Federal Register Vol. 81, No.210,

Federal Register Volume 81, Issue 210 (October 31, 2016)

Page Range75315-75670
FR Document

81_FR_210
Current View
Page and SubjectPDF
81 FR 75456 - Sunshine Act MeetingPDF
81 FR 75427 - Indian Gaming; Tribal-State Class III Gaming Compact Taking Effect in the State of CaliforniaPDF
81 FR 75426 - Indian Gaming; Tribal-State Class III Gaming Compact Taking Effect in the State of CaliforniaPDF
81 FR 75427 - Indian Gaming; Approval of Amended Tribal-State Class III Gaming Compact in the State of South DakotaPDF
81 FR 75428 - Indian Gaming; Approval of Amendment to Tribal-State Class III Gaming Compact in the State of OregonPDF
81 FR 75427 - Indian Gaming; Approval of Amendment to Tribal-State Class III Gaming Compact in the State of CaliforniaPDF
81 FR 75428 - Indian Gaming; Approval of Amended Tribal-State Class III Gaming Compact in the State of CaliforniaPDF
81 FR 75405 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
81 FR 75411 - Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; AvailabilityPDF
81 FR 75406 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 75349 - Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry; AvailabilityPDF
81 FR 75351 - Good Laboratory Practice for Nonclinical Laboratory Studies; Extension of Comment PeriodPDF
81 FR 75419 - Labeling for Permanent Hysteroscopically Placed Tubal Implants Intended for Sterilization; Guidance for Industry and Food and Drug Administration Staff; AvailabilityPDF
81 FR 75409 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
81 FR 75429 - Atlantic Wind Lease Sale 6 (ATLW-6) for Commercial Leasing for Wind Power on the Outer Continental Shelf Offshore New York-Final Sale Notice MMAA104000PDF
81 FR 75476 - Petition for Exemption; Summary of Petition Received; Douglas MyersPDF
81 FR 75477 - Petition for Exemption; Summary of Petition Received; Pentastar Aviation Charter, Inc.PDF
81 FR 75438 - Environmental Assessment for Commercial Wind Lease Issuance and Site Assessment Activities on the Atlantic Outer Continental Shelf Offshore New York; MMAA104000PDF
81 FR 75352 - Withholding of Unclassified Technical Data and Technology From Public DisclosurePDF
81 FR 75327 - Drawbridge Operation Regulation; Newtown Creek, Brooklyn and Queens, NYPDF
81 FR 75315 - Temporary Exceptions to FIRREA Appraisal Requirements in Areas Affected by Severe Storms and Flooding in LouisianaPDF
81 FR 75361 - Approval and Promulgation of Air Quality Implementation Plans; State of Utah; Revisions to Nonattainment Permitting RegulationsPDF
81 FR 75398 - Combined Notice of FilingsPDF
81 FR 75397 - Applied Energy LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 75393 - Moapa Southern Paiute Solar, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 75398 - Combined Notice of Filings #1PDF
81 FR 75399 - Combined Notice of FilingsPDF
81 FR 75394 - Combined Notice of Filings #1PDF
81 FR 75395 - Combined Notice of Filings #1PDF
81 FR 75401 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
81 FR 75387 - Agency Information Collection Activities; Comment Request; National Professional Development Program: Grantee Performance ReportPDF
81 FR 75345 - Fisheries of the Exclusive Economic Zone Off Alaska; Groundfish by Vessels Using Trawl Gear in the of the Gulf of AlaskaPDF
81 FR 75378 - Polyethylene Retail Carrier Bags From Malaysia: Final Results of the Antidumping Duty Administrative Review; 2014-2015PDF
81 FR 75373 - Foreign-Trade Zone (FTZ) 38-Spartanburg, South Carolina Authorization of Production Activity Benteler Automotive Corporation (Automotive Suspension and Body Components) Duncan, South CarolinaPDF
81 FR 75374 - Call for Applications for the International Buyer Program Select Service for Calendar Year 2018PDF
81 FR 75400 - Children's Health Protection Advisory CommitteePDF
81 FR 75379 - Call for Applications for the International Buyer Program Calendar Year 2018PDF
81 FR 75453 - New Postal ProductsPDF
81 FR 75376 - Certain Frozen Warmwater Shrimp From India: Initiation and Preliminary Results of Antidumping Duty Changed Circumstances ReviewPDF
81 FR 75439 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Special Dipping and Coating Operations (Dip Tanks)PDF
81 FR 75440 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Safety Standards for Underground Coal Mine Ventilation-Belt Entry Used as an Intake Air Course To Ventilate Working Sections and Areas Where Mechanized Mining Equipment Is Being Installed or RemovedPDF
81 FR 75449 - NuScale Power, LLC, Design-Specific Review Standard and Scope and Safety Review MatrixPDF
81 FR 75365 - Mercury and Air Toxics Standards (MATS) Completion of Electronic Reporting RequirementsPDF
81 FR 75478 - Pilot Program for Transit-Oriented Development Planning Project SelectionsPDF
81 FR 75452 - Duke Energy Florida, LLC; Levy Nuclear Plant Units 1 and 2PDF
81 FR 75392 - Environmental Management Site-Specific Advisory Board, Savannah River SitePDF
81 FR 75370 - Submission for OMB Review; Comment RequestPDF
81 FR 75444 - TUV Rheinland of North America, Inc.: Applications for Expansion of Recognition and Proposed Modification to the List of Appropriate NRTL Test StandardsPDF
81 FR 75442 - Intertek Testing Services NA, Inc.: Application for Expansion of RecognitionPDF
81 FR 75446 - Curtis-Strauss LLC: Application for Expansion of RecognitionPDF
81 FR 75371 - National Urban and Community Forestry Advisory CouncilPDF
81 FR 75347 - Refunding Baggage Fees for Delayed Checked BagsPDF
81 FR 75368 - Petitions for Reconsideration and Clarification of Action in Rulemaking ProceedingPDF
81 FR 75400 - Schedule Change Open Commission Meeting, Thursday, October 27, 2016PDF
81 FR 75370 - Forest Resource Coordinating CommitteePDF
81 FR 75388 - National Assessment Governing Board Quarterly Board MeetingPDF
81 FR 75390 - Request for Information on Interagency Working Group on Language and Communication's Report on Research and Development ActivitiesPDF
81 FR 75480 - Nondiscrimination on the Basis of Disability in Air Travel: Negotiated Rulemaking Committee Seventh MeetingPDF
81 FR 75481 - Exploring Industry Practices on Distribution and Display of Airline Fare, Schedule, and Availability InformationPDF
81 FR 75396 - Breitburn Operating LP v. Florida Gas Transmission Company, LLC; Notice of ComplaintPDF
81 FR 75397 - City of Tuscaloosa, Alabama; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments and Motions To IntervenePDF
81 FR 75399 - Public Service Company of New Hampshire; Notice of Availability of Environmental AssessmentPDF
81 FR 75392 - Alabama Power Company v. Southwest Power Pool; Notice of ComplaintPDF
81 FR 75393 - Indianapolis Power & Light Company v. Midcontinent Independent System Operator, Inc.; Notice of ComplaintPDF
81 FR 75396 - Dominion Carolina Gas Transmission, LLC; Notice of ApplicationPDF
81 FR 75328 - Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals; CorrectionPDF
81 FR 75423 - Commercial Customs Operations Advisory Committee (COAC)PDF
81 FR 75366 - Notice of Proposed Supplementary Rules for Public Lands Managed by the Moab Field Office in Grand County, UtahPDF
81 FR 75384 - Notice of Intent To Grant Exclusive Patent License to RF Networking Solutions, LLC; East Brunswick, NJPDF
81 FR 75386 - Notice of Public Hearing and Business Meeting; November 9 and December 14, 2016PDF
81 FR 75344 - NASA Federal Acquisition Regulation Supplement: Remove NASA FAR Supplement Clause Engineering Change Proposals (2016-N030)PDF
81 FR 75385 - Submission for OMB Review; Comment RequestPDF
81 FR 75449 - Submission for OMB Review; Comment RequestPDF
81 FR 75425 - Endangered and Threatened Wildlife and Plants; 5-Year Status Review of the Red WolfPDF
81 FR 75454 - 2017 Railroad Experience Rating Proclamations, Monthly Compensation Base and Other DeterminationsPDF
81 FR 75424 - Announcement of Meetings: North American Wetlands Conservation Council; Neotropical Migratory Bird Conservation Advisory GroupPDF
81 FR 75371 - Allegheny Resource Advisory Committee MeetingPDF
81 FR 75316 - Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration InsurancePDF
81 FR 75439 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Proposed Renewal, With Change, of a Previously Approved Collection; Attorney Student Loan Repayment Program Electronic FormsPDF
81 FR 75384 - Proposed Information Collection; Comment Request; Natural Resource Damage Assessment Restoration Project Information SheetPDF
81 FR 75383 - Proposed Information Collection; Comment Request; Expanded Vessel Monitoring System Requirement in the Pacific Coast Groundfish FisheryPDF
81 FR 75388 - Agency Information Collection Activities; Comment Request; Evaluation of the Comprehensive Technical Assistance CentersPDF
81 FR 75374 - Proposed Information Collection; Comment Request; Report of Requests for Restrictive Trade Practice or BoycottPDF
81 FR 75383 - Submission for OMB Review; Comment RequestPDF
81 FR 75382 - Submission for OMB Review; Comment RequestPDF
81 FR 75372 - Notice of Invitation for Nominations to the Advisory Committee on Agriculture StatisticsPDF
81 FR 75373 - Notice of Intent To Request Revision and Extension of a Currently Approved Information CollectionPDF
81 FR 75428 - Information Collection Request: National Park Service Centennial National Household SurveyPDF
81 FR 75327 - Drawbridge Operation Regulation; Upper Mississippi River, Clinton, IAPDF
81 FR 75491 - Proposed Information Collection (Application Requirements To Receive VA Dental Insurance Plan Benefits Under 38 CFR 17.169) Activity: Comment RequestPDF
81 FR 75377 - Freshwater Crawfish Tail Meat From the People's Republic of China: Initiation of Antidumping Duty New Shipper ReviewPDF
81 FR 75477 - Railroad Safety Advisory Committee; Notice of MeetingPDF
81 FR 75478 - Norfolk Southern Railway Company's Request for Positive Train Control Safety Plan Approval and System CertificationPDF
81 FR 75448 - NASA Advisory Council; Aeronautics Committee; MeetingPDF
81 FR 75401 - Patient Safety Organizations: Voluntary Relinquishment From the Patient Safety Leadership Council PSOPDF
81 FR 75402 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 75454 - New Postal ProductPDF
81 FR 75473 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Add Commentary .14 to Rule 3317 (Compliance With Regulation NMS Plan To Implement a Tick Size Pilot)PDF
81 FR 75471 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Add Commentary .14 to Rule 4770 (Compliance With Regulation NMS Plan To Implement a Tick Size Pilot)PDF
81 FR 75468 - Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Add Commentary .14 to Rule 4770 (Compliance With Regulation NMS Plan To Implement a Tick Size Pilot)PDF
81 FR 75460 - Options Price Reporting Authority; Notice of Filing and Immediate Effectiveness of Proposed Amendment to the Plan for Reporting of Consolidated Options Last Sale Reports and Quotation Information To Amend OPRA's Non-Display Use FeesPDF
81 FR 75462 - Options Price Reporting Authority; Notice of Filing and Immediate Effectiveness of Proposed Amendment to the Plan for Reporting of Consolidated Options Last Sale Reports and Quotation Information To Amend the Professional Subscriber Device-Based Fees and Policies with Respect to Device-Based FeesPDF
81 FR 75458 - Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend EDGX Rule 11.11, Routing to Away Trade CentersPDF
81 FR 75466 - Self-Regulatory Organizations; Bats EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to EDGA Rule 11.11, Routing to Away Trading CentersPDF
81 FR 75464 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to BZX Rule 11.13, Order Execution and RoutingPDF
81 FR 75456 - Self-Regulatory Organizations; Bats BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend BYX Rule 11.13, Order Execution and RoutingPDF
81 FR 75423 - National Cancer Institute; Notice of MeetingPDF
81 FR 75421 - Government-Owned Inventions; Availability for LicensingPDF
81 FR 75421 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 75381 - Determination of Overfishing or an Overfished ConditionPDF
81 FR 75488 - Unblocking of Specially Designated Nationals and Blocked Persons Resulting From the Termination of the National Emergency and Revocation of Executive Orders Related to BurmaPDF
81 FR 75387 - Agency Information Collection Activities; Comment Request; GEPA Section 427 Guidance for All Grant ApplicationsPDF
81 FR 75408 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 75441 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Derricks StandardPDF
81 FR 75487 - Fee Schedule for the Transfer of U.S. Treasury Book-Entry Securities Held on the National Book-Entry SystemPDF
81 FR 75338 - Amendment of the Commission's Space Station Licensing Rules and Policies, Second Order on ReconsiderationPDF
81 FR 75330 - Procedures for Disclosure of Information Under the Freedom of Information ActPDF
81 FR 75624 - Qualified Financial Contracts Recordkeeping Related to Orderly Liquidation AuthorityPDF
81 FR 75494 - Teacher Preparation IssuesPDF

Issue

81 210 Monday, October 31, 2016 Contents Agency Health Agency for Healthcare Research and Quality NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 75402-75405 2016-26143 Patient Safety Organizations: Voluntary Relinquishment from Patient Safety Leadership Council, 75401-75402 2016-26144 Agriculture Agriculture Department See

Forest Service

See

National Agricultural Statistics Service

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 75370 2016-26205
Army Army Department NOTICES Exclusive Patent Licenses: RF Networking Solutions, LLC, East Brunswick, NJ, 75384-75385 2016-26177 Fiscal Bureau of the Fiscal Service NOTICES Fee Schedule for Transfer of U.S. Treasury Book-Entry Securities Held on National Book-Entry System, 75487-75488 2016-26079 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 75405-75406 2016-26248 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals, etc.; Correction, 75328-75330 2016-26182 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 75406-75411 2016-26246 2016-26122 2016-26242 Coast Guard Coast Guard RULES Drawbridge Operations: Newtown Creek, Brooklyn and Queens, NY, 75327-75328 2016-26235 Upper Mississippi River, Clinton, IA, 75327 2016-26150 Commerce Commerce Department See

Foreign-Trade Zones Board

See

Industry and Security Bureau

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Comptroller Comptroller of the Currency RULES Financial Institutions Reform, Recovery, and Enforcement Act Appraisal Requirements: Louisiana; Temporary Exceptions in Areas Affected by Severe Storms and Flooding, 75315-75316 2016-26234 Defense Department Defense Department See

Army Department

See

Navy Department

PROPOSED RULES Withholding of Unclassified Technical Data and Technology from Public Disclosure, 75352-75361 2016-26236
Delaware Delaware River Basin Commission NOTICES Meetings: Delaware River Basin Commission, 75386 2016-26176 Education Department Education Department RULES Teacher Preparation Issues, 75494-75622 2016-24856 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Evaluation of Comprehensive Technical Assistance Centers, 75388 2016-26158 Guidance for All Grant Applications, 75387-75388 2016-26123 National Professional Development Program: Grantee Performance Report, 75387 2016-26222 Meetings: National Assessment Governing Board, 75388-75390 2016-26194 Requests for Information: Interagency Working Group on Language and Communication's Report on Research and Development Activities, 75390-75392 2016-26193 Employee Benefits Employee Benefits Security Administration RULES Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance, 75316-75327 2016-26162 Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Meetings: Environmental Management Site-Specific Advisory Board, Savannah River Site, 75392 2016-26206
Environmental Protection Environmental Protection Agency PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Utah; Revisions to Nonattainment Permitting Regulations, 75361-75365 2016-26233 Mercury and Air Toxics Standards Completion of Electronic Reporting Requirements, 75365-75366 2016-26209 NOTICES Meetings: Children's Health Protection Advisory Committee, 75400 2016-26217 Federal Aviation Federal Aviation Administration NOTICES Petitions for Exemption; Summaries: Douglas Myers, 75476 2016-26239 Pentastar Aviation Charter, Inc., 75477 2016-26238 Federal Communications Federal Communications Commission RULES Space Station Licensing Rules and Policies, 75338-75344 2016-25935 PROPOSED RULES Petitions for Reconsideration and Clarification of Action in Rulemaking Proceeding, 75368-75369 2016-26198 NOTICES Meetings: Federal Communications Commission; Schedule Change, 75400-75401 2016-26197 Federal Deposit Federal Deposit Insurance Corporation RULES Financial Institutions Reform, Recovery, and Enforcement Act Appraisal Requirements: Louisiana; Temporary Exceptions in Areas Affected by Severe Storms and Flooding, 75315-75316 2016-26234 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Dominion Carolina Gas Transmission, LLC, 75396-75397 2016-26185 Combined Filings, 75394-75396, 75398-75400 2016-26224 2016-26225 2016-26226 2016-26228 2016-26231 Complaints: Alabama Power Co. v. Southwest Power Pool, 75392-75393 2016-26187 Breitburn Operating, LP v. Florida Gas Transmission Co., LLC, 75396 2016-26190 Indianapolis Power and Light Co. v. Midcontinent Independent System Operator, Inc., 75393-75394 2016-26186 Environmental Assessments; Availability, etc.: Public Service Co. of New Hampshire, 75399 2016-26188 Hydroelectric Applications: Tuscaloosa, AL, 75397 2016-26189 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Applied Energy, LLC, 75397-75398 2016-26230 Moapa Southern Paiute Solar, LLC, 75393 2016-26229 Federal Railroad Federal Railroad Administration NOTICES Meetings: Railroad Safety Advisory Committee, 75477-75478 2016-26147 Positive Train Control Safety Plans: Norfolk Southern Railway Co.; Approval and System Certification, 75478 2016-26146 Federal Reserve Federal Reserve System RULES Financial Institutions Reform, Recovery, and Enforcement Act Appraisal Requirements: Louisiana; Temporary Exceptions in Areas Affected by Severe Storms and Flooding, 75315-75316 2016-26234 NOTICES Changes in Bank Control: Acquisitions of Shares of Bank or Bank Holding Company, 75401 2016-26223 Federal Transit Federal Transit Administration NOTICES Pilot Program for Transit-Oriented Development Planning Project Selections, 75478-75480 2016-26208 Fish Fish and Wildlife Service NOTICES Endangered and Threatened Wildlife and Plants: 5-Year Status Review of Red Wolf, 75425-75426 2016-26168 Meetings: North American Wetlands Conservation Council; Neotropical Migratory Bird Conservation Advisory Group, 75424-75425 2016-26166 Food and Drug Food and Drug Administration PROPOSED RULES Good Laboratory Practice for Nonclinical Laboratory Studies, 75351-75352 2016-26244 Guidance: Describing Hazard that Needs Control in Documents Accompanying Food, as Required by Four Rules Implementing FDA Food Safety Modernization Act, 75349-75351 2016-26245 NOTICES Guidance: Labeling for Permanent Hysteroscopically Placed Tubal Implants Intended for Sterilization, 75419-75421 2016-26243 Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability, 75411-75419 2016-26247 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 75488-75491 2016-26124 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities: Benteler Automotive Corp., Foreign-Trade Zone 38, Spartanburg, SC, 75373-75374 2016-26219 Forest Forest Service NOTICES Meetings: Allegheny Resource Advisory Committee, 75371 2016-26165 Forest Resource Coordinating Committee, 75370-75371 2016-26195 National Urban and Community Forestry Advisory Council, 75371-75372 2016-26200 Health and Human Health and Human Services Department See

Agency for Healthcare Research and Quality

See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Food and Drug Administration

See

National Institutes of Health

RULES Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance, 75316-75327 2016-26162
Homeland Homeland Security Department See

Coast Guard

See

U.S. Customs and Border Protection

Indian Affairs Indian Affairs Bureau NOTICES Indian Gaming: Approval of Amended Tribal-State Class III Gaming Compact in State of California, 75428 2016-26250 Approval of Amended Tribal-State Class III Gaming Compact in State of South Dakota, 75427 2016-26253 Approval of Amendment to Tribal-State Class III Gaming Compact in State of California, 75427 2016-26251 Approval of Amendment to Tribal-State Class III Gaming Compact in State of Oregon, 75428 2016-26252 Tribal-State Class III Gaming Compact Taking Effect in State of California, 75426-75428 2016-26254 2016-26255 2016-26256 Industry Industry and Security Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Report of Requests for Restrictive Trade Practice or Boycott, 75374 2016-26157 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

Land Management Bureau

See

National Park Service

See

Ocean Energy Management Bureau

Internal Revenue Internal Revenue Service RULES Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance, 75316-75327 2016-26162 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Frozen Warmwater Shrimp from India, 75376-75377 2016-26214 Freshwater Crawfish Tail Meat from the People's Republic of China, 75377-75378 2016-26148 Polyethylene Retail Carrier Bags from Malaysia, 75378-75379 2016-26220 Requests for Applications: International Buyer Program Calendar Year 2018, 75379-75381 2016-26216 International Buyer Program Select Service for Calendar Year 2018, 75374-75376 2016-26218 Justice Department Justice Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Attorney Student Loan Repayment Program Electronic Forms, 75439 2016-26161 Labor Department Labor Department See

Employee Benefits Security Administration

See

Occupational Safety and Health Administration

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Derricks Standard, 75441-75442 2016-26121 Safety Standards for Underground Coal Mine Ventilation, etc., 75440-75441 2016-26212 Special Dipping and Coating Operations, 75439-75440 2016-26213
Land Land Management Bureau PROPOSED RULES Public Land Orders: Moab Field Office, Grand County, UT, 75366-75368 2016-26179 Legal Legal Services Corporation RULES Procedures for Disclosure of Information under the Freedom of Information Act, 75330-75338 2016-25832 NASA National Aeronautics and Space Administration RULES Federal Acquisition Regulation Supplement: Removal of Engineering Change Proposals Clause, 75344-75345 2016-26174 NOTICES Meetings: NASA Advisory Council Aeronautics Committee, 75448-75449 2016-26145 National Agricultural National Agricultural Statistics Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 75373 2016-26153 Requests for Nominations: Advisory Committee on Agriculture Statistics, 75372-75373 2016-26154 National Credit National Credit Union Administration RULES Financial Institutions Reform, Recovery, and Enforcement Act Appraisal Requirements: Louisiana; Temporary Exceptions in Areas Affected by Severe Storms and Flooding, 75315-75316 2016-26234 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 75449 2016-26169 National Institute National Institutes of Health NOTICES Government-Owned Inventions; Availability for Licensing, 75421-75423 2016-26129 Meetings: Center for Scientific Review, 75421 2016-26128 National Cancer Institute, 75423 2016-26130 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Groundfish by Vessels Using Trawl Gear in Gulf of Alaska, 75345-75346 2016-26221 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Expanded Vessel Monitoring System Requirement in Pacific Coast Groundfish Fishery, 75383 2016-26159 Licensing of Private Remote-Sensing Space Systems, 75383-75384 2016-26156 Natural Resource Damage Assessment Restoration Project Information Sheet, 75384 2016-26160 Papahanaumokuakea Marine National Monument Permit Application and Reports for Permits, 75382-75383 2016-26155 Determinations of Overfishing or Overfished Condition, 75381-75382 2016-26126 National Park National Park Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 75428-75429 2016-26151 Navy Navy Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 75385-75386 2016-26173 2016-26170 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Guidance: NuScale Power, LLC, Design-Specific Review Standard and Scope and Safety Review Matrix, 75449-75452 2016-26210 Indemnity Agreements: Duke Energy Florida, LLC; Levy Nuclear Plant Units 1 and 2; Modification Intent, 75452-75453 2016-26207 Occupational Safety Health Adm Occupational Safety and Health Administration NOTICES Applications for Expansion of Recognition: Curtis-Strauss, LLC, 75446-75448 2016-26202 Intertek Testing Services NA, Inc., 75442-75444 2016-26203 TUV Rheinland of North America, Inc., 75444-75446 2016-26204 Ocean Energy Management Ocean Energy Management Bureau NOTICES Atlantic Wind Lease Sales: Commercial Leasing for Wind Power on Outer Continental Shelf Offshore New York, 75429-75438 2016-26240 Environmental Assessments; Availability, etc.: Commercial Wind Lease Issuance and Site Assessment Activities on Atlantic Outer Continental Shelf Offshore New York, 75438 2016-26237 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 2016-26140 75453-75454 2016-26215 Railroad Retirement Railroad Retirement Board NOTICES 2017 Railroad Experience Rating Proclamations, Monthly Compensation Base, and Other Determinations, 75454-75456 2016-26167 Securities Securities and Exchange Commission NOTICES Meetings; Sunshine Act, 75456 2016-26304 Self-Regulatory Organizations; Proposed Rule Changes: Bats BYX Exchange, Inc., 75456-75458 2016-26131 Bats BZX Exchange, Inc., 75464-75466 2016-26132 Bats EDGA Exchange, Inc., 75466-75468 2016-26133 Bats EDGX Exchange, Inc., 75458-75460 2016-26134 NASDAQ BX, Inc., 75468-75471 2016-26137 NASDAQ PHLX, LLC, 75473-75476 2016-26139 NASDAQ Stock Market, LLC, 75471-75473 2016-26138 Options Price Reporting Authority, 2016-26135 75460-75464 2016-26136 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Railroad Administration

See

Federal Transit Administration

PROPOSED RULES Refunding Baggage Fees for Delayed Checked Bags, 75347-75349 2016-26199 NOTICES Exploring Industry Practices on Distribution and Display of Airline Fare, Schedule, and Availability Information, 75481-75487 2016-26191 Meetings: Advisory Committee on Accessible Air Transportation, 75480-75481 2016-26192
Treasury Treasury Department See

Bureau of the Fiscal Service

See

Comptroller of the Currency

See

Foreign Assets Control Office

See

Internal Revenue Service

RULES Qualified Financial Contracts Recordkeeping Related to Orderly Liquidation Authority, 75624-75670 2016-25329
Customs U.S. Customs and Border Protection NOTICES Meetings: Commercial Customs Operations Advisory Committee, 75423-75424 2016-26180 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application Requirements to Receive VA Dental Insurance Plan Benefits, 75491-75492 2016-26149 Separate Parts In This Issue Part II Education Department, 75494-75622 2016-24856 Part III Treasury Department, 75624-75670 2016-25329 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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81 210 Monday, October 31, 2016 Rules and Regulations DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency 12 CFR Part 34 [Docket No. OCC-2016-0030] FEDERAL RESERVE SYSTEM 12 CFR Part 225 [Docket No. R-1551] RIN 7100 AE-62 FEDERAL DEPOSIT INSURANCE CORPORATION 12 CFR Part 323 NATIONAL CREDIT UNION ADMINISTRATION 12 CFR Part 722 Temporary Exceptions to FIRREA Appraisal Requirements in Areas Affected by Severe Storms and Flooding in Louisiana AGENCY:

Office of the Comptroller of the Currency, Treasury (OCC); Board of Governors of the Federal Reserve System (Board); Federal Deposit Insurance Corporation (FDIC); and National Credit Union Administration (NCUA), collectively referred to as the Agencies.

ACTION:

Statement and order; temporary exceptions.

SUMMARY:

Section 2 of the Depository Institutions Disaster Relief Act of 1992 (DIDRA) authorizes the Agencies to make exceptions to statutory and regulatory appraisal requirements under Title XI of the Financial Institutions Reform, Recovery, and Enforcement Act of 1989 (FIRREA). The exceptions are available for transactions involving real property located within an area declared to be a major disaster area by the President if the Agencies determine, and describe by publication of a regulation or order, that the exceptions would facilitate recovery from the disaster and would be consistent with safety and soundness. In this statement and order, the Agencies exercise their authority to grant temporary exceptions to the FIRREA appraisal requirements for real estate related transactions, provided certain criteria are met, in the Louisiana parishes declared a major disaster area by President Obama on August 14, 2016, as a result of the severe storms and flooding in Louisiana. The expiration date for the exceptions is December 31, 2017.

DATES:

This order is effective on October 31, 2016 and expires for specific areas on December 31, 2017.

FOR FURTHER INFORMATION CONTACT:

OCC: Robert Parson, Senior Appraisal Policy Advisor, Chief National Bank Examiner's Office, at (202) 649-6423; Kevin Lawton, Appraisal Specialist, Chief National Bank Examiner's Office, at (202) 649-7152; Christopher Manthey, Special Counsel, Chief Counsel's Office, at (202) 649-6203; or Mitchell Plave, Special Counsel, Chief Counsel's Office, at (202) 649-6285 or, for persons who are deaf or hard of hearing, TTY (202) 649-5597.

Board: Carmen D. Holly, Senior Supervisory Financial Analyst, Division of Banking Supervision and Regulation at 202-973-6122; Gillian Burgess, Counsel, Legal Division, at (202) 736-5564.

FDIC: Beverlea S. Gardner, Senior Examination Specialist, Division of Risk Management and Supervision, at (202) 898-3640; Benjamin K. Gibbs, Counsel, Legal Division, at (202) 898- 6726; or Kimberly Stock, Counsel, Legal Division, at (202) 898-3815, Federal Deposit Insurance Corporation, 550 17th Street NW., Washington, DC 20429.

NCUA: D. Scott Neat, Director of Supervision, Office of Examination and Insurance, at (703) 518-6363; John Brolin, Staff Attorney, Office of General Counsel, at (703) 518-6438, National Credit Union Administration, 1775 Duke Street, Alexandria, VA 22314.

SUPPLEMENTARY INFORMATION: Statement

Section 2 of DIDRA, which added section 1123 to Title XI of FIRREA,1 authorizes the Agencies to make exceptions to statutory and regulatory appraisal requirements for certain transactions. These exceptions are available for transactions involving real property located in areas in which the President has determined a major disaster exists, pursuant to 42 U.S.C. 5170, provided that the exception would facilitate recovery from the major disaster and is consistent with safety and soundness.

1 12 U.S.C. 3352

On August 14, 2016, the President declared that 22 parishes in Louisiana were in a major disaster area (Major Disaster Area) due to extensive damage that occurred as a result of severe storms and subsequent flooding.2 The Agencies believe that granting relief from the appraisal requirements set forth in Title XI of FIRREA for real estate transactions in the Major Disaster Area is consistent with the provisions of DIDRA.

2 Press Release, The White House (Aug. 14, 2016), available at https://www.whitehouse.gov/the-press-office/2016/08/14/president-obama-signs-louisiana-disaster-declaration.

Facilitation of Recovery From the Storms and Flooding Declared as Major Disaster

The Agencies have determined that the disruption of real estate markets in the Major Disaster Area interferes with the ability of depository institutions to obtain appraisals that comply with all statutory and regulatory requirements. Further, the Agencies have determined that the disruption may impede institutions in making loans and engaging in other transactions that would aid in the reconstruction and rehabilitation of the affected area. Accordingly, the Agencies have determined that recovery from this major disaster would be facilitated by exempting certain transactions involving real estate located in the area directly affected by the severe storms and flooding from the real estate appraisal requirements of Title XI of FIRREA and its implementing regulations.3

3 12 U.S.C. 3331-3355; 12 CFR 34.41-34.47 (OCC); 12 CFR part 225, subpart G (Board); 12 CFR part 323, subpart A (FDIC); 12 CFR part 722 (NCUA).

Consistency With Safety and Soundness

The Agencies also have determined that the exceptions are consistent with safety and soundness, provided that the depository institution determines and maintains appropriate documentation of the following: (1) The transaction involves real property located in the Major Disaster Area; (2) there is a binding commitment to fund the transaction that was entered into on or after August 14, 2016, but no later than December 31, 2017; and (3) the value of the real property supports the institution's decision to enter into the transaction. In addition, the transaction must continue to be subject to review by management and by the Agencies in the course of examinations of the institution.

Expiration Date

Exceptions made under section 1123 of FIRREA may be provided for no more than three years after the President determines that a major disaster exists in the area.4 The Agencies have determined that the exceptions provided for by this order shall expire on December 31, 2017.

4 12 U.S.C. 3352(b).

Order

In accordance with section 2 of DIDRA, relief is hereby granted from the provisions of Title XI of FIRREA and the Agencies' appraisal regulations for any real estate-related financial transaction that requires the services of an appraiser under those provisions, provided that the institution determines, and maintains documentation made available to the Agencies upon request, of the following:

(1) The transaction involves real property located in one of the 22 parishes declared a major disaster area as a result of severe storms and flooding in Louisiana by the President on August 14, 2016 (identified in the Appendix);

(2) There is a binding commitment to fund a transaction that was entered into on or after August 14, 2016, but no later than December 31, 2017; and

(3) The value of the real property supports the institution's decision to enter into the transaction.

Appendix (Major Disaster Area)

Designated Parishes: Acadia, Ascension, Avoyelles, East Baton Rouge, East Feliciana, Evangeline, Iberia, Iberville, Jefferson Davis, Lafayette, Livingston, Pointe Coupee, St. Helena, St. James, St. Landry, St. Martin, St. Tammany, Tangipahoa, Vermilion, Washington, West Baton Rouge and West Feliciana.

Dated: October 19, 2016. Thomas J. Curry, Comptroller of the Currency. By order of the Board of Governors of the Federal Reserve System, October 21, 2016. Margaret McCloskey Shanks, Deputy Secretary of the Board. Dated at Washington, DC, October 19, 2016.

By order of the Board of Directors.

Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary. Dated at Alexandria, VA, October 27, 2016.

By order of the Board of Directors.

National Credit Union Administration. Gerard Poliquin, Secretary of the Board.
[FR Doc. 2016-26234 Filed 10-28-16; 8:45 am] BILLING CODE 6210-01-P
DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 54 [TD 9791] RIN 1545-BN44 DEPARTMENT OF LABOR Employee Benefits Security Administration 29 CFR Part 2590 RIN 1210-AB75 DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Parts 144, 146, 147, and 148 [CMS-9932-F] RIN 0938-AS93 Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance AGENCY:

Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Centers for Medicare & Medicaid Services, Department of Health and Human Services.

ACTION:

Final rules.

SUMMARY:

This document contains final regulations regarding the definition of short-term, limited-duration insurance for purposes of the exclusion from the definition of individual health insurance coverage, and standards for travel insurance and supplemental health insurance coverage to be considered excepted benefits. This document also amends a reference in the final regulations relating to the prohibition on lifetime and annual dollar limits.

DATES:

Effective date. These final regulations are effective on December 30, 2016.

Applicability date. These final regulations apply to group health plans and health insurance issuers beginning on the first day of the first plan year (or, in the individual market, the first day of the first policy year) beginning on or after January 1, 2017.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Schumacher or Matthew Litton of the Department of Labor, at 202-693-8335, Karen Levin, Internal Revenue Service, Department of the Treasury, at (202) 317-5500, David Mlawsky or Cam Clemmons, Centers for Medicare & Medicaid Services, Department of Health and Human Services, at 410-786-1565.

Customer Service Information: Individuals interested in obtaining information from the Department of Labor concerning employment-based health coverage laws may call the Employee Benefits Security Administration (EBSA) Toll-Free Hotline, at 1-866-444-EBSA (3272) or visit the Department of Labor's Web site (http://www.dol.gov/ebsa). In addition, information from the Department of Health and Human Services (HHS) on private health insurance for consumers can be found on the Centers for Medicare & Medicaid Services (CMS) Web site (www.cms.gov/cciio) and information on health reform can be found at www.HealthCare.gov.

SUPPLEMENTARY INFORMATION: I. Background

The Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191 (110 Stat. 1936), added title XXVII of the Public Health Service Act (PHS Act), part 7 of the Employee Retirement Income Security Act of 1974 (ERISA), and Chapter 100 of the Internal Revenue Code (the Code), providing portability and nondiscrimination rules with respect to health coverage. These provisions of the PHS Act, ERISA, and the Code were later augmented by other consumer protection laws, including the Mental Health Parity Act of 1996,1 the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008,2 the Newborns' and Mothers' Health Protection Act,3 the Women's Health and Cancer Rights Act,4 the Genetic Information Nondiscrimination Act of 2008,5 the Children's Health Insurance Program Reauthorization Act of 2009,6 Michelle's Law,7 and the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (Affordable Care Act).8

1 Public Law 104-204, 110 Stat. 2944 (September 26, 1996).

2 Public Law 110-343, 122 Stat. 3881 (October 3, 2008).

3 Public Law 104-204, 110 Stat. 2935 (September 26, 1996).

4 Public Law 105-277, 112 Stat. 2681-436 (October 21, 1998).

5 Public Law 110-233, 122 Stat. 881 (May 21, 2008).

6 Public Law 111-3, 123 Stat. 65 (February 4, 2009).

7 Public Law 110-381, 122 Stat. 4081 (October 9, 2008).

8 The Patient Protection and Affordable Care Act, Public Law 111-148, was enacted on March 23, 2010, and the Health Care and Education Reconciliation Act of 2010, Public Law 111-152, was enacted on March 30, 2010. (These statutes are collectively known as the “Affordable Care Act”.)

The Affordable Care Act reorganizes, amends, and adds to the provisions of part A of title XXVII of the PHS Act relating to group health plans and health insurance issuers in the group and individual markets. For this purpose, the term “group health plan” includes both insured and self-insured group health plans.9 The Affordable Care Act added section 715(a)(1) of ERISA and section 9815(a)(1) of the Code to incorporate the provisions of part A of title XXVII of the PHS Act (generally, sections 2701 through 2728 of the PHS Act) into ERISA and the Code to make them applicable to group health plans and health insurance issuers providing health insurance coverage in connection with group health plans.

9 The term “group health plan” is used in title XXVII of the PHS Act, part 7 of ERISA, and Chapter 100 of the Code, and is distinct from the term “health plan,” as used in other provisions of title I of the Affordable Care Act. The term “health plan” as used in other provisions of title I of the Affordable Care Act does not include self-insured group health plans.

II. Overview of the Final Regulations

On June 10, 2016, the Departments of Labor, Health and Human Services and the Treasury (the Departments 10 ) issued proposed regulations with respect to expatriate health plans, expatriate health plan issuers, and qualified expatriates; requirements for travel insurance, similar supplemental coverage, and hospital indemnity or other fixed indemnity insurance to be excepted benefits; the prohibition on lifetime and annual limits; and short-term, limited-duration insurance.11 After consideration of comments on the proposed regulations, the Departments are publishing final regulations regarding short-term, limited duration insurance, travel insurance, similar supplemental coverage, and lifetime and annual limits. The Departments intend to address hospital indemnity or other fixed indemnity insurance and expatriate health plans in future rulemaking, taking into account comments received on these issues.12

10 Note, however, that in sections under headings listing only two of the three Departments, the term “Departments” generally refers only to the two Departments listed in the heading.

11 81 FR 38019 (June 10, 2016).

12 The preamble to the proposed regulations also invited public comment on insurance coverage of specified diseases or illnesses as excepted benefits. While not addressed in this rulemaking, the Departments may address this issue in future regulations or guidance.

On July 20, 2015, the Internal Revenue Service published Notice 2015-43, 2015-29 IRB 73, to provide interim guidance with respect to the treatment of expatriate health plans, expatriate health plan issuers, and employers in their capacity as plan sponsors of expatriate health plans, as defined in the Expatriate Health Coverage Clarification Act of 2014 (EHCCA).13 The interim guidance in Notice 2015-43 generally allows a taxpayer to apply the requirements of the EHCCA using a reasonable good faith interpretation of the EHCCA until further guidance is issued, except as otherwise specifically provided with respect to the health insurance providers fee under section 9010 of the Affordable Care Act. Notice 2015-29 provided interim guidance pertaining to the fee under section 9010 for calendar years 2014 and 2015, and Notice 2016-14 provided guidance pertaining to the fee for calendar year 2016. Additionally, the preamble to the Departments' proposed regulations provides that issuers, employers, administrators, and individuals are permitted to rely on the proposed regulations pending the applicability date of final regulations in the Federal Register.14 Until final regulations are issued and effective, this reliance rule as well as the interim guidance in Notice 2015-43 remain in effect.

13 Division M of the Consolidated and Further Continuing Appropriations Act, 2015, Public Law 113-235.

14 81 FR 38019, 38033 (June 10, 2016).

A. Short-Term, Limited-Duration Insurance

Short-term, limited-duration insurance is a type of health insurance coverage that is designed to fill temporary gaps in coverage when an individual is transitioning from one plan or coverage to another plan or coverage. Although short-term, limited-duration insurance is not an excepted benefit, it is similarly exempt from PHS Act requirements because it is not individual health insurance coverage. Section 2791(b)(5) of the PHS Act provides that the term “individual health insurance coverage” means health insurance coverage offered to individuals in the individual market, but does not include short-term, limited-duration insurance. The PHS Act does not define short-term, limited-duration insurance. Under current regulations, short-term, limited-duration insurance means “health insurance coverage provided pursuant to a contract with an issuer that has an expiration date specified in the contract (taking into account any extensions that may be elected by the policyholder without the issuer's consent) that is less than 12 months after the original effective date of the contract.” 15

15 26 CFR 54.9801-2, 29 CFR 2590.701-2, 45 CFR 144.103.

Before enactment of the Affordable Care Act, short-term, limited-duration insurance was an important means for individuals to obtain health coverage when transitioning from one job to another (and from one group health plan to another) or when faced with other similar situations. However, with guaranteed availability of coverage and special enrollment period requirements in the individual health insurance market under the Affordable Care Act, individuals can purchase coverage with the protections of the Affordable Care Act to fill in the gaps in coverage.

The Departments have become aware that short-term, limited-duration insurance is being sold in situations other than those that the exception from the definition of individual health insurance coverage was initially intended to address.16 In some instances, individuals are purchasing this coverage as their primary form of health coverage and, contrary to the intent of the 12-month coverage limitation in the current definition of short-term, limited-duration insurance, some issuers are providing renewals of the coverage that extend the duration beyond 12 months. Because short-term, limited-duration insurance is exempt from certain consumer protections, the Departments are concerned that these policies may have significant limitations, such as lifetime and annual dollar limits on essential health benefits (EHB) and pre-existing condition exclusions, and therefore may not provide meaningful health coverage. Further, because these policies can be medically underwritten based on health status, healthier individuals may be targeted for this type of coverage, thus adversely impacting the risk pool for Affordable Care Act-compliant coverage.

16See e.g., Mathews, Anna W. “Sales of Short-Term Health Policies Surge,” The Wall Street Journal April 10, 2016, available at http://www.wsj.com/articles/sales-of-short-term-health-policies-surge-1460328539.

To address the issue of short-term, limited-duration insurance being sold as a type of primary coverage, the Departments proposed regulations to revise the definition of short-term, limited-duration insurance so that the coverage must be less than three months in duration, including any period for which the policy may be renewed. The proposed regulations also included a requirement that a notice must be prominently displayed in the contract and in any application materials provided in connection with enrollment in such coverage with the following language: THIS IS NOT QUALIFYING HEALTH COVERAGE (“MINIMUM ESSENTIAL COVERAGE”) THAT SATISFIES THE HEALTH COVERAGE REQUIREMENT OF THE AFFORDABLE CARE ACT. IF YOU DON'T HAVE MINIMUM ESSENTIAL COVERAGE, YOU MAY OWE AN ADDITIONAL PAYMENT WITH YOUR TAXES.

In addition to proposing to reduce the length of short-term, limited-duration insurance to less than three months, the proposed regulations modified the permitted coverage period to take into account extensions made by the policyholder “with or without the issuer's consent.” This modification was intended to address the Departments' concern that some issuers are taking liberty with the current definition of short-term, limited-duration insurance—either by automatically renewing such policies or having a simplified reapplication process with the result being that such coverage, which does not contain the important protections of the Affordable Care Act, lasts longer than 12 months and serves as an individual's primary health coverage.

The Departments received a number of comments relating to the treatment of short-term, limited-duration insurance. Several commenters supported the proposed rules and the reasoning behind them, noting that short-term, limited-duration insurance is not subject to the same consumer protections as major medical coverage and can discriminate based on health status by recruiting healthier consumers to the exclusion of sicker consumers. These commenters suggested the proposed rules would limit the number of consumers relying on short-term, limited-duration insurance as their primary form of coverage and improve the Affordable Care Act's single risk pool.

Some commenters requested that the Departments go further and prohibit issuers from offering short-term, limited-duration insurance to consumers who have previously purchased this type of coverage to prevent consumers from stringing together coverage under policies offered by the same or different issuers. However, in the Departments' view, such a restriction is not warranted. The individual shared responsibility provision of the Code,17 which generally requires individuals to obtain minimum essential coverage in order to avoid an additional payment with their taxes, provides sufficient incentive to discourage consumers from purchasing multiple successive short-term, limited-duration insurance policies. The added notice requirement ensures that individuals purchasing such policies are aware of the individual shared responsibility requirement and its potential implications. Furthermore, such a prohibition would be difficult for State regulators to enforce, since prior coverage of a consumer would have to be tracked.

17See Code section 5000A.

Other commenters expressed general opposition to the proposed rules or requested that short-term, limited-duration insurance be allowed to provide coverage for a longer period. Several commenters stated that some individuals who lose their employer-sponsored coverage may not be able to obtain COBRA continuation coverage 18 and that a job search can often take longer than three months. One commenter suggested alignment of short-term, limited-duration insurance with the employer waiting period rules by permitting a coverage period of up to four months.19 Another commenter asked that issuers be allowed to renew coverage beyond the three-month period in certain situations, such as when an individual experiences a triggering event for a special enrollment period.20 The Departments decline to adopt these suggestions. Short-term, limited-duration insurance allows for coverage to fill temporary coverage gaps when an individual transitions between sources of primary coverage. As explained above, for longer gaps in coverage, guaranteed availability of coverage and special enrollment period requirements in the individual health insurance market under the Affordable Care Act ensure that individuals can purchase individual market coverage through or outside of the Exchange that is minimum essential coverage and includes the consumer protections of the Affordable Care Act. Further, limiting the coverage of short-term, limited-duration insurance to less than three months is consistent with the exemption from the individual shared responsibility provision for gaps in coverage of less than three months (the short coverage gap exemption).21 Under current law, an individual who is not enrolled in minimum essential coverage (whether enrolled in short-term, limited-duration coverage or otherwise) for a period of three months or more generally cannot claim the short coverage gap exemption for any of those months. The final regulations help ensure that individuals who purchase a short-term, limited-duration insurance policy will be eligible for the short coverage gap exemption (assuming other requirements are met) during the temporary coverage period.

18 COBRA continuation coverage means coverage that satisfies an applicable COBRA continuation provision. These provisions are sections 601-608 of ERISA, section 4980B of the Code (other than paragraph (f)(1) of such section 4980B insofar as it relates to pediatric vaccines), or Title XXII of the PHS Act.

19See 26 CFR 54.9815-2708; 29 CFR 2590.715-2708; 45 CFR 147.116.

20See 26 CFR 54.9801-6; 29 CFR 2590.701-6; 45 CFR 146.117 and 147.104.

21 26 CFR 1.5000A-3(j).

After consideration of the comments and feedback received from stakeholders, the Departments are finalizing the proposed regulations without change.

The revised definition of short-term, limited-duration insurance applies for policy years beginning on or after January 1, 2017. The Departments recognize, however, that State regulators may have approved short-term, limited-duration insurance products for sale in 2017 that met the definition in effect prior to January 1, 2017. Accordingly, the Department of Health and Human Services (HHS) will not take enforcement action against an issuer with respect to the issuer's sale of a short-term, limited-duration insurance product before April 1, 2017 on the ground that the coverage period is three months or more, provided that the coverage ends on or before December 31, 2017 and otherwise complies with the definition of short-term, limited-duration insurance in effect under the regulations.22 States may also elect not to take enforcement actions against issuers with respect to such coverage sold before April 1, 2017.

22 This non-enforcement policy is limited to the requirement that short-term, limited-duration insurance must be less than three months. It does not relieve issuers of short-term, limited-duration insurance of the notice requirement, which applies for policy years beginning on or after January 1, 2017.

B. Excepted Benefits

Sections 2722 and 2763 of the PHS Act, section 732 of ERISA, and section 9831 of the Code provide that the respective requirements of title XXVII of the PHS Act, part 7 of ERISA, and Chapter 100 of the Code generally do not apply to the provision of certain types of benefits, known as “excepted benefits.” Excepted benefits are described in section 2791(c) of the PHS Act, section 733(c) of ERISA, and section 9832(c) of the Code.

The parallel statutory provisions establish four categories of excepted benefits. The first category, under section 2791(c)(1) of the PHS Act, section 733(c)(1) of ERISA and section 9832(c)(1) of the Code, includes benefits that are generally not health coverage (such as automobile insurance, liability insurance, workers compensation, and accidental death and dismemberment coverage). The benefits in this category are excepted in all circumstances. In contrast, the benefits in the second, third, and fourth categories are types of health coverage that are excepted only if certain conditions are met.

The second category of excepted benefits is limited excepted benefits, which may include limited scope vision or dental benefits, and benefits for long-term care, nursing home care, home health care, or community-based care. Section 2791(c)(2)(C) of the PHS Act, section 733(c)(2)(C) of ERISA, and section 9832(c)(2)(C) of the Code authorize the Secretaries of HHS, Labor, and the Treasury (collectively, the Secretaries) to issue regulations establishing other, similar limited benefits as excepted benefits. The Secretaries exercised this authority previously with respect to certain health flexible spending arrangements.23 To be excepted under this second category, the benefits must either: (1) Be provided under a separate policy, certificate, or contract of insurance; or (2) otherwise not be an integral part of a group health plan, whether insured or self-insured.24

23 26 CFR 54.9831-1(c)(3)(v), 29 CFR 2590.732(c)(3)(v), 45 CFR 146.145(b)(3)(v).

24 PHS Act section 2722(c)(1), ERISA section 732(c)(1), Code section 9831(c)(1).

The third category of excepted benefits, referred to as “noncoordinated excepted benefits,” includes both coverage for only a specified disease or illness (such as cancer-only policies), and hospital indemnity or other fixed indemnity insurance. These benefits are excepted under section 2722(c)(2) of the PHS Act, section 732(c)(2) of ERISA, and section 9831(c)(2) of the Code only if all of the following conditions are met: (1) The benefits are provided under a separate policy, certificate, or contract of insurance; (2) there is no coordination between the provision of such benefits and any exclusion of benefits under any group health plan maintained by the same plan sponsor; and (3) the benefits are paid with respect to any event without regard to whether benefits are provided under any group health plan maintained by the same plan sponsor.

The fourth category, under section 2791(c)(4) of the PHS Act, section 733(c)(4) of ERISA, and section 9832(c)(4) of the Code, is supplemental excepted benefits. These benefits are excepted only if they are provided under a separate policy, certificate, or contract of insurance and are Medicare supplemental health insurance (also known as Medigap), TRICARE supplemental programs, or “similar supplemental coverage provided to coverage under a group health plan.” The phrase “similar supplemental coverage provided to coverage under a group health plan” is not defined in the statute or regulations. However, the Departments issued regulations clarifying that one requirement to be similar supplemental coverage is that the coverage “must be specifically designed to fill gaps in primary coverage, such as coinsurance or deductibles.” 25

25 26 CFR 54.9831-1(c)(5)(i)(C), 29 CFR 2590.732(c)(5)(i)(C), and 45 CFR 146.145(b)(5)(i)(C).

In 2007 and 2008, the Departments issued guidance on the circumstances under which supplemental health insurance would be considered excepted benefits under section 2791(c)(4) of the PHS Act (and the parallel provisions of ERISA and the Code).26 The guidance identifies several factors the Departments will apply when evaluating whether supplemental health insurance will be considered to be “similar supplemental coverage provided to coverage under a group health plan.” The guidance provides a safe harbor that supplemental health insurance will be considered an excepted benefit if it is provided through a policy, certificate, or contract of insurance separate from the primary coverage under the plan and meets all of the following requirements: (1) The supplemental policy, certificate, or contract of insurance is issued by an entity that does not provide the primary coverage under the plan; (2) the supplemental policy, certificate, or contract of insurance is specifically designed to fill gaps in primary coverage, such as coinsurance or deductibles, but does not become secondary or supplemental only under a coordination of benefits provision; (3) the cost of the supplemental coverage is 15 percent or less of the cost of primary coverage (determined in the same manner as the applicable premium is calculated under a COBRA continuation provision); and (4) the supplemental coverage sold in the group health insurance market does not differentiate among individuals in eligibility, benefits, or premiums based upon any health factor of the individual (or any dependents of the individual).

26See EBSA Field Assistance Bulletin No. 2007-04 (available at http://www.dol.gov/ebsa/regs/fab2007-4.html); CMS Insurance Standards Bulletin 08-01 (available at http://www.cms.gov/CCIIO/Resources/Files/Downloads/hipaa_08_01_508.pdf); and IRS Notice 2008-23 (available at http://www.irs.gov/irb/2008-07_IRB/ar09.html).

On February 13, 2015, the Departments issued Affordable Care Act Implementation FAQs Part XXIII, providing additional guidance on the circumstances under which health insurance coverage that supplements group health plan coverage may be considered supplemental excepted benefits.27 The FAQ states that the Departments intend to propose regulations clarifying the circumstances under which supplemental insurance products that do not fill in cost-sharing gaps under the primary plan are considered to be specifically designed to fill gaps in primary coverage. Specifically, the FAQ provides that health insurance coverage that supplements group health coverage by providing coverage of additional categories of benefits (as opposed to filling in cost-sharing gaps under the primary plan) would be considered to be designed to “fill in the gaps” of the primary coverage only if the benefits covered by the supplemental insurance product are not EHB, as defined under section 1302(b) of the Affordable Care Act, in the State in which the product is being marketed. The FAQ further states that, until regulations are issued and effective, the Departments will not take enforcement action against an issuer of group or individual market coverage that otherwise meets the conditions to be supplemental excepted benefits that does not fill cost-sharing gaps in the group health plan and only provides coverage of additional categories of benefits that are not covered by the group health plan and are not EHB in the applicable State. States were encouraged to exercise similar enforcement discretion.

27 Frequently Asked Questions about Affordable Care Act Implementation (Part XXIII), available at http://www.dol.gov/ebsa/pdf/faq-AffordableCareAct23.pdf and https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/Supplmental-FAQ_2-13-15-final.pdf.

1. Similar Supplemental Coverage

The proposed regulations incorporated guidance from the Affordable Care Act Implementation FAQs Part XXIII addressing supplemental health insurance products that provide categories of benefits in addition to those in the primary coverage. Under the proposed regulations, if group or individual supplemental health insurance covers items and services not included in the primary coverage (referred to as providing “additional categories of benefits”), the coverage will be considered to be designed “to fill gaps in primary coverage,” for purposes of being supplemental excepted benefits if none of the benefits provided by the supplemental policy are an EHB, as defined under section 1302(b) of the Affordable Care Act, in the State in which the coverage is issued.28 Thus, if any benefit provided by the supplemental policy is either included in the primary coverage or is an EHB in the State where the coverage is issued, the insurance coverage would not be supplemental excepted benefits under the proposed regulations. Furthermore, supplemental health insurance products that both fill in cost sharing in the primary coverage, such as coinsurance or deductibles, and cover additional categories of benefits that are not EHB, would be considered supplemental excepted benefits under the proposed regulations provided all other criteria are met.

28 For this purpose, a supplemental plan would determine what benefits are EHB based on the EHB-benchmark plan applicable in the State, along with any additional benefits that are considered EHB consistent with 45 CFR 155.170(a)(2).

The Departments received several comments in support of the proposed regulations. One commenter expressed support but requested that the Departments provide additional examples in the regulations. Another commenter requested clarification regarding the application of the standards for similar supplemental coverage that provides benefits outside of the United States, noting that no State's EHB rules require coverage for services outside of the United States. If any benefit provided by the supplemental policy is a type of service that is an EHB in the State where the coverage is issued, the coverage would not be supplemental excepted benefits under the final regulations, even if the supplemental coverage was limited to covering the benefit in a location or setting where it would not be covered as an EHB.

After consideration of the comments, the Departments are finalizing the proposed regulations on similar supplemental coverage without substantive change. For purposes of consistency and clarity, HHS is also including a cross reference in the individual market excepted benefits regulations at 45 CFR 148.220 to reflect the standard for similar supplemental coverage under the group market regulations at 45 CFR 146.145(b)(5)(i)(C). The Departments may provide additional guidance on similar supplemental coverage that meets the criteria to be excepted benefits in the future.

2. Travel Insurance

The Departments are aware that certain travel insurance products may include limited health benefits. However, these products typically are not designed as major medical coverage. Instead, the risks being insured relate primarily to: (1) The interruption or cancellation of a trip; (2) the loss of baggage or personal effects; (3) damages to accommodations or rental vehicles; or (4) sickness, accident, disability, or death occurring during travel, with any health benefits usually incidental to other coverage.

Section 2791(c)(1)(H) of the PHS Act, section 733(c)(1)(H) of ERISA, and section 9832(c)(1)(H) of the Code provide that the Departments may, in regulations, designate as excepted benefits “benefits for medical care [that] are secondary or incidental to other insurance benefits.” Pursuant to this authority, and to clarify which types of travel-related insurance products are excepted benefits under the PHS Act, ERISA, and the Code, the Departments' proposed regulations identified travel insurance as an excepted benefit under the first category of excepted benefits and proposed a definition of travel insurance consistent with the definition of travel insurance under final regulations issued by the Treasury Department and the IRS for the health insurance providers fee imposed by section 9010 of the Affordable Care Act,29 which uses a modified version of the National Association of Insurance Commissioners definition of travel insurance.

29 26 CFR 57.2(h)(4).

The proposed regulations defined the term “travel insurance” as insurance coverage for personal risks incident to planned travel, which may include, but are not limited to, interruption or cancellation of a trip or event, loss of baggage or personal effects, damages to accommodations or rental vehicles, and sickness, accident, disability, or death occurring during travel, provided that the health benefits are not offered on a stand-alone basis and are incidental to other coverage. For this purpose, travel insurance does not include major medical plans that provide comprehensive medical protection for travelers with trips lasting six months or longer, including, for example, those working overseas as an expatriate or military personnel being deployed.

The Departments received a number of comments in favor of the treatment of travel insurance as an excepted benefit, as well as the proposed definition of travel insurance. Several comments expressed support for the proposed definition's consistency with regulations governing the health insurance providers fee. One commenter requested clarification that the requirement that health benefits are incidental to other coverage be determined based solely on coverage under the travel insurance policy, without regard to other coverage provided by an employer or plan sponsor; the Departments agree that this is correct. The Departments are finalizing without change the proposed regulations defining travel insurance and treating such coverage as an excepted benefit.

C. Definition of EHB for Purposes of the Prohibition on Lifetime and Annual Limits

Section 2711 of the PHS Act, as added by the Affordable Care Act, generally prohibits group health plans and health insurance issuers offering group or individual health insurance coverage from imposing lifetime and annual dollar limits on EHB, as defined under section 1302(b) of the Affordable Care Act. These prohibitions apply to both grandfathered and non-grandfathered health plans, except the annual limits prohibition does not apply to grandfathered individual health insurance coverage.

Under the Affordable Care Act, self-insured group health plans, large group market health plans, and grandfathered health plans are not required to offer EHB, but they generally cannot place lifetime or annual dollar limits on services they cover that are considered EHB. On November 18, 2015, the Departments issued final regulations implementing section 2711 of the PHS Act.30 The final regulations provide that, for plan years (in the individual market, policy years) beginning on or after January 1, 2017, a plan or issuer that is not required to provide EHB must define EHB, for purposes of the prohibition on lifetime and annual dollar limits, in a manner consistent with any of the 51 EHB base-benchmark plans applicable in a State or the District of Columbia, or one of the three Federal Employees Health Benefits Program (FEHBP) EHB base-benchmark plans, as specified under 45 CFR 156.100.31

30 80 FR 72192.

31 26 CFR 54.9815-2711(c), 29 CFR 2590.715-2711(c), 45 CFR 147.126(c).

The final regulations under section 2711 of the PHS Act include a reference to selecting a “base-benchmark” plan, as specified under 45 CFR 156.100, for purposes of determining which benefits cannot be subject to lifetime or annual dollar limits. The base-benchmark plan selected by a State or applied by default under 45 CFR 156.100, however, may not reflect the complete definition of EHB in the applicable State. For that reason, the Departments are amending the regulations at 26 CFR 54.9815-2711(c), 29 CFR 2590.715-2711(c), and 45 CFR 147.126(c) to refer to the provisions that capture the complete definition of EHB in a State.

Specifically, in these final regulations, the Departments replace the phrase “in a manner consistent with one of the three Federal Employees Health Benefit Program (FEHBP) options as defined by 45 CFR 156.100(a)(3) or one of the base-benchmark plans selected by a State or applied by default pursuant to 45 CFR 156.100” in each of the regulations with the following: “in a manner that is consistent with (1) one of the EHB-benchmark plans applicable in a State under 45 CFR 156.110, and includes coverage of any additional required benefits that are considered EHB consistent with 45 CFR 155.170(a)(2); or (2) one of the three Federal Employees Health Benefit Program (FEHBP) plan options as defined by 45 CFR 156.100(a)(3), supplemented, as necessary, to meet the standards in 45 CFR 156.110.” This change reflects the possibility that base-benchmark plans, including the FEHBP plan options, could require supplementation under 45 CFR 156.110, and ensures the inclusion of State-required benefit mandates enacted on or before December 31, 2011 in accordance with 45 CFR 155.170, which when coupled with a State's EHB-benchmark plan, establish the definition of EHB in that State under regulations implementing section 1302(b) of the Affordable Care Act.32

32 In the HHS Notice of Benefit and Payment Parameters for 2016 published February 27, 2015 (80 FR 10750), HHS instructed States to select a new base-benchmark plan to take effect beginning with plan or policy years beginning in 2017. The new final EHB base-benchmark plans selected as a result of this process are publicly available at downloads.cms.gov/cciio/Final%20List%20of%20BMPs_15_10_21.pdf. Additional information about the new base-benchmark plans, including plan documents and summaries of benefits, is available at www.cms.gov/CCIIO/Resources/Data-Resources/ehb.html. The definition of EHB in each of the 50 states and the District of Columbia is based on the base-benchmark plan, and takes into account any additions to the base-benchmark plan, such as supplementation under 45 CFR 156.110, and State-required benefit mandates in accordance with 45 CFR 155.170.

Some commenters requested clarification that self-insured group health plans, large group market health plans and grandfathered plans are not required to include as covered benefits any specific items and services covered by the State-EHB benchmark plan, including any additional State-required benefits considered EHB under 45 CFR 155.170(a)(2). The requirement in section 2707(a) of the PHS Act to provide the EHB package required under section 1302(a) of the Affordable Care Act applies only to non-grandfathered health insurance coverage in the individual and small group markets. Self-insured group health plans, large group market health plans and grandfathered health plans are not required to include coverage of EHB, but cannot place lifetime or annual dollar limits on any EHB covered by these plans.33 These plans are permitted to impose limits other than dollar limits on EHB, as long as they comply with other applicable statutory provisions. In addition, these plans can continue to impose annual and lifetime dollar limits on benefits that do not fall within the definition of EHB.

33 The annual limits prohibition does not apply to grandfathered individual market coverage.

One commenter urged the Departments to eliminate the option for large group market health plans to define EHB based on one of the three largest nationally available FEHBP benchmark plan options to ensure consistency with the definition of EHB in the individual and small group markets. However, these FEHBP plan options 34 are unique among benchmark plans in that they are available nationally, and thus can more appropriately be utilized to determine what benefits would be categorized as EHB for those employers that provide health coverage to employees throughout the United States and are not situated only in a single State. The Departments are finalizing the proposed clarification to the lifetime and annual limit regulations without change.

34 The three largest nationally available FEHBP plan options are available at https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Top3ListFinal-5-19-2015.pdf.

D. Applicability Date

These final regulations are applicable for plan years (or, in the individual market, policy years) beginning on or after January 1, 2017. The HHS final regulations specify the applicability dates in the group market regulations at 45 CFR 146.125 and in the individual market regulations at 45 CFR 148.102.

III. Economic Impact and Paperwork Burden A. Summary—Department of Labor and Department of Health and Human Services

These final regulations specify the conditions for similar supplemental coverage products that are designed to fill gaps in primary coverage by providing coverage of additional categories of benefits (as opposed to filling in gaps in cost sharing) to constitute supplemental excepted benefits, and clarify that certain travel-related insurance products that provide only incidental health benefits constitute excepted benefits.

These final regulations also revise the definition of short-term, limited-duration insurance so that the coverage (including renewals) has to be less than three months in total duration (as opposed to the current definition of less than 12 months in duration), and provide that a notice must be prominently displayed in the contract and in any application materials provided in connection with enrollment in the coverage indicating that such coverage is not minimum essential coverage.

Finally, the regulations amend the definition of “essential health benefits” for purposes of the prohibition on lifetime and annual dollar limits with respect to group health plans and health insurance issuers that are not required to provide essential health benefits, including self-insured group health plans, large group market health plans, and grandfathered health plans.

The Departments are publishing these final regulations to implement the protections intended by the Congress in the most economically efficient manner possible. The Departments have examined the effects of this rule as required by Executive Order 13563 (76 FR 3821, January 21, 2011), Executive Order 12866 (58 FR 51735, September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (September 19, 1980, Pub. L. 96-354), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on Federalism, and the Congressional Review Act (5 U.S.C. 804(2)).

B. Executive Orders 12866 and 13563—Department of Labor and Department of Health and Human Services

Executive Order 12866 (58 FR 51735) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects; distributive impacts; and equity). Executive Order 13563 (76 FR 3821, January 21, 2011) is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866.

Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a final rule—(1) having an annual effect on the economy of $100 million or more in any one year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

A regulatory impact analysis must be prepared for rules with economically significant effects (for example, $100 million or more in any 1 year), and a “significant” regulatory action is subject to review by the Office of Management and Budget. The Departments have determined that this regulatory action is not likely to have economic impacts of $100 million or more in any one year, and is not significant within the meaning of Executive Order 12866. However, the Departments are nonetheless providing a discussion of the benefits and costs that might stem from these final regulations in the Summary of Impacts section below.

1. Need for Regulatory Action

These final regulations clarify the conditions for similar supplemental coverage and travel insurance to be recognized as excepted benefits. These clarifications are necessary to provide health insurance issuers offering supplemental coverage and travel insurance products with a clearer understanding of the Federal standards that apply to these types of coverage. These final regulations also amend the definition of short-term, limited-duration insurance for purposes of the exclusion from the definition of individual health insurance coverage and impose a new notice requirement in response to reports that short-term, limited-duration insurance coverage is being sold to individuals as primary coverage.

2. Summary of Impacts

The final regulations outline the conditions for travel insurance and similar supplemental health insurance coverage to be considered excepted benefits, and revise the definition of short-term, limited-duration insurance.

The Departments received comments suggesting that the majority of travel insurance policies are issued for trips of short duration, with the average policy length being approximately three months, and these policies generally provide limited medical coverage and property and casualty coverage to protect against risks related to travel. The Departments believe that the designation of certain travel insurance products (as defined by the regulations) as excepted benefits is consistent with prevailing industry practices, and therefore, will not result in significant cost to issuers of these products or consumers who purchase them.

Short-term, limited-duration policies represent a very small fraction of the health insurance market, though their use is increasing. In 2015, total premiums earned for short-term, limited-duration insurance was approximately $160 million for approximately 1,517,000 member months and with approximately 148,000 covered lives at the end of the year,35 while in 2013, total premiums were approximately $98 million for 1,031,000 member months with approximately 80,400 covered lives at the end of the year.36

35 National Association of Insurance Commissioners, 2015 Accident and Health Policy Experience Report, 2016, available at http://naic.org/prod_serv/AHP-LR-16.pdf.

36 National Association of Insurance Commissioners, 2013 Accident and Health Policy Experience Report, 2014, available at http://naic.org/prod_serv/AHP-LR-14.pdf.

The Departments received comments indicating that a large majority of the short-term, limited-duration insurance plans are sold as transitional coverage, particularly for individuals seeking to cover periods of unemployment or gaps between employer-sponsored coverage, and typically provide coverage for less than three months. Therefore, the Departments believe that the final regulations will have no effect on the majority of consumers who purchase such coverage and issuers of those policies. The small fraction of consumers who purchase such policies for longer periods and who may have to transition to individual market coverage will benefit from the protections afforded by the Affordable Care Act, such as no preexisting condition exclusions, essential health benefits without annual or lifetime dollar limits, and guaranteed renewability. While some of these consumers may experience an increase in costs due to higher premiums compared with short-term, limited-duration coverage, they will also avoid potential tax liability by having minimum essential coverage. Some consumers may also be eligible for premium tax credits and cost-sharing reductions for coverage offered through the Exchanges. Finally, inclusion of these individuals, often relatively healthier individuals, in the individual market will help strengthen the individual market's single risk pool. The notice requirement will help ensure that consumers do not inadvertently purchase these products expecting them to be minimum essential coverage. Further, the Departments believe that any costs incurred by issuers of short-term, limited-duration insurance to include the required notice in application or enrollment materials will be negligible since the Departments have provided the exact text for the notice.

As a result, the Departments have concluded that the impacts of these final regulations are not economically significant.

C. Paperwork Reduction Act—Department of Health and Human Services

The final regulations provide that to be considered short-term, limited-duration insurance for policy years beginning on or after January 1, 2017, a notice must be prominently displayed in the contract and in any application materials, stating that the coverage is not minimum essential coverage and that failure to have minimum essential coverage may result in an additional tax payment. The Departments have provided the exact text for these notice requirements and the language will not need to be customized. The burden associated with these notices is not subject to the Paperwork Reduction Act of 1995 in accordance with 5 CFR 1320.3(c)(2) because they do not contain a “collection of information” as defined in 44 U.S.C. 3502(3).

D. Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) imposes certain requirements with respect to Federal rules that are subject to the notice and comment requirements of section 553(b) of the Administrative Procedure Act (5 U.S.C. 551 et seq.) and that are likely to have a significant economic impact on a substantial number of small entities. Unless an agency certifies that a proposed rule is not likely to have a significant economic impact on a substantial number of small entities, section 603 of RFA requires that the agency present an initial regulatory flexibility analysis at the time of the publication of the notice of proposed rulemaking describing the impact of the rule on small entities and seeking public comment on such impact. Small entities include small businesses, organizations and governmental jurisdictions.

The RFA generally defines a “small entity” as (1) a proprietary firm meeting the size standards of the Small Business Administration (13 CFR 121.201); (2) a nonprofit organization that is not dominant in its field; or (3) a small government jurisdiction with a population of less than 50,000. (States and individuals are not included in the definition of “small entity.”) The Departments use as their measure of significant economic impact on a substantial number of small entities a change in revenues of more than 3 to 5 percent.

The Departments expect the impact of these final regulations to be limited because the provisions are generally consistent with current industry practices and impact only a small fraction of the health insurance market. Therefore, the Departments certify that the final regulations will not have a significant impact on a substantial number of small entities. In addition, section 1102(b) of the Social Security Act requires agencies to prepare a regulatory impact analysis if a rule may have a significant economic impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. These final regulations will not affect small rural hospitals. Therefore, the Departments have determined that these final regulations will not have a significant impact on the operations of a substantial number of small rural hospitals.

E. Special Analysis—Department of the Treasury

Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. For applicability of RFA, see paragraph D of this section III.

Pursuant to section 7805(f) of the Code, these regulations have been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business.

F. Unfunded Mandates Reform Act

For purposes of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.), as well as Executive Order 12875, these final regulations do not include any Federal mandate that may result in expenditures by State, local, or tribal governments, or the private sector, which may impose an annual burden of $146 million adjusted for inflation since 1995.

G. Federalism—Department of Labor and Department of Health and Human Services

Executive Order 13132 outlines fundamental principles of federalism. It requires adherence to specific criteria by Federal agencies in formulating and implementing policies that have “substantial direct effects” on the States, the relationship between the national government and States, or on the distribution of power and responsibilities among the various levels of government. Federal agencies promulgating regulations that have these federalism implications must consult with State and local officials, and describe the extent of their consultation and the nature of the concerns of State and local officials in the preamble to the final regulation.

In the Departments' view, these final regulations have federalism implications because they would have direct effects on the States, the relationship between the national government and the States, or on the distribution of power and responsibilities among various levels of government. Under these final regulations, health insurance issuers offering short-term, limited-duration insurance, travel insurance and similar supplemental coverage will be required to follow the minimum Federal standards to not be subject to the market reform provisions under the PHS Act, ERISA and the Code. However, in the Departments' view, the federalism implications of these final regulations are substantially mitigated because, with respect to health insurance issuers, the Departments expect that the majority of States will enact laws or take other appropriate action resulting in their meeting or exceeding the Federal standards.

In general, through section 514, ERISA supersedes State laws to the extent that they relate to any covered employee benefit plan, and preserves State laws that regulate insurance, banking, or securities. While ERISA prohibits States from regulating an employee benefit plan as an insurance or investment company or bank, the preemption provisions of section 731 of ERISA and section 2724 of the PHS Act (implemented in 29 CFR 2590.731(a) and 45 CFR 146.143(a) and 148.210(b)) apply so that the requirements in title XXVII of the PHS Act (including those added by the Affordable Care Act) are not to be construed to supersede any provision of State law which establishes, implements, or continues in effect any standard or requirement solely relating to health insurance issuers in connection with individual or group health insurance coverage except to the extent that such standard or requirement prevents the application of a Federal requirement. The conference report accompanying HIPAA indicates that this is intended to be the “narrowest” preemption of State laws (See House Conf. Rep. No. 104-736, at 205, reprinted in 1996 U.S. Code Cong. & Admin. News 2018).

States may continue to apply State law requirements except to the extent that such requirements prevent the application of the market reform requirements that are the subject of this rulemaking. Accordingly, States have significant latitude to impose requirements on health insurance issuers that are more restrictive than the Federal law.

In compliance with the requirement of Executive Order 13132 that agencies examine closely any policies that may have federalism implications or limit the policy making discretion of the States, the Departments have engaged in efforts to consult with and work cooperatively with affected States, including consulting with, and attending conferences of, the National Association of Insurance Commissioners and consulting with State insurance officials on an individual basis. It is expected that the Departments will act in a similar fashion in enforcing the market reform provisions of the Affordable Care Act.

Throughout the process of developing these final regulations, to the extent feasible within the applicable preemption provisions, the Departments have attempted to balance the States' interests in regulating health insurance issuers, and Congress' intent to provide uniform minimum protections to consumers in every State. By doing so, it is the Departments' view that they have complied with the requirements of Executive Order 13132.

