor seals (Table 5), with an estimated 6.2% of the population potentially experiencing take from the proposed action. California sea lions population will experience 0.2% exposure, and Steller sea lions an approximate exposure rate of 0.6%. 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 mitigation and monitoring measures, NOAA Fisheries finds that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.

    Table 4—Estimated Take To Be Authorized and Proportion of Population Potentially Affected Estimated take by Level B harassment Abundance of stock Percentage of
  • stock potentially
  • affected
  • Population trend
    Harbor Seal 1,530 24,732 6.2 Stable/Carrying Capacity. California Sea Lion 372 153,337 0.2 Stable. Steller Sea Lion 372 59,968 0.6 Increasing.
    Impact on Availability of Affected Species for Taking for Subsistence Uses

    There are no relevant subsistence uses of marine mammals implicated by this action. Therefore, NOAA Fisheries has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

    Endangered Species Act (ESA)

    No species of marine mammal listed under the ESA are expected to be affected by these activities. Therefore, NOAA Fisheries has determined that a section 7 consultation under the ESA is not required.

    National Environmental Policy Act (NEPA)

    NOAA Fisheries prepared an Environmental Assessment (EA) in accordance with the National Environmental Policy Act (NEPA) considered comments submitted in response to this notice as part of that process. NMFS prepared and signed a Finding of No Significant Impact (FONSI) determining that preparation of an Environmental Impact Statement was not required. The FONSI was signed on October 24, 2016, prior to the issuance of the IHA for POK's construction activities. The EA and Finding of No Significant Impact (FONSI) have been posted at the foregoing internet site.

    Authorization

    NOAA Fisheries has issued an IHA to Port of Kalama for constructing the Kalama Marine Manufacturing and Export Facility on the Columbia River during the 2016-2017 in-water work season, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.

    Dated: December 7, 2016. Donna S. Wieting, Director, Office of Protected Resources, National Marine Fisheries Service. EN12DE16.028
    [FR Doc. 2016-29748 Filed 12-9-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; West Coast Region Vessel Monitoring System and Pre-Trip Reporting Requirements AGENCY:

    National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

    DATES:

    Written comments must be submitted on or before February 10, 2017.

    ADDRESSES:

    Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at [email protected].gov).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Shannon Penna, National Marine Fisheries Service (NMFS), West Coast Region (WCR) Long Beach Office, 501 West Ocean Blvd., Suite 4200, Long Beach, CA 90802, (562) 980-4238 or [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    This request is for revision and extension of a current information collection. The title will change from West Coast Region Longline Monitoring System and Pre-Trip Reporting Requirements to West Coast Region Vessel Monitoring System and Pre-trip Reporting Requirements. In addition, this collection will merge OMB Control Number 0648-0690 (Vessel Monitoring System Requirements in the Eastern Pacific Highly Migratory Species Fisheries) into this information collection.

    This collection applies to owners and operators of U.S. commercial fishing vessels that fish in the West Coast exclusive economic zone and the eastern Pacific Ocean waters of the Inter-American Tropical Tuna Commission (IATTC) Convention Area for highly migratory species (HMS) as defined by the Fishery Management Plan (FMP) for United States (U.S.) West Coast Fisheries for Highly Migratory Species, as well as a broader group of tuna and tuna-like species covered by the IATTC. These vessel owners and operators are required to submit information about their intended and actual fishing activities. These submissions would allow the National Marine Fisheries Service (NMFS) and the Pacific Fisheries Management Council to monitor the fisheries. Submissions include pre-trip reporting requirements and vessel monitoring systems (VMS). Pre-trip reporting requirements are essential for effectively and efficiently assigning available observer coverage to selected HMS vessels. Data collected by observers are critical to evaluate that the objectives of the HMS FMP are being achieved and for evaluating the impacts of potential changes in fishery management. VMS units facilitate enforcement of management measures associated with HMS fisheries, provide timely information on associated fleet activities and enable confirmation of reported vessel fishing activity locations, which help validate logbook record accuracy.

    II. Method of Collection

    VMS installation/activation and on/off reports are submitted electronically, VMS position reports are submitted via automated electronic transmission and pre-trip notifications are made by telephone.

    III. Data

    OMB Control Number: 0648-0498.

    Form Number(s): None.

    Type of Review: Regular submission (revision and extension of a current information collection).

    Affected Public: Business or other for-profit organizations.

    Estimated Number of Respondents: 34.

    Estimated Time per Response: Vessel monitoring system (VMS) activation reports, 15 minutes; pre-trip reports, 5 minutes; maintenance and repair, 60 minutes.

    Estimated Total Annual Burden Hours: 45.

    Estimated Total Annual Cost to Public: $22,187 (reporting costs for vessels 24 meters or more is covered by vessel owner/operators).

    IV. Request for Comments

    Comments are requested 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 (including hours and cost) of the proposed collection 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 on respondents, including through the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

    Dated: December 7, 2016. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2016-29688 Filed 12-9-16; 8:45 am] BILLING CODE 3510-22-P
    COMMODITY FUTURES TRADING COMMISSION Order Excluding Farm Credit System Institutions From the Commodity Exchange Act's Definition of “Commodity Trading Advisor” AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice and order.

    SUMMARY:

    Pursuant to the authority under section 1a(12)(B)(vii) of the Commodity Exchange Act (“CEA” or “Act”), the Commodity Futures Trading Commission (“Commission”) is issuing an order (“Order”) excluding institutions in the Farm Credit System (“FCS”) from the definition of “commodity trading advisor” (“CTA”). The Commission finds that FCS institutions are primarily engaged in lending to U.S. farmers, ranchers, and agricultural cooperatives, and that any commodity trading advice provided by FCS institutions to their clientele is solely incidental to that lending conduct, as required by CEA section 1a(12)(C). Therefore, the Commission concludes that FCS institutions are not entities within the intent of the statutory CTA definition, and that the issuance of this Order excluding them from the definition is appropriate.

    DATES:

    Effective date: December 12, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Amanda Olear, Associate Director, Division of Swap Dealer and Intermediary Oversight, (202) 418-5283, [email protected], or Elizabeth Groover, Special Counsel, Division of Swap Dealer and Intermediary Oversight, (202) 418-5985, [email protected].

    SUPPLEMENTARY INFORMATION: I. Background

    On October 28, 2016, the Farm Credit Council (“Farm Credit” or “Council”) petitioned the Commission for an order excluding FCS institutions from the CTA definition in the CEA. The Council is the national trade association for the FCS, a federally-chartered network of borrower-owned lending institutions comprised of cooperatives and related service organizations.1 Farm Credit's petition states that the FCS institutions should be excluded from the CTA definition because (1) the FCS institutions are not within the intent of the CTA definition because they are in the business of banking and lending, and (2) certain services provided by them, which could constitute commodity trading advice, are solely incidental to their primary lending business.2

    1Petition for Order to Exclude Farm Credit System Institutions from the Commodity Trading Advisor Definition in Accordance with Section 1a(12)(B)(vii) of the Commodity Exchange Act, Farm Credit Council (Oct. 28, 2016) (“Petition”), at 1.

    2Id. at 3.

    FCS institutions are important lenders to U.S. farmers, ranchers and agricultural cooperatives. The FCS institutions include the FCS Banks (CoBank, AgriBank, AgFirst Farm Credit Bank, and Farm Credit Bank of Texas), as well as Agricultural Credit Associations, Federal Land Credit Associations, and Production Credit Associations (together, the “Associations”).3 The FCS Banks make loans to affiliated Associations in their geographic areas, which, in turn, make loans to farmers, ranchers, and other eligible borrowers.4 Although FCS institutions do not take deposits, they provide loans, leases, and related services to farmers, ranchers, rural homeowners, aquatic producers, timber harvesters, agricultural cooperatives, rural utilities, and other eligible borrowers in all 50 states, the District of Columbia, and Puerto Rico.5

    3 An Agricultural Credit Association (ACA) can make short-, intermediate-, and long-term loans, as each ACA contains two subsidiaries: A Federal Land Credit Association (FLCA) that can only make long-term real estate loans, and a Production Credit Association (PCA) that makes short- and intermediate-term loans. Although legally separated, the ACA and its FLCA and PCA subsidiaries operate an integrated lending business with loans made through the subsidiary possessing the appropriate authority. The ACA, PCA, and FLCA are jointly and severally liable on the full amount of the indebtedness to the relevant FCS Bank under the FCS Bank's General Financing Agreement. Additionally, the ACA, PCA, and FLCA agree to guarantee each other's debts and obligations, pledge their respective assets as security for the guarantee, and share common capital. Petition, at 2.

    4Id. Additionally, CoBank also lends directly to agricultural cooperatives, rural utilities, and other eligible borrowers. Id.

    5 Petition, at 3.

    The Farm Credit Administration (“FCA”) is responsible for regulating and supervising the FCS institutions. The FCA is defined as an “appropriate federal banking agency” under the CEA6 and is one of the “Prudential Regulators” charged with implementing certain key regulatory requirements promulgated by the Dodd-Frank Act.7 The Petition states that the FCA regulates FCS institutions like banks, and that such regulation appropriately mitigates the risks of FCS institutions.8 In particular, the FCA promulgates policies and regulations intended to: Protect the safety and soundness of the FCS institutions; implement the FCA's statutory authority in the Farm Credit Act of 1971; 9 establish minimum requirements for lending, related services, investments, capital, liquidity, and mission; and ensure adequate financial disclosure and appropriate governance of the FCS institutions.10 Consequently, the FCS institutions are subject to investment guidelines,11 capital requirements,12 liquidity requirements,13 guidelines for the use of derivatives,14 risk management standards,15 periodic reporting obligations,16 as well as the FCA's examination authority.17

    6 7 U.S.C. 1a(2).

    7 Public Law 111-203, 124 Stat. 1376 (2010).

    8 Petition, at 3. In fact, Farm Credit believes that FCS institutions are, in fact, banks that would otherwise be excluded from the CTA definition by CEA section 1a(12)(B)(i). However, Farm Credit states that it petitioned for this Order to achieve greater certainty for the FCS institutions because the term “bank” is not defined in the CEA or the Commission's regulations. Id.

    9 12 U.S.C. 2001-2279cc.

    102015 Annual Report on the Farm Credit System, Farm Credit Administration, Regulator of the FCS, p. 5 (“FCA Annual Report”). See also id. at 41-44.

    11 12 CFR part 615, subpart E.

    12 12 CFR part 615, subparts H and K. The FCA published final rules in July 2016 that are intended to ensure that FCS capital requirements are appropriate for the FCS' cooperative structure, and comparable to the Basel III framework and the standardized approach adopted by the federal banking regulatory agencies. See Regulatory Capital Rules: Regulatory Capital, Implementation of Tier 1/Tier 2 Framework, 81 FR 49720 (July 28, 2016).

    13 12 CFR part 615, subpart E.

    14 David C. Baer, Director, Office of Examination, FCA to All Farm Credit Banks, “Guidelines for Utilizing Derivative Products,” Bookletter, BL-023 (Oct. 31, 1995) (“FCA Guidelines for Utilizing Derivatives”), available at http://ww3.fca.gov/readingrm/Handbook/_layouts/15/WopiFrame.aspx?sourcedoc=/readingrm/Handbook/FCA%20Bookletters/BL-023.docx&action=default. These Guidelines are designed to complement existing FCA regulations pertaining to risk management, investment practices, and asset and liability management practices. Id. at 3.

    15 12 CFR part 615, subpart G.

    16 12 CFR part 621, subpart D.

    17 FCA Annual Report, p. 5.

    FCS institutions use derivatives to manage their own risks, and also to offer their eligible borrowers or their affiliated Associations' eligible borrowers the ability to hedge the risks, including interest rate risk, associated with their loans through the use of over-the-counter (“OTC”) swaps.18 The use of derivatives is specifically permitted and overseen by the FCA and is subject to certain conditions, in order to protect the FCS institution eligible borrowers and to preserve the “safety and soundness” of the FCS as a whole.19 The Petition states that swaps offered to FCS institution eligible borrowers are intended to assist them in hedging their interest rate and other risks arising from FCS institution loans, and that FCS institutions do not enter into swaps with persons unless they are eligible borrowers of an FCS institution.20

    18 Petition, at 2. The Petition states that FCS institutions also use derivatives to manage interest rate, liquidity, and balance sheet risks, but because FCS institutions primarily enter into such transactions with registered swap dealers, the Council does not view such activity as raising CTA concerns. Id.

    19 Petition, at 5. The Petition specifically cites detailed FCA policies mandating counterparty credit risk management, as well as the “comprehensive safety and soundness regulation and oversight by the FCA.” Petition, at 5-6. As a result, all of the FCS institutions' derivatives activity, whether with swap dealers or eligible borrowers, falls within the definition of “hedging or mitigating commercial risk” in Commission regulations. Id. at 6. This is consistent with the FCA's historic position related to the use of derivatives by FCS institutions, as stated in the FCA Guidelines for Utilizing Derivatives: “The FCA considers any speculative use of derivatives an unsafe and unsound banking practice.” FCA Guidelines for Utilizing Derivatives, at 1.

    20 Petition, at 2. Further, the Petition states that FCS institutions are prohibited from engaging in speculative derivatives activity, and that approved swap transactions with eligible borrowers are limited to those that enable eligible borrowers to hedge risk or that are necessary for the financing of individual transactions. Id. at 6.

    In connection with the lending-related swap transactions, FCS institutions sometimes provide eligible borrowers with information about the financial instrument to be used, i.e., an interest rate swap, through presentations or in writing.21 The Petition further states that such information generally is generic and not intended as commodity trading advice.22 Additionally, an eligible borrower in this context acknowledges that the FCS institution is not its advisor, and that the borrower is not relying on the information as FCS institution advice.23 Nevertheless, because the FCS institution is providing information about a commodity interest transaction to an eligible borrower, Farm Credit and FCS institutions are concerned that the provision of such information could be construed as the provision of commodity trading advice requiring registration as a CTA with the Commission.24 Therefore, Farm Credit filed the Petition seeking an Order excluding the FCS institutions from the CEA's CTA definition to clarify their registration and compliance obligations with respect to the CEA and the regulations promulgated thereunder.25 Farm Credit's Petition argues that issuing such an Order is appropriate because FCS institutions are not within the intent of the CTA definition, and because any provision of information about commodity interests to eligible borrowers is solely incidental to the FCS institutions' primary business of lending.26

    21 Petition, at 2-3.

    22Id. at 3.

    23Id.

    24 Petition, at 2-3.

    25Id. at 3.

    26Id.

    II. Legal Authority and Analysis

    CEA section 1a(12)(A) defines “commodity trading advisor” as any person who for compensation or profit, engages in the business of advising others, either directly or through publications, writings, or electronic media, as to the value of or the advisability of trading in any commodity interest transactions; 27 any person who for compensation or profit, and as part of a regular business, issues or promulgates analyses or reports concerning any of the activities referred to in clause (i) of CEA section 1(a)(12)(A); 28 any person who is registered with the Commission as a commodity trading advisor; 29 or any person who the Commission, by rule or regulation, may include if the Commission determines that the rule or regulation will effectuate the purposes of the CEA.30

    27 7 U.S.C. 1a(12)(A)(i). Specifically, such transactions include any contract for sale of a commodity for future delivery, security futures product, or swap; any agreement, contract, or transaction described in 7 U.S.C. 2(c)(2)(i) or 7 U.S.C. 2(c)(2)(D)(i); any commodity option authorized under section 6c of this title; or any leverage transaction authorized under section 23 of this title. 7 U.S.C. 1a(12)(A)(i)(I)-(IV).

    28 7 U.S.C. 1a(12)(A)(ii).

    29 7 U.S.C. 1a(12)(A)(iii).

    30 7 U.S.C. 1a(12)(A)(iv).

    CEA section 1a(12)(B) excludes certain types of persons and entities from the CTA definition, and permits the Commission to further exclude, such other persons not within the intent of the CTA definition as the Commission may specify by rule, regulation, or order.31 Additionally, CEA section 1a(12)(C) states that these exclusions, including any additional exclusion adopted through rule, regulation or order by the Commission, shall apply only if the furnishing of such services by persons referred to in CEA section 1a(12)(B) is solely incidental to the conduct of their business or profession.32 Therefore, the Commission must consider whether the potential CTA activity is solely incidental to the primary business purposes and conduct of the FCS institutions, and whether FCS institutions may be properly excluded from the CTA definition.

    31 7 U.S.C. 1a(12)(B); 7 U.S.C. 1a(12)(B)(vii).

    32 7 U.S.C. 1a(12)(C).

    The Commission agrees with the Petition that the provision of general information about interest rate swaps to eligible borrowers of FCS institutions is solely incidental to the FCS institutions' main business and mission, i.e., agricultural lending. This conclusion is supported by the fact that the information is provided solely to eligible borrowers of the FCS institutions, and also by the strict limitations on the swap activities of FCS institutions—FCS institutions may only enter into swaps with an eligible borrower to hedge the risk(s) inherent in the underlying financing transaction between that borrower and an FCS institution.33 Additionally, the Petition states that FCS institutions do not incur significant costs in providing the information to eligible borrowers, do not charge eligible borrowers for the information, do not solicit eligible borrowers, do not require eligible borrowers to hedge their loan risks through an FCS institution, and do not hold themselves out to the public as an entity providing CTA services.34 Under these circumstances, the Commission concludes that the provision of information related to a swap transaction to eligible borrowers of FCS institutions is solely incidental to the FCS institutions' lending activity with such eligible borrowers.

    33 Petition, at 6.

    34Id. at 9.

    Further, the primary business activity of FCS institutions is engaging in direct lending to farmers, ranchers, and other eligible borrowers under the regulation and supervision of the FCA. This lending activity is generally comparable to the lending activities of banking institutions, which are excluded from the CTA definition under section 1a(12)(B) of the CEA.35 The Commission believes that it is reasonable under the facts and circumstances discussed above to conclude that granting FCS institutions an exclusion from CTA registration is consistent with the intent of section 1a(12) of the CEA.

    35See 7 U.S.C. 1a(12)(B)(i).

    III. Conclusion and Order

    The Commission finds that under the circumstances set forth above it is appropriate to exercise the statutory authority afforded to it under CEA section 1a(12)(B)(vii) to exclude FCS institutions from the CTA definition. Accordingly, the Commission is issuing this Order excluding FCS institutions from the CTA definition in CEA section 1a(12)(A). This Order is based upon the representations made by the petitioner. The Commission reserves authority, in its discretion, to revisit the Order.

    Issued in Washington, DC, on December 6, 2016, by the Commission. Robert N. Sidman, Deputy Secretary of the Commission.
    [FR Doc. 2016-29613 Filed 12-9-16; 8:45 am] BILLING CODE 6351-01-P
    DEPARTMENT OF ENERGY President's Council of Advisors on Science and Technology AGENCY:

    Office of Science, Department of Energy.