Pursuant to the requirements set forth in section 8(a) of Executive Order 13132, and by the signatures affixed to this final rule, the Departments certify that the Employee Benefits Security Administration and the Centers for Medicare & Medicaid Services have complied with the requirements of Executive Order 13132 for the attached final rules in a meaningful and timely manner.

H. Congressional Review Act

These final regulations are subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.) and will be transmitted to the Congress and to the Comptroller General for review in accordance with such provisions.

I. Statement of Availability of IRS Documents

IRS Revenue Procedures, Revenue Rulings notices, and other guidance cited in this document are published in the Internal Revenue Bulletin (or Cumulative Bulletin) and are available from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, or by visiting the IRS Web site at http://www.irs.gov.

IV. Statutory Authority

The Department of the Treasury regulations are adopted pursuant to the authority contained in sections 7805 and 9833 of the Code.

The Department of Labor regulations are adopted pursuant to the authority contained in 29 U.S.C. 1135 and 1191c; and Secretary of Labor's Order 1-2011, 77 FR 1088 (Jan. 9, 2012).

The Department of Health and Human Services regulations are adopted pursuant to the authority contained in sections 2701 through 2763, 2791, and 2792 of the PHS Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92), as amended.

List of Subjects 26 CFR Part 54

Pension and excise taxes.

29 CFR Part 2590

Continuation coverage, Disclosure, Employee benefit plans, Group health plans, Health care, Health insurance, Medical child support, Reporting and recordkeeping requirements.

45 CFR Parts 144, 146 and 147

Health care, Health insurance, Reporting and recordkeeping requirements.

45 CFR Part 148

Administrative practice and procedure, Health care, Health insurance, Penalties, Reporting and recordkeeping requirements.

John Dalrymple, Deputy Commissioner for Services and Enforcement, Internal Revenue Service. Approved: October 25, 2016. Mark J. Mazur, Assistant Secretary of the Treasury (Tax Policy). Signed this 25th day of October 2016. Phyllis C. Borzi, Assistant Secretary, Employee Benefits Security Administration, Department of Labor. Dated: October 24, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. Dated: October 25, 2016. Sylvia M. Burwell, Secretary, Department of Health and Human Services. DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Chapter I

Accordingly, 26 CFR part 54 is amended as follows:

PART 54—PENSION AND EXCISE TAXES Par. 1. The authority citation for part 54 continues to read in part as follows: Authority:

26 U.S.C. 7805 * * *

Par. 2. Section 54.9801-2 is amended by revising the definition of “short-term, limited-duration insurance”, and adding a definition of “travel insurance” in alphabetical order. The revision and addition read as follows:
§ 54.9801-2 Definitions.

Short-term, limited-duration insurance means health insurance coverage provided pursuant to a contract with an issuer that:

(1) Has an expiration date specified in the contract (taking into account any extensions that may be elected by the policyholder with or without the issuer's consent) that is less than 3 months after the original effective date of the contract; and

(2) Displays prominently in the contract and in any application materials provided in connection with enrollment in such coverage in at least 14 point type the following: “THIS IS NOT QUALIFYING HEALTH COVERAGE (“MINIMUM ESSENTIAL COVERAGE”) THAT SATISFIES THE HEALTH COVERAGE REQUIREMENT OF THE AFFORDABLE CARE ACT. IF YOU DON'T HAVE MINIMUM ESSENTIAL COVERAGE, YOU MAY OWE AN ADDITIONAL PAYMENT WITH YOUR TAXES.”

Travel insurance means insurance coverage for personal risks incident to planned travel, which may include, but is not limited to, interruption or cancellation of trip or event, loss of baggage or personal effects, damages to accommodations or rental vehicles, and sickness, accident, disability, or death occurring during travel, provided that the health benefits are not offered on a stand-alone basis and are incidental to other coverage. For this purpose, the term travel insurance does not include major medical plans that provide comprehensive medical protection for travelers with trips lasting 6 months or longer, including, for example, those working overseas as an expatriate or military personnel being deployed.

Par. 3. Section 54.9815-2711 is amended by revising paragraph (c) to read as follows:
§ 54.9815-2711 No lifetime or annual limits.

(c) Definition of essential health benefits. The term “essential health benefits” means essential health benefits under section 1302(b) of the Patient Protection and Affordable Care Act and applicable regulations. For this purpose, a group health plan or a health insurance issuer that is not required to provide essential health benefits under section 1302(b) must define “essential health benefits” in a manner that is consistent with—

(1) One of the EHB-benchmark plans applicable in a State under 45 CFR 156.110, and includes coverage of any additional required benefits that are considered essential health benefits consistent with 45 CFR 155.170(a)(2); or

(2) One of the three Federal Employees Health Benefits Program (FEHBP) plan options as defined by 45 CFR 156.100(a)(3), supplemented, as necessary, to meet the standards in 45 CFR 156.110.

Par. 4. Section 54.9831-1 is amended: a. In paragraph (b)(1) by removing the reference “54.9812-1T” and adding in its place the reference “54.9812-1, 54.9815-1251 through 54.9815-2719A,” and in paragraph (c)(1) by removing the reference “54.9811-1T, 54.9812-1T” and adding in its place the phrase “54.9811-1, 54.9812-1, 54.9815-1251 through 54.9815-2719A”; b. In paragraph (c)(2)(vii) by removing “and” at the end; c. In paragraph (c)(2)(viii) by removing the period and adding “; and” at the end; d. Adding paragraph (c)(2)(ix); and e. Revising paragraph (c)(5)(i)(C).

The revisions and additions are as follows:

§ 54.9831-1 Special rules relating to group health plans.

(c) * * *

(2) * * *

(ix) Travel insurance, within the meaning of § 54.9801-2.

(5) * * *

(i) * * *

(C) Similar supplemental coverage provided to coverage under a group health plan. To be similar supplemental coverage, the coverage must be specifically designed to fill gaps in the primary coverage. The preceding sentence is satisfied if the coverage is designed to fill gaps in cost sharing in the primary coverage, such as coinsurance or deductibles, or the coverage is designed to provide benefits for items and services not covered by the primary coverage and that are not essential health benefits (as defined under section 1302(b) of the Patient Protection and Affordable Care Act) in the State where the coverage is issued, or the coverage is designed to both fill such gaps in cost sharing under, and cover such benefits not covered by, the primary coverage. Similar supplemental coverage does not include coverage that becomes secondary or supplemental only under a coordination-of-benefits provision.

Par. 5. Section 54.9833-1 is amended by adding a sentence at the end to read as follows:
§ 54.9833-1 Effective dates.

* * * Notwithstanding the previous sentence, the definition of “short-term, limited-duration insurance” in § 54.9801-2 and paragraph (c)(5)(i)(C) of § 54.9831-1 apply for plan years beginning on or after January 1, 2017.

DEPARTMENT OF LABOR Employee Benefits Security Administration 29 CFR Chapter XXV

For the reasons stated in the preamble, the Department of Labor amends 29 CFR part 2590 as set forth below:

PART 2590—RULES AND REGULATIONS FOR GROUP HEALTH PLANS 6. The authority citation for part 2590 is revised to read as follows: Authority:

29 U.S.C. 1027, 1059, 1135, 1161-1168, 1169, 1181-1183, 1181 note, 1185, 1185a, 1185b, 1191, 1191a, 1191b, and 1191c; sec. 101(g), Pub. L. 104-191, 110 Stat. 1936; sec. 401(b), Pub. L. 105-200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. 110-343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), Pub. L. 111-148, 124 Stat. 119, as amended by Pub. L. 111-152, 124 Stat. 1029; Division M, Pub. L. 113-235, 128 Stat. 2130; Secretary of Labor's Order 1-2011, 77 FR 1088 (Jan. 9, 2012).

7. Section 2590.701-2 is amended by revising the definition of “short-term, limited-duration insurance”, and adding a definition of “travel insurance” in alphabetical order. The addition and revision read as follows:
§ 2590.701-2 Definitions.

Short-term, limited-duration insurance means health insurance coverage provided pursuant to a contract with an issuer that:

(1) Has an expiration date specified in the contract (taking into account any extensions that may be elected by the policyholder with or without the issuer's consent) that is less than 3 months after the original effective date of the contract; and

(2) Displays prominently in the contract and in any application materials provided in connection with enrollment in such coverage in at least 14 point type the following: “THIS IS NOT QUALIFYING HEALTH COVERAGE (“MINIMUM ESSENTIAL COVERAGE”) THAT SATISFIES THE HEALTH COVERAGE REQUIREMENT OF THE AFFORDABLE CARE ACT. IF YOU DON'T HAVE MINIMUM ESSENTIAL COVERAGE, YOU MAY OWE AN ADDITIONAL PAYMENT WITH YOUR TAXES.”

Travel insurance means insurance coverage for personal risks incident to planned travel, which may include, but is not limited to, interruption or cancellation of trip or event, loss of baggage or personal effects, damages to accommodations or rental vehicles, and sickness, accident, disability, or death occurring during travel, provided that the health benefits are not offered on a stand-alone basis and are incidental to other coverage. For this purpose, the term travel insurance does not include major medical plans that provide comprehensive medical protection for travelers with trips lasting 6 months or longer, including, for example, those working overseas as an expatriate or military personnel being deployed.

8. Section 2590.715-2711 is amended by revising paragraph (c) to read as follows:
§ 2590.715-2711 No lifetime or annual limits.

(c) Definition of essential health benefits. The term “essential health benefits” means essential health benefits under section 1302(b) of the Patient Protection and Affordable Care Act and applicable regulations. For this purpose, a group health plan or a health insurance issuer that is not required to provide essential health benefits under section 1302(b) must define “essential health benefits” in a manner that is consistent with—

(1) One of the EHB-benchmark plans applicable in a State under 45 CFR 156.110, and includes coverage of any additional required benefits that are considered essential health benefits consistent with 45 CFR 155.170(a)(2); or

(2) One of the three Federal Employees Health Benefits Program (FEHBP) plan options as defined by 45 CFR 156.100(a)(3), supplemented, as necessary, to meet the standards in 45 CFR 156.110.

9. Section 2590.732 is amended by adding paragraph (c)(2)(ix) and revising paragraph (c)(5)(i)(C) to read as follows:
§ 2590.732 Special rules relating to group health plans.

(c) * * *

(2) * * *

(ix) Travel insurance, within the meaning of § 2590.701-2.

(5) * * *

(i) * * *

(C) Similar supplemental coverage provided to coverage under a group health plan. To be similar supplemental coverage, the coverage must be specifically designed to fill gaps in the primary coverage. The preceding sentence is satisfied if the coverage is designed to fill gaps in cost sharing in the primary coverage, such as coinsurance or deductibles, or the coverage is designed to provide benefits for items and services not covered by the primary coverage and that are not essential health benefits (as defined under section 1302(b) of the Patient Protection and Affordable Care Act) in the State where the coverage is issued, or the coverage is designed to both fill such gaps in cost sharing under, and cover such benefits not covered by, the primary coverage. Similar supplemental coverage does not include coverage that becomes secondary or supplemental only under a coordination-of-benefits provision.

10. Section 2590.736 is amended by adding a sentence at the end to read as follows:
§ 2590.736 Applicability dates.

* * * Notwithstanding the previous sentence, the definition of “short-term, limited-duration insurance” in § 2590.701-2 and paragraph (c)(5)(i)(C) of § 2590.732 apply for plan years beginning on or after January 1, 2017.

DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Chapter 1

For the reasons stated in the preamble, the Department of Health and Human Services amends 45 CFR parts 144, 146, 147, and 148 as set forth below:

PART 144—REQUIREMENTS RELATING TO HEALTH INSURANCE COVERAGE 11. The authority citation for part 144 continues to read as follows: Authority:

Secs. 2701 through 2763, 2791, and 2792 of the Public Health Service Act, 42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92.

12. Section 144.103 is amended by revising the definition of “short-term, limited-duration insurance” and adding a definition of “travel insurance” in alphabetical order. The revision and addition read as follows:
§ 144.103 Definitions.

Short-term, limited-duration insurance means health insurance coverage provided pursuant to a contract with an issuer that:

(1) Has an expiration date specified in the contract (taking into account any extensions that may be elected by the policyholder with or without the issuer's consent) that is less than 3 months after the original effective date of the contract; and

(2) Displays prominently in the contract and in any application materials provided in connection with enrollment in such coverage in at least 14 point type the following: “THIS IS NOT QUALIFYING HEALTH COVERAGE (“MINIMUM ESSENTIAL COVERAGE”) THAT SATISFIES THE HEALTH COVERAGE REQUIREMENT OF THE AFFORDABLE CARE ACT. IF YOU DON'T HAVE MINIMUM ESSENTIAL COVERAGE, YOU MAY OWE AN ADDITIONAL PAYMENT WITH YOUR TAXES.”

Travel insurance means insurance coverage for personal risks incident to planned travel, which may include, but is not limited to, interruption or cancellation of trip or event, loss of baggage or personal effects, damages to accommodations or rental vehicles, and sickness, accident, disability, or death occurring during travel, provided that the health benefits are not offered on a stand-alone basis and are incidental to other coverage. For this purpose, the term travel insurance does not include major medical plans that provide comprehensive medical protection for travelers with trips lasting 6 months or longer, including, for example, those working overseas as an expatriate or military personnel being deployed.

PART 146—REQUIREMENTS FOR THE GROUP HEALTH INSURANCE MARKET 13. The authority citation for part 146 continues to read as follows: Authority:

Secs. 2702 through 2705, 2711 through 2723, 2791, and 2792 of the Public Health Service Act (42 U.S.C. 300gg-1 through 300gg-5, 300gg-11 through 300gg-23, 300gg-91, and 300gg-92.

14. Section 146.125 is amended by adding a sentence at the end to read as follows:
§ 146.125 Applicability dates.

* * * Notwithstanding the previous sentence, the definition of “short-term, limited-duration insurance” in § 144.103 of this subchapter and paragraph (c)(5)(i)(C) of § 146.145 apply for policy years and plan years beginning on or after January 1, 2017.

15. Section 146.145 is amended by adding paragraph (b)(2)(ix) and revising paragraph (b)(5)(i)(C) to read as follows:
§ 146.145 Special rules relating to group health plans.

(b) * * *

(2) * * *

(ix) Travel insurance, within the meaning of § 144.103 of this subchapter.

(5) * * *

(i) * * *

(C) Similar supplemental coverage provided to coverage under a group health plan. To be similar supplemental coverage, the coverage must be specifically designed to fill gaps in the primary coverage. The preceding sentence is satisfied if the coverage is designed to fill gaps in cost sharing in the primary coverage, such as coinsurance or deductibles, or the coverage is designed to provide benefits for items and services not covered by the primary coverage and that are not essential health benefits (as defined under section 1302(b) of the Patient Protection and Affordable Care Act) in the State where the coverage is issued, or the coverage is designed to both fill such gaps in cost sharing under, and cover such benefits not covered by, the primary coverage. Similar supplemental coverage does not include coverage that becomes secondary or supplemental only under a coordination-of-benefits provision.

PART 147—HEALTH INSURANCE REFORM REQUIREMENTS FOR THE GROUP AND INDIVIDUAL HEALTH INSURANCE MARKETS 16. The authority citation for part 147 continues to read as follows: Authority:

Secs. 2701 through 2763, 2791, and 2792 of the Public Health Service Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92), as amended.

17. Section 147.126 is amended by revising paragraph (c) to read as follows:
§ 147.126 No lifetime or annual limits.

(c) Definition of essential health benefits. The term “essential health benefits” means essential health benefits under section 1302(b) of the Patient Protection and Affordable Care Act and applicable regulations. For this purpose, a group health plan or a health insurance issuer that is not required to provide essential health benefits under section 1302(b) must define “essential health benefits” in a manner that is consistent with—

(1) One of the EHB-benchmark plans applicable in a State under 45 CFR 156.110, and includes coverage of any additional required benefits that are considered essential health benefits consistent with 45 CFR 155.170(a)(2); or

(2) One of the three Federal Employees Health Benefits Program (FEHBP) plan options as defined by 45 CFR 156.100(a)(3), supplemented, as necessary, to meet the standards in 45 CFR 156.110.

PART 148—REQUIREMENTS FOR THE INDIVIDUAL HEALTH INSURANCE MARKET 18. The authority citation for part 148 continues to read as follows: Authority:

Secs. 2701 through 2763, 2791, and 2792 of the Public Health Service Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92), as amended.

19. Section 148.102 is amended by adding a sentence at the end of paragraph (b) to read as follows:
§ 148.102 Scope, applicability, and effective dates.

(b) * * * Notwithstanding the previous sentence, the definition of “short-term, limited-duration insurance” in § 144.103 of this subchapter and paragraph (b)(7) of § 148.220 apply for policy years beginning on or after January 1, 2017.

20. Section 148.220 is amended by adding paragraph (a)(9) and revising paragraph (b)(7) to read as follows:
§ 148.220 Excepted benefits.

(a) * * *

(9) Travel insurance, within the meaning of § 144.103 of this subchapter.

(b) * * *

(7) Similar supplemental coverage provided to coverage under a group health plan (as described in § 146.145(b)(5)(i)(C) of this subchapter).

[FR Doc. 2016-26162 Filed 10-28-16; 8:45 am] BILLING CODE 4830-01-P; 4120-01-P; 4510-29-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0956] Drawbridge Operation Regulation; Upper Mississippi River, Clinton, IA 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 three drawbridges crossing the Upper Mississippi River in Iowa: The Illinois Central Railroad Drawbridge, mile 579.9, Dubuque, IA; the Sabula Railroad Drawbridge, mile 535.0, Sabula, IA; and the Clinton Railroad Drawbridge, mile 518.0, Clinton, IA. The deviation is necessary to allow the bridge owners time to perform preventive maintenance that is essential to the continued safe operation of the drawbridges and allows for a seasonal deviation issued for these bridges each year. Maintenance is scheduled in the winter, when there is less impact on navigation due to less traffic. This deviation allows the bridges to open on signal if at least 24 hours advance notice is given.

DATES:

This deviation is effective from 5 p.m., December 13, 2016 until 9 a.m., March 2, 2017.

ADDRESSES:

The docket for this deviation, (USCG-2016-0956) 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 Eric A. Washburn, Bridge Administrator, Western Rivers, Coast Guard; telephone 314-269-2378, email [email protected]

SUPPLEMENTARY INFORMATION:

The Illinois Central, Canadian Pacific, and Union Pacific Railroads requested a temporary deviation for the Illinois Central Railroad Drawbridge, mile 579.9, Dubuque, Iowa, Sabula Railroad Drawbridge, mile 535.0, Sabula, Iowa, and Clinton Railroad Drawbridge, mile 518.0, Clinton, Iowa, across the Upper Mississippi River to open on signal if at least 24 hours advance notice is given for 79 days from 5 p.m., December 13, 2016 to 9 a.m., March 2, 2017 for scheduled maintenance on the bridges.

The Illinois Central, Sabula, and Clinton Railroad Drawbridges currently operate in accordance with 33 CFR 117.5, which states the general requirement that drawbridges open on signal.

There are no alternate routes for vessels transiting these sections of the Upper Mississippi River. The bridges cannot open in case of emergency.

The Illinois Central Railroad Drawbridge provides a vertical clearance of 19.9 feet, Sabula Railroad Drawbridge provides a vertical clearance of 18.1 feet, and Clinton Railroad Drawbridge provides a vertical clearance of 18.7 feet, above normal pool in their closed-to-navigation positions. Navigation on the waterway consists primarily of commercial tows and recreational watercraft and will not be significantly impacted. This temporary deviation has been coordinated with waterway users. No objections were received.

In accordance with 33 CFR 117.35(e), each of these drawbridges 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: October 25, 2016. Eric A. Washburn, Bridge Administrator, Western Rivers.
[FR Doc. 2016-26150 Filed 10-28-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2016-0948] Drawbridge Operation Regulation; Newtown Creek, Brooklyn and Queens, NY 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 Pulaski Bridge across the Newtown Creek, mile 0.6, between Brooklyn and Queens, New York. This deviation is necessary to allow the bridge owner to perform span locks adjustment at the bridge.

DATES:

This deviation is effective from 12:01 a.m. on November 8, 2016 to 5 a.m. on December 2, 2016.

ADDRESSES:

The docket for this deviation, [USCG-2016-0948] 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 Pulaski Bridge, mile 0.6, across the Newtown Creek, has a vertical clearance in the closed position of 39 feet at mean high water and 43 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.801(g)(1).

The waterway is transited by commercial barge traffic of various sizes.

The bridge owner, New York City DOT, requested a temporary deviation from the normal operating schedule to perform span locks adjustment at the bridge.

Under this temporary deviation, the Pulaski Bridge shall remain in the closed position as follows:

November 8, 2016 between 12:01 a.m. and 5 a.m.

November 9, 2016 between 12:01 a.m. and 5 a.m.

November 10, 2016 between 12:01 a.m. and 5 a.m.

November 11, 2016 between 12:01 a.m. and 5 a.m.

November 15, 2016 between 12:01 a.m. and 5 a.m.

November 16, 2016 between 12:01 a.m. and 5 a.m.

November 17, 2016 between 12:01 a.m. and 5 a.m.

November 18, 2016 between 12:01 a.m. and 5 a.m.

November 22, 2016 between 12:01 a.m. and 5 a.m.

November 23, 2016 between 12:01 a.m. and 5 a.m.

November 24, 2016 between 12:01 a.m. and 5 a.m.

November 25, 2016 between 12:01 a.m. and 5 a.m.

November 29, 2016 between 12:01 a.m. and 5 a.m.

November 30, 2016 between 12:01 a.m. and 5 a.m.

December 1, 2016 between 12:01 a.m. and 5 a.m.

December 2, 2016 between 12:01 a.m. and 5 a.m.

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. The Coast Guard notified known companies of the commercial oil and barge vessels in the area and they have no objections to 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: October 26, 2016. C.J. Bisignano, Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2016-26235 Filed 10-28-16; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 405, 412, 413, and 489 [CMS-1655-CN3] RINs 0938-AS77; 0938-AS88; 0938-AS41 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals; Correction AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Final rule; correction.

SUMMARY:

This document corrects a typographical error in the final rule that appeared in the August 22, 2016 Federal Register as well as additional typographical errors in a related correction to that rule that appeared in the October 5, 2016 Federal Register. The final rule was titled “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals”.

DATES:

Effective Date: This correcting document is effective on October 28, 2016.

Applicability Date: This correcting document is applicable for discharges beginning October 1, 2016.

FOR FURTHER INFORMATION CONTACT:

Donald Thompson, (410) 786-4487.

SUPPLEMENTARY INFORMATION:

I. Background

In the final rule which appeared in the August 22, 2016 Federal Register (81 FR 56761) entitled “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules with Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low Volume Hospitals” (hereinafter referred to as the FY 2017 IPPS/LTCH PPS final rule), there were a number of technical and typographical errors. To correct the typographical and technical errors in the FY 2017 IPPS/LTCH PPS final rule, we published a correcting document that appeared in the October 5, 2016 Federal Register (81 FR 68947) (hereinafter referred to as the FY 2017 IPPS/LTCH PPS correcting document).

II. Summary of Errors A. Summary of Errors in the FY 2017 IPPS/LTCH PPS Final Rule

On page 57105, we inadvertently made a typographical error in defining an MSA-dominant hospital.

B. Summary of Errors in the FY 2017 IPPS/LTCH PPS Correcting Document

On page 68953 in the table titled “CHANGE OF FY 2016 STANDARDIZED AMOUNTS TO THE FY 2017 STANDARDIZED AMOUNTS,” we inadvertently made a typographical error in the Labor figure for the “National Standardized Amount for FY 2017 if Wage Index is Greater than 1.0000; Labor/Non-Labor Share Percentage (69.6/30.4)” under the classification of “Hospital did NOT submit quality data and is a meaningful EHR user”.

On page 68955 in the table titled “Table 1A—NATIONAL ADJUSTED OPERATING STANDARDIZED AMOUNTS, LABOR/NONLABOR (69.6 PERCENT LABOR SHARE/30.4 PERCENT NONLABOR SHARE IF WAGE INDEX IS GREATER THAN 1)—FY 2017,” we inadvertently made a typographical error in the Nonlabor figure under the classification of “Hospital submitted quality data and is a meaningful EHR user (update = 1.65 percent)”.

On page 68958 in the table titled “FY 2017 IPPS ESTIMATED PAYMENTS DUE TO RURAL AND IMPUTED FLOOR WITH NATIONAL BUDGET NEUTRALITY,” we made errors in the alignment of the data in the fourth column titled “Difference (in $ millions)”. Specifically, when creating the table in the correcting document, the data in the fourth column was inadvertently misaligned starting with the entry for Washington, DC and continuing to the end, resulting in incorrect values in that column.

III. Waiver of Proposed Rulemaking and Delay in Effective Date

We ordinarily publish a notice of proposed rulemaking in the Federal Register to provide a period for public comment before the provisions of a rule take effect in accordance with section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we can waive this notice and comment procedure if the Secretary finds, for good cause, that the notice and comment process is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons therefore in the notice.

Section 553(d) of the APA ordinarily requires a 30-day delay in the effective date of final rules after the date of their publication in the Federal Register. This 30-day delay in effective date can be waived, however, if an agency finds for good cause that the delay is impracticable, unnecessary, or contrary to the public interest, and the agency incorporates a statement of the findings and its reasons in the rule issued.

We believe that this correcting document does not constitute a rule that would be subject to the APA notice and comment or delayed effective date requirements. This correcting document corrects typographical errors in the FY 2017 IPPS/LTCH PPS final rule and the FY 2017 IPPS/LTCH PPS correcting document but does not make substantive changes to the policies or payment methodologies that were adopted in the final rule. As a result, this correcting document is intended to ensure that the information in the FY 2017 IPPS/LTCH PPS final rule accurately reflects the policies adopted in that final rule.

In addition, even if this were a rule to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the final rule or delaying the effective date would be contrary to the public interest because it is in the public's interest for providers to receive appropriate payments in as timely a manner as possible, and to ensure that the FY 2017 IPPS/LTCH PPS final rule accurately reflects our policies. Furthermore, such procedures would be unnecessary, as we are not altering our payment methodologies or policies, but rather, we are simply implementing correctly the policies that we previously proposed, received comment on, and subsequently finalized. This correcting document is intended solely to ensure that the FY 2017 IPPS/LTCH PPS final rule accurately reflects these payment methodologies and policies. Therefore, we believe we have good cause to waive the notice and comment and effective date requirements.

IV. Correction of Errors A. Correction of Errors in the Final Rule

In FR Doc. 2016-18476 of August 22, 2016 (81 FR 56761), we are making the following correction:

1. On page 57105, first column, first partial paragraph, lines 6 and 7, the phrase “total hospital's Medicare discharges” is corrected to read “total hospital Medicare discharges”.

B. Correction of Errors in the Correcting Document

In FR Doc. 2016-24042 of October 5, 2016 (81 FR 68947), we are making the following corrections:

1. On pages 68952 through 68954 in the table titled, “CHANGE OF FY 2016 STANDARDIZED AMOUNTS TO THE FY 2017 STANDARDIZED AMOUNTS”, the last entry on page 68953 is corrected to read as follows:

Hospital submitted
  • quality data and is
  • a meaningful
  • EHR user
  • Hospital submitted
  • quality data and is
  • NOT a meaningful
  • EHR user
  • Hospital did NOT
  • submit quality data
  • and is a meaningful
  • EHR user
  • Hospital did NOT
  • submit quality data
  • and is NOT
  • a meaningful
  • EHR user
  • National Standardized Amount for FY 2017 if Wage Index is Greater Than 1.0000; Labor/Non-Labor Share Percentage (69.6/30.4) Labor: $3,839.23
  • Nonlabor: $1,676.91
  • Labor: $3,762.75
  • Nonlabor: $1,643.50
  • Labor: $3,813.74
  • Nonlabor: $1,665.77
  • Labor: $3,737.25.
  • Nonlabor: $1,632.37.
  • 2. On page 68955, top of the page in the table titled, “Table 1A—NATIONAL ADJUSTED OPERATING STANDARDIZED AMOUNTS, LABOR/NONLABOR (69.6 PERCENT LABOR SHARE/30.4 PERCENT NONLABOR SHARE IF WAGE INDEX IS GREATER THAN 1)—FY 2017”, the first column of the table is corrected to read as follows:

    Hospital submitted quality data and is a meaningful EHR User
  • (update = 1.65 percent)
  • Labor Nonlabor
    $3,839.23 $1,676.91

    3. On page 68958, top of the page, the table titled, “FY 2017 IPPS ESTIMATED PAYMENTS DUE TO RURAL AND IMPUTED FLOOR WITH NATIONAL BUDGET NEUTRALITY” is corrected to read as follows:

    FY 2017 IPPS Estimated Payments Due to Rural and Imputed Floor With National Budget Neutrality State Number of
  • hospitals
  • Number of
  • hospitals that will receive the rural floor or imputed floor
  • Percent
  • change in payments due to application of rural floor and imputed floor with budget neutrality
  • Difference
  • (in $ millions)
  • (1) (2) (3) (4) Alabama 83 6 −0.3 −6 Alaska 6 4 2.1 4 Arizona 57 46 3.5 63 Arkansas 44 0 −0.4 −4 California 301 186 1.3 131 Colorado 48 3 0.2 3 Connecticut 31 8 0.2 4 Delaware 6 2 0 0 Washington, DC 7 0 −0.4 −2 Florida 171 16 −0.3 −18 Georgia 105 0 −0.4 −10 Hawaii 12 0 −0.3 −1 Idaho 14 0 −0.3 −1 Illinois 126 3 −0.4 −19 Indiana 89 0 −0.4 −11 Iowa 35 0 −0.4 −4 Kansas 53 0 −0.3 −3 Kentucky 65 0 −0.4 −6 Louisiana 95 2 −0.4 −5 Maine 18 0 −0.4 −2 Massachusetts 58 15 0.6 22 Michigan 95 0 −0.4 −18 Minnesota 49 0 −0.3 −6 Mississippi 62 0 −0.4 −4 Missouri 74 2 −0.3 −8 Montana 12 4 0.3 1 Nebraska 26 0 −0.3 −2 Nevada 24 3 −0.2 −2 New Hampshire 13 9 2.2 11 New Jersey 64 18 0.2 6 New Mexico 25 0 −0.3 −1 New York 154 21 −0.3 −20 North Carolina 84 1 −0.4 −12 North Dakota 6 1 −0.3 −1 Ohio 130 10 −0.4 −13 Oklahoma 86 2 −0.3 −4 Oregon 34 2 −0.4 −4 Pennsylvania 151 5 −0.4 −20 Puerto Rico 51 12 0.1 0 Rhode Island 11 10 4.7 18 South Carolina 57 5 −0.1 −2 South Dakota 18 0 −0.2 −1 Tennessee 92 20 −0.3 −7 Texas 320 3 −0.4 −26 Utah 33 1 −0.3 −2 Vermont 6 0 −0.2 −1 Virginia 76 1 −0.3 −8 Washington 49 6 −0.1 −1 West Virginia 29 3 −0.2 −1 Wisconsin 65 6 −0.3 −5 Wyoming 10 0 −0.1 0
    Dated: October 26, 2016. Madhura Valverde, Executive Secretary to the Department, Department of Health and Human Services.
    [FR Doc. 2016-26182 Filed 10-28-16; 8:45 am] BILLING CODE 4120-01-P
    LEGAL SERVICES CORPORATION 45 CFR Part 1602 Procedures for Disclosure of Information Under the Freedom of Information Act AGENCY:

    Legal Services Corporation.

    ACTION:

    Final rule, request for comments.

    SUMMARY:

    The Legal Services Corporation (LSC) is publishing for public comment a proposed final rule to implement the statutorily required amendments in the FOIA Improvement Act of 2016. LSC is also making technical changes to Part 1602 to improve the structure and clarity of its Freedom of Information Act (FOIA) regulations.

    DATES:

    The final rule is effective on December 15, 2016, unless LSC receives substantive adverse comments during the comment period. Written comments will be accepted until November 30, 2016.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Email: [email protected] Include “Part 1602 Proposed Final Rule” in the subject line of the message.

    Fax: (202) 337-6519, ATTN: Helen Guyton, Part 1602 Proposed Final Rule.

    Mail/Hand Delivery/Courier: Helen Guyton, Assistant General Counsel, Legal Services Corporation, 3333 K Street NW., Washington, DC 20007, ATTN: Part 1602 Proposed Final Rule.

    Instructions: Electronic submissions are preferred via email with attachments in Acrobat PDF format. LSC may not consider written comments sent via any other method or received after the end of the comment period.

    FOR FURTHER INFORMATION CONTACT:

    Helen Gerostathos Guyton, Assistant General Counsel, Legal Services Corporation, 3333 K Street NW., Washington, DC 20007, (202) 295-1632 (phone), (202) 337-6519 (fax), [email protected]

    SUPPLEMENTARY INFORMATION: I. Background

    LSC is subject to the FOIA by the terms of the Legal Services Corporation Act. 42 U.S.C. 2996d(g). LSC has implemented FOIA by adopting regulations that contain the rules and procedures LSC will follow in making its records available to the public. LSC last amended its FOIA regulations in 2008. 73 FR 67791, Dec. 31, 2008.

    On June 30, 2016, President Obama signed into law the FOIA Improvement Act of 2016 (“2016 Amendments” or the “Act”). The Act codifies a number of transparency and openness principles and enacts housekeeping measures designed to facilitate FOIA requests and production. LSC must review its current regulations and issue revised regulations on procedures for the disclosure of records consistent with the Act no later than December 27, 2016. The revised regulations described in this final rule reflect the required changes prescribed by the Act. LSC also identified and proposed technical changes to clarify the language and update the structure of its FOIA regulations.

    In light of the deadline established by Congress, LSC management requested that the Operations and Regulations Committee (Committee) recommend that the Board authorize expedited rulemaking and publication of this final rule. On October 16, 2016, the Committee considered the request and voted to make the recommendation to the Board. On October 18, 2016, the Board voted to authorize expedited rulemaking and the publication of this final rule.

    II. Section-by-Section Analysis § 1602.1 Purpose

    There are no proposed changes to this section.

    § 1602.2 Definitions

    LSC modified several existing definitions, deleted one definition, and added five new definitions to make its regulations clearer. Specifically, LSC amended the Definitions section as follows:

    Duplication. LSC is modifying this definition to require the release of records “in a form appropriate for release.” This change complies with FOIA guidance that records be released in the format requested, where possible.

    LSC. LSC is replacing all references to “the Corporation” with “LSC” for simplicity. LSC is introducing this definition to make clear that, unless otherwise specified, references to LSC in this rule include both the Corporation and LSC's Office of Inspector General.

    Office. LSC is adding this definition in order to simplify references to the Office of Inspector General and/or the Office of Legal Affairs, where appropriate.

    Office of Inspector General records. LSC is deleting this definition because the general definition of “Records” includes the Office of Inspector General records, making this definition redundant.

    Person. LSC's current regulations do not define person. To address this gap, LSC is adding a definition modeled after the definition of person contained in the FOIA, 5 U.S.C. 551(2).

    Records. LSC is modifying he definition of this term to comport with the definition of records in LSC's Records Management Policy, which was updated in September 2015. It also incorporates Office of Inspector General records, which were previously defined separately.

    Rule. LSC's FOIA regulations cite to personnel rules, rules of procedure, and substantive rules, but do not define the term rule. To address this gap, LSC has added a definition of rule modeled on the definition contained in the FOIA, 5 U.S.C. 551(4).

    Submitter. On February 14, 2003, LSC published in the Federal Register a final rule adding provisions for a submitter's rights process to its FOIA regulations. 68 FR 7433, Feb. 14, 2003. These provisions were modeled after the process outlined in Executive Order No. 12,600 (June 23, 1987). The 2003 final rule limited submitter solely to any person or entity from whom LSC receives grant application records. LSC is now expanding the definition of submitter to include “any person or applicant for funds who provides confidential commercial information to LSC.” This definition more closely conforms with the spirit of E.O. 12,600 and ensures that submitters who may have an interest in the protection of their confidential commercial information are properly notified.

    Confidential Commercial Information. LSC is adding a definition of “Confidential Commercial Information” modeled on the definition in E.O. 12,600, to comport with the new definition of “Submitter” described above.

    § 1602.3 Policy

    LSC is making minor technical edits to clarify this section.

    § 1602.4 Records Published in the Federal Register

    LSC is making minor technical edits to clarify this section.

    § 1602.5 Public Reading Room

    This section sets out the process by which LSC makes available for public inspection the records described in the FOIA, 5 U.S.C. 552(a)(2). In the current version of its FOIA regulations, LSC sets out the specific categories of records that must be publicly disclosed. LSC is deleting those specific provisions and replacing them with a broader reference to § 552(a)(2) generally in anticipation of implementing the “Release to One, Release to All” policy.

    The Department of Justice Office of Information Policy launched a pilot program as part of its Open Government Initiative called “Release to One, Release to All.” Under this policy, agencies would release FOIA processed records not only to a requester, but to the public at large by posting them online. LSC intends to comply with this policy immediately. As a result, it is revising the description of records in this section to track what LSC actually will be disclosing upon implementation of the “Release to One, Release to All” policy.

    LSC is also making minor technical revisions to clarify this section.

    § 1602.6 Procedures for Using the Public Reading Room

    LSC is adding a provision to this section that will provide requesters with onsite computer and printer access to electronic reading room records. This provision is consistent with federal agency practice and provides greater access to LSC's records to the public at large.

    § 1602.7 Index of Records

    LSC is updating this section to reflect its current practice of maintaining its index of records electronically.

    § 1602.8 Requests for Records

    The current version of § 1602.8 includes provisions relating to the format of requests for records, the timing of responses, and the format of responses to requests. There are no subheadings to distinguish these provisions within the section, making it difficult to follow. To improve readability, LSC is restructuring § 1602.8 by limiting the section solely to provisions related to the format of FOIA requests. LSC is also adding a provision that informs requesters of their right to specify the preferred form or format for the records sought and that requires requesters to provide their contact information to assist LSC in communicating with them about their request.

    § 1602.9 Timing and Responses to Requests for Records

    This is a new section. As described in the discussion of § 1602.8, LSC determined that it would be clearer if the provisions for timing and responses to requests were contained in a separate section. LSC also is making technical changes to the language and structure to improve clarity. In addition, LSC is adding provisions describing the dispute resolution processes available to the public as required by the 2016 Amendments. These provisions describe when a requester may seek assistance, including dispute resolution services, from an LSC FOIA Public Liaison or the U.S. National Archives and Record Administration's Office of Government Information Services.

    § 1602.10 Exemptions for Withholding Records

    LSC is amending this section to incorporate the 2016 Amendments' codification of the Department of Justice's foreseeable harm standard, which requires LSC to withhold information only if disclosure would harm an interest protected by an exemption or prohibited by law. It further obligates LSC to consider whether partial disclosure of information is possible when full disclosure is not and to take reasonable steps to segregate and release nonexempt information.

    In addition, LSC is modifying its rule regarding the applicability of the deliberative process privilege, as required by the 2016 Amendments. The privilege now applies only to records created within 25 years of the date on which the records were requested.

    Finally, LSC is adding exemptions 1, 8, and 9 from 5 U.S.C. 552(8)(B)(b) to its regulations. While these exemptions, which deal with national security, financial institutions, and geological information, generally do not apply to the work of LSC, their absence caused confusion because LSC's exemption numbers did not track the commonly used exemption numbers found in both the FOIA and case law. This change will eliminate any confusion.

    § 1602.11 Officials Authorized To Grant or Deny Requests for Records

    LSC is deleting paragraph (a) of this section, which describes the role of the General Counsel in adequately and consistently applying the provisions of this part within LSC. The 2016 Amendments establish the role of the Chief FOIA Officer in ensuring compliance with FOIA, thereby superseding LSC's current regulations.

    § 1602.12 Denials

    LSC is adding a provision to this section requiring it to include a provision in its denial decisions notifying the requester of his or her right to seek dispute resolution services from LSC's FOIA Public Liaison or the Office of Government Information Services.

    § 1602.13 Appeals of Denials

    LSC is making minor technical edits to clarify this section. LSC is also adding a provision required by the 2016 Amendments. This provision requires LSC to notify a requester of the mediation services offered by the Office of Government Information Systems as a non-exclusive alternative to litigation.

    § 1602.14 Fees

    LSC is adding a provision to this section that prohibits LSC from assessing fees if its response time is delayed, subject to limited exceptions described in the 2016 Amendments. LSC is also deleting references to the specific dollar amounts it will charge for search and reproduction costs because they are outdated and providing instead the web address for its FOIA page, which will contain current fee and cost schedules.

    § 1602.15 Submitter's Rights Process

    As previously described in the discussion of § 1602.2's definition of the term submitter, LSC is expanding the submitter's rights process to include “any person or applicant for funds who provides confidential commercial information to LSC.” This definition more closely conforms with the spirit of E.O. 12,600 and ensures that submitters who may have an interest in the protection of their confidential information are properly notified.

    LSC is further modifying this section to include a right to appeal to the Inspector General for Office of Inspector General-related requests, as the current regulations do not provide a mechanism to do so.

    Finally, LSC is clarifying an ambiguous provision that requires a submitter to provide to LSC within seven days his or her statement objecting to disclosure of his information. LSC must receive the submitter's statement within seven days of the date of LSC's notice to the submitter.

    List of Subjects in 45 CFR Part 1602

    Freedom of Information.

    For the reasons stated in the preamble, revise 45 CFR part 1602 to read as follows: PART 1602—PROCEDURES FOR DISCLOSURE OF INFORMATION UNDER THE FREEDOM OF INFORMATION ACT Sec. 1602.1 Purpose. 1602.2 Definitions. 1602.3 Policy. 1602.4 Records published in the Federal Register. 1602.5 Public reading room. 1602.6 Procedures for use of public reading room. 1602.7 Index of records. 1602.8 Requests for records. 1602.9 Timing and responses to requests for records. 1602.10 Exemptions for withholding records. 1602.11 Officials authorized to grant or deny requests for records. 1602.12 Denials. 1602.13 Appeals of denials. 1602.14 Fees. 1602.15 Submitter's rights process. Authority:

    42 U.S.C. 2996g(e)

    § 1602.1 Purpose.

    This part contains the rules and procedures the Legal Services Corporation (LSC) follows in making records available to the public under the Freedom of Information Act.

    § 1602.2 Definitions.

    (a) Commercial use request means a request from or on behalf of one who seeks information for a use or purpose that furthers the commercial, trade, or profit interests of the requester or the person on whose behalf the request is made. In determining whether a requester properly belongs in this category, LSC will look to the use to which a requester will put the documents requested. When LSC has reasonable cause to doubt the requester's stated use of the records sought, or where the use is not clear from the request itself, it will seek additional clarification before assigning the request to a category.

    (b) Confidential commercial information means records provided to LSC by a submitter that arguably contain material exempt from release under Exemption 4 of the FOIA, 5 U.S.C. 552(b)(4), because disclosure could reasonably be expected to cause substantial competitive harm.

    (c) Duplication means the process of making a copy of a requested record pursuant to this part in a form appropriate for release in response to a FOIA request.

    (d) Educational institution means a preschool, a public or private elementary or secondary school, an institution of undergraduate or graduate higher education, or an institution of professional or vocational education which operates a program or programs of scholarly research.

    (e) FOIA means the Freedom of Information Act, 5 U.S.C. 552.

    (f) LSC means the Legal Services Corporation. Unless explicitly stated otherwise, LSC includes the Office of Inspector General.

    (g) Non-commercial scientific institution means an institution that is not operated on a commercial basis and which is operated solely for the purpose of conducting scientific research, the results of which are not intended to promote any particular product or industry.

    (h) Office refers to the Office of Legal Affairs and/or the Office of Inspector General (OIG).

    (i) Person includes an individual, partnership, corporation, association, or public or private organization other than LSC.

    (j) Records are any type of information made or received by LSC or the OIG for purposes of transacting LSC or OIG business and preserved by LSC or the OIG (either directly or maintained by a third party under contract to LSC or the OIG for records management purposes) regardless of form (e.g., paper or electronic, formal or informal, copies or original) as evidence of LSC's or OIG's organization, functions, policies, decisions, procedures, operations, or other activities of LSC or the OIG or because the Record has informational value.

    (k) Representative of the news media means any person or entity that gathers information of potential interest to a segment of the public, uses its editorial skills to turn the raw materials into a distinct work, and distributes that work to an audience. In this clause, the term “news” means information that is about current events or that would be of current interest to the public. Examples of news media entities are television or radio stations broadcasting to the public at large and publishers of periodicals (but only if such entities qualify as disseminators of “news”) who make their products available for purchase or subscription or by free distribution to the general public. These examples are not all-inclusive. Moreover, as methods of news delivery evolve (for example, the adoption of the electronic dissemination of newspapers through telecommunications services), such alternative media shall be considered to be news media entities. A freelance journalist shall be regarded as working for a news media entity if the journalist can demonstrate a solid basis for expecting publication through that entity, whether or not the journalist is actually employed by the entity. A publication contract would present a solid basis for such an expectation. LSC may also consider the past publication record of the requester in making such a determination.

    (l) Review means the process of examining documents located in response to a request to determine whether any portion of any such document is exempt from disclosure. It also includes processing any such documents for disclosure. Review does not include time spent resolving general legal or policy issues regarding the application of exemptions.

    (m) Rule means the whole or a part of an LSC statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of LSC.

    (n) Search means the process of looking for and retrieving records that are responsive to a request for records. It includes page-by-page or line-by-line identification of material within documents and also includes reasonable efforts to locate and retrieve information from records maintained in electronic form or format. Searches may be conducted manually or by automated means and will be conducted in the most efficient and least expensive manner.

    (o) Submitter means any person or applicant for funds who provides confidential commercial information to LSC.

    § 1602.3 Policy.

    LSC will make records concerning its operations, activities, and business available to the public to the maximum extent reasonably possible. LSC will withhold records from the public only in accordance with the FOIA and this part. LSC will disclose records otherwise exempt from disclosure under the FOIA when disclosure is not prohibited by law and disclosure would not foreseeably harm a legitimate interest of the public, LSC, a recipient, or any individual.

    § 1602.4 Records published in the Federal Register.

    LSC routinely publishes in the Federal Register information on its basic structure and operations necessary to inform the public how to deal effectively with LSC. LSC will make reasonable efforts to currently update such information, which will include basic information on LSC's location, functions, rules of procedure, substantive rules, statements of general policy, and information regarding how the public may obtain information, make submittals or requests, or obtain decisions.

    § 1602.5 Public reading room.

    (a) LSC will maintain a public reading room at its offices at 3333 K St. NW., Washington, DC 20007. This room will be supervised and will be open to the public during LSC's regular business hours. Procedures for use of the public reading room are described in § 1602.6. LSC also maintains an electronic public reading room that may be accessed at http://www.lsc.gov/about-lsc/foia/foia-electronic-public-reading-room.

    (b) Subject to the limitation stated in paragraph (c), LSC will make available for public inspection in its electronic public reading room the records described in 5 U.S.C. 552(a)(2).

    (c) Certain records otherwise required by FOIA to be available in the public reading room may be exempt from mandatory disclosure pursuant to 5 U.S.C. 552(b) and § 1602.10. LSC will not make such records available in the public reading room. LSC may edit other records maintained in the reading room by redacting details about individuals to prevent clearly unwarranted invasions of personal privacy. In such cases, LSC will attach a full explanation of the redactions to the record. LSC will indicate the extent of the redactions unless doing so would harm an interest protected by the exemption under which the redactions are made. If technically feasible, LSC will indicate the extent of the redactions at the place in the record where the redactions were made.

    § 1602.6 Procedures for use of public reading room.

    (a) A person who wishes to inspect or copy records in the public reading room should arrange a time in advance, by telephone or letter request made to the Office of Legal Affairs, Legal Services Corporation, 3333 K Street NW., Washington, DC 20007 or by email to [email protected]

    (1) In appropriate circumstances, LSC will advise persons making telephonic requests to use the public reading room that a written request would aid in the identification and expeditious processing of the records sought.

    (2) Written requests should identify the records sought in the manner provided in § 1602.8(b) and should request a specific date for inspecting the records.

    (b) LSC will advise the requester as promptly as possible if, for any reason, it is not feasible to make the records sought available on the date requested.

    (c) A computer terminal and printer are available upon request in the public reading room for accessing Electronic Reading Room records.

    § 1602.7 Index of records.

    LSC will maintain and make available for public inspection in an electronic format a current index identifying any matter within the scope of §§ 1602.4 and 1602.5(b).

    § 1602.8 Requests for records.

    (a) LSC will make its records promptly available, upon request, to any person in accordance with this section, unless:

    (1) The FOIA requires the records to be published in the Federal Register (§ 1602.4) or to be made available in the public reading room (§ 1602.5); or

    (2) LSC determines that such records should be withheld and are exempt from mandatory disclosure under the FOIA and § 1602.10.

    (b)(1) Requests for LSC records. All requests for LSC records must be clearly marked Freedom of Information Act Request and shall be addressed to the FOIA Analyst, Office of Legal Affairs, Legal Services Corporation, 3333 K Street NW., Washington, DC 20007. Email requests shall be sent to [email protected] Requests for LSC Records may also be made online using the FOIA Request Electronic Submission Form located at http://www.lsc.gov/about-lsc/foia.

    (2) Requests for Office of Inspector General records. All requests for records maintained by the OIG must be clearly marked Freedom of Information Act Request and shall be addressed to the FOIA Officer, Office of Inspector General, Legal Services Corporation, 3333 K Street NW., Washington, DC 20007. Email requests shall be sent to [email protected]

    (3) Any request not marked and addressed as specified in this section will be so marked by LSC personnel as soon as it is properly identified, and will be forwarded immediately to the appropriate Office. A request improperly addressed will be deemed to have been received as in accordance with § 1602.9 only when it has been received by the appropriate Office. Upon receipt of an improperly addressed request, the Chief FOIA Officer, Office of Inspector General Legal Counsel or their designees shall notify the requester of the date on which the time period began.

    (c) A request must reasonably describe the records requested so that employees of LSC who are familiar with the subject area of the request are able, with a reasonable amount of effort, to determine which particular records are within the scope of the request. Before submitting their requests, requesters may contact LSC's or OIG's FOIA Analyst or FOIA Public Liaison to discuss the records they seek and to receive assistance in describing the records. If LSC determines that a request does not reasonably describe the records sought, LSC will inform the requester what additional information is needed or why the request is otherwise insufficient. Requesters who are attempting to reformulate or modify their request may discuss their request with LSC's or OIG's FOIA Analyst or FOIA Public Liaison. If a request does not reasonably describe the records sought, LSC's response to the request may be delayed.

    (d) To facilitate the location of records by LSC, a requester should try to provide the following kinds of information, if known:

    (1) The specific event or action to which the record refers;

    (2) The unit or program of LSC which may be responsible for or may have produced the record;

    (3) The date of the record or the date or period to which it refers or relates;

    (4) The type of record, such as an application, a grant, a contract, or a report;

    (5) Personnel of LSC who may have prepared or have knowledge of the record;

    (6) Citations to newspapers or publications which have referred to the record.

    (e) Requests may specify the preferred form or format (including electronic formats) for the records sought. LSC will provide records in the form or format indicated by the requester to the extent such records are readily reproducible in the requested form or format. LSC reserves the right to limit the number of copies of any document that will be provided to any one requester or to require that special arrangements for duplication be made in the case of bound volumes or other records representing unusual problems of handling or reproduction.

    (f) Requesters must provide contact information, such as their phone number, email address, and/or mailing address, to assist LSC in communicating with them and providing released records.

    (g) LSC is not required to create a record or to perform research to satisfy a request.

    (h) Any request for a waiver or reduction of fees should be included in the FOIA request, and any such request should indicate the grounds for a waiver or reduction of fees, as set out in § 1602.14(g). LSC shall respond to such request as promptly as possible.

    § 1602.9 Timing and responses to requests for records.

    (a)(1)(i) Upon receiving a request for LSC or Inspector General records under § 1602.8, the Chief FOIA Officer, Office of Inspector General Legal Counsel or their designees shall make an initial determination of whether to comply with or deny such request. The Chief FOIA Officer, Office of Inspector General Legal Counsel or their designees will send the determination to the requester within 20 business days after receipt of the request and will notify the requester of their right to seek assistance from an LSC FOIA Public Liaison.

    (ii) If the processing Office determines that a request or portion thereof is for the other Office's records, the processing Office shall promptly refer the request or portion thereof to the appropriate Office and send notice of such referral to the requester.

    (2) The 20-day period under paragraph (a)(1)(i) of this section shall commence on the date on which the request is first received by the appropriate Office, but in no event later than 10 working days after the request has been received by either the Office of Legal Affairs or the Office of Inspector General. The 20-day period shall not be tolled by the Office processing the request except that the processing Office may make one request to the requester for information pursuant to paragraph (b) of this section and toll the 20-day period while

    (i) It is awaiting such information that it has reasonably requested from the requester under this section; or

    (ii) It communicates with the requester to clarify issues regarding fee assessment. In either case, the processing Office's receipt of the requester's response to such a request for information or clarification ends the tolling period.

    (b)(1) In unusual circumstances, as specified in paragraph (b)(3) of this section, LSC may extend the time limit for up to 10 working days by written notice to the requester setting forth the reasons for such extension and the date on which LSC expects to send its determination.

    (2) If a request is particularly broad or complex so that it cannot be completed within the time periods stated in paragraph (a)(1)(i) of this section, LSC may ask the requester to narrow the request or agree to an additional delay. In addition, to aid the requester, LSC shall make available a FOIA Public Liaison, who shall assist in the resolution of any disputes between the requester and LSC, and shall notify the requester of his right to seek dispute resolution services from the U.S. National Archives and Records Administration's Office of Government Information Services.

    (3) Unusual circumstances. As used in this part, unusual circumstances are limited to the following, but only to the extent reasonably necessary for the proper processing of the particular request:

    (i) The need to search for and collect the requested records from establishments that are separate from the office processing the request;

    (ii) The need to search for, collect, and appropriately examine a voluminous amount of separate and distinct records which are demanded in a single request; or

    (iii) The need for consultation, which shall be conducted with all practicable speed, with another agency or organization, such as a recipient, having a substantial interest in the determination of the request or among two or more components of LSC having substantial subject matter interest therein.

    (c)(1) When the processing Office cannot send a determination to the requester within the applicable time limit, the Chief FOIA Officer, Office of the Inspector General Legal Counsel, or their designees shall inform the requester of the reason for the delay, the date on which the processing Office expects to send its determination, and the requester's right to treat the delay as a denial and to appeal to LSC's President or Inspector General, in accordance with § 1602.13, or to seek dispute resolution services from a FOIA Public Liaison or the Office of Government Information Services.

    (2) If the processing Office has not sent its determination by the end of the 20-day period or the last extension thereof, the requester may deem the request denied, and exercise a right of appeal in accordance with § 1602.13, or seek dispute resolution services from LSC's or OIG's FOIA Public Liaison or the National Archives and Records Administration's Office of Government Information Services. The Chief FOIA Officer, Office of Inspector General Legal Counsel, or their designees may ask the requester to forego appeal until a determination is made.

    (d) After the processing Office determines that a request will be granted, LSC or the OIG will act with due diligence in providing a substantive response.

    (e)(1) Expedited treatment. Requests and appeals will be taken out of order and given expedited treatment whenever the requester demonstrates a compelling need. A compelling need means:

    (i) Circumstances in which the lack of expedited treatment could reasonably be expected to pose an imminent threat to the life or physical safety of an individual;

    (ii) An urgency to inform the public about an actual or alleged LSC activity and the request is made by a person primarily engaged in disseminating information;

    (iii) The loss of substantial due process rights; or

    (iv) A matter of widespread and exceptional media interest raising questions about LSC's integrity which may affect public confidence in LSC.

    (2) A request for expedited processing may be made at the time of the initial request for records or at any later time. For a prompt determination, a request for expedited processing must be properly addressed and marked and received by LSC pursuant to § 1602.8.

    (3) A requester who seeks expedited processing must submit a statement demonstrating a compelling need and explaining in detail the basis for requesting expedited processing. The requester must certify that the statement is true and correct to the best of the requester's knowledge and belief.

    (4) Within 10 calendar days of receiving a request for expedited processing, the Chief FOIA Officer, Office of Inspector General Legal Counsel or their designees shall decide whether to grant the request and shall notify the requester of the decision. If a request for expedited treatment is granted, the request shall be given priority and shall be processed as soon as practicable. If a request for expedited processing is denied, the requester may appeal in writing to LSC's President or Inspector General in the format described in § 1602.13(a). Any appeal of a denial for expedited treatment shall be acted on expeditiously by LSC.

    § 1602.10 Exemptions for withholding records.

    (a) LSC shall—

    (1) Withhold information under this section only if—

    (i) LSC reasonably foresees that disclosure would harm an interest protected by an exemption described in paragraph (b); or

    (ii) Disclosure is prohibited by law; and

    (2)(i) Consider whether partial disclosure of information is possible whenever LSC determines that a full disclosure of a requested record is not possible; and

    (ii) Take reasonable steps necessary to segregate and release nonexempt information; and

    (b) LSC may withhold a requested record from public disclosure only if one or more of the following exemptions authorized by the FOIA apply:

    (1)(i) Matter that is specifically authorized under criteria established by an Executive order to be kept secret in the interest of national defense or foreign policy and

    (ii) Is in fact properly classified pursuant to such Executive Order;

    (2) Matter that is related solely to the internal personnel rules and practices of LSC;

    (3) Matter that is specifically exempted from disclosure by statute (other than the exemptions under FOIA at 5 U.S.C. 552(b)), provided that such statute requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue, or establishes particular criteria for withholding, or refers to particular types of matters to be withheld;

    (4) Trade secrets and commercial or financial information obtained from a person and privileged or confidential;

    (5) Inter-agency or intra-agency memoranda or letters that would not be available by law to a party other than an agency in litigation with the Corporation, provided that the deliberative process privilege shall not apply to records created 25 years or more before the date on which the records were requested;

    (6) Personnel and medical files and similar files, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;

    (7) Records or information compiled for law enforcement purposes, including enforcing the Legal Services Corporation Act or any other law, but only to the extent that the production of such law enforcement records or information:

    (i) Could reasonably be expected to interfere with enforcement proceedings;

    (ii) Would deprive a person or a recipient of a right to a fair trial or an impartial adjudication;

    (iii) Could reasonably be expected to constitute an unwarranted invasion of personal privacy;

    (iv) Could reasonably be expected to disclose the identity of a confidential source, including a State, local, or foreign agency or authority or any private institution that furnished information on a confidential basis, and in the case of a record or information compiled by a criminal law enforcement authority in the course of a criminal investigation, information furnished by a confidential source;

    (v) Would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law; or

    (vi) Could reasonably be expected to endanger the life or physical safety of any individual;

    (8) Matter that is contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions; or

    (9) Geological and geophysical information and data, including maps, concerning wells.

    (c) In the event that one or more of the exemptions in paragraph (b) of this section applies, any reasonably segregable portion of a record shall be provided to the requester after redaction of the exempt portions. The amount of information redacted and the exemption under which the redaction is being made shall be indicated on the released portion of the record, unless doing so would harm the interest protected by the exemption under which the redaction is made. If technically feasible, the amount of information redacted and the exemption under which the redaction is being made shall be indicated at the place in the record where the redaction occurs.

    (d) No requester shall have a right to insist that any or all of the techniques in paragraph (c) of this section should be employed in order to satisfy a request.

    (e) Records that may be exempt from disclosure pursuant to paragraph (b) of this section may be made available at the discretion of the LSC official authorized to grant or deny the request for records, after appropriate consultation as provided in § 1602.11. Records may be made available pursuant to this paragraph when disclosure is not prohibited by law and does not appear adverse to legitimate interests of LSC, the public, a recipient, or any person.

    § 1602.11 Officials authorized to grant or deny requests for records.

    (a) The Chief FOIA Officer, Office of Inspector General Legal Counsel or their designees are authorized to grant or deny requests under this part. In the absence of an Office of Inspector General Legal Counsel, the Inspector General shall name a designee who will be authorized to grant or deny requests under this part and who will perform all other functions of the Office of Inspector General Legal Counsel under this part.

    (b)(1) The Chief FOIA Officer or designee shall consult with the Office of Inspector General Legal Counsel or designee prior to granting or denying any request for records or portions of records which originated with the OIG, or which contain information which originated with the OIG, but which are maintained by other components of LSC.

    (2) The Office of Inspector General Legal Counsel or designee shall consult with the Chief FOIA Officer or designee prior to granting or denying any request for records or portions of records which originated with any component of LSC other than the OIG, or which contain information which originated with a component of LSC other than the OIG, but which are maintained by the OIG.

    § 1602.12 Denials.

    (a) A denial of a written request for a record that complies with the requirements of § 1602.8 shall be in writing and shall include the following:

    (1) A reference to the applicable exemption or exemptions in § 1602.10(b) upon which the denial is based;

    (2) An explanation of how the exemption applies to the requested records;

    (3) A statement explaining why it is deemed unreasonable to provide segregable portions of the record after deleting the exempt portions;

    (4) An estimate of the volume of requested matter denied unless providing such estimate would harm the interest protected by the exemption under which the denial is made;

    (5) The name and title of the person or persons responsible for denying the request;

    (6) An explanation of the right to appeal the denial and of the procedures for submitting an appeal, as described in § 1602.13, including the address of the official to whom appeals should be submitted; and

    (7) An explanation of the right of the requester to seek dispute resolution services from a FOIA Public Liaison or the Office of Government Information Services.

    (b) Whenever LSC makes a record available subject to the deletion of a portion of the record, such action shall be deemed a denial of a record for purposes of paragraph (a) of this section.

    (c) All denials shall be treated as final opinions under § 1602.5(b)(1).

    § 1602.13 Appeals of denials.

    (a) Any person whose written request has been denied is entitled to appeal the denial within 90 days of the date of the response by writing to the President of LSC or, in the case of a denial of a request for OIG records, the Inspector General, at the mailing or email addresses given in § 1602.8(b)(1) and (2). The envelope and letter or email appeal should be clearly marked: “Freedom of Information Appeal.” An appeal need not be in any particular form, but should adequately identify the denial, if possible, by describing the requested record, identifying the official who issued the denial, and providing the date on which the denial was issued.

    (b) No personal appearance, oral argument, or hearing will ordinarily be permitted on appeal of a denial. Upon request and a showing of special circumstances, however, this limitation may be waived and an informal conference may be arranged with the President, Inspector General or their designees for this purpose.

    (c) The decision of the President or the Inspector General on an appeal shall be in writing and, in the event the denial is in whole or in part upheld, shall contain an explanation responsive to the arguments advanced by the requester, the matters described in § 1602.12(a)(1) through (4), and the provisions for judicial review of such decision under 5 U.S.C. 552(a)(4). The decision must also notify the requester of the mediation services offered by the National Archives and Records Administration's Office of Government Information Systems as a non-exclusive alternative to litigation.

    (d) LSC will send its decision to the requester within 20 business days after receipt of the appeal, unless an additional period is justified due to unusual circumstances, as described in § 1602.9, in which case LSC may extend the time limit for up to 10 working days by written notice to the requester setting forth the reasons for such extension and the date on which LSC expects to send its determination. The decision of the President or the Inspector General shall constitute the final action of LSC. All such decisions shall be treated as final opinions under § 1602.5(b)(1).

    (e) On an appeal, the President or designee shall consult with the OIG prior to reversing in whole or in part the denial of any request for records or portions of records which originated with the OIG, or which contain information which originated with the OIG, but which are maintained by other components of LSC. The Inspector General or designee shall consult with the President prior to reversing in whole or in part the denial of any request for records or portions of records which originated with LSC, or which contain information which originated with LSC, but which are maintained by the OIG.

    § 1602.14 Fees.

    (a) LSC will not charge fees for information routinely provided in the normal course of doing business.

    (b)(1) When records are requested for commercial use, LSC shall limit fees to reasonable standard charges for document search, review, and duplication.

    (2) LSC shall not assess any search fees (or if the requester is a representative of the news media, duplication fees) if LSC has failed to comply with the time limits set forth in § 1602.9 and no unusual circumstances, as defined in that section apply.

    (3)(i) If LSC has determined that unusual circumstances as defined in § 1602.9 apply and LSC has provided timely written notice to the requester in accordance with § 1602.9(b)(1), a failure described in paragraph § 1602.9(c)(2) is excused for an additional 10 days. If LSC fails to comply with the extended time limit, LSC may not assess any search fees (or, if the requester is a representative of the news media, duplication fees).

    (ii) If LSC has determined that unusual circumstances as defined in § 1602.9 apply and more than 5,000 pages are necessary to respond to the request, LSC may charge search fees or duplication fees if LSC has provided a timely written notice to the requester in accordance with § 1602.9 and LSC has discussed with the requester via written mail, electronic mail, or telephone (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request in accordance with paragraph § 1602.9.

    (c) When records are sought by a representative of the news media or by an educational or non-commercial scientific institution, LSC shall limit fees to reasonable standard charges for document duplication after the first 100 pages; and

    (d) For all other requests, LSC shall limit fees to reasonable standard charges for search time after the first 2 hours and duplication after the first 100 pages.

    (e) The schedule of charges and fees for services regarding the production or disclosure of the Corporation's records may be viewed on LSC's FOIA home page at http://www.lsc.gov/about-lsc/foia.

    (f) LSC may charge for time spent searching even if it does not locate any responsive records or it withholds the records located as exempt from disclosure.

    (g) Fee waivers. A requester may seek a waiver or reduction of the fees established under paragraph (e) of this section. A fee waiver or reduction request will be granted where LSC has determined that the requester has demonstrated that disclosure of the information is in the public interest because it is likely to contribute significantly to public understanding of the operations of LSC and is not primarily in the commercial interest of the requester.

    (1) In order to determine whether disclosure of the information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of LSC, LSC shall consider the following four factors:

    (i) The subject of the request: Whether the subject of the requested records concerns “the operations or activities of LSC.” The subject of the requested records must concern identifiable operations or activities of LSC, with a connection that is direct and clear, not remote or attenuated.

    (ii) The informative value of the information to be disclosed: Whether the disclosure is “likely to contribute” to an understanding of LSC operations or activities. The requested records must be meaningfully informative about LSC operations or activities in order to be likely to contribute to an increased public understanding of those operations or activities. The disclosure of information that is already in the public domain, in either a duplicative or a substantially identical form, would not be likely to contribute to such understanding where nothing new would be added to the public's understanding.

    (iii) The contribution to an understanding of the subject by the public likely to result from disclosure: Whether disclosure of the requested records will contribute to “public understanding.” The disclosure must contribute to a reasonably broad audience of persons interested in the subject, as opposed to the personal interest of the requester. A requester's expertise in the subject area and ability and intention to effectively convey information to the public shall be considered. LSC shall presume that a representative of the news media will satisfy this consideration.

    (iv) The significance of the contribution to public understanding: Whether the disclosure is likely to contribute “significantly” to public understanding of LSC operations or activities. The disclosure must enhance the public's understanding of the subject in question to a significant extent.

    (2) In order to determine whether disclosure of the information is not primarily in the commercial interest of the requester, LSC will consider the following two factors:

    (i) The existence and magnitude of a commercial interest: Whether the requester has a commercial interest that would be furthered by the requested disclosure. LSC shall consider any commercial interest of the requester (with reference to the definition of “commercial use” in this part) or of any person on whose behalf the requester may be acting, that would be furthered by the requested disclosure.

    (ii) The primary interest in disclosure: Whether the magnitude of the identified commercial interest is sufficiently large, in comparison with the public interest in disclosure, that disclosure is “primarily” in the commercial interest of the requester. A fee waiver or reduction is justified where the public interest is of greater magnitude than is any identified commercial interest in disclosure. LSC ordinarily shall presume that where a news media requester has satisfied the public interest standard, the public interest will be the interest primarily served by disclosure to that requester. Disclosure to data brokers or others who merely compile and market government information for direct economic return shall not be presumed primarily to serve a public interest.

    (3) Where LSC has determined that a fee waiver or reduction request is justified for only some of the records to be released, LSC shall grant the fee waiver or reduction for those records.

    (4) Requests for fee waivers and reductions shall be made in writing and must address the factors listed in this paragraph as they apply to the request.

    (h) Requesters must agree to pay all fees charged for services associated with their requests. LSC will assume that requesters agree to pay all charges for services associated with their requests up to $25 unless otherwise indicated by the requester. For requests estimated to exceed $25, LSC will consult with the requester prior to processing the request, and such requests will not be deemed to have been received by LSC until the requester agrees in writing to pay all fees charged for services.

    (i) No requester will be required to make an advance payment of any fee unless:

    (1) The requester has previously failed to pay a required fee within 30 days of the date of billing, in which case an advance deposit of the full amount of the anticipated fee together with the fee then due plus interest accrued may be required (and the request will not be deemed to have been received by LSC until such payment is made); or

    (2) LSC determines that an estimated fee will exceed $250, in which case the requester shall be notified of the amount of the anticipated fee or such portion thereof as can readily be estimated. Such notification shall be transmitted as soon as possible, but in any event within five working days of receipt by LSC, giving the best estimate then available. The notification shall offer the requester the opportunity to confer with appropriate representatives of LSC for the purpose of reformulating the request so as to meet the needs of the requester at a reduced cost. The request will not be deemed to have been received by LSC for purposes of the initial 20-day response period until the requester makes a deposit on the fee in an amount determined by LSC.

    (j) Interest may be charged to those requesters who fail to pay the fees charged. Interest will be assessed on the amount billed, starting on the 31st day following the day on which the billing was sent. The rate charged will be as prescribed in 31 U.S.C. 3717.

    (k) If LSC reasonably believes that a requester or group of requesters is attempting to break a request into a series of requests for the purpose of evading the assessment of fees, LSC shall aggregate such requests and charge accordingly. Likewise, LSC will aggregate multiple requests for documents received from the same requester within 45 days.

    § 1602.15 Submitter's rights process.

    (a) When LSC receives a FOIA request seeking the release of confidential commercial information, LSC shall provide prompt written notice of the request to the submitter in order to afford the submitter an opportunity to object to the disclosure of the requested confidential commercial information. The notice shall reasonably describe the confidential commercial information requested and inform the submitter of the process required by paragraph (b) of this section.

    (b) If a submitter who has received notice of a request for the submitter's confidential commercial information wishes to object to the disclosure of the confidential commercial information, the submitter must provide LSC with a detailed written statement identifying the information which it objects to LSC disclosing. The submitter must send its objections to the Office of Legal Affairs or, if it pertains to Office of Inspector General records, to the Office of Inspector General, and must specify the grounds for withholding the information under FOIA or this part. In particular, the submitter must demonstrate why the information is commercial or financial information that is privileged or confidential. The submitter's statement must be received by LSC within seven business days of the date of the notice from LSC. If the submitter fails to respond to the notice from LSC within that time, LSC will deem the submitter to have no objection to the disclosure of the information.

    (c) Upon receipt of written objection to disclosure by a submitter, LSC shall consider the submitter's objections and specific grounds for withholding in deciding whether to release the disputed information. Whenever LSC decides to disclose information over the objection of the submitter, LSC shall give the submitter written notice which shall include:

    (1) A description of the information to be released and a notice that LSC intends to release the information;

    (2) A statement of the reason(s) why the submitter's request for withholding is being rejected; and

    (3) Notice that the submitter shall have five business days from the date of the notice of proposed release to appeal that decision to the LSC President or Inspector General (as provided in § 1602.13 (c)), whose decision shall be final.

    (d) The requirements of this section shall not apply if:

    (1) LSC determines upon initial review of the requested confidential commercial information that the requested information should not be disclosed;

    (2) The information has been previously published or officially made available to the public; or

    (3) Disclosure of the information is required by statute (other than FOIA) or LSC's regulations.

    (e) Whenever a requester files a lawsuit seeking to compel disclosure of a submitter's information, LSC shall promptly notify the submitter.

    (f) Whenever LSC provides a submitter with notice and opportunity to oppose disclosure under this section, LSC shall notify the requester that the submitter's rights process under this section has been triggered. Likewise, whenever a submitter files a lawsuit seeking to prevent the disclosure of the submitter's information, LSC shall notify the requester.

    Dated: October 20, 2016. Stefanie K. Davis, Assistant General Counsel.
    [FR Doc. 2016-25832 Filed 10-28-16; 8:45 am] BILLING CODE P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 25 [IB Docket No. 02-34; FCC 16-108] Amendment of the Commission's Space Station Licensing Rules and Policies, Second Order on Reconsideration AGENCY:

    Federal Communications Commission.

    ACTION:

    Final rule.

    SUMMARY:

    The Federal Communications Commission addresses the remaining petitions for reconsideration of the First Space Station Licensing Reform Order, and amends, clarifies, or eliminates certain provisions to streamline its procedures and ease administrative burdens on applicants and licensees.

    DATES:

    Effective November 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Jay Whaley, 202-418-7184, or if concerning the information collections in this document, Cathy Williams, 202-418-2918.

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's Second Order on Reconsideration, FCC 16-108, adopted on August 15, 2016 and released August 16, 2016. The full text of the Second Order on Reconsideration is available at https://apps.fcc.gov/edocs_public/attachmatch/FCC-16-108A1.pdf. It is also available for inspection and copying during business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CYA257, Washington, DC 20554. To request materials in accessible formats for people with disabilities, send an email to [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

    Synopsis

    In the First Space Station Licensing Reform Order, 68 FR 51499, the Commission adopted new satellite licensing procedures intended to enable the Commission to issue satellite licenses more quickly without allowing satellite license applicants to abuse the Commission's licensing procedures. In response, a number of petitions for reconsideration were filed. The Commission addressed those petitions that were focused on the satellite bond requirements in the First Order on Reconsideration and Fifth Report and Order. This Second Order on Reconsideration addresses the remaining petitions for reconsideration of the First Space Station Licensing Reform Order and amends the Commission's rules in order to streamline these new satellite licensing procedures, and to clarify and reaffirm safeguards against subversion of the licensing process, thus furthering the goals of the First Space Station Licensing Reform Order to develop a faster satellite licensing procedure while safeguarding against speculative applications, thereby expediting service to the public.

    NGSO-Like Processing Round Procedure

    We revise section 25.157(e) of the current rules to eliminate the requirement that the Commission withhold spectrum for use in a subsequent processing round if fewer than three qualified applicants file applications in the initial processing round, known as the “three-licensee presumption.” We find that the “three-licensee presumption” is overly restrictive for its intended purpose. We agree with petitioners that a specific frequency band does not necessarily equate to a market, and thus having fewer than three licensees in a band does not necessarily indicate a harmful lack of competition in some market that we should attempt to remedy. We find it common that licensees in different bands compete with each other in the provision of satellite-based services in broader markets, and we note that there are numerous NGSO-like system operators that currently compete across frequency bands.

    We also recognize that in cases where one or more applicants in a processing round request less spectrum than they would be assigned if all the available spectrum were divided equally among all the qualified applicants, some spectrum would remain unassigned, thus we retain the procedure that the Commission adopted in the First Space Station Licensing Reform Order, to redistribute the remaining spectrum among the other qualified applicants who have previously applied for the spectrum. If spectrum still remains, then interested parties would be free to apply for that unassigned spectrum in another processing round.

    Procedures for Redistribution of Spectrum

    We clarify the procedures that apply when we redistribute spectrum among the remaining NGSO-like systems after an authorization for a NGSO-like system has been canceled or otherwise becomes available. This redistribution procedure applies only in cases where spectrum was granted pursuant to a processing round, and one or more of those grants of spectrum is lost or surrendered for any reason. In these cases, the Commission will issue a public notice or order announcing the loss or surrender of such spectrum, and will then propose to modify the remaining grants to redistribute the returned spectrum among the remaining system operators that have requested use of the spectrum. The returned spectrum will generally be redistributed equally among the remaining operators that requested the spectrum, although no operator will receive more spectrum on redistribution than it requested in its application. Additionally, if an operator has not requested use of a particular spectrum band, it will not receive spectrum in that band. If the Commission is unable to make a finding that there will be reasonably efficient use of the spectrum, we will consider on a case-by-case basis whether to open a new processing round for the returned spectrum, leave it unassigned at that point, or repurpose it for another use.

    Safeguards Against Speculation

    In the First Space Station Licensing Reform Order, the Commission eliminated the anti-trafficking rule for satellites, which prohibited satellite licensees from selling “bare” satellite licenses for profit, so as not to prevent a satellite license from being transferred to an entity that would put it to its highest valued use in the shortest amount of time. The Commission put in place certain safeguards, including a determination of whether the seller obtained the license in good faith or for the primary purpose of selling it for profit, whether the licensee made serious efforts to develop a satellite or constellation, and/or whether the licensee faces changed circumstances. Petitioners expressed concern that by making this determination, the Commission would undercut the public interest benefits it identified in eliminating the anti-trafficking rule. We reiterate that this limited exception does not undermine our elimination of the anti-trafficking rule, and we require that parties opposing a transaction based on a seller's motivation to provide, at a minimum, substantial evidence that a satellite license was obtained for purposes of selling the license for profit, thus preventing opponents to a transaction from delaying the transaction on purely frivolous grounds and ensuring that these transactions do not encounter any unwarranted delay.

    In the First Space Station Licensing Reform Order, the Commission adopted a rule prohibiting sales of places in the queue as an additional safeguard against speculation and revised its rules so that an applicant proposing to merge with another company could do so without losing its place in the processing queue. The revised rule treated transfers of control as minor amendments, thus within the queue, and major amendments to applications as newly filed applications, thus moving to the end of the queue. We find that it is not inconsistent to prohibit an applicant from selling its place in the queue, while allowing an applicant that transfers control over itself to a new controlling party to retain its place in the queue, especially when the new company is better positioned to compete in the marketplace, and that an applicant's transfer of control is less likely to be used as an abusive strategy than selling its place in the queue.

    Effect of License Surrender Prior to Milestone Deadlines on Application Limit

    Under section 25.159(d) of the rules, adopted in the First Space Station Licensing Reform Order and commonly referred to as the “Three-Strikes” rule, if a licensee misses three milestones in any three-year period, it is prohibited from filing additional satellite applications if it possesses two satellite applications and/or unbuilt satellites in any frequency band. This limit remains in force until the licensee demonstrates that it would be very likely to construct its licensed facilities if it were allowed to file more applications. The Commission reasoned that a licensee that consistently obtains licenses but does not meet its milestones precludes others from going forward with their business plans while it holds those licenses.

    SES Americom (SES) maintains that the Commission should not consider a licensee's relinquishing a license prior to the contract execution milestone in determining whether to impose the limit on satellite applications and/or unbuilt satellites on that licensee. As an initial matter, we note that the milestone rules have been revised in the Part 25 Review Second R&O to eliminate interim milestones. As a result, there is no longer a contract execution milestone, and thus SES's arguments are now moot in part. However, since we retained the final milestone requirement, any authorization surrendered prior to fulfilling the remaining milestone requirement will continue to be subject to the “Three-Strikes” rule. For the reasons set forth in the Part 25 Review Second R&O, we continue to believe that, on balance, retaining this milestone and the resulting operation of the “Three Strikes” rule best serves the public interest, and we see no compelling justification to counter-balance the public interest benefits in retaining the current requirements. Accordingly, we will continue to presume that these licensees (i.e., those covered under the “Three Strikes” rule) acquired licenses for speculative purposes, and we will restrict the number of additional satellite applications they may file to limit the potential for future speculation while the presumption is in effect.

    Effects of Mergers on Application Limits

    SIA asserts that it is unclear in the First Space Station Licensing Reform Order how the limit on pending and licensed but unlaunched satellites applies to satellite operators that would be formed by the merger of two companies. We clarify that the limit on satellite applications does not prevent the filing of an application for transfer of control or assignment of licenses, even if the combined entities would not meet the limits on pending applications and unbuilt stations specified in the rule. Of course, any such approval of the transfer of control will ultimately be conditioned on the entity coming into compliance with the limits within a reasonable amount of time.1

    1 In ruling on proposed mergers, the Commission routinely assesses “whether the proposed transaction complies with the specific provisions of the Act, other applicable statutes, and the Commission's rules.”

    Needs for Safeguards in Different Parts of the GSO Orbit

    In its Petition, Hughes asserts that the limit on pending applications and licensed-but-unlaunched satellites is not necessary for those orbital locations not covering the United States.2 Hughes also advocates eliminating the bond requirement for applicants for satellites that will operate at non-U.S. orbital locations.3 Hughes proposes to define “U.S.” orbital locations as those within the orbital arc between 60° W.L. and 140° W.L., and to define “non-U.S.” locations as those outside that arc. Hughes argues that the limit should not apply to the “non-U.S.” orbital locations because other Administrations have international coordination priority at many of those locations and because many other Administrations have volatile economies. Hughes argues that the demand for such locations has been “reasoned and measured,” so that the Commission can address them in an orderly fashion.

    2 As noted above, the First Space Station Licensing Reform Order established two limits on pending applications and/or unbuilt satellites, the stricter of the two limits is applicable to licensees that have established a pattern of missing milestones. Hughes maintains that the stricter limit should not apply to orbital locations not covering the United States. We also observed above that the Part 25 Review Second R&O eliminated one of the two limits on pending applications and/or unbuilt satellites and the bond requirement. As a result, this issue is moot.

    3 In the Part 25 Review Second R&O, the Commission adopted significant revisions to the bond requirement adopted in the First Space Station Licensing Reform Order. However, the Commission continues to require a bond for all satellite licenses regardless of the orbit location.

    The purpose of the safeguards in section 25.159 of the Commission's rules is not to reduce the number of satellite applications to a “reasoned and measured” level. Rather, the Commission intended the safeguards to discourage speculators from applying for satellite licenses, thereby precluding another applicant from obtaining a license, constructing a satellite, and providing service to the customers. Hughes assumes that, because fewer applications are filed outside of the arc from 60° W.L. to 140° W.L. than within that arc, speculation is not a concern. Although demand may not be as great for locations that cannot serve large portions of the United States, we have licensed many satellites at orbital locations in this portion of the arc that are subject to competition. We have also granted U.S. market access to many non-U.S.-licensed satellites operating at those locations to provide services to U.S. customers. Thus, allowing operators to hold these orbital locations while they decide whether to proceed with implementation could preclude other operators whose plans also involve providing international service from going forward. For these reasons, we will continue to apply the safeguards against speculation, including the bond requirement, where appropriate, regardless of orbital location.

    Satellite System Implementation Requirements

    In its petition for reconsideration, ICO asserts that the First Space Station Licensing Reform Order does not state clearly that NGSO-like licensees acquiring additional spectrum from other NGSO-like licensees are permitted to implement a single, integrated NGSO system under a single milestone schedule. ICO requests the Commission to clarify that such licensees will not be required to construct multiple separate satellite systems.

    The Commission eliminated the anti-trafficking rule to allow NGSO-like licensees in modified processing rounds to acquire rights to operate on additional spectrum from other licensees if they feel it is necessary to meet their business needs. It would be inefficient to require these licensees to build two incompatible satellite networks, each operating in only part of the spectrum rights that the licensee is authorized to use. We therefore clarify that NGSO-like licensees acquiring spectrum rights from other NGSO-like licensees are permitted to build a single, integrated NGSO-like system operating on all authorized frequency bands, under a single milestone schedule. These cases are inherently fact-specific, and so we decline to adopt a blanket approach about the milestone schedule that would apply in these cases.4 If the milestone schedules of each license differ, we will address, on a case-by-case basis, the particular milestone schedule that will be imposed on the integrated system.

    4 For example, depending on the differences in the milestone schedules, permitting licensees to adopt a schedule with significantly more time might encourage licensees to acquire other licensees merely to gain more time to fulfill their milestone schedules. On the other hand, integrating additional spectrum into a single network may legitimately require more time in some cases.

    Non-U.S.-Licensed Satellites

    Under the terms of the World Trade Organization (WTO) Agreement on Basic Telecommunication Services (WTO Telecom Agreement),5 WTO signatories, including the United States, have made binding commitments to open their markets to foreign competition in satellite services.6 Consistent with those commitments, the Commission adopted DISCO II in 1997 to establish procedures for non-U.S.-licensed satellite operators seeking access to the U.S. market. In the DISCO II First Reconsideration Order, the Commission streamlined those procedures.

    5 The WTO came into being on January 1, 1995, pursuant to the Marrakesh Agreement Establishing the World Trade Organization (the Marrakesh Agreement). The Marrakesh Agreement includes multilateral agreements on the trade in goods, services, intellectual property, and dispute settlement. The General Agreement on Trade in Service (GATS) is Annex 1B of the Marrakesh Agreement. The WTO Telecom Agreement was incorporated into the GATS by the Fourth Protocol to the GATS (April 30, 1996).

    6 The United States made market access commitments for Direct-to-Home (DTH) Service, Direct Broadcast Satellite (DBS) Service, and Digital Audio Radio Service (SDARS), and took an exemption from most-favored nation (MFN) treatment for those services as well. Generally, GATS requires WTO member countries to afford MFN treatment to all other WTO member nations.

    In the First Space Station Licensing Reform Order, the Commission established a procedure for addressing changes in ownership of non-U.S.-licensed satellites. Specifically, when the operator of such a satellite undergoes a change in ownership, the Commission requires the satellite operator to notify the Commission of the change. The Commission then issues a public notice announcing that the transaction has taken place and inviting comment on whether the transaction affects any of the considerations made when the original satellite operator was allowed to enter the U.S. market. In addition, if control of the satellite was transferred to an operator not based in a WTO member country, the Commission would invite comment on whether the purchaser has satisfied all applicable DISCO II requirements. The Commission then determines whether any commenter raised any concern that would warrant precluding the new operator from entering the U.S. market, including concerns relating to national security, law enforcement, foreign policy, or trade issues.

    According to SIA, the rule revisions adopted in the First Space Station Licensing Reform Order to implement this satellite transfer procedure do not state clearly that satellite operators are allowed to notify the Commission of transfers of ownership of satellites after the transfer takes place. SIA asks us to revise section 25.137(g) of the Commission's rules to make clear that non-U.S.-satellite operators may notify the Commission of a change of ownership after the transfer takes place. We will do so. The Commission did not intend to require foreign entities to notify the Commission of the transaction before it had been completed. Rather, the Commission adopted its proposal in the Space Station Licensing Reform NPRM to address such changes in ownership by “issuing a public notice announcing that the transaction has taken place.” Therefore, we revise section 25.137(g) as SIA suggests, as set forth in Appendix B of the Second Order on Reconsideration. We also clarify that parties must notify the Commission within 30 days after consummation of the transaction in order to enable the Commission to perform the review described in the First Space Station Licensing Reform Order in a meaningful and timely manner while the new foreign operator is permitted to access the U.S. market.

    Further, in the First Space Station Licensing Reform Order, the Commission stated that operators requesting authority to provide service in the United States from a foreign-licensed satellite must file Form 312 (Application for Satellite Space and Earth Station Authorizations). Hughes asserts that the electronic Form 312 does not allow a non-U.S.-licensed satellite operator to indicate that it is not seeking a Commission license, but is instead seeking U.S. market access. Hughes also questions whether parties seeking U.S. market access must file their requests electronically. First, contrary to Hughes's assertion, the electronic version of Form 312 provides a place to indicate that the applicant is filing for a petition for declaratory ruling, which is the procedure for requesting U.S. market access. Second, the Commission stated explicitly in the First Space Station Licensing Reform Order that U.S. market access requests must be filed electronically, and we continue to believe that mandatory electronic filing serves the public interest by facilitating prompt receipt of petitions for declaratory ruling and accurate recording of the time of filing under the first-come, first-served processing procedure, and by providing other administrative efficiencies.

    ITU Priority

    In the First Space Station Licensing Reform Order, the Commission discussed the interrelationship between its domestic licensing framework and the international coordination framework set forth in the Radio Regulations of the International Telecommunication Union (ITU). Hughes requests that we clarify how we will determine whether to grant or deny market access requests from non-U.S.-licensed satellite operators, particularly in cases where a non-U.S. operator has ITU coordination date-filing priority, i.e., an earlier ITU protection date, but is behind a U.S. applicant in the U.S. space station queue. In particular, Hughes argues that the first-come, first-served procedure should not “block” a non-U.S.-licensed satellite operator with ITU priority.

    The Commission discussed international coordination issues in the First Space Station Licensing Reform Order. Specifically, the Commission stated that it will license satellites at orbital locations at which another Administration has ITU priority. In fact, if a later-filed market access request—with or without ITU priority—is mutually exclusive with an earlier-filed, granted application, it may be dismissed absent a coordination agreement between the applicants. The Commission further stated, however, that it will issue the earlier-filed authorization subject to the outcome of the international coordination process, and emphasized that the Commission is not responsible for the success or failure of the required international coordination. Absent such coordination, a U.S.-licensed satellite making use of an ITU filing with a later protection date would be required to cease service to the U.S. market immediately upon launch and operation of a non-U.S.-licensed satellite with an earlier protection date, or be subject to further conditions. We continue to follow this general approach today.

    Modifications

    Hughes notes that the rule revisions adopted in the First Space Station Licensing Reform Order require the Commission to treat modification requests involving new orbital locations or new frequency bands in the application processing queue, and other modification requests outside of the queue. Hughes supports this approach, but asserts that the Commission stated elsewhere in the First Space Station Licensing Reform Order that, unless it could categorically classify certain modification requests involving new frequencies or orbital locations as “minor,” it would treat all such modification requests in the processing queue. Hughes requests the Commission to reconcile these two statements.

    In the First Space Station Licensing Reform Order, the Commission revised its rules to adopt a clear, simple test for determining whether to process a modification request in the processing queue: modification requests involving new orbital locations or new frequency bands are considered in the queue, and other modifications are considered outside of the queue.7 We clarify here that nothing in the text of the First Space Station Licensing Reform Order was intended to alter the Commission's decision to consider modification requests in this fashion. The Commission also suggested, however, that it could, at a later date, adopt rules to define certain modification requests involving new orbital locations as minor, and to consider such modification requests outside the queue. In this regard, in the Second Space Station Licensing Reform Order, the Commission decided to treat certain fleet management modification requests involving orbital reassignment of specific satellites outside the queue. We affirm, however, that, absent a rulemaking finding public interest reasons to create additional exceptions, we will continue to process orbital reassignment and frequency modification requests as set forth in section 25.117(d)(2)(iii).

    7 The Commission adopted this test instead of a more complex proposal to place “major” modification requests in the queue, and to define “major” modification requests as those that would “degrade the interference environment.”

    Supplemental Final Regulatory Flexibility Analysis

    As required by the Regulatory Flexibility Act (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Further Notice of Proposed Rulemaking in the Matter of Comprehensive Review of Licensing and Operating Rules for Satellite Services. The Commission sought written public comment on the proposals in the Further Notice, including comment on the IRFA. No comments were received on the IRFA. This Final Regulatory Flexibility Analysis (FRFA) conforms to the RFA.

    Paperwork Reduction Act

    This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. Therefore it does not contain any new or modified “information burden for small business concerns with fewer than 25 employees” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198. Thus, on October 14, 2016, the Office of Management and Budget (OMB) determined that the rule changes in this document are non-substantive changes to the currently approved collection, OMB Control Number 3060-0678. ICR Reference Number: 201610-3060-011.

    Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), we previously sought specific comment on how the Commission might further reduce the information collection burden for small business concerns with fewer than 25 employees. We received no comments on this issue. We have assessed the effects of the revisions adopted that might impose information collection burdens on small business concerns, and find that the impact on businesses with fewer than 25 employees will be an overall reduction in burden. The amendments adopted in this Second Order on Reconsideration eliminate unnecessary information filing requirements for licensees and applicants; eliminate unnecessary technical restrictions and enable applicants and licensees to conserve time, effort, and expense in preparing applications and reports. Overall, these changes may have a greater positive impact on small business entities with more limited resources.

    Congressional Review Act

    The Commission will send copies of this Second Order on Reconsideration to Congress and the General Accountability Office pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A).

    Effective Date

    The effective date for the rules adopted in this Second Order on Reconsideration is 30 days after date of publication in the Federal Register.

    Need for, and Objectives of, the Rules

    This Order adopts minor changes to part 25 of the Commission's rules, which governs licensing and operation of space stations and earth stations for the provision of satellite communication services.8 We revise the rules to, among other things, further the goals of the First Space Station Licensing Reform Order to develop a faster satellite licensing procedure while safeguarding against speculative applications, thereby expediting service to the public.

    8 47 CFR part 25, Satellite Communications.

    This Order revises two sections of part 25 of the rules. Specifically, it revises the rules to:

    (1) Eliminate the “three-licensee presumption” that applies to the NGSO-like processing round procedure, and also revise the procedures that we will apply when we redistribute spectrum among remaining NGSO-like licensees when a license is cancelled for any reason.

    (2) Clarify that non-U.S.-satellite operators may notify the Commission of a change of ownership after the transfer takes place.

    Summary of Significant Issues Raised by Public Comments in Response to the IRFA

    No party filing comments in this proceeding responded to the IRFA, and no party filing comments in this proceeding otherwise argued that the policies and rules proposed in this proceeding would have a significant economic impact on a substantial number of small entities. The Commission has, nonetheless, considered any potential significant economic impact that the rule changes may have on the small entities which are impacted. On balance, the Commission believes that the economic impact on small entities will be positive rather than negative, and that the rule changes move to streamline the part 25 requirements.

    Response to Comments by the Chief Counsel for Advocacy of the Small Business Administration

    Pursuant to the Small Business Jobs Act of 2010, the Commission is required to respond to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration, and to provide a detailed statement of any change made to the proposed rules as a result of those comments. The Chief Counsel did not file any comments in response to the proposed rules in this proceeding.

    Description and Estimate of the Number of Small Entities to Which the Rules May Apply

    The RFA directs agencies to provide a description of, and, where feasible, an estimate of, the number of small entities that may be affected by the rules adopted herein. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). Below, we describe and estimate the number of small entity licensees that may be affected by the adopted rules.

    Satellite Telecommunications and All Other Telecommunications

    The rules adopted in this Order will affect some providers of satellite telecommunications services. Satellite telecommunications service providers include satellite and earth station operators. Since 2007, the SBA has recognized two census categories for satellite telecommunications firms: “Satellite Telecommunications” and “Other Telecommunications.” Under the “Satellite Telecommunications” category, a business is considered small if it had $32.5 million or less in annual receipts. Under the “Other Telecommunications” category, a business is considered small if it had $32.5 million or less in annual receipts.

    The first category of Satellite Telecommunications “comprises establishments primarily engaged in providing point-to-point telecommunications services to other establishments in the telecommunications and broadcasting industries by forwarding and receiving communications signals via a system of satellites or reselling satellite telecommunications.” For this category, Census Bureau data for 2007 show that there were a total of 512 satellite communications firms that operated for the entire year. Of this total, 482 firms had annual receipts of under $25 million.

    The second category of Other Telecommunications is comprised of entities “primarily engaged in providing specialized telecommunications services, such as satellite tracking, communications telemetry, and radar station operation. This industry also includes establishments primarily engaged in providing satellite terminal stations and associated facilities connected with one or more terrestrial systems and capable of transmitting telecommunications to, and receiving telecommunications from, satellite systems. Establishments providing Internet services or voice over Internet protocol (VoIP) services via client-supplied telecommunications connections are also included in this industry.” For this category, Census Bureau data for 2007 show that there were a total of 2,383 firms that operated for the entire year. Of this total, 2,346 firms had annual receipts of under $25 million. We anticipate that some of these “Other Telecommunications firms,” which are small entities, are earth station applicants/licensees that will be affected by our adopted rule changes.

    We anticipate that our rule changes will have an impact on space station applicants and licensees. Space station applicants and licensees, however, rarely qualify under the definition of a small entity. Generally, space stations cost hundreds of millions of dollars to construct, launch and operate. Consequently, we do not anticipate that any space station operators are small entities that would be affected by our actions.

    Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements for Small Entities

    The Order adopts a number of rule changes that will affect reporting, recordkeeping and other compliance requirements for space station operators. These changes, as described below, will decrease the burden for all businesses operators, especially firms that are applicants for licenses to operate NGSO-like space stations.

    We simplify the rules to facilitate improved compliance. First, the Order simplifies information collections in applications for NGSO-like space station licenses. Specifically, the Order eliminates reporting requirements that are more burdensome than necessary. For example, the Order removes the “three-licensee presumption,” a rebuttable presumption that assumes, for purposes of the modified processing round procedure for NGSO-like space station applications, a sufficient number of licensees in the frequency band is three, and if the processing round results in less than three applicants, 1/3 of the spectrum in the allocated band will be reserved for an additional processing round. To rebut this presumption, a party must provide convincing evidence that allowing less than three licensees in the frequency band will result in extraordinarily large, cognizable, and non-speculative efficiencies. Thus, applicants for NGSO-like space stations will not need to expend resources, both technical and legal, to demonstrate that their NGSO-like systems are designed to provide such efficiencies in order to rebut the three-licensee presumption. Furthermore, in cases where spectrum was granted pursuant to a processing round, and one or more of those grants of spectrum is lost or surrendered for any reason, the rules now allow for the returned spectrum to be redistributed without automatically triggering a new processing round and the corresponding costs and paperwork involved, thus reducing the administrative burdens on those applicants.

    Another example is that we see no reason to require non-U.S.-satellite operators with satellites on the Permitted List to notify the Commission of a change of ownership before the transfer takes place. Thus, we revise our rule to state clearly that non-U.S.-satellite operators are allowed to notify the Commission of transfers of ownership of Permitted List satellites after the transfer takes place. Thus, these satellite operators are relieved of any additional burden that could result from a delay in completing a transfer of Permitted List satellites pending Commission approval.

    Steps Taken To Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered

    The RFA requires an agency to describe any significant, specifically small business, alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rules for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.”

    The Commission is aware that some of the revisions may impact small entities. The First Space Station Licensing Reform Order sought comment from all interested parties, and small entities were encouraged to bring to the Commission's attention any specific concerns they may have with the proposals outlined in the First Space Station Licensing Reform Order. No commenters raised any specific concerns about the impact of the revisions on small entities. This order adopts rule revisions to modernize the rules and advance the satellite industry. The revisions eliminate unnecessary requirements and expand routine processing to applications in additional frequency bands, among other changes. Together, the revisions in this Order lessen the burden of compliance on small entities with more limited resources than larger entities.

    The adopted changes for NGSO-like space station licensing clarify requirements for NGSO-like modified processing rounds. Each of these changes will lessen the burden in the licensing process. Specifically, this Order adopts revisions to reduce filing requirements and clarify the procedures for redistribution of surrendered spectrum in such a way that applicant burden will be reduced. Thus, the revisions will ultimately lead to benefits for small NGSO-like space station operators in the long-term.

    Report to Congress

    The Commission will send a copy of this Second Report and Order, including this FRFA, in a report to be sent to Congress pursuant to the Congressional Review Act. In addition, the Commission will send a copy of this Order, including this FRFA, to the Chief Counsel for Advocacy of the SBA. A copy of this Report and Order and FRFA (or summaries thereof) will also be published in the Federal Register.

    Legal Basis

    The action is authorized under sections 4(i), 7(a), 303(c), 303(f), 303(g), and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 157(a), 161, 303(c), 303(f), 303(g), and 303(r).

    Ordering Clauses

    It is ordered, that pursuant to sections 4(i), 301, 302, 303(r), 308, 309, and 310 of the Communications Act, 47 U.S.C. 154(i), 301, 302, 303(r), 308, 309, and 310, and section 1.429 of the Commission's rules, 47 CFR 1.429, the petitions for reconsideration listed in Appendix A to the Second Order on Reconsideration are granted in part, denied in part, and dismissed as moot in part, to the extent indicated above.

    It is further ordered, pursuant to sections 4(i), 7(a), 303(c), 303(f), 303(g), and 303(r) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 157(a), 303(c), 303(f), 303(g), 303(r), that this Second Order on Reconsideration in IB Docket 02-34 is hereby adopted.

    It is further ordered, that part 25 of the Commission's Rules is amended as set forth in Appendix B of the Second Order on Reconsideration and section 25.157 is revised to remove the “three-licensee presumption” as well as the requirement that the Commission withhold spectrum for use in a subsequent processing round if fewer than three qualified applicants are licensed in the initial processing round.

    It is further ordered, that section 25.137(g) is amended to clarify that satellite operators are allowed to notify the Commission of transfers of ownership of Permitted List satellites after the transfer takes place.

    It is further ordered, that all rule revisions will be effective on the same date, which will be announced in a Public Notice.

    It is further ordered, that the Consumer Information Bureau, Reference Information Center, shall send a copy of this Order, including the Final Regulatory Flexibility Certification, to the Chief Counsel for Advocacy of the Small Business Administration.

    It is further ordered, that the Chief, International Bureau is delegated authority to modify satellite licenses consistent with the provisions of this Order above.

    It is further ordered, that this proceeding is terminated pursuant to section 4(i) and 4(j) of the Communications Act, 47 U.S.C. 154(i) and (j), absent applications for review or further appeals of this Second Order on Reconsideration.

    Federal Communications Commission. Marlene H. Dortch, Secretary. List of Subjects in 47 CFR Part 25

    Administrative practice and procedure, Earth stations, Satellites.

    For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 25 as follows:

    PART 25—SATELLITE COMMUNICATIONS 1. The authority citation for part 25 continues to read as follows: Authority:

    Interprets or applies 47 U.S.C. 154, 301, 302, 303, 307, 309, 310, 319, 332, 605, and 721, unless otherwise noted.

    2. Revise § 25.137(g) to read as follows:
    § 25.137 Requests for U.S. market access through non-U.S.-licensed space stations.

    (g) A non-U.S.-licensed satellite operator that acquires control of a non-U.S.-licensed space station that has been permitted to serve the United States must notify the Commission within 30 days after consummation of the transaction so that the Commission can afford interested parties an opportunity to comment on whether the transaction affected any of the considerations we made when we allowed the satellite operator to enter the U.S. market. A non-U.S.-licensed satellite that has been transferred to new owners may continue to provide service in the United States unless and until the Commission determines otherwise. If the transferee or assignee is not licensed by, or seeking a license from, a country that is a member of the World Trade Organization for services covered under the World Trade Organization Basic Telecommunications Agreement, the non-U.S.-licensed satellite operator will be required to make the showing described in paragraph (a) of this section.

    3. Amend § 25.157 by revising paragraph (e) and removing paragraph (g)(3) to read as follows:

    (e)(1) In the event that there is insufficient spectrum in the frequency band available to accommodate all the qualified applicants in a processing round, the available spectrum will be divided equally among the licensees whose applications are granted pursuant to paragraph (d) of this section, except as set forth in paragraph (e)(2) of this section.

    (2) In cases where one or more applicants apply for less spectrum than they would be warranted under paragraph (e)(1) of this section, those applicants will be assigned the bandwidth amount they requested in their applications. In those cases, the remaining qualified applicants will be assigned the lesser of the amount of spectrum they requested in their applications, or the amount of spectrum that they would be assigned if the available spectrum were divided equally among the remaining qualified applicants.

    [FR Doc. 2016-25935 Filed 10-28-16; 8:45 am] BILLING CODE 6712-01-P
    NATIONAL AERONAUTICS AND SPACE ADMINISTRATION 48 CFR Parts 1801, 1843 and 1852 RIN 2700-AE35 NASA Federal Acquisition Regulation Supplement: Remove NASA FAR Supplement Clause Engineering Change Proposals (2016-N030) AGENCY:

    National Aeronautics and Space Administration.

    ACTION:

    Final rule.

    SUMMARY:

    NASA is issuing a final rule amending the NASA Federal Acquisition Regulation Supplement (NFS) to remove the Engineering Change Proposals (ECPs) basic clause with its Alternate I & II and associated information collection from the NFS.

    DATES:

    Effective: November 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Andrew O'Rourke, telephone 202-358-4560.

    SUPPLEMENTARY INFORMATION:

    I. Background

    NASA published a proposed rule in the Federal Register at 81 FR 54783 on August 17, 2016, to amend the NFS to remove contract clause 1852.243-70, Engineering Change Proposals (ECPs) with its Alternate I & II and associated information collection from the NFS. Six comments were received in response to the proposed rule.

    II. Discussion and Analysis

    NASA reviewed the public comments received in the development of the final rule. The six comments received were advertisements for personal services from the same respondent and completely unrelated to the purpose of this rule. Therefore, no change was made to the final rule as a result of the public comments received.

    III. Executive Orders 12866 and 13563

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

    IV. Regulatory Flexibility Act

    A final regulatory flexibility analysis has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., and is summarized as follows:

    The National Aeronautics and Space Administration (NASA) is issuing a final rule to amend the NASA FAR Supplement (NFS) to remove NFS clause 1852.243-70, Engineering Change Proposals (ECPs) basic clause with its Alternate I & II and associated information collection from the NFS because the NFS clause is no longer used in procurements and is duplicative to FAR requirements. NASA conducted a retrospective review of its regulations and determined NFS clause 1852.243-70 should be removed along with the corresponding information collection requirement OMB Control No. 2700—054.

    No changes were made to the final rule as a result of public comments received. Comments received in response to the proposed rule were advertisements for personal services and deemed out of scope.

    NASA does not expect this final rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., because we are removing a NFS clause and its associated information collection requirements for contractors. By removing this clause, the information collection burden on contractors will be reduced, thus providing all entities, both large and small, with a positive benefit.

    This rule does not include any new reporting, recordkeeping, or other compliance requirements for small businesses. There are no significant alternatives that could further minimize the already minimal impact on businesses, small or large.

    V. Paperwork Reduction Act

    The rule contains information collection requirements that require the approval of the OMB under the Paperwork Reduction Act (44 U.S.C. chapter 35); however, the changes to the NFS removes the information collection requirements previously approved under OMB Control Number 2700-0054, entitled NFS 1843 Contract Modifications for Engineering Change Proposals (ECP).

    List of Subjects in 48 CFR Parts 1801, 1843, and 1852

    Government procurement.

    Manuel Quinones, NASA FAR Supplement Manager.

    Accordingly, 48 CFR parts 1801, 1843, and 1852 are amended as follows:

    1. The authority citation for parts 1801, 1843 and 1852 continues to read as follows: Authority:

    51 U.S.C. 20113(a) and 48 CFR chapter 1.

    PART 1801—FEDERAL ACQUISITION REGULATIONS SYSTEM 2. Revise section 1801.106 to read as follows:

    1801.106 OMB approval under the Paperwork Reduction Act.

    The following OMB control numbers apply:

    NFS Segment OMB
  • control
  • No.
  • 1823 2700-0089 1827 2700-0052 1852.223-70 2700-0160 NF 533 2700-0003 NF 1018 2700-0017
    PART 1843—CONTRACT MODIFICATIONS 3. Revise section 1843.205-70 to read as follows:
    1843.205-70 NASA contract clauses.

    The contracting officer may insert a clause substantially as stated at 1852.243-72, Equitable Adjustments, in solicitations and contracts for—

    (a) Dismantling, demolishing, or removing improvements; or

    (b) Construction, when the contract amount is expected to exceed the simplified acquisition threshold and a fixed-price contract is contemplated.

    PART 1852—SOLICITATION PROVISIONS AND CONTRACT CLAUSES
    1852.243-70 [Removed and Reserved]
    4. Section 1852.243-70 is removed and reserved.
    1852.243-72 [Amended]
    5. Amend section 1852.243-72 by removing “1843.205-70(b)” and adding “1843.205-70” in its place.
    [FR Doc. 2016-26174 Filed 10-28-16; 8:45 am] BILLING CODE 7510-13-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150818742-6210-02] RIN 0648-XF007 Fisheries of the Exclusive Economic Zone Off Alaska; Groundfish by Vessels Using Trawl Gear in the of the Gulf of Alaska AGENCY:

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

    ACTION:

    Temporary rule; opening.

    SUMMARY:

    NMFS is opening directed fishing for groundfish by vessels using trawl gear in the Gulf of Alaska (GOA). This action is necessary to fully use the 2016 groundfish total allowable catch in the GOA.

    DATES:

    Effective 1200 hours, Alaska local time (A.l.t.), October 28, 2016, through 2400 hours, A.l.t., December 31, 2016.

    Comments must be received at the following address no later than 4:30 p.m., A.l.t., November 15, 2016.

    ADDRESSES:

    You may submit comments on this document, identified by FDMS Docket Number NOAA-NMFS-2015-0110, by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2015-0110, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Address written comments to Glenn Merrill, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region NMFS, Attn: Ellen Sebastian. Mail comments to P.O. Box 21668, Juneau, AK 99802-1668.

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous). Attachments to electronic comments will be accepted in Microsoft Word, Excel, or Adobe PDF file formats only.

    FOR FURTHER INFORMATION CONTACT:

    Josh Keaton 907-586-7228.

    SUPPLEMENTARY INFORMATION:

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

    NMFS prohibited directed fishing for groundfish by vessels using trawl gear in the GOA, effective 1200 hours, A.l.t., October 22, 2016 (81 FR 74313) under § 679.21(d)(6)(i). That action was necessary because the annual prohibited species catch (PSC) limit for Pacific halibut specified for vessels using trawl gear in the GOA was reached.

    As of October 25, 2016, NMFS has determined that approximately 250 metric tons of the trawl Pacific halibut PSC limit remains. Therefore, in accordance with § 679.25(a)(1)(i), (a)(2)(i)(C), and (a)(2)(iii)(D), and to fully utilize the 2016 groundfish total allowable catch, NMFS is terminating the previous closure and is opening directed fishing for groundfish by vessels using trawl gear in the GOA. The Administrator, Alaska Region (Regional Administrator) considered the following factors in reaching this decision: (1) The current harvest of Pacific halibut PSC in the trawl fishery the of the GOA and, (2) the harvest capacity and stated intent on future harvesting patterns of vessels in participating in this fishery.

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the opening of directed fishing for groundfish by vessels using trawl gear in the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 25, 2016.

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

    Without this inseason adjustment, NMFS could not allow the trawl deep-water species fishery in the GOA to be harvested in an expedient manner and in accordance with the regulatory schedule. Under § 679.25(c)(2), interested persons are invited to submit written comments on this action to the above address until November 15, 2016.

    This action is required by §§ 679.21 and 679.25 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: October 26, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-26221 Filed 10-26-16; 4:15 pm] BILLING CODE 3510-22-P
    81 210 Monday, October 31, 2016 Proposed Rules DEPARTMENT OF TRANSPORTATION Office of the Secretary 14 CFR Part 259 [Docket No. DOT-OST-2016-0208] RIN 2105-AE53 Refunding Baggage Fees for Delayed Checked Bags AGENCY:

    Office of the Secretary (OST), Department of Transportation (DOT).

    ACTION:

    Advance notice of proposed rulemaking (ANPRM).

    SUMMARY:

    The Department of Transportation (DOT or Department) is soliciting public comment and feedback on various issues related to the requirement for airlines to refund checked baggage fees when they fail to deliver the bags in a timely manner, as provided by the FAA Extension, Safety, and Security Act of 2016.

    DATES:

    Comments should be filed by November 30, 2016. Late-filed comments will be considered to the extent practicable.

    ADDRESSES:

    You may file comments identified by the docket number DOT-OST-2016-0208 by any of the following methods:

    Federal eRulemaking Portal: go to http://www.regulations.gov and follow the online instructions for submitting comments.

    Mail: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Ave. SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001.

    Hand Delivery or Courier: West Building Ground Floor, Room W12-140, 1200 New Jersey Ave. SE., Washington, DC, between 9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays.

    Fax: (202) 493-2251.

    Instructions: You must include the agency name and docket number DOT-OST-2016-0208 or the Regulatory Identification Number (RIN) for the rulemaking at the beginning of your comment. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided.

    Privacy Act: Anyone is able to search the electronic form of all comments received in any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act statement in the Federal Register published on April 11, 2000 (65 FR 19477-78), or you may visit http://DocketsInfo.dot.gov.

    Docket: For access to the docket to read background documents and comments received, go to http://www.regulations.gov or to the street address listed above. Follow the online instructions for accessing the docket.

    FOR FURTHER INFORMATION CONTACT:

    Clereece Kroha, Senior Trial Attorney, Office of the Assistant General Counsel for Aviation Enforcement and Proceedings, U.S. Department of Transportation, 1200 New Jersey Ave. SE., Washington, DC 20590, 202-366-9342 (phone), 202-366-7152 (fax), [email protected] (email).

    SUPPLEMENTARY INFORMATION:

    The Department of Transportation (DOT or Department) is seeking comment on the appropriate means to implement a requirement in recent legislation for airlines to refund checked baggage fees when they fail to deliver the bags in a timely manner. Specifically, the Department seeks comment on how to define a baggage delay, and the appropriate method for providing the refund for delayed baggage.

    Background

    On April 25, 2011, the Department of Transportation published its second Enhancing Airline Passenger Protections final rule that requires, among other things, that U.S. and foreign air carriers adopt and adhere to a customer service plan that addresses various consumer issues. See 76 FR 23110 (April 25, 2011). In the proposal preceding that final rule, the Department solicited comments on whether we should include as standards: (1) That carriers reimburse passengers the fee charged to transport a bag if that bag is lost or not timely delivered, and (2) the time when a bag should be considered not to have been timely delivered (e.g., delivered on same or earlier flight than the passenger, delivered within 2 hours of the passenger's arrival). After reviewing the comments received, we adopted in the final rule a customer service standard that requires carriers to reimburse passengers for any fee charged to transport a bag if the bag is lost. We decided to not require carriers to reimburse passengers for any fee charged to transport a bag that is not timely delivered. In making this determination, we stated that, as is the case with transporting passengers, while delay in receiving baggage may be inconvenient, once the carrier delivers a bag, the service has been performed. We clarified that although not required to refund baggage fees in the case of delayed delivery of a checked bag, carriers must comply with the Department's baggage liability rule, 14 CFR part 254, and applicable international agreements, to compensate passengers for direct or consequential damages resulting from the delay in delivering of luggage, up to the limits set by the rule and the agreements.

    Baggage fees, along with other ancillary fees, have become an increasingly important component of the airline industry's revenue structure. According to data from the Department's Bureau of Transportation Statistics (BTS), the top 13 U.S. carriers collectively generated over $3.8 billion in revenue in 2015 from baggage fees.1 While we have no doubt that airlines continue to invest in baggage handling infrastructure and technology to improve the efficiency and quality of their services, we also realize that baggage delays do occur and affect many consumers on a daily basis. Data from the Department's Air Travel Consumer Report demonstrate that, in 2015, the 13 largest U.S. carriers received close to 2 million mishandled baggage reports from passengers for their domestic scheduled flights.2 Although these mishandled baggage reports also include reports of lost, damaged, and pilfered baggage in addition to delayed baggage, this figure suggests that the number of delayed baggage incidents is likely significant.3 Since the issuance of the 2011 final rule in which the Department decided not to require airlines to refund baggage fees for delayed bags, many consumers and consumer rights advocacy groups have voiced their opinion that airlines should be required to refund checked baggage fees if they fail to deliver bags on time.

    1 Source: Baggage Fees by Airline 2015, Bureau of Transportation Statistics, Office of the Assistant Secretary for Research and Technology, updated on May 2, 2016. https://www.rita.dot.gov/bts/sites/rita.dot.gov.bts/files/subject_areas/airline_information/baggage_fees/html/2015.html.

    2 Source: Air Travel Consumer Report, February 2016 Edition, Page 31. https://www.rita.dot.gov/bts/sites/rita.dot.gov.bts/files/subject_areas/airline_information/baggage_fees/html/2015.html. The Department does not collect information on mishandled baggage for international flights.

    3 The mishandled baggage data as reported to the Department is based on the number of mishandled baggage reports received from passengers by the reporting carriers. Each report may involve more than one piece of mishandled baggage.

    This matter has also caught the attention of the Congress. In 2016, both the Senate and the House of Representatives included in their Federal Aviation Administration reauthorization bills a provision to require the Department to issue a rule that mandates refunds of baggage fees for delayed bags.4 On July 15, 2016, the President signed into law the FAA Extension, Safety, and Security Act of 2016 (“FAA Extension Act” or “Act”) which includes a requirement for the Department to issue a rule mandating that airlines provide automated refunds to passengers for any fee charged to transport a bag if the bag is delayed.5

    4 Sec. 3109, Federal Aviation Administration Reauthorization Act of 2016, S. 2658, 114th Cong. (2015-2016); Sec. 507, Aviation Innovation, Reform, and Reauthorization Act of 2016, H.R. 4441, 114th Cong. (2015-2016).

    5 See, FAA Extension, Safety, and Security Act of 2016, Public Law 114-190, July 15, 2016.

    Defining a Baggage Delay

    Section 2305 of the FAA Extension Act provides that the Department shall issue a final rule within one year of the enactment of the Act that requires U.S. and foreign carriers to promptly provide an automated refund for any ancillary fees paid by the passenger for checked baggage if the carriers fail to deliver the bag to passengers within 12 hours of arrival for domestic flights and within 15 hours of arrival for international flights, if the passenger notifies the carrier about the delayed or lost baggage. The Act also allows the Department to extend these timeframes to up to 18 hours for domestic flights and up to 30 hours for international flights, if the Department determines that the 12-hour or 15-hour standards are not feasible and would adversely affect consumers in certain cases.

    Each delayed bag affects an individual passenger's travel experience, resulting in inconvenience and other harms. The Department is seeking comments from all stakeholders in order to determine how to implement section 2305 of the Act so the mandated regulation would best achieve Congress' and the Department's goal of mitigating the inconvenience and harm to consumers caused by delayed baggage.

    DOT is seeking comment to help it determine the appropriate length of delay within the statutory parameters that would trigger the refund requirement. As stated above, the Act provides that a refund should be issued to passengers if the carrier fails to deliver the checked baggage to the passenger not later than 12 hours after the arrival of a domestic flight, or not later than 15 hours after the arrival of an international flight. The Act also authorizes the Department to extend these timeframes to up to 18 hours for domestic flights and 30 hours for international flights if the Secretary determines that the 12-hour or 15-hour standards are infeasible and would “adversely affect consumers in certain cases.” The Department invites public input on the 12 and 15 hour standards prescribed in the Act as well as any other standards within the statutory parameters, which are for domestic flights between 12 and 18 hours after the flight's arrival and for international flights between 15 and 30 hours after the flight's arrival. The Department seeks comment on why a particular length of time within this timeframe would be more appropriate than other times.

    The Department also seeks comment on how the rule should deal with a passenger itinerary that consists of an international flight connecting to a domestic flight. Is there a reason that this itinerary should be considered an international flight within the meaning of the statute, or does the final domestic flight cause the passenger to be treated as domestic for purposes of the statute and rule? Is there a reason to distinguish between a standard interline (i.e., multiple-carrier) connection on a single ticket and a connection constructed by the passenger using two tickets (e.g., where the carriers do not interline with each other)?

    We solicit comments on the ways in which standard industry practice for baggage interlining and mishandled baggage may affect the mandated rule. For example, the last carrier on an interline itinerary is generally responsible for handling a mishandled-baggage report to conclusion, but on a baggage delay on an interline trip this will generally not be the carrier to whom the passenger paid the baggage fee.

    In addition to situations, such as interline, in which there are multiple entities involved in the transportation of bags, there are also situations in which there are multiple entities involved in the transactions of bag fees. Specifically, although not a common practice among most carriers, there are instances in which a carrier authorizes a ticket agent, by contractual agreement, to collect baggage fees from the ticket agent's customers on behalf of the carrier. To the extent an entity other than the carrier is involved in collecting baggage fees, we seek comments on who should be held responsible to refund the bag fees for delayed bags. Should we hold both entities responsible? Based on the structure of the agreement between the two entities, and common business practice, what is the best way to ensure that bag fees are refunded in a timely manner and to avoid passengers being sent back and forth between two entities to determine which entity is responsible?

    As the statute gives the Department some flexibility to modify the length of delay taking into consideration feasibility and any negative impact on consumers, we construe the statute's use of the phrase “in certain cases” to mean that Congress intends to provide the Department the flexibility to differentiate the length of delay that triggers a refund based on certain circumstances, if appropriate, instead of applying one standard to all domestic flights, and another standard to all international flights, if the Department determines this is appropriate. In that regard, in addition to domestic versus international flights, is there a reason that the rule should establish a secondary set of criteria, such as the flight duration and/or the frequency of service in question? Is the frequency of the operation by the transporting carrier or all carriers that operate on the same route relevant to defining the delay? Since some international flights are short haul flights (e.g., trans-border flights), and some domestic flights can last for over 10 hours (e.g., New York to Honolulu), should we instead tier the delay standard based on the length of the passenger's flight(s)?

    DOT is also seeking comment on how to determine when the clock stops running for purposes of measuring the delay. The Act provides that the 12 hour and 15 hour clock stops when the carrier “delivers the checked baggage to the passenger.” Sometimes, a passenger may stay at the arrival airport and wait for the delayed baggage if the delay is likely to be within a few hours. However, when the delay goes beyond a certain point, the industry's common practice is to deliver the bags to the passenger's residence or a designated location requested by the passenger. In some cases, the passengers may choose to receive notice when their bags arrive and pick up the bags at the carrier's baggage office at the destination airport. How should we determine that the bags have been “delivered” to the passenger and therefore stop the clock from running in each of these situations?

    DOT seeks comment on the number of bags that are delayed annually based on the 12 and 18 hour and 15 and 30 hour statutory timeframes, and lost bags. The Department receives information on the number of mishandled-baggage reports filed by passengers, but we do not have data on how many of these are delayed bags, and how many are lost. Information on the number of delayed and lost bags that would be affected by this rulemaking would help the Department to better estimate the impact this rule would have on consumers and airlines.

    Method for Refunding Delayed Baggage

    The Department is also seeking comment on the appropriate method for providing a refund for delayed baggage. The Department's credit card refund regulation, 14 CFR part 374, implements the Consumer Credit Protection Act and Regulation Z of the Board of Governors of the Federal Reserve System, 15 U.S.C. 1601-1693r and 12 CFR part 226 (Regulation Z) with respect to air carriers and foreign air carriers. It states that when refunds are due on purchases with a credit card, a carrier must transmit a credit statement to the credit card issuer within seven business days of receipt of full documentation for the refund requested. In addition, the Department requires that, with respect to purchases with forms of payment other than credit cards, an airline must provide a refund within 20 days of receipt of full documentation of such a request. See 14 CFR 259.5(b)(5). The Department applies these refund standards to all refunds that are due to consumers, including airfare refunds and ancillary fee refunds. In order to receive a refund under Regulation Z, a consumer must request the refund from the carrier and provide all necessary supporting documents. In contrast, the Act states that carriers should “promptly provide an automated refund” to an eligible passenger when the carriers fail to meet the applicable time limit in delivering the checked bag, and the passenger has notified the carrier of the lost or delayed checked baggage. Under the Act, an “automated refund” should be issued to passengers as long as the delay has met the threshold timeframe and the passenger has notified the carrier about the delayed or lost bag. In that regard, we view the delayed baggage fee refund provision in the FAA Extension Act differently from Regulation Z in that the Act only requires a passenger to notify the carrier that a bag is delayed or lost, and there is not a requirement for the passenger to request a refund for the baggage fee. We emphasize that since the Act's automated refund requirement covers all bags that are delayed for more than a set number of hours, it will also cover “lost bags,” refunding fees charged for which is already required by 14 CFR 259.5(b)(3).6 As such, both bags delayed for more than the set number of hours and bags that are considered “lost” would be eligible for an automated refund.

    6 We have not defined “lost” for purposes of 14 CFR 259.5(b)(3) mandating a refund of the baggage fee for lost bags. Instead, in a Frequently Asked Questions document issued by the Department's Office of Aviation Enforcement and Proceedings, that office states that if a carrier unreasonably refuses to consider a bag to be lost after it has been missing for a considerable period of time, it could be subject to enforcement action for violating the statutory prohibition against unfair and deceptive practices. See, Answers to Frequently Asked Questions Concerning the Enforcement of the Second Final Rule on Enhancing Airline Passenger Protections (EAPP #2), last updated May 8, 2015, https://www.transportation.gov/sites/dot.gov/files/docs/EAPP_2_FAQ_2_0.pdf.

    The Department seeks comment on whether prescribing a specific mechanism for the carriers to use to provide the statutorily required automated refund would negatively or positively impact carriers and consumers. What procedures would be necessary on interline itineraries, for which the carrier to whom the passenger reports the delayed bag at his or her destination or stopover is not the carrier to whom the passenger had paid the baggage fee? In addition to soliciting comment on all of the issues and concerns identified above, we also welcome and any other information relevant to this issue. This specifically includes comments and data on the cost impact on new-entrant carriers (many of whom do not have interline agreements) of the time standard developed in this proceeding, and the cost impact on regional airlines.

    Issued this 18th day of October, 2016, in Washington, DC. Anthony R. Foxx, Secretary of Transportation.
    [FR Doc. 2016-26199 Filed 10-28-16; 8:45 am] BILLING CODE 4910-9X-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 112, 117, and 507 [Docket No. FDA-2016-D-2841] Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notification of availability.

    SUMMARY:

    The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled “Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry.” This draft guidance explains our current thinking on disclosure statements made by an entity, in documents accompanying food, that certain hazards have not been controlled by that entity as required by certain provisions in four final rules. This document describes our current thinking on how to describe the hazard under each of the four rules and which documents we consider to be “documents of the trade” for the purpose of disclosure statements.

    DATES:

    Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 1, 2017. Submit either electronic or written comments on the proposed collection of information by May 1, 2017.

    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-2841 for “Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    Submit written requests for single copies of the draft guidance to Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration (HFS-300), 5001 Campus Drive, College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.

    FOR FURTHER INFORMATION CONTACT:

    With regard to this draft guidance: For questions regarding this draft guidance as it relates to our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food,” contact Jenny Scott, Center for Food Safety and Applied Nutrition, (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166.

    For questions regarding this draft guidance as it relates to our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals,” contact Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6246.

    For questions regarding this draft guidance as it relates to our regulation entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” contact Samir Assar, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-401-1636.

    For questions regarding this draft guidance as it relates to our regulation entitled “Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals,” contact Rebecca Buckner, Office of Food and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4576.

    SUPPLEMENTARY INFORMATION:

    I. Background

    We are announcing the availability of a draft guidance for industry entitled “Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry.” We are issuing the draft guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.

    The draft guidance relates to four of the seven foundational rules that we have established in Title 21 of the Code of Federal Regulations (21 CFR) as part of our implementation of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353). Table 1 lists these four rules. Each of these rules includes “customer provisions” as specified in table 1.

    Table 1—The Four Foundational FSMA Rules Relevant to the Draft Guidance Title and abbreviations for the purpose of this document Regulatory codification “Customer provisions” Publication Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (part 117) 21 CFR part 117 21 CFR 117.136(a)(2), (3), and (4) 80 FR 55908, September 17, 2015. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (part 507) 21 CFR part 507 21 CFR 507.36(a)(2), (3), and (4) 80 FR 56170, September 17, 2015. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (produce safety regulation) 21 CFR part 112 21 CFR 112.2(b) 80 FR 74354, November 27, 2015. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (FSVP regulation) 21 CFR part 1, subpart L 21 CFR 1.507(a)(2)(i), (a)(3)(i), and (a)(4)(i) 80 FR 74226, November 27, 2015.

    The “customer provisions” of part 117 and part 507 each include a requirement for a “disclosure statement” in which a manufacturer/processor must disclose, in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to control [identified hazard]” in certain circumstances. Likewise, the “customer provisions” of the FSVP regulation include a requirement for a “disclosure statement” in which an importer must disclose, in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to control [identified hazard]” in certain circumstances. The “customer provisions” of the produce safety regulation relate to an exemption from that regulation that includes a requirement for a “disclosure statement” in which a farm must disclose, in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to adequately reduce the presence of microorganisms of public health significance.”

    The draft guidance responds to industry questions regarding these requirements for a disclosure statement. On March 23, 2016, FDA met with a food trade association at their request to listen to concerns regarding the customer provisions of part 117 (Ref. 1), including concerns regarding the disclosure statement in part 117. At the meeting, the trade association expressed concern about providing a disclosure statement when multiple hazards may be present, including chemical hazards (such as mycotoxins) and physical hazards (such as stones in raw agricultural commodities), as well as for multiple biological hazards (such as microbial pathogens). The trade association also asked us to allow a variety of types of documents that accompany the food to have the disclosure statement (e.g., contractual agreements, Web sites referenced on labels and in contracts, labels, letters of guarantee, shipment-specific certificates of analysis, shipping documents, specifications, and terms and conditions).

    The trade association focused its discussion on the requirements of part 117, but noted that it had parallel concerns for the analogous provisions of part 507 and the FSVP regulation (Ref. 1). Although the trade association did not express concern with the disclosure statement in the produce safety regulation, we believe it will be helpful to businesses subject to the produce safety regulation, to include our current thinking on the disclosure statement in all four rules that have requirements for a disclosure statement, not just the three rules mentioned by the trade association.

    II. Paperwork Reduction Act of 1995

    This draft 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 117 have been approved under OMB control number 0910-0751. The collections of information in 21 CFR part 507 have been approved under OMB control number 0910-0789. The collections of information in 21 CFR part 112 have been approved under OMB control number 0910-0816. The collections of information in 21 CFR part 1, subpart L have been approved under OMB control number 0910-0752.

    III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous sentence to find the most current version of the guidance.

    IV. References

    The following references are on display in the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http://www.regulations.gov.

    1. Grocery Manufacturers Association, “21 CFR 117.136. Industry Impacts from Disclosure and Written Assurance Requirements,” 2016. Dated: October 26, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-26245 Filed 10-28-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16 and 58 [Docket No. FDA-2010-N-0548] Good Laboratory Practice for Nonclinical Laboratory Studies; Extension of Comment Period AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Proposed rule; extension of comment period.

    SUMMARY:

    The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of August 24, 2016. In the proposed rule, FDA requested comments on its proposal to amend the regulations for good laboratory practice for nonclinical studies. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

    DATES:

    FDA is extending the comment period on the proposed rule published August 24, 2016 (81 FR 58342). Submit either electronic or written comments by January 21, 2017.

    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-2010-N-0548 for “Good Laboratory Practice for Nonclinical Laboratory Studies.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

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

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

    FOR FURTHER INFORMATION CONTACT:

    Vernon Toelle, Office of Surveillance and Compliance, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., MPN4-142, Rockville, MD 20855, 240-402-5637; or Kristin Webster Maloney, Office of Policy and Risk Management, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4373, Silver Spring, MD 20993, 240-402-4993.

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of August 24, 2016, FDA published a proposed rule with a 90-day comment period to request comments on its proposal to amend the regulations for good laboratory practice for nonclinical studies. Comments on the proposed amendments will inform FDA's rulemaking to establish regulations for good laboratory practice for nonclinical laboratory studies.

    The Agency has received requests for a 90-day extension of the comment period for the proposed rule. Each request conveyed concern that the current 90-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule.

    FDA has considered the requests and is extending the comment period for the proposed rule for 60 days, until January 21, 2017. The Agency believes that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues.

    Dated: October 26, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-26244 Filed 10-28-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 250 [Docket ID: DOD-2015-OS-0126] RIN 0790-AI73 Withholding of Unclassified Technical Data and Technology From Public Disclosure AGENCY:

    Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics, DoD.

    ACTION:

    Proposed rule.

    SUMMARY:

    This rulemaking establishes policy, assigns responsibilities, and prescribes procedures for the dissemination and withholding of certain unclassified technical data and technology subject to the International Traffic in Arms Regulations (ITAR) and Export Administration Regulations (EAR). It applies to DoD components, their contractors and grantees and is meant to control the transfer of technical data and technology contributing to the military potential of any country or countries, groups, or individuals that could prove detrimental to U.S, national security or critical interests.

    DATES:

    Comments must be received by December 30, 2016.

    ADDRESSES:

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

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

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24, Alexandria, VA 22350-1700.

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

    FOR FURTHER INFORMATION CONTACT:

    Vakare Valaitis, 703-767-9159.

    SUPPLEMENTARY INFORMATION: Background

    For the purposes of this regulation, public disclosure of technical data and technology is the same as providing uncontrolled foreign access. This rule instructs DoD employees, contractors, and grantees to ensure unclassified technical data and technology that discloses technology or information with a military or space application may not be exported without authorization and should be controlled and disseminated consistent with U.S. export control laws and regulations. These policies preserve the U.S. military's technological superiority, establish and maintain interoperability with allies and coalition partners, and manage direct and indirect impacts on defense industrial base.There are penalties for export control violations. For export control violations involving items controlled by the United States Department of State under the International Traffic in Arms Regulations (ITAR), including many munitions items, the statute authorizes a maximum criminal penalty of $1 million per violation and, for an individual person, up to 10 years imprisonment. In addition, ITAR violations can result in the imposition of a maximum civil fine of $500,000 per violation, as well as debarment from exporting defense articles or services. For export control violations involving dual-use and certain munitions items controlled by the United States Department of Commerce under the Export Administration Regulations, criminal and civil penalties are currently provided by the International Emergency Economic Powers Act (IEEPA), 50 U.S.C. 1705, which has continued the Export Administration Regulations (EAR) in effect while the Export Administration Act is in lapse through Executive Order 13222 of August 17, 2001 (3 CFR 2001 Comp. 783 (2002)), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by successive Presidential Notices, the most recent being that of August 4, 2016 (81 FR 52587 (Aug. 8, 2016)). Under the EAR and IEEPA, as adjusted by 15 CFR 5.4(b), the penalty for persons who violate, attempt or conspire to violate, or cause a violation of the export control regulations includes civil penalties of not more than $284,582 per transaction or twice the amount of the transaction, whichever is greater, and criminal penalties of not more than $1,000,000, imprisonment of not more than 20 years, or both. Violations of the EAR may also result in the denial of export priveleges and other administrative sanctions.

    Authority To Issue This Regulation

    In accordance with 10 U.S.C. 133 part (b)(2), the Under Secretary of Defense for Acquisition, Technology and Logistics (USD(AT&L)) may exercise powers relating to establishing policies for acquisition (including procurement of goods and services, research and development, developmental testing, and contract administration) for all elements of the Department of Defense. In addition, U.S. export control laws, including 22 U.S.C. 2778 (also known as the “Arms Export Control Act”); 50 U.S.C. chapter 35 (also known as the “International Emergency Economic Powers Act” (IEEPA)); 22 CFR parts 120 through 130 (also known as “International Traffic in Arms Regulations” (ITAR)); and 15 CFR parts 730 through 774 (also known as “Export Administration Regulations” (EAR)) govern this rule.

    Summary of the Major Provisions of the Rulemaking

    This proposed rule describes procedures for the release of technical information; discusses procedures for technical data and technology to be marked for distribution; and provides an example of the notice to accompany export-controlled technical data and technology.

    Costs and Benefits

    DoD is proposing this regulation to update the CFR and DoD Directive 5230.25 (available at http://dtic.mil/whs/directives/corres/pdf/523025p.pdf). The Department currently spends $571,876 annually on export control certification activities. The costs to DoD contractors and grantee consist primarily of the time needed to organize, format, and submit information to the U.S./Canada Joint Certification Office to qualify for export controlled technical data and technology.

    The program has no discernible increase in anticipated costs and benefits as the program is being updated to conform to national security guidance cited in the text in §§ 250.1 through 250.7.

    The potential benefits include greater public access and understanding of information about the qualifications needed for access to export controlled technical data and technology. Such information may help potential contractors and grantees to better understand their options for participating in DoD activities; to better enable funders and researchers to determine the need for information and technolgy; to provide more complete information of those who use information from DoD research and contracts to inform other decisions; and to better enable the scientific community to examine the overall state of information and technology in this area as a basis for engaging in quality improvement (e.g., with regard to research methods). The proposed rule is also expected to provide greater clarity about what is required for those who are authorized holders of export controlled technical data and technology.

    This proposed rule is included in DoD's retrospective plan, completed in August 2011, and will be reported in future status updates of DoD's retrospective review in accordance with the requirements in Executive Order 13563. DoD's full plan can be accessed at: http://www.regulations.gov/#!docketDetail;D=DOD-2011-OS-0036.

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

    Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Although this rulemaking is not “economically significant” because it does not have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, it has been deemed “other significant” for raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive Orders. For that reason, it has been reviewed by the Office of Management and Budget (OMB).

    Section 202, Public Law 104-4, “Unfunded Mandates Reform Act”

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

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

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

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

    It has been certified that this proposed rule does impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995. These reporting requirements have been approved by OMB under OMB Control Number 0704-0207 titled DD Form 2345, Militarily Critical Technical Data Agreement.

    Cost to the Public

    In exchange for Government-owned unclassified export controlled technical data and technology, a contractor provides basic company information, identifies a technical data and technology custodian, and describes need-to-know. The reporting burden is estimated to average 20 minutes per response. The DD Form 2345 and supporting documentation must be submitted to the U.S./Canada Joint Certification Office in hardcopy. Approximately 24,000 U.S. companies have active certifications.

    24,000 responses $9.94 * per response $19.99 postage ** per response $638,400 * U.S. Department of Labor. Bureau of Labor Statistics. 2014 median weekly earnings of full-time workers with at least a bachelor's degree: $1,193. http://www.bls.gov/spotlight/2015/a-look-at-pay-at-the-top-the-bottom-and-in-between/home.htm. ** Most applicants choose Priority Mail Express Flat Rate Envelope USPS Postage Price Calculator http://postcalc.usps.com/. Cost to the Government 4 FTE registrars GS 9 step 5 $59,036 * $236,144 1 FTE Team Lead GS11 step 5 71,429 * 71,429 .5 FTE US Representative GS13 step 5 101,807 50,904 .25 FTE Division Chief GS14 step 5 120,303 30,075 .25 FTE Director GS15 step 5 35,378 * 35,378 O&M for IT SP4701-15-F-0031 2,958,915 147,946 Total 571,876 * 2014 General Schedule (Base) Office of Personnel Management Salaries and Wages https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2014/general-schedule/. Executive Order 13132, “Federalism”

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

    List of Subjects in 32 CFR Part 250

    Exports, Science and technology.

    Accordingly, 32 CFR part 250 is proposed to be revised to read as follows:

    PART 250—WITHHOLDING OF UNCLASSIFIED TECHNICAL DATA AND TECHNOLOGY FROM PUBLIC DISCLOSURE Sec. 250.1 Purpose. 250.2 Applicability. 250.3 Definitions. 250.4 Policy. 250.5 Responsibilities. 250.6 Procedures. 250.7 Directly arranged visits. Authority:

    10 U.S.C. 133.

    § 250.1 Purpose.

    This part establishes policy, assigns responsibilities, and prescribes procedures for the dissemination and withholding of certain unclassified technical data and technology consistent with the requirements of 10 U.S.C. 130.

    § 250.2 Applicability.

    This part:

    (a) Applies to:

    (1) The Office of the Secretary of Defense, the Military Departments, the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the Combatant Commands, the Office of Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities, and all other organizational entities within the DoD (referred to collectively in this part as the “DoD Components”).

    (2) All unclassified technical data and technology that discloses technology or information with military or space application, in the possession or under the control of a DoD Component, that may not be exported lawfully without an approval, authorization, license, license exception, or exemption in accordance with U.S. export control laws and regulations: 22 U.S.C. 2778 (also known as the “Arms Export Control Act”); 50 U.S.C. chapter 35 (also known as the “International Emergency Economic Powers Act”); 22 CFR parts 120-130 (also known as “International Traffic in Arms Regulations” (ITAR)); and 15 CFR parts 730 through 774 (also known as “Export Administration Regulations” (EAR)).

    (b) Does not modify or supplant the regulations governing the export of technical data and technology established by 22 U.S.C. 2778, 50 U.S.C. chapter 35, 22 CFR parts 120 through 130, 10 CFR 810, and 15 CFR parts 730 through 774.

    (c) Does not apply to technical information under the control of the Department of Energy or the Nuclear Regulatory Commission pursuant to the Atomic Energy Act of 1954, as amended, and the Nuclear Non-Proliferation Act of 1978, as amended.

    (d) Does not introduce any additional controls on the dissemination of technical data and technology by private enterprises or individuals beyond those specified by export control laws and regulations or in contracts or other agreements, including certifications as specified in paragraph (a)(9) of § 250.5. Accordingly, the fact that DoD may possess such technical data and technology does not in itself provide a basis for control of such technical data and technology under this part.

    (e) Does not introduce any controls on the dissemination of:

    (1) Scientific, educational, or other items that are not subject to the EAR or exclusively controlled for export or reexport by another department or agency pursuant to 15 CFR 734.3, 734.7 through 734.8;

    (2) Information in the public domain as described in 22 CFR 120.11 and technical data that has been approved for release in accordance with 22 CFR 125.4(b)(13)).

    (f) Does not alter the responsibilities of the DoD Components to protect proprietary technical data and technology of a private party, including:

    (1) In which the DoD has less than unlimited rights (e.g., pursuant to 48 CFR 227.7202, 252.227-7013, 252.227-7014, 252.227-7015, and 252.227.7018); and

    (2) That is authorized to be withheld from public disclosure pursuant to 5 U.S.C. 552, also known and referred to in this part as the “Freedom of Information Act (FOIA).”

    (g) Does not pertain to or affect the release of technical data and technology by DoD Components to foreign governments, international organizations or their respective representatives, or contractors pursuant to official agreements or formal arrangements with the U.S. Government (USG), or pursuant to USG-licensed transactions involving such entities or individuals. However, in the absence of such USG-sanctioned relationships this part does apply.

    (h) Does not apply to classified technical data. However, after declassification, dissemination of the technical data and technology within the scope of paragraph (a)(2) of this section is governed by this part.

    (i) Does not alter the responsibilities of the DoD Components to mark and protect information qualifying for designation as controlled unclassified information in accordance with Executive Order 13556, “Controlled Unclassified Information,” as implemented by volume 4 of DoD Manual 5200.01, “DoD Information Security Program” (available at http://www.dtic.mil/whs/directives/corres/pdf/520001_vol4.pdf).

    § 250.3 Definitions.

    Unless otherwise noted, these terms and their definitions are for the purpose of this part.

    Certification. The United States-Canada Joint Certification Program certifies contractors of each country for access, on an equally favorable basis, to unclassified technical data and technology that discloses technology or information with military or space application controlled in the United States by this part and in Canada by Canada Minister of Justice, Technical Data Control Regulations SOR/86-345, May 27, 2014 current edition (available at http://laws-lois.justice.gc.ca/PDF/SOR-86-345.pdf).

    Controlling DoD office. The DoD activity that sponsored the work that generated the technical data and technology or received the technical data and technology on behalf of the DoD and therefore is responsible for determining the distribution of a document containing the technical data and technology. In the case of joint sponsorship, the controlling office is determined by advance agreement and may be a party, a group, or a committee representing the interested activities or the DoD Components.

    Critical technology. Technology or technologies essential to the design, development, production, operation, application, or maintenance of an defense or dual-use article or service, which makes or could make a significant contribution to the military potential of any country, including the United States (also referred to as militarily critical technology). This includes, but is not limited to, design and manufacturing know-how, technical data, keystone equipment including manufacturing, inspection, and test equipment that is required for the effective application of technical information and technical know-how.

    (1) With respect to defense articles or defense services: Those technologies specified in 22 CFR 121.1.

    (2) With respect to categories of systems, equipment, and components; test, inspection, and production equipment; materials; software; and technology subject to the EAR: Those technologies specified in 15 CFR part 774.

    (3) With respect to nuclear equipment, materials, and technology: Those technologies specified in 10 CFR part 810.

    (4) With respect to select agents and toxins: Those technologies specified in 7 CFR part 331, 9 CFR part 121, and 42 CFR part 73; and any other technologies affecting the critical infrastructure.

    (5) With respect to emerging critical defense technology: Research and engineering development, or engineering and technology integration that will produce a defense article or defense service, including its underlying technology and software, covered by 22 CFR parts 120 through 130, or a dual-use or munitions item, including its underlying technology and software, covered by 15 CFR parts 730 through 774.

    Defense article. Defined at 22 CFR 120.6.

    Defense services. Defined at 22 CFR 120.9.

    Formal arrangement. An instrument that provides the formal authorization to establish a voluntary agreement between two or more parties for mutual sharing of resources and tasks to achieve a common set of objectives, such as The Technical Cooperation Program.

    Legitimate business relationship. A relationship in which the DoD determines that a need exists to acquire, share, exchange, or disseminate DoD technical information to anyone other than a DoD employee for supporting the DoD mission. The relationship may be established by a memorandum of understanding, agreement, contract, or grant. The DoD has the sole responsibility for determining that a legitimate business relationship exists since the only purpose is to provide access to information created by or under the control of the DoD. Relationships may be established with an individual or organization in another Federal department or agency; contractors, grantees, or potential DoD contractors; other branches of the Federal Government; State and local governments; and foreign countries.

    Limited rights. The rights to use, modify, reproduce, release, perform, display, or disclose technical data and technology, in whole or in part, within the government.

    Other legitimate business purposes. Include:

    (1) Providing or seeking to provide equipment or technology to a foreign government with USG approval (for example, through foreign military sale).

    (2) Bidding, or preparing to bid, on a sale of surplus property.

    (3) Selling or producing products for the commercial domestic marketplace or for the commercial foreign marketplace, providing that any required export license is obtained.

    (4) Engaging in scientific research in a professional capacity.

    (5) Acting as a subcontractor to a qualified contractor.

    Potential DoD contractor. An individual or organization outside the DoD declared eligible for DoD information services by a sponsoring DoD activity.

    Public disclosure. Making technical data available without restricting its dissemination or use.

    Qualified contractor. A qualified U.S. contractor or a qualified Canadian contractor referred to in and governed by Canada Minister of Justice, Technical Data Control Regulations SOR/86-345, May 27, 2014 current edition and certified in the Joint Certification Program through acceptance of a valid DD Form 2345.

    Qualified Canadian contractor. Canadian contractors are qualified for technical data and technology that do not require a license or other authorization for export to Canada under 22 CFR 126.5 by submitting a certification request to the United States-Canada Joint Certification Office established at the Defense Logistics Agency, Battle Creek, Michigan, in accordance with the “Memorandum of Understanding Between the Government of Canada and the Government of the United States Concerning Strategic Technical Exchange”.

    Qualified U.S. contractor. A private individual or enterprise that, in accordance with procedures established by the Under Secretary of Defense for Acquisition, Technology, and Logistics (USD(AT&L)) and as a condition of obtaining export-controlled technical data and technology subject to this part from the DoD:

    (1) Certifies that the individual who will act as recipient of the export-controlled technical data and technology on behalf of the U.S. contractor is a U.S. citizen or a person admitted lawfully into the United States for permanent residence and is located in the United States.

    (2) Certifies that such data and technology are needed to bid or perform on a contract with the DoD or other USG agency, or for other legitimate business purposes in which the U.S. contractor is engaged or plans to engage. The purpose for which the data and technology are needed must be described sufficiently in such certification to permit an evaluation of whether subsequent requests for data and technology are related properly to such business purpose.

    (3) Acknowledges its responsibilities under U.S. export control laws and regulations (including the obligation, under certain circumstances, to obtain an export license prior to the release of technical data and technology within the United States) and agrees that it will not disseminate any export-controlled technical data and technology subject to this part in violation of applicable export control laws and regulations.

    (4) Agrees that, unless dissemination is permitted by paragraph (i) of § 250.6, it will not provide access, including network access, to export-controlled technical data and technology subject to this part to persons other than its employees or persons acting on its behalf, and who meet the same citizenship or residency requirements without the permission of the DoD Component that provided the technical data and technology.

    (5) To the best of its knowledge, knows of no person employed by it or acting on its behalf who will have access to such data and technology, who is debarred, suspended, or otherwise ineligible from performing on USG contracts; or has violated U.S. export control laws or a certification previously made to the DoD under the provisions of this part.

    (6) Asserts that it is not debarred, suspended, or otherwise determined ineligible by any agency of the USG to perform on USG contracts, has not been convicted of export control law violations, and has not been disqualified under the provisions of this part.

    (7) Requests the certification be accepted based on its description of extenuating circumstances when the certifications required by this definition cannot be made truthfully.

    Restricted rights. The government's rights to use a computer program with one computer at one time. Applicable only to noncommercial computer software.

    Technical data. Defined at 22 CFR 120.10.

    (1) Classified data relating to defense articles and defense services on the U.S. Munitions List;

    (2) Information covered by an invention secrecy order; or

    (3) Software (see 22 CFR 120.45(f)) directly related to defense articles.

    (4) The definition does not include information concerning general scientific, mathematical, or engineering principles commonly taught in schools, colleges, and universities, or information in the public domain as defined in 22 CFR 120.11 or telemetry data as defined in note 3 to Category XV(f) of in 22 CFR part 121. It also does not include basic marketing information on function or purpose or general system descriptions of defense articles.