    ACTION:

    Notice of partially-closed meeting.

    SUMMARY:

    This notice sets forth the schedule and summary agenda for a partially-closed meeting of the President's Council of Advisors on Science and Technology (PCAST), and describes the functions of the Council. The Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.

    DATES:

    January 6, 2017, 9:00 a.m. to 12:00 p.m.

    ADDRESSES:

    The meeting will be held at the National Academy of Sciences, 2101 Constitution Avenue NW., Washington, DC in the Lecture Room.

    FOR FURTHER INFORMATION CONTACT:

    Information regarding the meeting agenda, time, location, and how to register for the meeting is available on the PCAST Web site at: http://whitehouse.gov/ostp/pcast. A live video webcast and an archive of the webcast after the event are expected to be available at http://whitehouse.gov/ostp/pcast. The archived video will be available within one week of the meeting. Questions about the meeting should be directed to Ms. Jennifer Michael at [email protected], (202) 456-4444. Please note that public seating for this meeting is limited and is available on a first-come, first-served basis.

    SUPPLEMENTARY INFORMATION:

    The President's Council of Advisors on Science and Technology (PCAST) is an advisory group of the nation's leading scientists and engineers, appointed by the President to augment the science and technology advice available to him from inside the White House, cabinet departments, and other Federal agencies. See the Executive Order at http://www.whitehouse.gov/ostp/pcast. PCAST is consulted about and provides analyses and recommendations concerning a wide range of issues where understandings from the domains of science, technology, and innovation may bear on the policy choices before the President. PCAST is co-chaired by Dr. John P. Holdren, Assistant to the President for Science and Technology, and Director, Office of Science and Technology Policy, Executive Office of the President, The White House; and Dr. Eric S. Lander, President, Broad Institute of the Massachusetts Institute of Technology and Harvard.

    Type of Meeting: Open and Closed.

    Proposed Schedule and Agenda: The President's Council of Advisors on Science and Technology (PCAST) is scheduled to meet in open session on January 6, 2017 from 9:00 a.m. to 12:00 p.m.

    Open Portion of Meeting: During this open meeting, PCAST is scheduled to discuss its study semiconductors as well as its review on the National Nanotechnology Initiative, and other science and technology topics. Additional information and the agenda, including any changes that arise, will be posted at the PCAST Web site at: http://whitehouse.gov/ostp/pcast.

    Closed Portion of the Meeting: PCAST may hold a closed meeting of approximately one hour with the President on January 6, 2017, which must take place in the White House for the President's scheduling convenience and to maintain Secret Service protection. This meeting will be closed to the public because such portion of the meeting is likely to disclose matters that are to be kept secret in the interest of national defense or foreign policy under 5 U.S.C. 552b(c)(1).

    Public Comments: It is the policy of the PCAST to accept written public comments of any length, and to accommodate oral public comments whenever possible. The PCAST expects that public statements presented at its meetings will not be repetitive of previously submitted oral or written statements.

    The public comment period for this meeting will take place on January 6, 2017 at a time specified in the meeting agenda posted on the PCAST Web site at http://whitehouse.gov/ostp/pcast. This public comment period is designed only for substantive commentary on PCAST's work, not for business marketing purposes.

    Oral Comments: To be considered for the public speaker list at the meeting, interested parties should register to speak at http://whitehouse.gov/ostp/pcast, no later than 9:00 a.m. (Eastern Time) on December 30, 2016. Phone or email reservations will not be accepted. To accommodate as many speakers as possible, the time for public comments will be limited to two (2) minutes per person, with a total public comment period of up to 15 minutes. If more speakers register than there is space available on the agenda, PCAST will randomly select speakers from among those who applied. Those not selected to present oral comments may always file written comments with the committee. Speakers are requested to bring at least 25 copies of their oral comments for distribution to the PCAST members.

    Written Comments: Although written comments are accepted continuously, written comments should be submitted to PCAST no later than 12:00 p.m. (Eastern Time) on December 30, 2016 so that the comments may be made available to the PCAST members prior to this meeting for their consideration. Information regarding how to submit comments and documents to PCAST is available at http://whitehouse.gov/ostp/pcast in the section entitled “Connect with PCAST.”

    Please note that because PCAST operates under the provisions of FACA, all public comments and/or presentations will be treated as public documents and will be made available for public inspection, including being posted on the PCAST Web site.

    Meeting Accommodations: Individuals requiring special accommodation to access this public meeting should contact Ms. Jennifer Michael at least ten business days prior to the meeting so that appropriate arrangements can be made.

    Issued in Washington, DC, on December 6, 2016. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2016-29657 Filed 12-9-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY [OE Docket No. PP 400] Record of Decision for Issuing a Presidential Permit to Transmission Developers, Inc.—New England, for the New England Clean Power Link Transmission Line Project AGENCY:

    Office of Electricity Delivery and Energy Reliability, U.S. Department of Energy.

    ACTION:

    Record of decision.

    SUMMARY:

    The Department of Energy (DOE) announces its decision to issue a Presidential permit to Champlain VT, LLC, d/b/a Transmission Developers, Inc.—New England (TDI-NE), to construct, operate, maintain, and connect an electric transmission line across the U.S./Canada international border in northern Vermont. The potential environmental impacts associated with the transmission line are analyzed in the New England Clean Power Link (NECPL) Project Final Environmental Impact Statement (DOE/EIS-0503).

    As proposed, the NECPL Transmission Line would extend south from the U.S./Canada international border approximately 154 miles to a new converter station in Ludlow, Vermont and the existing Coolidge Substation in the towns of Ludlow and Cavendish, Vermont.

    ADDRESSES:

    The Final Environmental Impact Statement (EIS) and this Record of Decision (ROD) are available on the DOE National Environmental Policy Act (NEPA) Web site at http://nepa.energy.gov/ and on the NECPL Project EIS Web site at http://necplinkeis.com. Copies of the Final EIS and ROD are also available for review on the NECPL Project EIS Web site.

    Copies of the Final EIS and this ROD may be requested by contacting Mr. Brian Mills, Office of Electricity Delivery and Energy Reliability (OE-20), U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585; phone 202-586-8267; email [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For further information on the NECPL Project EIS, contact Mr. Brian Mills as indicated in the ADDRESSES section above. For general information on the DOE NEPA process, contact Carol Borgstrom, Director, Office of NEPA Policy and Compliance (GC-54), U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585; email [email protected]; or facsimile to 202-586-7031.

    SUPPLEMENTARY INFORMATION: Background

    Executive Order (EO) 10485 (September 9, 1953), as amended by EO 12038 (February 7, 1978), requires that a Presidential permit be issued by DOE before electricity transmission facilities may be constructed, operated, maintained, or connected at the U.S. border. DOE may issue or amend a permit if it determines that the permit is in the public interest and after obtaining favorable recommendations from the U.S. Departments of State and Defense. In determining whether issuance of a permit for a proposed action is in the public interest, DOE considers the potential environmental impacts of the proposed project, the project's impact on electricity reliability by ascertaining whether the proposed project would adversely affect the operation of the U.S. electric power supply system under normal and contingency conditions, and any other factors that DOE considers relevant to the public interest.

    On June 23, 2014, TDI-NE applied to DOE for a Presidential permit to construct, operate, maintain, and connect a high-voltage direct current (HVDC) transmission line across the U.S./Canada international border. The proposed transmission line would be capable of transmitting up to 1,000 megawatts (MW) of electricity. The line would extend south from the U.S./Canada international border approximately 154 miles. The transmission line would be located underground in Alburgh, Vermont, for approximately 0.5 miles and would enter Lake Champlain. The cables would then be installed in Lake Champlain, primarily buried in sediments, for 97.6 miles in a southern direction. The cables would emerge from Lake Champlain in the town of Benson, Vermont, and would be buried primarily along town roads and state highway rights-of-way for approximately 55.7 miles in a south-easterly direction until terminating at a proposed converter station in Ludlow, Vermont. The alternating current (AC) system would run approximately 0.3 miles from the converter station in Ludlow to the Coolidge Substation located in the towns of Ludlow and Cavendish, Vermont.

    Consultation

    Pursuant to Section 7 of the Endangered Species Act, DOE has consulted with the U.S. Fish and Wildlife Service (USFWS) regarding the potential impacts on federally listed threatened or endangered species in the area of the proposed NECPL Project, and DOE has prepared a Biological Assessment (BA). The USFWS concurred on December 1, 2015, with DOE's determination that the project would not adversely impact the Indiana bat and the northern long eared bat.

    DOE and the Vermont State Historic Preservation Officer (VTSHPO) consulted under Section 106 of the National Historic Preservation Act and signed a Programmatic Agreement (PA) regarding historic properties in October 2015. The PA requires TDI-NE to prepare a Cultural Resources Management Plan, which will meet the survey, data collection and mitigation measures necessary as identified by the VTSHPO.

    Documents associated with both these consultations are available on the NECPL Project EIS Web site at http://necplinkeis.com.

    NEPA Review

    On August 26, 2014, DOE issued a Notice of Intent (79 FR 50901) to prepare an EIS for the NECPL Project and conduct public scoping.

    On June 12, 2015, the U.S. Environmental Protection Agency (EPA) published a Notice of Availability (NOA) of the Draft EIS (80 FR 33519), that began a 60-day public review period. DOE held two public hearings on the Draft EIS in Burlington and Rutland, Vermont, and received no oral comments on the Draft EIS. Throughout the EIS process, DOE worked with the cooperating agencies to ensure that impacts will be appropriately addressed. DOE considered all comments received on the Draft EIS in the preparation of the Final EIS. The comments received and DOE's responses are contained in Appendix M of the Final EIS. DOE issued the Final EIS in October 2015. On November 6, 2015, the U.S. EPA published a NOA of the Final EIS (80 FR 68868).

    The U.S. EPA Region 1 (USEPA), the New England District of the U.S. Army Corps of Engineers (USACE), and the U.S. Coast Guard (USCG) participated as cooperating agencies in the preparation of the EIS.

    Alternatives Considered

    In the EIS, DOE analyzed the No Action Alternative and the Proposed Action of granting the Presidential permit for the construction, operation, maintenance, and connection of the proposed NECPL Project facilities. Under the No Action Alternative, DOE would not issue a Presidential permit for the proposed NECPL Project and the transmission line would not be built. Under the Proposed Action of granting the Presidential permit (the DOE Preferred Alternative), the transmission line would be constructed from the U.S./Canada international border to the new converter station in Ludlow, Vermont and the existing Coolidge Substation in the towns of Ludlow and Cavendish, Vermont.

    Analysis of Environmental Impacts

    The EIS analyzes potential environmental impacts associated with the alternatives for each of the following resource areas: Land use, transportation and traffic, water resources and quality, aquatic and terrestrial habitats and species, aquatic and terrestrial protected and sensitive species, wetlands, geology and soils, cultural resources, infrastructure, recreation, public health and safety, hazardous materials and wastes, air quality, noise, socioeconomics, environmental justice, and cumulative impacts. This analysis assumes the implementation of all TDI-NE-proposed measures to avoid or minimize adverse impacts (Section 5 and Appendix G of the EIS). The potential impacts of the Proposed Action would be predominantly associated with construction activities and would generally have either no effect (e.g., on infrastructure) or minor, temporary, and/or short-term impacts (e.g., on water quality and recreation).

    In the floodplain analysis contained in Sections 5.1.3 and 5.2.3 of the EIS, DOE concluded that the proposed NECPL Project would avoid floodplains to the maximum extent practicable, and that appropriate measures to minimize potential harm to or within the floodplains would be taken. The Vermont Secretary of Natural Resources issued a Flood Hazard Area & River Corridor Individual Permit to TDI-NE on November 24, 2015. This permit is available under Public Documents on the NECPL Project EIS Web site at http://necplinkeis.com.

    Implementation of the No Action Alternative would not result in changes to existing conditions in these resource areas and is, therefore, the environmentally preferable alternative.

    Comments Received on the Final EIS

    EPA provided comments on the Final EIS to DOE on December 4, 2015. EPA noted that earlier comments on the Draft EIS focused on impacts during construction, operation and maintenance of the project to wetlands, water quality, drinking water, environmental justice, and air quality and that the Final EIS addressed many of their environmental concerns. The EPA provided additional comments on “areas where more could be done to characterize and address project impacts.” The comments, and DOE's responses, are discussed herein.

    EPA referred to its comments on the Draft EIS regarding DOE's purpose and need and stated that “an analysis of a broader set of alternatives would have improved the environmental review process” for the NECPL Project. DOE reiterates that its role is limited to deciding whether the issuance of a Presidential permit is in the public interest, and that the purpose and need is to respond to the applicant's request for a Presidential permit.

    EPA expressed support for the overland routing approach for the project adjacent to and within existing transportation corridor right-of-way, and added that proper mitigation to address impacts from project construction and operation would be an important part of the project design. In regard to the segment within Lake Champlain, EPA observed that the project “appears to be designed to avoid impacts to shallow water areas” and expressed support for the use of horizontal directional drilling to achieve that objective.

    Regarding water supply and water resources, EPA recommended that any future maps of the project mark the location of the ten surface water systems, nine groundwater systems, and four private wells in the vicinity of the project. DOE notes that the locations of the public water supply system sources (lake intakes and groundwater wells) and associated Source Protection Areas are depicted on the Natural Resource and Public Water Supply Map Series (December 2, 2014) that is available at www.necplink.com. TDI-NE intends to add the locations of the ten surface water systems and nine groundwater systems to the issued-for-construction drawings. Mapping of these features is intended as a precautionary measure and would not imply that construction activities would have an impact on these features. Also, EPA pointed out that the Final EIS indicates that the “deep intake of one supplier (Grand Isle Consolidated Water District [GICWD]) is within one hundred feet of the project.” DOE notes that more recent information on intake locations from the Applicant indicates that the GICWD's deep intake is over 300 feet from the NECPL Project alignment.

    EPA commented that the Final EIS does not describe how the proposed project would meet state regulations and any state guidance for protection of surface and groundwater drinking supplies and recommends that DOE provide this information before the close of the NEPA process. EPA encourages DOE to underscore the importance that TDI-NE consider all state and local land use restrictions designed to protect water supplies. DOE notes that oversight of public water systems is managed by “primacy” agencies, which are either state government agencies or EPA regional offices. The State of Vermont received primacy approval from EPA to supervise the public water systems in its jurisdiction. TDI-NE received a 401 Water Quality Certificate from the State of Vermont on November 24, 2015. The Vermont Agency for Natural Resources (VT ANR) considered the potential impact of the project on groundwater, in accordance with Section 1-04(A)(2) of the Vermont Water Quality Standards (CVR-12-030-025), and associated Anti-degradation Implementation Procedure. TDI-NE also prepared an Overall Oil and Hazardous Materials Spill Prevention and Contingency Plan for the NECPL Project.

    EPA commented that TDI-NE should provide real-time turbidity data to water suppliers that draw water from Lake Champlain to inform water treatment decisions. EPA recommended that DOE include in the ROD a specific requirement that TDI-NE provide water suppliers this notification. DOE notes that TDI-NE will be required by its permit from the Vermont Public Service Board to notify public water systems, which would involve notifying all ten public water systems with lake intakes near the project in writing at least three weeks prior to construction. The notification would include detailed information regarding the Project schedule, methods, and predicted effects (if any) to sediment and turbidity. Also, the public water systems monitor turbidity in real time at their own intakes already, as required by permits issued by VT ANR.

    EPA also recommended to DOE that TDI-NE provide construction management plans to water suppliers prior to construction. TDI-NE will be required by state permit to notify water suppliers in advance of construction and to provide details on the construction process and contact information. Regarding spill notification, TDI-NE would comply with all applicable state and federal laws and would request approval of the Oil and Hazardous Materials Spill Prevention and Contingency Plan from the VT ANR at least 90 days prior to construction.

    Regarding sediments and water quality, EPA recommended that town and state culverts be replaced whenever necessary to avoid or minimize any negative environmental impacts. DOE notes that TDI-NE received a stream alternation permit from the VT ANR on November 24, 2015. Specific techniques for crossing all regulated streams were approved after consultation with VT ANR, local towns, and the Vermont Agency of Transportation (VTrans). In a limited number of circumstances, the replacement of a culvert may be necessary due to the size or condition of the culvert. For the majority of streams that are crossed, the culverts would either not be impacted by the project or the need for replacement would be assessed during construction. The specific design at each stream crossing would ensure that the cable is buried at a sufficient depth below each stream's stable longitudinal profile to allow the culverts to be replaced by appropriately-sized structures in the future without needing to disturb the cable. This additional burial depth would help avoid and minimize future negative environmental impacts that would occur when these structures are replaced.

    EPA also recommended that TDI-NE commit to compliance with Vermont road and bridge standards during roadside ditch construction. TDI-NE made such commitments in their agreements with VTrans and the Towns of Alburgh, Benson and Ludlow. These commitments can be viewed on TDI-NE's project Web site at www.necplink.com.

    EPA commented that DOE should require TDI-NE to consult with the Lake Champlain Basin Project (LCBP) on the issue of invasive species prior to project construction. TDI-NE would be subject to State of Vermont stipulations related to invasive species, which are documented in the Section 401 Water Quality Certificate, Lake Encroachment Permits, and Vermont Wetlands Permits issued by the VT ANR. For the Lake segment, TDI-NE would:

    Prior to placing any equipment (e.g., boat, trailer, vehicle, or gear) that has been in or on any other waterbody other than Lake Champlain into public waters for Project construction or related to Project operation, the Permittee shall inspect and decontaminate the equipment in accordance with the “Aquatic Invasive Species Management and Control Plan, for the New England Clean Power Link HVDC Transmission Project.”

    DOE notes that TDI-NE consulted with the LCBP staff during the development of the NECPL Project, as well as with parties staffing a similar program in New York. TDI-NE's Invasive Species Management Plan is based on a guidance document that was developed in cooperation with the LCBP and was reviewed and approved by the VT ANR.

    Regarding the overland segment of the NECPL Project, TDI-NE is obligated to comply with a Vegetation Management Plan which details the plan for managing, monitoring and controlling non-native invasive species along the project corridor. Monitoring of invasive species per this plan would be required for three years after construction.

    In regard to greenhouse gas (GHG) emissions and climate change, EPA commented that it was inappropriate for DOE to compare Project emissions to global levels in Section 5 of the Final EIS. DOE notes that the Final EIS concludes that GHG emissions from construction and operation of the project would be small in comparison to total annual emissions for the state. Moreover, the Final EIS explains that operation of the Project would be expected to offset the need for other sources of electricity, including those with higher levels of GHG emissions. As such, the proposed project could contribute positively to Vermont achieving its GHG reduction goals. EPA stated that DOE should recommend that TDI-NE ensure that specific detailed mitigation measures are implemented during construction to help reduce and minimize air quality impacts from the construction phase of the project. The Presidential permit will include conditions requiring TDI-NE to implement mitigation measures in the Final EIS including those related to local air emissions during construction of the project.