    Technical information. Includes technical data and technology as defined in 15 CFR parts 730 through 774, as well as technical information that is not subject to 22 CFR parts 120 through 130 or 15 CFR parts 730 through 774. It also includes technical data or computer software of any kind that can be used or adapted for use in the design, production, manufacture, assembly, repair, overhaul, processing, engineering, development, operation, maintenance, adapting, testing, or reconstruction of goods or materiel; or any technology that advances the state of the art, or establishes a new art, in an area of significant military or space applicability in the United States. The data may be in tangible form, such as a blueprint, photograph, plan, instruction, or an operating manual, or may be intangible, such as a technical service or oral, auditory, or visual descriptions. Examples of technical data include research and engineering data, engineering drawings, and associated lists, specifications, standards, process sheets, manuals, technical reports, technical orders, catalog item identifications, data sets, studies and analyses and related information, and computer software.

    Technology. Defined in 15 CFR 772.1.

    United States. The 50 States, the District of Columbia, and the territories and possessions of the United States.

    United States-Canada Joint Certification Office. The office established to certify contractors of each country for access, on an equally favorable basis, to unclassified technical data and technology disclosing technology controlled in the United States by this part and in Canada by Canada Minister of Justice, Technical Data Control Regulations SOR/86-345, May 27, 2014 current edition.

    U.S. DoD contractor. Those qualified U.S. contractors currently holding grants or contracts with DoD or those contractors declared eligible for DoD information services by a sponsoring DoD activity on the basis of participation in a DoD Potential Contractor Program.

    § 250.4 Policy.

    It is DoD policy that:

    (a) Pursuant to 10 U.S.C. 130 and 133, the Secretary of Defense may withhold from public disclosure any technical data and technology with military or space application in the possession or under the control of the DoD, if such technical data and technology may not be exported lawfully without a license, exception, exemption, or other export authorization, in accordance with U.S. export control laws and regulations (including 22 U.S.C. 2778, 50 U.S.C. chapter 35, 22 CFR parts 120 through 130, and 15 CFR parts 730 through 774). However, technical data and technology may not be withheld if regulations distributed in accordance with 22 U.S.C. 2778 authorize the export of such technical data and technology pursuant to a general unrestricted license or exemption.

    (b) Because public disclosure of technical data and technology subject to this part is the same as providing uncontrolled foreign access, withholding such technical data and technology from public disclosure, unless approved, authorized, or licensed in accordance with export control laws, is necessary and in the national interest.

    (c) Notwithstanding the authority in paragraph (c)(1) of this section, it is DoD policy to provide technical data and technology governed by this part to individuals and enterprises that are:

    (1) Currently qualified U.S. contractors, when such technical data and technology relate to a legitimate business purpose for which the contractor is certified; or

    (2) A certified Canadian contractor referred to in and governed by Canada Minister of Justice, Technical Data Control Regulations SOR/86-345, May 27, 2014 current edition (available at http://laws-lois.justice.gc.ca/PDF/SOR-86-345.pdf) and registered at the United States-Canada Joint Certification Office when a legitimate business relationship has been established between the government and the contractor.

    (d) This part may not be used by the DoD Components as authority to deny access to technical data and technology to the Congress or to any Federal, State, or local government agency that requires the technical data and technology for regulatory or other official government purposes. Dissemination of the technical data and technology will include a statement that DoD controls it, in accordance with this part.

    (e) The authority in this part may not be used to withhold from public disclosure unclassified information regarding DoD operations, policies, activities, or programs, including the costs and evaluations of performance and reliability of military and space equipment. When information does contain technical data and technology subject to this part, the technical data and technology must be excised from what is disclosed publicly.

    (f) This part may not be used as a basis for the release of limited rights or restricted rights data as defined in 48 CFR or those that are authorized to be withheld from public disclosure pursuant to the 5 U.S.C. 552.

    (g) This part may not be used to provide protection for technical data that should be classified in accordance with Executive Order 13526, “Classified National Security Information,” and volume 1 of DoD Manual 5200.01 (available at http://www.dtic.mil/whs/directives/corres/pdf/520001_vol1.pdf).

    (h) This part provides immediate authority to cite section (b)(3) of 5 U.S.C. 552 (FOIA Exemption 3) described in 32 CFR part 286 as the basis for denials under 5 U.S.C. 552 of technical data and technology currently determined to be subject to the provisions of this part. The technical data will be withheld under the authority of 10 U.S.C.130. If the information originated or is under the control of a Government Agency outside the DoD, DoD Components will refer to that Government Agency for a release determination.

    (i) Technical data and technology subject to this part must be marked in accordance with DoD Instruction 5230.24, “Distribution Statements on Technical Documents” (available at http://www.dtic.mil/whs/directives/corres/pdf/523024p.pdf) and volume 4 of DoD Manual 5200.01 and released in accordance with DoD Instruction 2040.02, “International Transfers of Technology, Articles, and Services” (available at http://www.dtic.mil/whs/directives/corres/pdf/204002_2014.pdf), DoD Directive 5230.09, “Clearance of DoD Information for Public Release” (available at http://www.dtic.mil/whs/directives/corres/pdf/523009p.pdf), DoD Instruction 5230.29, “Security and Policy Review of DoD Information for Public Release” (available at http://www.dtic.mil/whs/directives/corres/pdf/523029p.pdf), and 32 CFR part 285.

    (j) Technical data and technology subject to this part, when disseminated electronically, must be marked in accordance with volume 4 of DoD Manual 5200.01 and are subject to all applicable security requirements specified in DoD Instruction 8500.01, “Cybersecurity” (available at http://www.dtic.mil/whs/directives/corres/pdf/850001_2014.pdf) and Chairman of the Joint Chiefs of Staff Instruction 6510.01F, “Information Assurance (IA) and Support to Computer Network Defense (CND),” February 9, 2011, as amended (available at http://www.dtic.mil/cjcs_directives/cdata/unlimit/6510_01.pdf).

    (k) In accordance with DoD Instruction 5015.02, “DoD Records Management Program” (available at http://www.dtic.mil/whs/directives/corres/pdf/501502p.pdf), technical data and technology subject to this part must be maintained and managed consistent with National Archives and Records Administration approved dispositions to ensure proper maintenance, use, accessibility, and preservation, regardless of format or medium.

    § 250.5 Responsibilities.

    (a) The Under Secretary of Defense for Acquisition, Technology, and Logistics (USD(AT&L)) has overall responsibility for the implementation of this part and will designate an office to:

    (1) Administer and monitor compliance with this part.

    (2) Receive and disseminate notifications of temporary revocation of contractor qualification in accordance with paragraph (e) of § 250.6.

    (3) Receive recommendations for contractor disqualification made in accordance with paragraph (f) of § 250.6, and act as disqualification authority.

    (4) Provide technical assistance when necessary to the DoD Components to assess the significance of the military or space application of technical data and technology that may be withheld from public disclosure in accordance with this part.

    (5) Maintain and update procedures and appropriate mechanisms for the certification of qualified contractors, in accordance with paragraph (c) of § 250.4 of this part.

    (6) Ensure that the requirements of this part are incorporated into 48 CFR for application to contracts involving technical data and technology governed by this part.

    (7) Develop, in conjunction with the Office of the General Counsel of the Department of Defense (GC DoD), guidelines for responding to appeals, as identified in paragraph (k) of § 250.6.

    (8) Develop procedures to ensure that the DoD Components apply consistent criteria in authorizing exceptions in accordance with paragraph (j) of § 250.6.

    (9) Prescribe procedures to develop, collect, and disseminate certification statements; to ensure their sufficiency, accuracy, and periodic renewal; and to make final determinations of qualification.

    (10) Take such other actions that may be required to ensure consistent and appropriate implementation of this part within the DoD.

    (b) The Under Secretary of Defense for Policy (USD(P)):

    (1) Prepares and issues policy guidance regarding the foreign disclosure and security controls for information in international programs within the scope of this part.

    (2) Provides consultation to DoD offices on export control and commodity jurisdiction determinations.

    (c) The Deputy Chief Management Officer (DCMO) of the Department of Defense:

    (1) Monitors the implementation of the provisions of this part that pertain to 5 U.S.C. 552 and 32 CFR part 285.

    (2) Provides such other assistance as may be necessary to ensure compliance with this part.

    (d) The GC DoD:

    (1) Advises DoD Components with respect to the statutory and regulatory requirements governing the export of technical data and technology.

    (2) Advises the USD(AT&L) regarding consistent and appropriate implementation of this part.

    (e) The DoD Component heads:

    (1) Disseminate and withhold from public disclosure technical data and technology subject to this part consistent with its policies and procedures.

    (2) Designate a focal point to:

    (i) Ensure implementation of this part.

    (ii) Identify classes of technical data and technology whose release are governed by paragraph (d)(3) of § 250.6.

    (iii) Act on appeals relating to case-by-case denials for release of technical data and technology.

    (iv) Temporarily revoke a contractor's qualification in accordance with paragraph (e) of § 250.6.

    (v) Receive and evaluate requests for reinstatement of a contractor's qualification in accordance with paragraph (e)(4) of § 250.6.

    (vi) Recommend contractor's disqualification to the USD(AT&L) in accordance with paragraph (f) of § 250.6.

    (3) Develop, distribute, and effect Component regulations to implement this part.

    (4) Ensure that the controlling DoD office that created or sponsored the technical information exercises its inherently governmental responsibility to determine the appropriate marking in accordance with DoD Instruction 5230.24 and volumes 2 and 4 of DoD Manual 5200.01 (volume 2 available at http://www.dtic.mil/whs/directives/corres/pdf/520001_vol2.pdf) and that all technical documents, including research, development, engineering, test, sustainment, and logistics information, regardless of media or form, are marked correctly.

    § 250.6 Procedures.

    (a) Procedures for release of technical information must be made under the following guidelines:

    (1) DoD Components may make their technical information for other than military or space application available for public disclosure in accordance with DoD Directive 5230.09 and DoD Instruction 5230.29. DoD has the authority to withhold technical data and technology as defined in § 250.3 from public disclosure.

    (2) DoD Components will process FOIA requests from the public for technical information in accordance with 32 CFR part 286 and governing DoD Component issuances. All requested technical data and technology currently determined to be subject to the withholding authority in this part will be denied under Exemption 3 of 5 U.S.C. 552 and 10 U.S.C. 130. Any FOIA appeals for the denied information will be processed in accordance with 32 CFR part 286 and governing DoD Component issuances.

    (3) DoD Components may give qualified contractors access to their technical data and technology as permitted by the provisions of this part.

    (i) United States-Canada Joint Certification Office adjudicates certification of qualified contractors.

    (ii) To qualify, U.S. and Canadian contractors must submit a completed DD Form 2345 “Militarily Critical Technical Data Agreement,” to the United States-Canada Joint Certification Office.

    (iii) To qualify, Canadian contractors will submit a completed DD Form 2345 when a Canadian contractor intends to request access to DoD-controlled technical data and technology.

    (iv) A copy of the company's State/Provincial Business License, Incorporation Certificate, Sales Tax Identification Form, ITAR Controlled Goods Registration letter or certificate, or other documentation that verifies the legitimacy of the company must accompany all DD Forms 2345.

    (v) The contractor's business activity is a key element of the certification process since this information is used by the controlling office as a basis for approving or disapproving specific requests for technical data and technology. The business activity statement should be sufficiently detailed to support requests for any data that the contractor expects for legitimate business purposes.

    (b) Upon receipt of a request for technical information in the possession of, or under the control of the DoD, the controlling DoD office for the requested information will determine whether the information is governed by this part.

    (1) The determination will be based on whether

    (i) The information is subject to 22 CFR part 121 or 15 CFR part 774.

    (ii) The information would require a license, exception, exemption, or other export authorization in accordance with U.S. export control laws and regulations in accordance with 22 U.S.C. 2778, 50 U.S.C. chapter 35, 22 CFR parts 120 through 130, and 15 CFR parts 730 through 774.

    (iii) The information would not fall into the categories of information described in paragraphs (c) and (d) of § 250.2.

    (2) In making such a determination, the controlling office may consult with the Defense Technology Security Administration for advice on whether U.S. export control laws or regulations apply. The controlling DoD office may request assistance in making this determination from the USD(AT&L), and if necessary, consult the Departments of State, Commerce, or Energy.

    (c) The controlling DoD office will ensure technical data and technology governed by this part are marked for distribution in accordance with DoD Instruction 5230.24 and volume 4 of DoD Manual 5200.01.

    (d) The controlling DoD office will authorize release of technical data and technology governed by this part to qualified contractors, as defined in § 250.3, unless either:

    (1) The qualification of the contractor concerned has been temporarily revoked in accordance with paragraph (e) of this section;

    (2) The controlling DoD office judges the requested technical data and technology to be unrelated to the purpose for which the qualified contractor is certified. When release of technical data and technology is denied in accordance with this paragraph, the controlling DoD office will request additional information to explain the intended use of the requested technical data and technology and, if appropriate, request a new certification (see § 250.3) describing the intended use of the requested technical data and technology; or

    (3) The technical data and technology are being requested for a purpose other than to permit the requester to bid or perform on a contract with the DoD or other USG agency. In this case, the controlling DoD office will withhold the technical data and technology if the DoD Component focal point determines the release of the technical data and technology may jeopardize an important technological or operational military advantage of the United States.

    (e) Upon receipt of substantial and credible information that a qualified U.S. contractor has violated U.S. export control law; violated its certification; made a certification in bad faith; or omitted or misstated material fact, the DoD Component will temporarily revoke the U.S. contractor's qualification. Canadian contractors are disqualified in accordance with Canada Minister of Justice, Technical Data Control Regulations SOR/86-345, May 27, 2014 current edition.

    (1) The DoD Component may delay such temporary revocations with the potential to compromise a USG investigation.

    (2) Immediately upon a temporary revocation, the DoD Component will notify the contractor and the USD(AT&L).

    (3) The contractor will be given an opportunity to respond in writing to the information upon which the temporary revocation is based before being disqualified.

    (4) Any U.S. contractor whose qualification has been temporarily revoked may present information to the DoD Component showing that the basis for revocation was in error or has been remedied and be reinstated.

    (f) When the basis for a contractor's temporary revocation cannot be removed within 20 working days, the DoD Component will recommend to the USD(AT&L) that the contractor be disqualified.

    (g) After receipt of substantial and credible information that a qualified U.S. contractor has violated U.S. export control law, the DoD Component must notify the appropriate law enforcement agency.

    (h) Charges for copying, certifying, and searching records rendered to requesters will be levied in accordance with chapter 4, appendix 2 of volume 11A of DoD 7000.14-R, “Department of Defense Financial Management Regulations (FMRs)” (available at http://comptroller.defense.gov/Portals/45/documents/fmr/Volume_11a.pdf). Normally, only one copy of the same record or document will be provided to each requester. Each release to qualified contractors of controlled technical data and technology governed by this part will be accompanied by a “Notice to Accompany the Dissemination of Export-Controlled Technical Data and Technology” (see Figure to § 250.6(h)).

    BILLING CODE 5001-06-P EP31OC16.007 BILLING CODE 5001-06-C

    (i) Qualified U.S. contractors who receive technical data and technology governed by this part may disseminate that technical data and technology for purposes consistent with their certification without the permission of the controlling DoD office or when dissemination is:

    (1) To any foreign recipient for which the technical data and technology are approved, authorized, or licensed in accordance with 22 U.S.C. 2778 or 15 CFR parts 730 through 774.

    (2) To another qualified U.S. contractor including existing or potential subcontractors, but only within the scope of the certified legitimate business purpose of the recipient.

    (3) To the Departments of State and Commerce to apply for approvals, authorizations, or licenses for export pursuant to 22 U.S.C. 2778 or 15 CFR parts 730 through 774. The application will include a statement that the technical data and technology for which the approval, authorization, or license is sought is controlled by the DoD in accordance with this part.

    (4) To the Congress or any Federal, State, or local governmental agency for regulatory purposes or otherwise as may be required by law or court order. Any such dissemination will include a statement that the technical data and technology are controlled by the DoD in accordance with this part.

    (j) A qualified contractor desiring to disseminate technical data and technology subject to this part in a manner not permitted expressly by the terms of this part must be granted authority to do so by the controlling DoD office, consistent with U.S. export control laws and regulations specified in 22 U.S.C. 2778, 50 U.S.C. chapter 35, 22 CFR parts 120 through 130, and 15 CFR parts 730 through 774 and DoD policies.

    (k) Any requester denied technical data and technology or any qualified U.S. contractor denied permission to disseminate such technical data and technology in accordance with this part will be promptly provided with a written statement of reasons for that action, and advised of the right to make a written appeal to a specifically identified appellate authority within the DoD Component. Other appeals will be processed as directed by the USD(AT&L).

    (l) Denials will cite 10 U.S.C. 130 and 133 as implemented by this part. Implementing procedures will provide for resolution of any appeal within 20 working days.

    § 250.7 Directly arranged visits.

    (a) USG officials and certified U.S. contractors and Canadian government officials and certified Canadian contractors may use the certification process to facilitate directly arranged visits that involve access to unclassified technical data and technology. Activities under this process are limited to:

    (1) Procurement activities such as unclassified pre-solicitation conferences, discussions related to unclassified solicitations, and collection of procurement unclassified documents.

    (2) Performance of an unclassified contract.

    (3) Scientific research, in support of unclassified U.S. or Canadian national defense initiatives.

    (4) Attendance at restricted meetings, conferences, symposia, and program briefings where technical data and technology governed by this part or Canada Minister of Justice, Technical Data Control Regulations SOR/86-345, May 27, 2014 current edition will be presented, or the event is being held in an unclassified access controlled area.

    (b) A directly arranged visit does not apply to uncertified U.S. or Canadian contractors; classified visits, where confirmation of the visitors' security clearances is required; or unsolicited marketing visits.

    (c) A directly arranged visit related to the release of information controlled in the United States by this part or in Canada by Canada Minister of Justice, Technical Data Control Regulations SOR/86-345, May 27, 2014 current edition, is permitted when two conditions are satisfied.

    (1) First condition:

    (i) There is a valid license covering the export of the technical data and technology;

    (ii) The export or release is permitted under the Canadian exemption on 22 CFR 126.5;

    (iii) The export or release is covered by the general exemptions in 22 CFR 125.4; or

    (iv) The export or release qualifies for a license exception under 15 CFR parts 730 through 774.

    (2) Second condition:

    (i) The distribution statement applied to the technical data and technology pursuant to DoD Instruction 5230.24 permits release; or

    (ii) The originator or government controlling office authorizes release.

    Dated: October 26, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-26236 Filed 10-28-16; 8:45 am] BILLING CODE 5001-06-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R08-OAR-2016-0620; FRL-9954-67-Region 8] Approval and Promulgation of Air Quality Implementation Plans; State of Utah; Revisions to Nonattainment Permitting Regulations AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to conditionally approve State Implementation Plan (SIP) revisions submitted by the state of Utah on August 20, 2013, with supporting administrative documentation submitted on September 12, 2013. These submittals revise the Utah Administrative Code (UAC) that pertain to the issuance of Utah air quality permits for major sources in nonattainment areas. The EPA proposes a conditional approval because while the submitted revisions to Utah's nonattainment permitting rules do not fully address the deficiencies in the state's program, Utah has committed to address additional remaining deficiencies in the state's nonattainment permitting program no later than a year from the EPA finalizing this conditional approval. If finalized, and upon the EPA finding a timely meeting of this commitment in full, the proposed conditional approval of the SIP revisions would convert to a final approval of Utah's plan. This action is being taken under section 110 of the Clean Air Act (CAA) (Act).

    DATES:

    Written comments must be received on or before November 30, 2016.

    ADDRESSES:

    Submit your comments, identified by EPA-R08-OAR-2016-0620 at http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from regulations.gov. 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, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly-available docket materials are available at http://www.regulations.gov or in hard copy at the EPA Region 8, Office of Partnerships and Regulatory Assistance, Air Program, 1595 Wynkoop Street, Denver, Colorado 80202-1129. The EPA requests that if at all possible, you contact the individual listed in the FOR FURTHER INFORMATION CONTACT section to view the hard copy of the docket. You may view the hard copy of the docket Monday through Friday, 8:00 a.m. to 4:00 p.m., excluding federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Kevin Leone, Air Program, EPA, Region 8, Mailcode 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6227, [email protected]

    SUPPLEMENTARY INFORMATION: I. General Information What should I consider as I prepare my comments for the EPA?

    a. Submitting CBI. Do not submit CBI to EPA through http://www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to the EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

    b. Tips for Preparing Your Comments. When submitting comments, remember to:

    i. Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number).

    ii. Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

    iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

    iv. Describe any assumptions and provide any technical information and/or data that you used.

    v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

    vi. Provide specific examples to illustrate your concerns, and suggest alternatives.

    vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

    viii. Make sure to submit your comments by the comment period deadline identified.

    II. Background

    On May 10, 2001, the EPA sent Utah a letter outlining concerns that Utah's nonattainment permitting rules, which are codified in UAC R307-403 (Permits: New and Modified Sources in Nonattainment Areas and Maintenance Areas), have not been consistent with federal requirements (see docket R08-OAR-2016-0620). On August 20, 2013, with supporting administrative documentation submitted on September 12, 2013, Utah sent the EPA revisions to their nonattainment permitting regulations, specifically to address EPA identified deficiencies in their nonattainment permitting regulations that affected the EPA's ability to approve Utah's PM10 maintenance plan and that may affect the EPA's ability to approve of Utah's PM2.5 SIP. These revisions addressed R307-403-1 (Purpose and Definitions), R307-403-2 (Applicability), R307-403-11 (Actual Plant-wide Applicability Limits (PALs)), and R307-420 (Ozone Offset Requirements in Davis and Salt Lake Counties). In addition, Utah moved R307-401-19 (Analysis of Alternatives) to R307-403-10 and moved R307-401-20 (Relaxation of Limits) to R307-403-2. On June 2, 2016, the EPA entered into a consent decree with the Center for Biological Diversity, Center for Environmental Health, and Neighbors for Clean Air regarding a failure to act, pursuant to CAA sections 110(k)(2)-(4), on certain complete SIP submissions from states intended to address specific requirements related to the 2006 p.m.2.5 NAAQS for certain nonattainment areas, including the submittal from the Governor of Utah dated August 20, 2013.

    The SIP revisions submitted by the Utah Department of Air Quality (UDAQ) on August 20, 2013, establish specific nonattainment new source review permitting requirements. In this revision, the UDAQ has incorporated federal regulatory language—establishing permitting requirements for new and modified major stationary sources in a nonattainment area—from portions of 40 CFR 51.165 and reformatted it into state-specific requirements for sources in Utah under R307-403-1 (Purpose and Definitions) and R307-403-2 (Applicability), including provisions relevant to nonattainment NSR programs for PM2.5 nonattainment areas. Additionally, UDAQ incorporated by reference the provisions of 40 CFR 51.165(f)(1)-(f)(14) into 307-403-11 (Actual PALs), and revised R307-420 to state that the definitions and applicability provisions in R307-403-1 apply to this section.

    CAA section 110(a)(2)(C) requires each state plan to include “a program to provide for . . . regulation of the modification and construction of any stationary source within the areas covered by the plan as necessary to assure that [NAAQS] are achieved, including a permit program as required in parts C and D of this subchapter,” and CAA section 172(c)(5) provides that the plan “shall require permits for the construction and operation of new or modified major stationary sources anywhere in the nonattainment area, in accordance with section [173].” CAA section 173 lays out the requirements for obtaining a permit that must be included in a state's SIP-approved permit program. CAA section 110(a)(2)(A) requires that SIPs contain enforceable emissions limitations and other control measures. Under section CAA section 110(a)(2), the enforceability requirement in section 110(a)(2)(A) applies to all plans submitted by a state. CAA section 110(i) (with certain limited exceptions) prohibits states from modifying SIP requirements for stationary sources except through the SIP revision process. CAA section 172(c)(7) requires that nonattainment plans, including nonattainment New Source Review (NSR) programs required by section 172(c)(5), meet the applicable provisions of section 110(a)(2), including the requirement in section 110(a)(2)(A) for enforceable emission limitations and other control measures. CAA section 110(l) provides that the EPA cannot approve a SIP revision that interferes with any applicable requirement of the Act.

    Section 51.165 in title 40 of the CFR (Permit Requirements) sets out the minimum plan requirements states are to meet within each SIP nonattainment NSR permitting program. Generally, 40 CFR 51.165 consists of a set of definitions, minimum plan requirements regarding procedures for determining applicability of nonattainment NSR and use of offsets, and minimum plan requirements regarding other source obligations, such as recordkeeping.

    Specifically, subparagraphs 51.165(a)(1)(i) through (xlvi) enumerate a set of definitions which states must either use or replace with definitions that a state demonstrates are more stringent or at least as stringent in all respects. Subparagraph 51.165(a)(2) sets minimum plan requirements for procedures to determine the applicability of the nonattainment NSR program to new and modified sources. Subparagraph 51.165(a)(3), (a)(9) and (a)(11) set minimum plan requirements for the use of offsets by sources subject to nonattainment NSR requirements. Subparagraphs (a)(8) and (a)(10) regard precursors, and subparagraphs (a)(6) and (a)(7) regard recordkeeping obligations. Subparagraph 51.165(a)(4) allows nonattainment NSR programs to treat fugitive emissions in certain ways. Subparagraph 51.165(a)(5) regards enforceable procedures for after approval to construct has been granted. Subparagraph 51.165(b) sets minimum plan requirements for new major stationary sources and major modifications in attainment and unclassifiable areas that would cause or contribute to violations of the national ambient air quality standards (NAAQS.) Finally, subparagraph 51.165(f) sets minimum plan requirements for the use of PALs. Please refer to docket EPA-R08-OAR-2016-0620 to view a cross-walk table which outlines how Utah's nonattainment permitting rules correlate with the requirements of 40 CFR 51.165.

    Clean Air Act section 189(e) requires that state SIPs apply the same control requirements that apply to major stationary sources of PM10 to major stationary sources of PM10 precursors, “except where the Administrator determines that such sources do not contribute significantly to PM10 levels which exceed the standard in the area.” On January 4, 2013, the U.S. Court of Appeals for the District of Columbia Circuit, in Natural Resources Defense Council v. EPA, 706 F.3d 428 (D.C. Cir. 2013), issued a decision that remanded the EPA's 2008 PM2.5 NSR Implementation Rule (73 FR 28321). The court found that the EPA erred in implementing the PM2.5 NAAQS in these rules solely pursuant to the general implementation provisions of subpart 1 of part D of title I of the CAA, rather than pursuant to the additional implementation provisions specific to particulate matter nonattainment areas in subpart 4. In particular, subpart 4 includes section 189(e) of the CAA, which requires the control of major stationary sources of PM10 precursors (and hence under the court decision, PM2.5 precursors) “except where the Administrator determines that such sources do not contribute significantly to PM10 levels which exceed the standard in the area.” Accordingly, nonattainment NSR programs that are submitted for PM2.5 nonattainment areas must regulate all PM2.5 precursors, i.e., SO2, NOX, VOC, and ammonia, unless the Administrator determines that such sources of a particular precursor do not contribute significantly to nonattainment in the nonattainment area. The EPA recently finalized a new provision at 40 CFR 51.165(a)(13) that codifies this requirement, as it applies to PM2.5, in the federal regulations.

    As a result, it became clear that Utah needed to submit further revisions to address remaining deficiencies in the nonattainment permitting program for the EPA to approve the August 20, 2013, submittal. Included as part of those deficiencies was that Utah has not submitted an analysis demonstrating that sources of ammonia, as a PM2.5 precursor, do not contribute significantly to PM2.5 levels that exceed the NAAQS in nonattainment areas in the State. On September 30, 2016, Utah submitted to EPA a commitment letter in which Utah commits to address additional remaining deficiencies in the State's nonattainment permitting program in R307-403 by December 8, 2017, that were not addressed in the August 20, 2013, submittal, including revisions to R307-403-2, R307-403-3, and R307-403-4. In Utah's commitment letter, Utah specifies that:

    1. UDAQ commits to submit a SIP revision that either regulates major stationary sources of the pursuant to Utah's nonattainment new source review (NNSR) permitting program, consistent with all applicable federal regulatory requirements or demonstrates that sources of ammonia, as a PM2.5 precursor, do not contribute significantly to PM2.5 levels that exceed the NAAQS in nonattainment areas in the state, consistent with new provisions at 40 CFR 51.1006(a)(3);

    2. UDAQ commits to revise R307-403-2 consistent with the new definitions in 40 CFR 51.165 that EPA recently finalized in the PM2.5 SIP Requirements Rules;

    3. UDAQ commits to revise R307-403-3, including R307-403-3(3), to remove the reference to NNSR determinations being made “at the time of the source's proposed start-up date”;

    4. UDAQ commits to revise R307-403-3, including R307-403-3(2) and R307-403-3(3), to specify that NNSR permit requirements are applicable to all new major stationary sources or major modifications located in a nonattainment area that are major for the pollutant for which the area is designated nonattainment;

    5. UDAQ commits to revise R307-403-3, in addition to the previously adopted definition of lowest achievable emission rate (LAER) in R307-403-1, to explicitly state that LAER applies to all major new sources and major modifications for the relevant pollutants in nonattainment areas;

    6. UDAQ commits to revise R307-403-4 to incorporate the requirements from 40 CFR 51.165 to establish that all general offset permitting requirements apply for all offsets regardless of the pollutant at issue, and to revise the provision to impose immediate and direct general offset permitting requirements on all new major stationary sources or major modifications located in a nonattainment area that are major for the pollutant for which the area is designated nonattainment;

    7. UDAQ commits to work with the Utah Air Quality Board to revise R307-403-4 to reference the criteria discussed in section IV.D. of 40 CFR 51, Appendix S; and

    8. UDAQ will update R307-403 to include a new section that imposes requirements that address emission offsets for PM2.5 nonattainment areas (as required in 40 CFR 51.165(a)(11)) on NNSR sources in Utah. UDAQ will revise R307-403-3, including R307-403-3(3)(c), to cross reference this new section, as well as the requirements in R307-403-4, R307-403-5, and R307-403-6; and UDAQ commits to work with the Utah Air Quality Board to revise this section to include the requirements of CAA Section 173(c)(1) and 40 CFR 51.165 (specifically 40 CFR 51.165(a)(3)) concerning the requirement that creditable reductions be calculated based on actual emissions for offset purposes.

    Under section 110(k)(4) of the Act, the EPA may approve a SIP revision based on a commitment by the state to adopt specific enforceable measures by a date certain, but not later than one year after the date of approval of the plan revision. Under a conditional approval, the state must adopt and submit the specific revisions it has committed to within one year of the EPA's finalization. If the EPA fully approves the submittal of the revisions specified in the commitment letter, the conditional nature of the approval would be removed and the submittal would become fully approved. If the state does not submit these revisions within one year, or if the EPA finds the state's revisions to be incomplete, or EPA disapproves the state's revisions, a conditional approval will convert to a disapproval. If any of these occur and the EPA's conditional approval converts to a disapproval, that will constitute a disapproval of a required plan element under part D of title I of the Act, which starts an 18-month clock for sanctions, see section 179(a)(2), and the two-year clock for a federal implementation plan (FIP), see section 110(c)(1)(B).

    III. Proposed Action

    The EPA is proposing to conditionally approve Utah's revisions submitted on August 20, 2013, which have not been withdrawn by Utah. These revisions addressed R307-403-1 (Purpose and Definitions), R307-403-2 (Applicability), R307-403-11 (Actual PALs), and R307-420 (Ozone Offset Requirements in Davis and Salt Lake Counties). In addition, Utah moved R307-401-19 (Analysis of Alternatives) to R307-403-10 and moved R307-401-20 (Relaxation of Limits) to R307-403-2. The EPA proposes that these changes, when combined with the changes Utah has committed to submitting to the EPA by December 8, 2017, in Utah's September 30, 2016 commitment letter, create enforceable obligations for sources and are consistent with the CAA and EPA regulations, including the requirements of CAA section 110(a)(2)(A), 110(a)(2)(C), 110(i), 110(l), 172(c)(5), 172(c)(7), 173.

    The crosswalk table in the docket details how the submittal corresponds to specific requirements in 40 CFR 51.165; however, as stated earlier, we are not proposing to determine that Utah's PM2.5 nonattainment permitting rules meet all requirements of 40 CFR 51.165 at this time, but rather are conditionally approving these revisions based on Utah's September 30, 2016 commitment letter. If we finalize our proposed conditional approval, Utah must adopt and submit to the EPA the specific revisions it has committed to by December 8, 2017. If the EPA fully approves the submittal of the revisions specified in the commitment letter, the conditional nature of this proposed approval would be removed and the August 20, 2013 submittal would, at that time, become fully approved. If Utah does not submit these revisions by December 8, 2017, or if we find Utah's revisions to be incomplete, or we disapprove Utah's revisions, the final conditional approval will convert to a disapproval. If any of these occur and our final conditional approval converts to a disapproval, that will constitute a disapproval of a required plan element under part D of title I of the Act, which starts an 18-month clock for sanctions, see CAA section 179(a)(2), and the two-year clock for a FIP, see CAA section 110(c)(1)(B).

    Specifically, we are proposing to conditionally approve:

    R307-401-19 (Analysis of Alternatives)

    Section R307-401-19 being moved removed from R307-401-19 and being added to R307-403-10. Because this section applies only to major sources or major modifications that are located in a nonattainment area or impact a nonattainment area, this section is more appropriately located in R307-403.

    R307-401-20 (Relaxation of Limits)

    Section R307-401-20 being moved removed from R307-401-19 and being added to R307-403-2. Because this section applies only to major sources or major modifications that are located in a nonattainment area or impact a nonattainment area, this section is more appropriately located in R307-403.

    R307-403-1 (Purpose and Definitions)

    Language being added in R307-403-1(1)-(4) to parallel federal nonattainment permitting regulations in 40 CFR 51.165; however, Utah committed to addressing further deficiencies regarding ammonia as a precursor to PM2.5 in this section, as specified in Utah's September 30, 2016 commitment letter.

    In particular, R307-403-1(4)(b) states that “ammonia is not a precursor to PM2.5 in the Logan, Salt Lake City, and Provo PM2.5 nonattainment areas as defined in the July 1, 2010 version of 40 CFR 81.345,” however, UDAQ has not submitted an analysis demonstrating that sources of ammonia, as a PM2.5 precursor, do not contribute significantly to PM2.5 levels that exceed the NAAQS in nonattainment areas in the State. UDAQ committed to submit a SIP revision that either regulates major stationary sources of ammonia pursuant to Utah's NNSR permitting program, consistent with all applicable federal regulatory requirements or demonstrates that sources of ammonia, as a PM2.5 precursor, do not contribute significantly to PM2.5 levels that exceed the NAAQS in nonattainment areas in the State, consistent with new provisions at 40 CFR 51.1006(a)(3).

    R307-403-2 (Applicability)

    The title of this section being changed from “Emission Limitations” to “applicability” and language being added to R307-403-2(1)-(12) to parallel federal nonattainment permitting regulations in 40 CFR 51.165; however, Utah committed to addressing further deficiencies in this section in its September 30, 2016 commitment letter. Utah committed to revise R307-403-2 consistent with the new definitions in 40 CFR 51.165 that the EPA recently finalized in the PM2.5 SIP Requirements Rules.

    On September 23, 2016, Utah submitted a letter to the EPA requesting to withdraw R307-403-2(12) (see docket EPA-R08-OAR-2016-0620.) As a result, we will not be acting on that subparagraph.

    R307-403-11 (Actuals PALs)

    R307-403-11 being added to implement a portion of the EPA's NSR Reform provisions that were adopted in the federal regulations in 2002 and have not yet been incorporated into the Utah Air Quality Rules. R307-403-11 incorporates by reference the provisions of 40 CFR 51.165(f)(1) through (14).

    R307-403-20 (Permits: Ozone Offset Requirements in Davis and Salt Lake Counties)

    This rule being revised to include the definitions and applicability provisions of R307-403-1. This rule change will ensure that the definitions and applicability provisions in R307-420 are consistent with related permitting rules in R307-403.

    UDAQ additionally committed to submit a revised SIP by December 8, 2017 to: (1) Revise R307-403-3, including R307-403-3(3), to remove the reference to NNSR determinations being made “at the time of the source's proposed start-up date; (2) revise R307-403-3, including R307-403-3(2) and R307-403-3(3), to specify that NNSR permit requirements are applicable to all new major stationary sources or major modifications located in a nonattainment area that are major for the pollutant for which the area is designated nonattainment; (3) revise R307-403-3, in addition to the previously adopted definition of LAER in R307-403-1, to explicitly state that LAER applies to all major new sources and major modifications for the relevant pollutants in nonattainment areas; (4) revise R307-403-4 to incorporate the requirements from 40 CFR 51.165 to establish that all general offset permitting requirements apply for all offsets regardless of the pollutant at issue, and to revise the provision to impose immediate and direct general offset permitting requirements on all new major stationary sources or major modifications located in a nonattainment area that are major for the pollutant for which the area is designated nonattainment; (5) revise R307-403-4 to reference the criteria discussed in section IV.D. of 40 CFR 51, Appendix S; (6) update R307-403, to include a new section that imposes requirements that address emission offsets for PM2.5 nonattainment areas (as required in 40 CFR 51.165(a)(11)) on NNSR sources, and revise R307-403-3, including R307-403-3(3)(c), to cross reference this new section, as well as the requirements in R307-403-4, R307-403-5, and R307-403-6, and revise this section to include the requirements of CAA Section 173(c)(1) and 40 CFR 51.165 (specifically 40 CFR 51.165(a)(3)) concerning the requirement that creditable reductions be calculated based on actual emissions for offset purposes; and (7) address further deficiencies regarding ammonia as a precursor to PM2.5.

    IV. Consideration of Section 110(l) of the CAA

    Under section 110(l) of the CAA, the EPA cannot approve a SIP revision if the revision would interfere with any applicable requirements concerning attainment and reasonable futher progress (RFP) toward attainment of the NAAQS, or any other applicable requirement of the Act. In addition, section 110(l) requires that each revision to an implementation plan submitted by a state shall be adopted by the state after reasonable notice and public hearing.

    The Utah SIP revisions that the EPA is proposing to approve do not interfere with any applicable requirements of the Act. The revisions to R307-401 and R307-403 submitted by the Utah on August 20, 2013, are intended to strengthen the SIP. Therefore, CAA section 110(l) requirements are satisfied.

    V. 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 UDAQ rules promulgated in the DAR, R307-400 Series as discussed in section III of this preamble. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region 8 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

    VI. 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 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 CAA; and

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

    In addition, 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 proposed 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).

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide, Intergovernmental relations, Incorporation by reference, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organization compounds.

    Authority:

    42 U.S.C. 7401 et seq.

    Dated: October 20, 2016. Shaun L. McGrath, Regional Administrator, Region 8.
    [FR Doc. 2016-26233 Filed 10-28-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63 [EPA-HQ-OAR-2009-0234; FRL-9954-62-OAR] RIN 2060-AS75 Mercury and Air Toxics Standards (MATS) Completion of Electronic Reporting Requirements AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule; extension of comment period.

    SUMMARY:

    On September 29, 2016, the Environmental Protection Agency (EPA) proposed a rule titled, “Mercury and Air Toxics Standards (MATS) Completion of Electronic Reporting Requirements.” The EPA is extending the comment period on the proposed rule that was scheduled to close on October 31, 2016, by 15 days until November 15, 2016. The EPA is making this change based on three requests for additional time to prepare comments on this proposed rule.

    DATES:

    The public comment period for the proposed rule published in the Federal Register on September 29, 2016 (81 FR 67062), is being extended. Written comments must be received on or before November 15, 2016.

    ADDRESSES:

    The EPA has established a docket for the proposed rulemaking (available at http://www.regulations.gov). The Docket ID No. is EPA-HQ-OAR-2009-0234. Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2009-0234, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. 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. If you need to include CBI as part of your comment, please visit http://www.epa.gov/dockets/comments.html for instructions. 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.

    For additional submission methods, the full EPA public comment policy, and general guidance on making effective comments, please visit http://www.epa.gov/dockets/comments.html.

    FOR FURTHER INFORMATION CONTACT:

    For additional information on this action, contact Barrett Parker, Sector Policies and Programs Division, Office of Air Quality Planning and Standards (D243-05), Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number: (919) 541-5635; email address: [email protected].

    SUPPLEMENTARY INFORMATION:

    To allow additional time for stakeholders to provide comments, the EPA has decided to extend the public comment period until November 15, 2016.

    Dated: October 24, 2016. Stephen Page, Director, Office of Air Quality Planning and Standards.
    [FR Doc. 2016-26209 Filed 10-28-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management 43 CFR Part 8360 [16XL 1109AF LLUTY0100 L12200000.EA0000 24-1A] Notice of Proposed Supplementary Rules for Public Lands Managed by the Moab Field Office in Grand County, Utah AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Proposed supplementary rule.

    SUMMARY:

    The Bureau of Land Management (BLM) is proposing a supplementary rule addressing conduct on public lands in the vicinity of Corona Arch and Gemini Bridges in Grand County, Utah. The proposed supplementary rule would prohibit roped activities around Corona Arch and Gemini Bridges. Such activities involve the use of ropes or other climbing aids, and include, but are not limited to, ziplining, highlining, slacklining, traditional rock climbing, sport rock climbing, rappelling, and swinging.

    DATES:

    Comments on the proposed supplementary rule must be received or postmarked by December 30, 2016 to be assured of consideration. Comments received, postmarked or electronically dated after that date will not necessarily be considered in the development of the final supplementary rules.

    ADDRESSES:

    Please mail or hand deliver all comments concerning the proposed supplementary rule to the Bureau of Land Management, 82 E. Dogwood, Moab, UT 84532, or email comments to Katie Stevens, at [email protected] The proposed supplementary rule and a map depicting the area that would be affected are available for public review at the Moab Field Office, located at 82 E. Dogwood, Moab, UT 84532. The affected area is also shown on a map on the Moab Field Office's Web site at http://www.blm.gov/ut/st/en/fo/moab.html.

    FOR FURTHER INFORMATION CONTACT:

    Beth Ransel, Moab Field Manager, BLM Moab Field Office, 82 E. Dogwood, Moab, UT 84532, or telephone (435) 259-2110. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800-877-8339 to leave a message or question with the above individual. The FIRS is available 24 hours a day, 7 days a week. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    I. Public Comment Procedures

    The public is invited to provide comments on the proposed supplementary rule. See the DATES and ADDRESSES sections for information on submitting comments. Written comments on the proposed supplementary rule must be sent in accordance with the information outlined in the DATES and ADDRESSES sections of this notice. The BLM need not consider, or include in the Administrative Record for the final supplementary rule, (a) comments delivered to an address other than those listed above (See ADDRESSES), or (b) comments that the BLM receives after the close of the comment period (See DATES), unless they are postmarked or electronically dated before the deadline.

    Written comments on the proposed supplementary rule should be specific, confined to issues pertinent to the proposed supplementary rule, and should explain the reason for any recommended change. Where possible, comments should reference the specific section of the rule that the comment is addressing. Comments, including names, street addresses, and other contact information of respondents, will be available for public review at 82 E. Dogwood, Moab, UT 84532, during regular business hours (8:00 a.m. to 4:30 p.m.), Monday through Friday, except Federal holidays. Before including your address, telephone number, email address, or other personal identifying information in your comment, be advised that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold from public review your personal identifying information, we cannot guarantee that we will be able to do so.

    II. Background

    The BLM establishes supplementary rules under the authority of 43 CFR 8365.1-6, which allows the BLM State Directors to establish such rules for the protection of persons, property, and public lands and resources. This regulation allows the BLM to issue rules of less than national effect without codifying the rules in the Code of Federal Regulations.

    Corona Arch and Gemini Bridges are two of the most popular locations in the Moab Field Office. Corona Arch is a partly freestanding arch with a 110-foot by 110-foot opening. Gemini Bridges are two large arches standing side-by-side. Corona Arch is visited by approximately 40,000 visitors per year, and Gemini Bridges are visited by approximately 50,000 visitors per year. The BLM has received many complaints that roped activities, including swinging from the arches, conflict with other visitors' use and enjoyment of the arches. The BLM finds merit in these complaints. People setting up and using swings and rappels from the arches endanger both themselves and those viewing them from below. In addition, the rock arches may be damaged by ropes “sawing” on the rock spans. The supplementary rules currently in effect in the Moab Field Office (at 81 FR 9498 (Feb. 25, 2016)) do not address roped activities on the affected arches, although a temporary restriction (80 FR 27703 (May 14, 2015)) is in effect until May 2017.

    The legal descriptions of the affected public lands are:

    Salt Lake Meridian T. 25 S., R. 20 E., Sec. 34, NW1/4 SW1/4, that part surrounding Gemini Bridges. T. 25 S., R. 21 E., sec. 32, SE1/4 SE1/4, that part surrounding Corona Arch. T. 26 S., R. 21 E., sec. 5, NE1/4, that part surrounding Corona Arch.

    The areas described aggregate 37.3 acres.

    This proposed supplementary rule would allow for enforcement as a tool in minimizing the adverse effects of roped activities within the affected areas. After it goes into effect, the supplementary rule will be available for inspection in the Moab Field Office, and it will be announced broadly through the news media and direct mail to the constituents included on the Moab Field Office mailing list. It will also be posted on signs at main entry points to the affected areas.

    III. Discussion of the Proposed Supplementary Rule

    The Moab Field Office proposes to ban roped activities in the vicinity of Corona Arch and Gemini Bridges. The prohibited activities would include, but not be limited to, ziplining, highlining, slacklining, traditional rock climbing, sport rock climbing, rappelling, and swinging, using equipment such as ropes, cables, climbing aids, webbing, or anchors. The proposed supplementary rule would affect 31 acres surrounding Corona Arch and 6.3 acres surrounding Gemini Bridges. The proposed supplementary rule is necessary for the protection of visitors and for the protection of the arches.

    IV. Procedural Matters Executive Order 12866, Regulatory Planning and Review

    This proposed supplementary rule is not a significant regulatory action and is not subject to review by the Office of Management and Budget under Executive Order 12866. This proposed supplementary rule would not have an annual effect of $100 million or more on the economy. It is not intended to affect commercial activity, but imposes a rule of conduct on recreational visitors for public safety and resource protection reasons in a limited area of public lands. This supplementary rule would not adversely affect, in a material way, the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. This proposed supplementary rule would not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. This proposed supplementary rule does not materially alter the budgetary effects of entitlements, grants, user fees, or loan programs or the right or obligations of their recipients, nor does it raise novel legal or policy issues; it merely strives to protect public safety and the environment.

    Clarity of the Rule

    Executive Order 12866 requires each agency to write regulations that are simple and easy to understand. The BLM invites comments on how to make this proposed supplementary rule easier to understand, including answers to questions such as the following:

    (1) Are the requirements in the proposed supplementary rule clearly stated?

    (2) Does the proposed supplementary rule contain technical language or jargon that interferes with their clarity?

    (3) Does the format of the proposed supplementary rule (grouping and order of sections, use of headings, paragraphing, etc.) aid or reduce its clarity?

    (4) Would the proposed supplementary rule be easier to understand if it was divided into more (but shorter) sections?

    (5) Is the description of the proposed supplementary rule in the SUPPLEMENTARY INFORMATION section of this preamble helpful to your understanding of the proposed supplementary rule? How could this description be more helpful in making the proposed supplementary rule easier to understand?

    Please send any comments you have on the clarity of the proposed supplementary rule to the address specified in the ADDRESSES section.

    National Environmental Policy Act (NEPA)

    A temporary restriction on roped activities was analyzed in Environmental Assessment (EA) DOI-BLM-UT-2014-0170-EA, Temporary Restriction of Roped Activities at Corona Arch and Gemini Bridges. This document was subject to a 30-day public comment period; it was signed on January 6, 2015. The permanent restriction on roped activities was analyzed in Environmental Assessment DOI-BLM-UT-2015-0227, Permanent Restriction of Corona Arch and Gemini Bridges to Roped Activities. This document was subject to a 30-day scoping period and a 30-day public comment period. The Decision Record was signed on May 5, 2016. The EA found that the proposed supplementary rule would not constitute a major Federal action significantly affecting the quality of the human environment under Section 102(2)(C) of the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4332(2)(C). The proposed supplementary rule merely contains rules of conduct for the BLM public lands administered by the Moab Field Office within a 31-acre area around Corona Arch and 6.3-acre area around Gemini Bridges. This rule is designed to protect the environment and public safety. A detailed impact statement under NEPA is not required. The BLM has placed the EA and the Finding of No Significant Impact on file in the BLM Administrative Record at the address specified in the ADDRESSES section.

    Regulatory Flexibility Act

    Congress enacted the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, to ensure that Government regulations do not unnecessarily or disproportionately burden small entities. The RFA requires a regulatory flexibility analysis if a rule would have a significant economic impact, either detrimental or beneficial, on a substantial number of small entities. The proposed supplementary rule does not pertain specifically to commercial or governmental entities of any size, but to public recreational use of specific public lands. Therefore, the BLM has determined under the RFA that the proposed supplementary rule would not have a significant economic impact on a substantial number of small entities.

    Small Business Regulatory Enforcement Fairness Act

    This proposed supplementary rule would not constitute a “major rule” as defined at 5 U.S.C. 804(2). This proposed supplementary rule merely contains rules of conduct for recreational use of public lands. This proposed rule would not affect business, commercial, or industrial use of public lands.

    Unfunded Mandates Reform Act

    This proposed supplementary rule would not pose an unfunded mandate on State, local, or tribal governments of more than $100 million per year; nor would it have a significant or unique effect on small governments. This proposed supplementary rule does not require anything of State, local, or tribal governments. Therefore, the BLM is not required to prepare a statement containing the information required by the Unfunded Mandates Reform Act, 2 U.S.C. 1531 et seq.

    Executive Order 12630, Governmental Actions and Interference With Constitutionally Protected Property Rights (Takings)

    This proposed supplementary rule is not a government action capable of interfering with constitutionally protected property rights. This proposed supplementary rule does not address property rights in any form, and does not cause the impairment of anybody's property rights. Therefore, the BLM has determined that this proposed supplementary rule would not cause a taking of private property or require further discussion of takings implications under this Executive Order.

    Executive Order 13132, Federalism

    This proposed supplementary rule would not have a substantial direct effect on the states, on the relationship between the Federal government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, the BLM has determined that this proposed supplementary rule does not have sufficient Federalism implications to warrant preparation of a Federalism assessment.

    Executive Order 12988, Civil Justice Reform

    Under Executive Order 12988, the BLM has determined that this proposed supplementary rule would not unduly burden the judicial system and that the requirements of sections 3(a) and 3(b)(2) of the Order are met. This supplementary rule contains rules of conduct for recreational use of certain public lands to protect public safety and the environment.

    Executive Order 13175, Consultation and Coordination With Indian Tribal Governments

    In accordance with Executive Order 13175, the BLM has found that this proposed supplementary rule does not include policies that have tribal implications. This proposed supplementary rule does not affect lands held in trust for the benefit of Native American tribes, individual Indians, Aleuts, or others, nor does it affect lands for which title is held in fee status by Indian tribes or U.S. Government-owned lands managed by the Bureau of Indian Affairs.

    Paperwork Reduction Act

    This proposed supplementary rule does not contain information collection requirements that the Office of Management and Budget must approve under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

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

    This proposed supplementary rule does not comprise a significant energy action. This proposed supplementary rule would not have an adverse effect on energy supplies, production, or consumption. It only addresses rules of conduct for recreational use of certain public lands to protect public safety and the environment, and has no connection with energy policy.

    Author

    The principal author of the proposed supplementary rule is Beth Ransel, Field Manager for the Moab Field Office, Utah.

    For the reasons stated in the preamble, and under the authority for supplementary rules at 43 U.S.C. 1740 and 43 CFR 8365.1-6, the Utah State Director, BLM, proposes to issue this supplementary rule for public lands managed by the BLM in Utah, to read as follows:

    V. Proposed Supplementary Rule Definitions

    Roped activities means activities that involve the use of ropes, cables, climbing aids, webbing, or anchors, and includes, but is not limited to, ziplining, highlining, slacklining, traditional rock climbing, sport rock climbing, rappelling, and swinging.

    Prohibited Acts

    1. You must not participate in any roped activities on public lands in the vicinity of Corona Arch or Gemini Bridges. This prohibition includes, but is not limited to, the use of ropes, cables, climbing aids, webbing, anchors, and similar devices.

    Exemptions

    The following persons are exempt from this supplementary rule: Any Federal, State, local government officer or employee in the scope of their duties; members of any organized law enforcement, rescue, or firefighting force in performance of an official duty; and any persons, agencies, municipalities or companies whose activities are authorized in writing by the BLM.

    Enforcement

    Any person who violates this supplementary rule may be tried before a United States Magistrate and fined in accordance with 18 U.S.C. 3571, imprisoned no more than 12 months under 43 U.S.C. 1733(a) and 43 CFR 8360.0-7, or both. In accordance with 43 CFR 8365.1-7, State or local officials may also impose penalties for violations of Utah law.

    Jenna Whitlock, Bureau of Land Management, Acting State Director, Utah.
    [FR Doc. 2016-26179 Filed 10-28-16; 8:45 am] BILLING CODE 4310-DQ-P
    FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 1 and 4 [GN Docket No. 15-206; Report No. 3052] Petitions for Reconsideration and Clarification of Action in Rulemaking Proceeding AGENCY:

    Federal Communications Commission.

    ACTION:

    Petitions for reconsideration and clarification.

    SUMMARY:

    Petitions for Reconsideration and Clarification (Petitions) have been filed in the Commission's rulemaking proceeding by Andrew D. Lipman, on behalf of Submarine Cable Coalition, and Kent D. Bressie, on behalf of North American Submarine Cable Association.

    DATES:

    Oppositions to the Petition must be filed on or before November 15, 2016. Replies to an opposition must be filed on or before November 25, 2016.

    ADDRESSES:

    Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.

    FOR FURTHER INFORMATION CONTACT:

    Peter Shroyer, Public Safety and Homeland Security Bureau, email: [email protected]; phone: (202) 418-1575.

    SUPPLEMENTARY INFORMATION:

    This is a summary of the Commission's document, Report No. 3052, released October 12, 2016. The full text of the Petitions is available for viewing and copying at the FCC Reference Information Center, 445 12th Street SW., Room CY-A257, Washington, DC 20554 or may be accessed online via the Commission's Electronic Comment Filing System at http://apps.fcc.gov/ecfs/. The Commission will not send a copy of this Notice pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A), because this Notice does not have an impact on any rules of particular applicability.

    Subject: Improving Outage Reporting for Submarine Cables and Enhanced Submarine Cable Outage Data; NORS; FCC 16-81, published at 81 FR 52354, August 8, 2016 in GN 15-206. This Notice 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: 2.

    Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2016-26198 Filed 10-28-16; 8:45 am] BILLING CODE 6712-01-P
    81 210 Monday, October 31, 2016 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request October 26, 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 November 30, 2016 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 and Plant Health Inspection Service

    Title: Untreated Oranges, Tangerines, and Grapefruit From Mexico Transiting the United States to Foreign Countries.

    OMB Control Number: 0579-0303.

    Summary of Collection: Under the Plant Protection Act (7 U.S.C. 7701 et seq.), the Secretary of Agriculture is authorized to prohibit or restrict the importation, entry, or movement of plants and plant pests to prevent the introduction of plant pests into the United States or their dissemination within the United States. The Code of Federal Regulations, § 352.30 addresses the movement into or through the United States of untreated oranges, tangerines, and grapefruit from Mexico that transit the United States en route to foreign countries.

    Need and Use of the Information: The Animal and Plant Health Inspection Service (APHIS) is taking action to provide additional protection against the possible introduction of fruit flies via untreated oranges, tangerines, and grapefruit from Mexico that transit the United States. Untreated oranges, tangerines, and grapefruit from Mexico transiting the United States for export to another country must be shipped in sealed, refrigerated containers and insect-proof packaging. A transportation and export permit must be issued by an inspector for shipments of untreated oranges, tangerines, and grapefruit from Mexico, as well as an inspection certificate and notice of arrival. Without the information, APHIS would not be able to allow the movement of untreated citrus to transit the United States to foreign countries.

    Description of Respondents: Business, importers.

    Number of Respondents: 3.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 26.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2016-26205 Filed 10-28-16; 8:45 am] BILLING CODE 3410-34-P
    DEPARTMENT OF AGRICULTURE Forest Service Forest Resource Coordinating Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Forest Resource Coordinating Committee (Committee) will meet in Washington, DC. The Committee is authorized under Section 8005 of the Food, Conservation, and Energy Act of 2008 (the Act) (Pub. L. 110-246). Additional information concerning the Committee, including the meeting agenda, supporting documents and minutes, can be found by visiting the Committee's Web site at http://www.fs.fed.us/spf/coop/frcc/.

    DATES:

    The meeting will be held on the following dates and time:

    • Wednesday, November 9, 2016, from 8:30 a.m. to 5:00 p.m. EST • Thursday, November 10, 2016, from 8:30 a.m. to 5:00 p.m. EST

    All meetings are subject to cancellation. For updated status of the meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Hotel Indigo, Inspiration Conference Room, 151 Haywood Street, Asheville, North Carolina.

    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 placed on the Committee's Web site listed above.

    FOR FURTHER INFORMATION CONTACT:

    Scott Stewart, Forest Resource Coordinating Committee Designated Federal Officer, Cooperative Forestry Staff by phone at 202-205-1618 or Jennifer Helwig, Forest Resource Coordinating Committee Program Coordinator, Cooperative Forestry Staff by phone at 202-205-0892. 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 Daylight Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to:

    1. Discuss current and emerging recommendation efforts and develop a briefing-paper for incoming Administration;

    2. Meet partners to hear concerns and opportunities to collaborate; and

    3. Conduct Work Group break out sessions.

    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 November 3, 2016 to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the Committee may file written statements with the Committee staff before November 3, 2016. Written comments and time requests for oral comments must be sent to Scott Stewart, 1400 Independence Ave. SW., Mailstop 1123, Washington, DC 20250; or by email to [email protected] A summary of the meeting will be posted at http://www.fs.fed.us/spf/coop/frcc within 21 days after the meeting.

    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 accommodations for access to the facility or proceedings by contacting the person listed under the FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: October 21, 2016. Patricia Hirami, Associate Deputy Chief, State and Private Forestry.
    [FR Doc. 2016-26195 Filed 10-28-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Allegheny Resource Advisory Committee Meeting AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Allegheny Resource Advisory Committee (RAC) will meet in Warren, Pennsylvania. 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 can be found at the following Web site: http://www.fs.usda.gov/main/allegheny/workingtogether/advisorycommittees.

    DATES:

    The meeting will be held Thursday, December 8, 2016, at 10:00 a.m. EST.

    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 Allegheny National Forest Supervisor's Office, 4 Farm Colony Drive, Warren, Pennsylvania.

    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 Allegheny National Forest Supervisor's Office. Please call ahead at 814-728-6100 to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Ruth Sutton, RAC Coordinator by phone at 814-728-6100, 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. 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 above.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to review and approve project submissions.

    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 November 30, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Ruth Sutton, RAC Coordinator, Allegheny National Forest Supervisor's Office, 4 Farm Colony Drive, Warren, Pennsylvania 16365; by email to [email protected], or via facsimile to 814-726-1465.

    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: October 24, 2016. Sherry A. Tune, Forest Supervisor.
    [FR Doc. 2016-26165 Filed 10-28-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service National Urban and Community Forestry Advisory Council AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The National Urban and Community Forestry Advisory Council (Council) will meet in Washington, DC The Council is authorized under Section 9 of the Cooperative Forestry Assistance Act, as amended by Title XII, Section 1219 of Public Law 101-624 (the Act) (16 U.S.C. 2105g) and the Federal Advisory Committee Act (FACA) (5 U.S.C. App. II). Additional information concerning the Council, can be found by visiting the Council's Web site at: http://www.fs.fed.us/ucf/nucfac.shtml.

    DATES:

    The meeting will be held on the following dates and times:

    • Monday, November 13, 2016, from 9:00 a.m. to 5:00 p.m. Central Time or until Council business is completed. All meetings are subject to cancellation. For an 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 Santa Fe Room, Indianapolis Marriot Downtown, 350 West Maryland Street, Indianapolis, Indiana.

    Written comments concerning this meeting should 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 USDA Forest Service, Sidney Yates Building, Room 3SC-01C, 201 14th Street SW., Washington, DC 20024. Please call ahead at 202-205-7829 to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Nancy Stremple, Executive Staff, National Urban and Community Forestry Advisory Council, Sidney Yates Building, Room 3SC-01C, 201 14th Street SW., Washington, DC 20024 by telephone at 202-205-7829, or by email at [email protected], or by cell phone at 202-309-9873, or via facsimile at 202-690-5792. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to:

    1. Introduce new members;

    2. Finalize the 2016 Accomplishment and Recommendations;

    3. Update status of the 2017 grant review;

    4. Listen to local constituents urban forestry concerns;

    5. Provide updates on the 10-year action plan (2016-2026);

    6. Receive Forest Service budget and program updates; and

    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 November 1, 2016, to be scheduled on the agenda. Council discussion is limited to Forest Service staff and Council members, however anyone who would like to bring urban and community forestry matters to the attention of the Council may file written statements with the Council's staff before or after the meeting. Written comments and time requests for oral comments must be sent to Nancy Stemple, Executive Staff, National Urban and Community Forestry Advisory Council, Sidney Yates Building, Room 3SC-01C, 201 14th Street SW., Washington, DC 20024, or by email at [email protected].

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or proceedings by contacting the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

    Dated: October 25, 2016. Steven W. Koehn, Director, Cooperative Forestry.
    [FR Doc. 2016-26200 Filed 10-28-16; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE National Agricultural Statistics Service Notice of Invitation for Nominations to the Advisory Committee on Agriculture Statistics AGENCY:

    National Agricultural Statistics Service (NASS), Department of Agriculture.

    ACTION:

    Solicitation of Nominations to the Advisory Committee on Agriculture Statistics.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces an invitation from the Office of the Secretary of Agriculture for nominations to the Advisory Committee on Agriculture Statistics.

    On August 15, 2016, the Secretary of Agriculture renewed the Advisory Committee charter for a two-year term to expire on August 15, 2018. The purpose of the Committee is to advise the Secretary of Agriculture on the scope, timing, content, etc., of the periodic censuses and surveys of agriculture, other related surveys, and the types of information to obtain from respondents concerning agriculture. The Committee also prepares recommendations regarding the content of agriculture reports and presents the views and needs for data of major suppliers and users of agriculture statistics.

    DATES:

    The nomination period for interested candidates will close 30 days after publication of this notice.

    ADDRESSES:

    You may submit nominations by any of the following methods:

    Email: Scan the completed form and email to: [email protected].

    eFax: 855-493-0445.

    Mail: Nominations should be mailed to Renee Picanso, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, 1400 Independence Avenue SW., Room 5041 South Building, Washington, DC 20250-2010.

    Hand Delivery/Courier: Hand deliver to: Renee Picanso, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, 1400 Independence Avenue SW., Room 5041 South Building, Washington, DC 20250-2010.

    FOR FURTHER INFORMATION CONTACT:

    Renee Picanso, Associate Administrator, National Agricultural Statistics Service, (202) 720-2707.

    SUPPLEMENTARY INFORMATION:

    Each person nominated to serve on the committee is required to submit the following form: AD-755 (Advisory Committee Membership Background Information, OMB Number 0505-0001), available on the Internet at https://www.nass.usda.gov/About_NASS/Advisory_Committee_on_Agriculture_Statistics/AD-755.pdf. This form may also be requested by telephone, fax, or email using the information above. Completed forms may be faxed to the number above, mailed, or completed and emailed directly from the Internet site. For more information on the Advisory Committee on Agriculture Statistics, see the NASS Web site at https://www.nass.usda.gov/About_NASS/Advisory_Committee_on_Agriculture_Statistics/index.php. The Committee draws on the experience and expertise of its members to form a collective judgment concerning agriculture data collected and the statistics issued by NASS. This input is vital to keep current with shifting data needs in the rapidly changing agricultural environment and keeps NASS informed of emerging issues in the agriculture community that can affect agriculture statistics activities.

    The Committee, appointed by the Secretary of Agriculture, consists of 20 members representing a broad range of disciplines and interests, including, but not limited to, producers, representatives of national farm organizations, agricultural economists, rural sociologists, farm policy analysts, educators, State agriculture representatives, and agriculture-related business and marketing experts.

    Members serve staggered 2-year terms, with terms for half of the Committee members expiring in any given year. Nominations are being sought for 10 open Committee seats. Members can serve up to 3 terms for a total of 6 consecutive years. The Chairperson of the Committee shall be elected by members to serve a 1-year term.

    Equal opportunity practices, in line with USDA policies, will be followed in all membership appointments to the Committee. To ensure that the recommendations of the Committee have taken into account the needs of the diverse groups served by USDA, membership will include to the extent possible, individuals with demonstrated ability to represent the needs of all racial and ethnic groups, women and men, and persons with disabilities.

    The duties of the Committee are solely advisory. The Committee will make recommendations to the Secretary of Agriculture with regards to the agricultural statistics programs of NASS, and such other matters as it may deem advisable, or which the Secretary of Agriculture; Under Secretary for Research, Education, and Economics; or the Administrator of NASS may request. The Committee will meet at least annually. All meetings are open to the public. Committee members are reimbursed for official travel expenses only.

    Send questions, comments, and requests for additional information to the email address, fax number, or address listed above.

    Signed at Washington, DC, October 20, 2016. R. Renee Picanso, Associate Administrator, National Agricultural Statistics Service.
    [FR Doc. 2016-26154 Filed 10-28-16; 8:45 am] BILLING CODE 3410-20-P
    DEPARTMENT OF AGRICULTURE National Agricultural Statistics Service Notice of Intent To Request Revision and Extension of a Currently Approved Information Collection AGENCY:

    National Agricultural Statistics Service, USDA.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the National Agricultural Statistics Service (NASS) to request revision and extension of a currently approved information collection, the Cotton Ginning Survey. Revision to burden hours will be needed due to changes in the size of the target population, sampling design, and/or questionnaire length.

    DATES:

    Comments on this notice must be received by December 30, 2016 to be assured of consideration.

    ADDRESSES:

    You may submit comments, identified by docket number 0535-0220, by any of the following methods:

    Email: [email protected]. Include docket number above in the subject line of the message.

    E-fax: (855) 838-6382.

    Mail: Mail any paper, disk, or CD-ROM submissions to: David Hancock, NASS Clearance Officer, U.S. Department of Agriculture, Room 5336 South Building, 1400 Independence Avenue SW., Washington, DC 20250-2024.

    Hand Delivery/Courier: Hand deliver to: 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) 720-2707. Copies of this information collection and related instructions can be obtained without charge from David Hancock, NASS—OMB Clearance Officer, at (202) 690-2388 or at [email protected].

    SUPPLEMENTARY INFORMATION:

    Title: Cotton Ginning Survey.

    OMB Control Number: 0535-0220.

    Expiration Date of Approval: March 31, 2017.

    Type of Request: Intent to Seek Approval to Revise and Extend an Information Collection for a period of three years.

    Abstract: The primary objective of the National Agricultural Statistics Service (NASS) is to collect, prepare and issue State and national estimates of crop and livestock production, prices, and disposition as well as economic statistics, environmental statistics related to agriculture and also to conduct the Census of Agriculture. The Cotton Ginning surveys provide cotton ginning statistics from August through May by State. Data collected consists of bales of cotton ginned to date, cotton to be ginned, lint cotton produced, cottonseed produced, cottonseed sold to oil mills, cottonseed used for other uses, number of gins by type, bales produced by county of origin, and cottonseed prices received by producers. The forecasting procedure involves calculating a weighted percent ginned to date as well as an allowance for cross-state movement and bale weight adjustments. Production by State allows adjustments for year-end State and county estimates. Total pounds of lint cotton produced, is used to derive an actual bale weight which increases the precision of production estimates.

    Authority: These data will be collected under authority of 7 U.S.C. 2204(a). Individually identifiable data collected under this authority are governed by Section 1770 of the Food Security Act of 1985 as amended, 7 U.S.C. 2276, which requires USDA to afford strict confidentiality to non-aggregated data provided by respondents. This Notice is submitted in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3501, et seq.) and Office of Management and Budget regulations at 5 CFR part 1320.

    NASS also complies with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),” Federal Register, Vol. 72, No. 115, June 15, 2007, p. 33362.

    Estimate of Burden: Public reporting burden for this collection of information is estimated to be between 10 to 15 minutes per respondent per survey.

    Respondents: Active Cotton Gins.

    Estimated Number of Respondents: 650.

    Estimated Total Annual Burden on Respondents: 1,250 hours.

    Comments: Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (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 those who are to respond, including through the use of appropriate automated, electronic, mechanical, technological, or other forms of information technology collection methods.

    All responses to this notice will become a matter of public record and be summarized in the request for OMB approval.

    Signed at Washington, DC, October 18, 2016. R. Renee Picanso, Associate Administrator.
    [FR Doc. 2016-26153 Filed 10-28-16; 8:45 am] BILLING CODE 3410-20-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-48-2016] Foreign-Trade Zone (FTZ) 38—Spartanburg, South Carolina Authorization of Production Activity Benteler Automotive Corporation (Automotive Suspension and Body Components) Duncan, South Carolina

    On June 28, 2016, the South Carolina State Ports Authority, grantee of FTZ 38, submitted a notification of proposed production activity to the FTZ Board on behalf of Benteler Automotive Corporation, within Subzone 38F, in Duncan, South Carolina.

    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 49927, July 29, 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: October 25, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-26219 Filed 10-28-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE Bureau of Industry and Security Proposed Information Collection; Comment Request; Report of Requests for Restrictive Trade Practice or Boycott AGENCY:

    Bureau of Industry and Security, Department of 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 take this opportunity 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 December 30, 2016.

    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]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Mark Crace, BIS ICB Liaison, (202) 482-8093, [email protected].

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    This information is used to monitor requests for participation in foreign boycotts against countries friendly to the U.S. The information is analyzed to note changing trends and to decide upon appropriate action to be taken to carry out the United States' policy of discouraging its citizens from participating in foreign restrictive trade practices and boycotts directed against friendly countries.

    II. Method of Collection

    Submitted on paper or electronically.

    III. Data

    OMB Control Number: 0694-0012.

    Form Number(s): BIS-621P, BIS-6051P, BIS-6051 P-a.

    Type of Review: Regular submission.

    Affected Public: Business or other for-profit organizations.

    Estimated Number of Respondents: 892.

    Estimated Time per Response: 1 hour to 1 hour and 30 minutes.

    Estimated Total Annual Burden Hours: 1171.

    Estimated Total Annual Cost to Public: $0.

    IV. Request for Comments

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (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.

    Sheleen Dumas, PRA Departmental Lead, Office of the Chief Information Officer.
    [FR Doc. 2016-26157 Filed 10-28-16; 8:45 am] BILLING CODE 3510-33-P
    DEPARTMENT OF COMMERCE International Trade Administration [Docket No.: 161012955-6955-01] Call for Applications for the International Buyer Program Select Service for Calendar Year 2018 AGENCY:

    International Trade Administration, Department of Commerce.

    ACTION:

    Notice and call for applications.

    SUMMARY:

    The U.S. Department of Commerce (DOC), International Trade Administration (ITA) announces that it will accept applications for the International Buyer Program (IBP) Select service for calendar year 2018 (January 1, 2018, through December 31, 2018). This announcement sets out the objectives, procedures and application review criteria for IBP Select. Under IBP Select, ITA recruits international buyers to U.S. trade shows to meet with U.S. suppliers exhibiting at those shows. The main difference between IBP and IBP Select is that IBP offers worldwide promotion, whereas IBP Select focuses on promotion and recruitment in up to five international markets. Specifically, through the IBP Select, the DOC selects domestic trade shows that will receive DOC assistance in the form of targeted promotion and recruitment in up to five foreign markets, export counseling to exhibitors, and export counseling and matchmaking services at the trade show. This notice covers selection for IBP Select participation during calendar year 2018.

    DATES:

    Applications for IBP Select must be received by Friday, January 6, 2017.

    ADDRESSES:

    The application form can be found at www.export.gov/ibp. Applications may be submitted by any of the following methods: (1) Mail/Hand (including express) Delivery Service: International Buyer Program, Trade Promotion Programs, International Trade Administration, U.S. Department of Commerce, Ronald Reagan Building, 1300 Pennsylvania Ave. NW., Suite 800—Mezzanine Level—Atrium North, Washington, DC 20004; (2) Facsimile: (202) 482-7800; or (3) email: [email protected]. Facsimile and email applications will be accepted as interim applications, and must be followed by a signed original application that is received by the program no later than five (5) business days after the application deadline. To ensure that applications are received by the deadline, applicants are strongly urged to send applications by express delivery service (e.g., U.S. Postal Service Express Delivery, Federal Express, UPS, etc.).

    FOR FURTHER INFORMATION CONTACT:

    Vidya Desai, Senior Advisor, Trade Promotion Programs, International Trade Administration, U.S. Department of Commerce, 1300 Pennsylvania Ave. NW., Ronald Reagan Building, Suite 800M—Mezzanine Level—Atrium North, Washington, DC 20004; Telephone (202) 482-2311; Facsimile: (202) 482-7800; Email: [email protected].

    SUPPLEMENTARY INFORMATION:

    The IBP was established in the Omnibus Trade and Competitiveness Act of 1988 (Pub. L. 100-418, title II, § 2304, codified at 15 U.S.C. 4724) to bring international buyers together with U.S. firms by promoting leading U.S. trade shows in industries with high export potential. The IBP emphasizes cooperation between the DOC and trade show organizers to benefit U.S. firms exhibiting at selected shows and provides practical, hands-on assistance such as export counseling and market analysis to U.S. companies interested in exporting. Shows selected for the IBP Select will provide a venue for U.S. companies interested in expanding their sales into international markets.

    Through the IBP Select, the DOC selects trade shows that DOC determines to be leading trade shows with participation by U.S. firms interested in exporting. DOC provides successful applicants with assistance in the form of targeted overseas promotion of the show by U.S. Embassies and Consulates; outreach to show participants about exporting; recruitment of potential buyers to attend the shows; and staff assistance in setting up and staffing international trade centers at the shows. Targeted promotion in up to five markets can be executed through the overseas offices of ITA or in U.S. Embassies in countries where ITA does not maintain offices.

    ITA is accepting applications for IBP Select from trade show organizers of trade shows taking place between January 1, 2018, and December 31, 2018. Selection of a trade show for IBP Select is valid for one show. A trade show organizer seeking selection for a recurring show must submit a new application for selection for each occurrence of the show. For shows that occur more than once in a calendar year, the trade show organizer must submit a separate application for each show.

    There is no fee required to submit an application. For IBP Select in calendar year 2018, ITA expects to select approximately 10 shows from among the applicants. ITA will select those shows that are determined to most clearly support the statutory mandate in 15 U.S.C. 4721 to promote U.S. exports, especially those of small- and medium-sized enterprises, and that best meet the selection criteria articulated below. Once selected, applicants will be required to enter into a Memorandum of Agreement (MOA) with the DOC, and submit payment of the $6,000 2018 participation fee (by check or credit card) within 30 days of written notification of acceptance into IBP Select. The MOA constitutes an agreement between the DOC and the show organizer specifying which responsibilities for international promotion and export assistance services at the trade shows are to be undertaken by the DOC as part of the IBP Select and, in turn, which responsibilities are to be undertaken by the show organizer. Anyone requesting application information will be sent a sample copy of the MOA along with the application form and a copy of this Federal Register Notice. Applicants are encouraged to review the MOA closely, as IBP Select participants are required to comply with all terms, conditions, and obligations in the MOA. Trade show organizer obligations include the construction of an International Trade Center at the trade show, production of an export interest directory, and provision of complimentary hotel accommodations for DOC staff as explained in the MOA. ITA responsibilities include targeted promotion of the trade show and, where feasible, recruitment of international buyers to that show from up to five target markets identified, provision of on-site export assistance to U.S. exhibitors at the show, and the reporting of results to the show organizer.

    Selection as an IBP Select show does not constitute a guarantee by DOC of the show's success. IBP Select participation status is not an endorsement of the show except as to its international buyer activities. Non-selection of an applicant for IBP Select status should not be viewed as a determination that the show will not be successful in promoting U.S. exports.

    Eligibility: 2018 U.S. trade shows with 1,350 or fewer exhibitors are eligible to apply, through the show organizer, for IBP Select participation. First-time shows will also be considered.

    Exclusions: U.S. trade shows with over 1,350 exhibitors will not be considered for IBP Select.

    General Evaluation Criteria: ITA will evaluate applicants for IBP Select using the following criteria:

    (a) Export Potential: The trade show promotes products and services from U.S. industries that have high export potential, as determined by DOC sources, including industry analysts' assessment of export potential, ITA best prospects lists, and U.S. export analysis.

    (b) Level of International Interest: The trade show meets the needs of a significant number of overseas markets and corresponds to marketing opportunities as identified by ITA. Previous international attendance at the show may be used as an indicator.

    (c) Scope of the Show: The show must offer a broad spectrum of U.S. made products and services for the subject industry. Trade shows with a majority of U.S. firms as exhibitors are given priority.

    (d) U.S. Content of Show Exhibitors: Trade shows with exhibitors featuring a high percentage of products produced in the United States or products with a high degree of U.S. content will be preferred.

    (e) Stature of the Show: The trade show is clearly recognized by the industry it covers as a leading show for the promotion of that industry's products and services both domestically and internationally, and as a showplace for the latest technology or services in that industry.

    (f) Level of Exhibitor Interest: There is significant interest on the part of U.S. exhibitors in receiving international business visitors during the trade show. A significant number of U.S. exhibitors should be new-to-export or seeking to expand their sales into additional export markets.

    (g) Level of Overseas Marketing: There has been a demonstrated effort by the applicant to market prior shows overseas. In addition, the applicant should describe in detail the international marketing program to be conducted for the show, and explain how efforts should increase individual and group international attendance.

    (h) Level of Cooperation: The applicant demonstrates a willingness to cooperate with ITA to fulfill the program's goals and adhere to the target dates set out in the MOA and in the show timetables, both of which are available from the program office (see the FOR FURTHER INFORMATION CONTACT section above). Past experience in the IBP will be taken into account in evaluating the applications received.

    (i) Delegation Incentives: Waived or reduced (by at least 50% off lowest price) admission fees are required for international attendees who are participating in IBP Select. Delegation leaders also must be provided complimentary admission to the show. In addition, show organizers should offer a range of incentives to delegations and/or delegation leaders recruited by the DOC overseas posts. Examples of incentives to international visitors and to organized delegations include: Special organized events, such as receptions, meetings with association executives, briefings, and site tours; or complimentary accommodations for delegation leaders.

    Review Process: ITA will vet all applications received based on the criteria set out in this notice. Vetting will include soliciting input from ITA industry analysts, as well as domestic and international field offices, focusing primarily on the export potential, level of international interest, and stature of the show. In reviewing applications, ITA will also consider sector and calendar diversity in terms of the need to allocate resources to support selected shows.

    Application Requirements: Show organizers submitting applications for 2018 IBP Select are required to submit: (1) A narrative statement addressing each question in the application, OMB 0625-0143 (found at www.export.gov/ibp); and (2) a signed statement that “The above information provided is correct and the applicant will abide by the terms set forth in this Call for Applications for the International Buyer Program Select (January 1, 2018 through December 31, 2018);” on or before the deadline noted above. Applications for IBP Select must be received by Friday, January 6, 2017. There is no fee required to apply. ITA expects to issue the results of this process in April 2017.

    Legal Authority: The statutory program authority for ITA to conduct the IBP is 15 U.S.C. 4724. ITA has the legal authority to enter into MOAs with show organizers under the provisions of the Mutual Educational and Cultural Exchange Act of 1961 (MECEA), as amended (22 U.S.C. 2455(f) and 2458(c)). MECEA allows ITA to accept contributions of funds and services from firms for the purposes of furthering its mission.

    The Office of Management and Budget (OMB) has approved the information collection requirements of the application to this program (0625-0143) under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (OMB Control No. 0625-0143). Notwithstanding any other provision of law, no person is 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 currently valid OMB Control Number.

    For further information please contact: Vidya Desai, Senior Advisor, Trade Promotion Programs ([email protected]).

    Frank Spector, Trade Promotion Programs.
    [FR Doc. 2016-26218 Filed 10-28-16; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-533-840] Certain Frozen Warmwater Shrimp From India: Initiation and Preliminary Results of Antidumping Duty Changed Circumstances Review AGENCY:

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

    SUMMARY:

    Avanti Frozen Foods Private Limited (Avanti Frozen) requested a changed circumstances review of the antidumping duty order on certain frozen warmwater shrimp (shrimp) from India. The Department of Commerce (Department) is initiating this changed circumstances review and preliminarily determining that Avanti Frozen is the successor-in-interest to Avanti Feeds Limited (Avanti Feeds).

    DATES:

    Effective October 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    E. Whitley Herndon, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: 202-482-6274.

    SUPPLEMENTARY INFORMATION:

    Background

    On February 1, 2005, the Department published in the Federal Register an antidumping duty order on shrimp from India.1 In the tenth administrative review of the Order, Avanti Feeds was assigned a cash deposit rate of 2.20 percent.2

    1See Notice of Amended Final Determination of Sales at Less Than Fair Value and Antidumping Duty Order: Certain Frozen Warmwater Shrimp from India, 70 FR 5147 (February 1, 2005) (Order).

    2See Certain Frozen Warmwater Shrimp From India: Final Results of Antidumping Duty Administrative Review; Final Determination of No Shipments; 2014-2015, 81 FR 62867 (September 13, 2016) (10th AR).

    On September 7, 2016, Avanti Frozen requested that, pursuant to section 751(b)(1) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.216(b), the Department conduct a changed circumstances review of the Order to confirm that Avanti Frozen is the successor-in-interest to Avanti Feeds.3 In its submission, Avanti Frozen explained that Avanti Feeds undertook a business reorganization and transferred its shrimp business to its subsidiary company, Avanti Frozen.4 The domestic industry did not file any comment for these preliminary results.

    3See Letter from Avanti Frozen entitled “Frozen Warmwater Shrimp form India: Request to Initiate a Successor-in-Interest Changed Circumstances Review,” dated September 7, 2016 (Avanti Frozen CCR Request).

    4Id. at 2.

    Scope of the Order

    The merchandise subject to the order is certain frozen warmwater shrimp.5 The product is currently classified under the following Harmonized Tariff Schedule of the United States (HTSUS) item numbers: 0306.17.00.03, 0306.17.00.06, 0306.17.00.09, 0306.17.00.12, 0306.17.00.15, 0306.17.00.18, 0306.17.00.21, 0306.17.00.24, 0306.17.00.27, 0306.17.00.40, 1605.21.10.30, and 1605.29.10.10. Although the HTSUS numbers are provided for convenience and customs purposes, the written product description remains dispositive.

    5 For a complete description of the Scope of the Order, see 10th AR, and accompanying Issues and Decision Memorandum at “Scope.”

    Initiation and Preliminary Results

    Pursuant to section 751(b)(1) of the Act, the Department will conduct a changed circumstances review upon receipt of information concerning, or a request from, an interested party for a review of an antidumping duty order which shows changed circumstances sufficient to warrant a review of the order. As indicated in the “Background” section, we received information indicating that Avanti Feeds has transferred its shrimp business to Avanti Frozen. This constitutes changed circumstances warranting a review of the order.6 Therefore, in accordance with section 751(b)(1) of the Act and 19 CFR 351.216(d) and (e), we are initiating a changed circumstances review based upon the information contained in Avanti Frozen's submission.

    6See 19 CFR 351.216(d).

    Section 351.221(c)(3)(ii) of the Department's regulations permits the Department to combine the notice of initiation of a changed circumstances review and the notice of preliminary results if the Department concludes that expedited action is warranted. In this instance, because the record contains information necessary to make a preliminary finding, we find that expedited action is warranted and have combined the notice of initiation and the notice of preliminary results.

    In this changed circumstances review, pursuant to section 751(b) of the Act, the Department conducted a successor-in-interest analysis. In making a successor-in-interest determination, the Department examines several factors, including, but not limited to, changes in the following: (1) Management; (2) production facilities; (3) supplier relationships; and (4) customer base.7 While no single factor or combination of factors will necessarily provide a dispositive indication of a successor-in-interest relationship, generally, the Department will consider the new company to be the successor to the previous company if the new company's resulting operation is not materially dissimilar to that of its predecessor.8 Thus, if the record evidence demonstrates that, with respect to the production and sale of the subject merchandise, the new company operates as the same business entity as the predecessor company, the Department may assign the new company the cash deposit rate of its predecessor.9

    7See, e.g., Notice of Final Results of Changed Circumstances Antidumping Duty Administrative Review: Polychloroprene Rubber From Japan, 67 FR 58 (January 2, 2002).

    8See, e.g., Fresh and Chilled Atlantic Salmon From Norway; Final Results of Changed Circumstances Antidumping Duty Administrative Review, 64 FR 9979, 9980 (March 1, 1999).

    9See, e.g., Circular Welded Non-Alloy Steel Pipe From the Republic of Korea; Preliminary Results of Antidumping Duty Changed Circumstances Review, 63 FR 14679 (March 26, 1998), unchanged in Circular Welded Non-Alloy Steel Pipe From Korea; Final Results of Antidumping Duty Changed Circumstances Review, 63 FR 20572 (April 27, 1998), in which the Department found that a company which only changed its name and did not change its operations is a successor-in-interest to the company before it changed its name.

    In accordance with 19 CFR 351.216, we preliminarily determine that Avanti Frozen is the successor-in-interest to Avanti Feeds. Record evidence, as submitted by Avanti Frozen, indicates that Avanti Frozen operates as essentially the same business entity as Avanti Feeds with respect to the subject merchandise.10 For the complete successor-in-interest analysis, including discussion of business proprietary information, refer to the accompanying successor-in-interest memorandum.11

    10See Avanti Frozen CCR Request.

    11See Memorandum to Melissa G. Skinner, Director, Office II, entitled “Certain Frozen Warmwater Shrimp from India: Preliminary Successor-In-Interest Determination” dated concurrently with this notice.

    Record evidence, as submitted by Avanti Frozen, indicates that the shrimp business was transferred fully from Avanti Feeds to its subsidiary, Avanti Frozen. Specifically, Avanti Frozen provided a Business Transfer Agreement which transfers Avanti Feed's entire shrimp business to Avanti Frozen; approvals from various governing entities approving/confirming the transfer of the shrimp business from Avanti Feeds to Avanti Frozen; letters notifying customers, suppliers, and employees of the business transfer; Avanti Frozen's first annual report; charts demonstrating the board of directors and equity stockholders of both Avanti Feed and Avanti Frozen; and a list of suppliers, customers, and production and business locations before and after the transfer.12 In summary, Avanti Frozen presented evidence to support its claim of successorship and the transfer did not impact any of the criteria that the Department typically looks to when making a changed circumstances determination.

    12See Avanti Frozen CCR Request.

    We find that the evidence provided by Avanti Frozen is sufficient to preliminarily determine that the transfer of shrimp operations from Avanti Feeds to its subsidiary Avanti Frozen did not affect the company's operations in a meaningful way. Therefore, based on the aforementioned reasons, we preliminarily determine that Avanti Frozen is the successor-in-interest to Avanti Feeds and, thus, should receive the same antidumping duty treatment with respect to the subject merchandise as Avanti Feeds.

    Public Comment

    Pursuant to 19 CFR 351.310(c), any interested party may request a hearing within 30 days of publication of this notice. In accordance with 19 CFR 351.309(c)(1)(ii), interested parties may submit case briefs not 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 case briefs, in accordance with 19 CFR 351.309(d). Parties who submit case or rebuttal briefs are encouraged to submit with each argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities. All comments are to be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS) available to registered users at http://iaaccess.trade.gov and in the Central Records Unit, Room B8024 of the main Department of Commerce building, and must also be served on interested parties.29 An electronically filed document must be received successfully in its entirety by ACCESS by 5:00 p.m. Eastern Time on the day it is due.13

    13See 19 CFR 351.303(b).

    Consistent with 19 CFR 351.216(e), we will issue the final results of this changed circumstances review no later than 270 days after the date on which this review was initiated, or within 45 days if all parties agree to our preliminary finding. This notice is published in accordance with sections 751(b)(1) and 777(i) of the Act and 19 CFR 351.216(b), 351.221(b) and 351.221(c)(3).

    Dated: October 24, 2016. Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2016-26214 Filed 10-28-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-570-848] Freshwater Crawfish Tail Meat From the People's Republic of China: Initiation of Antidumping Duty New Shipper Review AGENCY:

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

    DATES:

    Effective October 31, 2016.

    SUMMARY:

    Based on a request, the Department of Commerce (the Department) is initiating a new shipper review (NSR) of the antidumping duty order on freshwater crawfish tail meat from the People's Republic of China (PRC) with respect to Jingzhou Tianhe Aquatic Products Co., Ltd. (Jingzhou Tianhe). We have determined that this request meets the statutory and regulatory requirements for initiation.

    FOR FURTHER INFORMATION CONTACT:

    Dmitry Vladimirov, AD/CVD Operations Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; Telephone: (202) 482-0665.

    SUPPLEMENTARY INFORMATION:

    Background

    The antidumping duty order on freshwater crawfish tail meat from the PRC published in the Federal Register on September 15, 1997.1 Pursuant to section 751(a)(2)(B)(i) of the Tariff Act of 1930, as amended (the Act), the Department received a timely and properly filed request for a NSR of the order from Jingzhou Tianhe during the anniversary month of the antidumping duty order.2 In its request, Jingzhou Tianhe certified that it is both the producer and exporter of the subject merchandise upon which the request was based.3

    1See Notice of Amendment to Final Determination of Sales at Less Than Fair Value and Antidumping Duty Order: Freshwater Crawfish Tail Meat From the People's Republic of China, 62 FR 48218 (September 15, 1997) (Crawfish Order).

    2See Letter from Jingzhou Tianhe, “RE: Freshwater Crawfish Tail meat From the People's Republic of China; Request for New Shipper Review,” dated September 30, 2016.

    3Id., at 2.

    Pursuant to section 751(a)(2)(B)(i)(I) of the Act and 19 CFR 351.214(b)(2)(i), Jingzhou Tianhe certified that it did not export subject merchandise to the United States during the period of investigation (POI).4 In addition, pursuant to section 751(a)(2)(B)(i)(II) of the Act and 19 CFR 351.214(b)(2)(iii)(A), Jingzhou Tianhe certified that, since the initiation of the investigation, it has never been affiliated with any exporter or producer who exported subject merchandise to the United States during the POI, including those respondents not individually examined during the POI.5 As required by 19 CFR 351.214(b)(2)(iii)(B), Jingzhou Tianhe also certified that its export activities were not controlled by the government of the PRC.6

    4Id., at Attachment 1.

    5Id.

    6Id.

    In addition to the certifications described above, pursuant to 19 CFR 351.214(b)(2), Jingzhou Tianhe submitted documentation establishing the following: (1) The date on which it first shipped subject merchandise for export to the United States; (2) the volume of its first shipment; and (3) the date of its first sale to an unaffiliated customer in the United States.7

    7Id., at Attachment 2; see also Jingzhou Tianhe's October 14, 2016, response to the Department's request for additional information, dated October 3, 2016.

    Period of Review

    In accordance with 19 CFR 351.214(g)(1)(i)(A), the period of review (POR) for a NSR initiated in the month immediately following the anniversary month will be the twelve-month period immediately preceding the anniversary month. Therefore, the POR for this NSR is September 1, 2015, through August 31, 2016.

    Initiation of New Shipper Review

    Pursuant to section 751(a)(2)(B) of the Act and 19 CFR 351.214(b), we find that the request from Jingzhou Tianhe meets the threshold requirements for initiation of a NSR for shipments of freshwater crawfish tail meat from the PRC produced and exported by Jingzhou Tianhe.8

    8See the memorandum to the file entitled, “Freshwater Crawfish Tail Meat From the People's Republic of China: Initiation Checklist for Antidumping Duty New Shipper Review of Jingzhou Tianhe Aquatic Products Co., Ltd.,” dated concurrently with this notice.

    On February 24, 2016, the President signed into law the “Trade Facilitation and Trade Enforcement Act of 2015,” H.R. 644, which made several amendments to section 751(a)(2)(B) of the Act. We will conduct this NSR in accordance with section 751(a)(2)(B) of the Act, as amended by the Trade Facilitation and Trade Enforcement Act of 2015.9

    9 Notably, the Trade Facilitation and Trade Enforcement Act of 2015 removed from section 751(a)(2)(B) of the Act the provision directing the Department to instruct U.S. Customs and Border Protection (CBP) to allow an importer the option of posting a bond or security in lien of a cash deposit during the pendency of an NSR.

    Unless extended, the Department intends to issue the preliminary results of this NSR no later than 180 days from the date of initiation and final results of the review no later than 90 days after the date the preliminary results are issued.10

    10See section 751(a)(2)(B)(iv) of the Act.

    It is the Department's usual practice, in cases involving non-market economy countries, to require that a company seeking to establish eligibility for an antidumping duty rate separate from the country-wide rate provide evidence of de jure and de facto absence of government control over the company's export activities. Accordingly, we will issue a questionnaire to Jingzhou Tianhe which will include a section requesting information concerning its eligibility for a separate rate. We will rescind the NSR of Jingzhou Tianhe if we determine that Jingzhou Tianhe has not demonstrated that it is eligible for a separate rate.

    Because Jingzhou Tianhe certified that it produced and exported subject merchandise, the sale of which is the basis for the request for a NSR, we will instruct CBP to continue to suspend liquidation of all entries of subject merchandise produced and exported by Jingzhou Tianhe.

    To assist in its analysis of the bona fides of Jingzhou Tianhe's sales, upon initiation of this NSR, the Department will require Jingzhou Tianhe to submit on an ongoing basis complete transaction information concerning any sales of subject merchandise to the United States that were made subsequent to the POR.

    Interested parties requiring access to proprietary information in the NSR should submit applications for disclosure under administrative protective order, in accordance with 19 CFR 351.305 and 351.306.

    This initiation and notice are published in accordance with section 751(a)(2)(B) of the Act and 19 CFR 351.214 and 351.221(c)(1)(i).

    Christian Marsh, DAS for AD/CVD Operations.
    [FR Doc. 2016-26148 Filed 10-28-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [A-557-813] Polyethylene Retail Carrier Bags From Malaysia: Final Results of the Antidumping Duty Administrative Review; 2014-2015 AGENCY:

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

    SUMMARY:

    On June 24, 2016, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on polyethylene retail carrier bags (PRCBs) from Malaysia. The review covers one producer/exporter of the subject merchandise, Euro SME Sdn Bhd (Euro SME) for the period of review (POR) August 1, 2014, through July 31, 2015. The final estimated weighted-average dumping margin is listed below in the “Final Results of Review” section of this notice.

    DATES:

    Effective October 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Bryan Hansen or Minoo Hatten, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3683 or (202) 482-1690, respectively.

    SUPPLEMENTARY INFORMATION:

    Background

    On June 24, 2016, the Department published the Preliminary Results in the Federal Register, and invited parties to comment.1 For events subsequent to the Preliminary Results, see the Department's Final Decision Memorandum.2 The Department conducted this review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act).

    1See Polyethylene Retail Carrier Bags From Malaysia: Preliminary Results of Antidumping Duty Administrative Review; 2014-2015, 81 FR 41294 (June 24, 2016) (Preliminary Results).

    2See Memorandum from Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, to Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance, “Issues and Decision Memorandum for Final Results of Antidumping Duty Administrative Review: Polyethylene Retail Carrier Bags from Malaysia,” dated concurrently with, and hereby adopted by this notice (Final Decision Memorandum).

    Scope of the Order

    The merchandise subject to the order is PRCBs. The product is currently classified under the Harmonized Tariff Schedules of the United States (HTSUS) subheading 3923.21.0085. While the HTSUS subheading is provided for convenience and customs purposes, the written description is dispositive. A full description of the scope of the order is contained in the Final Decision Memorandum.3

    3Id.

    Analysis of Comments Received

    All issues raised in the case and rebuttal briefs by parties to this review are addressed in the Final Decision Memorandum, which is hereby adopted by this notice. A list of the issues raised is attached to this notice as Appendix. The Final 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 https://access.trade.gov, and to all parties in the Central Records Unit (CRU), Room B8024 of the main Department of Commerce building. In addition, a complete version of the Final Decision Memorandum can be accessed directly on the Internet at http://enforcement.trade.gov/frn/index.html.

    Changes Since the Preliminary Results

    Based on our analysis of comments received, we made one revision that changed the results for Euro SME.4

    4 We corrected a programming error in the margin calculation we included in the Preliminary Results. A detailed discussion of the correction we made is in the final analysis memorandum for Euro SME, dated concurrently with this notice, which is available in ACCESS, to registered users at https://access.trade.gov, or available in the CRU.

    Final Results of the Review

    As a result of this administrative review, we determine that a weighted-average dumping margin of 0.00 percent exists for Euro SME for this POR.

    Disclosure

    We intend to disclose the calculations performed to parties in this proceeding within five days after public announcement of the final results, in accordance with 19 CFR 351.224(b).

    Assessment Rates

    In accordance with 19 CFR 351.212 and the Final Modification, 5 the Department will instruct U.S. Customs and Border Protection (CBP) to liquidate all appropriate entries for Euro SME without regard to antidumping duties. For entries of subject merchandise during the POR produced by Euro SME for which it did not know its merchandise was destined for the United States, we will instruct CBP to liquidate un-reviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. We intend to issue instructions to CBP 15 days after publication of the final results of this review.

    5See Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Duty Proceedings; Final Modification, 77 FR 8101, 8102 (February 14, 2012) (Final Modification).

    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 PRCBs from Malaysia 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 rate for Euro SME will be 0.00 percent, the rate 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 of this proceeding in which that manufacturer or exporter participated; (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 manufacturer of the merchandise for the most recently completed segment of this proceeding for the manufacturer of the merchandise; (4) the cash deposit rate for all other manufacturers or exporters will continue to be 84.94 percent.6 These cash deposit requirements, when imposed, shall remain in effect until further notice.

    6 This all-others rate was established in the Notice of Final Determination of Sales at Less Than Fair Value: Polyethylene Retail Carrier Bags From Malaysia, 69 FR 34128 (June 18, 2004).

    Notification to Importers

    This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

    Administrative Protective Orders

    This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

    Notification to Interested Parties

    The Department is issuing and publishing these final results of administrative review in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(h).

    Dated: October 24, 2016. Ronald K. Lorentzen, Acting Assistant Secretary for Enforcement and Compliance. Appendix List of Topics Discussed in the Final Decision Memorandum: I. Summary II. Background III. Scope of the Order IV. Margin Calculation V. Discussion of the Issues Issue 1: Whether the U.S. Sale is Bona Fide Issue 2: Home Market Window Period VI. Recommendation
    [FR Doc. 2016-26220 Filed 10-28-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [Docket No. 161012954-6954-01] Call for Applications for the International Buyer Program Calendar Year 2018 AGENCY:

    International Trade Administration, Department of Commerce.

    ACTION:

    Notice and call for applications.

    SUMMARY:

    In this notice, the U.S. Department of Commerce (DOC) International Trade Administration (ITA) announces that it will accept applications for the International Buyer Program (IBP) for calendar year 2018 (January 1, 2018, through December 31, 2018). The announcement also sets out the objectives, procedures and application review criteria for the IBP. The purpose of the IBP is to bring international buyers together with U.S. firms in industries with high export potential at leading U.S. trade shows. Specifically, through the IBP, the ITA selects domestic trade shows which will receive ITA assistance in the form of global promotion in foreign markets, provision of export counseling to exhibitors, and provision of matchmaking services at the trade show. This notice covers selection for IBP participation during calendar year 2018.

    DATES:

    Applications for the IBP must be received by Friday, January 6, 2017.

    ADDRESSES:

    The application form can be found at www.export.gov/ibp. Applications may be submitted by any of the following methods: (1) Mail/Hand (including express) Delivery Service: International Buyer Program, Trade Promotion Programs, International Trade Administration, U.S. Department of Commerce, Ronald Reagan Building, 1300 Pennsylvania Ave. NW., Suite 800M—Mezzanine Level—Atrium North, Washington, DC 20004; (2) Facsimile: (202) 482-7800; or (3) email: [email protected] Facsimile and email applications will be accepted as interim applications, but must be followed by a signed original application that is received by the program no later than five (5) business days after the application deadline. To ensure that applications are received by the deadline, applicants are strongly urged to send applications by express delivery service (e.g., U.S. Postal Service Express Delivery, Federal Express, UPS, etc.).

    FOR FURTHER INFORMATION CONTACT:

    Vidya Desai, Senior Advisor for Trade Events, Trade Promotion Programs, International Trade Administration, U.S. Department of Commerce, 1300 Pennsylvania Ave. NW., Ronald Reagan Building, Suite 800M—Mezzanine Level—Atrium North, Washington, DC 20004; Telephone (202) 482-2311; Facsimile: (202) 482-7800; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The IBP was established in the Omnibus Trade and Competitiveness Act of 1988 (Pub. L. 100-418, codified at 15 U.S.C. 4724) to bring international buyers together with U.S. firms by promoting leading U.S. trade shows in industries with high export potential. The IBP emphasizes cooperation between the DOC and trade show organizers to benefit U.S. firms exhibiting at selected events and provides practical, hands-on assistance such as export counseling and market analysis to U.S. companies interested in exporting. Shows selected for the IBP will provide a venue for U.S. companies interested in expanding their sales into international markets.

    Through the IBP, ITA selects U.S. trade shows with participation by U.S. firms interested in exporting that ITA determines to be leading international trade shows, for promotion in overseas markets by U.S. Embassies and Consulates. The DOC is authorized to provide successful applicants with assistance in the form of overseas promotion of the show; outreach to show participants about exporting; recruitment of potential buyers to attend the events; and staff assistance in setting up international trade centers at the shows. Worldwide promotion is executed through ITA offices at U.S. Embassies and Consulates in more than 70 countries representing the United States' major trading partners, and also in Embassies in countries where ITA does not maintain offices.

    The International Trade Administration (ITA) is accepting applications from trade show organizers for the IBP for trade shows taking place between January 1, 2018, and December 31, 2018. Selection of a trade show is valid for one show, i.e., a trade show organizer seeking selection for a recurring show must submit a new application for selection for each occurrence of the show. For shows that occur more than once in a calendar year, the trade show organizer must submit a separate application for each show.

    For the IBP in calendar year 2018, the ITA expects to select approximately 20 shows from among the applicants. The ITA will select those shows that are determined to most clearly meet the statutory mandate in 15 U.S.C. 4721 to promote U.S. exports, especially those of small- and medium-sized enterprises, and the selection criteria articulated below.

    There is no fee required to submit an application. If accepted into the program for calendar year 2018, a participation fee of $9,800 is required for shows of five days or fewer. For trade shows more than five days in duration, or requiring more than one International Trade Center, a participation fee of $15,000 is required. For trade shows ten days or more in duration, and/or requiring more than two International Trade Centers, the participation fee will be determined by DOC and stated in the written notification of acceptance. It would be calculated on a full cost recovery basis. Successful applicants will be required to enter into a Memorandum of Agreement (MOA) with ITA within 10 days of written notification of acceptance into the program. The participation fee (by check or credit card) is due within 30 days of written notification of acceptance into the program.

    The MOA constitutes an agreement between ITA and the show organizer specifying which responsibilities for international promotion and export assistance services at the trade shows are to be undertaken by ITA as part of the IBP and, in turn, which responsibilities are to be undertaken by the show organizer. Anyone requesting application information will be sent a sample copy of the MOA along with the application and a copy of this Federal Register Notice. Applicants are encouraged to review the MOA closely as IBP participants are required to comply with all terms, conditions, and obligations in the MOA. Trade show organizer obligations include, but are not limited to, providing waived or reduced admission fees for international attendees who are participating in the IBP, the construction of an International Trade Center at the trade show, production of an export interest directory, and provision of complimentary hotel accommodations for DOC staff as explained in the MOA. Some of the most important commitments is for the trade show organizer to: Include in the terms and conditions of its exhibitor contracts provisions for the protection of intellectual property rights (IPR); to have procedures in place at the trade show to address IPR infringement which, at a minimum, provide information to help U.S. exhibitors procure legal representation during the trade show; and to agree to assist the DOC to reach and educate U.S. exhibitors on the Strategy Targeting Organized Piracy (STOP!), IPR protection measures available during the show, and the means to protect IPR in overseas markets, as well as in the United States. ITA responsibilities include, but are not limited to, the worldwide promotion of the trade show and, where feasible, recruitment of international buyers to that show, provision of on-site export assistance to U.S. exhibitors at the show, and the reporting of results to the show organizer.

    Selection as an IBP partner does not constitute a guarantee by DOC of the show's success. IBP partnership status is not an endorsement of the show except as to its international buyer activities. Non-selection of an applicant for IBP partnership status should not be viewed as a determination that the show will not be successful in promoting U.S. exports.

    Eligibility: All 2018 U.S. trade shows are eligible to apply for IBP participation through the show organizer.

    Exclusions: Trade shows that are either first-time or horizontal (non-industry specific) shows generally will not be considered.

    General Evaluation Criteria: The ITA will evaluate shows to be International Buyer Program partners using the following criteria:

    (a) Export Potential: The trade show promotes products and services from U.S. industries that have high export potential, as determined by DOC sources, including industry analysts' assessment of export potential, ITA best prospects lists and U.S. export statistics.

    (b) Level of International Interest: The trade show meets the needs of a significant number of overseas markets and corresponds to marketing opportunities as identified by ITA. Previous international attendance at the show may be used as an indicator of such interest.

    (c) Scope of the Show: The show offers a broad spectrum of U.S. made products and services for the subject industry. Trade shows with a majority of U.S. firms as exhibitors will be given priority.

    (d) U.S. Content of Show Exhibitors: Trade shows with exhibitors featuring a high percentage of products produced in the United States or products with a high degree of U.S. content will be preferred.

    (e) Stature of the Show: The trade show is clearly recognized by the industry it covers as a leading show for the promotion of that industry's products and services both domestically and internationally, and as a showplace for the latest technology or services in that industry.

    (f) Level of Exhibitor Interest: U.S. exhibitors have expressed interest in receiving international business visitors during the trade show. A significant number of U.S. exhibitors should be seeking to begin exporting or to expand their sales into additional export markets.

    (g) Level of Overseas Marketing: There has been a demonstrated effort by the applicant to market this show and prior related shows. For this criterion, the applicant should describe in detail, among other information, the international marketing program to be conducted for the show, and explain how efforts should increase individual and group international attendance.

    (h) Logistics: The trade show site, facilities, transportation services, and availability of accommodations at the site of the exhibition (i.e. International Trade Center, interpreters) are capable of accommodating large numbers of attendees whose native language will not be English.

    (i) Level of Cooperation: The applicant demonstrates a willingness to cooperate with the ITA to fulfill the program's goals and adhere to the target dates set out in the MOA and in the show timetables, both of which are available from the program office (see the FOR FURTHER INFORMATION CONTACT section above). Past experience in the IBP will be taken into account in evaluating the applications received.

    (j) Delegation Incentives: The IBP Office will be evaluating the level and/or range of incentives offered to delegations and/or delegation leaders recruited by U.S. overseas Embassies and Consulates. Examples of incentives to international visitors and to organized delegations include: Special organized shows, such as receptions, meetings with association executives, briefings, and site tours; and complimentary accommodations for delegation leaders (beyond those required in the MOA).

    Review Process: ITA will evaluate all applications received based on the criteria set out in this notice. Vetting will include soliciting input from ITA industry analysts, as well as domestic and international field offices, focusing primarily on the export potential, level of international interest, and stature of the show. In reviewing applications, ITA will also consider scheduling and sector balance in terms of the need to allocate resources to support selected shows.

    Application Requirements: Show organizers submitting applications for the 2018 IBP are requested to submit: (1) A narrative statement addressing each question in the application, Form OMB 0625-0143 (found at www.export.gov/ibp); (2) a signed statement that “The information submitted in this application is correct and the applicant will abide by the terms set forth in the Call for Applications for the 2018 International Buyer Program (January 1, 2018 through December 31, 2018);” and (3) two copies of the application: one copy of the application printed on company letterhead, and one electronic copy of the application submitted on a CD-RW (preferably in Microsoft Word® format), on or before the deadline noted above. There is no fee required to apply. Applications for the IBP must be received by Friday, January 6, 2017. ITA expects to issue the results of its review process in April 2017.

    Legal Authority: The statutory program authority for the ITA to conduct the International Buyer Program is 15 U.S.C. 4724. The DOC has the legal authority to enter into MOAs with show organizers under the provisions of the Mutual Educational and Cultural Exchange Act of 1961 (MECEA), as amended (22 U.S.C. 2455(f) and 2458(c)). MECEA allows ITA to accept contributions of funds and services from firms for the purposes of furthering its mission.

    The Office of Management and Budget (OMB) has approved the information collection requirements of the application to this program (Form OMB 0625-0143) under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (OMB Control No. 0625-0143). Notwithstanding any other provision of law, no person is 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 currently valid OMB Control Number.

    For further information please contact: Vidya Desai, Senior Advisor for Trade Events, Trade Promotion Programs ([email protected]).

    Frank Spector, Trade Promotion Programs.
    [FR Doc. 2016-26216 Filed 10-28-16; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE906 Determination of Overfishing or an Overfished Condition AGENCY:

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

    ACTION:

    Notice.

    SUMMARY:

    This action serves as a notice that NMFS, on behalf of the Secretary of Commerce (Secretary), has found that the following stocks are subject to overfishing—Hood Canal coho salmon and Pribilof Islands blue king crab; the following salmon stocks are approaching an overfished condition—Quillayute Fall coho and Snohomish coho; and the following stocks are still both overfished and subject to overfishing—Western and Central North Pacific striped marlin and Atlantic and Gulf of Mexico dusky shark. NMFS, on behalf of the Secretary, notifies the appropriate fishery management council (Council) whenever it determines that overfishing is occurring, a stock is in an overfished condition, a stock is approaching an overfished condition, or when a rebuilding plan has not resulted in adequate progress toward ending overfishing and rebuilding affected fish stocks.

    FOR FURTHER INFORMATION CONTACT:

    Regina Spallone, (301) 427-8568.

    SUPPLEMENTARY INFORMATION:

    Pursuant to sections 304(e)(2) and (e)(7) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1854(e)(2) and (e)(7), and implementing regulations at 50 CFR 600.310(e)(2) and (j)(1), NMFS, on behalf of the Secretary, must notify Councils whenever it determines that a stock or stock complex is overfished or approaching an overfished condition; or if an existing rebuilding plan has not ended overfishing or resulted in adequate rebuilding progress. NMFS also notifies Councils when it determines a stock or stock complex is subject to overfishing.

    NMFS has determined that Hood Canal coho is subject to overfishing, based on the most recent salmon stock assessments conducted by the Pacific Fishery Management Council (Pacific Council) Salmon Technical Team (STT). The Pacific Council has, consistent with the Pacific Coast Salmon Fishery Management Plan, already taken action shaping the 2016 fisheries to ensure Pacific Council area fisheries are not contributing to overfishing (May 2, 2016, 81 FR 26157). In addition, NMFS has determined that Pribilof Islands blue king crab is subject to overfishing based on catch levels exceeding the stock's overfishing limit. The North Pacific Fishery Management Council has been informed that they must take action to end overfishing immediately on this stock.

    NMFS has determined that Quillayute Fall coho and Snohomish coho salmon are both approaching an overfished condition, based on the most recent salmon stock assessments conducted by the Pacific Council STT. These salmon stocks will be considered approaching an overfished condition if the 3-year geometric mean of the stock's two most recent postseason estimates of spawning escapement and the current preseason forecast of spawning escapement is below the stock's minimum stock size threshold. The Pacific Council has been informed that if either of these stocks becomes overfished, they must direct the STT to prepare a rebuilding plan within one year.

    In addition, NMFS has determined that both Western and Central North Pacific striped marlin and Atlantic and Gulf of Mexico dusky shark are still overfished and subject to overfishing, based on the most recent assessments of these stocks. The striped marlin's determination was based on a 2015 assessment conducted by the Billfish Working Group of the International Scientific Committee for Tuna and Tuna-like Species in the North Pacific Ocean. On May 19, 2014, NMFS had announced its overfishing and overfished status determination for striped marlin, and informed the Western Pacific Fishery Management Council and the Pacific Fishery Management Council of their obligations under the MSA to address the domestic and international impact of U.S. fisheries on this stock (79 FR 28686). NMFS continues to work with the Councils and its partners to meet its domestic and international obligations, as specified in that earlier notice.

    The dusky shark determination is based on a 2016 stock assessment update to the 21st Southeast Data Assessment and Review benchmark assessment for this stock, finalized in 2011. NMFS manages dusky shark under the 2006 Consolidated Atlantic Highly Migratory Species Fishery Management Plan and its amendments. Dusky shark has been a prohibited species since 2000, and may not be landed or retained in any fisheries. However, multiple commercial and recreational fisheries sometimes interact with the species as bycatch.

    Dated: October 25, 2016. Jennifer M. Wallace, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-26126 Filed 10-28-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: Papahānaumokuākea Marine National Monument Permit Application and Reports for Permits (fka Northwestern Hawaiian Islands Marine National Monument).

    OMB Control Number: 0648-0548.

    Form Number(s): None.

    Type of Request: Regular (revision and extension of a currently approved information collection).

    Number of Respondents: 192.

    Average Hours per Response: Research, Conservation and Management and Education (“general” permits), 5 hours; Special Ocean Use permits, 10 hours; Native Hawaiian Practices permits, 8 hours; Recreation permits, 6 hours; modification requests and final reports, 10 hours; annual reports, 5 hours.

    Burden Hours: 1,343.

    Needs and Uses: This request is for revision and extension of a currently approved information collection. There will be minor changes to the forms and instructions.

    On June 15, 2006, President Bush established the Papahānaumokuākea Marine National Monument by issuing Presidential Proclamation 8031 (71 FR 36443, June 26, 2006) under the authority of the Antiquities Act (16 U.S.C. 431). The proclamation includes restrictions and prohibitions regarding activities in the monument consistent with the authority provided by the act. Specifically, the proclamation prohibits access to the monument except when passing through without interruption or as allowed under a permit issued by NOAA and the U.S. Fish and Wildlife Service (FWS). Vessels passing through the monument without interruption are required to notify NOAA and FWS upon entering into and leaving the monument. Individuals wishing to access the monument to conduct certain regulated activities must first apply for and be granted a permit issued by NOAA and FWS to certify compliance with vessel monitoring system requirements, monument regulations and best management practices. On August 29, 2006, NOAA and FWS published a final rule codifying the provisions of the proclamation (71 FR 51134).

    Affected Public: Individuals, not for profit institutions; Federal, State, local, government, Native Hawaiian organizations; business or other for-profit organizations.

    Frequency: Annually and on occasion.

    Respondent's Obligation: Required to obtain or maintain benefits.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: October 26, 2016. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2016-26155 Filed 10-28-16; 8:45 am] BILLING CODE 3510-NK-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Expanded Vessel Monitoring System Requirement in the Pacific Coast Groundfish Fishery 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 take this opportunity 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 December 30, 2016.

    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]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Karen Palmigiano, (206) 526-4491 or [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    This request is for extension of a currently approved information collection.

    The National Oceanic and Atmospheric Administration (NOAA) has established large-scale depth-based management areas, referred to as Groundfish Conservation Areas (GCAs), where groundfish fishing is prohibited or restricted. These areas were specifically designed to reduce the catch of species while allowing healthy fisheries to continue in areas and with gears where little incidental catch of overfished species is likely to occur. Because NOAA needs methods to effectively enforce area restrictions, certain commercial fishing vessels are required to install and use a vessel monitoring system (VMS) that automatically send hourly position reports. Exemptions from the reporting requirement are available for inactive vessels or vessels fishing outside the monitored area. The vessels are also required to declare what gear will be used.

    To ensure the integrity of the GCAs and Rockfish Conservation Areas, a pilot VMS program was implemented on January 1, 2004. The pilot program required vessels registered to Pacific Coast groundfish fishery limited entry permits to carry and use VMS transceiver units while fishing off the coasts of Washington, Oregon and California. On January 1, 2007, the VMS program coverage was expanded on to include all open access fisheries in addition to the limited entry fisheries. Finally, in 2010, NMFS expanded the declaration reports to include several more limited entry categories.

    II. Method of Collection

    The installation/activation reports are available over the Internet. Due to the need for the owner's signature, installation reports must be faxed or mailed to the National Marine Fisheries Service (NMFS). Hourly position reports are automatically sent from VMS transceivers installed aboard vessels. Exemption reports and declaration reports are submitted via a toll-free telephone number.

    III. Data

    OMB Control Number: 0648-0573.

    Form Number(s): None.

    Type of Review: Regular (extension of a currently approved collection).

    Affected Public: Business or other for-profits organizations; individuals or households.

    Estimated Number of Respondents: 1,500.

    Estimated Time per Response: VMS installation: 4 hours; VMS maintenance: 4 hours; installation, exemption and activation reports: 5 minutes each; and declaration reports: 4 minutes.

    Estimated Total Annual Burden Hours: 12,872.

    Estimated Total Annual Cost to Public: $4,350,375.

    IV. Request for Comments

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (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: October 26, 2016. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2016-26159 Filed 10-28-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: Licensing of Private Remote-Sensing Space Systems.

    OMB Control Number: 0648-0174.

    Form Number(s): None.

    Type of Request: Regular (extension of a currently approved information collection).

    Number of Respondents: 18.

    Average Hours per Response: 0 hours for the submission of a license application; 10 hours for the submission of a data protection plan; 5 hours for the submission of a plan describing how the licensee will comply with data collection restrictions; 3 hours for the submission of an operations plan for restricting collection or dissemination of imagery of Israeli territory; 3 hours for submission of a data flow diagram; 2 hours for the submission of satellite sub- systems drawings; 3 hours for the submission of a final imaging system specifications document; 2 hours for the submission of a public summary for a licensed system; 2 hours for the submission of a preliminary design review; 2 hours for the submission of a critical design review; 1 hour for notification of a binding launch services contract; 1 hour for notification of completion of pre-ship review; 10 hours for the submission of a license amendment; 2 hours for the submission of a foreign agreement notification; 2 hours for the submission of spacecraft operational information submitted when a spacecraft becomes operational; 2 hours for notification of deviation in orbit or spacecraft disposition; 2 hours for notification of any operational deviation; 2 hours for notification of planned purges of information to the National Satellite Land Remote Sensing Data Archive; 3 hours for the submission of an operational quarterly report; 8 hours for an annual compliance audit; 10 hours for an annual operational audit; and 2 hours for notification of the demise of a system or a decision to discontinue system operations.

    Burden Hours: 552.

    Needs and Uses: This request is for extension of a current information collection.

    NOAA has established requirements for the licensing of private operators of remote-sensing space systems. The information in applications and subsequent reports is needed to ensure compliance with the Land Remote-Sensing Policy Act of 1992 and with the national security and international obligations of the United States. The requirements are contained in 15 CFR part 960.

    Affected Public: Business or other for-profit organizations.

    Frequency: Quarterly, annually and on occasion.

    Respondent's Obligation: Mandatory.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: October 26, 2016. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2016-26156 Filed 10-28-16; 8:45 am] BILLING CODE 3510-HR-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Proposed Information Collection; Comment Request; Natural Resource Damage Assessment Restoration Project Information Sheet 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 take this opportunity 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 December 30, 2016.

    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]).

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument and instructions should be directed to Megan Brockway, (301) 427-8692 or [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    This request is for an extension of a currently approved information collection.

    The purpose of this information collection is to assist state and federal Natural Resource Trustees in more efficiently carrying out the restoration planning phase of Natural Resource Damage Assessments (NRDA), in compliance with the National Environmental Policy Act (NEPA) of 1969, 42 U.S.C. 4321-4370d; 40 CFR 1500-1500 and other federal and local statutes and regulations as applicable. The NRDA Restoration Project Information Sheet is designed to facilitate the collection of information on existing, planned, or proposed restoration projects. This information will be used by the Natural Resource Trustees to develop potential restoration alternatives for natural resource injuries and service losses requiring restoration, during the restoration planning phase of the NRDA process.

    II. Method of Collection

    The Restoration Project Information Sheet can be submitted on paper through the mail or faxed, or can be submitted electronically via the internet or email.

    III. Data

    OMB Control Number: 0648-0497.

    Form Number: None.

    Type of Review: Regular submission (extension of a current information collection).

    Affected Public: State, local, or tribal governments; individuals or households; business or other for-profits organizations; not-for-profit institutions; farms; and the federal government.

    Estimated Number of Respondents: 300.

    Estimated Time per Response: 20 minutes.

    Estimated Total Annual Burden Hours: 100.

    Estimated Total Annual Cost to Public: $0 in recordkeeping/reporting costs.

    IV. Request for Comments

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (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: October 26, 2016. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2016-26160 Filed 10-28-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF DEFENSE Department of the Army Notice of Intent To Grant Exclusive Patent License to RF Networking Solutions, LLC; East Brunswick, NJ AGENCY:

    Department of the Army, DoD.

    ACTION:

    Notice of Intent.

    SUMMARY:

    In compliance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i), the Department of the Army hereby gives notice of its intent to grant to RF Networking Solutions, LLC; a company having its principle place of business at 4 Huron Court, East Brunswick, NJ 08816, exclusive license in all fields. The proposed license would be relative to the following: U.S. Patent Number 6,844,841 entitled “Radio Frequency Link Performance Tool Process and System”, Inventor Michael Masciulli, Issue Date January 18, 2005.

    DATES:

    The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the U.S. Army Research Laboratory receives written objections including evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. Competing applications completed and received by the U.S. Army Research Laboratory within fifteen (15) days from the date of this published notice will also be treated as objections to the grant of the contemplated exclusive license.

    Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

    ADDRESSES:

    Send written objections to U.S. Army Research Laboratory Technology Transfer and Outreach Office, RDRL-DPT/Thomas Mulkern, Building 321, Room 110, Aberdeen Proving Ground, MD 21005-5425.

    FOR FURTHER INFORMATION CONTACT:

    Thomas Mulkern, (410) 278-0889,E-Mail: [email protected]

    SUPPLEMENTARY INFORMATION:

    None.

    Brenda S. Bowen, Army Federal Register Liaison Officer.
    [FR Doc. 2016-26177 Filed 10-28-16; 8:45 am] BILLING CODE 5001-03-P
    DEPARTMENT OF DEFENSE Department of the Navy [Docket ID USN-2014-0017] Submission for OMB Review; Comment Request ACTION:

    Notice.

    SUMMARY:

    The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

    DATES:

    Consideration will be given to all comments received by November 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Fred Licari, 571-372-0493.

    SUPPLEMENTARY INFORMATION:

    Title, Associated Form and OMB Number: Candidate Application Procedures for the United States Naval Academy; USNA 1110/11, 1110/12, 1110/14, 1110/15, 1110/91, 1110/92, 1110/23, 1110/19, 1110/93, 1110/96, 1531/34, and 5500/1; OMB Control Number 0703-0036.

    Type of Request: Reinstatement, with change, of a previously approved collection for which approval has expired.

    Number of Respondents: 84,000.

    Responses per Respondent: 1.

    Annual Responses: 84,000.

    Average Burden per Response: 1 hour and 21 minutes.

    Annual Burden Hours: 99,165.

    Needs and Uses: The information is collected to determine the eligibility, overall competitive standing, scholastic, and leadership potential of candidates for an appointment to the USNA. Respondents are high school or college students applying for admission to the USNA, officials assisting with the application process, Chain of Command officials for active duty applicants, Blue and Gold Officers, and local law enforcement officials.

    Affected Public: Individuals or households; state, local, or tribal government.

    Frequency: Annually.

    Respondent's Obligation: Voluntary.

    OMB Desk Officer: Ms. Jasmeet Seehra.

    Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at [email protected] Please identify the proposed information collection by DoD Desk Officer and the Docket ID number and title of the information collection.

    You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

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

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

    DOD Clearance Officer: Mr. Frederick Licari.

    Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 03F09, Alexandria, VA 22350-3100.

    Dated: October 26, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-26170 Filed 10-28-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Department of the Navy [Docket ID: USN-2013-0040] Submission for OMB Review; Comment Request ACTION:

    Notice.

    SUMMARY:

    The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

    DATES:

    Consideration will be given to all comments received by November 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Fred Licari, 571-372-0493.

    SUPPLEMENTARY INFORMATION:

    Title, Associated Form and OMB Number: Camp Lejeune Notification Database; OMB Control Number 0703-0057.

    Type of Request: Reinstatement.

    Number of Respondents: 10,000.

    Responses per Respondent: 1.

    Annual Responses: 10,000.

    Average Burden per Response: 6 minutes.

    Annual Burden Hours: 1,000 hours.

    Needs and Uses: The information collection requirement is used to obtain and maintain contact information on people who may have been exposed to contaminated drinking water in the past aboard Marine Corps Base Camp Lejeune, NC, as well as other persons interested in the issue. The information will be used to provide notifications and updated information as it becomes available. The information will also be used to correspond with registrants, as necessary (e.g. respond to voicemails or letters).

    Affected Public: Individuals or households; Federal Government.

    Frequency: On occasion.

    Respondent's Obligation: Voluntary.

    OMB Desk Officer: Ms. Jasmeet Seehra.

    Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at [email protected] Please identify the proposed information collection by DoD Desk Officer and the Docket ID number and title of the information collection.

    You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

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

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

    DOD Clearance Officer: Mr. Frederick Licari.

    Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 03F09, Alexandria, VA 22350-3100.

    Dated: October 26, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-26173 Filed 10-28-16; 8:45 am] BILLING CODE 5001-06-P
    DELAWARE RIVER BASIN COMMISSION Notice of Public Hearing and Business Meeting; November 9 and December 14, 2016

    Notice is hereby given that the Delaware River Basin Commission will hold a public hearing on Wednesday, November 9, 2016. A business meeting will be held the following month, on Wednesday, December 14, 2016. The hearing and business meeting are open to the public and will be held at the Washington Crossing Historic Park Visitor Center, 1112 River Road, Washington Crossing, Pennsylvania.

    Public Hearing. The public hearing on November 9, 2016 will begin at 1:30 p.m. Hearing items will include draft dockets for the withdrawals, discharges and other water-related projects subject to the Commission's review. The Commission will also accept public input on the persistent dry conditions throughout the basin and how to address them. The Commission would then be prepared, if conditions worsen, to consider a declaration of water supply emergency under section 10.4 of the Compact.

    The list of projects scheduled for hearing, including project descriptions, will be posted on the Commission's Web site, www.drbc.net, in a long form of this notice at least ten days before the hearing date. Draft resolutions scheduled for hearing also will be posted at www.drbc.net ten or more days prior to the hearing.

    Written comments on matters scheduled for hearing on November 9 will be accepted through 5:00 p.m. on November 10. After the hearing on all scheduled matters has been completed, and as time allows, an opportunity for Open Public Comment will also be provided.

    The public is advised to check the Commission's Web site periodically prior to the hearing date, as items scheduled for hearing may be postponed if additional time is deemed necessary to complete the Commission's review, and items may be added up to ten days prior to the hearing date. In reviewing docket descriptions, the public is also asked to be aware that project details commonly change in the course of the Commission's review, which is ongoing.

    Public Meeting. The public business meeting on December 14, 2016 will begin at 10:30 a.m. and will include: adoption of the Minutes of the Commission's September 14, 2016 business meeting, announcements of upcoming meetings and events, a report on hydrologic conditions, reports by the Executive Director and the Commission's General Counsel, and consideration of any items for which a hearing has been completed or is not required.

    After all scheduled business has been completed and as time allows, the meeting will also include up to one hour of Open Public Comment.

    There will be no opportunity for additional public comment for the record at the December 14 business meeting on items for which a hearing was completed on November 9 or a previous date. Commission consideration on December 14 of items for which the public hearing is closed may result in approval of the item (by docket or resolution) as proposed, approval with changes, denial, or deferral. When the Commissioners defer an action, they may announce an additional period for written comment on the item, with or without an additional hearing date, or they may take additional time to consider the input they have already received without requesting further public input. Any deferred items will be considered for action at a public meeting of the Commission on a future date.

    Advance Sign-Up for Oral Comment. Individuals who wish to comment on the record during the public hearing on November 9 or to address the Commissioners informally during the Open Public Comment portion of the meeting on either November 9 or December 14 as time allows, are asked to sign up in advance by contacting Ms. Paula Schmitt of the Commission staff, at [email protected]

    Addresses for Written Comment. Written comment on items scheduled for hearing may be delivered by hand at the public hearing or: By hand, U.S. Mail or private carrier to: Commission Secretary, P.O. Box 7360, 25 State Police Drive, West Trenton, NJ 08628; by fax to Commission Secretary, DRBC at 609-883-9522; or by email (preferred) to [email protected] If submitted by email, written comments on a docket should also be sent to Mr. David Kovach, Manager, Project Review Section at [email protected]

    Accommodations for Special Needs. Individuals in need of an accommodation as provided for in the Americans with Disabilities Act who wish to attend the informational meeting, conference session or hearings should contact the Commission Secretary directly at 609-883-9500 ext. 203 or through the Telecommunications Relay Services (TRS) at 711, to discuss how we can accommodate your needs.

    Additional Information, Contacts. Additional public records relating to hearing items may be examined at the Commission's offices by appointment by contacting Carol Adamovic, 609-883-9500, ext. 249. For other questions concerning hearing items, please contact Judith Scharite, Project Review Section assistant at 609-883-9500, ext. 216.

    Dated: October 25, 2016. Pamela M. Bush, Commission Secretary and Assistant General Counsel.
    [FR Doc. 2016-26176 Filed 10-28-16; 8:45 am] BILLING CODE 6360-01-P
    DEPARTMENT OF EDUCATION [Docket No. ED-2016-ICCD-0120] Agency Information Collection Activities; Comment Request; National Professional Development Program: Grantee Performance Report AGENCY:

    Department of Education (ED), Office of English Language Acquisition (OELA).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before December 30, 2016.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2016-ICCD-0120. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 2E-347, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Samuel Lopez, 202-401-1423.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: National Professional Development Program: Grantee Performance Report.

    OMB Control Number: 1885-0555.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 138.

    Total Estimated Number of Annual Burden Hours: 6,900.

    Abstract: The National Professional Development (NPD) program provides professional development activities intended to improve instruction for students with limited English proficiency and assists education personnel working with such children to meet high professional standards. The NPD program office is submitting this application to request approval to collect information from NPD grantees. This data collection serves two purposes; the data are necessary to assess the performance of the NPD program on Government Performance Results Act measures, also, budget information and data on project-specific performance measures are collected from NPD grantees for project-monitoring information.

    Dated: October 26, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-26222 Filed 10-28-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2016-ICCD-0118] Agency Information Collection Activities; Comment Request; GEPA Section 427 Guidance for All Grant Applications AGENCY:

    Office of the Secretary (OS), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before December 30, 2016.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2016-ICCD-0118. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 2E-343, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Alfreida Pettiford, 202-245-6110.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: GEPA Section 427 Guidance for All Grant Applications.

    OMB Control Number: 1894-0005.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 12,396.

    Total Estimated Number of Annual Burden Hours: 18,594.

    Abstract: On October 20, 1994, the Improving America's Schools Act, Public Law 103-382 (The Act), became law. The Act added a provision to the General Education Provisions Act (GEPA). Section 427 of GEPA requires an applicant for assistance under Department programs to develop and describe in the grant application the steps it proposes to take to ensure equitable access to, and equitable participation in, its proposed project for students, teachers, and other program beneficiaries with special needs. The current GEPA Section 427 guidance for discretionary grant applications and formula grant applications has approval through March 31, 2014, the Department is requesting an extension of this approval.

    Dated: October 25, 2016. Stephanie Valentine, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-26123 Filed 10-28-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No. ED-2016-ICCD-0119] Agency Information Collection Activities; Comment Request; Evaluation of the Comprehensive Technical Assistance Centers AGENCY:

    Institute of Education Sciences (IES), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before December 30, 2016.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2016-ICCD-0119. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 400 Maryland Avenue SW., LBJ, Room 2E-347, Washington, DC 20202-4537.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Amy Johnson, 202-245-7781.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Evaluation of the Comprehensive Technical Assistance Centers.

    OMB Control Number: 1850-0914.

    Type of Review: A revision of an existing information collection.

    Respondents/Affected Public: Individuals or Households.

    Total Estimated Number of Annual Responses: 648.

    Total Estimated Number of Annual Burden Hours: 236.

    Abstract: The National Evaluation of the Comprehensive Technical Assistance Centers will examine and document how the Comprehensive Center program and its individual centers intend to build SEA capacity and what types of activities they actually conduct to build capacity. The study will use surveys and interviews of center staff and technical assistance recipients, as well as technical assistance event observations, to collect information about how the Comprehensive Centers design their work, how they operate, and the results of their work.

    Dated: October 26, 2016. Kate Mullan, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2016-26158 Filed 10-28-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION National Assessment Governing Board Quarterly Board Meeting AGENCY:

    National Assessment Governing Board, U.S. Department of Education.

    ACTION:

    Announcement of open and closed meetings.

    SUMMARY:

    This notice sets forth the agenda for the November 17-19, 2016 Quarterly Board Meeting of the National Assessment Governing Board (hereafter referred to as Governing Board). This notice provides information to members of the public who may be interested in attending the meeting or providing written comments on the meeting. The notice of this meeting is required under § 10(a)(2) of the Federal Advisory Committee Act (FACA).

    DATES:

    The Quarterly Board Meeting will be held on the following dates:

    • November 17, 2016 from 12:30 p.m. to 6:00 p.m. • November 18, 2016 from 8:30 a.m. to 5:00 p.m. • November 19, 2016 from 7:30 a.m. to 11:45 a.m. ADDRESSES:

    Sheraton Pentagon City, 900 South Orme Street, Arlington, Virginia 22204.

    FOR FURTHER INFORMATION CONTACT:

    Munira Mwalimu, Executive Officer/Designated Federal Official of the Governing Board, 800 North Capitol Street NW., Suite 825, Washington, DC 20002, telephone: (202) 357-6938, fax: (202) 357-6945.

    SUPPLEMENTARY INFORMATION:

    Statutory Authority and Function: The Governing Board is established under the National Assessment of Educational Progress Authorization Act, Title III of Public Law 107-279. Information on the Governing Board and its work can be found at www.nagb.gov.

    The Governing Board is established to formulate policy for the National Assessment of Educational Progress (NAEP). The Governing Board's responsibilities include the following: Selecting subject areas to be assessed, developing assessment frameworks and specifications, developing appropriate student achievement levels for each grade and subject tested, developing standards and procedures for interstate and national comparisons, improving the form and use of NAEP, developing guidelines for reporting and disseminating results, and releasing initial NAEP results to the public.

    November 17-19, 2016 Committee Meetings

    The Governing Board's standing committees will meet to conduct regularly scheduled work based on agenda items planned for this Quarterly Board Meeting and follow-up items as reported in the Governing Board's committee meeting minutes available at http://nagb.gov/what-we-do/board-committee-reports-and-agendas.html.

    Detailed Meeting Agenda: November 17-19, 2016

    November 17: Assessment Development Committee (ADC): Closed Session: 12:30 p.m. to 2:30 p.m.; Open Session: 2:30 p.m. to 4:00 p.m.

    November 17: Executive Committee: Open Session: 4:30 p.m. to 5:35 p.m.; Closed Session: 5:35 p.m. to 6:00 p.m.

    November 18: Full Governing Board and Committee Meetings

    Full Governing Board: Open Session: 8:30 a.m. to 10:00 a.m.; Closed Sessions: 12:45 p.m. to 3:15 p.m.; Open Session: 3:30 p.m. to 5:00 p.m.

    ADC and Committee on Standards, Design and Methodology (COSDAM): Joint Open Session: 10:15 a.m. to 11:00 a.m.; Joint Closed Session: 11:00 a.m. to 11:30 a.m.;

    ADC: Closed Session: 11:45 a.m. to 12:30 p.m.

    COSDAM: Open Session: 11:30 a.m. to 12:30 p.m.

    Reporting & Dissemination (R&D) Committee: Open Session 10:15 a.m. to 12:30 p.m.

    November 19: Full Governing Board and Committee Meetings

    Nominations Committee: Closed Session: 7:30 a.m. to 8:15 a.m.

    Full Governing Board: Closed Session: 8:30 a.m. to 9:45 a.m.; Open Session: 10:00 a.m. to 11:45 a.m.

    On Thursday, November 17, 2016, ADC will meet in closed session from 12:30 p.m. to 2:30 p.m. to review secure digital-based tasks in mathematics for grade 12 and for science at grades 4 and 8. This meeting must be conducted in closed session because the test items are secure and have not been released to the public. Public disclosure of the secure test items would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of § 552b(c) of Title 5 of the United States Code.

    From 2:30 p.m. to 4:00 p.m. the ADC will meet in open session to review grade 12 contextual questions for students, teachers, and schools in reading and mathematics.

    The Executive Committee will meet in open session on November 17 from 4:30 p.m. to 5:35 p.m. and thereafter in closed session from 5:35 p.m. to 6:00 p.m. During the closed session, the Executive Committee will be briefed on the development of the NAEP research grants program and the forthcoming request for proposals (RFP). This discussion will include secure information that will be included in the request for proposals which is not yet available to the public. This meeting must be conducted in closed session because premature public disclosure of this information would likely have an adverse impact on the proposed agency action if conducted in open session. Such matters are protected by exemption 9(B) of § 552b(c) of Title 5 of the United States Code.

    On Friday, November 18, the full Governing Board will meet in open session from 8:30 a.m. to 10:00 a.m. The Governing Board will review and approve the November 17-19, 2016 Governing Board meeting agenda and meeting minutes from the August 2016 Quarterly Board Meeting. Thereafter, the Secretary of Education, John B. King, Jr. will administer the oath of office to a new Board member and four reappointed members following which he will provide remarks to the Governing Board.

    This session will be followed by a report from the Executive Director of the Governing Board, William Bushaw, followed by an update on National Center for Education Statistics (NCES) work by Holly Spurlock, Branch Chief, National Assessment Operations, NCES.

    The Governing Board will recess for committee meetings at 10:00 a.m. which are scheduled to take place from 10:15 a.m. to 12:30 p.m.

    On November 18, 2016, the ADC will meet in a joint open session with COSDAM from 10:15 a.m. to 11:00 a.m. Thereafter the two committees will meet in a joint closed session from 11:00 a.m. to 11:30 a.m. to receive a briefing on an embargoed NCES research study involving 2015 mathematics data from grades 4 and 8 at national and state levels. The data and analyses are secure and have not been released to the public. Public disclosure of the secure test data and analyses would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of § 552b(c) of Title 5 of the United States Code.

    Following this joint meeting, ADC will meet in closed session from 11:45 a.m. to 12:30 p.m. to receive a briefing on the history and content of the NAEP Long-Term Trend assessments in reading and mathematics, which are conducted at ages 9, 13, and 17. The briefing will include secure reading and mathematics test items from these three age-level assessments that have not been released to the public. This meeting must be conducted in closed session because the test items are secure and have not been released to the public. Public disclosure of the secure test items would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of § 552b(c) of Title 5 of the United States Code.

    On November 18, the COSDAM will meet in open session from 11:30 a.m. to 12:30 p.m. to conduct regularly scheduled work. On November 17, the R&D Committee will meet in open session from 10:15 a.m. to 12:30 p.m. to conduct regularly scheduled work.

    Following the committee meetings on Friday, November 18, the Governing Board will meet in closed session from 12:45 p.m. to 1:45 p.m. to receive a briefing on the 2015 National Indian Education Study in reading and mathematics from James Deaton, NCES. Results from this study have not been released to the public. Public disclosure of the study results would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of § 552b(c) of Title 5 of the United States Code.

    Following this closed session, the Governing Board will meet in closed session from 2:00 p.m. to 3:15 p.m. to receive a briefing from Eunice Greer, NCES, on data from recent NAEP digital-based pilot assessments in reading, mathematics, and writing. Secure test questions in each subject area as well as embargoed data will be presented during this briefing. The test questions and data have not been released to the public and the session must be conducted in closed session. Public disclosure of the secure test items and data would significantly impede implementation of the NAEP assessment program if conducted in open session. Such matters are protected by exemption 9(B) of § 552b(c) of Title 5 of the United States Code.

    Thereafter, the Governing Board will take a fifteen-minute break and reconvene in open session from 3:30 p.m. to 4:15 p.m. to discuss and take action on the Governing Board's Strategic Vision. The discussion will be led by the Governing Board's Vice Chair Lucille Davy, with a presentation from Lily Clark of the Governing Board staff.

    From 4:15 p.m. to 5:00 p.m., Marcella Goodridge-Keiller, Office of the General Counsel will provide the annual ethics briefing, and William Bushaw, Governing Board Executive Director, and Peggy Carr, NCES Acting Commissioner, will provide a briefing on keeping embargoed data secure.

    The November 18, 2016 meeting will adjourn at 5:00 p.m.

    On November 19, the Nominations Committee will meet in closed session from 7:30 a.m. to 8:15 a.m. The committee will receive a briefing on nominations received for Governing Board terms beginning in October 1, 2017. The Nominations Committee's discussions pertain solely to internal personnel rules and practices of an agency and information of a personal nature where disclosure would constitute a clearly unwarranted invasion of personal privacy. As such, the discussions are protected by exemptions 2 and 6 of § 552b(c) of Title 5 of the United States Code.

    On November 19, the Governing Board will meet from 8:30a.m. to 9:45 a.m. to receive a briefing from the National Academy of Sciences on the Evaluation of the NAEP Achievement Levels for Mathematics and Reading. The evaluation report has not yet been publically released by the National Academy of Sciences. Public disclosure of the evaluation results would significantly impede implementation of the NAEP assessment and reporting program if conducted in open session. Such matters are protected by exemption 9(B) of § 552b(c) of Title 5 of the United States Code.

    Thereafter, the Governing Board will have a short break and reconvene from 10:00 a.m. to 10:30 a.m. to receive an update on committee reports and take action on the R&D recommended release plan for the 2016 NAEP Arts assessment. The Governing Board will also take action on a joint delegation of authority to COSDAM and the Executive Committee for providing an official response to the Evaluation of NAEP Achievement Levels.

    Following a short break, from 10:30 a.m. to 10:45 a.m., the Governing Board will meet in open session from 10:45 a.m. to 11:45 a.m. to receive a briefing on draft Governing Board guidelines for Releasing, Reporting, and Disseminating Results.

    The November 19, 2016 meeting is scheduled to adjourn at 11:45 a.m.

    Access to Records of the Meeting: Pursuant to FACA requirements, the public may also inspect the meeting materials at www.nagb.gov beginning on Thursday, November 17, 2016 by 10:00 a.m. ET. The official verbatim transcripts of the public meeting sessions will be available for public inspection no later than 30 calendar days following the meeting.

    Reasonable Accommodations: The meeting site is accessible to individuals with disabilities. If you will need an auxiliary aid or service to participate in the meeting (e.g., interpreting service, assistive listening device, or materials in an alternate format), notify the contact person listed in this notice at least two weeks before the scheduled meeting date. Although we will attempt to meet a request received after that date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the Adobe Web site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Authority:

    Public Law 107-279, Title III—National Assessment of Educational Progress § 301.

    Dated: October 26, 2016. William J. Bushaw, Executive Director, National Assessment Governing Board (NAGB), U. S. Department of Education.
    [FR Doc. 2016-26194 Filed 10-28-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF EDUCATION [Docket No. ED-2016-IES-0109] Request for Information on Interagency Working Group on Language and Communication's Report on Research and Development Activities AGENCY:

    Institute of Education Sciences, U.S. Department of Education.

    ACTION:

    Request for information.

    SUMMARY:

    To assist National Science and Technology Council's (NSTC) Interagency Working Group on Language and Communication (IWGLC) in its efforts to further improve coordination and collaboration of research and development (R & D) agendas related to language and communication across the Federal Government, the Institute of Education Sciences (the Institute) requests information from interested parties through this notice.

    DATES:

    Written submissions must be received by the Department on or before December 30, 2016.

    ADDRESSES:

    Submit your comments through the Federal eRulemaking Portal or via postal mail or commercial delivery. We will not accept comments by fax, email, or hand delivery. To ensure that we do not receive duplicate copies, please submit your comments only one time. In addition, please include the Docket ID and the term “Language and Communication R & D Activities response” at the top of your comments.

    Federal eRulemaking Portal: Go to www.regulations.gov to submit your comments electronically. Information on using Regulations.gov, including instructions for accessing agency documents, submitting comments, and viewing the docket, is available on the site under “Are you new to this site?”

    Postal Mail or Commercial Delivery: If you mail your comments, address them to Rebecca McGill-Wilkinson, National Center for Education Research, Institute of Education Sciences, Attention: Language and Communication R & D Activities RFI, U.S. Department of Education, 400 Maryland Avenue SW., PCP-4127, Washington, DC 20202.

    Privacy Note: The Department's policy for comments received from members of the public (including comments submitted by mail or commercial delivery) is to make these submissions available for public viewing in their entirety on the Federal eRulemaking Portal at www.regulations.gov. Therefore, commenters should be careful to include in their comments only information that they wish to make publicly available on the Internet.

    Submission of Proprietary Information: Given the subject matter, some comments may include proprietary information as it relates to confidential commercial information. The Freedom of Information Act defines “confidential commercial information” as information the disclosure of which could reasonably be expected to cause substantial competitive harm. You may wish to request that we not disclose what you regard as confidential commercial information.

    To assist us in making a determination on your request, we encourage you to identify any specific information in your comments that you consider confidential commercial information. Please list the information by page and paragraph numbers.

    This is a request for information (RFI) only. This RFI is not a request for proposals (RFP) or a promise to issue an RFP or a notice inviting applications (NIA). This RFI does not commit the Department to contract for any supply or service whatsoever. Further, the Department is not seeking proposals and will not accept unsolicited proposals. The Department will not pay for any information or administrative costs that you may incur in responding to this RFI. If you do not respond to this RFI, you may still apply for future contracts and grants. The Department posts RFPs on the Federal Business Opportunities Web site (www.fbo.gov). The Department announces grant competitions in the Federal Register (www.thefederalregister.org/fdsys). It is your responsibility to monitor these sites to determine whether the Department issues an RFP or NIA after considering the information received in response to this RFI. The documents and information submitted in response to this RFI become the property of the U.S. Government and will not be returned.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Rebecca McGill-Wilkinson, U.S. Department of Education, 400 Maryland Avenue SW., PCP 4127, Washington, DC. Telephone: (202) 245-7613 or by email: [email protected]

    If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION:

    Introduction

    The Institute requests information from interested parties to help inform its work with the IWGLC as it moves forward to improve coordination and collaboration of research and development agendas related to a recently published report on language and communication across the Federal Government. The Report from the Interagency Working Group on Language & Communication (Report) is available at: www.whitehouse.gov/sites/default/files/microsites/ostp/NSTC/report_of_the_interagency_working_group_on_language_and_communication_final.pdf.

    Background

    The NSTC is the principal means by which the Executive Branch coordinates science and technology policy across the Federal Government. A primary objective of the NSTC is establishing clear national goals for Federal science and technology investments. The IWGLC serves as part of the internal deliberative process of the NSTC. The IWGLC includes representatives from the White House Office of Science and Technology Policy, National Science Foundation, Department of Health and Human Services, Department of Education, Department of Defense, Department of Agriculture, Department of Justice, Department of Energy, Department of Homeland Security, Department of State, Department of Commerce, National Endowment for the Humanities, National Aeronautics and Space Administration, and the Department of Transportation, and recently researched and authored the Report.

    Human interaction in society depends upon language and communication. Across the Federal Government, agencies support R & D activities focused on furthering the understanding of and supporting better language and communication. To date, however, there has been no systematic accounting or description of the range of language and communication R & D that is programs and activities being supported by the Federal Government. In the Report, the IWGLC took on the challenge of creating a taxonomy of language and communication R & D activities and summarizing current and recent Federal investment in this area.

    The taxonomy included in the Report identified four broad R & D topics in language and communication funded by the Federal Government, along with a number of subtopics under each broad topic. Please consult the taxonomy on pages 48-50 in the Report. The four broad topic headings include:

    1. Knowledge and Processes Underlying Language and Communication.

    2. Language and Communication Abilities and Skills.

    3. Using Language and Communication to Influence Behavior and Share Information.

    4. Language and Communication Technologies.

    The taxonomy also identified four types of R & D activities that could be supported within each topic area:

    1. Basic/foundational.

    2. Translational.

    3. Applied.

    4. Implementation.

    The Report provides programmatic recommendations for key areas for investment and collaboration in language and communication research to support a broad range of government functions such as environmental protection, education, national security, law enforcement, transportation, and public health.