    EPA also commented that DOE could have improved the Final EIS by discussing the emissions profile of the electricity to be imported with that of the “electricity it would likely displace from the New England Power grid.” EPA recommends that DOE use tools on the Council of Environmental Quality's NEPA.gov Web site. DOE notes that it consulted directly with EPA staff on the Motor Vehicle Emission Simulator (MOVES) program to quantify GHG emissions and associated effects and presented the analysis in Section 5 and Appendix K of the Final EIS.

    EPA also commented that the Final EIS could have been “improved with a discussion of the environmental effects that would be avoided through potential reductions in the need to operate power plants with significant cooling water needs.” DOE notes that such a discussion might be beneficial but would be premised on substantial uncertainty.

    In regard to environmental justice, EPA acknowledged that analysis in the Final EIS identifies low-income populations and minority populations at the census tract level but commented that it “does not differentiate between the overland and lake segments.” EPA further commented that, “This is significant in that populations likely to be affected by the project will be in the overland section, and the proximity of the project to those populations would be useful to examine.” DOE notes that its analysis did include potential impacts to low-income populations and minority populations in communities throughout the potentially affected area.

    EPA also recommended that DOE and TDI-NE conduct public outreach during the construction phase of the project to keep environmental justice populations informed about the project's progress and potential impacts, even those anticipated to be minor in nature. DOE notes that in addition to the four public meetings held during DOE's NEPA process, TDI-NE conducted comprehensive outreach throughout the development of the project using town offices, Front Porch Forums, and targeted letters to landowners in the vicinity of the project route to communicate project information. TDI-NE conducted six local open house meetings in several communities along the project route. TDI-NE plans to continue to use these forums to communicate with local citizens along the project route.

    The construction phase of the NECPL project including stipulations, mitigation measures, and public outreach efforts, would be under the jurisdiction of the USACE, VT-ANR, VTrans, the VT Public Service Board, and the Towns of Alburgh, Benson and Ludlow.

    Decision

    DOE has decided to issue Presidential Permit PP-400 to authorize TDI-NE to construct, operate, maintain, and connect a 1,000-MW HVDC transmission line across the U.S./Canada international border. The permit will include a condition requiring TDI-NE to implement the Applicant-proposed avoidance and minimization measures identified in the EIS.

    Basis for Decision

    DOE's decision to grant this Presidential permit is based on consideration of environmental impacts, impacts on the reliability of the U.S. electric power supply system under normal and contingency conditions, and the favorable recommendations of the U.S. Departments of State and Defense (which were provided, respectively, in July and August of 2015).

    DOE determined that the proposed international electric transmission line would not have an adverse impact on the reliability of the U.S. electric power supply system. In reaching this determination, DOE reviewed the System Impact Study produced by the Independent System Operator New England Inc. (ISO-NE) in October 2016 and a November 1, 2016, letter from ISO-NE. Based on the information available, DOE staff has determined that the 1000 MW of incremental north-to-south transfer, which represents south-bound transmission service requests from Quebec to the United States, will not have a negative impact on the reliability of the United States electric grid if operated consistent with both ISO-New England and North American Electric Reliability Corporation policies and standards, terms and conditions of the Presidential Permit and other regulatory and statutory requirements. Neither DOE nor ISO-NE has studied a south-to-north transfer, so the permit does not authorize such a transfer.

    Mitigation

    All practicable means to avoid or minimize environmental harm from the alternative selected have been, or will be, adopted. TDI-NE's proposed measures to avoid and minimize adverse impacts are described in the EIS, the BA, and the PA. TDI-NE will be responsible for implementing these avoidance and minimization measures. Additional measures will be required as a result of ongoing consultations (e.g., regarding Clean Water Act Section 404, the Cultural Resources Management Plan) between TDI-NE and state and federal agencies as part of approval and permitting processes.

    Issued in Washington, DC, on December 5, 2016. Meghan Conklin, Deputy Assistant Secretary, Office of Electricity Delivery and Energy Reliability.
    [FR Doc. 2016-29700 Filed 12-9-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2242-078] Eugene Water and Electric Board; Notice of Settlement Agreement and Soliciting Comments

    Take notice that the following settlement agreement has been filed with the Commission and is available for public inspection.

    a. Type of Application: Settlement agreement (amending settlement agreement filed October 23, 2008).

    b. Project No.: 2242-078.

    c. Date filed: November 30, 2016.

    d. Applicant: Eugene Water and Electric Board.

    e. Name of Project: Carmen-Smith Hydroelectric Project.

    f. Location: On the McKenzie River in Lane and Linn counties, near the town of McKenzie Bridge, Oregon. The project occupies approximately 560 acres of the Willamette National Forest.

    g. Filed Pursuant to: Rule 602 of the Commission's Rules of Practice and Procedure, 18 CFR 385.602.

    h. Applicant Contact: Frank Lawson, General Manager, Eugene Water and Electric Board, 500 East 4th Avenue, P.O. Box 10148, Eugene, Oregon 97440-2148; (541) 685-7000.

    i. FERC Contact: Dianne Rodman; (202) 502-6077 or [email protected]

    j. Deadline for Filing Comments: January 2, 2017. Reply comments due January 17, 2017.

    The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-2242-078.

    The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.

    k. Eugene Water and Electric Board (EWEB) filed the settlement agreement on behalf of itself and the National Marine Fisheries Service, U.S. Fish and Wildlife Service, Forest Service, Oregon Department of Environmental Quality, Oregon Department of Fish and Wildlife, Oregon Parks and Recreation Department, Confederated Tribes of the Grand Ronde Community of Oregon, Confederated Tribes of Siletz Indians of Oregon, Confederated Tribes of the Warm Springs Reservation of Oregon, McKenzie Flyfishers, Rocky Mountain Elk Foundation, Inc., and Trout Unlimited. The purpose of the settlement agreement is to resolve among the signatories all issues associated with issuance of a new license for the project regarding water quality, instream flows, fish passage and habitat, wildlife, recreation, aesthetics, and cultural resources. EWEB requests that the Commission accept and incorporate into any new license for the project the protection, mitigation, and enhancement measures stated in the amended settlement agreement.

    l. A copy of the settlement agreement is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support. A copy is also available for inspection and reproduction at the address in item h above.

    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    Dated: December 2, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-29620 Filed 12-9-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. TS17-1-000] Northern California Power Agency; Notice of Filing

    Take notice that on November 29, 2016, Northern California Power Agency filed a notice of potential change in material facts and a request for continued waiver of the Standards of Conduct.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern Time on December 20, 2016.

    Dated: December 6, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-29699 Filed 12-9-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project Nos. 1855-049, 1892-029, 1904-077, 2077-106, 2323-214] TransCanada Hydro Northeast Inc.; TC Hydro Inc.; Notice of Application for Transfer of Licenses and Soliciting Comments and Motions To Intervene

    On November 18, 2016, the above mentioned transferor and TC Hydro Inc. (transferee) filed an application for transfer of licenses for the following projects.

    Project No. Project name Location P-1855-049 Bellows Falls Project Connecticut River, Cheshire and Sullivan counties, NH and Windham and Windsor counties, VT. P-1892-029 Wilder Project Connecticut River, Windsor and Orange counties, VT and Grafton County, NH. P-1904-077 Vernon Project Connecticut River, Grafton County, NH and Caledonia County, VT. P-2077-106 Mile Falls Hydroelectric Project Connecticut River, Grafton County, NH and Caledonia County, VT. P-2323-214 Deerfield River Project Windham and Bennington, counties, VT and Franklin and Berkshire counties, MA.

    The transferor and transferee seek Commission approval to transfer the licenses for the above mentioned projects from the transferor to the transferee.

    Applicant Contacts: For Transferor and Transferee: Ms. Erin A. O'Dea, Legal Counsel, TransCanada U.S. Northeast, 110 Turnpike Road, Suite 300, Westborough, MA 01581, Phone: 508-599-1434, Email: [email protected] And John A. Whittaker, IV, Winston & Strawn LLP, and 1700 K Street NW., Washington, DC 20006-3817, Phone: 202-282-5766, Email: [email protected]

    FERC Contact: Patricia W. Gillis, (202) 502-8735.

    Deadline for filing comments and motions to intervene: 30 days from the issuance date of this notice, by the Commission. The Commission strongly encourages electronic filing. Please file motions to intervene and comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-1855-049, P-1892-029, P-1904-077, P-2077-106, or P-2323-214.

    Dated: December 2, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-29619 Filed 12-9-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the New York Independent System Operator, Inc. (NYISO):

    NYISO Electric System Planning Working Group Meeting December 7, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and teleconference.

    The above-referenced meeting is open to stakeholders.

    Further information may be found at: http://www.nyiso.com/public/committees/documents.jsp?com=bic_espwg&directory=2016-12-07.

    NYISO Business Issues Committee Meeting December 14, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and teleconference.

    The above-referenced meeting is open to stakeholders.

    Further information may be found at: http://www.nyiso.com/public/committees/documents.jsp?com=bic&directory=2016-12-14.

    NYISO Operating Committee Meeting December 15, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and teleconference.

    The above-referenced meeting is open to stakeholders.

    Further information may be found at: http://www.nyiso.com/public/committees/documents.jsp?com=oc&directory=2016-12-15.

    NYISO Management Committee Meeting December 21, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and teleconference.

    The above-referenced meeting is open to stakeholders.

    Further information may be found at: http://www.nyiso.com/public/committees/documents.jsp?com=mc&directory=2016-12-21.

    The discussions at the meetings described above may address matters at issue in the following proceedings:

    New York Independent System Operator, Inc., Docket No. ER13-102.

    New York Independent System Operator, Inc., Docket No. ER15-2059.

    New York Transco, LLC, Docket No. ER15-572.

    For more information, contact James Eason, Office of Energy Market Regulation, Federal Energy Regulatory Commission at (202) 502-8622 or [email protected]

    Dated: December 1, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-29624 Filed 12-9-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. Ef16-6-001] Western Area Power Administration; Notice of Filing

    Take notice that on December 5, 2016, Western Area Power Administration submitted a tariff filing per: DSW_NTS/AS_WAPA175A-20161201 to be effective 10/1/2016.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern time on January 4, 2017.

    Dated: December 6, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-29698 Filed 12-9-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP16-501-000] Texas Eastern Transmission, LP; Notice of Schedule for Environmental Review of the Proposed Marshall County Mine Panel 17W Project

    On September 15, 2016, Texas Eastern Transmission, LP (Texas Eastern) filed an application in Docket No. CP16-501-000 requesting a Certificate of Public Convenience and Necessity pursuant to Section 7(c) of the Natural Gas Act to construct and operate certain natural gas pipeline facilities. The proposed project is known as Marshall County Mine Panel 17W Project (Project) located in Marshall County, West Virginia.

    On September 29, 2016, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the Project. Among other things, that notice alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization within 90 days of the date of issuance of the Commission staff's Environmental Assessment (EA) for the Project. This instant notice identifies the FERC staff's planned schedule for the completion of the EA for the Project.

    Schedule for Environmental Review Issuance of EA—January 24, 2017 90-day Federal Authorization Decision Deadline—April 24, 2017

    If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.

    Project Description

    Texas Eastern proposes to excavate and elevate sections of its Lines 10 (30-inch-diameter), 15 (30-inch-diameter), 25 (36-inch-diameter) and 30 (36-inch-diameter) to minimize and monitor potential strains on the pipelines due to anticipated longwall mining activities of Marshall Coal. Concurrent with pipeline elevation, portions of two of the lines, Lines 10 and 15, will be replaced with new pipe to accommodate a minimum US Department of Transportation Class 2 design. The sections of Lines 25 and 30 will be removed and Texas Eastern will perform maintenance activities on them. The four mainline sections will be returned to natural gas service while remaining elevated using sandbags and skids during the longwall mining activities and potential ground subsidence. Once the mining-induced subsidence and the 2017-2018 heating season have both ended, the two sections of Lines 10 and 15 located within wetlands will be removed and the four elevated pipeline sections will be re-installed belowground, hydrostatically tested, and placed back into service.

    Background

    On September 30, 2016, the Commission issued a Notice of Intent to Prepare an Environmental Assessment for the Proposed Marshall County Mine Panel 17W Project and Request for Comments on Environmental Issues (NOI). The NOI was sent to affected landowners; federal, state, and local government agencies; elected officials; environmental and public interest groups; Native American tribes; other interested parties; and local libraries and newspapers. The Commission did not receive any comments in response to the NOI.

    Additional Information

    In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC Web site (www.ferc.gov). Using the “eLibrary” link, select “General Search” from the eLibrary menu, enter the selected date range and “Docket Number” excluding the last three digits (i.e., CP16-501), and follow the instructions. For assistance with access to eLibrary, the helpline can be reached at (866) 208-3676, TTY (202) 502-8659, or at [email protected] The eLibrary link on the FERC Web site also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rule makings.

    Dated: December 6, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-29696 Filed 12-9-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 4253-002] River Street Associates; Contoocook Hydro, LLC; Notice of Transfer of Exemption

    1. By letter filed November 23, 2016, Contoocook Hydro, LLC informed the Commission that the exemption from licensing for the River Street Project No. 4253, originally issued May 4, 1982 1 has been transferred to Contoocook Hydro, LLC. The project is located on the Nubanusit River in Hillsborough County, New Hampshire. The transfer of an exemption does not require Commission approval.

    1 19 FERC 62,193, Order Granting Exemption from Licensing of a Small Hydroelectric Project of 5Megawatts or Less (1982).

    2. Contoocook Hydro, LLC is now the exemptee of the River Street Project No. 4253. All correspondence should be forwarded to: Ms. Lori Barg, President, Contoocook Hydro, LLC, 581 Quaker Street, Henniker, NH 03242, Phone: 802-454-8458, Email: [email protected]

    Dated: December 2, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-29622 Filed 12-9-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EF16-5-001] Western Area Power Administration; Notice of Filing

    Take notice that on December 5, 2016, Western Area Power Administration submitted a tariff filing per: RMR_WACM_LAP_CRSP_174Refile-20161205 to be effective 10/1/2016.

    Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern time on January 4, 2017.

    Dated: December 6, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-29697 Filed 12-9-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RM01-5-000] Electronic Tariff Filings; Notice of Additional eTariff Type of Filing Codes

    Take notice that, effective January 3, 2017, the Chief Administrative Law Judge requires that all settlements in Parts 35, 154, 284 and 341 1 proceedings set for trial-type evidentiary hearing and/or settlement judge procedures before a Presiding Judge or Settlement Judge must be filed in eTariff. Filers are required to use the following list of available eTariff Type of Filing Codes (TOFC) to make these filings in eTariff.2

    1 18 CFR parts 35, 154, 284 and 341 (2016).

    2 The type of filing business process categories are described in the Implementation Guide for Electronic Filing of Parts 35, 154, 284, 300, and 341 Tariff Filings (November 14, 2016), found on the Commission's Web site, http://www.ferc.gov/docs-filing/etariff/implementation-guide.pdf.

    TOFC Filing title Filing category Description of change 1380 ALJ Settlement Compliance Settlement in a Part 35 FPA Traditional Cost of Service and Market Based Rate Program proceeding. 1390 ALJ Settlement Compliance Settlement in a Part 35 FPA Market Based Rate Program proceeding. 1400 ALJ Settlement Compliance Settlement in a Part 154 NGA Gas Pipelines Program proceeding. 1410 ALJ Settlement Compliance Settlement in a Part 284 NGPA 311 Gas Pipelines Program proceeding. 1420 ALJ Settlement Compliance Settlement in a Part 341 Oil Pipelines Program proceeding.

    For more information, contact H. Keith Pierce, Office of Energy Market Regulation at (202) 502-8525 or send an email to [email protected]

    Dated: December 1, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-29623 Filed 12-9-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project Nos. 2386-004; 2387-003; 2388-004] City of Holyoke Gas and Electric Department; Notice of Application Accepted for Filing and Soliciting Motions To Intervene and Protests

    Take notice that the following hydroelectric applications have been filed with the Commission and are available for public inspection.

    a. Type of Applications: Subsequent Licenses.

    b. Project Nos.: 2386-004, 2387-003, and 2388-004.

    c. Date filed: August 31, 2016.

    d. Applicant: City of Holyoke Gas and Electric Department.

    e. Names of Projects: Holyoke Number 1 Hydroelectric Project, P-2386-004; Holyoke Number 2 Hydroelectric Project, P-2387-003; and Holyoke Number 3 Hydroelectric Project, P-2388-004.

    f. Locations: Holyoke Number 1 (P-2386-004) and Holyoke Number 2 (P-2387-003) are located between the first and second level canals, and Holyoke Number 3 (P-2388-004) is located between the second and third level canals on the Holyoke Canal System, adjacent to the Connecticut River, in the city of Holyoke in Hampden County, Massachusetts. The project does not occupy federal land.

    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).

    h. Applicant Contact: Paul Ducheney, Superintendent, City of Holyoke Gas and Electric Department, 99 Suffolk Street, Holyoke, MA 01040, (413) 536-9340 or [email protected]

    i. FERC Contact: Kyle Olcott at (202) 502-8963; or email at [email protected]

    j. Deadline for filing motions to intervene and protests: 60 days from the issuance date of this notice.

    The Commission strongly encourages electronic filing. Please file motions to intervene and protests using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket numbers P-2386-004, P-2387-003, and 2388-004.

    The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.

    k. These applications have been accepted for filing, but are not ready for environmental analysis at this time.

    l. The existing Holyoke Number 1 project consists of: (1) An intake at the wall of the first level canal fed by the Holyoke Canal System (licensed under FERC Project No. 2004) with two 14-foot-8-inch-tall by 24-foot-7.5-inch wide trash rack screens with 3.5-inch clear spacing; (2) two parallel 10-foot-diameter, 36.5-foot-long penstocks; (3) a 50-foot-long by 38-foot-wide brick powerhouse with two 240-kilowatt and two 288-kilowatt turbine generator units; (4) two parallel 20-foot-wide, 328.5-foot-long brick arched tailrace conduits discharging into the second level canal; and, (5) appurtenant facilities. There is no transmission line associated with the project as it is located adjacent to the substation of interconnection. The project is estimated to generate 2,710,000 kilowatt-hours annually.

    The existing Holyoke Number 2 project consists of: (1) An intake at the wall of the first level canal fed by the Holyoke Canal System (licensed under FERC Project No. 2004) with three trash rack screens (one 16-foot-2-inch tall by 26-foot-2-inch-wide and two 14-foot-9-inch tall by 21-foot-10-inch long) with 3-inch clear spacing; (2) two 9-foot diameter, 240-foot-long penstocks; (3) a 17-foot-high by 10-foot-diameter surge tank; (4) a 60-foot-long by 40-foot-wide by 50-foot high powerhouse with one 800-kilowatt vertical turbine generator unit; (4) two parallel 9-foot-wide, 10-foot-high, 120-foot-long brick arched tailrace conduits discharging into the second level canal; (5) an 800-foot-long, 4.8-kilovolt transmission line; and (6) appurtenant facilities. The project is estimated to generate 4,710,000 kilowatt-hours annually.

    The existing Holyoke Number 3 project consists of: (1) A 52-foot-3-inch long by 14-foot-high intake trash rack covering an opening in the second level canal fed by the Holyoke Canal System (licensed under FERC Project No. 2004); (2) two 11-foot-high by 11-foot-wide headgates; (3) two 85-foot-long, 93-square-foot in cross section low pressure brick penstocks; (4) a 42-foot-long by 34-foot-wide by 28-foot-high reinforced concrete powerhouse with one 450-kilowatt turbine generator unit; (5) a 29.7-foot-wide, 10-foot-deep, 118-foot-long open tailrace discharging into the third level canal; and, (6) 4.8-kilovolt generator leads that connect directly to the 4.8-kilovolt area distribution system; and (7) appurtenant facilities. The project is estimated to generate 2,119,000 kilowatt-hours annually.

    m. A copy of the applications are available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support. Copies are also available for inspection and reproduction at the address in item h above.

    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.

    n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, 385.211, and 385.214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any protests or motions to intervene must be received on or before the specified deadline for the particular application.

    All filings must (1) bear in all capital letters the title “PROTEST” or “MOTION TO INTERVENE;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application.

    Dated: December 2, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-29621 Filed 12-9-16; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9956-43-OARM] Senior Executive Service Performance Review Board; Membership AGENCY:

    U.S. Environmental Protection Agency.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given of the membership of the U.S. Environmental Protection Agency Performance Review Board for 2016.

    FOR FURTHER INFORMATION CONTACT:

    Karen D. Higginbotham, Director, Executive Resources Division, 3606A, Office of Human Resources, Office of Administration and Resources Management, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 564-7287.

    SUPPLEMENTARY INFORMATION:

    Section 4314(c)(1) through (5) of Title 5, U.S.C., requires each agency to establish in accordance with regulations prescribed by the Office of Personnel Management, one or more SES performance review boards. This board shall review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any recommendations to the appointment authority relative to the performance of the senior executive.

    Members of the 2016 EPA Performance Review Board are:

    John Armstead, Director, Land and Chemicals Division, Region 3 Beverly Banister, Director, Air, Pesticides and Toxics Management Division, Region 4 Sheryl Bilbrey, Director, Office of Environmental Cleanup, Region 10 Jerry Blancato, Director, Office of Science Information Management, Office of Research and Development David Bloom, Deputy Chief Financial Officer, Office of the Chief Financial Officer Rebecca Clark, Deputy Director, Office of Ground Water and Drinking Water, Office of Water Sam Coleman, Deputy Regional Administrator, Region 6 Rafael DeLeon, Deputy Director, Office of Site Remediation Enforcement, Office of Enforcement and Compliance Assurance Lilian Dorka (Ex-Officio), Acting Director, Office of Civil Rights, Office of the Administrator Alfred P. Dufour, Senior Research Microbiologist, Office of Research and Development John Filippelli, Director, Clean Air and Sustainability Division, Region 2 Karen Flournoy, Director, Water, Wetlands and Pesticides Division, Region 7 Lynn Flowers, Associate Director for Health, National Center for Environmental Assessment, Office of Research and Development Linda Gray (Ex-Officio), Director, Office of Human Resources, Office of Administration and Resources Management Peter Grevatt, Director, Office of Ground Water and Drinking Water, Office of Water Christopher Grundler, Director, Office of Transportation and Air Quality, Office of Air and Radiation Margaret Guerriero, Director, Land and Chemicals Division, Region 5 Karen D. Higginbotham (Ex-Officio), Director, Executive Resources Division, Office of Human Resources, Office of Administration and Resources Management Randy Hill, Deputy Assistant Administrator, Office of International and Tribal Affairs Richard Keigwin, Deputy Director, Office of Pesticide Programs, Office of Chemical Safety and Pollution Prevention Michael Kenyon, Assistant Regional Administrator for Administration and Resources Management, Region 1 Kenneth Lapierre, Assistant Regional Administrator for Policy and Management, Region 4 David Lloyd, Director, Office of Brownfields and Land Revitalization, Office of Land and Emergency Management James McDonald, Assistant Regional Administrator for Management, Region 6 Robert McKinney, Senior Agency Information Security Officer, Office of Environmental Information Oscar Morales, Associate Assistant Administrator for Management, Office of Chemical Safety and Pollution Prevention Rebecca Moser, Director, Office of Enterprise Information Programs, Office of Environmental Information Elise Packard, Associate General Counsel, Civil Rights and Finance Law, Office of General Counsel Kimberly Patrick, Director, Office of Acquisition Management, Office of Administration and Resources Management Michelle Pirzadeh, Deputy Regional Administrator, Region 10 Denise Polk, Director, Office of Grants and Debarment, Office of Administration and Resources Management John Reeder, Deputy Chief of Staff, Office of the Administrator Christopher Robbins, Acting Deputy Assistant Administrator, Office of Research and Development John Showman, Acting Deputy Assistant Administrator, Office of Administration and Resources Management Carol Ann Siciliano, Associate General Counsel, Cross—Cutting Issues, Office of General Counsel Stefan Silzer, Controller, Office of the Chief Financial Officer Nigel Simon, Director, Office of Program Management, Office of Land and Emergency Management Walker Smith, Director, Office of Global Affairs and Policy, Office of International and Tribal Affairs Allyn Stern, Regional Counsel, Region 10, Office of Enforcement and Compliance Assurance Alexis Strauss, Acting Regional Administrator, Region 9 Susan Studlien, Director, Office of Environmental Stewardship, Region 1 Debra Thomas, Deputy Regional Administrator, Region 8 Donna Vizian, (Ex-Officio), Principal Deputy Assistant Administrator, Office of Administration and Resources Management Jeffery Wells, Deputy Director, Office of Customer Advocacy, Policy and Portfolio Management, Office of Environmental Information Pai-Yei Whung, Senior Research Scientist, Office of Research and Development Anna Wood, Director, Air Quality Policy Division, Office of Air and Radiation Christopher Zarba, Director, Science Advisory Board Staff Office, Office of the Administrator Dated: November 29, 2016. Donna J. Vizian, Principal Deputy Assistant Administrator, Office of Administration and Resources Management.
    [FR Doc. 2016-29743 Filed 12-9-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9956-34-Region 2] Proposed CERCLA Section 122(h) Cost Recovery Settlement for the Columbia Smelting and Refining Works Site, Brooklyn, Kings County, New York AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice; request for public comment.

    SUMMARY:

    In accordance with Section 122(i) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended (“CERCLA”), 42 U.S.C. 9622(i), notice is hereby given by the U.S. Environmental Protection Agency (“EPA”), Region II, of a proposed cost recovery settlement agreement pursuant to Section 122(h) of CERCLA, 42 U.S.C. 9622(h), with the City of New York (the “Settling Party”) for the Columbia Smelting and Refining Works Site (“Site”) in Brooklyn, Kings County, New York. The Site is a “facility” as defined by Section 101(9) of CERCLA, 42 U.S.C. 9601(9).

    The Site is composed of (1) Red Hook Recreation Area Ball Field Numbers 5, 6, 7, and 8 (“Ball Fields 5-8”); (2) areas surrounding Ball Fields 5-8 where grass is planted (referred to as “Planting Strips”); (3) Red Hook Recreation Area Ball Field Number 9 (“Ball Field 9”); (4) the Ball Field 9 Planting Strips; (5) the sidewalks bordering the Ball Fields 5-8 Planting Strips and the Ball Field 9 Planting Strips; and (6) any other areas that have been impacted by the historic operations of the former Columbia Smelting and Refining Works facility. Ball Fields 5-8 and the Ball Fields 5-8 Planting Strips, collectively, comprise approximately 4.17 acres and are located on Block 581, Lot 1 of the Tax Map of Kings County, New York, bordered on the north by Lorraine Street, on the east by Henry Street, on the south by Bay Street, and on the west by Hicks Street. Ball Field 9 and the Ball Field 9 Planting Strips, collectively, comprise approximately 3.4 acres and are bordered on the north by Bay Street, on the east by Soccer Field #2, on the south by Halleck Street, and on the west by a track surrounding Soccer Field #3, located generally in the vicinity of Block 614, Lot 300 and Block 602, Lot 1 of the Tax Map of Kings County, New York. Settling Party is the current owner of the Site.

    The Settling Party agrees to pay EPA $395,105.40 in reimbursement of past response costs related to the performance of work performed by EPA at the Site.

    The settlement includes a covenant by EPA not to sue or to take administrative action against the Settling Party pursuant to Section 107(a) of CERCLA, 42 U.S.C. 9607(a), with regard to the response costs related to work performed at the Site. For thirty (30) days following the date of publication of this notice, EPA will receive written comments relating to the settlement. EPA will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations that indicate that the proposed settlement is inappropriate, improper, or inadequate. EPA's response to any comments received will be available for public inspection at EPA Region II, 290 Broadway, New York, New York 10007-1866.

    DATES:

    Comments must be submitted on or before January 11, 2017.

    ADDRESSES:

    The proposed settlement is available for public inspection at EPA Region II offices at 290 Broadway, New York, New York 10007-1866. Comments should reference the Columbia Smelting and Refining Works Site, Index No. CERCLA-02-2016-2018. To request a copy of the proposed settlement agreement, please contact the EPA employee identified below.

    FOR FURTHER INFORMATION CONTACT:

    Andrew Praschak, Assistant Regional Counsel, New York/Caribbean Superfund Branch, Office of Regional Counsel, U.S. Environmental Protection Agency, 290 Broadway—17th Floor, New York, New York 10007-1866. Email: [email protected] Telephone: 212-637-3172.

    Dated: November 21, 2016. Walter Mugdan, Director, Emergency and Remedial Response Division, U.S. Environmental Protection Agency.
    [FR Doc. 2016-29745 Filed 12-9-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination; 10256 Home National Bank, Blackwell, OK

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10256 Home National Bank, Blackwell, OK (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Home National Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective December 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: December 7, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-29736 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination; 10123 Southern Colorado National Bank, Pueblo, Colorado

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10123 Southern Colorado National Bank, Pueblo, Colorado (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Southern Colorado National Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective December 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: December 7, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-29734 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination; 10045 Colorado National Bank, Colorado Springs, Colorado

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10045 Colorado National Bank, Colorado Springs, Colorado (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Colorado National Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective December 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: December 7, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-29733 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of the Termination of the Receivership of 10327—Oglethorpe Bank, Brunswick, Georgia

    Notice is hereby given that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for Oglethorpe Bank, Brunswick, Georgia (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of Oglethorpe Bank on January 14, 2011. The liquidation of the receivership assets has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

    Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.

    No comments concerning the termination of this receivership will be considered which are not sent within this time frame.

    Dated: December 7, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-29738 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination of the Receivership of 10474, First Federal Bank, Lexington, Kentucky

    The Federal Deposit Insurance Corporation (“FDIC”), as Receiver for 10474, First Federal Bank, Lexington, Kentucky (“Receiver”), has been authorized to take all actions necessary to terminate the receivership estate of First Federal Bank (“Receivership Estate”); the Receiver has made all dividend distributions required by law. The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds. Effective December 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: December 6, 2016. Federal Deposit Insurance Corporation. Valerie J. Best, Assistant Executive Secretary.
    [FR Doc. 2016-29635 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of the Termination of the Receivership of 10247—First National Bank, Rosedale, Mississippi

    Notice is hereby given that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for First National Bank, Rosedale, Mississippi (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of First National Bank on June 4, 2010. The liquidation of the receivership assets has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

    Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.

    No comments concerning the termination of this receivership will be considered which are not sent within this time frame.

    Dated: December 7, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-29735 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination; 10010 First Priority Bank, Bradenton, Florida

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10010 First Priority Bank, Bradenton, Florida (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of First Priority Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective December 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: December 7, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-29739 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination of the Receivership of 10010, First Priority Bank, Bradenton, Florida

    The Federal Deposit Insurance Corporation (“FDIC”), as Receiver for 10010, First Priority Bank, Bradenton, Florida (“Receiver”), has been authorized to take all actions necessary to terminate the receivership estate of First Priority Bank (“Receivership Estate”); the Receiver has made all dividend distributions required by law. The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds. Effective December 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: December 6, 2016. Federal Deposit Insurance Corporation. Valerie J. Best, Assistant Executive Secretary.
    [FR Doc. 2016-29692 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination; 10487 Sunrise Bank of Arizona, Phoenix, Arizona

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10487 Sunrise Bank of Arizona, Phoenix, Arizona (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Sunrise Bank of Arizona (Receivership Estate); the Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective December 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: December 7, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-29741 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination, 10500 Slavie Federal Savings Bank, Bel Air, Maryland

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10500 Slavie Federal Savings Bank, Bel Air, Maryland (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Slavie Federal Savings Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective December 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: December 7, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-29740 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination of the Receivership of 10487, Sunrise Bank of Arizona, Phoenix, Arizona

    The Federal Deposit Insurance Corporation (“FDIC”), as Receiver for 10487, Sunrise Bank of Arizona, Phoenix, Arizona (“Receiver”), has been authorized to take all actions necessary to terminate the receivership estate of Sunrise Bank of Arizona (“Receivership Estate”); the Receiver has made all dividend distributions required by law. The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds. Effective December 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: December 6, 2016. Federal Deposit Insurance Corporation. Valerie J. Best, Assistant Executive Secretary.
    [FR Doc. 2016-29691 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of Intent To Terminate the Receivership of 10327, Oglethorpe Bank, Brunswick, Georgia

    Notice is hereby given that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for Oglethorpe Bank, Brunswick, Georgia (the “Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of Oglethorpe Bank on January 14, 2011. The liquidation of the receivership assets has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

    Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to:

    Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.

    No comments concerning the termination of this receivership will be considered which are not sent within this time frame.

    Dated: December 6, 2016. Valerie J. Best, Assistant Executive Secretary,Federal Deposit Insurance Corporation.
    [FR Doc. 2016-29638 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination of the Receivership of 10271, Bayside Savings Bank, Port Saint Joe, Florida

    The Federal Deposit Insurance Corporation (“FDIC”), as Receiver for 10271, Bayside Savings Bank, Port Saint Joe, Florida (“Receiver”) has been authorized to take all actions necessary to terminate the receivership estate of Bayside Savings Bank (“Receivership Estate”); the Receiver has made all dividend distributions required by law. The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds. Effective December 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Date: December 6, 2016. Federal Deposit Insurance Corporation. Valerie J. Best, Assistant Executive Secretary.
    [FR Doc. 2016-29636 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination of the Receivership of 10500, Slavie Federal Savings Bank, Bel Air, Maryland

    The Federal Deposit Insurance Corporation (“FDIC”), as Receiver for 10500, Slavie Federal Savings Bank, Bel Air, Maryland (“Receiver”) has been authorized to take all actions necessary to terminate the receivership estate of Slavie Federal Savings Bank (“Receivership Estate”); the Receiver has made all dividend distributions required by law. The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds. Effective December 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: December 6, 2016. Federal Deposit Insurance Corporation. Valerie J. Best, Assistant Executive Secretary.
    [FR Doc. 2016-29693 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination; 10316 Gulf State Community Bank, Carrabelle, Florida

    The Federal Deposit Insurance Corporation (FDIC), as Receiver for 10316 Gulf State Community Bank, Carrabelle, Florida (Receiver) has been authorized to take all actions necessary to terminate the receivership estate of Gulf State Community Bank (Receivership Estate); the Receiver has made all dividend distributions required by law.

    The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds.

    Effective December 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: December 7, 2016. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2016-29737 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice of Termination of the Receivership of 10316, Gulf State Community Bank, Carrabelle, Florida

    The Federal Deposit Insurance Corporation (“FDIC”), as Receiver for 10316, Gulf State Community Bank, Carrabelle, Florida (“Receiver”), has been authorized to take all actions necessary to terminate the receivership estate of Gulf State Community Bank (“Receivership Estate”); the Receiver has made all dividend distributions required by law. The Receiver has further irrevocably authorized and appointed FDIC-Corporate as its attorney-in-fact to execute and file any and all documents that may be required to be executed by the Receiver which FDIC-Corporate, in its sole discretion, deems necessary; including but not limited to releases, discharges, satisfactions, endorsements, assignments and deeds. Effective December 1, 2016, the Receivership Estate has been terminated, the Receiver discharged, and the Receivership Estate has ceased to exist as a legal entity.

    Dated: December 6, 2016. Federal Deposit Insurance Corporation. Valerie J. Best, Assistant Executive Secretary.
    [FR Doc. 2016-29637 Filed 12-9-16; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB AGENCY:

    Board of Governors of the Federal Reserve System.

    SUMMARY:

    The Board of Governors of the Federal Reserve System (Board or Federal Reserve) is adopting a proposal to revise, with revision, the Joint Standards for Assessing Diversity Policies and Practices (Policy Statement).

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

    FOR FURTHER INFORMATION CONTACT: Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551. OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503.

    Final approval under OMB delegated authority of the extension for three years, with revision, of the following report:

    Report title: Joint Standards for Assessing Diversity Policies and Practices.

    Agency form number: FR 2100.

    OMB control number: 7100-0368.

    Frequency: Annual.

    Respondents: Financial institutions regulated by the Federal Reserve.

    Estimated annual burden hours: 3,912 hours.

    Estimated average hours per response: 8 hours.

    Number of respondents: 488.

    General description of report: Section 342 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (Dodd-Frank Act) requires the Office of the Comptroller of the Currency (OCC), Board of Governors of the Federal Reserve System (Board), Federal Deposit Insurance Corporation (FDIC), National Credit Union Administration (NCUA), Bureau of Consumer Financial Protection (CFPB), and Securities and Exchange Commission (SEC) (the Agencies) each to establish an Office of Minority and Women Inclusion (OMWI) to be responsible for all matters of the Agency relating to diversity in management, employment, and business activities. Section 342 requires each OMWI director to develop standards for “assessing the diversity policies and practices of entities regulated by the agency.” The Policy Statement, published jointly by the Agencies in June 2015, contain those standards.

    Legal authorization and confidentiality: The Board's Legal Division has determined that the information collections contained within the Policy Statement are authorized by section 342 of the Dodd-Frank Act, which requires the Board's OMWI director to develop standards for assessing regulated entities' diversity policies and practices and are voluntary.

    The Standard regarding transparency, and a portion of the self-assessment Standard, call for regulated entities to provide information to the public, so confidentiality is not an issue with respect to those aspects of the Policy. A regulated entity may provide self-assessment material to the Board that contains confidential commercial information protectable under exemption 4 of the Freedom of Information Act, 5 U.S.C. 552(b)(4), and may request that the information be kept confidential on a case-by-case basis. The Federal Reserve will determine whether the information is entitled to confidential treatment on an ad hoc basis in connection with such a request. As noted in the Policy Statement, an entity's primary federal regulator may share information obtained from regulated entities with other Agencies, but will publish information disclosed to them only in a form that does not identify a particular entity or individual or disclose confidential business information.

    Current Actions: The Federal Reserve previously received OMB approval for a voluntary information collection with respect to the Policy Statement, pursuant to which entities regulated by the Federal Reserve voluntarily self-assess their diversity policies and practices.1 This revision to that collection adds the Diversity Self-Assessment Template to assist with the self-assessment. The Template (1) asks for general information about a respondent; (2) includes a checklist of the standards set forth in the Policy Statement; (3) seeks additional diversity data; and (4) provides an opportunity for a respondent to provide other information regarding or comment on the self-assessment of its diversity policies and practices.

    1 80 FR 33016 (June 10, 2015).

    On September 27, 2016, the Federal Reserve published a notice in the Federal Register (81 FR 66275) requesting comment on the proposal to include a reporting tool entitled “Diversity Self-Assessment Template.” The comment period for this notice expired on November 28, 2016. The Federal Reserve did not receive any comments. The reporting template will be implemented as proposed.

    Board of Governors of the Federal Reserve System, December 6, 2016. Robert deV. Frierson, Secretary of the Board.
    [FR Doc. 2016-29606 Filed 12-9-16; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than January 9, 2017.

    A. Federal Reserve Bank of Atlanta (Chapelle Davis, Assistant Vice President) 1000 Peachtree Street NE., Atlanta, Georgia 30309. Comments can also be sent electronically to [email protected]:

    1. First IC Corporation; to become a bank holding company by acquiring 100 percent of the outstanding shares of First Intercontinental Bank, both of Doraville, Georgia.

    2. Marine Bancorp of Florida, Inc.; to become a bank holding company by acquiring 100 percent of the outstanding shares of Marine Bank & Trust Company, both of Vero Beach, Florida.

    Board of Governors of the Federal Reserve System, December 7, 2016. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2016-29689 Filed 12-9-16; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than January 6, 2017.

    A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:

    1. Stratford Bancshares Inc., Stratford, Wisconsin; to merge with Spencer Bancorporation, Inc., Spencer, Wisconsin, and thereby indirectly acquire Stratford State Bank, Stratford, Wisconsin.

    Board of Governors of the Federal Reserve System, December 6, 2016. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2016-29618 Filed 12-9-16; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than January 6, 2017.

    A. Federal Reserve Bank of St. Louis (David L. Hubbard, Senior Manager) P.O. Box 442, St. Louis, Missouri 63166-2034. Comments can also be sent electronically to [email protected]:

    1. Home BancShares, Inc., Conway, Arkansas; to acquire 100 percent of Bank of Commerce, Sarasota, Florida.

    Board of Governors of the Federal Reserve System, December 6, 2016. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2016-29617 Filed 12-9-16; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Sunshine Act Meeting Agency Holding the Meeting:

    Board of Governors of the Federal Reserve System.

    Time and Date:

    11:00 a.m. on Thursday, December 15, 2016.

    Place:

    Marriner S. Eccles Federal Reserve Board Building, 20th Street entrance between Constitution Avenue and C Streets NW., Washington, DC 20551.

    Status:

    Open.

    On the day of the meeting, you will be able to view the meeting via webcast from a link available on the Board's public Web site. You do not need to register to view the webcast of the meeting. A link to the meeting documentation will also be available approximately 20 minutes before the start of the meeting. Both links may be accessed from the Board's public Web site at www.federalreserve.gov.

    If you plan to attend the open meeting in person, we ask that you notify us in advance and provide your name, date of birth, and social security number (SSN) or passport number. You may provide this information by calling 202-452-2474 or you may register online. You may pre-register until close of business on Wednesday, December 14, 2016. You also will be asked to provide identifying information, including a photo ID, before being admitted to the Board meeting. The Public Affairs Office must approve the use of cameras; please call 202-452-2955 for further information. If you need an accommodation for a disability, please contact Penelope Beattie on 202-452-3982. For the hearing impaired only, please use the Telecommunication Device for the Deaf (TDD) on 202-263-4869.

    Privacy Act Notice: The information you provide will be used to assist us in prescreening you to ensure the security of the Board's premises and personnel. In order to do this, we may disclose your information consistent with the routine uses listed in the Privacy Act Notice for BGFRS-32, including to appropriate federal, state, local, or foreign agencies where disclosure is reasonably necessary to determine whether you pose a security risk or where the security or confidentiality of your information has been compromised. We are authorized to collect your information by 12 U.S.C §§ 243 and 248, and Executive Order 9397. In accordance with Executive Order 9397, we collect your SSN so that we can keep accurate records, because other people may have the same name and birth date. In addition, we use your SSN when we make requests for information about you from law enforcement and other regulatory agency databases. Furnishing the information requested is voluntary; however, your failure to provide any of the information requested may result in disapproval of your request for access to the Board's premises. You may be subject to a fine or imprisonment under 18 U.S.C. 1001 for any false statements you make in your request to enter the Board's premises.

    Matters to be Considered:

    Discussion Agenda 1. Final Rule Establishing Total Loss-Absorbing Capacity and Buffers, Long-term Debt, and Clean Holding Company Requirements for U.S. Global Systemically Important Banking Holding Companies and U.S. Intermediate Holding Companies of Foreign Global Systemically Important Banking Organizations Notes

    1. The staff memo to the Board will be made available to attendees on the day of the meeting in paper and the background material will be made available on a compact disc (CD). If you require a paper copy of the entire document, please call Penelope Beattie on 202-452-3982. The documentation will not be available until about 20 minutes before the start of the meeting.

    2. This meeting will be recorded for the benefit of those unable to attend. The webcast recording and a transcript of the meeting will be available after the meeting on the Board's public Web site http://www.federalreserve.gov/aboutthefed/boardmeetings/ or if you prefer, a CD recording of the meeting will be available for listening in the Board's Freedom of Information Office, and copies can be ordered for $4 per disc by calling 202-452-3684 or by writing to:

    Freedom of Information Office Board of Governors of the Federal Reserve System Washington, DC 20551 FOR MORE INFORMATION PLEASE CONTACT:

    Michelle Smith, Director, or Dave Skidmore, Assistant to the Board, Office of Board Members at 202-452-2955.

    SUPPLEMENTARY INFORMATION:

    You may access the Board's public Web site at www.federalreserve.gov for an electronic announcement. (The Web site also includes procedural and other information about the open meeting.)

    Dated: December 8, 2016. Margaret M. Shanks, Deputy Secretary of the Board.
    [FR Doc. 2016-29892 Filed 12-8-16; 4:15 pm] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Notice of Proposals To Engage in or To Acquire Companies Engaged in Permissible Nonbanking Activities

    The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y, (12 CFR part 225) to engage de novo, or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States.

    Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act.

    Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than January 9, 2017.

    A. Federal Reserve Bank of San Francisco (Gerald C. Tsai, Director, Applications and Enforcement) 101 Market Street, San Francisco, California 94105-1579:

    1. Hope Bancorp, Inc., to retain 9.90 percent of the voting stock of Broadway Financial Corporation, and indirectly its wholly-owned subsidiary, Broadway Federal Bank, F.S.B., all of Los Angeles, California, pursuant to section 225.28 of Regulation Y.

    Board of Governors of the Federal Reserve System, December 7, 2016. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2016-29690 Filed 12-9-16; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-17-1009] Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

    Proposed Project

    Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (OMB No. 0920-1009, exp. 3/31/2017)—Revision—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    The information collection activity provides a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Federal government's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public.

    If this information is not collected, vital feedback from customers and stakeholders on the Agency's services will be unavailable. CDC/ATSDR will only submit a collection for approval under this generic clearance if it meets the following conditions:

    • The collections are voluntary;

    • The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;

    • The collections are noncontroversial and do not raise issues of concern to other Federal agencies;

    • Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future;

    • Personally identifiable information (PII) is collected only to the extent necessary and is not retained;

    • Information gathered is intended to be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency (if released, the agency must indicate the qualitative nature of the information);

    • Information gathered will not be used for the purpose of substantially informing influential policy decisions; and

    • Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study.

    This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.

    As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.

    OMB approval is requested for three years. There are no costs to respondents other than their time. The estimated annualized burden hours are 20,350.

    Estimated Annualized Burden Hours Type of respondent Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • In person surveys, online surveys, telephone surveys, in person observation/testing GenIC_Request Template 7,000 1 30/60 Focus groups GenIC_Request Template 800 1 2 Customer comment cards, interactive voice surveys GenIC_Request Template 61,000 1 15/60
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-29731 Filed 12-9-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-17-16AWJ] Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs.

    To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to [email protected] Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written comments should be received within 30 days of this notice.

    Proposed Project

    Behavioral Risk Factor Surveillance System (BRFSS) Asthma Call-back Survey (ACBS)—Existing Collection in Use without an OMB Control Number—National Center for Environmental Health NCEH), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    The Centers for Disease Control and Prevention (CDC) is requesting a three-year Paperwork Reduction Act (PRA) clearance to conduct information collection under “The Behavioral Risk Factor Surveillance System (BRFSS) Asthma Call-back Survey (ACBS)” for three years beginning with the 2017 data collection cycle. The ACBS is an existing collection in use without an OMB Control Number. BRFSS (OMB Control No. 0920-1061, expiration date 3/31/2018) is a nationwide system of customized, cross-sectional telephone health surveys sponsored by CDC's National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) Division of Population Health. The BRFSS information collection is conducted in a continuous, three-part telephone interview process: Screening, participation in a common BRFSS core survey, and participation in optional question modules that states use to customize survey content.

    The ACBS is not an optional state module, but rather, is a follow-up survey to the regular BRFSS efforts. It is funded by the National Asthma Control Program (NACP) in the Air Pollution and Respiratory Health Branch (APRHB) of the National Center for Environmental Health (NCEH). The ACBS is administered by NCCDPHP on behalf of NCEH using its existing BRFSS sampling frame. BRFSS coordinators in the health departments in U.S. states, territories, and the District of Columbia (collectively referred to as states) are responsible for survey administration. Currently CDC provides its 40 participating states with technical and methodological assistance.

    The purpose of ACBS is to gather state-level asthma data and to make them available to track the burden of the disease, to monitor adherence to asthma guidelines, and to direct and evaluate interventions undertaken by asthma control programs located in state health departments. Beyond asthma prevalence estimates, for most states, the ACBS provides the only sources of adult and child asthma data on the state and local level.

    As a follow-up, the ACBS is conducted within two weeks after the BRFSS survey. Data collection for ACBS involves (1) screening, (2) obtaining permission, (3) consenting and telephone interviewing on a subset of the BRFSS respondents from participating states. The ACBS eligible respondents are BRFSS adults, 18 years and older, who report ever being diagnosed with asthma. In addition, some states include children, below 18 years of age, who are randomly selected subjects in the BRFSS household. Parents or guardians serve as ACBS proxy respondents for their children ever diagnosed with asthma. If both the BRFSS adult respondent and the selected child in the household have asthma, then only one or the other is eligible for the ACBS.

    The ACBS adds considerable state-level depth to the existing body of asthma data. It addresses critical questions surrounding the health and experiences of persons with asthma. Health data include symptoms, environmental factors, and medication use among persons with asthma. Data on their experiences include activity limitation, health system use, and self-management education. These asthma data are needed to direct and evaluate interventions undertaken by asthma control programs located in state health departments. Federal agencies and other entities also rely on this critical information for planning and evaluating efforts and to reduce the burden from this disease.

    The CDC makes annual ACBS datasets available for public use and provides guidance on statistically appropriate uses of the data. Participation in the ACBS is voluntary and there are no costs to respondents other than their time. The burden table reflects the landline and cell phone data collection methods used in 2013 and later years. Additionally, the burden table accounts for reporting burden incurred by the states for the monthly or quarterly data submission to CDC. The burden hour estimates represent the 2013 data collection which is the most recent data released.

    The total estimated annualized burden hours for all respondents are 6,029 hours.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hrs.)
  • BRFSS Adults ACBS Landline Screener—Adult 21,424 1 1/60 ACBS Cell Phone Screener—Adult 8,976 1 1/60 BRFSS Parents or Guardians of Children ACBS Landline Screener—Child 4,245 1 1/60 ACBS Cell Phone Screener—Child 2,238 1 1/60 ACBS Adults ACBS Adult Consent and Survey—2013 19,954 1 10/60 ACBS Parents or Guardians of Children ACBS Child Consent and Survey—2013 3,887 1 10/60 State BRFSS Coordinators ACBS Data Submission Layout 40 12 3
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-29730 Filed 12-9-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request

    Title: Accomplishments of the Domestic Violence Hotline, Online Connections and Text (ADVHOCaT) Study.

    OMB No.: 0970-0468.

    Description: The National Domestic Violence Hotline (The Hotline) and loveisrespect (LIR), which are supported by the Division of Family Violence Prevention and Services within the Family and Youth Services Bureau (FYSB) of the Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), serve as partners in the intervention, prevention, and resource assistance efforts of the network of domestic violence and dating violence service providers.

    In order to describe the activities and accomplishments of The Hotline and LIR and develop potential new or revised performance measures, the ACF/HHS Office of Planning, Research and Evaluation (OPRE) and FYSB are proposing a data collection activity as part of the Accomplishments of the Domestic Violence Hotline, Online Connections and Text (ADVHOCaT) Study.

    As part of ongoing program activities and monitoring for The Hotline and LIR, ACF proposes to collect information via voluntary phone, chat, and web-based surveys of individuals who contact The Hotline and LIR. Participants will complete a baseline survey at the end of their contact with The Hotline and LIR, and a follow-up survey approximately two weeks later. The survey will include questions about reasons for contacting The Hotline/LIR, whether needs were met, satisfaction with services received, and helpfulness of information provided. This data collection builds on a previous data collection that was focused on understanding the preferred mode of contact by those who contact The Hotline and LIR. This new information will inform future efforts to monitor and improve the performance of domestic violence hotlines and provide hotline services.

    Respondents: Individuals aged 18 and older who contact The Hotline and LIR via phone or chat.

    Annual Burden Estimates—2 Year Request Instrument Total
  • number of
  • respondents
  • Annual
  • number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • Annual
  • burden hours
  • The Hotline/LIR Baseline Survey 2200 1100 1 0.056 62 The Hotline/LIR Follow Up Survey 2200 1100 1 0.1 110

    Estimated Total Annual Burden Hours: 172.

    In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201, Attn: OPRE Reports Clearance Officer. Email address: [email protected] All requests should be identified by the title of the information collection.

    The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

    Mary Jones, Reports Clearance Officer.
    [FR Doc. 2016-29709 Filed 12-9-16; 8:45 am] BILLING CODE 4184-32-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-3466] Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled “Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids.” FDA is issuing this guidance to communicate to consumers, hearing aid dispensers, hearing aid manufacturers, and hearing health professionals that FDA does not intend to enforce certain conditions for sale of hearing aid devices that are required per FDA regulation. Specifically, FDA does not intend to enforce the medical evaluation or recordkeeping requirements prior to the dispensing of certain hearing aid devices to individuals 18 years of age and older.

    DATES:

    Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-D-3466 for “Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled “Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids” to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request.

    FOR FURTHER INFORMATION CONTACT:

    Srinivas Nandkumar, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2436, Silver Spring, MD 20993-0002, 301-796-6480.

    SUPPLEMENTARY INFORMATION: I. Background

    FDA is issuing this guidance to communicate to consumers, hearing aid dispensers, hearing aid manufacturers, and hearing health professionals that FDA does not intend to enforce certain conditions for sale of hearing aid devices that are required per FDA regulation. Specifically, FDA does not intend to enforce the medical evaluation (§ 801.421(a) (21 CFR 801.421(a)) or recordkeeping (§ 801.421(d)) requirements prior to the dispensing of certain hearing aid devices to individuals 18 years of age and older.

    This guidance applies to the subset of hearing aids that are regulated as class I air-conduction hearing aids under § 874.3300(b)(1) (21 CFR 874.3300(b)(1)) and class II wireless air-conduction hearing aids under § 874.3305, where hearing aid means “any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing,” as defined in § 801.420(a)(1). This guidance does not apply to class II bone-conduction hearing aids as identified in § 874.3300(b)(2). Also, hearing aids labeled for prescription use only, e.g., those that are inserted deep in the ear canal by a hearing health professional, should continue to be sold only as directed.

    This guidance is being implemented without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate (see section 701(h)(1)(C)(i) of the FD&C Act (21 U.S.C. 371(h)(1)(C)(i)) and § 10.115.(g)(2) (21 CFR 10.115(g)(2))). FDA believes that immediate implementation of the guidance is needed to assist in addressing a significant public health issue. Further, FDA has determined that this guidance document presents a less burdensome policy that is consistent with public health. Although this guidance is immediately in effect, FDA will consider all comments received and revise the guidance document as appropriate.

    II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance practices regulation (§ 10.115). The guidance represents the current thinking of FDA on conditions for sale for air-conduction hearing aids. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

    III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of “Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 16041 to identify the guidance you are requesting.

    IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485.

    Dated: December 1, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-29724 Filed 12-9-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-P-1363] Determination That SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (Sodium Chloride), Injectable, 234 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) has determined that SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for sodium chloride, injectable, 234 mg/mL, if all other legal and regulatory requirements are met.

    FOR FURTHER INFORMATION CONTACT:

    David Faranda, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-796-8767.

    SUPPLEMENTARY INFORMATION:

    In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

    The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

    A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

    SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, is the subject of NDA 019329, held by Abraxis Pharmaceutical Products, and initially approved on April 22, 1987. SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER is indicated for use in patients who have special problems of sodium electrolyte intake or excretion, and for the treatment of sodium chloride and water deficiencies, which commonly occur in many diseases.

    In a letter dated January 18, 1996, the original NDA holder, Fujisawa USA, Inc., notified FDA that SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, was being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book.

    Gordon Johnston Regulatory Consultants, LLC, submitted a citizen petition dated May 25, 2016 (Docket No. FDA-2016-P-1363), under 21 CFR 10.30, requesting that the Agency determine whether SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, was withdrawn from sale for reasons of safety or effectiveness.

    After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness.

    Accordingly, the Agency will continue to list SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to this drug product may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

    Dated: December 7, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-29674 Filed 12-9-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Ebola Virus Disease Vaccines—Amendment ACTION:

    Notice of Amendment to the December 3, 2014, Declaration under the Public Readiness and Emergency Preparedness Act for Ebola Virus Disease Vaccines.

    SUMMARY:

    The Secretary is amending the Declaration issued pursuant to section 319F-3 of the Public Health Service Act on December 3, 2014 (79 FR 73314) and amended on December 1, 2015 (80 FR 76541) to extend the effective time period for an additional 24 months and to clarify the description of Covered Countermeasures consistent with the terms of the Declaration and republishing the Declaration in its entirety as amended.

    DATES:

    The Amended Declaration is effective as of December 3, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Nicole Lurie, MD, MSPH, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201, Telephone 202-205-2882.

    SUPPLEMENTARY INFORMATION:

    The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the administration or use of medical countermeasures (Covered Countermeasures), except for claims that meet the PREP Act's definition of willful misconduct. The Secretary may, through publication in the Federal Register, amend any portion of a Declaration. Using this authority, the Secretary is amending the Declaration that provides liability immunity to Covered Persons for activities related to the Covered Countermeasures, Ebola Virus Disease Vaccines listed in Section VI of the Declaration, to extend the effective time period for an additional 24 months and to clarify the description of Covered Countermeasures consistent with the terms of this Declaration.

    The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, Section 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified in the U.S. Code as 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.

    The Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, was enacted on March 13, 2013. Among other things, PAHPRA added sections 564A and 564B to the Federal Food, Drug, and Cosmetic (FD&C) Act to provide new authorities for the emergency use of approved products in emergencies and products held for emergency use. PAHPRA accordingly amended the definitions of “Covered Countermeasures” and “qualified pandemic and epidemic products” in section 319F-3 of the Public Health Service Act (PREP Act provisions), so that products made available under these new FD&C Act authorities could be covered under PREP Act Declarations. PAHPRA also extended the definition of qualified pandemic and epidemic products that may be covered under a PREP Act Declaration to include products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic or epidemic or against adverse events from these products.

    The Ebola virus causes an acute, serious illness that is often fatal. From 2014 to 2015, West Africa experienced the largest and most complex Ebola outbreak since the virus was discovered in 1976, affecting populations in West African countries and travelers who left West Africa. In 2014, the World Health Organization (WHO) declared the Ebola Virus Disease Outbreak as a Public Health Emergency of International Concern under the framework of the International Health Regulations (2005). In March 2016, WHO determined that the Ebola outbreak no longer constituted a Public Health Emergency of International Concern, but emphasized the crucial need for continued support to prevent, detect and respond rapidly to any new Ebola outbreak in West Africa. Thus, there is a continuing need for development of vaccines against Ebola Virus Disease.

    Unless otherwise noted, all statutory citations below are to the U.S. Code.

    Section I, Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency

    Before issuing a Declaration under the PREP Act, the Secretary is required to determine that a disease or other health condition or threat to health constitutes a public health emergency or that there is a credible risk that the disease, condition, or threat may constitute such an emergency. This determination is separate and apart from a Declaration issued by the Secretary under section 319 of the PHS Act that a disease or disorder presents a public health emergency or that a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, or other Declarations or determinations made under other authorities of the Secretary. Accordingly, in Section I, the Secretary determines that there is a credible risk that the spread of Ebola virus and the resulting disease may constitute a public health emergency.

    Section II, Factors Considered

    In deciding whether and under what circumstances to issue a Declaration with respect to a Covered Countermeasure, the Secretary must consider the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the countermeasure. In Section II, the Secretary states that she has considered these factors.

    Section III, Recommended Activities

    The Secretary must recommend the activities for which the PREP Act's liability immunity is in effect. These activities may include, under conditions as the Secretary may specify, the manufacture, testing, development, distribution, administration, or use of one or more Covered Countermeasures (Recommended Activities). In Section III, the Secretary recommends activities for which the immunity is in effect.

    Section IV, Liability Immunity

    The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities. These liability protections provide that, “[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration . . . has been issued with respect to such countermeasure.” In Section IV, the Secretary states that liability protections are in effect with respect to the Recommended Activities.

    Section V, Covered Persons

    The PREP Act's liability immunity applies to “Covered Persons” with respect to administration or use of a Covered Countermeasure. The term “Covered Persons” has a specific meaning and is defined in the PREP Act to include manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States. The PREP Act further defines the terms “manufacturer,” “distributor,” “program planner,” and “qualified person” as described below.

    A manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure; and any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.

    A distributor means a person or entity engaged in the distribution of drug, biologics, or devices, including but not limited to: Manufacturers; repackers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.

    A program planner means a state or local government, including an Indian tribe; a person employed by the state or local government; or other person who supervises or administers a program with respect to the administration, dispensing, distribution, provision, or use of a Covered Countermeasure, including a person who establishes requirements, provides policy guidance, or supplies technical or scientific advice or assistance or provides a facility to administer or use a Covered Countermeasure in accordance with the Secretary's Declaration. Under this definition, a private sector employer or community group or other “person” can be a program planner when it carries out the described activities.

    A qualified person means a licensed health professional or other individual authorized to prescribe, administer, or dispense Covered Countermeasures under the law of the state in which the countermeasure was prescribed, administered, or dispensed; or a person within a category of persons identified as qualified in the Secretary's Declaration. Under this definition, the Secretary can describe in the Declaration other qualified persons, such as volunteers, who are Covered Persons. Section V describes other qualified persons covered by this Declaration.

    The PREP Act also defines the word “person” as used in the Act: A person includes an individual, partnership, corporation, association, entity, or public or private corporation, including a federal, state, or local government agency or department.

    Section V describes Covered Persons under the Declaration, including Qualified Persons.

    Section VI, Covered Countermeasures

    As noted above, section III describes the Secretary's Recommended Activities for which liability immunity is in effect. This section identifies the countermeasures for which the Secretary has recommended such activities. The PREP Act states that a “Covered Countermeasure” must be: A “qualified pandemic or epidemic product,” or a “security countermeasure,” as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with sections 564, 564A, or 564B of the FD&C Act.

    A qualified pandemic or epidemic product means a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that is: (i) Manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause; (ii) manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product, or device; (iii) or a product or technology intended to enhance the use or effect of such a drug, biological product, or device.

    A security countermeasure is a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that: (i)(a) The Secretary determines to be a priority to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat by the Secretary of Homeland Security, or (b) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent; and (ii) is determined by the Secretary of Health and Human Services to be a necessary countermeasure to protect public health.

    To be a Covered Countermeasure, qualified pandemic or epidemic products or security countermeasures also must be approved or cleared under the FD&C Act; licensed under the PHS Act; or authorized for emergency use under sections 564, 564A, or 564B of the FD&C Act.

    A qualified pandemic or epidemic product also may be a Covered Countermeasure when it is subject to an exemption (that is, it is permitted to be used under an Investigational Drug Application or an Investigational Device Exemption) under the FD&C Act and is the object of research for possible use for diagnosis, mitigation, prevention, treatment, or cure, or to limit harm of a pandemic or epidemic or serious or life-threatening condition caused by such a drug or device. A security countermeasure also may be a Covered Countermeasure if it may reasonably be determined to qualify for approval or licensing within 10 years after the Department's determination that procurement of the countermeasure is appropriate.

    Section VI lists the Ebola Virus Disease Vaccines that are Covered Countermeasures. The Secretary is amending the description of Covered Countermeasures to clarify that coverage for vaccines includes coverage of all components and constituent materials of the vaccines, and all devices and their constituent components used in the administration of these vaccines. The change is intended to clarify existing coverage; is consistent with PREP Act declarations for vaccines against other potential public health threats, and it is not intended to be a substantive legal change.

    Section VI also refers to the statutory definitions of Covered Countermeasures to make clear that these statutory definitions limit the scope of Covered Countermeasures. Specifically, the Declaration notes that Covered Countermeasures must be “qualified pandemic or epidemic products,” or “security countermeasures,” or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.

    Section VII, Limitations on Distribution

    The Secretary may specify that liability immunity is in effect only to Covered Countermeasures obtained through a particular means of distribution. The Declaration states that liability immunity is afforded to Covered Persons for Recommended Activities related to: (a) Present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements; or (b) Activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following a Declaration of an emergency.

    Section VII defines the terms “Authority Having Jurisdiction” and “Declaration of an emergency.” We have specified in the definition that Authorities having jurisdiction include federal, state, local, and tribal authorities and institutions or organizations acting on behalf of those governmental entities.

    For governmental program planners only, liability immunity is afforded only to the extent they obtain Covered Countermeasures through voluntary means, such as (1) donation; (2) commercial sale; (3) deployment of Covered Countermeasures from federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles. This last limitation on distribution is intended to deter program planners that are government entities from seizing privately held stockpiles of Covered Countermeasures. It does not apply to any other Covered Persons, including other program planners who are not government entities.

    Section VIII, Category of Disease, Health Condition, or Threat

    The Secretary must identify, for each Covered Countermeasure, the categories of diseases, health conditions, or threats to health for which the Secretary recommends the administration or use of the countermeasure. In Section VIII, the Secretary states that the disease threat for which she recommends administration or use of the Covered Countermeasures is Ebola virus disease.

    Section IX, Administration of Covered Countermeasures

    The PREP Act does not explicitly define the term “administration” but does assign the Secretary the responsibility to provide relevant conditions in the Declaration. In Section IX, the Secretary defines “Administration of a Covered Countermeasure:”

    Administration of a Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution, and dispensing of the countermeasures to recipients; management and operation of countermeasure programs; or management and operation of locations for purpose of distributing and dispensing countermeasures.

    The definition of “administration” extends only to physical provision of a countermeasure to a recipient, such as vaccination or handing drugs to patients, and to activities related to management and operation of programs and locations for providing countermeasures to recipients, such as decisions and actions involving security and queuing, but only insofar as those activities directly relate to the countermeasure activities. Claims for which Covered Persons are provided immunity under the Act are losses caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a Covered Countermeasure consistent with the terms of a Declaration issued under the Act. Under the Secretary's definition, these liability claims are precluded if they allege an injury caused by physical provision of a countermeasure to a recipient, or if the claims are directly due to conditions of delivery, distribution, dispensing, or management and operation of countermeasure programs at distribution and dispensing sites.

    Thus, it is the Secretary's interpretation that, when a Declaration is in effect, the Act precludes, for example, liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct. Likewise, the Act precludes a liability claim relating to the management and operation of a countermeasure distribution program or site, such as a slip-and-fall injury or vehicle collision by a recipient receiving a countermeasure at a retail store serving as an administration or dispensing location that alleges, for example, lax security or chaotic crowd control. However, a liability claim alleging an injury occurring at the site that was not directly related to the countermeasure activities is not covered, such as a slip and fall with no direct connection to the countermeasure's administration or use. In each case, whether immunity is applicable will depend on the particular facts and circumstances.

    Section X, Population

    The Secretary must identify, for each Covered Countermeasure specified in a Declaration, the population or populations of individuals for which liability immunity is in effect with respect to administration or use of the countermeasure. This section explains which individuals should use the countermeasure or to whom the countermeasure should be administered—in short, those who should be vaccinated or take a drug or other countermeasure. Section X provides that the population includes “any individual who uses or who is administered a Covered Countermeasure in accordance with the Declaration.”

    In addition, the PREP Act specifies that liability immunity is afforded: (1) To manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; and (2) to program planners and qualified persons when the countermeasure is either used by or administered to this population or the program planner or qualified person reasonably could have believed the recipient was in this population. Section X includes these statutory conditions in the Declaration for clarity.

    Section XI, Geographic Area

    The Secretary must identify, for each Covered Countermeasure specified in the Declaration, the geographic area or areas for which liability immunity is in effect with respect to administration or use of the countermeasure, including, as appropriate, whether the Declaration applies only to individuals physically present in the area or, in addition, applies to individuals who have a described connection to the area. Section XI provides that liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation. This could include claims related to administration or use in West Africa or other locations outside the U.S. It is possible that claims may arise in regard to administration or use of the Covered Countermeasures outside the U.S. that may be resolved under U.S. law.

    In addition, the PREP Act specifies that liability immunity is afforded: (1) To manufacturers and distributors without regard to whether the countermeasure is used by or administered to individuals in the geographic areas; and (2) to program planners and qualified persons when the countermeasure is either used or administered in the geographic areas or the program planner or qualified person reasonably could have believed the countermeasure was used or administered in the areas. Section XI includes these statutory conditions in the Declaration for clarity.

    Section XII, Effective Time Period

    The Secretary must identify, for each Covered Countermeasure, the period or periods during which liability immunity is in effect, designated by dates, milestones, or other description of events, including factors specified in the PREP Act. Section XII is amended to extend the effective time period for different means of distribution of Covered Countermeasures up to an additional 24 months.

    Section XIII, Additional Time Period of Coverage

    The Secretary must specify a date after the ending date of the effective period of the Declaration that is reasonable for manufacturers to arrange for disposition of the Covered Countermeasure, including return of the product to the manufacturer, and for other Covered Persons to take appropriate actions to limit administration or use of the Covered Countermeasure. In addition, the PREP Act specifies that for Covered Countermeasures that are subject to a Declaration at the time they are obtained for the Strategic National Stockpile (SNS) under 42 U.S.C. 247d-6b(a), the effective period of the Declaration extends through the time the countermeasure is used or administered pursuant to a distribution or release from the Stockpile. Liability immunity under the provisions of the PREP Act and the conditions of the Declaration continues during these additional time periods. Thus, liability immunity is afforded during the “Effective Time Period,” described under XII of the Declaration, plus the “Additional Time Period” described under section XIII of the Declaration.

    Section XIII provides for 12 months as the additional time period of coverage after expiration of the Declaration. Section XIII also explains the extended coverage that applies to any products obtained for the Strategic National Stockpile during the effective period of the Declaration.

    Section XIV, Countermeasures Injury Compensation Program

    Section 319F-4 of the PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to eligible individuals who sustain a serious physical injury or die as a direct result of the administration or use of a Covered Countermeasure. Compensation under the CICP for an injury directly caused by a Covered Countermeasure is based on the requirements set forth in this Declaration, the administrative rules for the Program, and the statute. To show direct causation between a Covered Countermeasure and a serious physical injury, the statute requires “compelling, reliable, valid, medical and scientific evidence.” The administrative rules for the Program further explain the necessary requirements for eligibility under the CICP. Please note that, by statute, requirements for compensation under the CICP may not align with the requirements for liability immunity provided under the PREP Act. Section XIV, “Countermeasures Injury Compensation Program” explains the types of injury and standard of evidence needed to be considered for compensation under the CICP.

    Further, the administrative rules for the CICP specify if countermeasures are administered or used outside the United States, only otherwise eligible individuals at American embassies, military installations abroad (such as military bases, ships, and camps) or at North Atlantic Treaty Organization (NATO) installations (subject to the NATO Status of Forces Agreement) where American servicemen and servicewomen are stationed may be considered for CICP benefits. Other individuals outside the United States may not be eligible for CICP benefits.

    Section XV, Amendments

    This is the second amendment to the Declaration issued December 3, 2014 (79 FR 73314). The first amendment was issued December 1, 2015 (80 FR 76541). The Secretary may amend any portion of this Declaration through publication in the Federal Register.

    Republished Declaration Declaration, as Amended, for Public Readiness and Emergency Preparedness Act Coverage for Ebola Virus Disease Vaccines

    This Declaration amends and republishes the December 3, 2014, Declaration, as amended on December 1, 2015, for coverage under the Public Readiness and Emergency Preparedness (“PREP”) Act for Ebola Virus Disease Vaccines. To the extent any term of the December 3, 2014, Declaration, as amended on December 1, 2015, is inconsistent with any provision of this Republished Declaration, the terms of this Republished Declaration are controlling.

    I. Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency 42 U.S.C. 247d-6d(b)(1)

    I have determined that there is a credible risk that the spread of Ebola virus and the resulting disease or conditions may in the future constitute a public health emergency.

    II. Factors Considered 42 U.S.C. 247d-6d(b)(6)

    I have considered the desirability of encouraging the design, development, clinical testing, or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures.

    III. Recommended Activities 42 U.S.C. 247d-6d(b)(1)

    I recommend, under the conditions stated in this Declaration, the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures.

    IV. Liability Immunity 42 U.S.C. 247d-6d(a), 247d-6d(b)(1)

    Liability immunity as prescribed in the PREP Act and conditions stated in this Declaration is in effect for the Recommended Activities described in section III.

    V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)

    Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States.

    In addition, I have determined that the following additional persons are qualified persons: (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency; (b) any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with section 564 of the FD&C Act; (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the FD&C Act.

    VI. Covered Countermeasures 42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)

    Covered Countermeasures are the following Ebola Virus Disease vaccines, all components and constituent materials of these vaccines, and all devices and their constituent components used in the administration of these vaccines:

    (1) Recombinant Replication Deficient Chimpanzee Adenovirus Type 3-Vectored Ebola Zaire Vaccine (ChAd3-EBO-Z);

    (2) Recombinant Vesicular Stomatitis Virus-vectored vaccine expressing EBOV-Zaire glycoprotein (rVSV-ZEBOV-GP), and;

    (3) Ad26.ZEBOV/MVA-BN-Filo (MVA-mBN226B).

    Covered Countermeasures must be “qualified pandemic or epidemic products,” or “security countermeasures,” or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.

    VII. Limitations on Distribution 42 U.S.C. 247d-6d(a)(5) and (b)(2)(E)

    I have determined that liability immunity is afforded to Covered Persons only for Recommended Activities involving Covered Countermeasures that are related to:

    (a) Present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements; or,

    (b) Activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of an emergency.

    i. The Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority.

    ii. A Declaration of emergency means any Declaration by any authorized local, regional, state, or federal official of an emergency specific to events that indicate an immediate need to administer and use the Covered Countermeasures, with the exception of a federal Declaration in support of an Emergency Use Authorization under section 564 of the FD&C Act unless such Declaration specifies otherwise;

    I have also determined that for governmental program planners only, liability immunity is afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, such as (1) donation; (2) commercial sale; (3) deployment of Covered Countermeasures from federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles.

    VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A)

    The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is Ebola virus disease.

    IX. Administration of Covered Countermeasures 42 U.S.C. 247d-6d(a)(2)(B)

    Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for purpose of distributing and dispensing countermeasures.

    X. Population 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C)

    The populations of individuals include any individual who uses or is administered the Covered Countermeasures in accordance with this Declaration.

    Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population.

    XI. Geographic Area 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)

    Liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation.

    Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered in any designated geographic area; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area.

    XII. Effective Time Period 42 U.S.C. 247d-6d(b)(2)(B)

    Liability immunity for Covered Countermeasures through means of distribution, as identified in Section VII(a) of this Declaration, other than in accordance with the public health and medical response of the Authority Having Jurisdiction began on December 3, 2014, and extends through December 2, 2018.

    Liability immunity for Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction begins with a Declaration and lasts through (1) the final day the emergency Declaration is in effect or (2) through December 2, 2018, whichever occurs first.

    XIII. Additional Time Period of Coverage 42 U.S.C. 247d-6d(b)(3)(B) and (C)

    I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures.

    Covered Countermeasures obtained for the SNS during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS.

    XIV. Countermeasures Injury Compensation Program 42 U.S.C 247d-6e

    The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services. Information about the CICP is available at the toll-free number 1-855-266-2427 or http://www.hrsa.gov/cicp/.

    XV. Amendments 42 U.S.C. 247d-6d(b)(4)

    Amendments to this Declaration will be published in the Federal Register.

    Authority:

    42 U.S.C. 247d-6d.

    Dated: December 2, 2016. Sylvia M. Burwell, Secretary, Department of Health and Human Services.
    [FR Doc. 2016-29610 Filed 12-9-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Ebola Virus Disease Therapeutics—Amendment ACTION:

    Notice of Amendment to the February 27, 2015, Declaration under the Public Readiness and Emergency Preparedness Act for Ebola Virus Disease Therapeutics.

    SUMMARY:

    The Secretary is amending the February 27, 2015, Declaration issued pursuant to the Public Health Service Act and amended December 9, 2015 (80 FR 76536) to extend the effective time period for an additional 24 months consistent with the terms of the Declaration and republishing the Declaration in its entirety as amended.

    DATES:

    The Amended Declaration is effective as of February 27, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Nicole Lurie, MD, MSPH, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW., Washington, DC 20201; Telephone 202-205-2882.

    SUPPLEMENTARY INFORMATION:

    The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the administration or use of medical countermeasures (Covered Countermeasures), except for claims that meet the PREP Act's definition of willful misconduct. The Secretary may, through publication in the Federal Register, amend any portion of a Declaration. Using this authority, the Secretary is amending the Declaration that provides liability immunity to Covered Persons for activities related to the Covered Countermeasures, Ebola Virus Disease Therapeutics as listed in Section VI of the Declaration to extend the effective time period for an additional 24 months, consistent with the terms of this Declaration.

    The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, Section 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These sections are codified in the U.S. Code as 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.

    The Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, was enacted on March 13, 2013. Among other things, PAHPRA added sections 564A and 564B to the Federal Food, Drug, and Cosmetic (FD&C) Act to provide authorities for the emergency use of approved products in emergencies and products held for emergency use.

    PAHPRA accordingly amended the definitions of “Covered Countermeasures” and “qualified pandemic and epidemic products” in section 319F-3 of the Public Health Service Act (PREP Act provisions), so that products made available under these new FD&C Act authorities could be covered under PREP Act Declarations. PAHPRA also extended the definition of qualified pandemic and epidemic products that may be covered under a PREP Act Declaration to include products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic or epidemic or against adverse events from these products.

    The Ebola virus causes an acute, serious illness that is often fatal. From 2014 to 2015, West Africa experienced the largest and most complex Ebola outbreak since the virus was first discovered in 1976, affecting populations in multiple West African countries and travelers from West Africa to the United States (U.S.) and other countries. The World Health Organization (WHO) declared the Ebola Virus Disease Outbreak as a Public Health Emergency of International Concern under the framework of the International Health Regulations (2005). In March 2016, WHO determined that the Ebola outbreak no longer constituted a Public Health Emergency of International Concern, but emphasized the crucial need for continued support to prevent, detect and respond rapidly to any new Ebola outbreak in West Africa. Thus, there is a continuing need for development of vaccines against Ebola Virus Disease.

    Unless otherwise noted, all statutory citations below are to the U.S. Code.

    Section I, Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency

    Before issuing a Declaration under the PREP Act, the Secretary is required to determine that a disease or other health condition or threat to health constitutes a public health emergency or that there is a credible risk that the disease, condition, or threat may in the future constitute such an emergency. This determination is separate and apart from a Declaration issued by the Secretary under section 319 of the PHS Act that a disease or disorder presents a public health emergency or that a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, or other Declarations or determinations made under other authorities of the Secretary. Accordingly, in Section I, the Secretary determines that there is a credible risk that the spread of Ebola virus and the resulting disease may constitute a public health emergency.

    Section II, Factors Considered

    In deciding whether and under what circumstances to issue a Declaration with respect to a Covered Countermeasure, the Secretary must consider the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the countermeasure. In Section II, the Secretary states that she has considered these factors.

    Section III, Recommended Activities

    The Secretary must recommend the activities for which the PREP Act's liability immunity is in effect. These activities may include, under conditions as the Secretary may specify, the manufacture, testing, development, distribution, administration, or use of one or more Covered Countermeasures (“Recommended Activities”). In Section III, the Secretary recommends activities for which the immunity is in effect under the conditions stated in the Declaration, including the condition that the activities relate to clinical trials permitted to proceed after review by the Food and Drug Administration (FDA) that administer or use the Covered Countermeasure under an investigational new drug application (IND) and that are directly supported by the U.S. The Secretary specifies that the term “directly supported” in this Declaration means that the United States has provided some form of tangible support such as supplies, funds, products, technical assistance, or staffing. This condition is intended to afford liability immunity only to activities related to clinical trials using the Covered Countermeasure being conducted in the U.S. and West Africa that are directly supported by the U.S.

    Section IV, Liability Immunity

    The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities. These liability protections provide that, “[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration . . . has been issued with respect to such countermeasure.” In Section IV, the Secretary states that liability protections are in effect with respect to the Recommended Activities.

    Section V, Covered Persons

    The PREP Act's liability immunity applies to Covered Persons with respect to administration or use of a Covered Countermeasure. The term “Covered Persons” has a specific meaning and is defined in the PREP Act to include manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the U.S. The PREP Act further defines the terms “manufacturer,” “distributor,” “program planner,” and “qualified person” as described below.

    A manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure; and any or all of the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.

    A distributor means a person or entity engaged in the distribution of drug, biologics, or devices, including but not limited to: Manufacturers; repackers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.

    A program planner means a state or local government, including an Indian tribe; a person employed by the state or local government; or other person who supervises or administers a program with respect to the administration, dispensing, distribution, provision, or use of a Covered Countermeasure, including a person who establishes requirements, provides policy guidance, or supplies technical or scientific advice or assistance or provides a facility to administer or use a Covered Countermeasure in accordance with the Secretary's Declaration. Under this definition, a private-sector employer or community group or other “person” can be a program planner when it carries out the described activities.

    A qualified person means a licensed health professional or other individual authorized to prescribe, administer, or dispense Covered Countermeasures under the law of the state in which the countermeasure was prescribed, administered, or dispensed; or a person within a category of persons identified as qualified in the Secretary's Declaration. Under this definition, the Secretary can describe in the Declaration other qualified persons, such as volunteers, who are Covered Persons. Section V describes other qualified persons covered by this Declaration.

    The PREP Act also defines the word “person” as used in the Act: A person includes an individual, partnership, corporation, association, entity, or public or private corporation, including a federal, state, or local government agency or department. Section V describes Covered Persons under the Declaration, including Qualified Persons.

    Section VI, Covered Countermeasures

    As noted above, section III describes the Secretary's Recommended Activities for which liability immunity is in effect. Section VI identifies the countermeasures for which the Secretary has recommended such activities. The PREP Act states that a Covered Countermeasure must be: A “qualified pandemic or epidemic product,” or a “security countermeasure,” as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with sections 564, 564A, or 564B of the FD&C Act.

    A qualified pandemic or epidemic product means a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that is: (i) Manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause; (ii) manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product, or device; (iii) or a product or technology intended to enhance the use or effect of such a drug, biological product, or device.

    A security countermeasure is a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that: (i)(a) The Secretary determines to be a priority to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat by the Secretary of Homeland Security, or (b) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent; and (ii) is determined by the Secretary of Health and Human Services to be a necessary countermeasure to protect public health.

    To be a Covered Countermeasure, qualified pandemic or epidemic products or security countermeasures also must be approved or cleared under the FD&C Act; licensed under the PHS Act; or authorized for emergency use under sections 564, 564A, or 564B of the FD&C Act.

    A qualified pandemic or epidemic product also may be a Covered Countermeasure when it is subject to an exemption (that is, it is permitted to be used under an Investigational Drug Application or an Investigational Device Exemption) under the FD&C Act and is the object of research for possible use for diagnosis, mitigation, prevention, treatment, or cure, or to limit harm of a pandemic or epidemic or serious or life-threatening condition caused by such a drug or device. A security countermeasure also may be a Covered Countermeasure if it may reasonably be determined to qualify for approval or licensing within 10 years after the Department's determination that procurement of the countermeasure is appropriate.

    Section VI lists the Ebola Virus Disease Therapeutics that are Covered Countermeasures. Section VI also refers to the statutory definitions of Covered Countermeasures to make clear that these statutory definitions limit the scope of Covered Countermeasures. Specifically, the Declaration notes that Covered Countermeasures must be “qualified pandemic or epidemic products, or security countermeasures, or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.”

    Section VII, Limitations on Distribution

    The Secretary may specify that liability immunity is in effect only to Covered Countermeasures obtained through a particular means of distribution. The Declaration states that liability immunity is afforded to Covered Persons for Recommended Activities related to clinical trials permitted to proceed after FDA review, that administer or use the Covered Countermeasure under an IND, and directly supported by the U.S., as described in Section III of this Declaration, through present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements or arrangements.

    This limitation is intended to afford liability immunity to activities that are related to clinical trials permitted to proceed after FDA review that administer or use the Covered Countermeasure under an IND and that are directly supported by the U.S. As stated in Section III of the Declaration, the term “directly support” means that the U.S. has provided some form of tangible support such as supplies, funds, products, technical assistance, or staffing. As of the date of this Declaration, activities primarily are those with a direct connection to the conduct of clinical trials in the U.S. and West Africa, but this Declaration also would apply to use in qualifying clinical trials outside those areas.

    For governmental program planners only, liability immunity is afforded only to the extent they obtain Covered Countermeasures through voluntary means, such as (1) donation; (2) commercial sale; (3) deployment of Covered Countermeasures from federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles.

    This last limitation on distribution is intended to deter program planners that are government entities from seizing privately held stockpiles of Covered Countermeasures. It does not apply to any other Covered Persons, including other program planners who are not government entities.

    Section VIII, Category of Disease, Health Condition, or Threat

    The Secretary must identify, for each Covered Countermeasure, the categories of diseases, health conditions, or threats to health for which the Secretary recommends the administration or use of the countermeasure. In Section VIII, the Secretary states that the disease threat for which she recommends administration or use of the Covered Countermeasures is Ebola Virus Disease.

    Section IX, Administration of Covered Countermeasures

    The PREP Act does not explicitly define the term “administration” but does assign the Secretary the responsibility to provide relevant conditions in the Declaration. In Section IX, the Secretary defines “Administration of a Covered Countermeasure”:

    Administration of a Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution, and dispensing of the countermeasures to recipients; management and operation of countermeasure programs; or management and operation of locations for purpose of distributing and dispensing countermeasures.

    The definition of “administration” extends only to physical provision of a countermeasure to a recipient, such as vaccination or handing drugs to patients, and to activities related to management and operation of programs and locations for providing countermeasures to recipients, such as decisions and actions involving security and queuing, but only insofar as those activities directly relate to the countermeasure activities. Claims for which Covered Persons are provided immunity under the Act are losses caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a Covered Countermeasure consistent with the terms of a Declaration issued under the Act. Under the Secretary's definition, these liability claims are precluded if the claims allege an injury caused by physical provision of a countermeasure to a recipient, or if the claims are directly due to conditions of delivery, distribution, dispensing, or management and operation of countermeasure programs at distribution and dispensing sites.

    Thus, it is the Secretary's interpretation that, when a Declaration is in effect, the Act precludes, for example, liability claims alleging negligence by a manufacturer in creating a therapeutic, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct. Likewise, the Act precludes a liability claim relating to the management and operation of a countermeasure distribution program or site, such as a slip-and-fall injury or vehicle collision by a recipient receiving a countermeasure at a retail store serving as an administration or dispensing location that alleges, for example, lax security or chaotic crowd control. However, a liability claim alleging an injury occurring at the site that was not directly related to the countermeasure activities is not covered, such as a slip-and-fall with no direct connection to the countermeasure's administration or use. In each case, whether immunity is applicable will depend on the particular facts and circumstances.

    Section X, Population

    The Secretary must identify, for each Covered Countermeasure specified in a Declaration, the population or populations of individuals for which liability immunity is in effect with respect to administration or use of the countermeasure. This section explains which individuals should use the countermeasure or to whom the countermeasure should be administered—in short, those who should be vaccinated or take a drug or other countermeasure. Section X provides that the population includes “any individual who uses or who is administered a Covered Countermeasure in accordance with the Declaration.”

    In addition, the PREP Act specifies that liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population and to program planners and qualified persons when the countermeasure is either used by or administered to this population or the program planner or qualified person reasonably could have believed the recipient was in this population. Section X includes these statutory conditions in the Declaration for clarity.

    Section XI, Geographic Area

    The Secretary must identify, for each Covered Countermeasure specified in the Declaration, the geographic area or areas for which liability immunity is in effect with respect to administration or use of the countermeasure, including, as appropriate, whether the Declaration applies only to individuals physically present in the area or, in addition, applies to individuals who have a described connection to the area. Section XI provides that liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation. This could include claims related to administration or use in West Africa or other locations outside the U.S. It is possible that claims may arise in regard to administration or use of the Covered Countermeasures outside the U.S. that may be resolved under U.S. law.

    In addition, the PREP Act specifies that liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to individuals in the geographic areas and to program planners and qualified persons when the countermeasure is either used or administered in the geographic areas or the program planner or qualified person reasonably could have believed the countermeasure was used or administered in the areas. Section XI includes these statutory conditions in the Declaration for clarity.

    Section XII, Effective Time Period

    The Secretary must identify for each Covered Countermeasure the period or periods during which liability immunity is in effect, designated by dates, milestones, or other description of events, including factors specified in the PREP Act. Section XII identifies the effective time period. The effective time period commences at the start of clinical trials permitted to proceed after FDA review that administer or use the Covered Countermeasure under an IND and that are directly supported by the U.S., as described in Section III of the Declaration. Liability immunity is afforded to claims arising from such administration or use of the Covered Countermeasures after that date that have a causal relationship with any of the Recommended Activities stated in this Declaration. Section XII is amended to extend the effective time period an additional 24 months.

    Section XIII, Additional Time Period of Coverage

    The Secretary must specify a date after the ending date of the effective period of the Declaration that is reasonable for manufacturers to arrange for disposition of the Covered Countermeasure, including return of the product to the manufacturer, and for other Covered Persons to take appropriate actions to limit administration or use of the Covered Countermeasure. In addition, the PREP Act specifies that for Covered Countermeasures that are subject to a Declaration at the time they are obtained for the Strategic National Stockpile (SNS) under 42 U.S.C. 247d-6b(a), the effective period of the Declaration extends through the time the countermeasure is used or administered pursuant to a distribution or release from the SNS. Liability immunity under the provisions of the PREP Act and the conditions of the Declaration continues during these additional time periods. Thus, liability immunity is afforded during the “Effective Time Period,” described under XII of the Declaration, plus the “Additional Time Period” described under section XIII of the Declaration.

    Section XIII provides for 12 months as the additional time period of coverage after expiration of the Declaration. Section XIII also explains the extended coverage that applies to products obtained for the SNS during the effective period of the Declaration.

    Section XIV, Countermeasures Injury Compensation Program

    Section 319F-4 of the PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to eligible individuals who sustain a serious physical injury or die as a direct result of the administration or use of a Covered Countermeasure. Compensation under the CICP for an injury directly caused by a Covered Countermeasure is based on the requirements set forth in this Declaration, the administrative rules for the Program, and the statute. To show direct causation between a Covered Countermeasure and a serious physical injury, the statute requires “compelling, reliable, valid, medical and scientific evidence.” The administrative rules for the Program further explain the necessary requirements for eligibility under the CICP. Please note that, by statute, requirements for compensation under the CICP may not always align with the requirements for liability immunity provided under the PREP Act. Section XIV, Countermeasures Injury Compensation Program, explains the types of injury and standard of evidence needed to be considered for compensation under the CICP.

    Further, the administrative rules for the CICP specify if countermeasures are administered or used outside the U.S., only otherwise eligible individuals at American embassies, military installations abroad (such as military bases, ships, and camps) or at North Atlantic Treaty Organization (NATO) installations (subject to the NATO Status of Forces Agreement) where American servicemen and servicewomen are stationed may be considered for CICP benefits. Other individuals outside the U.S. may not be eligible for CICP benefits.

    Section XV, Amendments

    This is the second amendment to the February 27, 2015, Declaration (80 FR 73314). The first amendment was issued December 9, 2015 (80 FR 76536). The Secretary may amend any portion of a Declaration through publication in the Federal Register.

    Republished Declaration Declaration, as Amended, Public Readiness and Emergency Preparedness Act Coverage for Ebola Virus Disease Therapeutics

    This Declaration amends and republishes the February 27, 2015 for coverage under the Public Readiness and Emergency Preparedness (PREP) Act for Ebola Virus Disease Therapeutics. To the extent any term of the February 27, 2015, Declaration is inconsistent with any provision of this Republished Declaration, the terms of this Republished Declaration are controlling.

    I. Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency 42 U.S.C. 247d-6d(b)(1)

    I have determined that there is a credible risk that the spread of Ebola virus and the resulting disease or conditions may in the future constitute a public health emergency.

    II. Factors Considered 42 U.S.C. 247d-6d(b)(6)

    I have considered the desirability of encouraging the design, development, clinical testing, or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures.

    III. Recommended Activities 42 U.S.C. 247d-6d(b)(1)

    I recommend the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures under the conditions stated in this Declaration, including the condition that the activities relate to clinical trials permitted to proceed after review by the Food and Drug Administration (FDA) that administer or use the Covered Countermeasure under an IND application and that are directly supported by the U.S. The term “directly supported” in this Declaration means that the U.S. has provided some form of tangible support such as supplies, funds, products, technical assistance, or staffing.

    IV. Liability Immunity 42 U.S.C. 247d-6d(a), 247d-6d(b)(1)

    Liability immunity as prescribed in the PREP Act and conditions stated in this Declaration is in effect for the Recommended Activities described in section III.

    V. Covered Persons 42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)

    Covered Persons who are afforded liability immunity under this Declaration are manufacturers, distributors, program planners, qualified persons, and their officials, agents, and employees, as those terms are defined in the PREP Act, and the U.S. In addition, I have determined that the following additional persons are qualified persons: Any person authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity to carry out clinical trials permitted to proceed after FDA review that administer or use the Covered Countermeasure under an IND and that are directly supported by the United States, as described in Section III of this Declaration.

    VI. Covered Countermeasures 42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)

    Covered Countermeasures are the following Ebola Virus Disease Therapeutics: ZMapp monoclonal antibody therapeutic.

    Covered Countermeasures must be “qualified pandemic or epidemic products,” or “security countermeasures,” or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.

    VII. Limitations on Distribution 42 U.S.C. 247d-6d(a)(5) and (b)(2)(E)

    I have determined that liability immunity is afforded to Covered Persons only for Recommended Activities involving Covered Countermeasures that are related to clinical trials permitted to proceed after FDA review that administer or use the Covered Countermeasure under an IND and that are directly supported by the United States, as described in Section III of this Declaration, through present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements or arrangements.

    I have also determined that for governmental program planners only, liability immunity is afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, such as (1) donation; (2) commercial sale; (3) deployment of Covered Countermeasures from federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from state, local, or private stockpiles.

    VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d-6d(b)(2)(A)

    The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is Ebola virus disease.

    IX. Administration of Covered Countermeasures 42 U.S.C. 247d-6d(a)(2)(B)

    Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for purpose of distributing and dispensing countermeasures.

    X. Population 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C)

    The populations of individuals include any individual who uses or is administered the Covered Countermeasures in accordance with this Declaration.

    Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population.

    XI. Geographic Area 42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)

    Liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation.

    Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered in any designated geographic area; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area.

    XII. Effective Time Period 42 U.S.C. 247d-6d(b)(2)(B)

    Liability immunity for Covered Countermeasures began on February 27, 2015, and extends through February 26, 2019.

    XIII. Additional Time Period of Coverage 42 U.S.C. 247d-6d(b)(3)(B) and (C)

    I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures.

    Covered Countermeasures obtained for the SNS during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS.

    XIV. Countermeasures Injury Compensation Program 42 U.S.C 247d-6e

    The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services. Information about the CICP is available by telephone at 855-266-2427 (toll-free) or http://www.hrsa.gov/cicp/.

    XV. Amendments 42 U.S.C. 247d-6d(b)(4)

    Any amendments to this Declaration will be published in the Federal Register.

    Authority:

    42 U.S.C. 247d-6d.

    Dated: December 2, 2016. Sylvia M. Burwell, Secretary, Department of Health and Human Services.
    [FR Doc. 2016-29609 Filed 12-9-16; 8:45 am] BILLING CODE 4150-28-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Neurogastroenterology.

    Date: December 14, 2016.

    Time: 9:00 a.m. to 10:00 a.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call)

    Contact Person: Ganesan Ramesh, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Dr., Room 2182, MSC 7818, Bethesda, MD 20892, [email protected].

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: December 6, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-29603 Filed 12-9-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Eye Institute; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Eye Council.

    The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Advisory Eye Council.

    Date: January 19, 2017.

    Open: 8:30 a.m. to 1:00 p.m.

    Agenda: Following opening remarks by the Director, NEI, there will be presentations by the staff of the Institute and discussions concerning Institute programs.

    Place: Terrace Level Conference Rooms, 5635 Fishers Lane, Rockville, MD 20852.

    Closed: 1:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Terrace Level Conference Rooms, 5635 Fishers Lane, Rockville, MD 20852.

    Contact Person: Paul A. Sheehy, Ph.D., Director, Division of Extramural Affairs, National Eye Institute, National Institutes of Health, 5635 Fishers Lane, Suite 1300, Bethesda, MD 20892, 301-451-2020, [email protected].

    Information is also available on the Institute's/Center's home page: www.nei.nih.gov, where an agenda and any additional information for the meeting will be posted when available.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.867, Vision Research, National Institutes of Health, HHS)
    Dated: December 6, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-29604 Filed 12-9-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY:

    National Institutes of Health, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

    FOR FURTHER INFORMATION CONTACT:

    Licensing information and copies of the U.S. patent application listed below may be obtained by communicating with the indicated licensing contact at the Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852; tel. 301-496-2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished patent applications.

    SUPPLEMENTARY INFORMATION:

    Technology description follows.

    Zika Virus Vaccines Description of Technology

    Zika virus (ZIKV) is a flavivirus transmitted by mosquitos that is strongly linked to neurological complications including Guillain-Barré syndrome, meningoencephalitis, and microcephaly. The association between active ZIKV infection during pregnancy and microcephaly and intrauterine growth retardation in the fetus has been confirmed in murine models of ZIKV infection.

    Scientists at NIAID have developed nucleic acid-based vaccine candidates to prevent ZIKV infection in humans. The current lead candidate vaccine is a plasmid DNA vaccine demonstrated to accord protection in preclinical models and is undergoing clinical trial evaluation. Nucleic acid-based vaccines have been developed previously for West Nile virus, another flavivirus similar to Zika (J.E. Ledgerwood, et al. J. Infect. Dis. (2011) 203 (10): 1396-1404). Immunization with the nucleic acid ZIKV vaccine candidate results in production of noninfectious virus like particles (VLPs) made of ZIKV proteins. These ZIKV VLPs elicit an immune response which includes neutralizing antibodies to ZIKV.

    Other preclinical ZIKV vaccine candidates include mRNA, protein, and noninfectious VLPs.

    NIAID is continuing development of these vaccine candidates. The DNA-based ZIKV vaccine candidate is currently in clinical trials. Consequently, for some fields of use, NIAID will evaluate a license applicant's capabilities and experience in advancing similar technologies through the regulatory process.

    This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration. This technology is not eligible for NIH's start up license.

    Potential Commercial Applications: • Prevention of Zika virus infection Competitive Advantages: • There is currently no licensed Zika virus vaccine Development Stage: • Currently, DNA-based vaccine candidate in Phase I clinical trial • Phase II clinical trial planned for early 2017 for DNA-based vaccine candidate • Other candidates are in pre-clinical development

    Inventors: Barney S. Graham (NIAID), Theodore C. Pierson (NIAID), Kimberly A. Dowd (NIAID), John R. Mascola (NIAID), Wing-Pui Kong (NIAID), Sung-Youl Ko (NIAID), Eun Sung Yang (NIAID), Wei Shi (NIAID), Lingshu Wang (NIAID), Christina R. Demaso (NIAID), Rebecca S. Pelc (NIAID), Adrian Creanga (NIAID), Julie Ledgerwood (NIAID), William Schief (The Scripps Research Institute), Sebastian Ramisch (The Scripps Research Institute), Leda Castilho (Federal University of Rio de Janeiro)

    Publications: K.A. Dowd, et al., Science, 354, 237-240 (2016).

    DOI: 10.1126/science.aai9137.

    Intellectual Property: U.S. Patent Application No. 62/396,613 filed September 19, 2016 (HHS Reference No. E-181-2016/0-US-01).

    Licensing Contact: Dr. Amy Petrik, 240-627-3721; [email protected].

    Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize Zika virus vaccine technologies. For collaboration opportunities, please contact Dr. Amy Petrik, 240-627-3721; [email protected].

    Dated: December 5, 2016. Suzanne Frisbie, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases.
    [FR Doc. 2016-29605 Filed 12-9-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs And Border Protection Modification and Clarification of the National Customs Automation Program Tests Regarding Post-Summary Corrections and Periodic Monthly Statements AGENCY:

    U.S. Customs and Border Protection, Department of Homeland Security.

    ACTION:

    General notice.

    SUMMARY:

    This document announces U.S. Customs and Border Protection's (CBP's) plan to modify and clarify the National Customs Automation Program (NCAP) test pertaining to the processing of post-summary correction (PSC) claims to entry summaries that are filed in the Automated Commercial Environment (ACE), as well as the periodic monthly statement (PMS) test. The modifications made by this notice eliminate some requirements and liberalize certain requirements needed for the filing of a PSC making it easier for importers to file a PSC for additional entry types, and allowing for additional time to make a deposit for duties, fees and taxes owed. With regard to the PMS test program, this notice announces the time at which CBP considers a PMS as paid when filers use the Automated Clearing House (ACH) debit process. Except to the extent expressly announced or modified by this document, all aspects, rules, terms and conditions announced in previous notices regarding the tests remain in effect.

    DATES:

    The changes made by this notice are effective January 14, 2017.

    ADDRESSES:

    Comments concerning these test programs may be submitted via email to Monica Crockett at [email protected] with a subject line identifier reading, “Post-Summary Corrections Processing.”

    FOR FURTHER INFORMATION CONTACT:

    For policy-related questions, contact John Everett via email at [email protected] For technical questions related to ABI transmissions, contact your assigned client representative. Interested parties without an assigned client representative should direct their questions to the Client Representative Branch at (703) 650-3500.

    SUPPLEMENTARY INFORMATION: I. Background Post-Summary Correction (PSC) and Periodic Monthly Statement (PMS) Test Programs

    The National Customs Automation Program (NCAP) was established by Subtitle B of Title VI—Customs Modernization in the North American Free Trade Agreement (NAFTA) Implementation Act (Customs Modernization Act) (Pub. L. 103-182, 107 Stat. 2057, 2170, December 8, 1993) (19 U.S.C. 1411). Through NCAP, the thrust of customs modernization was on trade compliance and the development of the Automated Commercial Environment (ACE), the planned successor to the Automated Commercial System (ACS) as the CBP-authorized electronic data interchange (EDI) system. ACE is an automated and electronic system for commercial trade processing which is intended to streamline business processes, facilitate growth in trade, ensure cargo security, and foster participation in global commerce, while ensuring compliance with U.S. laws and regulations and reducing costs for CBP and all of its communities of interest. The ability to meet these objectives depends on successfully modernizing CBP's business functions and the information technology that supports those functions. CBP's modernization efforts are accomplished through phased releases of ACE component functionality designed to replace specific legacy ACS functions and add new functionality. Section 101.9(b) of title 19 of the Code of Federal Regulations (19 CFR 101.9(b)) provides for the testing of NCAP components. See T.D. 95-21, 60 FR 14211 (March 16, 1995). A list of ACE tests is provided in Section III below.

    1. PSC Test Program

    On June 24, 2011, CBP published a notice in the Federal Register (76 FR 37136) that announced a plan to conduct an NCAP test concerning new ACE capabilities which allow importers to file a PSC for certain entry summaries using the Automated Broker Interface (ABI). Importers and other brokers are also allowed to use ABI to file a PSC to those pre-liquidation ACE entry summaries that were accepted by CBP, fully paid, and under CBP control. On November 19, 2013, CBP published a notice in the Federal Register modifying and clarifying the terms and conditions of the PSC test. See 78 FR 69434.

    2. PMS Test Program

    On February 4, 2004, CBP published a notice in the Federal Register (69 FR 5362) that announced a plan to conduct an NCAP test concerning PMS which allows importers to deposit estimated duties, fees and taxes on a monthly basis. CBP modified and clarified the PMS test in seven subsequent Federal Register notices published on: September 8, 2004 (69 FR 54302); February 1, 2005 (70 FR 5199); August 8, 2005 (70 FR 45736); September 22, 2005 (70 FR 55623); January 20, 2006 (71 FR 3315); June 2, 2006 (71 FR 32114); and October 17, 2008 (73 FR 61891).

    II. Test Modifications and Clarifications

    This document announces numerous modifications and clarifications to the PSC and PMS tests. Each modification and clarification is discussed separately below. Except to the extent expressly announced or modified by this document, all aspects, rules, terms, requirements, obligations and conditions announced in previous notices regarding the PSC and PMS tests remain in effect.

    A. Modifications and Clarifications of the PSC Test 1. Expansion of Entry Types

    This document announces that CBP is expanding the type of entries that may be corrected by filing a PSC, in addition to the current entry types 01 (Consumption—Free and Dutiable) and 03 (Consumption—Antidumping/Countervailing Duty). The additional entry types are as follows:

    • 02—Consumption—Quota/Visa • 06—Consumption—Foreign Trade Zone (FTZ) • 07—Consumption—Antidumping/Countervailing Duty and Quota/Visa Combination • 21—Warehouse • 22—Re-Warehouse • 23—Temporary Importation Bond (TIB) • 31—Warehouse Withdrawal—Consumption • 32—Warehouse Withdrawal—Quota • 34—Warehouse Withdrawal—Antidumping/Countervailing Duty • 38—Warehouse Withdrawal—Antidumping/Countervailing Duty & Quota/Visa Combination • 51—Defense Contract Administration Service Region (DCASR) • 52—Government—Dutiable 2. Merchandise Subject to Quota

    When filing a PSC for an entry of merchandise subject to quota, the date and time of submission will be considered the date and time of presentation of the merchandise to CBP. If a PSC is filed on an entry with merchandise subject to quota, and the quota is full or nearly full at threshold, the PSC filer must do two things. The filer must follow the Entry Summary Business Rules and Process Document on www.CBP.gov and also, within 24 hours of making the correction, contact Headquarters Quota Branch: (202) 863-6560 (public phone number), email address: [email protected], regardless of whether the correction concerns merchandise subject to quota.

    3. Deposit of Duties, Fees and Taxes With PSC Showing Increase in Liability

    This document announces that if a PSC is filed that increases the importer's liability for duties, fees or taxes, the importer must deposit those additional duties, fees and taxes within three business days of submitting the PSC. No additional PSCs can be filed until those duties, fees and taxes are deposited.

    4. Change of Entry Type When Antidumping and/or Countervailing Duties Are Involved

    Previously, a filer under the PSC test could not change a type 03 entry to a type 01 entry. See 76 FR 37136. This document announces that a PSC may declare that a previously filed entry which stated that merchandise covered by that entry was subject to antidumping and/or countervailing duties is not, in fact, subject to such duties. For instance, a PSC may declare that a previously filed 03 entry type is corrected to indicate it is a 01 entry type.

    5. Elimination of CBP's Policy of Rejecting a PSC When There Is No Deposit of Antidumping and/or Countervailing Duties at Time of Submission of PSC

    This notice announces a change in CBP policy which will allow an importer to deposit new or additional antidumping and/or countervailing duties within three business days of submitting the PSC. However, no additional PSCs can be filed until the duties are deposited. Previously, when a PSC declared that an entry was corrected to indicate it was subject to antidumping and/or countervailing duties, or a greater amount of antidumping and/or countervailing duties was owed, and those duties were not deposited at the time of submitting the PSC, CBP would reject the PSC.

    6. No Filing of PSC To Make a Post-Importation Claim Under 19 U.S.C. 1520(d)

    On June 24, 2011, CBP announced in the Federal Register (76 FR 37136) that one of the data elements that may not be modified via a PSC is the NAFTA indicator. This notice clarifies that such prohibition applies not only to a post-importation NAFTA claim under 19 U.S.C. 1520(d), but also to a claim made under other free trade agreements covered by 19 U.S.C. 1520(d).

    7. PSC Submission Within the Time Limitations Authorized by This Test

    On November 19, 2013, CBP published a notice in the Federal Register (78 FR 69434) that stated that a PSC cannot be filed when any merchandise covered by the original entry has been conditionally released and its right to admission has not been determined. This restriction was overly broad and prevented importers from filing a PSC because all goods are conditionally released and their admissibility is not legally determined until liquidation. This notice announces that this restriction does not prevent the filing of a PSC within the time periods allowed as long as all other requirements and limitations are met. The time limits authorized by this test are set forth in notices published in the Federal Register on June 24, 2011 (76 FR 37136) and November 19, 2013 (78 FR 69434). This clarification is in line with current practice.

    B. Modification to the PMS Test

    This notice announces that CBP will consider a PMS as paid, in the event the importer uses the Automated Clearing House (ACH) debit process, when CBP receives confirmation from the Treasury Department that funds are available and transferred to CBP from the financial institution designated by the importer for payment of the ACH debit authorization. Prior to this modification, CBP considered a PMS as paid when CBP transmitted the debit authorization to the designated financial institution. See 69 FR 5362 (February 4, 2004). This change will result in a delay of approximately two working days in the time that CBP uses to consider a PMS as paid. It is important to note that this modification applies only to importers who participate in the test program. For all other importers, the current regulation, 19 CFR 24.25(c)(4), still applies which means CBP will consider a statement as paid upon acceptance of the ACH debit authorization.

    III. Development of ACE Prototypes

    A chronological listing of Federal Register publications detailing ACE test developments is set forth below.

    • ACE Portal Accounts and Subsequent Revision Notices: 67 FR 21800 (May 1, 2002); 69 FR 5360 and 69 FR 5362 (February 4, 2004); 69 FR 54302 (September 8, 2004); 70 FR 5199 (February 1, 2005).

    • ACE System of Records Notice: 71 FR 3109 (January 19, 2006).

    • Terms/Conditions for Access to the ACE Portal and Subsequent Revisions: 72 FR 27632 (May 16, 2007); 73 FR 38464 (July 7, 2008).

    • ACE Non-Portal Accounts and Related Notice: 70 FR 61466 (October 24, 2005); 71 FR 15756 (March 29, 2006).

    • ACE Entry Summary, Accounts and Revenue (ESAR I) Capabilities: 72 FR 59105 (October 18, 2007).

    • ACE Entry Summary, Accounts and Revenue (ESAR II) Capabilities: 73 FR 50337 (August 26, 2008); 74 FR 9826 (March 6, 2009).

    • ACE Entry Summary, Accounts and Revenue (ESAR III) Capabilities: 74 FR 69129 (December 30, 2009).

    • ACE Entry Summary, Accounts and Revenue (ESAR IV) Capabilities: 76 FR 37136 (June 24, 2011).

    • Post-Entry Amendment (PEA) Processing Test: 76 FR 37136 (June 24, 2011).

    • ACE Announcement of a New Start Date for the National Customs Automation Program Test of Automated Manifest Capabilities for Ocean and Rail Carriers: 76 FR 42721 (July 19, 2011).

    • ACE Simplified Entry: 76 FR 69755 (November 9, 2011).

    • National Customs Automation Program (NCAP) Tests Concerning Automated Commercial Environment (ACE) Document Image System (DIS): 77 FR 20835 (April 6, 2012).

    • National Customs Automation Program (NCAP) Tests Concerning Automated Commercial Environment (ACE) Simplified Entry: Modification of Participant Selection Criteria and Application Process: 77 FR 48527 (August 14, 2012).

    • Modification of National Customs Automation Program (NCAP) Test Regarding Reconciliation for Filing Certain Post-Importation Preferential Tariff Treatment Claims under Certain FTAs: 78 FR 27984 (May 13, 2013).

    • Modification of Two National Customs Automation Program (NCAP) Tests Concerni