    Questions

    The Institute is interested in gathering information that would be of help to the IWGLC in coordinating and making recommendations about the range of R & D programs and activities related to key topics of language and communication that are supported across the Federal agencies. Specifically, the Institute, on behalf of the IWGLC, requests information on the following:

    1. Whether the taxonomy included in the Report captures all types of federally funded R & D programs and activities on language and communication. If not, please indicate which types of R & D activities should be added to the taxonomy.

    2. Whether there are language and communication R & D programs and activities carried out in the non-Federal sector (e.g., commercial industry, nonprofit organizations, institutions of higher education) that do not fall into any of the taxonomy subtopics (see pgs. 48-50 of the Report). If so, please describe those activities.

    3. Whether there are activities that are not included in the Report's list of recommended next steps for the Federal Government to take related to language and communication R & D programs and activities that should be considered (see pgs. 33-36). If so, please indicate what activities should be added to the Report's recommendations.

    Written comments may be submitted through any of the methods discussed in the ADDRESSES section of this notice. This notice is for information purposes only. The Institute and the other member Federal agencies on the IWGLC will review and consider information provided in response to this notice as the IWGLC moves forward with its new charter to improve coordination and collaboration of research and development agendas related to language and communication across the Federal Government.

    Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to Dr. Rebecca McGill-Wilkinson at (202) 245-7613 or [email protected]

    Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

    You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

    Authority: Executive Order 12881 of November 23, 1993, as amended by Executive Order 13284 of January 23, 2003. 20 U.S.C. 3402(4).

    Dated: October 26, 2016. Ruth Neild, Deputy Director for Policy and Research, Delegated the Duties of the Director, Institute of Education Sciences.
    [FR Doc. 2016-26193 Filed 10-28-16; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Savannah River Site AGENCY:

    Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Savannah River Site. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

    DATES:

    Monday, November 14, 2016, 1:00 p.m.-4:45 p.m. Tuesday, November 15, 2016, 8:30 a.m.-4:45 p.m. ADDRESSES:

    Applied Research Center, 301 Gateway Drive, Aiken, SC 29802.

    FOR FURTHER INFORMATION CONTACT:

    James Giusti, Office of External Affairs, Department of Energy, Savannah River Operations Office, P.O. Box A, Aiken, SC, 29802; Phone: (803) 952-7684.

    SUPPLEMENTARY INFORMATION:

    Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

    Tentative Agenda Monday, November 14, 2016 Opening and Agenda Review Combined Committees Session Order of committees: • Administrative & Outreach • Facilities Disposition & Site Remediation • Strategic & Legacy Management • Waste Management • Nuclear Materials Public Comments Adjourn Tuesday, November 15, 2016 Opening, Chair Update, and Agenda Review Agency Updates Public Comments Recommendation Voting • Waste Management Committee Draft Recommendation • Nuclear Materials Committee Draft Recommendation • Strategic & Legacy Management Committee Draft Recommendation Break Administrative & Outreach Committee Update • Voting for Board Chair and Vice Chair Facilities Disposition & Site Remediation Committee Update Lunch Break Strategic & Legacy Management Committee Update Waste Management Committee Update Public Comments Break Nuclear Materials Committee Update Strategic Plan Update Public Comments Adjourn

    Public Participation: The EM SSAB, Savannah River Site, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact James Giusti at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact James Giusti's office at the address or telephone listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

    Minutes: Minutes will be available by writing or calling James Giusti at the address or phone number listed above. Minutes will also be available at the following Web site: http://cab.srs.gov/srs-cab.html.

    Issued at Washington, DC, on October 25, 2016. LaTanya R. Butler, Deputy Committee Management Officer.
    [FR Doc. 2016-26206 Filed 10-28-16; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL17-11-000] Alabama Power Company v. Southwest Power Pool; Notice of Complaint

    Take notice that on October 24, 2016, pursuant to Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 and sections 205, 206, 306, and 309 of the Federal Power Act, (FPA) 1 Alabama Power Company (Complainant) filed a formal complaint against the Southwest Power Pool (Respondent) alleging that, Respondent levied unlawful charges upon the Complainant and Respondent's rates for transmission service are unjust, unreasonable, unduly discriminatory and preferential, all in violation of the FPA, as more fully explained in the complaint.

    1 16 U.S.C. 824(d), 824(e), 825(e), and 825(h) (2015).

    The Complainant certifies that a copy of the complaint has been served on the Respondent.

    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. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for electronic review in the Commission's Public Reference Room in Washington, DC There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern Time on November 14, 2016.

    Dated: October 25, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-26187 Filed 10-28-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER17-157-000] Moapa Southern Paiute Solar, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Moapa Southern Paiute Solar, LLC`s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability is November 14, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 25, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-26229 Filed 10-28-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL17-8-000] Indianapolis Power & Light Company v. Midcontinent Independent System Operator, Inc.; Notice of Complaint

    Take notice that on October 21, 2016, pursuant to sections 206 of the Federal Power Act, 16 U.S.C. 824e and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206, Indianapolis Power & Light Company (IPL or Complainant) filed a formal complaint against Midcontinent Independent System Operator, Inc., (MISO or Respondent) alleging that the Respondent's Open Access Transmission, Energy and Operating Reserve Markets Tariff is unjust and unreasonable, unduly discriminatory and preferential because it does not provide a means for IPL's Advancion® Energy Storage Array, a.k.a. the Harding Street Station Battery Energy Storage System to be compensated for services it provides to the MISO system, including Primary Frequency Response, as more fully explained in the complaint.

    Complainant certifies that copies of the complaint were served on the contacts for Respondent as listed on the Commission's list of Corporate Officials.

    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 and 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. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.

    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 November 10, 2016.

    Dated: October 25, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-26186 Filed 10-28-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER11-1844-003.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Midcontinent Independent System Operator, Inc. submits tariff filing per 35: 2016-10-24_Compliance filing to address ITC PARs Order to be effective 1/1/2011.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5046.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER16-833-003.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Compliance filing: 2016-10-21_Default Technology Specific Avoidable Cost to be effective 9/1/2016.

    Filed Date: 10/21/16.

    Accession Number: 20161021-5153.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER16-1314-002.

    Applicants: Southwest Power Pool, Inc.

    Description: Compliance filing: 2198R20 and 2198R21 KPP NITSA NOA Compliance Filing to be effective 3/1/2016.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5078.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER16-2402-001.

    Applicants: UGI Utilities Inc.

    Description: Compliance filing: Supplemental Revisions to Market Based Rate Tariff to be effective 10/10/2016.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5119.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER16-2403-001.

    Applicants: UGI Development Company.

    Description: Compliance filing: Supplemental Revisions to Market Based Rate Tariff to be effective 10/10/2016.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5126.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-158-000.

    Applicants: Western Farmers Electric Cooperative.

    Description: Petition for Tariff Waiver of Western Farmers Electric Cooperative.

    Filed Date: 10/21/16.

    Accession Number: 20161021-5173.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-159-000.

    Applicants: DTE Electric Company.

    Description: Notice of Cancellation of Tariff No. 1 of DTE Electric Company.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5033.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-160-000.

    Applicants: Public Service Company of New Mexico.

    Description: Tariff Cancellation: Notice of Cancellation of Third Revised NITSA and Third Revised NOA to be effective 12/31/2016.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5059.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-161-000.

    Applicants: Public Service Company of New Mexico.

    Description: Tariff Cancellation: Notice of Cancellation of Power Sale Agreement to be effective 12/31/2016.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5057.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-162-000.

    Applicants: Public Service Company of New Mexico.

    Description: Compliance filing: Executed Service Agreement for Electric Service under PNM?s Coordination Tariff to be effective 1/1/2017.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5058.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-163-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: First Revised ISA No. 4331, Queue No. AA2-139 to be effective 9/22/2016.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5113.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-164-000.

    Applicants: Wisconsin Public Service Corporation.

    Description: § 205(d) Rate Filing: WPS Corp and Daggett Agreement for Wholesale Distribution Service to be effective 1/1/2017.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5127.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-165-000.

    Applicants: Wisconsin Public Service Corporation.

    Description: § 205(d) Rate Filing: WPS Corp and Stephenson Agreement for Wholesale Distribution Service to be effective 1/1/2017.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5128.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-166-000.

    Applicants: Upper Michigan Energy Resources Corporation.

    Description: § 205(d) Rate Filing: UMERC to Daggett Rate Schedule No 6 to be effective 1/1/2017.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5129.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-167-000.

    Applicants: Upper Michigan Energy Resources Corporation.

    Description: § 205(d) Rate Filing: UMERC to Stephenson Rate Schedule No 7 to be effective 1/1/2017.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5135.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-168-000.

    Applicants: Applied Energy LLC.

    Description: Baseline eTariff Filing: Market-Based Rates Application to be effective 12/24/2016.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5141.

    Comments Due: 5 p.m. ET 11/14/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 24, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-26225 Filed 10-28-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC17-19-000.

    Applicants: Chisholm View Wind Project II, LLC.

    Description: Application for Authorization Under Section 203 of the Federal Power Act, Request for Expedited Consideration and Confidential Treatment for Chisholm View Wind Project II, LLC.

    Filed Date: 10/19/16.

    Accession Number: 20161019-5145.

    Comments Due: 5 p.m. ET 11/9/16.

    Docket Numbers: EC17-20-000.

    Applicants: Eurus Combine Hills I LLC, Crescent Ridge LLC.

    Description: Application for Authorization Under Section 203 of the Federal Power Act and Request for Waivers, Confidential Treatment, Expedited Action and Shortened Comment Period of Eurus Combine Hills I LLC, et al.

    Filed Date: 10/19/16.

    Accession Number: 20161019-5148.

    Comments Due: 5 p.m. ET 11/9/16.

    Docket Numbers: EC17-21-000.

    Applicants: Vantage Wind Energy LLC.

    Description: Application for Authorization Under Section 203 of the Federal Power Act and Request for Waivers and Expedited Action of Vantage Wind Energy LLC.

    Filed Date: 10/20/16.

    Accession Number: 20161020-5098.

    Comments Due: 5 p.m. ET 11/10/16.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER15-2571-003.

    Applicants: GenOn Energy Management, LLC.

    Description: Report Filing: Refund Report—Informational Filing to be effective N/A.

    Filed Date: 10/20/16.

    Accession Number: 20161020-5086.

    Comments Due: 5 p.m. ET 11/10/16.

    Docket Numbers: ER15-2572-002.

    Applicants: GenOn Energy Management, LLC.

    Description: Report Filing: Refund Report—Informational Filing to be effective N/A.

    Filed Date: 10/20/16.

    Accession Number: 20161020-5087.

    Comments Due: 5 p.m. ET 11/10/16.

    Docket Numbers: ER15-2573-002.

    Applicants: GenOn Energy Management, LLC.

    Description: Report Filing: Refund Report—Informational Filing to be effective N/A.

    Filed Date: 10/20/16.

    Accession Number: 20161020-5088.

    Comments Due: 5 p.m. ET 11/10/16.

    Docket Numbers: ER16-2518-001.

    Applicants: PJM Interconnection, L.L.C.

    Description: Compliance filing: OATT Revisions re: Earlier Queue Submittal per 10/7/16 Order in ER16-2518-000 to be effective 10/31/2016.

    Filed Date: 10/20/16.

    Accession Number: 20161020-5066.

    Comments Due: 5 p.m. ET 11/10/16.

    Docket Numbers: ER17-142-000.

    Applicants: Broadview Energy JN, LLC.

    Description: § 205(d) Rate Filing: Certificate of Concurrence to be effective 12/1/2016.

    Filed Date: 10/19/16.

    Accession Number: 20161019-5136.

    Comments Due: 5 p.m. ET 11/9/16.

    Docket Numbers: ER17-143-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) Rate Filing: EDC Letter Agreement between SCE and RPU to be effective 12/21/2016.

    Filed Date: 10/20/16.

    Accession Number: 20161020-5001.

    Comments Due: 5 p.m. ET 11/10/16.

    Docket Numbers: ER17-144-000.

    Applicants: New York Independent System Operator, Inc.

    Description: Request of New York Independent System Operator, Inc. for Limited Tariff Waiver, et al.

    Filed Date: 10/19/16.

    Accession Number: 20161019-5150.

    Comments Due: 5 p.m. ET 10/26/16.

    Docket Numbers: ER17-145-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 3006R1 CP Bloom Wind, LLC Generator Interconnection Agr to be effective9/26/2016.

    Filed Date: 10/20/16.

    Accession Number: 20161020-5037.

    Comments Due: 5 p.m. ET 11/10/16.

    Docket Numbers: ER17-146-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: Tariff Cancellation: Notice of Cancellation of Service Agreement No. 3780, Queue No. W4-045 to be effective 7/26/2016.

    Filed Date: 10/20/16.

    Accession Number: 20161020-5047.

    Comments Due: 5 p.m. ET 11/10/16.

    Docket Numbers: ER17-147-000.

    Applicants: Midcontinent Independent System Operator, Inc., MidAmerican Energy Company.

    Description: § 205(d) Rate Filing: 2016-10-20_MidAmerican-ITC Midwest Louisa Facilities and Operating Agreements to be effective 10/21/2016.

    Filed Date: 10/20/16.

    Accession Number: 20161020-5051.

    Comments Due: 5 p.m. ET 11/10/16.

    Docket Numbers: ER17-148-000.

    Applicants: Citizens Sunrise Transmission LLC.

    Description: § 205(d) Rate Filing: Annual TRBAA Filing to be effective1/1/2017.

    Filed Date: 10/20/16.

    Accession Number: 20161020-5067.

    Comments Due: 5 p.m. ET 11/10/16.

    Docket Numbers: ER17-149-000.

    Applicants: Grady Wind Energy Center, LLC.

    Description: Baseline eTariff Filing: Certificate of Concurrence to be effective 12/1/2016.

    Filed Date: 10/20/16.

    Accession Number: 20161020-5072.

    Comments Due: 5 p.m. ET 11/10/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 20, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-26224 Filed 10-28-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RP17-52-000] Breitburn Operating LP v. Florida Gas Transmission Company, LLC; Notice of Complaint

    Take notice that on October 24, 2016, pursuant to Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 and section 5 of the Natural Gas Act (NGA), 15 U.S.C. 717d (2009), Breitburn Operating LP (Complainant) filed a formal complaint against Florida Gas Transmission Company, LLC (Respondent) alleging that, Respondent: (1) Unduly discriminated against Complainant by unilaterally requiring its natural gas supplier to pay both the Western Division and Market Area rates while similarly situated shippers paid only the Western Division rate and (2) unlawfully charged and collected a rate under section 4 of the NGA without Commission authorization, all as more fully explained in the complaint.

    The Complainant certifies that a copy of the complaint has been served on the contacts for the Respondent.

    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. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.

    The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    This filing is accessible on-line at http://www.ferc.gov, using the “eLibrary” link and is available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an “eSubscription” link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Comment Date: 5:00 p.m. Eastern Time on November 14, 2016.

    Dated: October 25, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-26190 Filed 10-28-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP17-3-000] Dominion Carolina Gas Transmission, LLC; Notice of Application

    Take notice that on October 13, 2016, Dominion Carolina Gas Transmission, LLC, 707 East Main Street, Richmond, VA 23219, filed an application pursuant to section 7(b) of the Natural Gas Act (NGA) requesting authorization to abandon approximately 60 miles of mainline transmission pipeline facilities in Chester, Kershaw, Lancaster, and York Counties, South Carolina that comprise the Line A Abandonment Project, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing may also be viewed on the web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or TTY, contact (202) 502-8659.

    Any questions concerning this application may be directed to Richard D. Jessee, Gas Transmission Certificates Program Manager, Dominion Carolina Gas Transmission, LLC, 707 East Main Street, Richmond, VA 23219, telephone no. (866) 319-3382, facsimile no. (804) 771-4804 and email: [email protected]

    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9), within 90 days of this Notice, the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 5 copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, 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.

    Comment Date: 5:00 p.m. Eastern Time on November 15, 2016.

    Dated: October 25, 2016. Kimberly Bose, Secretary.
    [FR Doc. 2016-26185 Filed 10-28-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 14790-000] City of Tuscaloosa, Alabama; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments and Motions To Intervene

    On June 29, 2016, the City of Tuscaloosa, Alabama filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Lake Tuscaloosa Dam Hydroelectric Project (Lake Tuscaloosa Project or project) to be located on the North River, near the City of Tuscaloosa in Tuscaloosa County, Alabama. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.

    The proposed project would consist of the following: (1) The City of Tuscaloosa's existing 1,280-foot-long, 36-foot-wide earth filled embankment dam; (2) a reservoir with a surface area of 5,885 acres and a storage capacity of 122,755-acre-feet; (3) a 20-foot-long, 96-foot-wide intake channel; (4) a 200-foot-long, 66-inch-diameter penstock with a 66-inch-diameter butterfly valve at the junction of the existing outlet; (5) a powerhouse containing one generating unit with a total capacity of 3.0 megawatts; (6) a 540-foot-long, 20-foot-wide tailrace; and (7) a 3.9-mile-long, 15 kV transmission line. The proposed project would have an estimated average annual generation of 18,207 megawatt-hours.

    Applicant Contact: Mr. Scott B. Holmes, City of Tuscaloosa., 2201 University Blvd., Tuscaloosa, Alabama 35401; Phone (205) 248-5140; Email: [email protected]

    FERC Contact: Christiane Casey, [email protected], (202) 502-8577.

    Competing Application: This application competes with Project No. 14750-000 filed December 22, 2015. Competing applications had to be filed on or before June 30, 2016.

    Deadline for filing comments and motions to intervene: 60 days from the issuance of this notice. Comments and motions to intervene may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site 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] or toll free at 1-866-208-3676, or for TTY, (202) 502-8659. Although the Commission strongly encourages electronic filing, documents may also be paper-filed. To paper-file, mail an original and five copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-14790) in the docket number field to access the document. For assistance, contact FERC Online Support.

    Dated: October 25, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-26189 Filed 10-28-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER17-168-000] Applied Energy LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of Applied Energy LLC`s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability is November 14, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 25, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-26230 Filed 10-28-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP17-49-000.

    Applicants: Destin Pipeline Company, L.L.C.

    Description: § 4(d) Rate Filing: Tariff Changes in Response to Audit Order FA15-001-000 to be effective 12/1/2016.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5024.

    Comments Due: 5 p.m. ET 11/7/16.

    Docket Numbers: RP17-50-000.

    Applicants: Columbia Gulf Transmission, LLC.

    Description: Compliance filing Columbia Gulf Section 5 Settlement Implementation to be effective 7/1/2016.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5025.

    Comments Due: 5 p.m. ET 11/7/16.

    Docket Numbers: RP17-51-000.

    Applicants: Freeport-McMoRan Exploration & Productio,Anadarko US Offshore LLC.

    Description: Joint Petition for Temporary Waivers of Commission Policies, et. al. of Freeport-McMoRan Exploration & Production LLC, et. al. under RP17-51.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5148.

    Comments Due: 5 p.m. ET 11/1/16.

    Docket Numbers: RP17-52-000.

    Applicants: Breitburn Operating LP v. Florida Gas Tr.

    Description: Formal Complaint of Breitburn Operating LP under RP17-52.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5178.

    Comments Due: 5 p.m. ET 11/7/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 25, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-26231 Filed 10-28-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC17-22-000.

    Applicants: Bluestem Wind Energy, LLC.

    Description: Application for Authorization under Section 203 of the Federal Power Act of Bluestem Wind Energy, LLC.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5187.

    Comments Due: 5 p.m. ET 11/14/16.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-2249-005.

    Applicants: Portland General Electric Company.

    Description: Second Supplement to June 30, 2016 Triennial Market Power Analysis in the Northwest Region for Portland General Electric Company.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5065.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER16-2126-001.

    Applicants: ISO New England Inc., New England Power Pool Participants Committee.

    Description: Compliance filing: Compliance Filing Re: Automatically Matching Capacity & Multi-Year Lock In to be effective 12/27/2016.

    Filed Date: 10/25/16.

    Accession Number: 20161025-5022.

    Comments Due: 5 p.m. ET 11/15/16.

    Docket Numbers: ER17-169-000.

    Applicants: ALLETE, Inc.

    Description: § 205(d) Rate Filing: ALLETE Maintenance Services Agreement Filing to be effective 12/23/2016.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5143.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-170-000.

    Applicants: California Independent System Operator Corporation.

    Description: § 205(d) Rate Filing: 2016-10-24—Planning Coordinator Agreement with MWD and CEII Request to be effective 12/26/2016.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5144.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-171-000.

    Applicants: Pacific Gas and Electric Company.

    Description: Tariff Cancellation: Notice of Termination of Lathrop IA and WDT Service Agreement (SA 23) to be effective 8/31/2016.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5146.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-172-000.

    Applicants: Lockhart Power Company.

    Description: § 205(d) Rate Filing: Request for Revision to FERC Electric Tariff, Original Volume No. 1 to be effective 12/24/2016.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5147.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-173-000.

    Applicants: Wabash Valley Power Association, Inc.

    Description: Request for Revised and Additional Depreciation Rates of Wabash Valley Power Association, Inc.

    Filed Date: 10/24/16.

    Accession Number: 20161024-5170.

    Comments Due: 5 p.m. ET 11/14/16.

    Docket Numbers: ER17-174-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 2236R8 Golden Spread Electric Cooperative, Inc. NITSA NOA to be effective 10/1/2016.

    Filed Date: 10/25/16.

    Accession Number: 20161025-5021.

    Comments Due: 5 p.m. ET 11/15/16.

    Docket Numbers: ER17-175-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 1276R12 KCPL NITSA NOA to be effective 10/1/2016.

    Filed Date: 10/25/16.

    Accession Number: 20161025-5033.

    Comments Due: 5 p.m. ET 11/15/16.

    Docket Numbers: ER17-176-000.

    Applicants: Southern California Edison Company.

    Description: Tariff Cancellation: Notices of Cancellation of SGIA and Service Agreement for Lucerne Valley Solar to be effective 7/15/2016.

    Filed Date: 10/25/16.

    Accession Number: 20161025-5034.

    Comments Due: 5 p.m. ET 11/15/16.

    Docket Numbers: ER17-177-000.

    Applicants: UGI Energy Services, LLC.

    Description: Compliance filing: New Baseline Market Based Rate Filing to be effective 10/1/2013.

    Filed Date: 10/25/16.

    Accession Number: 20161025-5043.

    Comments Due: 5 p.m. ET 11/15/16.

    Docket Numbers: ER17-178-000.

    Applicants: UGI Energy Services, LLC.

    Description: § 205(d) Rate Filing: Supplemental Revisions to Market Based Rate Tariff to be effective 10/10/2016.

    Filed Date: 10/25/16.

    Accession Number: 20161025-5048.

    Comments Due: 5 p.m. ET 11/15/16.

    Docket Numbers: ER17-179-000.

    Applicants: PPL Electric Utilities Corporation, American Transmission Systems, Incorporated, PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: PJM and PJM Transmission Owners Submit Tariff Revisions re Supplemental Projects to be effective 12/31/9998.

    Filed Date: 10/25/16.

    Accession Number: 20161025-5063.

    Comments Due: 5 p.m. ET 11/15/16.

    Docket Numbers: ER17-180-000.

    Applicants: San Diego Gas & Electric Company.

    Description: § 205(d) Rate Filing: SDGE Resubmittal of Standard LGIA—Clone to be effective 10/22/2011.

    Filed Date: 10/25/16.

    Accession Number: 20161025-5085.

    Comments Due: 5 p.m. ET 11/15/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: October 25, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-26228 Filed 10-28-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2457-041-NH] Public Service Company of New Hampshire; Notice of Availability of Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office of Energy Projects has reviewed the application for a new license for the Eastman Falls Hydroelectric Project, located on the Pemigewasset River in the town of Franklin, in Merrimack and Belknap Counties, New Hampshire, and has prepared an Environmental Assessment (EA).

    The EA contains the staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.

    A copy of the EA 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 documents. For assistance, contact FERC Online Support at [email protected], (866) 208-3676 (toll free), or (202) 502-8659 (TTY).

    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.

    Any comments should be filed within 30 days from the date of this notice. 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. 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-2457-041.

    For further information, contact Steve Kartalia at (202) 502-6131 or [email protected]

    Dated: October 24, 2016. Kimberly D. Bose, Secretary.
    [FR Doc. 2016-26188 Filed 10-28-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP17-42-000.

    Applicants: Natural Gas Pipeline Company of America.

    Description: § 4(d) Rate Filing: Wells Fargo Negotiated Rate to be effective 11/1/2016.

    Filed Date: 10/20/16.

    Accession Number: 20161020-5105.

    Comments Due: 5 p.m. ET 11/1/16.

    Docket Numbers: RP17-43-000.

    Applicants: Iroquois Gas Transmission System, L.P.

    Description: § 4(d) Rate Filing: 10/20/16 Negotiated Rates—Trafigura Trading LLC (RTS) 7445-10 to be effective 11/1/2016.

    Filed Date: 10/20/16.

    Accession Number: 20161020-5114.

    Comments Due: 5 p.m. ET 11/1/16.

    Docket Numbers: RP17-44-000.

    Applicants: Midcontinent Express Pipeline LLC.

    Description: § 4(d) Rate Filing: Fuel Tracker Filing 10/21/16 to be effective 12/1/2016.

    Filed Date: 10/21/16.

    Accession Number: 20161021-5040.

    Comments Due: 5 p.m. ET 11/2/16.

    Docket Numbers: RP17-45-000.

    Applicants: Iroquois Gas Transmission System, L.P.

    Description: § 4(d) Rate Filing: 10/21/16 Negotiated Rates—Macquarie Energy LLC (RTS) 4090-13 to be effective 11/1/2016.

    Filed Date: 10/21/16.

    Accession Number: 20161021-5062.

    Comments Due: 5 p.m. ET 11/2/16.

    Docket Numbers: RP17-46-000.

    Applicants: Iroquois Gas Transmission System, L.P.

    Description: § 4(d) Rate Filing: 10/21/16 Negotiated Rates—Macquarie Energy LLC (RTS) 4090-14 to be effective 11/1/2016.

    Filed Date: 10/21/16.

    Accession Number: 20161021-5063.

    Comments Due: 5 p.m. ET 11/2/16.

    Docket Numbers: RP17-47-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Negotiated Rates—Cargill contract 510950 to be effective 11/1/2016.

    Filed Date: 10/21/16.

    Accession Number: 20161021-5065.

    Comments Due: 5 p.m. ET 11/2/16.

    Docket Numbers: RP17-48-000.

    Applicants: Iroquois Gas Transmission System, L.P.

    Description: § 4(d) Rate Filing: 10/21/16 Negotiated Rates—Twin Eagle Resource Management, LLC (RTS) 7300-01 to be effective 11/1/2016.

    Filed Date: 10/21/16.

    Accession Number: 20161021-5066.

    Comments Due: 5 p.m. ET 11/2/16.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    Filings in Existing Proceedings

    Docket Numbers: RP16-1301-001.

    Applicants: Rockies Express Pipeline LLC.

    Description: Tariff Amendment: Errata to Interim Fuel Filing RP16-1301 to be effective 11/1/2016.

    Filed Date: 10/20/16.

    Accession Number: 20161020-5116.

    Comments Due: 5 p.m. ET 11/1/16.

    Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated October 24, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-26226 Filed 10-28-16; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9954-64-OA] Children's Health Protection Advisory Committee AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of meeting of the Children's Health Protection Advisory Committee.

    SUMMARY:

    Pursuant to the provisions of the Federal Advisory Committee Act, Public Law 92-463, notice is hereby given that the next meeting of the Children's Health Protection Advisory Committee (CHPAC) will be held November 15 and 16, 2016 at the George Washington University Milken Institute School of Public Health, located at 950 New Hampshire Avenue NW., Washington, DC 20037.

    DATES:

    November 15 and 16, 2016.

    ADDRESSES:

    950 New Hampshire Avenue NW., Washington, DC 20037.

    SUPPLEMENTARY INFORMATION:

    The meetings of the CHPAC are open to the public. The CHPAC will meet on Thursday, November 15 from 1:00 p.m. to 5:30 p.m. and Friday, November 16 from 9:00 a.m. to 4:00 p.m. An agenda will be posted to www.epa.gov/children.

    Access and Accommodations: For information on access or services for individuals with disabilities, please contact Martha Berger at 202-564-2191 or [email protected], preferably at least 10 days prior to the meeting.

    FOR FURTHER INFORMATION CONTACT:

    Martha Berger, Designated Federal Officer, U.S. EPA; telephone (202) 564-2191 or [email protected]

    Dated: November 24, 2016. Martha Berger, Designated Federal Officer.
    [FR Doc. 2016-26217 Filed 10-28-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION Schedule Change Open Commission Meeting, Thursday, October 27, 2016 October 25, 2016.

    Please note that the time for the Federal Communications Commission Open Meeting is rescheduled from 10:30 a.m. to 9:30 a.m.

    The Federal Communications Commission will consider the Agenda items listed on the Commission's Notice of October 20 at the Open Meeting on Thursday, October 27, 2016, scheduled to commence at 9:30 a.m. in room TW-C305, at 445 12th Street SW., Washington, DC. The order of the agenda items is changed as follows:

    Item No. Bureau Subject 1 Enforcement Title: Locus Telecommunications, Inc. Summary: The Commission will consider a Memorandum Opinion and Order that dismisses and denies a Petition for Reconsideration of a Forfeiture Order issued by the Commission for the deceptive marketing of prepaid calling cards. 2 Enforcement Title: Lyca Tel, LLC. Summary: The Commission will consider a Memorandum Opinion and Order that dismisses and denies a Petition for Reconsideration of a Forfeiture Order issued by the Commission for the deceptive marketing of prepaid calling cards. 3 Enforcement Title: Touch-Tel USA, LLC. Summary: The Commission will consider a Memorandum Opinion and Order that dismisses and denies a Petition for Reconsideration of a Forfeiture Order issued by the Commission for the deceptive marketing of prepaid calling cards. 4 Enforcement Title: NobelTel, LLC. Summary: The Commission will consider a Memorandum Opinion and Order that dismisses and denies a Petition for Reconsideration of a Forfeiture Order issued by the Commission for the deceptive marketing of prepaid calling cards. 5 Wireline Competition Title: Protecting the Privacy of Customers of Broadband and Other Telecommunications Services Alerts (WC Docket No. 16-106). Summary: The Commission will consider a Report and Order that applies the privacy requirements of the Communications Act to broadband Internet access service providers and other telecommunications services to provide broadband customers with the tools they need to make informed decisions about the use and sharing of their information by their broadband providers. Federal Communications Commission. Marlene H. Dortch, Secretary.
    [FR Doc. 2016-26197 Filed 10-28-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than November 15, 2016.

    A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:

    1. Blair M. Bowman, Brighton, Michigan, and Peter D. Scodeller, Beverly Hills, Michigan, together as a group acting in concert; to acquire additional voting shares of Huron Valley Bancorp, Inc. and thereby indirectly acquire Huron Valley State Bank, both of Milford, Michigan.

    B. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:

    1. The Judy Svajgr Trust dated June 24, 1983, Cozad, Nebraska, the Judy Svajgr Trust dated March 20, 1997, Cozad, Nebraska, and Kirk Randal Riley, Cozad, Nebraska, individually and as voting representative of the foregoing trusts; to acquire voting shares of Midwest Banco Corporation, and thereby indirectly acquire voting shares of First Bank and Trust Company, both of Cozad Nebraska. In addition, the Rebecca Akers Irrevocable Trust, Cozad, Nebraska, the Kevin Olson Irrevocable Trust, Cozad, Nebraska, the Keith Olson 2016 Irrevocable Family Trust, Colorado Springs, Colorado, along with Rebecca Anne Akers, Monument, Colorado, Kevin Edward Olson, Colorado Springs, Colorado, and Steven K. Mulliken, Colorado Springs, Colorado, request approval as members of the Olson/Svajgr group acting in concert to control Midwest Banco Corporation, and thereby own shares of First Bank and Trust Company, Cozad, Nebraska.

    Board of Governors of the Federal Reserve System, October 26, 2016. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2016-26223 Filed 10-28-16; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Patient Safety Organizations: Voluntary Relinquishment From the Patient Safety Leadership Council PSO AGENCY:

    Agency for Healthcare Research and Quality (AHRQ), Department of Health and Human Services (HHS).

    ACTION:

    Notice of delisting.

    SUMMARY:

    The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, 73 FR 70732-70814, establish a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for the aggregation and analysis of patient safety events. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be “delisted” by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the Patient Safety Leadership Council PSO of its status as a PSO, and has delisted the PSO accordingly. The Patient Safety Leadership Council PSO submitted this request for voluntary relinquishment after receiving a Notice of Preliminary Finding of Deficiency.

    DATES:

    The directories for both listed and delisted PSOs are ongoing and reviewed weekly by AHRQ. The delisting was effective at 12:00 Midnight ET (2400) on September 30, 2016.

    ADDRESSES:

    Both directories can be accessed electronically at the following HHS Web site: http://www.pso.ahrq.gov/listed.

    FOR FURTHER INFORMATION CONTACT:

    Eileen Hogan, Center for Quality Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, Room 06N94B, Rockville, MD 20857; Telephone (toll free): (866) 403-3697; Telephone (local): (301) 427-1111; TTY (toll free): (866) 438-7231; TTY (local): (301) 427-1130; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background

    The Patient Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity are to conduct activities to improve patient safety and the quality of health care delivery.

    HHS issued the Patient Safety Rule to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs. The Patient Safety Rule authorizes AHRQ to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be “delisted” if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. Section 3.108(d) of the Patient Safety Rule requires AHRQ to provide public notice when it removes an organization from the list of federally approved PSOs.

    AHRQ has accepted a notification from the Patient Safety Leadership Council PSO, PSO number P0164, to voluntarily relinquish its status as a PSO. Accordingly, the Patient Safety Leadership Council PSO was delisted effective at 12:00 Midnight ET (2400) on September 30, 2016. AHRQ notes that the Patient Safety Leadership Council PSO submitted this request for voluntary relinquishment following receipt of the Notice of Preliminary Finding of Deficiency sent on September 1, 2016.

    More information on PSOs can be obtained through AHRQ's PSO Web site at http://www.pso.ahrq.gov.

    Sharon B. Arnold, Deputy Director.
    [FR Doc. 2016-26144 Filed 10-28-16; 8:45 am] BILLING CODE 4160-90-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Agency for Healthcare Research and Quality, HHS.

    ACTION:

    Notice.

    SUMMARY:

    This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “Agency for Healthcare Research and Quality's (AHRQ) Guide to Improving Patient Safety in Primary Care Settings by Engaging Patients and Families—Evaluation.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

    This proposed information collection was previously published in the Federal Register on August 11th, 2016 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

    DATES:

    Comments on this notice must be received by November 30, 2016.

    ADDRESSES:

    Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by email at [email protected] (attention: AHRQ's desk officer).

    FOR FURTHER INFORMATION CONTACT:

    Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Proposed Project Agency for Healthcare Research and Quality's Guide To Improving Patient Safety in Primary Care Settings by Engaging Patients and Families—Evaluation

    There is a substantial evidence base showing that engaging patients and families in their care can lead to improvements in patient safety. Since the 1999 release of To Err is Human, there has been an undeniable focus on improving patient safety and eliminating patient harm within acute care. What is not as well documented is how to achieve these improvements in primary care settings.

    Patient and Family Engagement (PFE) strategies for acute care settings include: patient and family advisory committees; membership on patient safety oversight bodies at both operations and governance levels; consultation in the development of patient information material; engaging patients in process improvement or redesign projects; rounding with patients and families; patient and family participation in clinical education programs, and welcoming patients and families to work alongside providers and health systems employees on transparency, culture change and high reliability organization initiatives.

    Although the field of PFE in patient safety for hospitals and health systems is maturing, leveraging PFE to improve patient safety in non-acute settings is in its infancy. Building sustainable processes and practice-based infrastructure are crucial to improving patient safety through patient and family engagement in primary care.

    In response to the limited guidance available for primary care practices to improve safety through patient and family engagement, the Agency for Healthcare Research and Quality (AHRQ) has funded the development of a Guide to Improving Safety in Primary Care Settings by Engaging Patients and Families (hereafter referred to as the Guide). The comprehensive guide will provide primary care practices with interventions that they can use to engage patients and families in ways that lead to improved patient safety. It will include explicit instructions to help primary care practices, providers, and patients and families adopt new behaviors. The Guide and its development are prefaced on several key insights relevant to primary care including:

    Active engagement requires organizational commitment to hearing the patient and family voice and action by leadership to include them as central members of the health care team.

    Patients and families expect and increasingly demand meaningful engagement in harm prevention efforts.

    Institutional courage is required to openly share patient safety vulnerabilities and proactively engage patients in developing solutions that prevent harm.

    Supportive infrastructure is needed to hardwire PFE into all facets of care delivery across the care continuum.

    When done well, patient engagement yields important and measurable results. When not done well, PFE activities may disenfranchise patients, contribute to misunderstanding about risk, result in lack of trust between providers and their organizations, and create fissures among members of the clinical care team.

    With these insights as a basis, three precepts undergird our approach to development for the Guide. The Guide interventions must yield:

    Meaningful relationship-based engagement for patients and families and primary care providers.

    Innovation and enabling technologies to support engagement, shared decision making and patient safety.

    Workable processes yielding sustainable engagement opportunities for patients, families, providers, and practice staff.

    The Guide will principally, but not exclusively, meet the needs of practices that have not already implemented effective PFE structures or processes. An environmental scan revealed several promising interventions for consideration for inclusion in the Guide. The four interventions selected as part of the Guide include:

    Teach-back Be Prepared to Be Engaged Medication Management Warm Handoff

    The interventions will be compiled into a Guide for adoption by primary care practices. The environmental scan also yielded several important implications for Guide development including:

    Engagement efforts in primary care to date have focused on the patient as the agent of change with limited guidance to providers on how to support patients in these efforts.

    Many interventions are focused heavily on educational efforts alone, either for the patient, the provider, or the practice.

    Few of the tools and interventions identified are immediately usable without the need for additional development or enabling materials to support sustainable adoption.

    Health equity and literacy considerations are limited. Tools for patients are often at a relatively high level of literacy, and/or health literacy is required for use.

    Current interventions, tools, and toolkits have a high level of complexity that may impede adoption.

    Existing evidence-based interventions are being refined to reduce complexity and enhance the opportunity for implementation. Implementation development activities including guidance for each intervention and the Guide as a whole are currently underway. Guide field testing will evaluate the implementation challenges faced by primary care practices thereby offering an opportunity to revise the Guide materials for optimal implementation success prior to widespread dissemination.

    The Guide will be made publicly accessible through the AHRQ Web site for easy referral, access, and use by other health care professionals and primary care practices. AHRQ recognizes the importance of ensuring that the Guide will be useful, well implemented and effective in achieving the goals of improving patient safety by engaging patients and families. Thus, the purpose of the Field Testing evaluation is to gain insight on the implementation challenges identified by the twelve primary care practices field testing the Guide. The Guide materials will be revised in an effort to overcome these implementation challenges prior to broad dissemination.

    The specific goals of the proposed Guide field testing evaluation are to examine the following:

    The feasibility of implementing a minimum of two of the four Guide interventions within twelve medium or large primary care practices.

    The challenges to implementing the interventions at the patient, clinician, practice staff, and practice level.

    The uptake and confidence among primary care practices to improve patient safety through patient and family engagement.

    How the implementation of two of the four Guide interventions changes the perception of patient safety among patients, clinicians, and practice staff.

    How the implementation of two of the four Guide interventions changes the perception of patient and family engagement among patients, clinicians, and practice staff.

    Whether primary care practices will continue to use the Guide (or its interventions) beyond the period of field testing and evaluation (i.e. examine sustainability).

    What changes patients, clinicians, and practice staff would recommend to the interventions and the Guide to enhance sustainability.

    This study is being conducted by AHRQ through its contractor, MedStar, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).

    Method of Collection

    To achieve the goals of the project, the following data collections will be implemented during the Field Testing evaluation:

    1. Baseline Practice Assessment of Primary Care Practices. This pen and paper survey will be administered to the twelve primary care practice champions, individuals at each practice responsible for coordinating Guide activities and responding to inquiries from MedStar during Field Testing, immediately following the recruitment as part of the Guide Field Test and prior to commencing implementation of the Guide. Information collected includes: (i) Practice name and location (e.g., city and State); (ii) non-identifying demographic information about the practice (e.g., number of clinicians by type, number of patients served by the practice, payer mix of patients served by practice, race and ethnicity of patients served by practice); (iii) general descriptive information on the practice's experience with patient safety and quality improvement activities (e.g., current experience with Guide interventions, patient safety culture routinely measured); (iv) information related to the practice's affiliation with larger health system; and (v) information related to any competing priorities or practice improvement initiatives (e.g., patient centered medical home designation, etc.).

    2. Post-Implementation Focus Groups for Patients and Families. Information from patients on their experiences with the Guide and its interventions will be solicited twice during the Field Test—once at 3-months and again at 6-months post-implementation of the Guide. Each patient and family focus group will aim to recruit between 6-8 participants and solicit feedback from patients and family members on their experiences with the Guide materials. Information collected will include: (i) Perceptions of patient safety in primary care practices; (ii) perceptions of patient and family engagement in primary care practices; (iii) feedback from the patient perspective on the Guide materials and their general use; (iv) feasibility of adopting the patient and family focused intervention materials in practice; (v) feedback on the patient and family experiences of the Guide and its relation to patient safety.

    3. Baseline Practice Readiness Assessment. Information from primary care practices about their readiness to adopt patient and family engagement strategies will be solicited through telephone interviews with practice staff champions. Information collected will include: (i) Descriptive information on the person completing the interview (e.g., position in the practice, length of employment, experience in implementing patient safety improvements); (ii) description of the patient safety culture of the primary care practice (e.g., teamwork, communication, patient safety culture, etc.,); (iii) perceptions of patient and family engagement within the practice; (iv) perceptions of change management strategies, challenges, and barriers (e.g., leadership support, competing initiatives, other production pressures); (v) capacity for ongoing internal measurement and assessment of the intervention. This process will also solicit general information the interviewee would like to share about the practice's readiness to implement the Guide strategies.

    4. Post-Implementation Interviews of Primary Care Clinicians. Information from primary care clinicians (e.g., physicians, nurses, nurse practitioners, social workers, etc.) on their experiences with the Guide and its interventions will be solicited twice during the Field Test—once at 3-months and again at 6-months post-implementation of the Guide. Interviews with 2 or 3 primary care clinicians per practice will be conducted during Field Testing to solicit feedback on their experiences with the Guide materials. Information collected will include: (i) Perceptions on patient safety in primary care practices; (ii) perceptions of patient and family engagement in primary care practices; (iii) feedback from the clinician perspective on the Guide materials and their general use; (iv) feasibility of adopting the intervention materials in practice; (v) feedback on the clinicians' experiences of the Guide and its relation to patient safety.

    5. Post-Implementation Focus Groups for Practice Staff Members. Information from practice staff members (e.g., practice administrators, medical assistants, schedulers, practice facilitators, other non-clinical staff, etc.) on their experiences with the Guide and its interventions will be solicited twice during the Field Test—once at 3-months and again at 6-months post-implementation of the Guide. Focus groups with between 6-8 primary care practice staff will be conducted in each practice during Field Testing to solicit feedback on their experiences with the Guide materials. Information collected will include: (i) Perceptions on patient safety in primary care practices; (ii) Perceptions of patient and family engagement in primary care practices; (iii) feedback from the practice staff perspective on the Guide materials and their general use; (iv) feasibility of adopting the intervention materials in practice; (v) feedback on the practice staff's experiences of the Guide and its relation to patient safety.

    6. Monthly Telephone Interviews with Practice Champions. This survey will be completed over the phone on a monthly basis with the practice champions from the twelve primary care practices engaged in the Field Testing of the Guide. Information collected will include: (i) Current progress towards implementation of the intervention(s); (ii) movement towards target goals set in the prior meeting; (iii) barriers to implementation; (iv) facilitators of implementation; (v) perceived impact on patient safety; (vi) perceived impact on patient and family engagement; vii) plans for the coming weeks/months.

    The Guide will be tested to evaluate the feasibility of adopting it in primary care practices. A mixed-methods approach will be used to identify barriers and facilitators to uptake and sustainability, and to answer the question “How and in what contexts do the chosen interventions work or can they be amended to work”, rather than “Do they work?” Testing will occur at up to 12 primary care sites and feasibility will be assessed at the patient, provider, and practice levels. The Guide will be revised based on these findings.

    Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in this evaluation of the Guide during field testing. Two formative evaluations will be conducted during field testing in twelve primary care practices in at least two geographic regions of the United States. Evaluation efforts will include collection of baseline practice level data prior to Guide implementation and two separate rounds of focus groups and interviews conducted 3-months and 6-months after Guide implementation. Baseline assessments will be conducted on paper via phone consultation between the Contractor and the local practice champion and will take between 30-60 minutes. Patient focus groups will be conducted at the 3- and 6-month evaluation periods; each lasting between 60-90 minutes. Practice staff focus groups will be conducted during each of the site visits, conducted outside regular practice hours, and last between 60-90 minutes. Primary care clinician interviews will last approximately 45 minutes. We estimate that approximately 12 individuals will participate in the monthly telephone interviews over the 9-month implementation and evaluation period.

    Exhibit 1—Estimated Annualized Burden Hours Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Hours per
  • response
  • Total burden
  • hours
  • Baseline Practice Assessment 12 1 1 12 Post-Implementation Focus Group for Patients and Family Members 72 2 1.5 216 Interview Guide—Baseline Practice Readiness 12 1 .75 9 Post-Implementation Interview Protocol—Providers 24 2 .75 36 Post-Implementation Focus Group Protocol—Practice Staff 72 2 1.5 216 Topic guide for Telephone Protocol- Guide Practice Champions 12 6 .5 36 Total 204 NA NA 525

    Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to participate in this project. The total cost burden is estimated to be $18,629.16.

    Exhibit 2—Estimated Annualized Cost Burden Form name Number of
  • respondents
  • Total burden
  • hours
  • Average
  • hourly wage
  • rate *
  • Total cost
  • burden
  • Baseline Practice Assessment 12 12 a $37.40 448.80 Post-Implementation Focus Group for Patients and Family Members 72 216 c 23.23 5,017.68 Interview Guide—Baseline Practice Readiness 12 9 a 37.40 336.60 Post-Implementation Interview Protocol—Providers 24 36 b 94.48 3,401.28 Post-Implementation Focus Group Protocol—Practice Staff 72 216 a 37.40 8,078.40 Topic guide for Telephone Protocol—Guide Practice Champions 12 36 a 37.40 1,346.40 Total 204 525 18,629.16 * National Compensation Survey: Occupational wages in the United States May 2015, “U.S. Department of Labor, Bureau of Labor Statistics.” http://www.bls.gov/oes/current/oes_nat.htm. a Based on the mean wages for Miscellaneous Health care Worker (Code 29-9090). b Based on the mean wages for Internists, General (Code 29-1063). c Based on the mean wages for All Occupations (Code 00-0000).
    Request for Comments

    In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

    Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

    Sharon B. Arnold, Deputy Director.
    [FR Doc. 2016-26143 Filed 10-28-16; 8:45 am] BILLING CODE 4160-90-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-17-17BX; Docket No. CDC-2016-0103] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled “Understanding the Needs, Challenges, Opportunities, Vision and Emerging Roles in Environmental Health (UNCOVER EH).” The purpose of the data collection is to collect information from the health department environmental health (EH) workforce to determine demographics, education/training, experience, areas of practice, and current and future needs to address emerging environmental issues.

    DATES:

    Written comments must be received on or before December 30, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2016-0103 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

    Please note: All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    Proposed Project

    Understanding the Needs, Challenges, Opportunities, Vision and Emerging Roles in Environmental Health (UNCOVER EH)—NEW—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    The environmental health (EH) workforce is an essential component of the public health workforce. According to recent health department surveys, EH professionals are employed at approximately 85% of local health departments, 81% of state health departments, and 30% of tribal health departments. Describing and characterizing the EH workforce is essential to identifying gaps in staffing, training, and ultimately ensuring EH professionals are prepared to meet future challenges.

    CDC seeks OMB approval for a one-time, one-year information collection designed to thoroughly describe the health department EH workforce on: (1) The current supply of EH professionals; (2) EH workforce demographics and professional roles; (3) gaps in current EH education and competencies and training needs; and (4) critical skills and resources needed to meet the evolving and emerging EH issues and challenges. This information will benefit the government and other entities by providing essential data to inform and support workforce development activities and initiatives and understand areas of practice and where gaps may exist in capacity to address current EH issues and future challenges.

    The respondent universe will be the estimated 20,000 EH professionals working within health departments. They will be enumerated and recruited by identifying a point of contact in each state, local, tribal, and territorial health department from whom a roster of EH professionals will be requested. A list of respondents and their business email addresses will be generated and used for recruitment and survey administration. Any contact information collected will be related to the respondents' role in the organization. Participation will be voluntary.

    Data will be collected one time from a census of members of the public health department EH workforce using a web-based survey instrument. The UNCOVER EH Survey will take approximately 30 minutes to complete per respondent, and it will take approximately 5 minutes for health department administrative staff to compile EH workforce names and email addresses into the Health Department Roster.

    There will be no cost to respondents other than their time. The requested time burden is 10,269 hours.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses
  • per
  • respondent
  • Average
  • burden
  • per
  • response
  • (in hrs.)
  • Total
  • burden
  • (in hrs.)
  • Health Department EH Administrative Staff Health Department Roster 3,231 1 5/60 269 Health Department EH Professionals UNCOVER EH Survey 20,000 1 30/60 10,000 Total 10,269
    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. 2016-26248 Filed 10-28-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-416, CMS-8003, CMS-10142, CMS-10396, and CMS-R-262] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments must be received by December 30, 2016.

    ADDRESSES:

    When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

    1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

    2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number ___, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    Reports Clearance Office at (410) 786-1326.

    SUPPLEMENTARY INFORMATION: Contents

    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

    CMS-416 Annual Early and Periodic Screening, Diagnostic and Treatment (EPSDT) Participation Report CMS-8003 1915(c) Home and Community Based Services (HCBS) Waiver CMS-10142 Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans (PDP) CMS-10396 Medication Therapy Management Program Improvements CMS-R-262 Contract Year 2018 Plan Benefit Package (PBP) Software and Formulary Submission

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

    Information Collection

    1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Annual Early and Periodic Screening, Diagnostic and Treatment (EPSDT) Participation Report; Use: The collected baseline data is used to assess the effectiveness of state early and periodic screening, diagnostic and treatment (EPSDT) programs in reaching eligible children (by age group and basis of Medicaid eligibility) who are provided initial and periodic child health screening services, referred for corrective treatment, and receiving dental, hearing, and vision services. This assessment is coupled with the state's results in attaining the participation goals set for the state. The information gathered from this report, permits federal and state managers to evaluate the effectiveness of the EPSDT law on the basic aspects of the program. Form Number: CMS-416 (OMB control number 0938-0354); Frequency: Yearly and on occasion; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 168; Total Annual Hours: 1,624. (For policy questions regarding this collection contact Kimberly Perrault at 410-786-2482.)

    2. Type of Information Collection Request: Extension without change of a currently approved collection; Title of Information Collection: 1915(c) Home and Community Based Services (HCBS) Waiver; Use: We will use the web-based application to review and adjudicate individual waiver actions. The web-based application will also be used by states to submit and revise their waiver requests. Form Number: CMS-8003 (OMB control number 0938-0449); Frequency: Yearly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 47; Total Annual Responses: 71; Total Annual Hours: 6,005. (For policy questions regarding this collection contact Kathy Poisal at 410-786-5940.)

    3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Bid Pricing Tool (BPT) for Medicare Advantage (MA) Plans and Prescription Drug Plans (PDP); Use: We require that Medicare Advantage organizations and Prescription Drug Plans complete the BPT as part of the annual bidding process. During this process, organizations prepare their proposed actuarial bid pricing for the upcoming contract year and submit them to us for review and approval. The purpose of the BPT is to collect the actuarial pricing information for each plan. The BPT calculates the plan's bid, enrollee premiums, and payment rates. We publish beneficiary premium information using a variety of formats (www.medicare.gov, the Medicare & You handbook, Summary of Benefits marketing information) for the purpose of beneficiary education and enrollment. Form Number: CMS-10142 (OMB control number 0938-0944); Frequency: Yearly; Affected Public: Business or other for-profits and Not-for-profit institutions; Number of Respondents: 555; Total Annual Responses: 4,995; Total Annual Hours: 149,850. (For policy questions regarding this collection contact Rachel Shevland at 410-786-3026.)

    4. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medication Therapy Management Program Improvements; Use: Information collected by Part D medication therapy management programs (as required by the standardized format for the comprehensive medication review summary) will be used by beneficiaries or their authorized representatives, caregivers, and their healthcare providers to improve medication use and achieve better healthcare outcomes. Form Number: CMS-10396 (OMB control number 0938-1154); Frequency: Occasionally; Affected Public: Business or other for-profits; Number of Respondents: 599; Total Annual Responses: 1,211,661; Total Annual Hours: 807,451. (For policy questions regarding this collection contact Victoria Dang at 410-786-3991.)

    5. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Contract Year 2018 Plan Benefit Package (PBP) Software and Formulary Submission; Use: We require that Medicare Advantage and Prescription Drug Plan organizations submit a completed PBP and formulary as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to us for review and approval. We publish beneficiary education information using a variety of formats. The specific education initiatives that utilize PBP and formulary data include web application tools on www.medicare.gov and the plan benefit insert in the Medicare & You handbook. In addition, organizations utilize the PBP data to generate their Summary of Benefits marketing information. Form Number: CMS-R-262 (OMB control number 0938-0763); Frequency: Yearly; Affected Public: Business or other for-profits and Not-for-profit institutions; Number of Respondents: 524; Total Annual Responses: 5,185; Total Annual Hours: 50,619. (For policy questions regarding this collection contact Kristy Holtje at 410-786-2209.)

    Dated: October 26, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2016-26246 Filed 10-28-16; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10629] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments must be received by December 30, 2016.

    ADDRESSES:

    When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

    1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

    2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number___, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    Reports Clearance Office at (410) 786-1326.

    SUPPLEMENTARY INFORMATION: Contents

    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

    CMS-10629 Waiver Application for Providers and Suppliers Subject to an Enrollment Moratorium

    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires Federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

    Information Collection

    1. Type of Information Collection Request: Extension of a currently approved collection;

    Title of Information Collection: Waiver Application for Providers and Suppliers Subject to an Enrollment Moratorium; Use: This demonstration, in conjunction with an expansion of the existing provider enrollment moratoria, will allow CMS to mitigate known vulnerabilities within the existing moratoria and will lead to increased investigations of fraud. Section 402(a)(l)(J) of the Social Security Amendments of 1967 (42 U.S.C. 1395b-l(a)(l)(J)) permits the Secretary to “develop or demonstrate improved methods for the investigation and prosecution of fraud in the provision of care or services under the health programs established by the Social Security Act.” In addition to the development and demonstration of improved methods for investigations, CMS will utilize this demonstration to address beneficiary access to care issues. Form Number: CMS-10629 (OMB control number: 0938-1313); Frequency: Occasionally; Affected Public: Business or other for-profit, Not-for-profit institutions; Number of Respondents: 800; Total Annual Responses: 800; Total Annual Hours: 4,800. (For policy questions regarding this collection contact Kim Jung at 410-786-9370).

    Dated: October 25, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2016-26122 Filed 10-28-16; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-10622, CMS-339, CMS-460, CMS-R-64, CMS-379, CMS-10311, CMS-1490, CMS-10137, and CMS-10237] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments on the collection(s) of information must be received by the OMB desk officer by November 30, 2016.

    ADDRESSES:

    When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 OR, Email: [email protected]

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    Reports Clearance Office at (410) 786-1326.

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

    1. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Evaluation of the CMS Quality Improvement Organizations: Reducing Healthcare-Acquired Conditions in Nursing Homes; Use: As mandated by Sections 1152-1154 of the Social Security Act, CMS directs the QIO program, one of the largest federal programs dedicated to improving health quality for Medicare beneficiaries. In the 11th SOW, CMS restructured the QIO program to funded Quality Innovation Networks (QIN)-QIOs, Beneficiary and Family-Centered Care (BFCC) organizations, National Coordinating Centers (NCCs), Program Collaboration Centers (PCCs), and the Strategic Innovation Engine (SIE). In the current SOW, 14 QIN-QIOs coordinate the work of 53 QIOs nationwide including all 50 states and other U.S. territories.

    CMS evaluates the quality and effectiveness of the QIO program as authorized in Part B of Title XI of the Social Security Act. CMS created the Independent Evaluation Center (IEC) to provide CMS and its stakeholders with an independent and objective program evaluation of the 11th SOW. Evaluation activities will focus on analyzing how well the QIO program is achieving the three aims of better care, better health, and lower cost as well as the effectiveness of the new QIO program structure. One of the QIN-QIOs' tasks to achieve these three aims is to support participating nursing homes in their efforts to improve quality of care and health outcomes among residents. According to the 2013 CMS Nursing Home Data Compendium, more than 15,000 nursing homes participated in Medicare and Medicaid programs with more than 1.4 million beneficiaries resided in U.S. nursing homes. These residents and their families rely on nursing homes to provide reliable, safe, high quality care. However, cognitive and functional impairments, pain, incontinence, antipsychotic drug use, and healthcare associated conditions (HAC), such as pressure ulcers and falls, remain areas of concern.

    This information collection is to provide data to assess QIN-QIOs efforts aimed at addressing these HACs in nursing homes. QIN-QIOs are responsible for recruiting nursing homes to participate in the program. We will conduct an annual survey of administrators of nursing homes participating in the QIN-QIO program (intervention group) and administrators at nursing homes that are not participating in the QIN-QIO program (comparison group). Our proposed survey assesses progress towards the goals of the QIN-QIO SOW, including activities and strategies to increase mobility among residents, reduce infections, reduce use of inappropriate antipsychotic medication among long-term stay residents.

    We plan to conduct qualitative interviews with nursing home administrators. This interview will supplement the Nursing Home Survey and provide more in-depth contextual information about the QIN-QIO program implementation within at nursing homes, including: (i) Their experience with, and perceived success of QIN-QIO collaboratives; (ii) their satisfaction with the QIN-QIO Collaborative and QIO support; (iii) perceived value and impact of QIO program; and (iv) drivers and barriers to QIN-QIO involvement and success.

    Information from QIO leadership and/or state/territory task leads will be collected by interviews and focus groups. Interviews with Nursing Home Task leaders at the QIN and QIO will be conducted in-person during site visits and/or over the phone. We will conduct focus groups with QIO-level Directors during the annual CMS Quality conference. The purpose of the interviews and focus groups is to examine: (i) QIO processes for recruiting nursing homes, peer coaches, and beneficiaries to participate in the program; (ii) strengths and challenges of QIN-QIO activities related to nursing homes; (iii) partnership and coordination with other QIN-QIO tasks; and (iv) overall lessons learned. We will also conduct qualitative interviews with nursing home peer coaches. Subsequent to the 60-day notice Federal Register notice, the survey has been revised by adding questions and rewording questions. Form Number: CMS-10622 (OMB control number: 0938-NEW); Frequency: Annually; Affected Public: Business or other For-profits and Not-for Profits institutions; Number of Respondents: 856; Total Annual Responses: 856; Total Annual Hours: 255. (For policy questions regarding this collection contact Robert Kambic at 410-786-1515.)

    2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Provider Cost Report Reimbursement Questionnaire; Use: The information collected in this form (Exhibits 1 and 2) is authorized under Sections 1815(a) and 1833(e) of the Social Security Act, 42 U.S.C. 1395g. Regulations at 42 CFR 413.20 and 413.24 require providers to submit financial and statistical records to verify the cost data disclosed on their annual Medicare cost report. Providers participating in the Medicare program are reimbursed for furnishing covered services to eligible beneficiaries on the basis of an annual cost report (filed with the provider's MAC) in which the proper reimbursement is computed. Consequently, it is necessary to collect this documentation of providers' costs and activities that supports the Medicare cost report data in order to ensure proper Medicare reimbursement to providers. Form Number: CMS-339 (OMB control number: 0938-0301); Frequency: Yearly; Affected Public: Private sector (Business or other For-profits); Number of Respondents: 2,273; Total Annual Responses: 2,273; Total Annual Hours: 15,911. (For policy questions regarding this collection contact Christine Dobrzycki at 410-786-3389.)

    3. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Participation Agreement for Physicians and Suppliers; Use: Section 1842(h) of the Social Security Act permits physicians and suppliers to voluntarily participate in Medicare Part B by agreeing to take assignment on all claims for services to Medicare beneficiaries. The law also requires that the Secretary provide specific benefits to the physicians, suppliers and other persons who choose to participate. The CMS-460 is the agreement by which the physician or supplier elects to participate in Medicare. Form Number: CMS-460 (OMB control number: 0938-0373); Frequency: Yearly; Affected Public: Private sector (Business or other For-profits); Number of Respondents: 120,000; Total Annual Responses: 120,000; Total Annual Hours: 30,000. (For policy questions regarding this collection contact Mark Baldwin at 410-786-8139.)

    4. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Indirect Medical Education and Supporting Regulations; Use: Section 1886(d)(5)(B) of the Social Security Act requires additional payments to be made under the Medicare Prospective Payment System (PPS) for the indirect medical educational costs a hospital incurs in connection with interns and residents (IRs) in approved teaching programs. In addition, Title 42, Part 413, sections 75 through 83 implement section 1886(d) of the Act by establishing the methodology for Medicare payment of the cost of direct graduate medical educational activities. These payments, which are adjustments (add-ons) to other payments made to a hospital under PPS, are largely determined by the number of full-time equivalent (FTE) IRs that work at a hospital during its cost reporting period. In Federal fiscal year (FY) 2015, the estimated Medicare program payments for indirect medical education (IME) costs amounted to $8.38 billion. Medicare program payments for direct graduate medical education (GME) are also based upon the number of FTE-IRs that work at a hospital. In FY 2015, the estimated Medicare program payments for GME costs amounted to $3.1 billion. Form Number: CMS-R-64 (OMB control number: 0938-0456); Frequency: Yearly; Affected Public: Private sector (Business or other For-profits); Number of Respondents: 1,245; Total Annual Responses: 1,245; Total Annual Hours: 2,490. (For policy questions regarding this collection contact Milton Jacobson at 410-786-7553.)

    5. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Financial Statement of Debtor; Use: Section 1893(f)(1)) of the Social Security Act and 42 CFR 401.607 provides the authority for collection of this information. Section 42 CFR 405.607 requires that, CMS recover amounts of claims due from debtors including interest where appropriate by direct collections in lump sums or in installments. In addition, the DOJ Final Rule, the Federal Claims Collection Standards, which was published as 32 CFR parts 900-904, on November 22, 2000, in the Federal Register, Section 32 CFR 900.1 stipulates that, standards for Federal agency use in the administrative collection, offset, compromise, and the suspension or termination of collection activity. Section 32 CFR 901.8(a) states that, Agencies should obtain financial statements from debtors who represent that they are unable to pay the debt in one lump sum. Form Number: CMS-379 (OMB control number: 0938-0270); Frequency: Yearly; Affected Public: Business or other for-profits; Number of Respondents: 500; Total Annual Responses: 500; Total Annual Hours: 1,000. (For policy questions regarding this collection contact Anita Crosier at 410-786-0217.)

    6. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Program/Home Health Prospective Payment System Rate Update for Calendar Year 2010: Physician Narrative Requirement and Supporting Regulation; Use: Section (o) of the Act (42 U.S.C. 1395 x) specifies certain requirements that a home health agency must meet to participate in the Medicare program. To qualify for Medicare coverage of home health services a Medicare beneficiary must meet each of the following requirements as stipulated in § 409.42: be confined to the home or an institution that is not a hospital, SNF, or nursing facility as defined in sections 1861(e)(1), 1819(a)(1) or 1919 of Act; be under the care of a physician as described in § 409.42(b); be under a plan of care that meets the requirements specified in § 409.43; the care must be furnished by or under arrangements made by a participating HHA, and the beneficiary must be in need of skilled services as described in § 409.42(c). Subsection 409.42(c) of our regulations requires that the beneficiary need at least one of the following services as certified by a physician in accordance with § 424.22: Intermittent skilled nursing services and the need for skilled services which meet the criteria in § 409.32; Physical therapy which meets the requirements of § 409.44(c), Speech-language pathology which meets the requirements of § 409.44(c); or have a continuing need for occupational therapy that meets the requirements of § 409.44(c), subject to the limitations described in § 409.42(c)(4). On March 23, 2010, the Affordable Care Act of 2010 (Pub. L., 111-148) was enacted. Section 6407(a) (amended by section 10605) of the Affordable Care Act amends the requirements for physician certification of home health services contained in Sections 1814(a)(2)(C) and 1835(a)(2)(A) by requiring that, prior to certifying a patient as eligible for Medicare's home health benefit, the physician must document that the physician himself or herself or a permitted non-physician practitioner has had a face-to-face encounter (including through the use of tele-health services, subject to the requirements in section 1834(m) of the Act)”, with the patient. The Affordable Care Act provision does not amend the statutory requirement that a physician must certify a patient's eligibility for Medicare's home health benefit, (see Sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act. Form Number: CMS-10311 (OMB control number: 0938-1083); Frequency: Yearly; Affected Public: Business or other For-profits; Number of Respondents: 345,600; Total Annual Responses: 345,600; Total Annual Hours: 28,800. (For policy questions regarding this collection contact Hillary Loeffler at 410-786-0456.)

    7. Type of Information Collection Request: New collection (Request for a new OMB control number); Title of Information Collection: Patient's Request for Medicare Payment; Use: The Form CMS-1490S form provides beneficiaries with a relatively easy form to use when filing their claims. Without the collection of this information, claims for reimbursement relating to the provision of Part B medical services/supplies could not be acted upon. This would result in a nationwide paralysis of the operation of the Federal Government's Part B Medicare program, and major problems for the patients/beneficiaries inflicting severe physical and financial hardship on beneficiaries. This form was explicitly developed for easy use by beneficiaries who file their own claims. The CMS-1490S form can be obtained from any Social Security office or Medicare Administrative Contractors or CMS. When the CMS-1490S is used, the beneficiary must attach to it his/her bills from physicians or suppliers. The form is, therefore, designed specifically to aid beneficiaries who cannot get assistance from their physicians or suppliers for completing claim forms. The form is currently approved under 0938-1197; however, we are submitting for approval as a standalone information collection request. Once a new OMB control number is issued, we will remove the burden for the CMS-1490S that is currently approved under OMB control number 0938-1197. Form Number: CMS-1490 (OMB control number: 0938-NEW); Frequency: Occasionally Affected Public: Individuals and Households; Number of Respondents: 167,839; Total Annual Responses: 167,839; Total Annual Hours: 83,920. (For policy questions regarding this collection contact Sumita Sen at 410-786-5755.)

    8. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Solicitation for Applications for Medicare Prescription Drug Plan 2018 Contracts; Use: Coverage for the prescription drug benefit is provided through contracted prescription drug (PD) plans or through Medicare Advantage (MA) plans that offer integrated prescription drug and health care coverage (MA-PD plans). Cost Plans that are regulated under Section 1876 of the Social Security Act, and Employer Group Waiver Plans may also provide a Part D benefit. Organizations wishing to provide services under the Prescription Drug Benefit Program must complete an application, negotiate rates, and receive final approval from CMS. Existing Part D Sponsors may also expand their contracted service area by completing the Service Area Expansion application. Form Number: CMS-10137 (OMB control number: 0938-0936); Frequency: Yearly; Affected Public: Private sector (Business or other For-profits and Not-for-profit institutions); Number of Respondents: 463; Total Annual Responses: 160; Total Annual Hours: 1,565. (For policy questions regarding this collection contact Arianne Spaccarelli at 410-786-5715.)

    9. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Applications for Part C Medicare Advantage, 1876 Cost Plans, and Employer Group Waiver Plans to Provide Part C Benefits; Use: This information collection includes the process for organizations wishing to provide healthcare services under MA and/or MA-PD plans must complete an application annually, file a bid, and receive final approval from CMS. The application process has two options for applicants that include: Request for new MA product or request for expanding the service area of an existing product. This collection process is the only mechanism for MA and/or MA-PD organizations to complete the required application process. CMS utilizes the application process as the means to review, assess and determine if applicants are compliant with the current requirements for participation in the Medicare Advantage program and to make a decision related to contract award. Form Number: CMS-10237 (OMB control number: 0938-0935); Frequency: Yearly; Affected Public: Private sector (Business or other For-profits and Not-for-profit institutions); Number of Respondents: 310; Total Annual Responses: 310; Total Annual Hours: 10,941. (For policy questions regarding this collection contact Marcella Watts at 410-786-5724.)

    Dated: October 26, 2016. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2016-26242 Filed 10-28-16; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-3083] Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the Food and Drug Administration (FDA or Agency) is required to report annually in the Federal Register on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct. A supplemental report entitled “Supplementary Report: Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements (PMRs) and Postmarketing Commitments (PMCs) (FY 2013 and FY 2014),” containing additional information and analyses on the status of PMRs and PMCs as of September 30, 2013, and September 30, 2014, is available on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm.

    FOR FURTHER INFORMATION CONTACT:

    Cathryn C. Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301-796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, 240-402-7911.

    SUPPLEMENTARY INFORMATION:

    I. Background A. Postmarketing Requirements and Commitments

    A PMR is a study or clinical trial that an applicant is required by statute or regulation to conduct postapproval. A PMC is a study or clinical trial that an applicant agrees in writing to conduct postapproval, but that is not required by statute or regulation. PMRs and PMCs can be issued upon approval of a drug 1 or postapproval, if warranted.

    1 For the purposes of this notice, references to “drugs” or “drug products” include drugs approved under the FD&C Act and biological products licensed under the Public Health Service Act, other than biological products that also meet the definition of a device in section 201(h) of the FD&C Act (21 U.S.C. 321(h)).

    FDA can require application holders to conduct postmarketing studies and clinical trials:

    • To assess a known serious risk, assess signals of serious risk, or identify an unexpected serious risk (when available data indicates the potential for a serious risk) related to the use of a drug product (section 505(o)(3) of the FD&C Act, as added by the Food and Drug Administration Amendments Act of 2007 (FDAAA)).

    • Under the Pediatric Research Equity Act (PREA), to study certain new drugs for pediatric populations, when these drugs are not adequately labeled for children. Under section 505B(a)(3) of the FD&C Act, the initiation of these studies may be deferred until required safety information from other studies in adults has first been submitted and reviewed.

    • To verify and describe the predicted effect or other clinical benefit for drugs approved in accordance with the accelerated approval provisions in section 506(c)(2)(A) of the FD&C Act (21 CFR 314.510 and 601.41).

    • For a drug that was approved on the basis of animal efficacy data because human efficacy trials are not ethical or feasible (21 CFR 314.610(b)(1) and 601.91(b)(1)). PMRs for drug products approved under the animal efficacy rule 2 can be conducted only when the drug product is used for its indication and when an exigency (or event or need) arises. In the absence of a public health emergency, these studies or clinical trials will remain pending indefinitely.

    2 21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products.

    B. Reporting Requirements

    Under the regulations (21 CFR 314.81(b)(2)(vii) and 601.70), applicants of approved drugs are required to submit annually a report on the status of each clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology study or clinical trial either required by FDA or that they have committed to conduct, either at the time of approval or after approval of their new drug application (NDA), abbreviated new drug application (ANDA), or biologics license application (BLA). Applicants are required to report to FDA on these requirements and commitments made for NDAs and ANDAs under 21 CFR 314.81(b)(2)(viii), and for BLAs under 21 CFR 601.70(b). The status of PMCs concerning chemistry, manufacturing, and production controls and the status of other studies or clinical trials conducted on an applicant's own initiative are not required to be reported under 21 CFR 314.81(b)(2)(vii) and 601.70 and are not addressed in this report. Furthermore, section 505(o)(3)(E) of the FD&C Act requires that applicants report periodically on the status of each required study or clinical trial and each study or clinical trial “otherwise undertaken . . . to investigate a safety issue . . . .”

    An applicant must report on the progress of the PMR/PMC on the anniversary of the drug product's approval 3 until the PMR/PMC is completed or terminated and FDA determines that the PMR/PMC has been fulfilled or that the PMR/PMC is either no longer feasible or would no longer provide useful information. The annual status report (ASR) must include a description of the PMR/PMC, a schedule for completing the PMR/PMC, and a characterization of the current status of the PMR/PMC. The report must also provide an explanation of the PMR/PMC status by describing briefly the progress of the PMR/PMC. A PMR/PMC schedule is expected to include the actual or projected dates for the following: (1) Submission of the final protocol to FDA; (2) completion of the study or clinical trial; and (3) submission of the final report to FDA.

    3 An applicant must submit an annual status report on the progress of each open PMR/PMC within 60 days of the anniversary date of U.S. approval of the original application or on an alternate reporting date that was granted by FDA in writing. Some applicants have requested and been granted by FDA alternate annual reporting dates to facilitate harmonized reporting across multiple applications.

    C. PMR/PMC Status Categories

    The status of the PMR/PMC must be described in the ASR according to the terms and definitions provided in 21 CFR 314.81 and 601.70. For its own reporting purposes, FDA has also established terms to describe when the conditions of the PMR/PMC have been met, and when it has been determined that a PMR/PMC is no longer necessary.4 The PMR/PMC status categories are summarized in the following list. As reflected in the definitions, the status of a PMR/PMC is generally determined based on the original schedule.5

    4 See the guidance for industry entitled “Reports on the Status of Postmarketing Study Commitments—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997.” We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    5 The definitions for the terms “pending,” “ongoing,” “delayed,” “terminated,” and “submitted” are adapted from 21 CFR 314.81 and 601.70; the definitions for the terms “fulfilled” and “released” are described in the guidance for industry entitled “Reports on the Status of Postmarketing Study Commitments—Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997.”

    Pending: The study or clinical trial has not been initiated (i.e., no subjects have been enrolled or animals dosed), but does not meet the criteria for delayed (i.e., the original projected date for initiation of subject accrual or initiation of animal dosing has not passed).6

    6 It is important to note that PMRs/PMCs that are in pending status are not yet delayed; that is, per the milestones, the studies or clinical trials are indeed on schedule and are not expected to be underway yet.

    Ongoing: The study or clinical trial is proceeding according to or ahead of the original schedule.

    Delayed: The study or clinical trial is behind the original schedule.7

    7 In some instances, an applicant may have justifiable reasons for delay of its PMR/PMC (see section I.D).

    Terminated: The study or clinical trial was ended before completion, but a final report has not been submitted to FDA.

    Submitted: The study or clinical trial has been completed or terminated, and a final report has been submitted to FDA.

    Fulfilled: The final report for the study or clinical trial was submitted to FDA and FDA notified the applicant that the requirement or commitment was fulfilled through written correspondence.

    Released: FDA has informed the applicant in writing that it is released from its obligation to conduct the study or clinical trial because the study or clinical trial is no longer feasible, would no longer provide useful information, or the underlying application has been formally withdrawn.

    In addition to the above statuses, PMRs/PMCs may also be characterized as closed or open. “Open” PMRs/PMCs comprise those that are pending, ongoing, delayed, submitted, or terminated; whereas “closed” 8 PMRs/PMCs are either fulfilled or released. Open PMRs are also described by whether they are on- or off-schedule. “On-schedule” PMRs/PMCs are those that are pending, ongoing, or submitted. “Off-schedule” PMRs/PMCs are those that have missed one of the milestone dates in the original schedule and are categorized as either delayed or terminated.

    8 Previous FDA reports on the status of PMRs/PMCs used the term “completed” to refer to PMRs/PMCs that are closed.

    D. Additional Requirements

    If an applicant fails to comply with the original schedule for completion of postmarketing studies or clinical trials required under section 505(o)(3) of the FD&C Act (i.e., under the FDAAA authorities), or fails to submit periodic reports on the status of the studies or clinical trials, the applicant is considered to be in violation of section 505(o)(3), unless it has demonstrated “good cause” for its noncompliance or other violation. Failure to meet an original milestone and, as a result, falling behind the original schedule is one type of noncompliance with a PMR issued under FDAAA. In these circumstances, the FDAAA PMR is considered delayed, with or without good cause.

    Section 505B(a)(3)(B) of the FD&C Act, as amended by the Food and Drug Administration Safety and Innovation Act, authorizes FDA to grant an extension of deferral of pediatric assessments that are required under PREA.9 On its own initiative or upon request, FDA may grant an extension of a pediatric assessment deferral, provided that certain applicable PREA criteria for deferral are still met and the applicant submits certain materials in support of the extension.10 Applicants must submit requests for deferral extensions to FDA not less than 90 days before the date the deferral would otherwise expire. If FDA grants the extension of a pediatric study deferral, this new deferral date is considered the original due date of the PMR. Consequently, the status of PREA PMRs would be determined based on the new deferral date (and not the original PREA PMR schedule).

    9 This provision does not apply to PMRs required under other provisions, or to PMCs.

    10 See section 505B(a)(3)(B) of the FD&C Act.

    FDA may take enforcement action against applicants who are noncompliant with or otherwise fail to conduct studies and clinical trials required under FDA statutes and regulations (see, for example, sections 505(o)(1), 502(z), and 303(f)(4) of the FD&C Act (21 U.S.C. 355(o)(1), 352(z), and 333(f)(4))).

    II. Understanding FDA's Data on Postmarketing Studies and Clinical Trials A. FDA's Internal PMR/PMC Databases

    Databases containing information on PMRs/PMCs are maintained at the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The information in these databases is periodically updated as new PMRs/PMCs are issued, upon FDA review of PMR/PMC ASRs or other PMR/PMC correspondence, upon receipt of final reports from completed studies and clinical trials, and after the final reports are reviewed and FDA determines that the PMR/PMC has been fulfilled, or when FDA determines that the PMR/PMC is either no longer feasible or would no longer provide useful information. Because applicants typically report on the status of their PMRs/PMCs annually, and because updating the status of PMRs/PMCs in FDA's databases involves FDA review of received information, there is an inherent lag in updating the data (that is, the data are not “real time”). FDA strives to maintain as accurate information as possible on the status of PMRs/PMCs.

    Both CDER and CBER have established policies and procedures to help ensure that FDA's data on PMRs/PMCs are current and accurate. When identified, data discrepancies are addressed as expeditiously as possible and/or are corrected in later reports.

    In 2013, CDER initiated an internal audit of a sample of PMRs and PMCs that had been established after March 25, 2008,11 to ascertain the accuracy of their status. The effort resulted in revisions to the status of certain PMRs/PMCs, and procedures to improve tracking and accuracy of data on PMRs and PMCs. The details of this audit and ensuing activities are summarized in an accompanying supplemental report that is available on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/ucm064436.htm. CDER's internal audit of its PMR/PMC data and subsequent processes for verifying and updating PMR/PMC status took several months to complete, therefore delaying FDA's reporting on PMR/PMC status for fiscal year 2013 (FY2013). As such, this report includes CDER and CBER information for both FY2013 and fiscal year 2014 (FY2014).

    11 This is the effective date of FDAAA. FDAAA included a new requirement for FDA to, among other things, review the entire backlog of PMRs and PMCs to determine which ones required revision or should be eliminated, and assign start dates and estimated completion dates for these PMRs and PMCs. FDAAA also gave new authority to require applicants to conduct and report on postmarketing studies or clinical trials to assess or identify a serious risk related to the use of a drug, and to take action against noncompliance with this requirement. Therefore, the effective date of FDAAA resulted in certain changes to FDA's establishment and monitoring of PMRs and PMCs, and the internal audit was intended to evaluate data for a sample of the PMRs and PMCs that had been established after FDAAA took effect.

    B. Publicly Available PMR/PMC Data

    FDA also maintains an online searchable and downloadable database that contains information about PMRs/PMCs that is publicly reportable (i.e., for which applicants must report on the status of the study or clinical trial, as required under section 506B of the FD&C Act). The data are a subset of all PMRs/PMCs and reflect only those postmarketing studies and clinical trials that, at the time of data retrieval, either had an open status or were closed within the past year. Information on PMRs/PMCs closed more than a year before the date the data are extracted (i.e., September 30 of the reporting fiscal year) are not included on the public Web site. The FDA Web site is updated quarterly.12 The FDA Web site does not include information about PMCs concerning chemistry, manufacturing, and controls. It is FDA policy not to post information on the Web site until it has been verified and reviewed for suitability for public disclosure.

    12http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm

    III. About This Report

    This report is published to fulfill the annual reporting requirement under section 506B(c) of the FD&C Act. Information in this report covers any PMR/PMC that was made, in writing, at the time of approval or after approval of an application or a supplement to an application (see section I.A) and summarizes the status of PMRs/PMCs in FY2013 (i.e., as of September 30, 2013) and FY2014 (i.e., as of September 30, 2014). The information in this report reflects the PMR/PMC status in CBER's and CDER's databases at the time the data were extracted (September 30 of the fiscal year). Specifically, the report summarizes the status of all open PMRs/PMCs at the end of the fiscal year, and the status of only those PMRs/PMCs that were closed in the fiscal year. If a requirement or commitment did not have a schedule, or an ASR was not received in the previous 12 months, the PMR/PMC is categorized according to the most recent information available to the Agency.13

    13 Although the data included in this report do not include a summary of reports that applicants have failed to file by their due date, the Agency notes that their inclusion or description in this report has no effect on the Agency's ability to take appropriate regulatory action in the event reports are not filed on a timely basis.

    This report reflects combined data from CDER and CBER. Information summarized in the report includes the following: (1) The number of applicants with open PMRs/PMCs 14 ; (2) the number of open PMRs/PMCs; (3) the number of applications for which an ASR was expected but was not submitted within 60 days of the anniversary date of U.S. approval or an alternate reporting date that was granted by FDA; (4) FDA-verified status of open PMRs/PMCs reported in 21 CFR 314.81(b)(2)(vii) or 601.70 ASRs; (5) the status of closed PMRs/PMCs; and (6) the distribution of the status by fiscal year of establishment 15 (fiscal year 2008 (FY2008) to FY2014) for PMRs and PMCs that were open at the end of FY2014 or closed within FY2014. The tables in this report distinguish between PMRs and PMCs, PMRs/PMCs for NDAs and BLAs,16 and on-schedule and off-schedule PMRs/PMCs, according to the original schedule milestones. A more detailed summary of this information and additional information about PMRs/PMCs is provided on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm. In the accompanying supplemental report, information is presented separately for CDER and CBER.

    14 At the end of FY2013 and FY2014, there were no PMRs/PMCs for ANDAs that met the reporting requirements under FDAMA. Therefore, this report reflects information for NDAs and BLAs only.

    15 The establishment date is the date of the formal FDA communication to the applicant that included the final FDA required (PMR), or requested (PMC), postmarketing study or clinical trial.

    16 Before July 2014, all BLA PMR/PMC data were maintained in CBER's data system. In July 2014, the data for CDER-managed BLAs were migrated to CDER's data system. Similar to previous reports, this report presents data for CDER and CBER BLAs combined.

    Numbers published in this report and in the accompanying supplemental report on FDA's Web site cannot be compared with the numbers resulting from searches of the publicly accessible and downloadable database. This is because this report incorporates data for all PMRs/PMCs in FDA databases as of the end of the fiscal year, including PMRs/PMCs undergoing review for accuracy. The publicly accessible and downloadable database includes a subset of PMRs/PMCs, specifically those that, at the time of data retrieval, either had an open status or were closed within the past 12 months. In addition, the status information in this report is updated annually while the downloadable database is updated quarterly (i.e., in January, April, July, and October).

    IV. Summary of Information on PMR/PMC Status

    This report provides information on PMRs/PMCs as of September 30, 2013 (i.e., for FY2013) and September 30, 2014 (i.e., for FY2014). It is important to note that a comparison of the number of open and on-schedule or off-schedule PMRs/PMCs over time can be misleading because it does not take into account that the cohort of open PMRs/PMCs is not static from year to year. New PMRs/PMCs are continually being established for studies and clinical trials with varying start dates and durations; and other PMRs/PMCs are closed because they are either fulfilled or released. Also, ongoing PMRs/PMCs are carried forward into the subsequent fiscal year. Therefore, the number of on- and off-schedule PMRs/PMCs can vary from year to year, and a year-to-year comparison of on- or off-schedule PMRs/PMCs (e.g., to assess for a potential trend) is not appropriate.

    Although a comparison of the number of open and on-schedule or off-schedule PMRs/PMCs over time is not appropriate for the aforementioned reasons, a comparison of the data for FY2013 and FY2014 may be helpful in understanding the effect of CDER's 2013 audit. The observed differences are considered to reflect the results of CDER's efforts to update the information on the statuses of PMRs and PMCs following the internal audit of the data for a sample of PMRs/PMCs (see section II.A), as well as the natural progress of postmarketing studies and clinical trials over time. Finally, due to rounding, the percentages in the tables may not add up to 100 percent.

    A. Applicants With Open PMRs/PMCs

    An applicant may have multiple approved drug products, and an approved drug product may have multiple PMRs and/or PMCs. Table 1 shows that as of September 30, 2013, there were 256 unique applicants with open PMRs/PMCs under 613 unique NDAs and BLAs. There were 184 unique NDA applicants (and 496 associated applications) and 72 unique BLA applicants (and 117 associated applications) with open PMRs/PMCs.

    As of September 30, 2014, there were 257 unique applicants with open PMRs/PMCs under 639 unique NDAs and BLAs. There were 181 unique NDA applicants (and 510 associated applications) and 76 unique BLA applicants (and 129 associated applications) with open PMRs/PMCs.

    B. Annual Status Reports Received

    As previously mentioned, applicants must submit an ASR on the progress of each open PMR/PMC within 60 days of the anniversary date of U.S. approval of the original application or an alternate reporting date that was granted by FDA (21 CFR 314.81 and 21 CFR 601.70).17 Table 2 shows that there were 530 NDAs and BLAs with an ASR due in FY2013 (429 NDAs and 101 BLAs).18 Of the NDA ASRs due in that fiscal year, 60 percent (257/429) were received on time, 21 percent (90/429) were not received on time, and 19 percent (82/429) were not received during FY2013. There were 101 BLAs with an ASR due in FY2013. Of the BLA ASRs due, 69 percent (70/101) were received on time, 20 percent (20/101) were not received on time, and 11 percent (11/101) were not received during FY2013.

    17 An applicant must submit an ASR on the progress of each open PMR/PMC within 60 days of the anniversary date of U.S. approval of the original application or on an alternate reporting date that was granted by FDA in writing. Some applicants have requested and been granted by FDA alternate annual reporting dates to facilitate harmonized reporting across multiple applications.

    18 The number of ASRs that were expected is different from the total number of unique applications with open PMRs/PMCs because not all applications had an ASR due during FY2013/FY2014. Applicants with PMRs/PMCs associated with multiple applications may have submitted the ASR to only one of the applications. In addition, if all of the PMRs/PMCs for an application were established in the preceding fiscal year, or if all PMRs/PMCs for an application were closed before the ASR due date, submission of an ASR would not have been expected.

    There were 569 NDAs and BLAs with an ASR due in FY2014 (454 NDAs and 115 BLAs). Of the 454 NDA ASRs due in that fiscal year, 58 percent (265/454) were received on time, 19 percent (88/454) were not received on time, and 22 percent (101/454) were not received during FY2014. Of the 115 BLA ASRs due, 63 percent (73/115) were received on time, 19 percent (20/115) were not received on time, and 19 percent (22/115) were not received during FY2014.

    C. Overview of On- and Off-Schedule Open PMRs/PMCs

    Table 3 shows that as of September 30, 2013, most open PMRs (84 percent for NDAs and 89 percent for BLAs) and most open PMCs (77 percent for NDAs and 74 percent for BLAs) were progressing on schedule (i.e., were not delayed or terminated). Similarly, as of September 30, 2014, most open PMRs (87 percent for NDAs and 88 percent for BLAs) and most open PMCs (68 percent for NDAs and 77 percent for BLAs) were progressing on schedule.

    D. Open and On-Schedule PMRs

    Table 4 shows that as of September 30, 2013, the majority of open NDA PMRs (60 percent; 534/887) and open BLA PMRs (45 percent; 80/179) were pending.19 This is similar to the findings from fiscal year 2012.20 As of September 30, 2014, 48 percent (456/943) of open NDA PMRs and 38 percent (74/194) of open BLA PMRs were pending. Table 4 also shows that the proportion of open NDA PMRs that were categorized as ongoing increased from 19 percent (166/887) at the end of FY2013 to 32 percent (303/943) at the end of FY2014.

    19 It is important to note that PMRs/PMCs that are in pending status are not yet delayed; that is, per the milestones, the studies/clinical trials are indeed on schedule and are not expected to be underway yet.

    20 As of September 30, 2012, 58 percent of open NDA PMRs and 46 percent of open BLA PMRs were pending (79 FR 9230, February 18, 2014).

    Table 4 also shows that the proportion of open BLA PMRs that were pending decreased between FY2013 (45 percent; 80/179) and FY2014 (38 percent; 74/194). The proportion of open BLA PMRs that were ongoing did not change substantially between FY2013 (32 percent; 57/179) and FY2014 (35 percent; 68/194).

    In addition, table 4 provides detail on the status of open PMRs and PMCs for each category of PMR. The table shows that as of September 30, 2013, 50 percent (305/614) of pending PMRs for drug and biological products were in response to the requirements under PREA. The next largest category of pending PMRs for drug and biological products (47 percent; 286/614) comprises those studies/clinical trials required by FDA under FDAAA. As of September 30, 2014, PREA PMRs and FDAAA PMRs comprised 55 percent (292/530) and 42 percent (222/530) of pending PMRs, respectively.

    E. Open and Off-Schedule PMRs

    Table 5 provides additional information on the status of open and off-schedule (i.e., delayed and terminated) PMRs. At the end of FY2013, 16 percent (143/887) of the open NDA PMRs and 11 percent (20/179) of the open BLA PMRs were off-schedule. The majority of the off-schedule NDA PMRs (98 percent; 140/143) were delayed; the remaining 2 percent (3/143) were terminated. At the end of that same fiscal year, 10 percent (18/179) of the open BLA PMRs were delayed and 1 percent (2/179) were terminated. Most of the off-schedule BLA PMRs (90 percent; 18/20) were delayed.

    As of September 30, 2014, 13 percent (126/943) of the open NDA PMRs were off-schedule. Of the off-schedule NDA PMRs, 94 percent (118/126) were off-schedule because they were delayed and the remaining 6 percent (8/126) were terminated. At the end of FY2014, 12 percent (24/194) of the open BLA PMRs were off-schedule. The majority of the off-schedule BLA PMRs (88 percent; 21/24) were off-schedule because they were delayed; the remaining 2 percent (3/194) were terminated.

    In certain situations, the original PMR schedules were adjusted for unanticipated delays in the progress of the study or clinical trial (e.g., difficulties with subject enrollment in a clinical trial for a marketed drug or need for additional time to analyze results). In this report, study or clinical trial status reflects the status in relation to the original 21 study or clinical trial schedule regardless of whether FDA has acknowledged that additional time was required to complete the study or clinical trial.

    21 With the exception of PREA PMRs for which a deferral extension of the final report submission date has been granted.

    F. Open On-Schedule and Off-Schedule PMCs

    Table 6 provides the status of open on-schedule and off-schedule PMCs. As shown in the table, pending NDA PMCs comprised the largest category of all open NDA PMCs as of September 30, 2013 (37 percent; 97/264), and September 30, 2014 (29 percent; 61/207). Among all open BLA PMCs, 35 percent (88/251) and 30 percent (69/228) were pending at the end of FY2013 and FY2014, respectively.

    As of September 30, 2013, the largest category of off-schedule PMCs were delayed according to the original schedule milestones.22 Similarly, as of September 30, 2014, the majority of off-schedule NDA and BLA PMCs were delayed according to the original schedule milestones.23

    22 As of September 30, 2013, off-schedule PMCs accounted for 23 percent (61/264) of open NDA PMCs and 26 percent (65/251) of open BLA PMCs.

    23 As of September 30, 2014, off-schedule PMCs accounted for 32 percent (66/207) of open NDA PMCs and 23 percent (53/228) of open BLA PMCs.

    G. Closed PMRs and PMCs

    Table 7 provides details about PMRs and PMCs that were closed (released or fulfilled) within FY2013 and FY2014. The majority of closed PMRs were fulfilled (53 percent of NDA PMRs and 88 percent of BLA PMRs at the end of FY2013; 72 percent of NDA PMRs and 77 percent of BLA PMRs at the end of FY2014). Similarly, the majority of PMCs closed within FY2013 and FY2014 were fulfilled.

    H. Distribution of the Status of PMRs and PMCs

    Tables 8 and 9 show the distribution of the statuses of PMRs/PMCs as of September 30, 2014, of all PMRs and PMCs, presented by the year that the PMR/PMC was established (FY2008 to FY2014).24 Note that the data shown for closed (fulfilled or released) PMRs/PMCs is for all PMRs/PMCs that were closed as of FY2014. Therefore, data for PMRs/PMCs that were closed in prior fiscal years are included. Based on the data shown in table 8, an average of 243 PMRs were established each year since fiscal year 2009.25 26 Most PMRs that were established in the earlier years were either fulfilled or released. For example, as of September 30, 2014, 45 percent (57/128) of the PMRs that were established in FY2008 were fulfilled, and 22 percent (28/128) were released. The majority of PMRs that were established in more recent years were either pending (i.e., not yet underway) or ongoing (i.e., still in progress and on schedule). For example, as of September 30, 2014, 87 percent (226/260) of the PMRs established in FY2014 were pending, and 9 percent (23/260) were ongoing. Overall, of the PMRs that were pending as of September 30, 2014, 81 percent (414/512) were created within the past 3 years. Finally, table 8 shows that, on average, 7 percent of the PMRs established since FY2008 were delayed (as of September 30, 2014). Table 9 provides an overview of PMCs in a similar manner as table 8 does for PMRs and shows similar results for PMCs as those for PMRs as described above and in table 8.

    24 The establishment date is the date of the formal FDA communication to the applicant that included the final FDA required (PMR) or requested (PMC) postmarketing study or clinical trial.

    25 The number of PMRs issued at any particular period is determined by a variety of factors including but not necessarily limited to: (1) The number of NDAs approved in that period; (2) whether additional efficacy or clinical benefit issues were evaluated; (3) if any drug-associated serious risk(s) have been identified; and (4) whether or not FDA determines that a postmarketing study or clinical trial is necessary to further assess risk(s) or efficacy issues.

    26 Data for FY2008 were not included in the calculation of the average number of PMRs established each year because, given that FDAAA took effect on March 25, 2008, data are only available for a partial fiscal year.

    Table 1—Applicants and Applications (NDA/BLA) With Open Postmarketing Requirements and Commitments [Numbers as of September 30, 2013, and September 30, 2014] FY 2013 NDA 1 BLA 2 Total
  • (NDA and BLA)
  • Number of unique applicants with open PMRs/PMCs 184 72 256 Number of applications with open PMRs/PMCs 496 117 613 FY 2014 NDA 1 BLA 2 Total
  • (NDA and BLA)
  • Number of unique applicants with open PMRs/PMCs 181 76 257 Number of applications with open PMRs/PMCs 510 129 639 1 Includes two NDAs with associated PMRs/PMCs managed by CBER. 2 Includes BLAs managed by both CDER and CBER.
    Table 2—Annual Status Reports Received [Numbers as of September 30, 2013, and September 30, 2014] 1 Expected 2 Received, on time 3
  • (% of expected)
  • Received, not on time 4
  • (% of expected)
  • Expected but not received
  • (% of expected)
  • FY 2013: NDA 429 257 (60%) 90 (21%) 82 (19%) BLA 101 70 (69%) 20 (20%) 11 (11%) FY 2014: NDA 454 265 (58%) 88 (19%) 101 (22%) BLA 115 73 (63%) 20 (19%) 22 (19%) 1 Percentages may not total 100 due to rounding. 2 ASR expected during fiscal year (within 60 days (before or after) of the anniversary of original approval date or alternate agreed-upon date). 3 ASR was received within 60 days (before or after) of the anniversary of the original approval date or alternate agreed-upon date. 4 ASR was received, but not within 60 days (before or after) of the anniversary of the original approval date or alternate agreed-upon date.
    Table 3—Summary of On- and Off-Schedule Postmarketing Requirements and Commitments [Numbers as of September 30, 2013, and September 30, 2014] 1 FY 2013 Open PMRs
  • N = 1,066
  • NDA
  • (% of Open NDA PMRs)
  • BLA
  • (% of Open BLA PMRs)
  • Open PMCs
  • N = 515
  • NDA
  • (% of Open NDA PMCs)
  • BLA
  • (% of Open BLA PMCs)
  • On-schedule 744 (84%) 159 (89%) 203 (77%) 186 (74%) Off-schedule 143 (16%) 20 (11%) 61 (23%) 65 (26%) Total 887 179 264 251 Open PMRs Open PMCs FY 2014 N = 1,137 N = 435 NDA
  • (% of Open NDA PMRs)
  • BLA
  • (% of Open BLA PMRs)
  • NDA
  • (% of Open NDA PMCs)
  • BLA
  • (% of Open BLA PMCs)
  • On-schedule 817 (87%) 170 (88%) 141 (68%) 175 (77%) Off-schedule 126 (13%) 24 (12%) 66 (32%) 53 (23%) Total 943 194 207 228 1 Percentages may not total 100 due to rounding.
    Table 4—Summary of Open and On-Schedule Postmarketing Requirements [Numbers as of September 30, 2013, and September 30, 2014] 1 FY 2013 Reporting authority/PMR status NDA
  • N = 887
  • (% of Total open NDA PMRs)
  • Pending Ongoing Submitted BLA
  • N = 179
  • (% of Total open BLA PMRs)
  • Pending Ongoing Submitted
    Accelerated approval 17 (2%) 12 (1%) 1 (<1%) 1 (<1%) 8 (4%) 0 PREA 2 272 (31%) 65 (7%) 10 (1%) 33 (18%) 13 (7%) 4 (2%) Animal efficacy 3 2 (<1%) 0 0 3 (2%) 0 0 FDAAA safety (since March 25, 2008) 4 243 (27%) 89 (10%) 5 33 (4%) 43 (24%) 36 (20%) 18 (10%) Total 534 (60%) 166 (19%) 44 (5%) 80 (45%) 57 (32%) 22 (12%) NDA BLA FY 2014 N = 943 N = 194 (% of Total open NDA PMRs) (% of Total open BLA PMRs) Reporting authority/PMR status Pending Ongoing Submitted Pending Ongoing Submitted Accelerated approval 8 (<1%) 26 (3%) 0 3 (2%) 4 (2%) 2 (1%) PREA 253 (27%) 136 (14%) 27 (3%) 39 (20%) 20 (10%) 8 (4%) Animal efficacy 2 (<1%) 0 1 (<1%) 3 (2%) 0 0 FDAAA safety (since March 25, 2008) 6 193 (20%) 141 (15%) 30 (3%) 29 (15%) 44 (23%) 18 (9%) Total 456 (48%) 303 (32%) 58 (6%) 74 (38%) 68 (35%) 28 (14%) 1 Percentages may not total 100 due to rounding. 2 Many PREA studies have a pending status. PREA studies are usually deferred because the drug product is ready for approval in adults. Initiation of these studies may be deferred until additional safety information from other studies has first been submitted and reviewed before beginning the studies in pediatric populations. 3 PMRs for drug products approved under the animal efficacy rule (21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products) can be conducted only when the drug product is used for its indication and when an exigency (or event or need) arises. In the absence of a public health emergency, these studies or clinical trials will remain pending indefinitely. 4 Includes one NDA PMR FDAAA safety study from CBER in pending status. 5 Includes one NDA PMR FDAAA safety study from CBER in submitted status. 6 Includes one NDA PMR FDAAA safety study from CBER in pending status.
    Table 5—Summary of Open and Off-Schedule Postmarketing Requirements [Numbers as of September 30, 2013, and September 30, 2014] 1 FY2013 Reporting authority/PMR status NDA
  • N = 887
  • (% of Open NDA PMRs)
  • Delayed Terminated BLA
  • N = 179
  • (% of Open BLA PMRs)
  • Delayed Terminated
    Accelerated approval 7 (0.8%) 1 (0.1%) 1 (0.6%) 0 PREA 94 (11%) 2 (0.2%) 6 (3%) 2 (1%) Animal efficacy 1 (0.1%) 0 0 0 FDAAA safety (since March 25, 2008) 38 (4%) 0 11 (6%) 0 Total 140 (16%) 3 (0.3%) 18 (10%) 2 (1%) NDA BLA FY 2014 N = 943 N = 194 (% of Open NDA PMRs) (% of Open BLA PMRs) Reporting authority/PMR status Delayed Terminated Delayed Terminated Accelerated approval 6 (0.6%) 2 (0.2%) 2 (1%) 0 PREA 67 (7%) 2 (0.2%) 5 (3%) 3 (2%) Animal efficacy 0 0 0 0 FDAAA safety (since March 25, 2008) 45 (5%) 4 (0.4%) 14 (7%) 0 Total 118 (13%) 8 (0.8%) 21 (11%) 3 (2%) 1 Percentages may not total 100 due to rounding.
    Table 6—Summary of Open Postmarketing Commitments [Numbers as of September 30, 2013, and September 30, 2014] 1 FY 2013 NDA
  • N = 264
  • (% Open PMCs)
  • BLA
  • N = 251
  • (% Open PMCs)
  • FY 2014 NDA
  • N = 207
  • (% Open PMCs)
  • BLA
  • N = 228
  • (% Open PMCs)
  • On-Schedule: Pending 97 (37%) 88 (35%) 61 (29%) 69 (30%) Ongoing 61 (23%) 61 (24%) 49 (24%) 76 (33%) Submitted 45 (17%) 37 (15%) 31 (15%) 30 (13%) Total 203 (77%) 186 (74%) 141 (68%) 175 (77%) Off-Schedule: Delayed 56 (21%) 63 (25%) 63 (30%) 51 (22%) Terminated 5 (2%) 2 (0.8%) 3 (1%) 2 (1%) Total 61 (23%) 65 (26%) 66 (32%) 53 (23%) 1 Percentages may not total 100 due to rounding.
    Table 7—Summary of Closed 1 Postmarketing Requirements and Commitments [Numbers as of September 30, 2013, and September 30, 2014] 2 Postmarketing requirements FY 2013 NDA
  • N = 134
  • BLA
  • N = 17
  • FY 2014 NDA
  • N = 188
  • BLA
  • N = 30
  • Closed PMRs (% of Total Closed PMRs): Requirement met (fulfilled) 71 (53%) 15 (88%) 136 (72%) 23 (77%) Requirement not met (released and new revised requirement issued) 27 (20%) 1 (6%) 14 (7%) 3 (10%) Requirement no longer feasible or drug product withdrawn (released) 36 (27%) 1 (6%) 38 (20%) 4 (13%) FY 2013 FY 2014 Postmarketing commitments NDA
  • N = 53
  • BLA
  • N = 33
  • NDA
  • N = 96
  • BLA
  • N = 70
  • Closed PMCs (% of Total Closed PMCs): Requirement met (fulfilled) 42 (79%) 28 (85%) 84 (88%) 57 (81%) Requirement not met (released and new revised requirement issued) 0 0 0 2 (3%) Requirement no longer feasible or drug product withdrawn (released) 11 (21%) 5 (15%) 12 (13%) 11 (16%) 1 The table shows data for only those PMRs/PMCs that were closed (fulfilled or released) within the fiscal year. Therefore, data for PMRs/PMCs that were closed in prior fiscal years are not included. 2 Percentages may not total 100 due to rounding.
    Table 8—Summary of Status of Postmarketing Requirements Established Between FY 2008 and FY 2014 1 2 [Numbers as of September 30, 2014] 3 PMR status as of FY 2014
  • (% of total PMRs in each establishment year)
  • Fiscal year of PMR establishment 2008 2009 2010 2011 2012 2013 2014
    Pending 11 (9%) 15 (6%) 29 (13%) 43 (17%) 60 (29%) 128 (49%) 226 (87%) Ongoing 20 (16%) 51 (20%) 49 (21%) 74 (29%) 58 (28%) 62 (24%) 23 (9%) Submitted 1 (<1%) 11 (5%) 21 (9%) 8 (3%) 15 (7%) 19 (7%) 1 (<1%) Delayed 11 (9%) 26 (11%) 18 (8%) 19 (7%) 18 (9%) 19 (7%) 0 Terminated 0 2 (<1%) 0 0 1 (<1%) 3 (1%) 1 (<1%) Released 28 (22%) 51 (21%) 22 (10%) 43 (17%) 20 (10%) 8 (3%) 1 (<1%) Fulfilled 57 (45%) 88 (36%) 92 (40%) 72 (28%) 33 (16%) 23 (9%) 8 (3%) Total 128 244 231 259 205 262 260 1 The establishment date is the date of the formal FDA communication to the applicant that included the final FDA required (PMR) or requested (PMC) postmarketing study or clinical trial. 2 The table shows data for PMRs that were closed (fulfilled or released) as of FY2014. Therefore, data for PMRs that were closed in prior fiscal years are included. 3 Percentages may not total 100 due to rounding.
    Table 9—Summary of Status of Postmarketing Commitments Established Between FY 2008 and FY 2014 1 2 [Numbers as of September 30, 2014] 3 PMC status as of FY2014
  • (% of total PMCs in each establishment year)
  • Fiscal year of PMC establishment 2008 2009 2010 2011 2012 2013 2014
    Pending 1 (1%) 4 (9%) 3 (3%) 11 (13%) 12 (23%) 22 (45%) 47 (82%) Ongoing 11 (9%) 5 (11%) 16 (18%) 25 (30%) 16 (30%) 14 (29%) 9 (16%) Submitted 1 (1%) 6 (13%) 9 (10%) 2 (2%) 5 (9%) 6 (12%) 0 Delayed 8 (7%) 8 (17%) 16 (18%) 8 (10%) 6 (11%) 3 (6%) 0 Terminated 0 1 (2%) 0 0 0 0 0 Released 12 (10%) 3 (6%) 6 (7%) 7 (9%) 0 0 0 Fulfilled 86 (72%) 20 (43%) 40 (44%) 29 (35%) 14 (26%) 4 (8%) 1 (2%) Total 119 47 90 82 53 49 57 1 The establishment date is the date of the formal FDA communication to the applicant that included the final FDA required (PMR) or requested (PMC) postmarketing study or clinical trial. 2 The table shows data for PMCs that were closed (fulfilled or released) as of FY2014. Therefore, data for PMCs that were closed in prior fiscal years are included. 3 Percentages may not total 100 due to rounding.
    Dated: October 25, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-26247 Filed 10-28-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0435] Labeling for Permanent Hysteroscopically Placed Tubal Implants Intended for Sterilization; 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 “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.” This guidance addresses the inclusion of a boxed warning and patient decision checklist in the product labeling for permanent hysteroscopically placed tubal implants intended for female sterilization, and the content and format of those materials. FDA believes that the labeling described in this guidance will help to ensure that a woman receives and understands information regarding the benefits and risks of this type of device prior to undergoing implantation. FDA considered comments received on the draft guidance and revised the guidance as appropriate.

    The guidance identifies the content and format of certain labeling components for permanent, hysteroscopically placed tubal implants that are intended for sterilization. The guidance applies to all devices of this type, regardless of the insert material composition, location of intended implantation, or exact method of delivery.

    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-0435 for “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Guidance for Industry and Food and Drug Administration Staff.” 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 “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Guidance for Industry and Food and Drug Administration Staff” 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:

    Jason Roberts, Division of Reproductive, Gastro-Renal and Urological Devices, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993-0002, 240-402-6400.

    SUPPLEMENTARY INFORMATION: I. Background

    Female sterilization is a commonly performed surgical procedure that permanently prevents a woman from becoming pregnant by occluding her fallopian tubes. Traditionally, such surgery has been performed by surgical bilateral tubal ligation (BTL) through a laparotomy, a mini-laparotomy, a transvaginal approach or at the time of cesarean delivery, and, more recently, laparoscopy. During surgical BTL, the fallopian tubes are cut or physically occluded by using various procedures or medical instruments, such as electrosurgical coagulation or implantable clips or rings. On November 4, 2002, FDA approved the Essure System for Permanent Birth Control, the first permanent hysteroscopically placed tubal implant, as an alternative, non-incisional method of providing female sterilization. As the number of hysteroscopic sterilizations with such devices has increased, additional information, including reports of adverse events, has accumulated. Some of these events have resulted in surgery and/or removal of the implants.

    In the Federal Register on July 22, 2015 (80 FR 43440), FDA announced a meeting of a public advisory committee to seek expert scientific and clinical opinion on the risks and benefits of the Essure System for Permanent Birth Control. On September 24, 2015, FDA convened its Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss available data regarding benefits, risks, and potential mitigation strategies to prevent or reduce the frequency/severity of the adverse events reported in association with this device (Ref. 1).

    A draft guidance regarding the labeling for permanent hysteroscopically placed tubal implants intended for sterilization was announced in the Federal Register on March 4, 2016 (81 FR 11577) and made available for public comment. The comment period closed on May 3, 2016. FDA reviewed and considered all public comments received and revised the guidance as appropriate, including revisions to the content and format of a boxed warning and patient decision checklist. FDA intends to require such labeling as part of a premarket approval application (PMA) for hysteroscopically placed tubal implants intended for sterilization (or a PMA supplement for an already marketed device).

    II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.” 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 “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500051 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 801, regarding labeling, have been approved under OMB control number 0910-0485.

    V. References

    The following reference is on display in the Division of Dockets Management (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    1. Meeting Materials of the Obstetrics and Gynecology Devices Panel (2015), available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/ucm463457.htm. Dated: October 26, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-26243 Filed 10-28-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Cell and Molecular Biology.

    Date: November 16-17, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road NW., Washington, DC 20015.

    Contact Person: Amy Kathleen Wernimont, Ph.D., Scientific Review Officer, Center for Scientific Review, 6701 Rockledge Drivem Bethesda, MD 20892, 301-827-6427, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Studies of HIV/AIDS and Aging.

    Date: November 21, 2016.

    Time: 10:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Robert Freund, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5216, MSC 7852, Bethesda, MD 20892, 301-435-1050, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Musculoskeletal, Oral and Skin Sciences Continuous Submission.

    Date: November 21, 2016.

    Time: 1:00 p.m. to 4:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892.

    Contact Person: Richard Ingraham, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4116, MSC 7814, Bethesda, MD 20892, 301-496-8551, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Neuroscience Assay, Diagnostics and Animal Model Development.

    Date: November 29, 2016.

    Time: 8:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: The St. Regis Washington DC, 923 16th Street NW., Washington, DC 20006.

    Contact Person: Susan Gillmor, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301-435-1730, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Nephrology.

    Date: November 29-30, 2016.

    Time: 9:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Atul Sahai, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2188, MSC 7818, Bethesda, MD 20892, 301-435-1198, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Biological Chemistry and Macromolecular Biophysics.

    Date: November 29, 2016.

    Time: 1:30 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: William A Greenberg, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4168, MSC 7806, Bethesda, MD 20892, (301) 435-1726, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Psycho/Neuropathology, Lifespan Development, and STEM Education.

    Date: November 29, 2016.

    Time: 12:00 p.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: John H Newman, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3222, MSC 7808, Bethesda, MD 20892, (301) 435-0628, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Molecular Cellular Developmental Neuroscience.

    Date: November 30, 2016.

    Time: 1:00 p.m. to 4:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Christine A Piggee, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4186, MSC 7850, Bethesda, MD 20892, 301-435-0657, [email protected]

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Cognition and Perception.

    Date: November 30, 2016.

    Time: 1:00 p.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Wind Cowles, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3172, Bethesda, MD 20892, [email protected]

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: October 25, 2016. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-26128 Filed 10-28-16; 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 and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 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 and/or co-development.

    ADDRESSES:

    Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD 20850-9702.

    FOR FURTHER INFORMATION CONTACT:

    Information on licensing and co-development research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD 20850-9702, Tel. 240-276-5515 or email [email protected] A signed Confidential Disclosure Agreement may be required to receive copies of the patent applications.

    SUPPLEMENTARY INFORMATION:

    Technology description follows.

    Title of Invention

    Small Molecule Inhibitors of Drug Resistant Forms of HIV-1 Integrase

    Description of Technology

    Integrase strand transfer inhibitors (“INSTIs”) are currently in use as a component of prophylactic antiretroviral therapy for preventing HIV-1 infection from progressing to AIDS. Three INSTIs are approved by the FDA for inclusion in antiretroviral regiments: Raltegravir (RAL), elvitegravir (EVG) and dolutegravir (DTG). Clinicians have already identified several HIV-1 integrase mutations that confer resistance to RAL and EVG, and additional mutations that confer resistance to all three INSTIs has been identified in the laboratory.

    Researchers at the National Cancer Institute discovered small-molecule compounds containing 1-hydroxy-2-oxo-1,8-naphthyridine moieties whose activity against HIV-1 integrase mutants confer resistance to currently approved INSTIs. These new compounds exhibit potent and selective activity against comprehensive and varied panels of INSTI-resistant mutants of HIV-1 integrase. Preliminary rodent efficacy, metabolic, and pharmacokinetic studies have been completed by the NCI researchers.

    The National Cancer Institute (NCI) seeks partners to in-license or co-develop this class of compounds for therapeutic use. Parties interested in licensing the technology should submit an Application for Licensing, and seek detailed information from the Licensing and Patenting Manager indicated below.

    Co-development partners would apply under a Cooperative Research and Development (CRADA) to conduct pre-clinical studies that include lead optimization, in vitro and in vivo evaluation and preclinical development of a novel series of INSTIs for the treatment of infection by HIV-1 strains with resistance to currently available integrase inhibitors, including raltegravir and elvitegravir. Under the CRADA, further in vitro and in vivo ADME, as well as activity studies, will be conducted by the partner on current and optimized lead compounds using rodent and non-rodent models. Efficacy studies in non-human primates of select compounds are needed and will be part of the CRADA program. The CRADA scope will also include all aspects of toxicity studies, and synthesis scale up under GMP of optimized lead compounds to support submission of a successful IND application.

    Interested potential CRADA collaborators can receive detailed information by contacting the Licensing and Patenting Manager (see below). Interested parties will receive detailed information on the current status of the project after signing a confidentiality disclosure agreement (CDA) with NCI. Interested candidate partners must submit a statement of interest and capability to the NCI point of contact for consideration by 5:00 p.m. Eastern Standard Time, December 30, 2016.

    Guidelines for the preparation of a full CRADA proposal will be communicated to all respondents with whom initial confidential discussions have been established. Licensing of background technology related to this CRADA opportunity, specifically HHS Reference No.: E-093-2013/0,1,2, entitled “Compounds for Inhibiting Drug-Resistant Strains of HIV-1 Integrase”, is also available to potential collaborators. All proposals received by the above date will be considered. NCI reserves the right to consider additional proposals or none at all if no partner is selected from the initial response.

    Further information about the NCI Technology Transfer Center can be found on its Web site http://techtransfer.cancer.gov.

    Potential Commercial Applications

    • HIV therapeutic for drug-resistant compounds of HIV-1 integrase

    Value Proposition

    • Currently, the only INSTI effective against drug resistant mutants of HIV-1 integrase

    Development Stage

    Pre-clinical (in vivo validation)

    Inventor(s)

    Terrence Burke, Stephen Hughes, Yves Pommier, Xue Zhao, Mathieu Metifiot, Stephen Smith, Barry Johnson, Christophe Marchand (all from NCI)

    Intellectual Property HHS Reference No.: E-093-2013/0,1,2; all entitled “Compounds For Inhibiting Drug-Resistant Strains Of HIV-1 Integrase” US Provisional App. No.: 61/952,928 filed May 16, 2013 US Provisional App. No.: 61/899,061 filed November 1, 2013 International App. No.: PCT/US2014/037905 filed May 13, 2014 Brazilian App. No.: BR1120150287603 filed May 13, 2014 Canadian App. No.: CA2912064 filed May 13, 2014 Chinese App. No.: 2014-80039611.5 filed May 13, 2014 European App. No.: 14728395.6 filed May 13, 2014 Indian App. No.: 3937/KOLNP/2015 filed May 13, 2014 Japanese App. No.: JP100078282 filed May 13, 2014 US Non-Provisional App. No.: 14/891,309 filed May 13, 2014 South African App. No.: ZA2015/08408 filed May 13, 2014 Publications Zhao, X.Z. et al., “HIV-1 Integrase Strand Transfer Inhibitors with Reduced Susceptibility to Drug Resistant Mutant Integrases”, ACS Chem Biol., Apr 15, 2016, 11(4):1074-81. Métifiot, M. et al., “Selectivity for strand-transfer over 3'-processing and susceptibility to clinical resistance of HIV-1 integrase inhibitors are driven by key enzyme-DNA interactions in the active site”, Nucleic Acids Res., Aug 19, 2016, 44(14):6896-906. Zhao, X. Z. et al., “4-Amino-1-hydroxy-2-oxo-1,8-naphthyridine-containing compounds having high potency against raltegravir-resistant integrase mutants of HIV-1”, J. Med. Chem., 57, 5190-5202 (2014), Doi: 10.1021/jm501059k Zhao, X. Z. et al., “Bicyclic 1-hydroxy-2-oxo-1,2-dihydropyridine-3-carboxamide-containing HIV-1 integrase inhibitors having high antiviral potency against cells harboring raltegravir-resistant integrase mutants”, J. Med. Chem., 57, 1573-1582 (2014), Doi: 10.1021/jm401902n Contact Information

    Requests for copies of the patent application and inquiries about licensing, research collaborations, and co-development opportunities for this invention should be sent to Lauren Nguyen-Antczak, Ph.D., J.D., Senior Licensing & Patenting Manager, NCI Technology Transfer Center, 8490 Progress Drive, Suite 400, Frederick, MD 21701, Tel: (301) 624-8752, email: [email protected]

    Dated: October 25, 2016. John D. Hewes, Technology Transfer Specialist, Technology Transfer Center, National Cancer Institute.
    [FR Doc. 2016-26129 Filed 10-28-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App. 2), notice is hereby given of the joint meeting of the National Cancer Advisory Board (NCAB) and NCI Board of Scientific Advisors (BSA).

    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 open session will be videocast and can be accessed from the NIH Videocasting and Podcasting Web site (http://videocast.nih.gov).

    A portion of the National Cancer Advisory Board meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended, for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Cancer Institute, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Cancer Advisory Board; Ad Hoc Subcommittee on Global Cancer Research.

    Open: December 5, 2016, 4:30 p.m. to 6:00 p.m.

    Agenda: Discussion on Global Cancer Research.

    Place: Gaithersburg Marriott Washingtonian Center, 9751 Washington Boulevard, Lakeside 1 Meeting Room, Gaithersburg, MD 20878.

    Contact Person: Dr. Edward Trimble, Executive Secretary, NCAB Ad Hoc Subcommittee on Global Cancer Research, National Cancer Institute—Shady Grove, National Institutes of Health, 9609 Medical Center Drive, Room 3W562, Bethesda, MD 20892, (240) 276-5796, [email protected]

    Name of Committee: National Cancer Advisory Board and NCI Board of Scientific Advisors.

    Open: December 6, 2016, 8:30 a.m. to 4:00 p.m.

    Agenda: Joint meeting of the National Cancer Advisory Board and NCI Board of Scientific Advisors; NCI Board of Scientific Advisors Concepts Review, NCI acting Director's report and presentations.

    Closed: December 6, 2016, 4:00 p.m. to 5:30 p.m.

    Agenda: Review of intramural program site visit outcomes and the discussion of confidential personnel issues.

    Open: December 7, 2016, 9:00 a.m. to 12:00 p.m.

    Agenda: Joint meeting of the National Cancer Advisory Board and NCI Board of Scientific Advisors and presentations.

    Place: National Cancer Institute—Shady Grove, National Institutes of Health, 9609 Medical Center Drive, Room TE406, Bethesda, MD 20892.

    Contact Person: Paulette S. Gray, Ph.D., Director, Division of Extramural Activities, National Cancer Institute—Shady Grove, National Institutes of Health, 9609 Medical Center Drive, Room 7W444, Bethesda, MD 20892, 240-276-6340, [email protected]

    Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.

    In the interest of security, NIH has instituted stringent procedures for entrance onto the NCI—Shady Grove campus. All visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit. Information is also available on the Institute's/Center's home page: NCAB: http://deainfo.nci.nih.gov/advisory/ncab/ncab.htm, BSA: http://deainfo.nci.nih.gov/advisory/bsa/bsa.htm, where an agenda and any additional information for the meeting will be posted when available.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS)
    Dated: October 25, 2016. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2016-26130 Filed 10-28-16; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection [Docket No. USCBP-2016-0066] Commercial Customs Operations Advisory Committee (COAC) AGENCY:

    U.S. Customs and Border Protection (CBP), Department of Homeland Security (DHS).

    ACTION:

    Committee Management; Notice of Federal Advisory Committee Meeting.

    SUMMARY:

    The Commercial Customs Operations Advisory Committee (COAC) will meet in Washington, DC. The meeting will be open to the public.

    DATES:

    The Commercial Customs Operations Advisory Committee (COAC) will meet on Thursday, November 17, 2016, from 12:30 p.m. to 4:30 p.m. EST. Please note that the meeting may close early if the committee has completed its business.

    Pre-Registration: Meeting participants may attend either in person or via webinar after pre-registering using a method indicated below:

    —For members of the public who plan to attend the meeting in person, please register by 5:00 p.m. EST by November 15, 2016 either online at https://apps.cbp.gov/te_reg/index.asp?w=97 by email to [email protected]; or by fax to (202) 325-4290. You must register prior to the meeting in order to attend the meeting in person. —For members of the public who plan to participate via webinar, please register online at https://apps.cbp.gov/te_reg/index.asp?w=96 by 5:00 p.m. EST by November 15, 2016. Please feel free to share this information with other interested members of your organization or association.

    Members of the public who are pre-registered and later need to cancel, please do so in advance of the meeting by accessing one (1) of the following links: https://apps.cbp.gov/te_reg/cancel.asp?w=97 to cancel an in person registration, or https://apps.cbp.gov/te_reg/cancel.asp?w=96 to cancel a webinar registration.

    ADDRESSES:

    The meeting will be held at the Washington Marriott Wardman Park Hotel, 2660 Woodley Road NW., Washington, DC 20008. There will be signage posted directing visitors to the location of the meeting room.

    For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact Ms. Karmeshia Tuck, Office of Trade Relations, U.S. Customs and Border Protection at (202) 325-1030 as soon as possible.

    To facilitate public participation, we are inviting public comment on the issues the committee will consider prior to the formulation of recommendations as listed in the “Agenda” section below.

    Comments must be submitted in writing no later than November 7, 2016, and must be identified by Docket No. USCBP-2016-0066, and may be submitted by one (1) of the following methods:

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

    Email: [email protected] Include the docket number in the subject line of the message.

    Fax: (202) 325-4290.

    Mail: Ms. Karmeshia Tuck, Office of Trade Relations, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Room 3.5A, Washington, DC 20229.

    Instructions: All submissions received must include the words “Department of Homeland Security” and the docket number (USCBP-2016-0066) for this action. Comments received will be posted without alteration at http://www.regulations.gov. Please do not submit personal information to this docket.

    Docket: For access to the docket or to read background documents or comments, go to http://www.regulations.gov and search for Docket Number USCBP-2016-0066. To submit a comment, click the “Comment Now!” button located on the top-right hand side of the docket page.

    There will be multiple public comment periods held during the meeting on November 17, 2016. Speakers are requested to limit their comments to two (2) minutes or less to facilitate greater participation. Contact the individual listed below to register as a speaker. Please note that the public comment period for speakers may end before the time indicated on the schedule that is posted on the CBP Web page, http://www.cbp.gov/trade/stakeholder-engagement/coac.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Karmeshia Tuck, Office of Trade Relations, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Room 3.5A, Washington, DC 20229; telephone (202) 344-1661; facsimile (202) 325-4290.

    SUPPLEMENTARY INFORMATION:

    Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. Appendix. The Commercial Customs Operations Advisory Committee (COAC) provides advice to the Secretary of Homeland Security, the Secretary of the Treasury, and the Commissioner of U.S. Customs and Border Protection (CBP) on matters pertaining to the commercial operations of CBP and related functions within the Department of Homeland Security and the Department of the Treasury.

    Agenda

    The COAC will hear from the following subcommittees on the topics listed below and then will review, deliberate, provide observations, and formulate recommendations on how to proceed:

    1. The Trade Enforcement and Revenue Collection (TERC) Subcommittee will discuss the progress made on prior TERC, Bond Working Group, and Intellectual Property Rights Working Group recommendations, as well the recommendations from the Forced Labor Working Group.

    2. The Global Supply Chain Subcommittee will provide an update report on the progress of the Customs-Trade Partnership Against Terrorism (C-TPAT) Working Group that is reviewing and developing recommendations to update the C-TPAT minimum security criteria.

    3. The One U.S. Government Subcommittee (1 USG) will discuss the progress of the North American Single Window (NASW) Working Group's NASW approach. The subcommittee will also discuss the progress of the Automated Commercial Environment (ACE) Single Window effort.

    4. The Exports Subcommittee will give an update on the Air, Ocean, and Rail Manifest Pilots and discuss the progress of the Truck Manifest Sub-Working Group, which is coordinating with the 1 USG NASW Working Group.

    5. The Trade Modernization Subcommittee will discuss the progress of the International Engagement and Trade Facilitation Working Group which will be identifying examples of best practices in the U.S. and abroad that facilitate trade. The subcommittee will discuss the startup of the Revenue Modernization Working Group which will be generating advice pertaining to the strategic modernization of Customs and Border Protection's revenue collections process and systems. Finally, the subcommittee will discuss the startup of the Rulings and Decisions Working Group which will be identifying process improvements in the receipt and issuance of Customs and Border Protection Headquarters' rulings and decisions.

    6. The Trusted Trader Subcommittee will continue their discussion on their vision for an enhanced Trusted Trader concept that includes engagement with CBP to include relevant partner government agencies with a potential for international interoperability.

    Meeting materials will be available by November 14, 2016, at: http://www.cbp.gov/trade/stakeholder-engagement/coac/coac-public-meetings.

    Dated: October 26, 2016. Maria Luisa Boyce, Senior Advisor for Private Sector Engagement, Office of Trade Relations.
    [FR Doc. 2016-26180 Filed 10-28-16; 8:45 am] BILLING CODE 9111-14-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-HQ-MB-2016-N184; 91100-3740-GRNT 7C] Announcement of Meetings: North American Wetlands Conservation Council; Neotropical Migratory Bird Conservation Advisory Group AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of meetings.

    SUMMARY:

    The North American Wetlands Conservation Council (Council) will meet to select North American Wetlands Conservation Act (NAWCA) grant proposals for recommendation to the Migratory Bird Conservation Commission (Commission). The Council will consider Canadian, Mexican, and U.S. Standard grant proposals. The Advisory Group for the Neotropical Migratory Bird Conservation Act (NMBCA) grants program (Advisory Group) also will meet. The Advisory Group will discuss the strategic direction and management of the NMBCA program. Both meetings are open to the public, and interested persons may present oral or written statements.

    DATES:

    Meetings: Council: December 1, 2016, from 8:30 a.m. to 4:30 p.m.

    Advisory Group: November 30, 2016, from 8:30 a.m. to 4:30 p.m.

    Participation Deadlines: Attendance: To attend either or both meetings, contact the Council/Advisory Group Coordinator (see FOR FURTHER INFORMATION CONTACT) no later than November 23, 2016.

    Submitting Information: To submit written information or questions before the Council or Advisory Group meeting for consideration during the meeting contact the Council/Advisory Group Coordinator (see FOR FURTHER INFORMATION CONTACT) no later than November 23, 2016.

    ADDRESSES:

    The Council and Advisory Group meetings will take place at the U.S. Fish and Wildlife Service Headquarters, 5275 Leesburg Pike, Falls Church, Virginia 22041.

    FOR FURTHER INFORMATION CONTACT:

    Sarah Mott, Council/Advisory Group Coordinator, by phone at 703-358-1784; by email at [email protected]; or by U.S. mail at U.S. Fish and Wildlife Service, 5275 Leesburg Pike MS: MB, Falls Church, Virginia 22041. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individual during normal business hours. FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    The Council meets two to three times per year to select. The Council will consider Canadian, Mexican, and U.S. Standard NAWCA grant proposals for recommendation to the Commission. Council meetings are open to the public, and interested persons may present oral or written statements. The Advisory Group for the Neotropical Migratory Bird Conservation Act (NMBCA) grants program meets once a year. The Advisory Group will discuss the strategic direction and management of the NMBCA program. This meeting is also open to the public, and interested persons may present oral or written statements.

    About the Council

    In accordance with NAWCA (Pub. L. 101-233, 103 Stat. 1968, December 13, 1989, as amended), the State-private-Federal Council meets to consider wetland acquisition, restoration, enhancement, and management projects for recommendation to, and final funding approval by, the Commission. NAWCA provides matching grants to organizations and individuals who have developed partnerships to carry out wetlands conservation projects in the United States, Canada, and Mexico. These projects must involve long-term protection, restoration, and/or enhancement of wetlands and associated uplands habitats for the benefit of all wetlands-associated migratory birds. Project proposal due dates, application instructions, and eligibility requirements are available on the NAWCA Web site at www.fws.gov/birds/grants/north-american-wetland-conservation-act.php.

    About the Advisory Group

    In accordance with NMBCA (Pub. L. 106-247, 114 Stat. 593, July 20, 2000), the Advisory Group will hold its meeting to discuss the strategic direction and management of the NMBCA program and provide advice to the Director of the Fish and Wildlife Service. NMBCA promotes long-term conservation of neotropical migratory birds and their habitats through a competitive grants program by promoting partnerships, encouraging local conservation efforts, and achieving habitat protection in 36 countries. The goals of NMBCA include perpetuating healthy bird populations, providing financial resources for bird conservation, and fostering international cooperation. Because the greatest need is south of the U.S. border, at least 75 percent of NMBCA funding supports projects outside the United States. Project proposal due dates, application instructions, and eligibility requirements are available on the NMBCA Web site at http://www.fws.gov/birds/grants/neotropical-migratory-bird-conservation-act.php.

    Public Input Submitting Written Information or Questions

    Interested members of the public may submit relevant information or questions to be considered during the public meetings. If you wish to submit a written statement so information may be made available to the Council or Advisory Group for their consideration prior to the meetings, you must contact the Council/Advisory Group Coordinator by the date in DATES. Written statements must be supplied to the Council/Advisory Group Coordinator in both of the following formats: One hard copy with original signature, and one electronic copy via email (acceptable file formats are Adobe Acrobat PDF, MS Word, MS PowerPoint, or rich text file).

    Giving an Oral Presentation

    Individuals or groups requesting to make an oral presentation at the meetings will be limited to 2 minutes per speaker, with no more than a total of 30 minutes for all speakers. Interested parties should contact the Council/Advisory Group Coordinator by the date in DATES, in writing (preferably via email; see FOR FURTHER INFORMATION CONTACT), to be placed on the public speaker list for either of these meetings. Nonregistered public speakers will not be considered during the Council or the Advisory Group meeting. Registered speakers who wish to expand upon their oral statements, or those who had wished to speak but could not be accommodated on the agenda, are invited to submit written statements to the Council or Advisory Group within 30 days following the meeting.

    Meeting Minutes

    Summary minutes of the Council and Advisory Group meetings will be maintained by the Council/Advisory Group Coordinator at the address under FOR FURTHER INFORMATION CONTACT. Meeting notes will be available by contacting the Council/Advisory Group Coordinator within 30 days following the meeting. Personal copies may be purchased for the cost of duplication.

    Jerome Ford, Assistant Director, Migratory Birds.
    [FR Doc. 2016-26166 Filed 10-28-16; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R4-ES-2016-N161; FXES11130900000C2-167-FF09E32000] Endangered and Threatened Wildlife and Plants; 5-Year Status Review of the Red Wolf AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of initiation of review; request for information.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), are initiating a 5-year status review for the red wolf (Canis rufus) under the Endangered Species Act of 1973, as amended (Act). A 5-year review is an assessment of the best scientific and commercial data available at the time of the review. We are requesting submission of information that has become available since the last review of this species.

    DATES:

    To allow us adequate time to conduct this review, we must receive your comments or information on or before December 30, 2016. However, we will continue to accept new information about any listed species at any time.

    ADDRESSES:

    For instructions on how to submit information and review information we receive on the red wolf, see “Request for New Information.”

    FOR FURTHER INFORMATION CONTACT:

    Aaron Valenta, Chief, Division of Restoration and Recovery, 404-679-4144.

    SUPPLEMENTARY INFORMATION:

    Why do we conduct a 5-year review?

    Under the Act (16 U.S.C. 1531 et seq.), we maintain lists of endangered and threatened wildlife and plant species in the Code of Federal Regulations (CFR) at 50 CFR 17.11 (for wildlife) and 17.12 (for plants). Section 4(c)(2)(A) of the Act requires us to review each listed species' status at least once every 5 years. Our regulations at 50 CFR 424.21 require that we publish a notice in the Federal Register announcing those species under active review. For additional information about 5-year reviews, go to http://www.fws.gov/endangered/what-we-do/recovery-overview.html, scroll down to “Learn More about 5-Year Reviews,” and click on our factsheet.

    Species Under Review

    This notice announces our active review of the red wolf (Canis rufus), which is currently listed as endangered.

    What information do we consider in our review?

    In conducting a 5-year review, the Service considers the best scientific and commercial data that have become available since the current listing determination or most recent status review of each species, such as:

    A. Species biology, including but not limited to population trends, distribution, abundance, demographics, and genetics;

    B. Habitat conditions, including but not limited to amount, distribution, and suitability;

    C. Conservation measures that have been implemented to benefit the species;

    D. Threat status and trends (see five factors under heading “How Do We Determine Whether a Species Is Endangered or Threatened?”); and

    E. Other new information, data, or corrections, including but not limited to taxonomic or nomenclatural changes, identification of erroneous information contained in the Lists of Endangered and Threatened Wildlife and Plants, and improved analytical methods.

    New information will be considered in the 5-year review and ongoing recovery programs for the species.

    Definitions

    A. Species means any species or subspecies of fish, wildlife, or plant, and any distinct population segment of any species of vertebrate which interbreeds when mature.

    B. Endangered means any species that is in danger of extinction throughout all or a significant portion of its range.

    C. Threatened means any species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.

    How do we determine whether a species is endangered or threatened?

    Section 4(a)(1) of the Act establishes that we determine whether a species is endangered or threatened based on one or more of the following five factors:

    A. The present or threatened destruction, modification, or curtailment of its habitat or range;

    B. Overutilization for commercial, recreational, scientific, or educational purposes;

    C. Disease or predation;

    D. The inadequacy of existing regulatory mechanisms; or

    E. Other natural or manmade factors affecting its continued existence.

    Request for New Information

    To do any of the following, contact Aaron Valenta at the Service's Southeast Regional Office, 1875 Century Boulevard, Atlanta, GA 30345; fax 404-679-7081; email at [email protected]:

    A. To get more information on the red wolf;

    B. To submit information on the red wolf; or

    C. To review information we receive, which will be available for public inspection by appointment, during normal business hours at the Southeast Regional Office, Ecological Services Division, at the address above.

    We request any new information concerning the status of the red wolf. See “What information do we consider in our review?” above for specific criteria. Information submitted should be supported by documentation such as maps, bibliographic references, methods used to gather and analyze the data, and/or copies of any pertinent publications, reports, or letters by knowledgeable sources.

    Public Availability of Comments

    Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that the entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Authority

    We publish this document under the authority of the Endangered Species Act (16 U.S.C. 1531 et seq.).

    Dated: September 23, 2016. Mike Oetker, Acting Regional Director, Southeast Region.
    [FR Doc. 2016-26168 Filed 10-28-16; 8:45 am] BILLING CODE 4310-55-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [178A2100DD/AAKC001030/A0A501010.999900 253G] Indian Gaming; Tribal-State Class III Gaming Compact Taking Effect in the State of California AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The State of California and the Viejas (Baron Long) Group of Capitan Grande Band of Mission Indians of the Viejas Reservation entered into a Tribal-State compact governing Class III gaming. This notice announces that the compact is taking effect.

    DATES:

    The effective date of the compact is October 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.

    SUPPLEMENTARY INFORMATION:

    Section 11 of the Indian Gaming Regulatory Act (IGRA) requires the Secretary of the Interior to publish in the Federal Register notice of approved Tribal-State compacts that are for the purpose of engaging in Class III gaming activities on Indian lands. See Public Law 100-497, 25 U.S.C. 2701 et seq. All Tribal-State Class III compacts, including amendments, are subject to review and approval by the Secretary under 25 CFR 293.4. The Secretary took no action on the compact within 45 days of its submission. Therefore, the compact is considered to have been approved, but only to the extent the compact is consistent with IGRA. See 25 U.S.C. 2710(d)(8)(C).

    Dated: October 21, 2016. Lawrence S. Roberts, Principal Deputy Assistant Secretary—Indian Affairs.
    [FR Doc. 2016-26255 Filed 10-28-16; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [178A2100DD/AAKC001030/A0A501010.999900 253G] Indian Gaming; Tribal-State Class III Gaming Compact Taking Effect in the State of California AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The State of California and the Agua Caliente Band of Cahuilla Indians of the Agua Caliente Indian Reservation entered into a Tribal-State compact governing Class III gaming. This notice announces that the compact is taking effect.

    DATES:

    The effective date of the compact is October 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.

    SUPPLEMENTARY INFORMATION:

    Section 11 of the Indian Gaming Regulatory Act (IGRA) requires the Secretary of the Interior to publish in the Federal Register notice of approved Tribal-State compacts that are for the purpose of engaging in Class III gaming activities on Indian lands. See Public Law 100-497, 25 U.S.C. 2701 et seq. All Tribal-State Class III compacts, including amendments, are subject to review and approval by the Secretary under 25 CFR 293.4. The Secretary took no action on the compact within 45 days of its submission. Therefore, the compact is considered to have been approved, but only to the extent the compact is consistent with IGRA. See 25 U.S.C. 2710(d)(8)(C).

    Dated: October 21, 2016. Lawrence S. Roberts, Principal Deputy Assistant Secretary—Indian Affairs.
    [FR Doc. 2016-26256 Filed 10-28-16; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [178A2100DD/AAKC001030/A0A501010.999900 253G] Indian Gaming; Approval of Amended Tribal-State Class III Gaming Compact in the State of South Dakota AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The Yankton Sioux Tribe of South Dakota and State of South Dakota negotiated an Amended Gaming Compact governing Class III gaming; this notice announces approval of the amended compact.

    DATES:

    Effective October 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.

    SUPPLEMENTARY INFORMATION:

    Section 11 of the Indian Gaming Regulatory Act (IGRA) requires the Secretary of the Interior to publish in the Federal Register notice of approved Tribal-State compacts that are for the purpose of engaging in Class III gaming activities on Indian lands. See Public Law 100-497, 25 U.S.C. 2701 et seq. All Tribal-State Class III compacts, including amendments, are subject to review and approval by the Secretary under 25 CFR 293.4. The Amended Compact adds games to the “no-limit” category, removes arbitration procedures, transfers responsibility for background checks to the Tribal Gaming Commission, increases the maximum number of slot machines the Tribe may operate, and adds a personal injury remedy for patrons. The Amended Compact is subject to review at four-year intervals. The Amended Compact is approved. See 25 U.S.C. 2710(d)(8)(A).

    Dated: October 21, 2016. Lawrence S. Roberts, Principal Deputy Assistant Secretary—Indian Affairs.
    [FR Doc. 2016-26253 Filed 10-28-16; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [178A2100DD/AAKC001030/A0A501010.999900 253G] Indian Gaming; Approval of Amendment to Tribal-State Class III Gaming Compact in the State of California AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The Yurok Tribe (Tribe) of the Yurok Reservation and State of California (State) entered into an amendment to an existing Tribal-State compact governing Class III gaming. This notice announces approval of the amendment.

    DATES:

    Effective October 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.

    SUPPLEMENTARY INFORMATION:

    Section 11 of the Indian Gaming Regulatory Act (IGRA) requires the Secretary of the Interior to publish in the Federal Register notice of approved Tribal-State compacts that are for the purpose of engaging in Class III gaming activities on Indian lands. See Public Law 100-497, 25 U.S.C. 2701 et seq. All Tribal-State Class III compacts, including amendments, are subject to review and approval by the Secretary under 25 CFR 293.4. The amendment provides that the Tribe may participate in the State's workers' compensation program or, in lieu of participation in the State's statutory workers' compensation system, the Tribe may create and maintain a system that provides redress for employees' work-related injuries. The amendment is approved. See 25 U.S.C. 2710(d)(8)(A).

    Dated: October 21, 2016. Lawrence S. Roberts, Principal Deputy Assistant Secretary—Indian Affairs.
    [FR Doc. 2016-26251 Filed 10-28-16; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [178A2100DD/AAKC001030/A0A501010.999900 253G] Indian Gaming; Tribal-State Class III Gaming Compact Taking Effect in the State of California AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The State of California and the Viejas (Baron Long) Group of Capitan Grande Band of Mission Indians of the Viejas Reservation entered into a Tribal-State compact governing Class III gaming. This notice announces that the compact is taking effect.

    DATES:

    The effective date of the compact is October 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.

    SUPPLEMENTARY INFORMATION:

    Section 11 of the Indian Gaming Regulatory Act (IGRA) requires the Secretary of the Interior to publish in the Federal Register notice of approved Tribal-State compacts that are for the purpose of engaging in Class III gaming activities on Indian lands. See Public Law 100-497, 25 U.S.C. 2701 et seq. All Tribal-State Class III compacts, including amendments, are subject to review and approval by the Secretary under 25 CFR 293.4. The Secretary took no action on the compact within 45 days of its submission. Therefore, the compact is considered to have been approved, but only to the extent the compact is consistent with IGRA. See 25 U.S.C. 2710(d)(8)(C).

    Dated: October 21, 2016. Lawrence S. Roberts, Principal Deputy Assistant Secretary—Indian Affairs.
    [FR Doc. 2016-26254 Filed 10-28-16; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [178A2100DD/AAKC001030/A0A501010.999900 253G] Indian Gaming; Approval of Amendment to Tribal-State Class III Gaming Compact in the State of Oregon AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The Coquille Indian Tribe and State of Oregon entered into an amendment to an existing Tribal-State compact governing Class III gaming. This notice announces approval of the amendment.

    DATES:

    Effective October 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.

    SUPPLEMENTARY INFORMATION:

    Section 11 of the Indian Gaming Regulatory Act (IGRA) requires the Secretary of the Interior to publish in the Federal Register notice of approved Tribal-State compacts that are for the purpose of engaging in Class III gaming activities on Indian lands. See Public Law 100-497, 25 U.S.C. 2701 et seq. All Tribal-State Class III compacts, including amendments, are subject to review and approval by the Secretary under 25 CFR 293.4. The amendment expands on the Coquille Tribal Gaming Commission's criteria for denial or termination of contracts for vendors based on the nature and severity of the conduct that constituted the offense or crime, the time that has passed since satisfactory completion of sentence, probation, or payment of fine imposed, the number of offenses or crimes, and any extenuating circumstances that enhance or reduce the impact of the crime. The amendment is approved. See 25 U.S.C. 2710(d)(8)(A).

    Dated: October 21, 2016. Lawrence S. Roberts, Principal Deputy Assistant Secretary—Indian Affairs.
    [FR Doc. 2016-26252 Filed 10-28-16; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [178A2100DD/AAKC001030/A0A501010.999900 253G] Indian Gaming; Approval of Amended Tribal-State Class III Gaming Compact in the State of California AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Notice.

    SUMMARY:

    The Jackson Band of Miwuk Indians (Tribe) and State of California entered into an amendment to the existing Tribal-State Compact governing Class III gaming. This notice announces approval of the amendment.

    DATES:

    Effective October 31, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.

    SUPPLEMENTARY INFORMATION:

    Section 11 of the Indian Gaming Regulatory Act (IGRA) requires the Secretary of the Interior to publish in the Federal Register notice of approved Tribal-State compacts that are for the purpose of engaging in Class III gaming activities on Indian lands. See Public Law 100-497, 25 U.S.C. 2701 et seq. All Tribal-State Class III compacts, including amendments, are subject to review and approval by the Secretary under 25 CFR 293.4. The amendment reduces and otherwise adjusts the existing compact's revenue sharing requirements and increases the available credits that may be claimed for certain infrastructure and other projects or programs underwritten by the Tribe. The amendment is approved. See 25 U.S.C. 2710(d)(8)(A).

    Dated: October 21, 2016. Lawrence S. Roberts, Principal Deputy Assistant Secretary—Indian Affairs.
    [FR Doc. 2016-26250 Filed 10-28-16; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE INTERIOR National Park Service [NPS-WASO-EQD-SSB-22271; PPAKGAARC6, PPMPRLE1Z.LS0000 (166)] Information Collection Request: National Park Service Centennial National Household Survey AGENCY:

    National Park Service, Interior.

    ACTION:

    Notice; request for comments.

    SUMMARY:

    We (National Park Service, NPS) have sent an Information Collection Request (ICR) to OMB for review and approval. We summarize the ICR below and describe the nature of the collection and the estimated annual burden. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB Control Number.

    DATES:

    To ensure that we are able to consider your comments on this ICR, we must receive them by November 30, 2016.

    ADDRESSES:

    Please direct all written comments on this ICR directly to the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs, Attention: Desk Officer for the Department of the Interior, to [email protected] (email) or 202-395-5806 (fax); and identify your submission as 1024-0254. Please also send a copy of your comments to Phadrea Ponds, Information Collection Coordinator, National Park Service, 1201 Oakridge Drive, Fort Collins, CO 80525 (mail); or [email protected] (email). Please reference Information Collection 1024-0254 in the subject line. You may also access this ICR at www.reginfo.gov.

    FOR FURTHER INFORMATION CONTACT:

    Bret Meldrum, Chief Social Science Program, National Park Service, 1201 Oakridge Drive, Fort Collins, CO 80525 (mail); or [email protected] (email). Please reference Information Collection 1024-0254 in the subject line.

    SUPPLEMENTARY INFORMATION:

    I. Abstract

    2016 marks the 100th anniversary of the National Park Service (NPS)—a defining moment that offers an opportunity to reflect on and celebrate our accomplishments as we move forward into a new century of stewardship and engagement. As we prepare for our centennial anniversary, discussions concerning the relevancy of the National Parks have ignited the need for a third iteration of the NPS Comprehensive Survey of the American Public. This survey will include questions from the original surveys as well as updated questions that can be used to provide views from a national audience concerning the current relevancy of the NPS that would otherwise be unavailable.

    This request is to reinstate OMB Control Number 1024-0254 in order to pretest the survey and collection methods before we ask OMB to review for the consideration of approval the final version of the survey instrument. The new content is sufficiently different enough to necessitate this request to pretest question, response choice wording, and survey length before requesting approval of the final survey. The purpose and intent of the final survey will be measure the awareness, engagement, values, and preferences of both visitors and non-visitors. This information will be used to assess the relevancy of NPS as well as to assess change over time, which in turn will be used to evaluate the effectiveness of NPS efforts to increase its relevancy.

    II. Data

    OMB Control Number: 1024-0254.

    Title: National Park Service Centennial National Household Survey.

    Type of Request: Reinstatement with change to a previously approved collection.

    Affected Public: Individuals and households.

    Respondent Obligation: Voluntary.

    Frequency of Collection: One time.

    Estimated Number of Annual Responses: 120.

    Annual Burden Hours: 54 hours.

    Estimated Annual Reporting and Recordkeeping “Non-Hour Cost”: None.

    III. Comments

    A notice was published in the Federal Register (80 FR 80384) on December 24, 2015, stating that we intended to submit an information collection OMB approval of the NPS Comprehensive Survey of the American Public. In this notice, we solicited public comment for 60 days ending February 22, 2016. We did not receive any comments in response to that notice that required changes to the collection instruments.

    We again invite comments concerning this information collection on:

    • Whether or not the collection of information is necessary, including whether or not the information will have practical utility;

    • The accuracy of our estimate of the burden for this collection of information;

    • Ways to enhance the quality, utility, and clarity of the information to be collected; and

    • Ways to minimize the burden of the collection of information on respondents.

    Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this IC. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

    Dated: October 26, 2016. Madonna L. Baucum, Information Collection Clearance Officer, National Park Service.
    [FR Doc. 2016-26151 Filed 10-28-16; 8:45 am] BILLING CODE 4310-EH-P
    DEPARTMENT OF THE INTERIOR Bureau of Ocean Energy Management [Docket No. BOEM-2016-0071] Atlantic Wind Lease Sale 6 (ATLW-6) for Commercial Leasing for Wind Power on the Outer Continental Shelf Offshore New York—Final Sale Notice MMAA104000 AGENCY:

    Bureau of Ocean Energy Management, Interior.

    ACTION:

    Final sale notice for commercial leasing for Wind Power on the Outer Continental Shelf Offshore New York.

    SUMMARY:

    This document is the Final Sale Notice (FSN) for the sale of one commercial wind energy lease on the Outer Continental Shelf (OCS) offshore New York, pursuant to 30 CFR 585.216. The Bureau of Ocean Energy Management (BOEM or “the Bureau”) will offer Lease OCS-A 0512 for sale using a multiple-factor auction format. This FSN contains information pertaining to the area available for leasing, lease provisions and conditions, auction details, the lease form, criteria for evaluating competing bids, award procedures, appeal procedures, and lease execution. The issuance of the lease resulting from this sale would not constitute an approval of project-specific plans to develop offshore wind energy. Such plans, if submitted by the lease sale winner, would be subject to subsequent environmental and public review prior to a decision to proceed with development.

    DATES:

    BOEM will hold a mock auction for the bidders starting at 8:30 a.m. Eastern Standard (EST) on December 13, 2016. The monetary auction will be held online and will begin at 8:30 a.m. Eastern Standard Time (EST) on December 15, 2016. Additional details are provided in the section entitled, “Deadlines and Milestones for Bidders.”

    FOR FURTHER INFORMATION CONTACT:

    Wright Frank, New York Project Coordinator and Auction Manager, BOEM Office of Renewable Energy Programs, 45600 Woodland Road, VAM-OREP, Sterling, Virginia, 20166, (703) 787-1325 or [email protected]

    Background: BOEM proposed this lease sale on June 6, 2016, in Proposed Sale Notice (PSN) for Commercial Leasing for Wind Power on the Outer Continental Shelf (OCS) Offshore New York, which was published in the Federal Register with a 60-day public comment period (81 FR 36336). BOEM received 401 comment submissions in response to the PSN, which are available in the Federal Register docket (Docket ID: BOEM-2016-0027) through BOEM's Web site at: http://www.boem.gov/New-York/. BOEM has posted a document containing responses to comments submitted during the PSN comment period. The document, entitled Response to Comments, can be found at the following URL: http://www.boem.gov/New-York/.

    BOEM made several changes from the description of the New York lease sale that was published in the PSN. Three changes worth highlighting are: A 10% bidding credit for entities that establish that they are a “government authority” meeting the definition included in this notice, an adaptation to the auction format, and the removal of a small portion of the lease area. The auction format described here differs slightly from past lease sales in that bidders may have a “limited opportunity to revoke” a provisionally winning bid without penalty if the next-highest bid was submitted by a governmental entity. An explanation regarding the reduction in the area of the LA relative to the area described in the PSN is provided in the section entitled “Area Offered for Leasing.”

    Environmental Reviews

    On May 28, 2014, BOEM published a Notice of Intent (NOI) to Prepare an Environmental Assessment (EA) for commercial wind lease issuance and approval of site assessment activities on the Atlantic OCS offshore New York with a 45-day public comment period (79 FR 30643). In response to the NOI, BOEM received 32 comment submissions, a link to which is available at http://www.boem.gov/New-York/. BOEM considered these comments in determining the scope of issues and alternatives analyzed in the EA.

    On June 6, 2016, in conjunction with the PSN, BOEM published an EA for public comment (81 FR 36344). BOEM received approximately 60 submittals. Submittals included letters, emails, comment cards, and comments made to a court reporter at public meetings. BOEM identified 300 discrete comments within the submittals received. Comments were received from various stakeholders, including private citizens, environmental groups, Federal agencies, trade associations, businesses, state agencies, universities, and Federal organizations.

    Concurrent with publication of this FSN, BOEM has published a Notice of Availability (NOA) for the revised EA and Finding of No Significant Impact (FONSI) for commercial wind lease issuance and site assessment activities on the Atlantic OCS offshore New York. The EA and FONSI are available at: http://www.boem.gov/New-York/.

    All consultations necessary to inform BOEM's lease issuance decision have been completed. BOEM completed consultations with the National Oceanic and Atmospheric Administration's National Marine Fisheries Service (NMFS) and the U.S. Fish and Wildlife Service (USFWS) under the Endangered Species Act (ESA). BOEM completed formal consultation with NMFS upon receipt of a Biological Opinion on March 10, 2013, (revised on April 10, 2013). That consultation covered lease issuance and site characterization activities (i.e., high resolution geophysical surveys, biological surveys, and geotechnical sampling). On September 14, 2016, the USFWS concurred with BOEM's determination that such activities were not likely to adversely affect piping plovers, roseate terns, and red knots, and BOEM's determination of no effect on the northern long-eared bat for site characterization and assessment activities.

    BOEM also consulted with the State Historic Preservation Offices of New York and New Jersey, the National Park Service, and Monmouth County New Jersey under the National Historic Preservation Act. The Finding of No Historic Properties Affected for the Issuance of a Commercial Lease with in the New York Wind Energy Area on the Outer Continental Shelf Offshore New York can be found at: http://www.boem.gov/Renewable-Energy/Historic-Preservation-Activities/. In August 2016, the States of New York and New Jersey concurred with BOEM's consistency determination under the Coastal Zone Management Act.

    On July 11, 2016, NMFS provided comments on the EA pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (MSFCMA) and recommended that BOEM coordinate with NMFS in the review of site-specific survey plans and Site Assessment Plans (SAPs). Because of the programmatic nature of the essential fish habitat (EFH) assessment, NMFS elected not to provide any specific EFH conservation measures until such time as site-specific plans are received.

    For the issuance of a commercial lease, BOEM considers the environmental consequences of associated site characterization activities (i.e., biological, archeological, geological and geophysical surveys, and core sampling). Therefore, mitigation measures designed to reduce or eliminate impacts from survey activities will be included as stipulations in Addendum “C” of the lease (OCS-A 0512). If a lease is issued, BOEM will prepare additional environmental reviews upon receipt of the lessee's SAP and/or Construction and Operations Plan (COP). BOEM will continue to work with affected stakeholders and assess ongoing and future research relating to potential survey, site assessment, and construction and operations impacts, including potential mitigation measures.

    List of Eligible Bidders: BOEM has determined that pursuant to 30 CFR 585.106 and 107, the following entities are legally, technically, and financially qualified to hold a commercial wind lease offshore New York, and therefore may participate in this lease sale as bidders subject to meeting the requirements outlined in this notice.

    Company name Company No. Avangrid Renewables, LLC 15019 CI-II NY Inc 15063 Clean Power Northeast Development Inc 15064 Convalt Energy LLC 15051 Deepwater Wind Hudson Canyon, LLC 15028 DONG Energy Wind Power (U.S.) Inc 15059 EDF Renewable Development, Inc 15027 Energy Management, Inc 15015 Fishermen's Energy, LLC 15005 Innogy US Renewable Projects LLC 15061 New York State Energy Research and Development Authority 15062 Sea Breeze Energy LLC 15044 Statoil Wind US LLC 15058 wpd offshore Alpha LLC 15060

    Deadlines and Milestones for Bidders: This section describes the major deadlines and milestones in the auction process from publication of this FSN to execution of leases pursuant to this sale. These are organized into various stages: The FSN Waiting Period; Conducting the Auction; and From the Auction to Lease execution.

    • FSN Waiting Period

    Bidder's Financial Form (BFF): Each bidder must submit a BFF to BOEM in order to participate in the auction. BOEM must receive each bidder's BFF no later than November 14, 2016. BOEM will consider extensions to this deadline only if BOEM determines that the failure to timely submit a BFF was caused by events beyond the bidder's control. The BFF can be downloaded at: http://www.boem.gov/New-York/. Once the BFF has been processed, bidders may log into pay.gov and submit bid deposits. For purposes of this auction, BOEM will not consider any BFFs submitted by bidders for previous lease sales. BOEM will only accept an originally executed paper copy of the BFF. The BFF must be executed by an authorized representative as shown on the bidder's legal qualifications. Each bidder is required to sign the self-certification in the BFF, in accordance with 18 U.S.C. 1001 (Fraud and False Statements).

    Bid Deposits: Each bidder must provide a bid deposit of $450,000 no later than November 28, 2016, in order to participate in the mock auction and the monetary auction. BOEM will consider extensions to this deadline only if BOEM determines that the failure to timely submit the bid deposit was caused by events beyond the bidder's control. Further information about bid deposits can be found in the “Bid Deposit” section of this notice.

    Non-Monetary Package: Each bidder must submit a non-monetary package if it is applying for a credit as a governmental authority as described in the “Auction Procedures: Credit Factors” section of this notice. For bidders applying for a credit, BOEM must receive non-monetary packages no later than November 28, 2016. BOEM will consider extensions to this deadline only if BOEM determines that the failure to timely submit a non-monetary package was caused by events beyond the bidder's control. Non-monetary packages must be submitted in both paper and electronic formats. BOEM considers Adobe .pdf files stored on an electronic media (i.e., flash drive) to be acceptable.

    Further information on this subject can be found in the section of this notice entitled,”Auction Procedures.”

    Reservation of Limited Opportunity to Revoke (RLOR): Under certain circumstances described in detail in this notice, a bidder that submits a provisionally winning bid may be afforded a one-hour opportunity to revoke its provisionally winning bid without penalty at the end of the auction. This opportunity will only be allowed if a governmental authority submitted the second-highest bid. In order to revoke a provisionally winning bid, a bidder must have reserved this opportunity in advance. BOEM must receive, no later than November 28, 2016, a completed form that can be downloaded from BOEM's Web site at http://www.boem.gov/New-York/, called the “Reservation of Limited Opportunity to Revoke” (RLOR). BOEM will consider extensions to this deadline only if it determines that the failure to timely submit the RLOR was caused by events beyond the bidder's control. By “opting-in,” the bidder will have an opportunity, if certain conditions are met, to revoke a provisionally winning bid without penalty during a short period of time following the auction. If the bidder does not “opt-in,” the bidder will not have this opportunity, and refusal to execute a lease pursuant to a provisionally winning bid will result in the loss of the bidder's bid deposit.

    Panel Convenes to Evaluate Non-Monetary Packages: A short time before the auction, the panel described in the “Auction Procedures” section will convene to evaluate non-monetary packages. The panel is tentatively scheduled to meet on December 9, 2016, for this purpose. If BOEM has not received a non-monetary package by November 28, 2016, then the BOEM panel designated as responsible for determining bidder eligibility for the credit may not consider that bidder for a non-monetary auction credit. Once it has made its decisions, the panel will report determinations of eligibility to BOEM. BOEM will then inform each bidder by email of the panel's determination as to whether the bidder qualifies for a non-monetary bid credit. Mock Auction: BOEM will hold a Mock Auction on December 13, 2016, beginning at 8:30 a.m. EST. The Mock Auction will be held online. BOEM will contact each bidder that has timely filed a BFF and bid deposit and provide instructions for participation. Only bidders that have timely submitted BFFs and bid deposits will be permitted to participate in the Mock Auction.

    Conducting the Auction: BOEM, through its contractor, will hold an auction as described in this notice.

    Auction: On December 15, 2016, BOEM, through its contractor, will hold the auction. The first round of the auction will start at 8:30 a.m. EST. The auction will proceed electronically according to a schedule to be distributed by the BOEM Auction Manager at the time of the auction. BOEM anticipates that the auction may continue on consecutive business days, as necessary, until the auction ends in accordance with the procedures described in the “Auction Format” section of this notice. The monetary bidding will end in the first round where BOEM receives one or zero bids at the asking price.

    Limited Opportunity to Revoke (LOR) (if criteria met): If the highest bidder has reserved an LOR, and a government authority is the second highest bidder, BOEM will contact the provisionally winning bidder through the auction system's messaging platform and ask whether the bidder would like to revoke its provisionally winning bid without penalty. The bidder will have one hour from the time the message is sent to respond via the messaging system. If the bidder fails to respond within the allotted hour, BOEM will presume the bidder does not wish to exercise its revocation right, and the bidder will lose the right to revoke its provisionally winning bid without penalty. Further information can be found in the Auction Procedures section of this notice.

    Announce Provisional Winner: BOEM will announce the provisional winner of the lease sale after the auction ends and the one-hour LOR period, if applicable, has elapsed.

    Reconvene the Panel: The panel will reconvene after the bidding has concluded to verify auction results.

    • From the Auction to Lease Execution

    Refund Non-Winners: Once the provisional winner has been announced and the panel has verified the auction results, BOEM will provide the non-winners a written explanation of why they did not win and return their bid deposits.

    Department of Justice (DOJ) Review: DOJ will have 30 days in which to conduct an antitrust review of the auction, pursuant to 43 U.S.C § 1337(c).

    Delivery of the Lease: BOEM will send three lease copies to the winner, with instructions on how to execute the lease. The first year's rent is due 45 calendar days after the winner receives the lease copies for execution.

    Return the Lease: Within 10 business days of receiving the lease copies, the auction winner must post financial assurance, pay any outstanding balance of its bonus bid (i.e., winning monetary bid minus applicable non-monetary credits and bid deposit), and sign and return the three executed lease copies.

    Execution of Lease: Once BOEM has received the lease copies and verified that all other required materials have been received, BOEM will make a final determination regarding its issuance of the lease and will execute the lease if appropriate.

    Area Offered for Leasing: The area available for sale will be auctioned as one lease, Lease OCS-A 0512 (New York LA). The New York LA consists of approximately 79,350 acres, which is reduced from the area originally proposed in the PSN. The reduction comprises five aliquots (sixteenths of an OCS block), which were removed in response to comments received from NMFS in response to the NOA of the EA and as part of consulations pursuant to the MSFCMA. A description of the final LA can be found in Addendum “A” of the lease, which BOEM has made available with this notice on its Web site at: http://www.boem.gov/New-York/.

    Map of the Area Offered for Leasing

    A map of the New York LA and GIS spatial files can be found on BOEM's Web site at: http://www.boem.gov/New-York/.

    A large scale map of the area, showing boundaries of the area with numbered blocks, is available from BOEM upon request at the following address: Bureau of Ocean Energy Management, Office of Renewable Energy Programs, 45600 Woodland Road, VAM-OREP, Sterling, Virginia, 20166, Phone: (703) 787-1300, Fax: (703) 787-1708.

    Potential Mitigation Measures and Restrictions on Development

    During the Area Identification (Area ID) process, BOEM identified three issues of concern associated with potential development of the New York Wind Energy Area (WEA): (1) Navigational safety; (2) commercial fishing; and (3) visual impacts to National Park Service lands and historic properties. Although BOEM did not remove any areas from leasing consideration during Area ID, potential bidders should be aware that future analysis of these or other issues could result in BOEM's requiring mitigation measures and/or development restrictions in all or part of the New York LA. In addition, mitigation measures and/or development restrictions could result from future BOEM environmental reviews and consultations (e.g., future consultations under section 106 of the National Historic Preservation Act or future government-to-government consultations with federally recognized tribes).

    Navigational Safety

    Potential bidders should note that future mitigation measures, including potential restrictions on the placement of structures, may be applied to development within all or portions of the New York LA to ensure navigation safety and the U.S. Coast Guard's (USCG's) ability to maintain mission readiness.

    The New York LA has been delineated to accommodate a setback of 1 nautical mile (nmi) from the adjacent Traffic Separation Schemes (TSSs) for the Port of New York and New Jersey. This setback is consistent with BOEM's delineation of other lease and wind energy areas that are in close proximity to TSSs (e.g., the lease areas offshore Massachusetts, Rhode Island/Massachusetts, Delaware, and Maryland; and the Wilmington West Wind Energy Area offshore North Carolina), and is based on input provided by the USCG as a member of the BOEM New York Intergovernmental Renewable Energy Task Force during development of the 2013 New York Request for Interest (RFI). As noted in the RFI, the LA includes aliquots that are transected by the 1 nmi setback line, and BOEM will require that no structures be installed on the portions of those aliquots located within the setback.

    In September 2015, BOEM received additional input from the USCG recommending a larger setback of 2 nmi from the TSSs and 5 nmi from the entry/exit points of the TSSs. USCG's correspondence to BOEM, which explains the recommendation, is available on BOEM's Web site at http://www.boem.gov/New-York/. In addition, on March 22, 2016, the USCG released its Final Report for its Atlantic Coast Port Access Route Study (ACPARS), available at http://www.uscg.mil/lantarea/acpars. The USCG's Marine Planning Guidelines, included as Enclosure 2 of the ACPARS, are consistent with its September 2015 recommendation to BOEM. Although BOEM did not adopt the USCG's recommendation during Area ID, BOEM may determine at a later stage in the process (e.g., after evaluating a Navigational Safety Risk Assessment that is submitted as a part of a COP) that, even with the application of mitigation measures, portions of the LA are not appropriate for the installation of wind facilities due to navigational safety concerns.

    Commercial Fishing

    Potential bidders should note that future mitigation measures may be applied to development within all or portions of the New York LA due to the use of the area as a fishery.

    BOEM received fishery-related comments in response to the RFI, Call for Information and Nominations, NOI, NOA, and several public outreach meetings. Commenters included NMFS, the New England and Mid-Atlantic Fishery Management Councils, and several fishing industry groups, primarily representing members of the sea scallop and squid fisheries. BOEM also received comments from commercial and recreational fishermen during BOEM's November 2015 fisheries workshops. A meeting summary of BOEM's November 2015 fisheries workshops and comments associated with these workshops are available on BOEM's Web site at http://www.boem.gov/New-York/, along with those comments received in response to BOEM's Federal Register notices relating to the New York LA.

    BOEM has also gathered information regarding the use of the LA as a fishery through a joint study with NMFS. This data, specific to the New York LA, is included in the revised EA and is available on BOEM's Web site at http://www.boem.gov/Fishing-Revenue-NY-Call-Area/. The spatial dataset is available at http://www.boem.gov/Renewable-Energy-GIS-Data/. Potential bidders should be aware that BOEM will be gathering additional data and may require plan-specific mitigation measures to minimize impacts.

    Between 2012 and 2016, BOEM collaborated with numerous stakeholders in the fishing and offshore wind industries to develop best management practices (BMPs) in furtherance of its goal of minimizing potential multiple use conflicts between offshore renewable energy developers and the fishing industry. As a result of this effort, BOEM has concluded that there would be great merit in a lessee's utilizing a fisheries liaison and a fisheries representative during the lessee's plan development process. BOEM has also received comments from the public regarding the importance of ensuring effective communication between the lessee and the fishing community. As a result, BOEM has issued guidance to lessees for communicating with fisheries stakeholders regarding social and economic impacts of renewable energy development on the Atlantic Outer Continental Shelf: http://www.boem.gov/Social-and-Economic-Conditions-Fishery-Communication-Guidelines/. Further, BOEM is requiring in Addendum C of the lease that the lessee develop a Fisheries Communication Plan that includes the utilization of a fisheries liaison to facilitate communication with the fishing industry.

    Visual Impacts to Historic Properties

    Potential bidders should note that future mitigation measures may be applied to development within all or portions of the New York LA to avoid, minimize, or mitigate adverse effects to historic properties or National Park Service (NPS) lands. The NPS, New York State Historic Preservation Office (NY SHPO), and New Jersey State Historic Preservation Office (NJ SHPO) have expressed concern regarding the potential for wind energy development within the New York WEA to cause adverse effects to onshore historic properties. Correspondence outlining these concerns is available on BOEM's Web site at http://www.boem.gov/New-York/.

    During the summer and fall of 2015, BOEM conducted stakeholder outreach with the NPS, NY SHPO, and NJ SHPO. BOEM also completed a study entitled, “Renewable Energy Viewshed Analysis and Visualization Simulation for the New York Outer Continental Shelf Call Area” to assist in this outreach effort and to provide scientific and technical information about visual impacts to inform its Area ID decision. Results of this study are available under the header “Visual Simulations” at http://www.boem.gov/New-York/.

    Withdrawal of Blocks: BOEM reserves the right to withdraw all or portions of the LA prior to executing the lease with the winning bidder, based upon relevant information provided to the Bureau.

    Lease Terms and Conditions: BOEM has included terms, conditions, and stipulations for the OCS commercial wind lease to be offered through this sale. After the lease is issued, BOEM reserves the right to require compliance with additional terms and conditions associated with approval of a SAP or COP.

    The lease is available on BOEM's Web site at http://www.boem.gov/New-York/. The lease includes the following seven attachments:

    • Addendum “A” (Description of Leased Area and Lease Activities);

    • Addendum “B” (Lease Term and Financial Schedule);

    • Addendum “C” (Lease Specific Terms, Conditions, and Stipulations);

    • Addendum “D” (Project Easement);

    • Addendum “E” (Rent Schedule post COP approval);

    • Appendix A to Addendum “C”: (Incident Report: Protected Species Injury or Mortality); and

    • Appendix B to Addendum “C”: (Required Data Elements for Protected Species Observer Reports).

    Addenda “A,” “B,” and “C” provide detailed descriptions of lease terms and conditions. Addenda “D” and “E” will be completed at the time of COP approval or approval with modifications.

    The most recent version of BOEM's renewable energy commercial lease form (BOEM-0008) is available on BOEM's Web site at: http://www.boem.gov/BOEM-OCS-Operation-Forms/.

    Potential bidders should note that BOEM and the Bureau of Safety and Environmental Enforcement (BSEE) are in the process of reassigning regulations relating to safety and environmental oversight and enforcement responsibilities for offshore renewable energy projects from BOEM to BSEE. Once this administrative reassignment is finalized, BOEM may make ministerial and non-substantive amendments to the lease to conform it to regulatory revisions.

    Plans: Pursuant to 30 CFR 585.601, the lessee must submit a SAP within 12 months of lease issuance. If the lessee intends to continue its commercial lease with an operations term, the lessee must submit a COP at least 6 months before the end of the site assessment term.

    Financial Terms and Conditions: This section provides an overview of the annual payments required of the lessee that will be fully described in the lease, and the financial assurance requirements that will be associated with the lease.

    Rent: Pursuant to 30 CFR 585.224(b) and 585.503, the first year's rent payment of $3 per acre is due within 45 calendar days of the date the lessee receives the lease for execution. Thereafter, annual rent payments are due on the anniversary of the Effective Date of the lease (the “Lease Anniversary”). Once commercial operations under the lease begin, BOEM will charge rent only for the portions of the lease not authorized for commercial operations, i.e., not generating electricity. However, instead of geographically dividing the LA into acreage that is “generating” and “non-generating,” the fraction of the lease accruing rent will be based on the fraction of the total nameplate capacity of the project that is not yet in operation. This fraction is calculated by dividing the nameplate capacity not yet authorized for commercial operations at the time payment is due by the anticipated nameplate capacity after full installation of the project (as described in the COP). The annual rent due for a given year is then derived by multiplying this fraction by the amount of rent that would have been due for the lessee's entire LA at the rental rate of $3 per acre.

    For a 79,350 acre lease (the size of the New York LA), the rent payment will be $238,050 per year ($3 times 79,350) if no portion of the leased area is authorized for commercial operations. If 300 megawatts (MW) of a project's nameplate capacity is operating (or authorized for operation), and the approved COP specifies a maximum project size of 500 MW, the rent payment will be $95,220. This payment is based on the 200 MW of nameplate capacity BOEM has not yet authorized for commercial operations. For the above example, this would be calculated as follows: 200MW/500MW × ($3/acre × 79,350 acres) = $95,220.

    If the lessee submits an application for relinquishment of a portion of its lease area within the first 45 calendar days following the date that the lease is received by the lessee for execution, and BOEM approves that application, no rent payment will be due on the relinquished portion of the LA. Later relinquishments of any portion of the LA will reduce the lessee's rent payments starting in the year following BOEM's approval of the relinquishment.

    The lessee also must pay rent for any project easement associated with the lease, commencing on the date that BOEM approves the COP (or modification thereof) that describes the project easement. Annual rent for a project easement is the greater of $5 per acre per year or $450 per year.

    Operating Fee

    For purposes of calculating the initial annual operating fee payment, pursuant to 30 CFR 585.506, an operating fee rate is applied to a proxy for the wholesale market value of the electricity expected to be generated from the project during its first twelve months of operations. This initial payment will be prorated to reflect the period between the commencement of commercial operations and the Lease Anniversary. The initial annual operating fee payment is due within 45 days of the commencement of commercial operations. Thereafter, subsequent annual operating fee payments are due on or before each Lease Anniversary.

    The subsequent annual operating fee payments are calculated by multiplying the operating fee rate by the imputed wholesale market value of the projected annual electric power production. For the purposes of this calculation, the imputed market value is the product of the project's annual nameplate capacity, the total number of hours in a year (8,760), the capacity factor, and the annual average price of electricity derived from a historical regional wholesale power price index. For example, the annual operating fee for a 100 MW wind facility operating at a 40% capacity (i.e., capacity factor of 0.4) with a regional wholesale power price of $50/MWh and an operating fee rate of 0.02 would be calculated as follows:

    EN31OC16.006

    Operating Fee Rate: The operating fee rate is the share of imputed wholesale market value of the projected annual electric power production due to BOEM as an annual operating fee. For the New York LA to be offered in this sale, this fee is set at 0.02 (i.e., 2%) during the entire life of commercial operations.

    Nameplate Capacity: Nameplate capacity is the maximum rated electric output, expressed in MW, that the turbines of the wind facility under commercial operations can produce at their rated wind speed as designated by the turbine's manufacturer. The lessee will specify in its COP the nameplate capacity available at the start of each year of commercial operations on the lease. For example, if the lessee specifies 20 turbines in its COP, and each is rated by the manufacturer at 5 MW, the nameplate capacity of the wind facility would be 100 MW.

    Capacity Factor: The capacity factor compares the amount of energy delivered to the grid during a period of time to the amount of energy the wind facility would have produced at full capacity. The amount of power delivered will always be less than the theoretical 100% capacity, largely because of the variability of wind speeds, transmission line loss, and down time for maintenance or other purposes.

    The capacity factor is expressed as a decimal between zero and one, and represents the share of anticipated generation of the wind facility that is delivered to the interconnection grid (i.e., where the lessee's facility interconnects with the electric grid) relative to the wind facility's generation at continuous full power operation at nameplate capacity. BOEM has set the capacity factor for the year in which commercial operations commence and the six full years thereafter at 0.4 (i.e., 40%). At the end of the sixth year, BOEM may adjust the capacity factor to reflect the performance over the previous five full years based upon the actual metered electricity generation at the delivery point to the electrical grid. BOEM may make similar adjustments to the capacity factor once every five years thereafter. The maximum change in the capacity factor from one period to the next will be limited to plus or minus 10 percent of the previous period's value.

    Wholesale Power Price Index: Pursuant to 30 CFR 585.506(c)(2)(i), the wholesale power price, expressed in dollars per MW-hour, is determined at the time each annual operating fee payment is due, based on the weighted average of the inflation-adjusted peak and off-peak spot price indices. Typically, BOEM's commercial wind leases specify an electric region and a source for referencing price information. However, at the current time, it is uncertain where a project's transmission cable may make landfall, so BOEM decided not to specify the electric region and source of price information at the lease issuance stage. The electric region of the wholesale power price index will encompass the location where the cable makes landfall. BOEM will specify the referencing price information upon approval of the COP. The wholesale power price is adjusted for inflation from the year associated with the published spot price indices to the year in which the operating fee is to be due, based on the Lease Anniversary and using annual implicit price deflators as reported by the U.S. Department of Commerce Bureau of Economic Analysis.

    Financial Assurance

    Within 10 business days after receiving the lease copies and pursuant to 30 CFR 585.515-.516, the provisional winner of the New York LA must provide an initial lease-specific bond or other approved means of meeting BOEM's initial financial assurance requirements. The provisional winner may meet financial assurance requirements by posting a surety bond or by setting up an escrow account with a trust agreement giving BOEM the right to withdraw the money held in the account on demand. BOEM encourages the provisionally winning bidder to discuss the financial assurance requirement with BOEM as soon as possible after the auction has concluded.

    BOEM will base the amount of all SAP, COP, and decommissioning financial assurance requirements on cost estimates for meeting all accrued lease obligations at the respective stages of development. The required amount of supplemental and decommissioning financial assurance will be determined on a case-by-case basis.

    The financial terms can be found in Addendum “B” of the lease, which BOEM has made available with this notice on its Web site at: http://www.boem.gov/New-York/.

    Bid Deposit: A bid deposit is an advance cash deposit submitted to BOEM in order to participate in the auction. Each bidder must submit a bid deposit of $450,000 no later than November 28, 2016. Any bidder that fails to submit the bid deposit by this deadline may be disqualified from participating in the auction. Bid deposits will be accepted online via pay.gov.

    Each bidder must fill out the BFF referenced in this FSN. BOEM has made a copy of the form available with this notice on its Web site at: http://www.boem.gov/New-York/. BOEM recommends that each bidder designate an email address in its BFF that the bidder will then use to create an account in pay.gov (if it has not already done so). Bidders may then use the Bid Deposit Form on the pay.gov Web site to leave a deposit.

    BOEM will not consider BFFs submitted by bidders for previous lease sales to satisfy the requirements of this auction. Further, BOEM will only consider BFFs submitted after the deadline if BOEM determines that the failure to timely submit the BFF was caused by events beyond the bidder's control. BOEM will only accept an original, executed paper copy of the BFF. The BFF must be executed by an authorized representative who has been identified in the qualifications package on file with BOEM as authorized to bind the company.

    Following the auction, bid deposits will be applied against bids or other obligations owed to BOEM. If the bid deposit exceeds a bidder's total financial obligation, the balance of the bid deposit will be refunded to the bidder. BOEM will refund bid deposits to non-winners once BOEM has announced the provisional winner.

    Bidders will forfeit their bid deposit if they are the provisionally winning bidder and they fail to execute a lease pursuant to their provisionally winning bid. Exercising the LOR pursuant to the rules described in this notice constitutes a limited exception to this rule, wherein if BOEM notifies a bidder that it may revoke its provisionally winning bid immediately following the lease sale, and if the bidder revokes such bid within the allotted time, then that bidder will not forfeit its $450,000 bid deposit. If a bidder exercises its LOR in this manner, BOEM will reoffer the lease to the government authority that is the second-highest bidder. In this case, the government authority would inherit the obligation to execute a lease pursuant to the government authority's now-provisionally winning bid, forfeiting its bid deposit if it does not execute the lease within the required timeframe.

    If BOEM offers a lease pursuant to a provisionally winning bid, and that bidder fails to timely return the signed lease form, establish financial assurance, or pay the balance of its bid, BOEM will retain that bidder's $450,000 bid deposit. BOEM reserves the right to reconvene the panel to determine which bidder would have won in the absence of the provisionally winning bid, and to offer a lease to that bidder.

    Minimum Bid: The minimum bid is the lowest bid price BOEM will accept as a winning bid, and it is where BOEM will start the monetary bidding. BOEM has established a minimum bid of $2.00 per acre for this lease sale. Accordingly, the minimum bid will be $158,700 for Lease OCS-A 0512.

    Auction Procedures Multiple-Factor Bidding

    As authorized under 30 CFR 585.220(a)(4) and 585.221(a)(6), BOEM will use a multiple-factor auction format, with a multiple-factor bidding system, for this lease sale. Under this system, BOEM may consider a combination of monetary and non-monetary factors, or “variables,” in determining the outcome of the auction. BOEM will appoint a panel of BOEM employees to review the non-monetary packages and verify the results of the lease sale. BOEM reserves the right to change the composition of this panel at any time.

    10% Non-Monetary Credit for Government Authorities

    In response to public comments on the PSN, BOEM is offering a 10% non-monetary bid credit in this lease sale for government authorities. In order to be considered for this non-monetary credit, BOEM must receive a bidder's non-monetary package no later than November 28, 2016, establishing that the bidder meets the definition of a government authority, below:

    Government Authority: A governmental entity, political subdivision thereof, or public benefit corporation exercising executive and/or regulatory functions within the United States.

    If a bidder wishes to establish itself as a government authority for the purposes of the auction, it must timely submit a non-monetary package for approval by BOEM. The non-monetary package may consist of new information to help a bidder demonstrate its status as a government authority, and/or may reference materials that the bidder has already submitted to BOEM to establish that the bidder is legally qualified to participate in the sale. If bidders wish to review what materials they have already submitted, they should contact Gina Best at 703-787-1341, as soon as practicable.

    Prior to the date of the auction, the panel will determine which bidders, if any, have qualified for the non-monetary credit. Bidders will be notified by email prior to the date of the auction if they have been granted a non-monetary credit. If the panel determines that no bidder is eligible to bid as a government authority and receive a credit, the auction will proceed with each bidder registered with no imputed credit. Bidders will not be notified whether other bidders have qualified for a non-monetary credit until after the bidding has concluded.

    Under the format for this sale, in each round a bidder may submit a bid proposal, i.e., a multiple-factor bid, for the LA. The multiple-factor bid made by a particular bidder in each round represents the sum of a non-monetary credit and a monetary (cash) amount. The non-monetary portion of the bid is represented by a 10% credit on the bid. This credit will be applied throughout the auction in each round as a form of imputed payment against the LA's asking price in a bidder's multiple-factor bid. The bid credit will be bundled into each bid. In each round, the auction system will show each bidder how their As-Bid auction price is affected by the credit imputed to its bid.

    Reservation of Limited Opportunity To Revoke (RLOR)

    In response to public comments on the PSN, BOEM is introducing the LOR as a feature of the New York lease sale. Each bidder may download, complete, sign and return the RLOR form from BOEM's Web site at http://www.boem.gov/New-York/. BOEM must receive the completed, signed RLOR no later than November 28, 2016. If BOEM does not receive the form by that date, BOEM will presume that the bidder does NOT wish to reserve the LOR. BOEM will consider extensions to this deadline only if BOEM determines that the failure to timely submit an RLOR was caused by events beyond the bidder's control.

    If a bidder opts into an LOR, and then becomes the provisional winner of the auction, it will be given a short opportunity just after the auction to revoke its provisionally winning bid without forfeiting its bid deposit of $450,000, if the second-place bidder is a government authority. Alternatively, bidders may choose not to opt-in. If a provisionally winning bidder does not reserve the LOR, that bidder will not be given an opportunity to revoke its provisionally winning bid following the sale without jeopardizing its bid deposit of $450,000. If a bidder fails to return the form in a timely manner, absent any extension granted by BOEM, it will be deemed to have opted out of its LOR. More information on LOR can be found in the “Determining Provisional Winner” section below.

    The Auction

    The auction will be conducted in a series of rounds. At the start of each round, BOEM will state an asking price for the LA. If a bidder is willing to meet that asking price for the LA, it will indicate this by submitting a bid equal to the asking price, i.e., a live bid. If the bidder has earned a non-monetary credit, it will meet the asking price by submitting a multiple-factor bid—that is, a live bid that consists of a monetary element (90%) and a non-monetary element (10%), the sum of which equals the asking price. Bidders without a non-monetary credit will submit a cash bid equal to the asking price.

    To participate in any round of the auction, a bidder must have submitted a live bid in the previous round. As long as there are two or more live bids for the LA, the auction proceeds to the next round. Between rounds, BOEM will raise the asking price for the LA by an increment that it determines appropriate. Asking price increments are within BOEM's sole discretion, but are based on a number of factors, including the number of bidders still active in the auction and BOEM's best estimate of how many rounds may remain before the auction is resolved. BOEM also reserves the right to increase or decrease bidding increments between rounds, if it determines that a different increment is warranted to enhance the efficiency of the auction process.

    As the auction proceeds, a bidder retains its eligibility to continue bidding as long as that bidder submitted a live bid on the LA in the previous round. Between rounds, BOEM will release information indicating the number of live bids for the LA in the previous round of the auction (i.e., the level of demand) and the asking price for the LA in the upcoming round of the auction. Bidders may be bound by any of their bids until the auction results are finalized.

    Exit Bidding

    In any round after the first round of the auction, a bidder may submit an exit bid that is higher than the previous round's asking price, but less than the current round's asking price. An exit bid must consist of a single offer price. If a bidder submits an exit bid, it is not eligible to participate in subsequent bidding rounds of the auction. During the auction, exit bids will be seen only by BOEM and not by other bidders.

    If the LA receives only exit bids in a round, BOEM will not raise the price and start another round, because no bidders would be eligible to bid in the next round.

    Determining the Provisional Winner

    The auction will end in the first round in which one or zero live bids is received. If one live bid is received, that bid is the provisionally winning bid. If no live bids are received, then the highest exit bid received is the provisionally winning bid. If there is a tie for the highest exit bid, BOEM's tie-breaking procedures will resolve the tie. If no live or exit bids are received, then there is a tie among all bidders that submitted live bids at the most recent asking price, and BOEM's tie-breaking procedures will determine the provisionally winning bid.

    LOR

    As noted, in response to public comments on the PSN, this lease sale includes an LOR. Ordinarily, if a provisionally winning bidder does not execute a lease pursuant to that provisionally winning bid, that bidder will forfeit its bid deposit. In this lease sale, a provisionally winning bidder will have a chance to revoke its provisionally winning bid without this penalty, but only under the following circumstances:

    1. The provisionally winning bidder reserved the right to a LOR through a timely-submitted RLOR in advance of the auction; and

    2. The second highest bid was submitted by a government authority.

    If these two elements are satisfied, then BOEM will offer the provisionally winning bidder one hour to revoke its provisionally winning bid. If there is a tie for the second highest bid, including a government authority, the tie will be resolved and an LOR will be offered only if the government authority has the second-place bid following resolution of the tie.

    The provisionally winning bidder will be given precisely one hour to revoke, using the messaging tool in the auction system. If that bidder wishes to revoke, the message should consist of the following statement:

    “We hereby revoke our provisionally winning bid for ATLW-6, pursuant to the Reservation of Limited Opportunity to Revoke form submitted previously.”

    If the statement above is not included verbatim in the message a bidder uses to exercise its limited right to revoke, BOEM may not accept the LOR. Once BOEM receives this message, it will consider the provisionally winning bid to be revoked. If the provisionally winning bidder revokes its bid, the government authority will then become the new provisionally winning bidder and will be subject to the conditions in 30 CFR 585.224. In this case, the provisionally winning bid will be the government authority's last bid for the LA.

    If the provisionally winning bidder does not revoke its bid within the designated hour, BOEM's requirements for the bidder will be the same as it would be for a sale without the LOR. Pursuant to 30 CFR 585.224, once BOEM sends the lease copies to the bidder, the bidder must timely pay the balance of its bid, establish financial assurance, and properly sign and return the lease copies. If the bidder fails to do so, then BOEM may not issue the lease to that bidder, in which case the bidder would forfeit its bid deposit. BOEM may consider failure of a bidder to timely pay the full amount due an indication that the bidder is no longer financially qualified to participate in other lease sales under BOEM's regulations at 30 CFR 585.106 and 585.107.

    If the highest bidder revokes its provisionally winning bid pursuant to an LOR, the government authority with the second-highest bid in the auction becomes the provisionally winning bidder and must follow all of BOEM's requirements contained in 30 CFR 585.224. The government authority would then need to execute a lease pursuant to its provisionally winning bid, or risk forfeiture of its bid deposit.

    BOEM will use its tie-breaking procedures to resolve any ties before determining whether the conditions have been met for offering a provisionally winning bidder a LOR. Ties are resolved by a random process. The auction system generates a random number for each bidder. In the event of a tie, these numbers are compared, and the bidder with the higher random number is deemed the provisional winner.

    Following the lease sale, the non-monetary panel will convene, review the auction record, and certify the results of the sale. Shortly thereafter, BOEM will notify the DOJ that it may begin its antitrust review pursuant to 43 U.S.C. 1337(c).

    If a bidder fails to execute a lease pursuant to a provisionally winning bid, BOEM may reoffer that lease to the next highest bidder. If the bidder that fails to execute is a government authority that had been declared the provisional winner after the exercise of a LOR, BOEM may first reoffer the lease to the bidder that had exercised the LOR. If BOEM reoffers the lease following a bidder's failure to execute a lease pursuant to a provisionally winning bid, the second bidder to which the lease is offered may decline the offer without forfeiting its bid deposit.

    Additional Information Regarding the Auction Format Bidder Authentication

    For the online auction, BOEM will require two-factor authentication. Prior to the auction, the Auction Manager will send several bidder authentication packages to the bidders shortly after BOEM has processed the BFFs. One package will contain digital authentication tokens allowing access to the auction Web site. The tokens will be mailed to the Primary Point of Contact indicated on the BFF. This individual is responsible for distributing the tokens to the individuals authorized to bid for that company. Bidders are to ensure that each token is returned within three business days following the auction. An addressed, stamped envelope will be provided to facilitate this process. In the event that a bidder fails to submit a bid deposit or does not participate in the auction, BOEM will de-activate that bidder's token and login information, and the bidder will be asked to return its tokens.

    The second package contains login credentials for authorized bidders. The login credentials will be mailed to the address provided in the BFF for each authorized individual. Bidders can confirm these addresses by calling 703-787-1320. This package will contain user login information and instructions for accessing the Auction System Technical Supplement and Alternative Bidding Form. The login information, along with the tokens, will be tested during the Mock Auction.

    Timing of Auction

    The auction will begin at 8:30 a.m. EST on December 15, 2016. Bidders may log in as early as 8:00 a.m. on that day. We recommend that bidders log in earlier than 8:30 a.m. on that day to ensure that any login issues are resolved prior to the start of the auction. Once bidders have logged in, they should review the auction schedule, which lists the start times, end times, and recess times of each round in the auction. Each round is structured as follows:

    • Round bidding begins;

    • Bidders enter their bids;

    • Round bidding ends and the Recess begins;

    • During the Recess, previous Round results are posted;

    • Bidders review the previous Round results and prepare their next Round bids; and

    • Next Round bidding begins.

    The first round will last about 30 minutes, though subsequent rounds may be shorter. Recesses are anticipated to last approximately 10 minutes. The descriptions of the auction schedule and asking price increments included with this FSN are tentative. Bidders should consult the auction schedule on the bidding Web site during the auction for updated times. Bidding will continue until about 6:00 p.m. each day. BOEM anticipates the auction will last one or two business days, but bidders are advised to prepare to continue bidding for additional business days as necessary to resolve the auction.

    BOEM and the auction contractors will use the auction platform messaging service to keep bidders informed on issues of interest during the auction. For example, BOEM may change the schedule at any time, including during the auction. If BOEM changes the schedule during the auction, it will use the messaging feature to notify bidders that a revision has been made, and direct bidders to the relevant page. BOEM will also use the messaging system for other changes and items of note during the auction.

    Bidders may place bids at any time during the round. At the top of the bidding page, a countdown clock will show how much time remains in the round. Bidders have until the scheduled time to place bids. Bidders should do so according to the procedures described in this notice, and the Auction System Technical Supplement. No information about the round is available until the round has closed and results have been posted, so there should be no strategic advantage to placing bids early or late in the round.

    The timing of the auction will be elaborated on and clarified in the Auction System Technical Supplement available on BOEM's Web site at: http://www.boem.gov/New-York/. The Auction System Technical Supplement describes auction procedures that are incorporated by reference in this notice, unless the procedures described in the Auction System Technical Supplement directly contradict this notice. In the event of a contradiction, this FSN is controlling.

    Prohibition on Communications Between Bidders During Auction

    During the auction, and including one hour after the auction if LOR is triggered, bidders are prohibited from communicating with each other regarding their participation in the auction. Additionally, during the auction, and including one hour after the auction if LOR is triggered, bidders are prohibited from communicating to the general public, including, but not limited to, through social media, updated Web sites, or press releases, regarding any aspect of their participation or lack thereof in the auction.

    Alternate Bidding Procedures

    Alternate Bidding Procedures enable a bidder that is having difficulties accessing the Internet to submit its bid via fax using an Alternate Bidding Form available on BOEM's Web site at: http://www.boem.gov/New-York/.

    In order to be authorized to use an Alternative Bidding Form, a bidder must call the help desk number listed in the Auction Manual before the end of the round. BOEM will authenticate the caller to ensure he/she is authorized to bid on behalf of the bidder. The bidder must explain the reasons for which he/she is forced to place a bid using the Alternate Bidding Procedures. BOEM may, in its sole discretion, permit or refuse to accept a request for the placement of a bid using the Alternate Bidding Procedures.

    If bidders need to submit an Alternate Bidding Form, they are strongly encouraged to do so before the round ends.

    Rejection or Non-Acceptance of Bids: BOEM reserves the right and authority to reject any and all bids that do not satisfy the requirements and rules of the auction, the FSN, and all applicable regulations and statutes.

    Anti-Competitive Review

    Bidding behavior in this sale is subject to Federal antitrust laws. Accordingly, following the auction, but before the acceptance of bids and the issuance of leases, BOEM will “allow the Attorney General, in consultation with the Federal Trade Commission, 30 days to review the results of the lease sale.” 43 U.S.C. 1337(c). If a bidder is found to have engaged in anti-competitive behavior in connection with its participation in the competitive bidding process, BOEM may reject the provisionally winning bid. Compliance with BOEM's auction procedures and regulations is not an absolute defense to violations of antitrust laws.

    Anti-competitive behavior determinations are fact-specific. However, such behavior may manifest itself in several different ways, including, but not limited to:

    • An express or tacit agreement among bidders not to bid in an auction, or to bid a particular price;

    • An agreement among bidders not to bid for a particular LA;

    • An agreement among bidders not to bid against each other; or

    • Other agreements among bidders that have the potential to affect the final auction price.

    BOEM will decline to award a lease if the Attorney General, in consultation with the Federal Trade Commission, determines that doing so would be inconsistent with the antitrust laws 43 U.S.C. 1337(c).

    For more information on whether specific communications or agreements could constitute a violation of Federal antitrust law, please see: http://www.justice.gov/atr/public/business-resources.html, or consult counsel.

    Process for Issuing the Lease: Once all post-auction reviews have been completed to BOEM's satisfaction, BOEM will issue three unsigned copies of the lease to the provisionally winning bidder. Within 10 business days after receiving the lease copies, the provisionally winning bidder must:

    1. Sign the lease on the bidder's behalf;

    2. File financial assurance, as required under 30 CFR 585.515-537; and

    3. Pay by electronic funds transfer (EFT) the balance (if any) of the bonus bid (winning bid less the bid deposit). BOEM requires bidders to use EFT procedures (not pay.gov, the Web site bidders used to submit bid deposits) for payment of the balance of the bonus bid, following the detailed instructions contained in the “Instructions for Making Electronic Payments” available on BOEM's Web site at: http://www.boem.gov/New-York/.

    BOEM will not execute a lease until the three requirements above have been satisfied, BOEM has accepted the provisionally winning bidder's financial assurance pursuant to 30 CFR 585.515, and BOEM has processed the provisionally winning bidder's payment.

    BOEM may extend the ten business day deadline for executing the lease on the bidder's behalf, filing the required financial assurance, and/or paying the balance of the bonus bid if it determines the delay was caused by events beyond the provisionally winning bidder's control.

    If the provisionally winning bidder does not meet these requirements or otherwise fails to comply with applicable regulations or the terms of the FSN, BOEM reserves the right to not issue the lease to that bidder. In such a case, the provisionally winning bidder will forfeit its bid deposit.

    Within 45 calendar days of the date that the provisionally winning bidder receives copies of the lease, it must pay the first year's rent using the pay.gov Renewable Energy Initial Rental Payment form available at: https://pay.gov/paygov/forms/formInstance.html?agencyFormId=27797604. Subsequent annual rent payments must be made following the detailed instructions contained in the “Instructions for Making Electronic Payments,” available on BOEM's Web site at:http://www.boem.gov/New-York/.

    Non-Procurement Debarment and Suspension Regulations: Pursuant to regulations at 43 CFR part 42, subpart C, an OCS renewable energy lessee must comply with the Department of the Interior's non-procurement debarment and suspension regulations at 2 CFR 180 and 1400. The lessee must also communicate this requirement to persons with whom the lessee does business relating to this lease, by including this term as a condition in its contracts and other transactions.

    Force Majeure: The Program Manager of BOEM's Office of Renewable Energy Programs has the discretion to change any auction details specified in the FSN, including the date and time, in case of a force majeure event that the Program Manager determines may interfere with a fair and proper lease sale process. Such events may include, but are not limited to: Natural disasters (e.g., earthquakes, hurricanes, floods, blizzards), wars, riots, acts of terrorism, fire, strikes, civil disorder or other events of a similar nature. In case of such an event, BOEM will notify all bidders via email, phone, or through the BOEM Web site at: http://www.boem.gov/Renewable-Energy-Program/index.aspx. Bidders should call 703-787-1320 if they have concerns.

    Appeals: The appeals procedures are provided in BOEM's regulations at 30 CFR 585.118(c) and 585.225. Pursuant to 30 CFR 585.225:

    (a) If BOEM rejects your bid, BOEM will provide a written statement of the reasons and refund any money deposited with your bid, without interest.

    (b) You will then be able to ask the BOEM Director for reconsideration, in writing, within 15 business days of bid rejection, under 30 CFR 585.118(c)(1). We will send you a written response either affirming or reversing the rejection.

    The procedures for appealing final decisions with respect to lease sales are described in 30 CFR 585.118(c).

    Protection of Privileged or Confidential Information

    Consistent with the Freedom of Information Act (FOIA), BOEM will protect privileged or confidential information that you submit. Exemption 4 of FOIA applies to “trade secrets and commercial or financial information that you submit that is privileged or confidential.” 5 U.S.C. 552(b)(4). If you wish to protect the confidentiality of such information, clearly mark it, “Contains Privileged or Confidential Information,” and consider submitting such information as a separate attachment. BOEM will not disclose such information, except as required by FOIA. Information that is not labeled as privileged or confidential will be regarded by BOEM as suitable for public release. Further, BOEM will not treat as confidential aggregate summaries of otherwise confidential information.

    Authority:

    This FSN is published pursuant to subsection 8(p) of the OCS Lands Act (43 U.S.C. 1337(p)) (“the Act”), as amended by section 388 of the Energy Policy Act of 2005 (EPAct), and the implementing regulations at 30 CFR part 585, including sections 211 and 216.

    Dated: October 25, 2016. Abigail Ross Hopper, Director, Bureau of Ocean Energy Management.
    [FR Doc. 2016-26240 Filed 10-28-16; 8:45 am] BILLING CODE 4310-MR-P
    DEPARTMENT OF THE INTERIOR Bureau of Ocean Energy Management [Docket No. BOEM-2016-0066] Environmental Assessment for Commercial Wind Lease Issuance and Site Assessment Activities on the Atlantic Outer Continental Shelf Offshore New York; MMAA104000 AGENCY:

    Bureau of Ocean Energy Management (BOEM), Interior.

    ACTION:

    Notice of availability of a revised environmental assessment and a finding of no significant impact.

    SUMMARY:

    BOEM is announcing the availability of a revised environmental assessment (EA) and finding of no significant impact (FONSI) for commercial wind lease issuance, site characterization activities (geophysical, geotechnical, archaeological, and biological surveys), and site assessment activities (including the installation and operation of a meteorological tower or buoys or both a tower and buoys) on the Atlantic Outer Continental Shelf offshore New York. The revised EA provides a discussion of potential impacts of the proposed action and an analysis of reasonable alternatives to the proposed action. In accordance with the requirements of the National Environmental Policy Act (NEPA) and the Council on Environmental Quality's (CEQ) regulations implementing NEPA at 40 CFR 1500-1508, BOEM issued a FONSI supported by the analysis in the revised EA. The FONSI concluded that the reasonably foreseeable environmental impacts associated with the proposed action and alternatives, as set forth in the EA, would not significantly impact the quality of the human environment; therefore, the preparation of an environmental impact statement is not required. This notice is being published concurrently with the Final Sale Notice for the New York Wind Energy Area (WEA). These documents and associated information are available on BOEM's Web site at http://www.boem.gov/New-York/.

    FOR FURTHER INFORMATION CONTACT:

    Michelle Morin, BOEM Office of Renewable Energy Programs, 45600 Woodland Road, Sterling, Virginia 20166, (703) 787-1340 or [email protected]

    SUPPLEMENTARY INFORMATION:

    In June 2016, BOEM published an EA to consider the reasonably foreseeable environmental consequences associated with commercial wind lease issuance, site characterization activities, and site assessment activities within the WEA offshore New York. A notice was published on June 6, 2016, to announce the availability of the EA and initiate a 30-day public comment period (81 FR 36344). Due to requests for extension, the public comment period closed on July 13, 2016. The EA was subsequently revised based on comments received through Regulations.gov and at public information meetings during the comment period. The revised EA provides updated environmental data, incorporates the results of consultations, and reflects a change to the proposed lease area (i.e., removal of Cholera Bank sensitive habitat). The revised EA also includes a summary of comments received on the June 2016 EA and BOEM's responses to those comments.

    In addition to the proposed action, the revised EA considers two alternatives: (1) Restricting site assessment structure placement within 2 nm (3.7 km) of the traffic separation scheme, and (2) no action. BOEM's analysis of the proposed action and alternatives takes into account standard operating conditions (SOCs) designed to avoid or minimize potential impacts to marine mammals and sea turtles. The SOCs can be found in Appendix B of the revised EA.

    BOEM will use the revised EA to inform its decisions regarding lease issuance in the New York WEA and subsequent review of site assessment plans in the lease area. The competitive leasing process is set forth at 30 CFR 585.210-585.225. A future lessee may propose a wind energy generation facility on its lease by submitting a construction and operations plan (COP) to BOEM. BOEM would then prepare a separate site- and project-specific NEPA analysis of the activities proposed in the COP.

    Authority:

    This notice of availability for an EA is in compliance with the National Environmental Policy Act (NEPA) of 1969, as amended (42 U.S.C. 4231 et seq.), and is published pursuant to 43 CFR 46.305.

    Dated: October 25, 2016. Abigail Ross Hopper, Director, Bureau of Ocean Energy Management.
    [FR Doc. 2016-26237 Filed 10-28-16; 8:45 am] BILLING CODE 4310-MR-P
    DEPARTMENT OF JUSTICE [OMB Number 1105-0086] Agency Information Collection Activities; Proposed eCollection eComments Requested; Proposed Renewal, With Change, of a Previously Approved Collection; Attorney Student Loan Repayment Program Electronic Forms AGENCY:

    Department of Justice.

    ACTION:

    30 day notice.

    SUMMARY:

    The Department of Justice (DOJ), Justice Management Division, Office of Attorney Recruitment and Management (OARM), will be submitting 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. This proposed information collection was previously published in the Federal Register at 81 FR 54604 on August 16, 2016, allowing for a 60 day comment period.

    DATES:

    Comments are encouraged and will be accepted for an additional 30 days until December 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the U.S. Department of Justice, Office of Attorney Recruitment and Management, 450 5th Street NW., Suite 10200, Attn: Deana Willis, Washington, DC 20530 or sent to [email protected] Written comments and/or suggestions can also be sent to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503 or sent to [email protected]

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    (2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information;

    (3) Enhance the quality, utility, and clarity of the information to be collected; and

    (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Overview of this information collection:

    1. Type of Information Collection: Revision and renewal of a currently approved collection.

    2. The Title of the Form/Collection: Attorney Student Loan Repayment Program Electronic Forms.

    3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: Form Number: None. Office of Attorney Recruitment and Management, Justice Management Division, U.S. Department of Justice.

    4. Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. Other: None.

    The Department of Justice Attorney Student Loan Repayment Program (ASLRP) is an agency recruitment and retention incentive program based on 5 U.S.C. 5379, as amended, and 5 CFR part 537. Anyone currently employed as an attorney or hired to serve in an attorney position within the Department may request consideration for the ASLRP. The Department selects new participants during an annual open season each spring and renews current beneficiaries who remain qualified for these benefits, subject to availability of funds. There are two application forms—one for new requests, and the other for renewal requests. A justification form (applicable to new requests only) and a loan continuation form complete the collection.

    5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The Department anticipates about 275 respondents annually will complete the new request form and justification form and apply for participation in the ASLRP. In addition, each year the Department expects to receive approximately 110 applications from attorneys requesting renewal of the benefits they received in previous years. It is estimated that each new request (including justification) will take two (2) hours to complete, and each renewal request approximately 20 minutes to complete.

    6. An estimate of the total public burden (in hours) associated with the collection: The estimated public burden associated with this collection is 586 hours, 40 minutes. It is estimated that new applicants will take 2 hours to complete the request form and justification and that current recipients requesting continued funding will take 20 minutes to complete a renewal form. The burden hours for collecting respondent data, 586 hours, 40 minutes, are calculated as follows: 275 new respondents × 2 hours = 550 hours, plus 110 renewing respondents × 20 minutes = 36 hours, 40 minutes.

    If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.

    Dated: October 26, 2016. Jerri Murray, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2016-26161 Filed 10-28-16; 8:45 am] BILLING CODE 4410-PB-P
    DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Special Dipping and Coating Operations (Dip Tanks) ACTION:

    Notice.

    SUMMARY:

    The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, “Special Dipping and Coating Operations (Dip Tanks),” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq. Public comments on the ICR are invited.

    DATES:

    The OMB will consider all written comments that agency receives on or before November 30, 2016.

    ADDRESSES:

    A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201604-1218-003 (this link will only become active on the day following publication of this notice) or by contacting Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected]

    Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email: [email protected] Commenters are encouraged, but not required, to send a courtesy copy of any comments by mail or courier to the U.S. Department of Labor-OASAM, Office of the Chief Information Officer, Attn: Departmental Information Compliance Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210; or by email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected]

    (Authority: 44 U.S.C. 3507(a)(1)(D)).
    SUPPLEMENTARY INFORMATION:

    This ICR seeks to extend PRA authority for the Special Dipping and Coating Operations (Dip Tanks) information collection. The Dipping and Coating Operations Standard requires employers to post a conspicuous sign near each piece of electrostatic detearing equipment that notifies employees of the minimum safe distance they must maintain between goods undergoing electrostatic detearing and the electrodes or conductors of the equipment used in the process. See 29 CFR 1910.126(g)(4). Occupational Safety and Health Act sections 2(b)(9), 6, and 8(c) authorize this information collection. See 29 U.S.C. 651(b)(9), 655 and 657(c).

    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under OMB Control Number 1218-0237.

    OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on October 31, 2016. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the Federal Register on March 11, 2016 (81 FR 12967).

    Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within thirty (30) days of publication of this notice in the Federal Register. In order to help ensure appropriate consideration, comments should mention OMB Control Number 1218-0237. The OMB is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Agency: DOL-OSHA.

    Title of Collection: Special Dipping and Coating Operations (Dip Tanks).

    OMB Control Number: 1218-0237.

    Affected Public: Private Sector—businesses or other for-profits.

    Total Estimated Number of Respondents: 10.

    Total Estimated Number of Responses: 10.

    Total Estimated Annual Time Burden: 1.

    Total Estimated Annual Other Costs Burden: $0

    Dated: October 25, 2016. Michel Smyth, Departmental Clearance Officer.
    [FR Doc. 2016-26213 Filed 10-28-16; 8:45 am] BILLING CODE 4510-26-P
    DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Safety Standards for Underground Coal Mine Ventilation—Belt Entry Used as an Intake Air Course To Ventilate Working Sections and Areas Where Mechanized Mining Equipment Is Being Installed or Removed ACTION:

    Notice.

    SUMMARY:

    The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, “Safety Standards for Underground Coal Mine Ventilation—Belt Entry Used as an Intake Air Course to Ventilate Working Sections and Areas Where Mechanized Mining Equipment is Being Installed or Removed,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq. Public comments on the ICR are invited.

    DATES:

    The OMB will consider all written comments that agency receives on or before November 30, 2016.

    ADDRESSES:

    A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201609-1219-002 (this link will only become active on the day following publication of this notice) or by contacting Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected]

    Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-MSHA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email: [email protected] Commenters are encouraged, but not required, to send a courtesy copy of any comments by mail or courier to the U.S. Department of Labor-OASAM, Office of the Chief Information Officer, Attn: Departmental Information Compliance Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210; or by email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected]

    (Authority: 44 U.S.C. 3507(a)(1)(D)).
    SUPPLEMENTARY INFORMATION:

    This ICR seeks to extend PRA authority for the Safety Standards for Underground Coal Mine Ventilation—Belt Entry Used as an Intake Air Course to Ventilate Working Sections and Areas Where Mechanized Mining Equipment is Being Installed or Removed information collection requirements codified in regulations 30 CFR part 75. More specifically, regulations 30 CFR 75.351 makes it mandatory for a mine operator electing to use belt air to ventilate a working section or area where mechanized equipment is being installed or removed to maintain records used by coal mine supervisors, miners, and Federal and State mine inspectors to show required examinations and tests were conducted. These records give insight into hazardous conditions that have been or may be encountered. Inspection records help in making decisions that ultimately affect the safety and health of miners working in belt air mines. Federal Mine Safety and Health Act of 1977 sections 101(a) and 103(h) authorize this information collection. See 30 U.S.C. 811(a) and 813(h).

    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1219-0138.

    OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on December 31, 2016. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the Federal Register on June 30, 2016 (81 FR 42735).

    Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within thirty (30) days of publication of this notice in the Federal Register. In order to help ensure appropriate consideration, comments should mention OMB Control Number 1219-0138. The OMB is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Agency: DOL-MSHA.

    Title of Collection: Safety Standards for Underground Coal Mine Ventilation—Belt Entry Used as an Intake Air Course to Ventilate Working Sections and Areas Where Mechanized Mining Equipment is Being Installed or Removed.

    OMB Control Number: 1219-0138.

    Affected Public: Private Sector—businesses or other for-profits.

    Total Estimated Number of Respondents: 17.

    Total Estimated Number of Responses: 205.

    Total Estimated Annual Time Burden: 3,441 hours.

    Total Estimated Annual Other Costs Burden: $54,740.

    Dated: October 25, 2016. Michel Smyth, Departmental Clearance Officer.
    [FR Doc. 2016-26212 Filed 10-28-16; 8:45 am] BILLING CODE 4510-43-P
    DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Derricks Standard ACTION:

    Notice.

    SUMMARY:

    The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, “Derricks Standard,” to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq. Public comments on the ICR are invited.

    DATES:

    The OMB will consider all written comments that agency receives on or before November 30, 2016.

    ADDRESSES:

    A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201608-1218-007 (this link will only become active on the day following publication of this notice) or by contacting Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected].

    Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OSHA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email: [email protected] Commenters are encouraged, but not required, to send a courtesy copy of any comments by mail or courier to the U.S. Department of Labor-OASAM, Office of the Chief Information Officer, Attn: Departmental Information Compliance Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210; or by email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Contact Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or by email at [email protected].

    Authority:

    44 U.S.C. 3507(a)(1)(D).

    SUPPLEMENTARY INFORMATION:

    This ICR seeks to extend PRA authority for the Derricks Standard information collection requirements codified in regulations 29 CFR 1910.181. The specified requirements are for marking the rated load on derricks, preparing certification records that verify the inspection of derrick ropes, and posting warning signs while the derrick is undergoing adjustments and repairs. Certification records must be maintained and disclosed upon request. Occupational Safety and Health Act sections 2(b)(3), 6(b)(7), and 8(c) authorize this information collection. See 29 U.S.C. 651(b)(3), 655(b)(7), and 657(c).

    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1218-0222.

    OMB authorization for an ICR cannot be for more than three (3) years without renewal, and the current approval for this collection is scheduled to expire on October 31, 2016. The DOL seeks to extend PRA authorization for this information collection for three (3) more years, without any change to existing requirements. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. For additional substantive information about this ICR, see the related notice published in the Federal Register on June 10, 2016 (81 FR 37644).

    Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within thirty (30) days of publication of this notice in the Federal Register. In order to help ensure appropriate consideration, comments should mention OMB Control Number 1218-0222. The OMB is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Agency: DOL-OSHA.

    Title of Collection: Derricks Standard.

    OMB Control Number: 1218-0222.

    Affected Public: Private Sector—businesses or other for-profits.

    Total Estimated Number of Respondents: 500.

    Total Estimated Number of Responses: 7,750.

    Total Estimated Annual Time Burden: 1,355 hours.

    Total Estimated Annual Other Costs Burden: $0.

    Dated: October 24, 2016. Michel Smyth, Departmental Clearance Officer.
    [FR Doc. 2016-26121 Filed 10-28-16; 8:45 am] BILLING CODE 4510-26-P
    DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2007-0039] Intertek Testing Services NA, Inc.: Application for Expansion of Recognition AGENCY:

    Occupational Safety and Health Administration (OSHA), Labor.

    ACTION:

    Notice.

    SUMMARY:

    In this notice, OSHA announces the application of Intertek Testing Services NA, Inc. for expansion of its recognition as a Nationally Recognized Testing Laboratory (NRTL) and presents the Agency's preliminary finding to grant the application.

    DATES:

    Submit comments, information, and documents in response to this notice, or requests for an extension of time to make a submission, on or before November 15, 2016.

    ADDRESSES:

    Submit comments by any of the following methods:

    1. Electronically: Submit comments and attachments electronically at http://www.regulations.gov, which is the Federal eRulemaking Portal. Follow the instructions online for making electronic submissions.

    2. Facsimile: If submissions, including attachments, are not longer than 10 pages, commenters may fax them to the OSHA Docket Office at (202) 693-1648.

    3. Regular or express mail, hand delivery, or messenger (courier) service: Submit comments, requests, and any attachments to the OSHA Docket Office, Docket No. OSHA-2007-0039, Technical Data Center, U.S. Department of Labor, 200 Constitution Avenue NW., Room N-3653, Washington, DC 20210; telephone: (202) 693-2350 (TTY number: (877) 889-5627). Note that security procedures may result in significant delays in receiving comments and other written materials by regular mail. Contact the OSHA Docket Office for information about security procedures concerning delivery of materials by express mail, hand delivery, or messenger service. The hours of operation for the OSHA Docket Office are 8:15 a.m.-4:45 p.m., e.t.

    4. Instructions: All submissions must include the Agency name and the OSHA docket number (OSHA-2007-0039). OSHA places comments and other materials, including any personal information, in the public docket without revision, and these materials will be available online at http://www.regulations.gov. Therefore, the Agency cautions commenters about submitting statements they do not want made available to the public, or submitting comments that contain personal information (either about themselves or others) such as Social Security numbers, birth dates, and medical data.

    5. Docket: To read or download submissions or other material in the docket, go to http://www.regulations.gov or the OSHA Docket Office at the address above. All documents in the docket are listed in the http://www.regulations.gov index; however, some information (e.g., copyrighted material) is not publicly available to read or download through the Web site. All submissions, including copyrighted material, are available for inspection at the OSHA Docket Office. Contact the OSHA Docket Office for assistance in locating docket submissions.

    6. Extension of comment period: Submit requests for an extension of the comment period on or before November 15, 2016 to the Office of Technical Programs and Coordination Activities, Directorate of Technical Support and Emergency Management, Occupational Safety and Health Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Room N-3655, Washington, DC 20210, or by fax to (202) 693-1644.

    FOR FURTHER INFORMATION CONTACT:

    Information regarding this notice is available from the following sources:

    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office of Communications, U.S. Department of Labor, 200 Constitution Avenue NW., Room N-3647, Washington, DC 20210; telephone: (202) 693-1999; email: [email protected]

    General and technical information: Contact Mr. Kevin Robinson, Director, Office of Technical Programs and Coordination Activities, Directorate of Technical Support and Emergency Management, Occupational Safety and Health Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Room N-3655, Washington, DC 20210; phone: (202) 693-2110 or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Notice of the Application for Expansion

    The Occupational Safety and Health Administration is providing notice that Intertek Testing Services NA, Inc. (ITSNA), is applying for expansion of its current recognition as an NRTL. ITSNA requests the addition of twenty-three (23) test standards to its NRTL scope of recognition.

    OSHA recognition of an NRTL signifies that the organization meets the requirements specified in 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition. Each NRTL's scope of recognition includes (1) the type of products the NRTL may test, with each type specified by its applicable test standard; and (2) the recognized site(s) that has/have the technical capability to perform the product-testing and product-certification activities for test standards within the NRTL's scope. Recognition is not a delegation or grant of government authority; however, recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification.

    The Agency processes applications by an NRTL for initial recognition and for an expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the Federal Register in processing an application. In the first notice, OSHA announces the application and provides its preliminary finding. In the second notice, the Agency provides its final decision on the application. These notices set forth the NRTL's scope of recognition or modifications of that scope. OSHA maintains an informational Web page for each NRTL, including ITSNA, which details the NRTL's scope of recognition. These pages are available from the OSHA Web site at http://www.osha.gov/dts/otpca/nrtl/index.html.

    ITSNA currently has fourteen (14) facilities (sites) recognized by OSHA for product testing and certification, with its headquarters located at: Intertek Testing Services NA, Inc., 545 East Algonquin Road, Suite F, Arlington Heights, Illinois 60005. A complete list of ITSNA's scope of recognition is available at https://www.osha.gov/dts/otpca/nrtl/its.html.

    II. General Background on the Application

    ITSNA submitted an application, dated April 21, 2015 (OSHA-2007-0039-0022), to expand its recognition to include twenty-three (23) additional test standards. OSHA staff performed detailed analysis of the application packet and reviewed other pertinent information. OSHA did not perform any on-site reviews in relation to this application.

    Table 1 below lists the appropriate test standards found in ITSNA's application for expansion for testing and certification of products under the NRTL Program.

    Table 1—Proposed List of Appropriate Test Standards for Inclusion in ITSNA's NRTL Scope of Recognition Test standard Test standard title UL 5C Standard for Surface Raceways and Fittings for Use with Data, Signal and Control Circuits. UL 50E Enclosures for Electrical Equipment, Environmental Considerations. UL 565 Standard for Liquid-Level Gauges for Anhydrous Ammonia and LP-Gas. UL 60745-2-1 Hand-Held Motor-Operated Electric Tools—Safety—Part 2-1: Particular Requirements for Drills and Impact Drills. UL 60745-2-14 Hand-Held Motor-Operated Electric Tools—Safety—Part 2-14: Particular Requirements for Planers. UL 60745-2-17 Hand-Held Motor-Operated Electric Tools—Safety—Part 2-17: Particular Requirements for Routers and Trimmers. UL 60745-2-3 Hand-Held Motor-Operated Electric Tools—Safety—Part 2-3: Particular Requirements for Grinders, Polishers and Disk-Type Sanders. UL 962A Standard for Furniture Power Distribution Units. UL 1769 Standard for Cylinder Valves. UL 2061 Standard for Adapters and Cylinder Connection Devices for Portable LP-Gas Cylinder Assemblies. UL 2108 Standard for Low-Voltage Lighting Systems. UL 2238 Standard for Cable Assemblies and Fittings for Industrial Control and Signal Distribution. UL 2305 Standard for Display Units, Fabrication and Installation. UL 2438 Standard for Outdoor Seasonal-Use Cord-Connected Wiring Devices. UL 5085-2 Low Voltage Transformers—Part 2: General Purpose Transformers. UL 61010-031 Safety-Requirements for Electrical Equipment for Measurement, Control and Laboratory Use—Part 031: Safety requirements for hand-held probe assemblies for electrical measurement and test. UL 61010-2-030 Safety requirements for electrical equipment for measurement, control and laboratory use—Part 2-030: Particular requirements for testing and measuring circuits. UL 60730-2-2 Standard for Automatic Electrical Controls for Household and Similar Use; Part 2: Particular Requirements for Thermal Motor Protectors. UL 60745-2-5 Hand-Held Motor-Operated Electric Tools—Safety—Part 2-5: Particular Requirements for Circular Saws. UL 60745-2-21 Hand-Held Motor-Operated Electric Tools—Safety—Part 2-21: Particular Requirements for Drain Cleaners. UL 60950-23 Information Technology Equipment—Safety—Part 23: Large Data Storage Equipment. UL 62368-1 Audio/video, information and communication technology equipment—Part 1: Safety requirements. UL 1691 Single Pole Locking-Type Separable Connectors. III. Preliminary Findings on the Application

    ITSNA submitted an acceptable application for expansion of its scope of recognition. OSHA's review of the application file, and pertinent documentation, indicate that ITSNA can meet the requirements prescribed by 29 CFR 1910.7 for expanding its recognition to include the addition of these twenty-three test standards for NRTL testing and certification listed above. This preliminary finding does not constitute an interim or temporary approval of ITSNA's application.

    OSHA welcomes public comment as to whether ITSNA meets the requirements of 29 CFR 1910.7 for expansion of its recognition as an NRTL. Comments should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request. Commenters must submit the written request for an extension by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer period. OSHA may deny a request for an extension if the request is not adequately justified. To obtain or review copies of the exhibits identified in this notice, as well as comments submitted to the docket, contact the Docket Office, Room N-3653, Occupational Safety and Health Administration, U.S. Department of Labor, at the above address. These materials also are available online at http://www.regulations.gov under Docket No. OSHA-2007-0039

    OSHA staff will review all comments to the docket submitted in a timely manner and, after addressing the issues raised by these comments, will recommend to the Assistant Secretary for Occupational Safety and Health whether to grant ITSNA's application for expansion of its scope of recognition. The Assistant Secretary will make the final decision on granting the application. In making this decision, the Assistant Secretary may undertake other proceedings prescribed in Appendix A to 29 CFR 1910.7.

    OSHA will publish a public notice of its final decision in the Federal Register.

    Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, 200 Constitution Avenue NW., Washington, DC 20210, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on October 25, 2016. David Michaels, Assistant Secretary of Labor for Occupational Safety and Health.
    [FR Doc. 2016-26203 Filed 10-28-16; 8:45 am] BILLING CODE 4510-26-P
    DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2007-0042] TUV Rheinland of North America, Inc.: Applications for Expansion of Recognition and Proposed Modification to the List of Appropriate NRTL Test Standards AGENCY:

    Occupational Safety and Health Administration (OSHA), Labor.

    ACTION:

    Notice.

    SUMMARY:

    In this notice, OSHA announces the applications of TUV Rheinland of North America, Inc., for expansion of its recognition as a Nationally Recognized Testing Laboratory (NRTL) and presents the Agency's preliminary finding to grant the applications. Additionally, OSHA proposes to add a new test standard to the NRTL listing of Appropriate Test Standards.

    DATES:

    Submit comments, information, and documents in response to this notice, or requests for an extension of time to make a submission, on or before November 15, 2016.

    ADDRESSES:

    Submit comments by any of the following methods: